PC-40 An evaluation of pharmacist prescribing for patients with hypertension

Mohammed Ommar Ahmed 1, Sandra O’Neill1, Fiona Reid1, Moira Kinnear1

1Lothian Pharmacy Practice Unit, Department of Pharmacy, NHS Lothian, Edinburgh, United Kingdom

Background and objective A pharmacist-led cardiovascular risk clinic is established in two general practices. The pharmacist has implemented supplementary prescribing into routine practice. This study evaluated the opinions and expectations of doctors and patients one year after pharmacist prescribing was established. Clinical outcomes associated with the clinic are reported elsewhere [1, 2].

Design A questionnaire was designed following semi-structured one to one audio taped interviews with three randomly selected patients. The questionnaire was piloted and posted to 201 patients. One to one structured interviews were audio taped with four doctors.

Setting Two general medical practices.

Main outcome measures Frequency and nature of questionnaire/interview responses.

Results The questionnaire response rate was 74% (148/201) with an equal proportion of responders from both practices with no gender differences. Hypertension management by the pharmacist was preferred by 91 (61%) patients, 6 (4%) preferred management by their doctor. The service was rated excellent or good by 133 (90%) patients, 132 patients (89%) fully understood the information provided about their medication. One hundred and fifteen patients (88%) were satisfied with the service they received from community pharmacy for minor ailments; however, only 32 patients (22%) agreed that they would be happy to have their hypertension managed in the community pharmacy. When suggested that a similar model to the practice clinic, might be available in community pharmacy, the proportion increased to 42%.

Doctors recognised the benefits of the clinic to both patients and themselves. Independent pharmacist prescribing was considered to be a natural development of this service and would enable prescribing for other conditions. Although the benefits in terms of continuity of care were acknowledged, doctors have concerns regarding competence and communication necessary to deliver a similar service from the community pharmacy.

Conclusions Patients and doctors are satisfied with the pharmacist’s supplementary prescribing clinic. They acknowledge that pharmacists have the skills and competence to provide these services which result in better patient care. Although the patients and GPs in this study were satisfied with the current service, they indicated less enthusiasm for new services with which they may lack confidence, an issue which must be addressed to support future development of supplementary prescribing.

References

  1. 1.

    Reid F; Murray P; Storrie M Implementation of a pharmacist-led clinic for hypertensive patients in primary care- a pilot study. Pharmacy World and Science. 2005;27:202–207.

  2. 2.

    Reid F. Supplementary prescribing one year on. Pharmaceutical Journal. 2005;275:PM2.

Keywords Hypertension, Pharmacist prescribing

PC-48 Provision of safety information by Portuguese community pharmacists: development of a conceptual model

Mara P. Guerreiro 1, Judy A. Cantrill1, A. Paula Martins2

1Drug Usage and Pharmacy Practice Group, School of Pharmacy and Pharmaceutical Sciences, The University of Manchester, Manchester, United Kingdom; 2Faculty of Pharmacy, University of Lisbon, CEFAR/ANF, Lisbon, Portugal

Background and objective A study was set up to investigate the feasibility and acceptability of using validated preventable drug-related morbidity (PDRM) indicators to manage therapeutic risk in Portuguese community pharmacy. This paper reports findings on the use of PDRM indicators for dispensing.

Design Nineteen pharmacists from 16 purposively selected community pharmacies were asked to apply four dispensing indicators (06/2005–02/2006) in current practice. Two indicators involved the provision of unsolicited safety information to patients on tiamazol and beta-blocker eye drops; the others referred to oral NSAIDs, each was split into “with” and “without” prescription. Face-to-face qualitative interviews were conducted with 13 pharmacists (10–11/2005) on their reported experiences; a focus group discussion was held with seven pharmacists (03/2006) to follow-up their feedback. Quantitative data were analysed for descriptive statistics (SPSS v. 11.5); analysis of verbatim transcripts was performed using a framework approach (1) with the aid of NVIVO v. 2.0.

Setting Community pharmacy.

Main outcome measures Number of cases, themes emerging from the analysis of textual data.

Results A total of 666 cases were collected. A three-stage conceptual model was developed to explain the acceptability of the indicators. Two attitudinal factors were identified as necessary: commitment to provide patient-oriented services and pharmacist’s confidence. Assessing the benefit for the patient (second stage) lead to a decision on whether to provide information or not. This was influenced by patient-related factors (e.g. patient traits), information-related factors (e.g. perceived relevance) and drug-related factors (e.g. therapeutic class). If the pharmacist decided to counsel the patient the provision of information was affected by factors such as patient and/or pharmacist’s lack of time. The latter was cited as the most common reason for not providing applicable counselling (n = 28), but qualitative data indicates it was a barrier mainly in high workload periods and secondary in importance to the perceived benefit of information.

Conclusions It appears to be feasible to use validated dispensing PDRM indicators in Portuguese community pharmacy. The model developed offers an in-depth understanding on the acceptability of the indicators, which may be of relevance in the development of training initiatives.

Reference

  1. 1.

    Pope C, Ziebland S, Mays N. Qualitative research in health care: Analysing qualitative data. BMJ 2000;320(7227):114–116.

Keywords Preventable drug-related morbidity indicators, Clinical risk management, Patient safety, Community pharmacy

PC-65 Acceptance and self-administration rate of a new administration form of darbepoetin alfa (SureClick) in predialysis chronic kidney disease patients

Xavier Bonafont 1, Albert Pérez1, Mercè Ardèvol1, Cristina Pérez1, Jordi Bonal2, Ramon Romero2

1Pharmacy Department, 2Nephrology Department, University Hospital Germans Trias i Pujol, Badalona, Spain

Background and objective In September 2005 a new subcutaneous administration form of darbepoetin alfa (DA) (SureClick®) was launched in Spain to facilitate self-administration and to prevent prick accidental injuries. The objective of this study is to evaluate acceptance and self-administration modification rate of SureClick® in predialysis chronic kidney disease outpatients treated previously with DA in prefilled syringe.

Design During 3 months (September to November 2006) predialysis outpatients treated with DA in prefilled syringe by subcutaneous route were switched to pen prefilled (SureClick®) and extended dosing (pat receiving Q2W administration were converted to QM and those patients to QW were converted to Q2W). Patients were included in a pharmaceutical care program to give them information and training in the pharmacy about pen use and precautions. Next visit to the pharmacy, 30 days latter, a survey was performed to know acceptance rate and problems related to this new administration form (local side effects specifically pain at injection site related to prior prefilled syringe use and difficulties to pen use). Also changes in self-administration rates from baseline data were registered.

Setting Pharmacy Department in a University Hospital.

Main outcome measures:

  • Preference of SureClick vs. prefilled syringe

  • Pain at injection site of SureClick vs. prefilled syringe

  • Difficulties to SureClick use after pharmacy training

  • Self-administration rate of SureClick vs. baseline time

Results 160 patients [75 females, mean age 66 years (range 26–94), mean GFR 21.6 ml/min/1.73 m2 (range 5.2–71.9), mean DA monthly dose 119.2 μg (range 20–600)] were included. 140 patients (87.5%) preferred the new administration form of DA. Eight patients (5%) were indifferent to SureClick® switch and 12 patients (7.5%) not accepted the new form and returned to prefilled syringe treatment. From 160 patients 29 (18.1%), 98 (61.3%) and 33 (20.6%) reported more, equal and less pain at injection site, respectively, and 19 (11.9%) reported some difficulties to pen use. SureClick® not acceptance reasons were more pain (3) haematoma (3) and difficulties to pen use (6). After switching to SureClick® 82 patients self-administered DA (self-administration rate = 51.5%), compared to 73 patients at baseline (self-administration rate = 45.6%).

Conclusions SureClick® has higher preference in patients with chronic kidney disease. Few patients have difficulties to SureClick® proper use. This administration form slightly increases self-administration rate and cause similar pain at injection site.

Keywords Darbepoetin alfa, SureClick, Chronic kidney disease

PC-73 Design and evaluation of a pharmacy transfer document for palliative care patients

Helen Moulsdale 1, Moira Kinnear2, Dorothy McArthur1

1Lothian Pharmacy Practice Unit, Western General Hospital, Edinburgh; 2Institute of Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To design and evaluate a transfer document to facilitate the transfer of pharmaceutical care issues (PCIs) for palliative care patients from hospital/hospice to community pharmacists.

Design Prospective cohort study involving case note review and clinical practice and validated (inter-rater reliability testing) categorisation of PCIs in 20 patients. Design and peer review (8 specialist palliative care and 8 community pharmacists) of a draft pharmacy transfer document by way of focus group discussions. Modification of the document after local pilot in 33 patients (20 hospitals, 13 hospices) and evaluation (postal questionnaire) from community pharmacists.

Setting Large teaching hospital, 2 hospices and 33 community pharmacies.

Main outcome measures Number and type of PCIs. Perceptions about clinical use of transfer document by community pharmacists.

Results PCIs suitable for transfer to community pharmacists were identified from 20 patients (70% male), [mean (SD) age 56 (16.8)]. There were 23 different PCIs in the total 179 categorised as: additional medication needs (27%), unnecessary medication use (13%), ineffective drug prescribed (1%), dose to low (11%), adverse drug reaction (27%), dose to high (4%), inappropriate patient compliance (16%). The checks or enquires identified as suitable for community pharmacist action were mainly medication needs (41%) and safety (32%). These were incorporated into the design of the document which was piloted in 33 patients and identified 144 PCIs for transfer. Following telephone reminders, 22 (67%) of questionnaires were returned. Information contained in the document was found to be useful in improving the pharmaceutical care provided in 91% of responses and 100% felt the document was user-friendly and facilitated communication between pharmacists in different care settings. Four respondents actioned all recommendations, 8 actioned none and 9 actioned 20–80% recommendations. Reasons given for lack of action included educational needs and confirmed action by others e.g. nurses.

Conclusions A pharmacy transfer document for palliative care patients has been designed and evaluated. The national palliative care pharmacists group have agreed to implement the document into practice with the aim of facilitating provision of consistent pharmaceutical care irrespective of care setting. Educational needs can be met through a currently available national distance-learning package.

Keywords Pharmaceutical care, Palliative care, Continuity of care

PC-81 Quality of life of male to female transgender who use and do not use female sex hormones

Surarong Chinwong 1, Dujrudee Chinwong1, Sasiraporn Sutanyawatchai1, Somchai Suja1, Supawinee Siri1, Pariya Tantipatthananandh1

1Department of Pharmaceutical Care, Faculty of Pharmacy Chiang Mai University, Chiang Mai, Thailand

Background and objective To study and compare quality of life (QOL) between male and female transgender who use and do not use female sex hormones living in Chiang Mai province, Thailand.

Design A descriptive study was conducted. Subjects were male to female transgender who use and do not use female sex hormones willing to participate in the study. A structured questionnaire including SF-36 questionnaire and direct interview were used for data collection. Descriptive and inferential statistics were applied for data analysis using SPSS version 10.0.

Setting Chiang Mai province, Thailand.

Main outcome measures Quality of life, adverse effects.

Results There were 200 participants who completed the interview, 100 in both groups—users and non-users. The mean (range) age was 21 (16, 34) and 22 (16, 37) years old in the groups of users and non-users female sex hormones, respectively. Sixty-three and 76% of the users and non-users were students, respectively. Only occupation was significantly different between the groups. In the group of female sex hormone users, the decrease in sexual desire and weight gain were the most common adverse effects (66% and 51%, respectively). The majority in the group reported that using female sex hormones increased expenditure but without financial problems. In the group of non-users female sex hormones, 55%, 55% and 49% reported that the use of female sex hormones was without benefit, led to concerns about adverse effects and was not approved by their family. The QOL assessed by SF-36 questionnaire demonstrated that the average QOL finding in 6 domains were significantly higher in the group of non-users than users of female sex hormones i.e., physical functioning, role physical, general health, vitality, social functioning and role emotion.

Conclusions The study could be considered as the preliminary and might be useful for further inquiry into transgender who consider whether or not to use female sex hormone. This information is also useful for health care professionals providing education and care to these people.

References

  • Leurmarnkul W and Meetam P. Development of a Quality of Life Questionnaire: SF-36 (Thai Version). Thai J Pharm Sci 2000;24:92–111.

  • Oriel KA. Medical care of transsexual patients. J Gay Lesbian Med Assoc 2004;4:185–94.

Keywords Male to female transgender, Female sex hormones, Quality of life

EDU-58 A staged approach to pharmacy education to meet workforce development needs in NHS Scotland

Moira Kinnear 1, Jenny Macdonald1

1Education and Training Steering Committee, NHS Scotland Directors of Pharmacy, Scotland, United Kingdom

Background and objective Pharmacy education and training programmes are necessary to meet the needs of the workforce in the design and implementation of service developments. We describe a national staged approach to learning and professional development which is supported by Schools of Pharmacy, the Royal Pharmaceutical Society of Great Britain (RPSGB), the College of Pharmacy Practice (CPP) and the Directors of Pharmacy across NHS Scotland.

Design Collaboration among senior pharmacy managers and professional institutions in the design and implementation of education and training programmes.

Setting Hospital pharmacy departments across Scotland.

Main outcome measures Implementation of nationally agreed education and training programmes.

Results In the 1990s there was acknowledgement that the traditional career structure of undergraduate degree and pre-registration training was insufficient to address the needs of a hospital pharmacist in carrying out their duties. Four week vocational placements were designed for undergraduate students (stage 0) to prepare them for the pre-registration year. A knowledge and skills framework was developed for achievement during these 4 weeks and to prepare graduates in a staged manner for demonstrating achievement of the performance standards of the RPSGB, a requisite for professional registration. In 1995, the Scottish Hospital Pharmacists Vocational Training Scheme (SHPVTS-stage 2) was developed and implemented. This was reviewed in 2005 to meet the training needs of today’s hospital pharmacist. The scheme covers clinical, technical, medicines information and quality assurance areas of practice. The knowledge and skills framework of this scheme attempts to develop the knowledge and skills required at registration and prepares pharmacists for specialisation, for example to study for Diploma/MSc in Clinical Pharmacy (stage 3). The reviewed SHPVTC manual contains the knowledge and skills framework for stages 0, 1 and 2 which allows trainees to clearly assess their position on the escalator. The portfolio of evidence is assessed by nationally approved local tutors and reviewed through a national peer review process. Qualification at the stage 2 level is accredited by CPP and provides eligibility for membership of CPP. Stage 3 is currently under development in terms of specialised modules within postgraduate university degree courses. The fourth stage of learning and development is completion of a leadership portfolio which is also accredited with CPP and provides eligibility for fellowship with CPP.

Conclusions The implementation of nationally agreed standards for education and training provides an infra-structure to support the development of a suitable trained workforce responsive to a continually changing Health Service.

Keywords Education, Scotland

DI-314 New tools to register pharmacist interventions: implementation and analysis of the new system

Elisabete Ardanza 1, Montserrat M. G. Garcia1, Victor V. D. Depedro1, Joan J. A. Altimiras1

1Pharmacy, Corporacio Sanitaria Parc Tauli, Sabadell, Spain

Background and objective To analyze the registry system of pharmacist interventions (PIs) in a new unit dose (UD) program in the context of a pharmacy department and to evaluate PIs recorded during 6 months.

Design Retrospective study of clinical pharmacy interventions in a total of 371 beds for surgery, cardiology, medicine and psychiatry under the new system between August and December 2006.

Setting Clinical Pharmacy Service, Corporacio Sanitari Parc Tauli, Sabadell, Spain.

Main outcome measures The previous unit dose program could not send any alerts or messages, so they were communicated by telephone or with a note on paper. Afterwards we had to record everything in a database. Now the prescriptions are printed daily for each patient and there is an option to send alerts or recommendations with the prescription. These messages can be classified in 20 different categories and are recorded automatically.

Results With the previous system 297 pharmacist interventions were registered in the database over 3 months for nearly 800 beds.

Since the implementation of the new system, 1464 alerts have been sent by the pharmacy department. Drug substitutions, according to internal pharmaceutical guidelines accounted for 28.27% (414). Prescriptions without a specified dose represented 20.69% (303), prescriptions not able to be understood made up 11, 20% (164) and 131 messages were unclassified. Alerts were sent about drugs evaluated as without therapeutic efficacy on 66 occasions (4.5%). Forty-six messages were sent about the risk of adverse effects and 44 about drug therapeutic duplication. Other categories of messages were 9%.

Conclusions This system has been very useful because PIs are sent and registered automatically. The system has improved communication with physicians and nursing staff, facilitating drug substitutions according to our pharmaceutical guidelines.

The system is a tool to aid in improving the quantity, quality and registration of PIs and positively impact on prescribing practices.

Keyword Unit dose

NUTR-71 Total parenteral nutrition (TPN) from birth to two years old—a standard bag approach

David Hoole 1, Cathy Sedgeworth1, Julie Fisher1

1Lothian Pharmacy Practice Unit, Royal Hospital for Sick Children, Edinburgh, United Kingdom

Background and objective Traditionally paediatric TPN admixtures are aseptically prepared which requires precise calculation and compounding of up to 15 ingredients to produce a stable formulation. This is labour intensive and there are risks of dispensing errors. Currently there is a Scottish Neonatal Standard bag suitable from birth to 1 month of age. It was decided to investigate if a standard off-the-shelf aqueous TPN bag can be formulated which meets the nutritional requirements of children up to 2 years old.

Design Literature review and retrospective analysis of 12 months of TPN prescriptions for children up to 2 years old. Formulation of a standard TPN bag to meet nutritional needs.

Setting Pharmacy department, large teaching children’s hospital.

Main outcome measures Number of patients under 2 years old whose nutritional requirements are met using the standard TPN bag.

Results Analysis of 12 months TPN prescriptions for patients up to 2 years old (n = 1540 prescriptions) confirmed that 80–90% received regimens that were theoretically amenable to standardisation. Discussion with peers in six paediatric centres in the United Kingdom and a supplier of unlicensed “TPN Specials” confirmed no single standard formulation was available for children under 2 years old. Current national nutrition guidelines for the age group were reviewed and a 1 l TPN regimen formulated. Chemical stability information was obtained for the formulation, with and without the addition of a range of electrolytes, vitamins and trace elements. The formulation was manufactured at comparable costs to in-house formulation and stability data supported a 90 day shelf life. In the first 6 months of using the standard TPN bag 96% of prescriptions for patients (n = 334 prescriptions) under 2 years old were for a standard bag. The new standard bag supplied 84% (n = 292) and the Scottish Neonatal Standard bag 12% (n = 42) of the TPN prescriptions. The remaining 4% (n = 15 prescriptions), mostly fluid-restricted ICU patients, received tailor-made bags in line with previous practice.

Conclusions The new formulation meets the nutritional requirements for most patients. Additional advantages include minimization of dispensing errors, less aseptic manipulation and timeous availability of a product with which staff are familiar. This new standard formulation is now current practice.

Reference

  • Koletzko B, Goulet O, et al. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Society for Clinical Nutrition and Metabolism, Supported by the European Society of Paediatric Research. Journal of Paediatric Gastroenterology and Nutrition 2005;41:S1–S87.

Keywords ‘Paediatric total parenteral nutrition’, ‘Total parenteral nutrition formulation’

PC-89 Pharmaceutical care needs of diabetic patients attending a pharmacist-run cardiovascular risk clinic

Alison Cockburn 1, Moira Kinnear2, Caroline Warnock3

1Metabolic Unit, Western General Hospital, Edinburgh, 2Lothian Pharmacy Practice Unit, Strathclyde University, Glasgow, United Kingdom; 3School of Pharmacy, University of Colorado, Denver, Canada

Background and objective A Pharmacist-led Diabetes Cardiovascular Risk (DCVR) reduction clinic is established in a hospital out-patient setting to optimize treatment of hypertension and hyperlipidaemia in high-risk diabetic patients. The pharmaceutical care issues identified by the pharmacist have been categorized and the contributions made to improve adherence to national prescribing guidelines are described. Clinical outcomes associated with the clinic are reported elsewhere [1].

Design Retrospective review and categorization of pharmacist care plan documentation related to 134 patients who attended the clinic between 2003 and 2006.

Setting Pharmacist-led cardiovascular risk clinic within the metabolic unit of a large teaching hospital.

Main outcome measures Number and type of pharmaceutical care issues.

Results The mean (SD) age was 63.7 (11.6) years, 51.5% were male and 91.8% had Type 2 Diabetes. Prior to establishing the pharmacist-led cardiovascular clinic, a local audit of prescribing found three areas of low adherence to national prescribing guidelines [2]. The clinic pharmacist has addressed these, leading to 14 (10.4%) patients being started on an ACE inhibitor as well as 15 (12.4%) and 16 (13.2%) primary prevention patients (n = 121) being newly started on aspirin and statin therapy (respectively).

Of 490 documented pharmaceutical care issues, 153 (31%) were lowering blood pressures to target by increasing doses of antihypertensives, 149 (30%) were adding new drugs and 59 (12%) were adverse drug reactions. The pharmacist undertook 1034 monitoring checks and 941 recommended changes to patients medication. Most patient monitoring checks were effectiveness enquiries (731, 70.7%) and most drug therapy changes were drug selection issues (198, 21%).

Conclusions The pharmacist addresses areas that a previous audit identified as having low adherence to national prescribing guidelines. Other pharmaceutical care issues addressed by the pharmacist were optimization of antihypertensive dosage, prescription of additional therapy and avoidance of adverse drug reactions. The prescribing criteria most frequently addressed by the pharmacist will be incorporated into a pharmaceutical care plan to ensure consistent delivery of care among clinic pharmacists and other members of the health care team.

References

  1. 1.

    Cockburn AJ, McKnight JA, Kinnear M, Lannigan NA and Strachan MWJ. Impact of a Pharmacist-led Cardiovascular Risk Reduction Clinic on Cardiovascular Risk Factor targets in patients with Diabetes. Diabetes UK Conference 2004.

  2. 2.

    Ernst A, Kinnear M, Hudson S. Quality of prescribing: a study of guideline adherence of medication in patients with diabetes mellitus. Practical Diabetes Int 2005:22(8):285–290.

Keyword Pharmacist-led clinic cardiovascular

PC-98 Evaluation of pharmaceutical care provided by a pharmacist supplementary prescriber

Zaher Alsami 1, John McAnaw1, Richard Lowrie2, Ian Millar1, Stephen Hudson1

1Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 2Pharmacy and Prescribing Support Unit, Greater Glasgow and Clyde Health Board, Glasgow, United Kingdom

Background and objective To characterise the pharmaceutical care provided by a pharmacist prescriber after a structured medication review.

Design A retrospective study of documented pharmaceutical care plans, conducted September 2005, among a patient cohort, after a 6–8 weeks follow up interval. Information from individual pharmaceutical care plans, including clinical management plans (CMP) was categorized and transferred into a Microsoft Access® database for analysis.

Setting 146 patients [mean (SD) age of 66 (12) years] from a Medical Health Centre in primary care where a pharmacist supplementary prescriber had provided a medication review clinic for the previous 9 months. Patients with a CMP in place, and prescribed four or more medications.

Main outcome measures Frequency distribution of pharmaceutical care issues in terms of pharmacist’s recorded clinical checks and changes within the pharmaceutical care plan. Frequency distribution of drug therapy problems identified by the care issues. Percentage adherence of prescribed medication to evidence-based guideline recommendations for (i) coronary heart disease (CHD) and (ii) hypertension.

Results There were 756 pharmaceutical care issues [PCIs; mean (SD) 5.2 (2.4) per patient; comprising 46% treatment plan checks and 54% changes] A total of 686 drug therapy problems were identified [DTPs; mean (SD) 4.7 (2.5) per patient]. At follow-up 78% DTPs were found to be resolved and 594 (79%) of these were resolved by the pharmacist. The pharmacist prescriber was able to implement 347 (85%) of all changes and 228 (66%) of all checks. The remaining 15% changes and 34% checks were referred to the medical prescriber for implementation. Of these 53 (86%) changes and 106 (89%) checks were found to resolved at follow up. There was an increase in adherence to evidence-based guideline recommendations for coronary heart disease (73.5–78.2%; P < 0.001; n = 55 patients) but not for hypertension (80.7–82.2%; P > 0.05, n = 66 patients).

Conclusions The pharmacist prescriber successfully addressed most PCIs with a single assessment and follow-up. Further studies are required to explore other models of pharmacist supplementary prescribing for the long-term management of chronic illness.

References

  1. 1.

    Scottish Executive Health Department. Supplementary prescribing: pharmacist practitioners-A guide for implementation within NHS Scotland. Edinburgh 2004.

  2. 2.

    Scottish Executive Health Department. Delivering for Health. Edinburgh: Scottish Executive 2005.

  3. 3.

    Ernst A, Kinnear M, Hudson S. Quality of prescribing: a study of guideline adherence of medication in patients with diabetes mellitus. Pract Diab Int 2005;22:1–6.

Keywords Pharmacist prescribing, Medication review, Pharmaceutical care

PC-111 Pharmaceutical care to adult surgical and trauma intensive care patients in a teaching hospital in Qatar

Yolande Hanssens 1, Marie-Anne Kettern2, Nissar Firdous2, Jean Du Plessis3, André Louon2

1Pharmacy, 2Anesthesia and Intensive Care Unit, 3Nursing Department—Trauma Intensive Care Unit, Hamad Medical Corporation, Doha, Qatar

Background and objective Background

In March 2004, a clinical pharmacy services unit was established. Within 6 months, clinical pharmacy services were provided to medical, surgical and trauma intensive care units (S and TICU) and to the coronary units 6 months later.

Anesthetists with expertise in surgical and trauma intensive care are in charge of the overall management of the admitted patients in S and TICU.

Objective

To evaluate the pharmaceutical care provided to patients treated in S and TICU during 2006.

Design Prospective evaluation of pharmaceutical care provided during 2006.

Setting Surgical and Trauma Intensive Care Unit (adult patients) in Hamad Medical Corporation, Doha, Qatar.

Main outcome measures Type of pharmaceutical care provided and evaluation of clinical pharmacy services by medical and paramedical staff.

Results During 2006, 914 patients were admitted. The majority (513) were trauma patients with 456 being male. 237 suffered head injury.

The clinical pharmacist provided 2832 pharmaceutical care contributions (PCCs) during 161 rounding days with the S and TICU medical and paramedical team. The majority of the PCCs were for gastrointestinal (19.6%), nutrition (16.7%), antiepileptic (12.4%), anti-infective (11.2%) and analgesic items and optimizing transfer orders (involving different drug categories) added up to 13.1%.

The type of PCCs were related to drug route such as change from parenteral to enteral (17.9%), duration of treatment (17.6%), therapeutic drug monitoring (15.3%), dose adjustments (13.1%), addition of drug (11.8%) and 12.5% were related to transfer orders.

The acceptance rate was 98.6%, 39.2% resulted in efficacy improvement, 22% in avoiding unwanted effects, 20.3% in avoiding unnecessary exposure to a particular drug and 17.6% in avoiding injection. At least 70% of PCCs resulted in cost savings while for 29.4%, the cost impact was unknown.

In April 2006, medical and paramedical staff of the units rated the PCCs as 94% and 88% respectively.

Conclusions Despite the recent introduction of clinical pharmacy services in this institution, pharmaceutical care contributions result in improved patients’ therapeutic management and overall cost saving. Moreover, the service is highly appreciated by medical and paramedical staff.

Keywords Pharmaceutical care, Intensive care unit, Qatar

PC-168 Development and assessment of a model system to transfer pharmaceutical care issues from secondary to primary care

Gillian Paterson 1, Stephen Hudson2

1Pharmacy Department, Stirling Royal Infirmary, Stirling, 2Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To apply a qualitative research approach to develop and evaluate a standardised document—an interface pharmaceutical care plan (IPCP)—for the transfer of relevant pharmaceutical care issues (PCIs) to facilitate continuity of care after hospital discharge.

Design Validation and field-testing of IPCP based on pharmacists’ perceptions in respect of identified themes, those being: benefits to patients; benefits to the pharmacist; practical use of the IPCP; process of documentation; time spent in preparation; and attitudes of doctors. Survey to profile the nature of the PCIs.

Setting Field-testing was in a cohort of medical in-patients discharged from an acute general hospital (n = 45) to 11 community pharmacies from two community health partnerships which provided a survey of PCIs (n = 163).

Main outcome measures A validated and field-tested interface pharmaceutical care plan with demonstrated feasibility and utility of application. Categorised care issues in the plan and number actioned by the pharmacist; proportions leading to changes in drug therapy and to clinically significant improvements in patient care.

Results A total of 133/163 (82%) of the PCIs transferred at discharge were recorded as having been addressed by the community pharmacist. Those recorded care issues led to 156 changes to the patients’ drug therapy; and 112/156 (72%) of those were rated as leading to a clinically significant improvement in patient care.

Conclusions There is a need to achieve continuity of care (‘seamless care’) between primary and secondary care [1, 2]. Drug therapy problems are common after hospital discharge [3]. The challenge to improve exchange of medication-related information identifies particular responsibilities for pharmacists [4]. The IPCP helps to address the current gap in continuity of pharmaceutical care between sectors. The successful findings are preliminary, based on selective application, and so require wider testing.

References

  1. 1.

    Scottish Office Department of Health. Designed to Care. Renewing the NHS in Scotland. Edinburgh; 1997.

  2. 2.

    Scottish Intercollegiate Guideline Network. SIGN 65. The Immediate Discharge Document. Edinburgh; 2003.

  3. 3.

    Sexton J, Brown A. Problems with medicines following hospital discharge: not always the patients fault? J Soc Admin Pharm 1999;16:199–207.

  4. 4.

    ASHP Continuity of Care Task Force. Continuity of Care in Medication Management: Review of issues and consideration for pharmacy. Am J Health-Sys Pharm 2005;62:1714–20.

Keywords Hospital discharge, Pharmaceutical care issues, Documentation

PC-244 Satisfaction of a hospital pharmacy service to paediatric day case cancer patients

Stephan Dewar1, Janet Ferguson1, Moira Kinnaer1

1Lothian Pharmacy Practice Unit, Department of Pharmacy, Royal Hospital for Sick Children, Edinburgh, Scotland, United Kingdom

Background and objective Standards have been set in NHS Scotland for the provision, management and safe use of medicines in the care of patients with cancer [1]. This study investigates the parent/patient satisfaction to pharmacy services provided to haematology/oncology outpatients.

Design Semi-structured one-to-one interviews with nursing staff and parents: ascertaining their perception of concerns they may have about the pharmacy service to inform the design of a patient satisfaction questionnaire. The questionnaire was piloted and modified before being distributed personally to a parent of every child attending the haematology/oncology outpatient clinic over a 3 month period (n = 38).

Setting Haematology/oncology outpatient clinic within a paediatric hospital.

Main outcome measures Parent perception of waiting times for medicines, and comparison with existing pharmacy statistics. Parent perception of information received and quality and satisfaction of general pharmacy service.

Results All parents/patients responded (100% response). Two-thirds, 22/33 (67%) believed they waited more than 1 h for their outpatient prescription. Patients perceived longer waiting times than pharmacy statistics suggest (approximately 50 min). Eighteen (58%) patients/parents reported a feeling of frustration or anger at the length of wait. Parents/patients were generally satisfied with the information, communication and general pharmacy service as a whole. Approximately half the respondents reported detailed explanations of drug side effects, indications and appropriate use. In 97% of cases, communication was provided by the pharmacist in the patients preferred way. Parent/patient satisfaction with the pharmacy service was similar to that reported for the hospital service in general.

Conclusions The perception of waiting for medicine was a source of dissatisfaction. Education and awareness of the complexity of the processes involved in chemotherapy dispensing (series of systematic checks for safety and accuracy) may reduce this dissatisfaction. The design of a patient journey poster will help in this respect, and more parents will be encouraged to collect medicines at more convenient times. The introduction of an appointment system for the outpatient clinic may reduce the overall time spent in hospital, although at present this remains as a recommendation. The standard of counselling, supply and information provided by the pharmacist to patients/parents was satisfactory and should be maintained.

Reference

  1. 1.

    Cancer in Scotland: Sustaining Change. Scottish Executive. Edinburgh; 2004.

Keywords Satisfaction Survey, Cancer, Paediatric, Hematology, Outpatients

PC-321 An audit of the role of the interface pharmacist

Janette Sim 1

1Pharmacy, Royal Alexandra Hospital, Paisley, United Kingdom

Background and objective An Interface Pharmacist post, based at the Royal Alexandra Hospital Paisley, was established in September 2006 to support the aims of the Community Healthcare Partnership Intermediate Care Development Group. The role involves working with the multidisciplinary teams across the interface to improve health and well being of older people in the home setting.

The purpose of the study is to assess the effectiveness of the interface pharmacist in elderly patients.

Design An ongoing audit of the activities and outcomes from the work of the interface pharmacist.

Setting Medication reviews are carried out with ‘at risk’ patients at home or at day hospital.

Main outcome measures Actual or potential increased effectiveness of treatment, reduction in side-effects or adverse drug reactions and improvement in compliance with medication.

Results To date 130 patients have been referred from hospital discharge teams (29%), intermediate care services (67%) and primary care sources (3%). The main issues addressed include non-compliance with medication (45%), management of side-effects (36%), alterations to drug therapy (46%), discontinuation of inappropriate medication (18%) and incorrect use of analgesics (24%). Patients (78%) and their carers (35%) required education to solve problems identified or medication changes made. More effective treatment has been achieved for 60% of patients and side effects reduced or prevented in 36%. Potential improvement in compliance has been realised for 57% of those referred.

Conclusions The results demonstrate that the interface pharmacist is an effective member of the intermediate care team. Promotion of the benefits of the role to increase the use of the service by community care professionals is needed.

The pharmacist’s role may have affected rates of admission or readmission to hospital but this is difficult to assess because of other contributory factors.

References

  1. 1.

    Royal Pharmaceutical Society of Great Britain. Pharmacists and the new intermediate care agenda. 2002.

  2. 2.

    Royal Pharmaceutical Society of Great Britain, Pharmaceutical Services Negotiating Committee, Primary Care Pharmacists’ Association, Guild of Healthcare Pharmacists. Moving patients, moving medicines, moving safely: guidance on discharge and transfer planning. 2006.

  3. 3.

    Coleman EA, Parry C, Chalmers S, Min Sung-joon. The Care Transitions Intervention. Arch Intern Med. 2006;166:1822–1828.

  4. 4.

    George J, Munro K, McCaig D, Stewart D. Risk factors for medication misadventure among residents in sheltered housing complexes. Brit J Clin Pharmacol. 2007;63(2):171–176.

Keywords Interface, Pharmacist, Medication review

PEPI-162 Evaluation of a pharmacy-led, community based, health information network to promote cancer prevention

Mahtab Aryana 1, Niall Coggans1, Stephen Hudson1, Susan McKellar1, Elizabeth Grant2, Scott Bryson2, Neil Edwards2

1SIPBS, University of Strathclyde, 2Pharmacy Prescribing and Support Unit, NHS Greater Glasgow and Clyde, Glasgow, United Kingdom

Background and objective Cancer prevention [1, 2] information “Actively Preventing Cancer” (APC) is provided by a Glasgow Pharmacy Public Health Project by website and touch screen information (TSI) points in a community pharmacy and health centres, targeted at deprived communities with lower than average life expectancy. Data reported here are from the second year of a two-year evaluation. First-year results were reported previously [3].

To assess new users’ perceptions of usability and satisfaction with content, and to assess impact on lifestyle among those who had either used APC at least 3 months or at least 1 year previously.

Design User survey using a structured questionnaire. TSI users were recruited in TSI sites and website users were recruited online and in the local library, June–November 2006.

Setting A total of 294 APC users: (a) 25 followed up for 1 year (impact), (b) 51 new recruits who had used APC for at least 3 months (impact), and (c) 218 new recruits who used APC for <3 months (perceptions). TSI systems were located in two health centres and one pharmacy.

Main outcome measures User ratings of scales to assess usability, satisfaction with information content, and impact on users’ lifestyles.

Results

218 new users: highly satisfied with usability and content; 90% said instructions easy/very easy to follow, 89% found information easy/very easy to understand. They found prevention topics useful/very useful: healthy eating (90%), sensible drinking (90%), general health (90%), sun protection (83%), stopping smoking (84%), early detection and screening (87%), and physical activity (89%). Of 25 users followed up after 1 year 82% reported changes in lifestyle. Of 51 users followed up at least 3 months after first use of APC 88% reported changes in lifestyle. Lifestyle changes included more physical activity, reduced alcohol consumption, used high-factor sunscreen, reduced cigarette intake, increased fruit/veg. intake. Some had cancer screening tests.

Conclusions APC was well received. There was high satisfaction with usability and content and positive impacts on lifestyles.

References

  1. 1.

    The Right Medicine: A Strategy for Pharmaceutical Care in Scotland. Edinburgh: the Scottish Executive, 2002.

  2. 2.

    Reduce the Risk: raising awareness of cancer prevention and early diagnosis. (accessed 29 March, 2006); [1]. www.cancerresearchuk.org.

  3. 3.

    Aryana M, Coggans N, Hudson S, McKellar S, Grant EM, Bryson S et al. Evaluation of a pharmacy led, community based, health information network to promote cancer prevention. Int J Pharm Prac 2006;14 (supp 2) B122/3.

Keywords Cancer, Prevention, Evaluation

PEPI-174 Patients’ reasons for early discontinuation of inhaled corticosteroids and their disease control

Tanja Menckeberg1, Marcel L. Bouvy 1, Madelon Bracke1, Jacqueline G. Hugtenburg2, Bert G. M. Leufkens1, Jan A. M. Raaijmakers1

1Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht, 2Department of Medical Pharmacology, VU University Medical Centre, Amsterdam, Netherlands

Background

Although early discontinuation of treatment in new users of inhaled corticosteroids (ICS) has been widely discussed, patients’ reasons for this have not been investigated in depth. We aimed to describe reasons for discontinuation from a patient’s perspective in relation to their disease control at the time of the investigation assessed by the Asthma Control Questionnaire (ACQ).

Methods A cross-sectional study among new users of ICS that discontinued use in 15 community pharmacies in the Netherlands. Patients were interviewed by telephone and automated dispensing records of all patients were retrieved.

Results From 287 eligible patients, 230 (78.2%) were interviewed. A decrease in symptoms was the main reason for discontinuation (45%). Thirty patients (13%) were considered inadequately controlled (ACQ score ≥ 1.5). These patients reported more seasonal variation of their symptoms and were more often prescribed a short-acting beta agonist (SABA).

Conclusion

Although a decrease in symptoms was the main reason for discontinuing ICS, a non-negligible proportion of patients has residual symptoms and is in need of continuous ICS use. Physicians and pharmacists could cooperate in identifying and motivating these patients to continue ICS use.

Reference

  1. 1.

    Juniper EF, Bousquet J, Abetz L, Bateman ED. Identifying ‘well-controlled’ and ‘not well-controlled’ asthma using the Asthma Control Questionnaire. Respir Med. 2006;100:616–21.

Keywords Adherence, Discontinuing treatment, Disease control, ACQ, Inhaled corticosteroids, Pharmacist

PEPI-32 Medication management in Belgian nursing homes

Charlotte Verrue 1, Els Mehuys1, Annemie Somers2, Anne Spinewine3, Marc Bauwens4, Monique Elseviers5, Jean-Paul Remon6, Robert Vander Stichele4

1Pharmaceutical Care Unit, Ghent University, 2Pharmacy, UZ Gent, Gent, 3School of Pharmacy, Université Catholique de Louvain, Bruxelles, 4Heymans Institute, Ghent University, Gent, 5Epdiemiological Research, Universiteit Antwerpen, Antwerpen, 6Pharmaceutical Technology, Ghent University, Gent, Belgium

Background and objective Due to growing concern about the quality of medication usage in Belgian nursing homes (NHs), the PHEBE-project (Prescribing in Homes for the Elderly in Belgium) was set up. Part of that project focussed on how the medication use process (i.e. the whole process from the prescription until the follow-up of pharmacotherapy) is organised in NHs.

Design A cross-sectional descriptive study. The director and at least one head nurse of each NH were interviewed using structured questionnaires. The questionnaire for the director focussed on general characteristics of the NH, general care management, medication management systems and pharmaceutical care activities of supplying pharmacists. The questionnaire for the head nurses concentrated on the medication distribution process (registration, storage, distribution and intake control of medication).

Setting 76 randomly selected NHs in 3 Belgian provinces.

Main outcome measures Non applicable.

Results A self-reporting medication error system had been set up in 69.7% of the NHs. The medication process was regularly evaluated in 21.1% of the NHs only, while 39.5% had never performed such an evaluation. 31.6% of the NHs used an electronic prescribing system. The drug regimen of the residents was systematically evaluated in consultation with the GP in 66.1% of NHs. For mentally intact elderly, intake was visually controlled afterwards in 71.7% of NHs and during swallowing in 19.2% of the NHs. Pharmacists not only dispensed medications, but were also involved in evaluation (26.3% of NHs) and consulting tasks (42.1% of NHs). 69.6% of the nurses did not wait for a prescription before ordering chronic medication to the pharmacy. Before crushing medication, information was consulted only in 21.4% of the wards.

Conclusions Despite quality of care regulations, the organisation of the medication process still offers potential for improvement. Pharmacists can have an important role in this amelioration, since they are specialised in medication usage and already more or less involved in the process.

Keywords Nursing homes, Medication usage, Quality of care

PEPI-86 Frequency and potential risk factors for Hospital Admissions Related to Medication (HARM) in The Netherlands

Anne J. Leendertse 1, L. S. Stoker2, A. C. G. Egberts1, P. M. L. A. van den Bemt3

1Department of Clinical Pharmacy, and Division of Pharmacoepidemiology and Pharmacotherapy, University Medical Centre Utrecht and Utrecht University, 2Department of Clinical Pharmacy, Diakonessenhuis Utrecht/Zeist/Doorn, 3Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, Utrecht, Netherlands

Background and objective To determine the frequency and potential risk factors of drug related hospital admissions.

Design Cross sectional study with a case–control design to determine potential risk factors.

Setting All acute admissions were assessed in 21 different hospitals during 40 days. Patients under 18 and obstetric and psychiatric admissions were excluded. From all remaining admissions the documented reason for admission combined with the drug use before admission, was compared with a trigger list, which contained combinations of symptoms and drugs, that can possibly cause a medication related hospitalisation. Any admission that matched this list was discussed with the patients physician. If a relation with the drug use was deemed possible, the patient was followed up during admission and the patient’s medical history, medication history and details of the admission were collected. For each case, one control patient was included in the study, matched on gender, age and hospital of admission.

Main outcome measures Causality and preventability was assessed centrally according to Kramer et al. [1] and preventability according to Shumock et al. [2]. Medication errors were also classified [3]. A multivariate logistic regression analysis was performed, using a Cox regression model with stratification on matching variables.

Results Almost 13,000 acute admissions were screened of which 714 (5.6%) were drug related. Almost half (46%; n = 332) of these admissions were assessed as potentially preventable. Extrapolated to the Dutch situation this implies 16,000 potentially preventable admissions every year with associated costs of 76 million euro per year.

Most drug related hospitalisations were haemorrhages associated with drugs affecting the blood coagulation like anticoagulants, antiplatelet drugs, NSAIDs or a combination of drugs.

The main potential risk factors for preventable drug related hospital admissions were polypharmacy, the number of comorbidities, non-compliance, impaired renal function, impaired cognition and non-independent living situation.

Conclusions Adverse drug events are an important cause of hospital admissions of which almost half may be preventable. Measures are urgently needed to decrease the number of drug related hospital admissions and reduce the burden of these admissions. Patients with potential risk factors identified in this study are an important target for (pharmacy based) intervention programmes.

References

  1. 1.

    Kramer MS, Leventhal JM, et al. An algorithm for the operational assessment of adverse drug reactions. I. Background, description, and instructions for use. JAMA 1979;242:623–631.

  2. 2.

    Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992;27:538.

  3. 3.

    Bemt van den PMLA, Egberts ACG. Drug-related problems: definitions and classification. EJHP Practice 2006;12(suppl):10–12.

Keywords Hospital admission, Patient safety, Adverse drug event

PK-97 Pharmacokinetic interaction between tacrolimus and corticosteroids in liver transplant patients

Alessio Provenzani 1, Roberta Di Stefano1, Silvana Bavetta1, Silvia Cammarata1, Anna Carollo1, Piera Polidori1, Michael J. Romano2, Maria Grazia Sidoti1, Francesca Venuti1, Valentina Zampardi1, Natale D’Alessandro3, Giovanni Vizzini4

1Pharmacy, IsMeTT, Palermo, Italy; 2Pharmacy, UPMC, Pittsburgh (PA), United States; 3Scienze Farmacologiche, Università degli Studi, 4Medicina, IsMeTT, Palermo, Italy

Background and objective Tacrolimus (FK) is an immunosuppressive drug with a narrow therapeutic index and high interindividual pharmacokinetic variability. It is a substrate of cytochrome P-450 3A (CYP3A) enzymes and P-glycoprotein (P-gp). The purpose of this work is to investigate the possible clinical interaction between corticosteroids and tacrolimus in liver transplant patients.

Design We reviewed 26 liver transplant patients treated with FK. All patients during surgery received induction therapy with standard dose of methylprednisolone 500 mg IV plus basiliximab 20 mg IV or daclizumab 2 mg/kg IV or MMF 1 g IV according to the different protocols. We also recorded all possible administered drugs known to interact with CYP3A and/or P-gp. Patients were divided into two groups: the first (12 patients) was treated with 20 mg of oral prednisone tapered to 5 mg daily after 1 month and then suspended if no sign of rejection occurred. The second (14 patients) was steroid-free. One and three-month serum creatinine levels (SCr), FK dosages and FK trough blood concentrations (Co) were recorded. Tacrolimus level/dose [L/D] was obtained by dividing the FK trough level (ng/ml) by the corresponding 24 h dose (mg/kg).

Setting IsMeTT Palermo, Italy.

Main outcome measures Review of clinical chart and laboratory data.

Results One month after transplantation the average [L/D] was 87.2 ± 33.7 in the steroid group and 141.9 ± 83.7 in the steroid-free group. The three-month average [L/D] was 125.7 ± 46.3 in the steroid group and 227.6 ± 141.7 in the steroid-free group. The difference between the two groups was statistically significant (P < 0.05) at 1 month but not at 3 months. One and three-month mean SCr levels after transplantation were respectively 1.16 ± 0.24 and 1.59 ± 0.74 in the steroid group. In the steroid-free group the SCr level remained in the normal range and no significant difference was found at 1 month (1.22 ± 0.25) and 3 months (1.14 ± 0.25) after transplantation. Furthermore, the differences between SCr at 1 and 3 months were statistically significant (P < 0.05, T-test for paired samples) in the steroid group, but not in the steroid-free group.

Conclusions These results show that the use, even in low doses, of steroids in combination with FK, may change the pharmacokinetics of the latter agent. This might occur through induction of the CYP3A and/or P-gp activities. Although the limited number of patients involved we suggest that the interaction of steroids with FK could cause significant adverse reactions, in particular after discontinuation of steroids. For this reason, appropriate monitoring of FK trough level should be done.

PT-131 Medication errors in orthopaedic surgery unit: impact of systematic pharmaceutical round and computerized system for prescription and administration of drugs

Pourrat Xavier 1, Helene Bourgoin1, Dominique Delerue2, Philippe Rosset3, Luc Favard3, Jacqueline Grassin1, Daniel Antier1

1Pharmacy Logipole, 2Anesthesiology, 3Orthopaedic Surgery, Chu de Tours, Tours, France

Background and objective To measure the medical errors rate related to prescription and administration to in- patients over two consecutive 30-day periods: [P1] and [P2] before and after implementation of a computerized system dedicated to prescription and nurse’s order plan for drugs administration and to systematize pharmaceutical round in orthopaedic surgery unit. During P2 the impact of the computerised system and the impact of the pharmacist were evaluated separately. The tasks of pharmaceutical rounds were control of doses, drug-interactions and interactions with biological and clinical data.

Design Prospective study.

Setting Orthopaedic surgery department, Anaesthesia department and Pharmacy department.

Main outcome measures Over P1 & P2 periods daily prescriptions and orders plans were analysed the next day: (1) prescriptions were analysed with a dedicated pharmacy software package; (2) administrations noticed by nurses were compared to prescriptions; (3) Identified errors were classified according to a clinical impact scale from 0 (no clinical impact) to 3 (fatal).

Results Without systematic pharmaceutical round, during P2 [2 852 prescription lines] by comparison to P1 [1 659 prescription lines], prescription errors (PE) were significantly lower during P2 for level > 1 [1.8% v/s 3.4% P < 10−6] and for those potentially harmful [level > 2] [0.4% v/s 0.8%, P < 0.01]. With a systematic pharmaceutical round, during P2 by comparison to P1, the PE [level > 1] decreased of 67% [0.6% v/s 1.8% P < 10−5], for those potentially harmful decreased of 50%, but the difference between with or without pharmaceutical round was not significant [0.2% v/s 0.4%, P > 0.11].Administration errors (AE) were significantly lower over P2 [3 327 drug administrations] during than during P1 [2 860 drug administrations] for level > 1 [2.5% v/s 5.6%, P < 10−14] and for AE potentially harmful [level > 2] [1.2% v/s 2.4%, P < 10−6].

Conclusions This study highlights the potential interest of computerised prescription associated to pharmaceutical round in orthopaedic unit. It shows that computerised system associated to pharmaceutical round decreases at least serious PE of 75% and serious AE of 50%.

References

  • Bates D. JAMA. 1998;280(15):1311–6.

  • Leappe L. JAMA. 1999;282(3):267–70.

Keywords CPOE, Computerized system, Pharmacist intervention

PT-264 Associated predictors of medication adherence in HIV-positive adults

Lok-hang Yan1, Isabelle Auperin2, Dalenda Gherissi2, Pauline Roller1, Aurélie Levesque2, Nathalie Menard1, Jacques Gilquin2, Yvonnick Bezie 1

1Pharmacy, 2Infectious Diseases, Hôpital Saint-Joseph, Paris, France

Background and objective It is widely recognized that adherence to antiretroviral therapy is critical to long-term treatment success, yet rates of adherence to antiretroviral medications are frequently subtherapeutic. Our aim was to assess the prevalence of adherence to antiretroviral treatment in French immunodeficiency virus (HIV)-infected patients and to evaluate factors associated with adherence.

Design Interview of patients with a pre-filled specific questionnaire by a pharmacist.

Setting 450-bed metropolitan general private hospital.

Main outcome measures Measures of personal and situational factors including demographic characteristics, social support, self-efficacy and current adherence to antiretroviral medications were recorded.

Results In total 97 patients participated. Eleven patients reported missing a dose during the 4 days prior to the completion of the questionnaire and the proportion classified as ‘non-adherent’ was 52%. The first eleven patients were characterised by social insulation (P < 0.05), dissatisfaction of the treatment (P < 0.001) and of the quality of life (P < 0.01). For theses patients, non-adherence was associated with a higher median viral load (P < 0.001).

For the other patients reported partial adherence, “simply forgot” and occupation were the most common reasons. Apprehension of the glance of the other on the disease is a frequent cause of shift of the drugs intake (P < 0.01).

Conclusions Our data confirm the poor adherence to antiretrovirals therapy and support components in predicting medication adherence among HIV-patients. These findings identify targets for adherence interventions and highlight the importance of evaluating and supporting patients to optimize adherence. Investment is crucial to improve adherence in ART recipients, and only a strong implication of the whole of the actors of health (practitioners, pharmacists, nurses) will make it possible.

Keywords Adherence, HIV-patients, Antiretroviral therapy

DI-122 Drug use in pregnancy—are there differences between common sources of information?

Sofia Frost 1, Jan Schjott2

1RELIS Vest, Regional Drug Information, 2Section of Clinical Pharmacology and Drug Information (RELIS Vest), Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway

Background and objective Safety regarding use in pregnancy is not established for many drugs. Thus, inadequate or contradictory information from different sources can affect decision-making among health care providers with possible therapeutic consequences. The purpose of this study was to compare two easy accessible Norwegian sources providing advice on drug use in pregnancy, the product monographs in Felleskatalogen (FK) published by the drug companies, and the regional drug information centres (DIC’s) in Norway.

Design Descriptive and retrospective.

Setting Advice on drug use in pregnancy provided by DIC’s in 2003 and 2005, were compared to advice in the product monographs for the respective drugs in FK.

Main outcome measures Any advice were placed in one of four defined categories:

The drug can be used by pregnant women,

The drug should only be used by pregnant women after a risk-benefit assessment,

The drug should not be used by pregnant women,

No information on drug use in pregnancy.

Results 443 drug assessments were included. Seven out of ten of the most frequently assessed drugs were drugs acting on the nervous system. For 208 drug assessments (47%) advice on drug use in pregnancy differed between DIC’s and FK. In the case where a DIC gave the advice “can be used” (Category 1), FK gave the same advice in only 23% of the cases, and advised against the use (Category 3) in 21% of the cases. However, when FK gave the advice “can be used” (Category 1), DIC’s agreed in 94% of the cases, and provided no advice against use (Category 3) in any of these cases.

Conclusions The present results show considerable differences between two common Norwegian sources providing advice on the use of drugs in pregnancy. Based on the experience that health care providers chose sources of information randomly, our study indicates therapeutic consequences for the pregnant women and her foetus.

Keyword Pregnancy drug information

EDU-156 “Dieciannidivitainpiù” (life 10 years longer) for hypertensive patients over the Mediterranean Sea

Daniela Scala 1, Santolo Cozzolino1, Antonio Mancini1, Laura Zeuli1, Stefano Lombardi1, Barbara Andria1, Maria D’Avino2, Giuseppe Caruso2, Alessandra Izzo2, Gianfranco Tajana3, Domenico Caruso2

1Centre of Biotechnologies, 2Centre for the Diagnosis and Treatment of Hypertension, Cardarelli Hospital, Naples; 3Department of Pharmacautical Science, University of Salerno, Salerno, Italy

Background and objective The higher prevalence of hypertension in lower socio-economic groups may be due to differences in living habits and points to opportunities for reducing health inequalities by optimizing prevention, detection and treatment of hypertension. The Hypertension Working Group of Cardarelli Hospital of Naples, Italy and the Department of Medicine B of the Charles Nicolle Hospital of Tunis, Tunis; planned a transfer of the programme Dieciannidivitainpiù (life 10 years longer) aimed at reducing systolic blood pressure (SBP) in patients with hypertension.

The goal is to evaluate the effectiveness of this programme transferred from Naples to Tunis.

Design Randomized trial, evaluation study.

Setting General Pathology and Aging Department of the Cardarelli Hospital and Department of Medicine B of the Charles Nicolle Hospital.

Main outcome measures Systolic blood pressure values and lifestyle modification. Analysis was performed using SPSS version 10.0.

Results 58 Italian and 60 Tunisian patients with SBP respectively 146 ± 5 and 144 ± 6 mmHg filled a multiple choice questionnaire developed to assess knowledge and habit modification about hypertension and then received a Patient Information Leaflet (PIL) on hypertension. PIL and questionnaire, developed by the Hypertension Working Group of Cardarelli Hospital, were translated in French and then in Arabic. Subsequently patients participated to the focus group. After 6 months they were recalled and filled the questionnaire again to assess life style modification and had the SBP measured. There was a statistically significant reduction of the SBP (Italian 138 ± 4 mmHg, P < 0.0001; Tunisian 133 ± 5 mmHg, P < 0.003) in both groups. There was no significant difference between questionnaires’ scores unless a positive trend forward a modification of lifestyle after 6 months.

Conclusions Pharmacists can play a crucial role as catalyst in developing new and effective policies to improve good pharmaceutical care and reduce health inequalities.

References

  1. 1.

    Burke V, Beilin LJ, Cutt HE, Mansour J, Wilson A, Mori TA. Effects of a lifestyle programme on ambulatory blood pressure and drug dosage in treated hypertensive patients: a randomized controlled trial. J Hypertens. 2005 Jun;23(6):1241–9.

  2. 2.

    Svetkey LP, Erlinger TP, Vollmer WM, Feldstein A, Cooper LS, Appel LJ, Ard JD, Elmer PJ, Harsha D, Stevens VJ. Effect of lifestyle modifications on blood pressure by race, sex, hypertension status, and age. J Hum Hypertens. 2005 Jan;19(1):21–3.

Keywords Patient education, Hypertension, Health inequalities

EDU-167 Pharmacist’s interventions analysis within the first computerized wards in a French University Hospital

Emilie Prevost 1, Anne Claire Buire1, Catherine Mennesson1, Amélie Servettaz2, Bertrand Gourdier1

1Pharmacy, 2Infections Diseases, Reims University Hospital, Reims, France

Background and objective Prescribing errors are among the most common types of medication errors. Computerized Physician Order Entry (CPOE) systems with decision support have shown to decrease prescribing error. In October 2006, our hospital implemented this system on two-first medical units. The aim of this study was to assess pharmacist’s interventions in daily routine in this two computerized wards.

Design This prospective study took place over a two-month period (from November to December 2006). Prescriptions were analyzed and validated by pharmacists. The number of validations and a description of each intervention was reported on a checklist. A physician of the unit has retrospectively checked the clinical impact of every deviation noticed during pharmacist’s statement.

Setting 2 medicine wards of 26 beds each (infectiology and internal medicine) in Reims University Hospital.

Main outcome measures Number, type, rate of prescriber acceptation and potential impact of pharmacist’s interventions.

Results During 2 months 234 patients has been hospitalised in the 2 wards and 1811 prescriptions were analysed (approximately 21/ward/day). 1497 prescriptions (82.7%) were accepted without reservation. There are no significant difference between two wards. 407 pharmacist’s interventions were collected: 60 (14.7%) due to computer’s parameters and use, 61 (15%) stocking’s drug problem (no stock or out of stock) and 286 (70.3%) related to drug related problem (DRP). Most of the intervention was transmitted orally. 19.0% of DRP targeted cardiovascular drugs, 19.0% central nervous drugs, 19.0% digestive and metabolic drugs 17.3% anti-infectious drugs and 9.9% antithrombin drugs. Pharmacist’s major recommendations were related to dosage (34.6%), drug administration rhythm (11.9%), drug choice (11.2%), optimizing administration (10.5%), inappropriate dosage units or pharmaceutical form (8.7%), treatment duration (7.7%), administration route (7.3%), drug-drug interaction (4.2%) and perfusion duration (3.8%). The rate of intervention acceptation by the prescriber was 64.3% (23.4% refusals and 12.3% been unaware of). Clinical impacts were classified with Hatoum scale [1] as follow: 19.3% without significant impact, 71.7% with a significant impact, 9.0% a high significant impact and none with a vital impact.

Conclusions These data confirm the importance of prescription analysis by pharmacist. Pharmacist’s interventions are well accepted by the prescribers, but there is a need to found a privileged oral dialogue with them. Those will be in the future more scientific and less technical with experiment of the system.

Reference

  1. 1.

    Hatoum HT, Hutchinson RA, Elliott LR, Kendzierski DL. Physician’s review of significant interventions by clinical pharmacists in inpatient care. Drug Intell Clin Pharm. 1988;22:980–2.

Keywords Computerized prescriptions, Pharmacist’s interventions, Clinic impact

EDU-248 Project patient care: an interactive CE course format focusing on pharmacotherapeutic knowledge and communicative skills

Veerle Foulon 1, Annelies Driesen2

1Research Centre for Pharmaceutical Care and Pharmaco-Economics, K.U. Leuven, Leuven, 2IPSA, Institute for Permanent Study for Pharmacists, Brussels, Belgium

Background and objective Given the rapid evolution of knowledge and the changing role of the pharmacist in patient care, improving professional competence is a lifelong challenge. Previous work from our research centre revealed that gathering practical knowledge is one of the strongest facilitators for Flemish community pharmacists to participate in continuing education (CE) programs. Lectures still remain the most preferred instruction method, followed by interactive sessions. Our studies further indicate that the concept of patient-centred care has gained general interest [1, 2]. Based on these findings, we developed and pilot tested an interactive, patient-centred course format (Project Patient Care) with oncology as the working theme.

Design In spring 2006, a CE course on oncology was organized by IPSA, the main provider of CE programs for community pharmacists in Flanders. The course consisted of five evening lectures, focusing on clinical and pharmacotherapeutic aspects as well as psychosocial dimensions of cancer. The interactive sessions, which were organised a few weeks later, consisted of two major parts: (1) small group discussions based on one prescription for a particular patient and (2) role plays based on the same prescriptions, with one of the course-participants as the pharmacist. Feedback was provided, both by participants and instructors, on pharmacotherapeutic aspects and communicative skills. Participants evaluated the interactive session on 11 items using a four-point Likert-scale (1 = totally disagree; 4 = totally agree) and graded their overall satisfaction.

Setting Interactive sessions on eight different locations in Flanders. Number of participants varying between 3 and 16 community pharmacists.

Main outcome measures Ability of the format to bridge the gap between information obtained from the lectures and its applicability in the pharmacy. Overall satisfaction with the interactive course format.

Results The pharmacists who participated in the pilot project (n = 63) agreed that both the small group discussions and the role plays were good ways of processing the content of the lectures (mean scores 3.3 and 3.0 respectively). Participants gave an average appreciation of 16.6/20 with the course format. Additionally, 94% indicated that they would participate again if this kind of CE activity was organized later.

Conclusions Although Flemish pharmacists are not yet used to interactive sessions, especially not to role playing, the evaluation of this project shows a high satisfaction among participants on the course format. Results further indicate that both a problem-based pharmacotherapeutic approach and a communicative approach may contribute to the processing of the subject matter and hence to the improvement of professional competence.

References

  1. 1.

    Driesen A, Leemans L, Baert H, Laekeman G. Pharm World Sci. 2005;27:447–52.

  2. 2.

    Driesen A, Airaksinen M, Simoens S, Laekeman G. Int J Pharm Practice (in press).

Keywords Continuing education, Interactive course, Community pharmacy

NUTR-17 Stability of 5-fluorouracil and sodium folinate solutions in ambulatory infusion systems

Jean-Daniel Hecq 1, Julie Cadrobbi2, Patricia Gillet1, Natacha Leonard1, Danielle Vanbeckbergen2, Jacques Jamart3, Laurence Galanti2

1Hospital Pharmacy, 2Medical Laboratory, 3Centre of Biostastitics, Cliniques Universitaires UCL de Mont-Godinne, Yvoir, Belgium

Background and objective 5-fluorouracil (5-FU) and sodium folinate are used in association to treat a wide variety of malignancies. The simultaneous administration of 5-FU and sodium folinate in one infusion system, rather than by separate infusion lines, would be more convenient and less expensive, especially for home care and ambulatory patients. The purpose of this study was to evaluate the stability of admixtures of 5-FU and sodium folinate in two types of ambulatory infusion system, Easypump® (Braun) and Infusor® (Baxter), placed in the dark at 32°C to simulate clinical use conditions.

Design The stability of mixtures of 24 mg/ml of 5-FU and 3.2 mg/ml of sodium folinate in 5% dextrose infusion prepared under aseptic conditions and stored at 32°C in five Easypump® and five Infusor® was studied during 2 weeks.

Setting Medical Laboratory, Hospital Pharmacy, Centre of Biostatistics and Medical Documentation.

Main outcome measures Concentrations were measured by high-performance liquid chromatography using a reversed-phase column, a mobile phase consisting of 5% of methanol (v/v) in KH2PO4 buffer 0.01 M, pH 7.50 ± 0.05, and UV detection at 300 nm. Solutions were visually inspected and pH measured.

Results No color change or precipitation occurred in the preparations and pH remained stable during the period of the study. Based on a shelf-life of 90% residual potency, 5-FU and sodium folinate mixtures were stable into Easypump® and Infusor® reservoirs for at least 2 weeks at 32°C, period where lower confidence limits of the results value for each drug remained superior to 90% of the initial concentration.

Conclusions Within these limits, 5-FU and sodium folinate remain stable for 2 weeks at 32°C when mixed together in two types of ambulatory infusion systems. This has practical importance for both the patient and the medical staff because it determines the suitability of in-house administration.

Keywords 5-Fluorouracil, Sodium folinate, Centralized intravenous admixture services

NUTR-69 Clinical risk in parenteral nutrition

Anna Bianca A. B. Calzona1, Fabio F. Caricari1, Gianluca G. Garritano1, Giovanni G. Guarany1, Paola P. Incitti1, Gaia G. Mastropietro1, Gerardo G. Miceli Sopo1, Grazia G. Mingolla1, Emilia E. Scotti1, Roberto Tazza 1

1Clinical Pharmacy, Sandro Pertini, Rome, Italy

Background and objective Prescription evaluation in the equipment of parenteral nutrition solutions in Sandro Pertini Hospital.

Design To evaluate prescriptions of Parenteral Nutrition Solutions administrated to patients of Sandro Pertini Hospital (Azienda Sanitaria Locale Roma B) and to analyse the reduction of the clinical risk sequel of introduction of the new procedure in the Centralised Unit.

Setting The study took place in the Clinical Pharmacy of Sandro Pertini Hospital, ASL Roma B, Rome, Italy.

Main outcome measures Prescriptions were evaluated by pharmacists in the Centralised Unit through the analysis of the various parameters and indications of the original prescriptions by ASL Roma B specialists. Osmolality, content (in grams) of nitrogen, glucose and lipids, E/T index, composition of electrolytes, components compatibility were controlled. Presence of errors was then marked to the specialist to correct the prescription.

Results The investigation was held in 2005, involving the screening of 2463 medical prescriptions by 18 hospital departments.

The 80.9% of prescriptions was by Diabetology Service request and 19.1% from the Medical Doctors division.

Prescriptions was then elaborated using a software linked to an automatic filling system.

The analysis showed 419 erroneous prescriptions. The subdivision in % was defined as follows: 70.1% to the hyperosmolality; 10.5% to the quantity in grams of nitrogen skipped; 9.9% to mistakes in the transcription of electrolytes values; 8.8% by errors in the lipids/total calories and 0.7% by clerical error of patient personal details.

Conclusions Equipment of Parenteral Nutrition Solutions under the direct responsibility of the clinical pharmacist allowed to avoid errors of administration in the 17.2% of cases.

Keywords Parenteral nutrition, Clinical risk

NUTR-128 Compatibility and stability of analgesic admixtures for parenteral use: paracetamol, ketoprofen and tramadol

Lise Badaroux1, Celine Rodier1, David Balayssac 1, Valérie Sautou-Miranda2, Jean Chopineau2

1Pharmacy, CHU Gabriel Montpied, 2Laboratory of Clinical Pharmacy and Biotechnics, Faculty of Pharmacy, Clermont-Ferrand, France

Background and objective The management of moderate post-operative pains is well relieved by the associations of several analgesic drugs as, paracetamol, ketoprofen and tramadol. These combinations improve post-operative analgesia and functional outcome after surgery. The admixture of these drugs for parenteral use would simplify the nursing care of patient; however this practice is forbidden by the technical documents of each drug. Consequently, the aim of this study was to validate the compatibility and the stability of paracetamol, ketoprofen and tramadol admixtures for parenteral use.

Design Stability of drug alone, and compatibility and stability of admixtures were assessed at 0, 15, 30, 60, 120 and 240 min, and after 24 h of experiment, at room temperature (22 ± 2°C) and day light. Solutions were monitored by liquid chromatography, pH measure and visual control of each analgesic solution.

Setting Laboratory of Control-Development, Department of Pharmacy.

Main outcome measures Stability of admixtures was considered effective until 10% variation compared with theoretical concentrations (paracetamol 10 mg/ml + ketoprofen 1 mg/ml; paracetamol 9.8 mg/ml + tramadol 0.98 mg/ml; paracetamol 9.8 mg/ml + ketoprofen 0.98 mg/ml + tramadol 0.98 mg/ml) and initial concentrations of each solution, and by the absence of degradation products. Admixture incompatibility has been defined as a pH change of more than 1 unit and/or visible particulate formation or colour change.

Results Variations of analgesic concentrations, alone or mixed, remained under the limit of 10% compared with theoretical and initial concentrations, without degradation products. PH of analgesic admixtures was in a range of 4.7–5.5. No pH variation was monitored during the study for each solution. No alteration of solution aspect was detected.

Conclusions Over the 24 h of experiment, analgesic concentrations remained stable, pH and visual control of each association were unchanged. According to the results of the present study, admixtures of paracetamol, ketoprofen and tramadol are compatible and stable. These admixtures would allow an efficient and safer treatment of moderate post-operative pains.

Keywords Compatibility, Analgesics, Pain

NUTR-135 Release of a plasticizer, tri-2-ethylhexyl trimellitate, from polyvinylchloride tubings

Sophie Trevis1, Valérie Sautou-Miranda 2, Sandrine Bagel-Boithias1, David Balayssac1, Jean Chopineau2

1Pharmacy, G. Montpied Hospital, 2Laboratory of Clinical Pharmacy, Faculty of Pharmacy, Clermont-Ferrand, France

Background and objective Di-(2-ethylhexyl)phthlate (DEHP) is the most common plasticizer used to increase the flexibility of PVC medical devices as tubings for infusions. Because DEHP is not chemically bound to PVC it can leach from a PVC-containing medical-device into infused solutions and expose the patient to risk of toxicity: DEHP is a suspected human endocrine disruptor and a possibly reproductive toxicant. Pharmaceutical laboratories investigate alternatives to the DEHP as tri-(2-ethylhexyl)trimellitate (TETM) to give flexibility to PVC medical devices.

Design Quantify the release of the TETM from PVC tubings in solutions in contact with these tubings.

Setting Laboratory of clinical pharmacy and biotechnics, Faculty of Pharmacy.

Main outcome measures We have put in contact PVC tubings containing TETM with solutions of polysorbate 80 known to support the release of DEHP from PVC medical devices. We have exposed these tubings to various concentrations of polysorbate 80 (0.05–2 μg/ml), to different conditions of temperature (4, 25, 37°C). After 1, 5 and 24 h of contact, we have quantified TETM in the solutions by liquid chromatography after liquid/liquid extraction.

Results A release of TETM was highlighted in all the solutions of polysorbate 80 in contact with PVC tubings. However the quantity of TETM was very weak even 0.071 μg/ml. The release ± negligible. The average TETM concentration was 0.079 was not proportional to the concentration of polysorbate in solutions. It did not increase with the temperature or with the time of contact contrary to the release of DEHP. The concentration of TETM leached did not vary significantly with the temperature, the time of contact and the concentration of polysorbate 80 (P > 0.05).

Conclusions TETM seems to be an interesting alternative plasticizer to DEHP in PVC tubings because its release is very limited. However very little information is available on its biological effects and some studies including toxicity, disposition and metabolism are required.

Keywords Tri-2-ethylhexyl trimellitate, Release, Tubings

PC-12 Exploring the feasibility and value of pharmacist prescribing of antimicrobials in secondary care

Antonella Tonna 1, Derek Stewart1, Bernice West2, Dorothy McCaig1

1School of Pharmacy, 2School of Nursing and Midwifery, The Robert Gordon University, Aberdeen, United Kingdom

Background and objective The desire to optimise antimicrobial use has led to recommendations on a national, European and global level. These include setting up multidisciplinary teams with strong pharmacist involvement [1]. The introduction of non-medical prescribing in the UK is likely to provide opportunities and challenges for pharmacists to help ensure prudent use of antimicrobials [2, 3]. The objective of this research was to explore pharmacist perceptions of the feasibility and value of pharmacist prescribing of antimicrobials in secondary care.

Design A qualitative, exploratory approach was adopted. Pharmacists’ perceptions were explored using focus groups in six Scottish regions representing (a) rural and urban areas (b) district general hospitals and large teaching hospitals. Senior hospital pharmacists working in specialities where antimicrobials are crucial to patient management were invited to participate. A topic guide was developed to lead the discussions which were audio recorded and transcribed. The ‘framework’ approach to data analysis was used.

Setting Secondary care, Scotland.

Main outcome measures Pharmacists views and perceptions.

Results Six focus groups (37 participants; duration 40–70 min) have taken place and emerging themes and issues are presented. Pharmacists believe that the feasibility of antimicrobial prescribing is dependent upon the area of care. They identified potential roles and opportunities for prescribing of antimicrobials. Benefits included giving patients quicker access to medicines, reducing risk of resistance and applying evidence based medicine. Overall, hospital pharmacists felt more comfortable if prescribing for physician diagnosed conditions, but agreed that they have the adequate knowledge base to prescribe antimicrobials. Pharmacists are keen to work as part of a multidisciplinary team, with integration and communication even more important if they take on a prescribing role.

Conclusions Practice developments should involve discussion with pharmacists to ensure integrated services aimed at optimising antimicrobial use. Roles within a multidisciplinary microbial team need to be clearly defined.

References

  1. 1.

    MacKenzie FM, Struelens MJ, Towner KJ, Gould IM, On behalf of the ARPAC Steering Group and the ARPAC Consensus Conference Participants. Clinical Microbiol Infection. 2005;11:937–54.

  2. 2.

    Weller TMA, Jamieson CE. The expanding role of the antibiotic pharmacist. J Antimicrobial Chemother. 2004;54:295–8.

  3. 3.

    Knox K, Lawson W, Dean B, Homes A. Multidisciplinary antimicrobial management and the role of the infectious diseases pharmacist—A UK perspective. J Hospital Infection. 2003;53:85–90.

Keywords Pharmacist prescribing, Antimicrobials, Optimisation

PC-100 Design and evaluation of a structured assessment of pharmaceutical care issues

Hanan Al-Lawati 1, Lorraine Perry1, B. J. Johnson1, Stephen A. Hudson1

1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To define the pharmaceutical care needs of rheumatoid arthritis patients receiving infliximab therapy and develop a validated pharmaceutical care plan to standardise and maintain continuity of care.

Design Enumeration and editing of clinical checks and records, conducted July 2006, for inclusion in the design of documentation using literature review and tape-recorded group interview with rheumatology pharmacists/nurses. Survey of the use of a prototype pharmaceutical care plan and categorisation of pharmaceutical care issues.

Setting Rheumatology outpatients (n = 24, 79% female, median age 52 years) at three hospital sites for field testing. Group of four rheumatology specialists.

Main outcome measures A 63-item standard operating procedure (SOP) and a standard pharmaceutical care plan, validated by field testing and by potential end-users.

Results Pharmaceutical care issues were identified comprising 276 ‘checks’ [mean (SD) 11.5 (3.0) per patient] and 106 recommended ‘changes’ [mean (SD) 4.4 (1.8) per patient] representing 382 actual or potential drug therapy problems (21.5% actual, 78.5% potential). Records of the BSR eligibility assessment [1] and the pre-treatment disease activity scores [2, 3] were not accessible in the case notes for 67% and 75% of the patients respectively.

Conclusions The documentation of care, relevant to each of the infliximab infusions, was found not to be appropriately maintained, poorly accessible and often was lacking in important details required to meet standards [1–3]. The study identified the need for an SOP to improve treatment standardisation. The pharmaceutical care plan and SOP would benefit the documentation of treatment and co-ordination between healthcare team members.

References

  1. 1.

    British Society for Rheumatology. National Guidelines For the Monitoring of Second Line Drugs July 2000. www.rheumatology.org.uk.

  2. 2.

    National Institute for Clinical Excellence (NICE). Technology Appraisal Guidance 36: guidance on the use of etanercept and infliximab for the treatment of rheumatoid arthritis; March 2002 [http://www.nice.org.uk/].

  3. 3.

    American College Of Rheumatology Ad Hoc Committee On Clinical Guidelines. Guidelines for Monitoring Drug Therapy in Rheumatoid Arthritis. Arthritis Rheum 1996;39:723–31.

Keywords Rheumatoid arthritis, DMARDs, Pharmaceutical care

PC-130 Assessment of the training of the community pharmacists (cp) inside the oncologic network ‘réseau onco 93’

Claire Judel 1, Christophe Najem2, Marthe Rigal1, Mathieu Ferry3, Claude Boiron4, Alexandra Fabreguettes2, Francis Fauvelle3, Olivier Petitjean1

193, Pharmacy, Avicenne, Bobigny, 293, Pharmacy, CH R. Ballanger, Aulnay Sous Bois, 393, Pharmacy, CH Montfermeil, Montfermeil, 493, Réseau Onco 93, Bobigny, France

Background and objective Since the parution on 06/16/2004 of the regulatory text “décret” n° 2004-546, many cytotoxic drugs are available in community pharmacies. It has radically transformed the part of pharmacists in out-patients’ care. Hospital pharmacists (HP) aimed to develop an intervention to inform CP on new oral chemotherapy, focusing on vinorelbine and capecitabine, in order to improve the quality of their counselling. The objective of this study is to assess the overall satisfaction and the impact of this meeting on the CP.

Design The HP group nested in the regional oncologic network “Réseau Onco 93” has been meeting every 2 months with the network’s coordinator, an oncologist physician. Share of local experiences, standardisation of practice and elaboration of a teaching program destinated to CP are the main purpose of such meetings. Workshops destinated to CP were then set up and animated by a local HP in collaboration with an oncologist and a social worker in each of the three participating hospitals of the Seine Saint Denis department. The satisfaction of CP was anonymously assessed at the end of the 2 h meeting by mean of a standardized query.

Setting University Hospital (Avicenne, Bobigny), Regional hospitals (Montfermeil and Aulnay-sous-bois), Réseau Onco 93 (Bobigny), France.

Main outcome measures Interest of the topic, quality of the orators, estimated impact on usual practice and overall satisfaction were collected.

Results Of the 437 community pharmacies contacted, 90 CP working in 51 pharmacies (12%) were present. 94% of them were interested in the subject (81/86) and 91% found the quality of the interventions good (78/86). All the CP think that they are going to change their practice: totally for 74% of them (60/81) and partially for 26% (21/81). They prefer to be informed about the date of the next meetings by post-mailing (69%), e-mailing (26%), and phone call (5%). All of them were overall satisfied (very satisfied 41% and 59% satisfied).

Conclusions According to overall satisfaction, other trainings will be organised within the framework of this network: the management of post-chemotherapy side effects will be evocated on March 2007, and later on, the topic of the coverage of pain. The comments of the present CP led us to choose the topics of the next trainings, to modify their contents, and especially to determine their waitings on work (improvement of the contacts, diffusion of pre-established standardized prescription forms). The CP will then become the first line health interlocutor of cancer out-patient. It is necessary to promote collaboration between the CP and the hospital health care team.

Keywords Oral chemotherapy, Oncologic network, Community pharmacies

PC-145 Overestimation of the risk for ADR’s due to the presentation in the package leaflets

Mai Lindström1, Eva Tärning2, Anders Ekedahl 3

1Department of Health Sciences, Luleå University of Technology, Luleå, 2Department of Medicine and Care, Division of Pharmacology, Faculty of Health Sciences, Linköping University, Linköping, 3R and D, National Corp. of Swedish Pharmacies and School of Pure and Applied Natural Sciences, University of Kalmar, Sweden

Background and objective Assessing the risk of drug treatment is important in the decision making by patients and is linked to compliance. Patients’ interpretation and estimation of risk depend on how the information is presented and may play a role for how the receiver understands and interprets the information as well as the acceptance or denial of risk.

It has been known for long that we tend to overestimate the risk for unusual and underestimate the risk for common events. Presentation of the risk for adverse drug reactions in verbal form is associated with large individual differences and overestimation of the risk, and increase negative perceptions of the medicine that may increase non-compliant behaviour.

Objective: To study how the risk for adverse drug reactions is presented in patient information leaflets (PIL).

Design PIL for betablockers; opioids; anxiolytics; antihistamines and NSAID’s were collected at http://www.lakemedelsverket.se (the Swedish Medical Product Agency).

Setting Sweden.

Main outcome measures Which adverse drug reactions are mentioned and how the risk is expressed—verbally, numerically or both.

Results On two-thirds of the 123 PIL, the risk for adverse drug reaction was expressed both verbally and numerically. On one-fifth verbal expressions only were used, and for about as many the risk was sometimes expressed numerically, sometimes verbally only and sometimes in a mix. For substances, where several brands are available on the market, the ADR’s mentioned in the patient information leaflets varied from 23% (3/13) to 93% (37/40) of those found in the Summary of product Characteristics (SPC).

Conclusions There is a large variation for the adverse drug reactions mentioned and how the risk is expressed. When assessing the benefit-risk ratio of a drug treatment, the presentation of the risk for ADR’s in patient information leaflets may lead to patients’ overestimate the risk and contribute to non-compliant behaviour.

References

  1. 1.

    Halpern DF, Blackman S, Salzman B. Using statistical risk information to assess oral-contraceptive safety. Appl Cogn Psychol. 1989;3:251–60.

  2. 2.

    Kahneman D, Tversky A. Choice, values and frames. Am Psychol. 1984;39:341–50.

  3. 3.

    Kahneman D, Tversky A: Propspect theory: an analysis of decisions under risk. Econometrica 1979;47:313–27.

  4. 4.

    Berry DC, Raynor DK, Knapp P, Bersellini E. Patients’ understanding of risk associated with medication use: impact of European Commission guidelines and other risk scales. Drug Saf. 2003;26(1):1–11. Review.

  5. 5.

    Berry DC, Knapp P, Raynor DK. Provision of information about side-effects to patients. Lancet 2002;359:853–4.

  6. 6.

    Knapp P, D K Raynor, D C Berry. Comparison of two methods of presenting risk information to patients about the side effects of medicines. Q Saf Health Care. 2004;13:176–80.

Keywords Drug information, Package leaflets, Adverse drug reactions

PC-169 Implementation of individual drug dispensing system in a pilot surgical care unit

Déborah Schlecht 1, Sébastien S. B. Bauer2, Xavier X. P. Pourrat2, Julie J. B. Bourgueil2, Daniel D. A. Antier2, Jacqueline J. G. Grassin2

1Pharmacy, University Hospital of Tours, TOURS, 2Pharmacy, University Hospital, Tours, France

Background and objective In France, there are two drug dispensing systems: global and individual drug dispensing (GDD and IDD).The aim of this study was to compare preparation errors rates after implementation in a pilot care unit of an IDD system.

To compare IDD vs. GDD in term of safety for inpatients and if superiority is demonstrated proving the necessity of extending this system in the hospital.

Design One-month prospective study.

Setting Pilot Surgical Care Unit; Department of Pharmacy.

Main outcome measures Data related to drug preparation were collected by 2 pharm D students over a 30 day period and analysed: (1) prescriptions and drug preparations were compared by a pharmacist; (2) Identified preparation errors were classified in four groups: discordance between prescription and distribution (speciality, form, dosage, wrong route of administration), treatment in excess, omission errors and unidentified delivered drugs; (3) errors were divided in potential or effective errors.

Results GDD: 1 631 drug units were prepared by nurses. The total distribution errors rate was 21.4% (348.5 from 1631) and the nursing’s delivery was not secured for 12.5% (204 from 1631) mainly because of unidentified drugs but from effective errors represented 8.9% of preparation drugs (144.5 from 1631): 53% were concerned by treatment in excess, 36% units drugs were missing and 10% concerned errors between prescriptions and preparations.

IDD: 1 443 units were prepared by technicians. The total distribution errors rate was 1% (15 from 1446). The distribution was not secured for 0.7% (10 from 1446) potential errors: 80% concerned errors between prescription and distribution and due to change of prescription after drugs preparation by pharmacist. Effective errors represented 0.3% of preparation drugs (5 from 1446): one drug was in excess, 3 drugs were missing and there was one error of drug.

Conclusions This study allowed to prove the major benefit offered by IDD vs. GDD. The information gathered in these systems brings to the role of the pharmacy staff, enabling them to know in detail a patient’s drug therapy, reduce the incidence of medication errors (21.4% vs. 1%, P < 0.001), develop clinical systems and promote a rational use of medicines.

References

  • Fontan JE. Pharm World Sci. 2003;25(3):112–7.

  • Beso A. Pharm World Sci. 2005;27(3):182–90.

Keyword Individual drug dispensing

PC-39 Adherence to prescribing guidelines and design of a pharmaceutical care plan for stroke patients

Esperanza Palenzuela1, Anne E. Kinnear 1, Moira Kinnear2

1Lothian Pharmacy Practice Unit, Department of Pharmacy, Royal Infirmary of Edinburgh, Edinburgh, 2Institute for Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To evaluate the quality of prescribing in patients with acute stroke using criteria developed from national guidelines and to develop a pharmaceutical care plan (PCP) for stroke patients incorporating these criteria.

Design Design of audit criteria and application through prospective case note review. Design and evaluation of a PCP for stroke patients through structured audio-taped focus group discussion and piloting by clinical pharmacists (n = 6).

Setting Admission ward and acute stroke unit in a large teaching hospital.

Main outcome measures Percentage of overall and individual adherence to 36 audit criteria. Proportion and evaluation of “Justified” and “Unjustified” non-adherence and “Pharmacist Contribution” to achieve adherence. Overall perception of the clinical use of the PCP by clinical pharmacists.

Results Overall criteria adherence was 79% in 36 criteria applied to 125 patients (53.6% male, mean (SD) age 71.9 (13.7) years). “Justified” non-adherence was 8% and “Unjustified” non-adherence changed from 13% to 6% after pharmacist contribution. Criteria with the lowest adherence were “prescription of aspirin as stat dose” (46%) and “oxygen is prescribed according to local oxygen policy” (33%).Clinical pharmacists agreed that use of the evidence-based PCP would aid in the provision of consistent quality of pharmaceutical care during the stroke patient’s hospital journey and agreed its usefulness both in clinical practice and to support education and training.

Conclusions Prescribing adherence to national guidelines was generally good and the pharmacist contributions further improved appropriateness of prescribing. The audit identified a need to redesign the prescription chart and the method of oxygen prescribing to improve prescribing practice in stroke patients. It also indicated the need for the PCP to be initiated by the pharmacist in the admissions unit to ensure timely prescribing of aspirin. Design of the PCP to include evidence-based prescribing criteria in accordance with national strategy provides a tool to aid pharmacists in the provision of equitable pharmaceutical care to stroke patients throughout their hospital journey. Use in routine clinical practice will refine the tool further. Audit of stroke management in primary care will inform further development of the tool to support the continuity of pharmaceutical care between hospital and community.

Keywords Pharmaceutical care, Stroke, Clinical guidelines

PC-27 Screening program for osteoporosis in postmenopausal Thai women

Siriporn Krittathanmakul 1, Kamala Thaksinawisut1, Yada Boonjaroen1, Natcha Dounrak1

1Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Prince of Songkla University, Hat Yai, Thailand

Background and objective Osteoporosis frequently results in fractures that may lead to chronic pain, deformity, long term disability, low quality of life, and death (Law and Shapiro 2005). There is a need to increase screening and awareness of osteoporosis risk in order to prevent fractures and related morbidity (Cadarette et al. 2000; Nelson et al. 2002).The objective of this study was to assess awareness of and to screen risk of osteoporosis in postmenopausal women.

Design This is a questionnaire survey study with intervention. The questionnaire then was conducted among convenient sample of postmenopausal women in community pharmacies and hospital during October 12–November 17, 2005.

Setting Convenient sample of postmenopausal women in community pharmacies and hospital were interviewed to assess the level of awareness and risk.

Main outcome measures Patients’ knowledge and risk about osteoporosis were assessed. This was followed by an educational intervention. Based on risk level identified, a recommendation was made for follow-up with doctor and/or life style modification.

Results Eighty-six postmenopausal women were interviewed with mean age of 54 ± 8.91 years. Mean postmenopausal period was 4.40 ± 4.18 years. Mean awareness score (range 0–10) and risk score (range 0–15) were 4.60 ± 2.10 (medium level) and 3.33 ± 2.49 (medium level), respectively. Women with low, medium, and high level of awareness score were 44.19%, 50%, and 5.81%, respectively. Most women were concerned with premature menopause, etiology, risk and symptoms of fractures. Women with low, medium, and high level of risk score were 41.86%, 33.72%, and 24.72%, respectively. Those with high risk level were advised to see doctor for further bone mass density measurement. Most common risks among this group were not taking hormone replacement therapy, less exercise, and less bone mass index. Subgroup analysis showed no relation between each awareness and risk level, P = 0.305.

Conclusions Simple screening program conducted by pharmacists would be a valuable tool for women of menopausal age or older because it helps identifying those at risk of osteoporosis and thus proper recommendation could be made.

References

  1. 1.

    Law AV, Shapiro K. Impact of a community pharmacist-directed clinic in improving screening and awareness of osteoporosis. J Eval Clin Pract. 2005;11(3):247–55.

  2. 2.

    Cadarette SM, Jaglal SB, Kreiger N, Mclsaac WJ, Darlington GA, Tu JV. Development and validation of the osteoporosis risk assessment instrument to facilitate selection of women for bone densitometry. CMAJ. 2000;162(9):1289–94.

  3. 3.

    Nelson HD, Helfand M, Woolf SH, Allan JD. Screening for postmenopausal osteoporosis: a review of the evidence for the U.S. preventive services task force. Ann Intern Med. 2002;137:529–41.

Keywords Osteoporosis, Risk, Awareness

PC-57 Design of a pharmaceutical care plan for haematology transplant patients

Claire Mathieson 1, Moira Kinnear2, Heather Dalrymple1, Jill Macintyre1

1Lothian Pharmacy Practice Unit, Western General Hospital, Edinburgh; 2Institute of Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To design a tool to provide pharmaceutical care to patients receiving haematopoietic stem cell transplants for the treatment of haematological malignancy.

Design Retrospective review of case notes and validated (inter-rater reliability testing) categorisation of pharmaceutical care issues (PCIs) in 36 patients. Design and multi-disciplinary peer review of a draft pharmaceutical care plan (PCP). Modification of the PCP following national piloting and evaluation (postal questionnaire) by specialist clinical pharmacists.

Setting Transplant unit within Cancer Centre at large teaching hospital. Piloted at five transplant units across Scotland.

Main outcome measures Number and type of pharmaceutical care issues (PCI). Perceptions about clinical use of PCP by specialist clinical pharmacists.

Results PCIs were identified from 36 patients (42% male), 11 had allogeneic [mean (SD) age 38 (10.8)] and 25 had autologous haematopoietic stem cell transplants [mean (SD) age 46 (11.5)]. Of the 1079 care issues, 43 different PCIs occurred [mean (SD) 30 (4.2) PCIs per patient per admission]. PCIs were categorised as: adverse drug reaction (15%), additional medication needs (20%), dose too low (20%), dose too high (12%), unnecessary medication use (10%), inappropriate patient compliance (2%) and ineffective drug prescribed (2%). The checks or enquiries carried out by the pharmacist were mainly medication needs (41%), safety (39%) and effectiveness (13%). Incidence of PCIs was similar in autologous and allogeneic transplants except monitoring immunosuppressive medication (allogeneic = 100%, autologous = 0%). Thirteen PCIs occurred in every patient. The inter-rater reliability test demonstrated ‘good’ (k = 0.61–0.80) or ‘very good’ (k = 0.80–1.0) reliability of categorisation by the investigator. Pharmacists who piloted the pharmaceutical care plan rated the content, layout and ease of use of the document as good or very good. All would use the document in their clinical practice.

Conclusions A pharmaceutical care plan has been developed, validated and agreed for use in haematopoetic stem cell transplantation in Scotland. The document will facilitate the equitable provision of pharmaceutical care to, assist in training of less experienced pharmacists and serve as a tool for the prospective audit of pharmacist activities.

Keywords Haematology, Transplant, Pharmaceutical care plan

PC-222 A survey of the characteristics of critical care pharmacy services in the UK

Matts Balgard 1, Ruth Forrest2, Steve Hudson3

1The Hospital pharmacy, Norrlands University Hospital, Umea, Sweden; 2Pharmacy Department, Western Infirmary, 3Division of Pharmaceutical Care, University of Strathclyde, Glasgow, United Kingdom

Background and objective To characterise the core components of UK critical care pharmacy and relative priorities, drawing on American experience (1) and an earlier UK survey (2).

Design A 43-item web-based structured questionnaire survey based on defined service features identified from a literature review and five qualitative interviews with practitioners.

Setting Pharmacist respondents identified (n = 42) after a general email invitation to practitioners on a professional association register with two reminders (UK Clinical Pharmacy Association critical care group’s mail base; n = 238).

Main outcome measures Investigation of relative priority of all 43 service items (19 clinical features, 10 administrative/economic/quality assurance features, and 14 education/research features).

Results Respondents in general were experienced and 42% had more than 5 years experience in critical care pharmacy. For 75% their present unit was general adult intensive care unit. The aim of the study was not to quantify prevalence of delivery so the low response rate (17.6%) does not invalidate the findings.

The most common features regarded as core service components were; evaluating safety and effectiveness of prescribed items (97%), advice on drug administration (79%), providing medicines information to support prescribing decisions (62%), therapeutic drug monitoring (62%) and obtaining updated patient medication history (57%). These were predominantly clinical features.

The highest priorities for further development were; advice on the evidence base for therapies (48%), maintaining documentation of pharmaceutical care issues and actions (43%), advice on drug administration (40%), improved systems to reduce medication errors (40%), writing local drug monographs and protocols (40%) and policies for safe and effective medication use in ICU (40%). Four of these were administrative/economic/quality assurance features. Education and training and the conduct of research were generally identified as core components/high priorities for development by <20% of respondents.

Conclusions The findings represent relative prioritisation amongst a group of established practitioners. Critical care pharmacists provide general clinical pharmacy contributions with an emphasis on advice on therapeutic drug monitoring and drug administration in ICUs. There is a priority to develop the administrative and quality assurance sides of practice. Developing educational activities or research in ICU patients was not an identified priority and requires further investigation.

This work has provided a structure for generating a service specification to match perceived needs of the critical care team in Sweden.

References

  1. 1.

    Rudis MI, Brandl KM. Position paper on critical care pharmacy services. Crit Care Med. 2000;28:3746–50.

  2. 2.

    Timmins A. The contribution of the intensive care pharmacist in the United Kingdom. Pharm J. 2000;265:341–43.

Keywords Critical care, Survey, Service specification

PC-62 A community pharmacist service to support patients with heart failure: a study of pharmacists’ and patients’ perceptions

Lina Johansson 1, Susan McKellar1, Richard Lowrie2, Margaret Reid3, Paul Forsyth2, Ian Millar1, Stephen Hudson1

1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 2Pharmacy and Prescribing Support Unit, Greater Glasgow and Clyde Health Board, 3Department of Public Health, University of Glasgow, Glasgow, United Kingdom

Background and objective To obtain information on pharmacists’ and patients’ perceptions of a novel heart failure service provided in community pharmacies.

Design Individual and group interviews of pharmacists, individual patient interviews including telephone questionnaire survey.

Setting Eighteen pharmacists (8 in individual and 10 in group interviews). 65 patients who had received the service.

Main outcome measures Content analysis of transcribed tape-recordings. Quantified survey responses.

Results In pharmacist group interviews perceptions of the strengths of the service were accessibility to the patient and quality of transfer of clinical information provided by the GP practice. Pharmacists thought current limitations of the service were the need for greater integration into the existing structure. Pharmacists were generally very comfortable talking about symptoms with their patients. Pharmacists thought that patients felt encouraged by the service to describe symptoms in a way that they may not have done previously.

In the patient survey the important findings were that: 66% of patients felt that talking to a pharmacist made a difference to how much they know about HF, with 72% and 58% overall saying that they knew more about their HF medicines and HF symptoms respectively. Some 48% thought that the service would make them more likely to tell their doctor or nurse about new symptoms. However, only 9% of the patients felt that it had made a difference to their routine for taking their medicines.

Conclusions Patients with chronic heart failure are increasingly recognised as a target group for pharmaceutical care support [1, 2]. The evaluation showed that HF patients perceive educational benefit from the Community Pharmacy Heart Failure Service. The evidence from patients is that the service encourages early self-referral to primary care providers, an important advance for this patient group which has one of the highest rates of hospitalisation. The service requires to be developed to transfer the educational benefits into measurable changes in patient outcomes.

References

  1. 1.

    Rodgers A, Addington-Hall J, McCoy A, Edmonds P, Abbey A, Coats A, Gibbs J. A qualitative study of chronic heart failure patients’ understanding of their symptoms and drug therapy. European Journal of Heart Failure, 2002;4:283–287.

  2. 2.

    Clark A, McMurray JJV, Morrison C, Murdoch D, Capewell S and Reid M. A qualitative study of the contribution of pharmacists to heart failure management in Scotland, Pharmacy World & Science, 2005;27:453–458.

Keywords Heart failure, Community Pharmacy

PC-329 Pharmaceutical care in tuberculosis

Carla Sousa 1

1Pharmacy, Hospital Distrital de Faro, Faro, Portugal

Background and objective Tuberculosis (TB) is a worldwide public health problem, caused by Mycobacterium tuberculosis, affecting about one-third of world population [1]. TB treatment is provided, mainly, in ambulatory regimen in Pneumological Diagnosis Centres (PDC). The last official data (provisional) from the SVIG-TB (Portuguese TB-vigilance system) indicate a prevalence of 38.02 in the Algarve (Portugal) region [2].

The main objective is to evaluate the impact of pharmaceutical care in negative clinical results due to pharmacotherapy and in quality of life of patients with TB (new cases), in ambulatory regimen in 6 PDC in Algarve, during the period of 01/06/2006–31/12/2006.

Design Evolution of TB patients’ health condition from 01/06/2006–31/12/2006 was recorded. Patients who gave informed consent were, randomly, distributed by the study and control group. PI were directed to the patient’s physician or/and to the patient himself. A quality of life EuroQol EQ-5D questionnaire was used. At the moment, only provisional data are available. Data were processed with SPSS14.0.

Setting

Pneumological Diagnosis Centres of 6 Councils in East Algarve.

Main outcome measures Pharmaceutical interventions (PI) applied, negative clinical results, number of drugs used by each patient, adhesion to TB therapeutics, quality of life.

Results Fifty-five patients were registered, of which 5 refused to enter the study and 1 died (24 in the study group and 25 in the control group). Data indicate a proportion of 12.24% of TB/AIDS. During this period 148 negative clinical results (medicine related problems) were detected and 136 PI were applied, of which 85 (62.50%) were directed to the patient’s physician. Sixty-one PI were accepted, 14 were not accepted and 10 were not given an answer.

Results on therapeutical adhesion and health condition of the study group seam to indicate a positive impact of PI, particularly regarding the diminution of the number of medicines used by the patients (<4 drugs).

Conclusions Pharmaceutical interventions were well accepted by patients as well as by physicians. Data suggest a positive impact of the pharmacist’s intervention in the health condition of TB patients. However, this study population has social-behavioural characteristics which influence in the results may indicate the need to analyse sub-groups separately.

References

  1. 1.

    “Tratamento da tuberculose—Linhas orientadoras para programas nacionais”; Direcção-Geral da Saúde, Organização Mundial da Saúde, 2006.

  2. 2.

    Sistema de Vigilância da Tuberculose; Direcção-Geral de Saúde (dados provisórios); Jan-2007.

Keywords Tuberculosis, Care, Algarve

PC-301 A quality management project in post-operative pain therapy

Verena Koenig 1, Elisabeth Kretschmer1, Beate Tiz2, Marion Hundt2, Harald Boszotta3, Günther Sinz4

1Apotheke Barmherzige Brueder, 2Department of Anesthesiology, 3Department of Traumatology, 4Department of Orthopedic Surgery, Krankenhaus Barmherzige Brueder, Eisenstadt, Austria

Background and objective The aim of the study was to evaluate the status of post-operative pain therapy and to identify goals for quality improvement in post-operative pain therapy in patients with hip and knee endoprothesis and patients with traumatic bone fractures with foreign body implantation.

Data relating to the adherence to the pain therapy protocols of the anesthesiologist was recorded, the extent of switch therapy in pain medication, gastric ulcer prophylaxis with NSAIDs therapy and the patients’ evaluation of their respective pain therapy was recorded. The project was carried out in three steps.

Step one: pharmacists collected data of patient group A.

Step two: pharmacists informed doctors and nursing staff of the results found in step one. Anesthesiologists and pharmacists established and handed out written recommendations for post-operative pain therapy to doctors and nurses to support quality management in post-operative pain therapy.

Step three: pharmacists recorded data of patient group B, additional intervention by pharmacists.

Design Observational study from March until November 2006.

Patient demographics: group A: 97 patients (29 male, 68 female; mean age 74.3 years; 37 knee endoprotheses, 41 hip endoprotheses, 19 traumatic bone fractures with foreign body implantations) group B: 116 patients (40 male, 76 female; mean age 72.5 years; 42 knee endoprotheses, 38 hip endoprotheses, 36 traumatic bone fractures with foreign body implantations).

Setting Department of Traumatology, Department of Orthopedic Surgery; Krankenhaus der Barmherzigen Brueder.

Main outcome measures Number of implemented pain therapy protocols, number of switch therapies in post-operative pain therapy, number of gastric ulcer prophylaxis with NSAIDs, number of patients’ evaluations of pain therapy (VAS), number and acceptance of pharmaceutical recommendations.

Results Number of Protocols of anesthesiologists: Group A n = 94 (96.9%), implemented n = 28 (29.8%); group B n = 114 (97.4%), implemented n = 48 (42.1%).

Number of Switch Therapies within two days after surgery: group A n = 79 (81.4%), group B n = 104 (89.7%).

Number of gastric ulcer prophylaxis: group A n = 73 (93.6%), group B n = 90 (95.7%).

Number of patient evaluations of post-operative pain therapy: group A n = 64 (66%), group B n = 86 (74.1%).

Number of pharmaceutical interventions in group B: n = 7, (3 gastric ulcer prophylaxis, 4 switch therapy, 1 oral opioid instead of NSAR because of contraindication to NSAR, 1 additional opioid because of insufficient pain relief). All recommendations were applied to the therapy protocol.

Conclusions This study improved the sensibility of doctors and nurses concerning quality management in post-operative pain therapy. Additional recommendations given by the clinical pharmacists were accepted and intensified the quality of the post-operative pain therapy.

Keyword

Post-operative pain therapy

PC-68 Development of training to promote the Lothian joint formulary (LJF) to practice nurses

Maureen Reid 1, Carol Philip2, Pauline M. Westwood1, Dawn Wilson3, Anne Young4

1Primary Care Pharmacist, South West Edinburgh LHP, 2Primary Care Pharmacist, South Central Edinburgh LHP, 3Primary Care Pharmacist, South East Edinburgh LHP, 4Prescribing Support Pharmacist, South Central Edinburgh LHP, Edinburgh, United Kingdom

Background and objective Nurses influence prescribing in respiratory and other chronic diseases and had not previously received training on using the LJF (www.ljf.scot.nhs.uk).

To develop, deliver and evaluate an educational module and training session on respiratory disease to practice nurses/non medical prescribers promoting the use of the Lothian Joint Formulary web- site to select evidence based cost effective medication.

Design Analyse prescribing data. Assess and adapt LJF training previously aimed at GP’s and community pharmacists, create educational module, plan and deliver half day educational session to include lectures, practical workshops on spirometry, inhaler technique and discussion time. Course evaluation questionnaire.

Setting General Practice Nurses from South Edinburgh Community Health Partnership, IT training suite and workshop area.

Main outcome measures Participants judgment of the value of the course in the following areas:

  • Relevance to learning needs

  • New information gained

  • Intention to utilise LJF in their practice

  • Overall rating of the course

Results

  • 15 Practice Nurses attended

  • Relevance of the event

  • Attendees were asked to score the relevance of the event to their learning needs on a scale of 1–7. 1 = not at all, 7 = fully

  • The median score was 7 (Range: min score 4 max score 7)

  • How much new information was picked up

  • Attendees were asked to rate how much new information they picked up on a score of 1–7. 1 = taught me little I did not already know, 7 = taught me a lot

  • The median score was 5 (Range: min score 4 max score 7)

  • Use of the LJF

  • 7 practice nurses who fully completed the evaluation identified areas where they would make use of the LJF in practice

  • Overall the course was rated as excellent or good by participants

Conclusions The course will be better tailored to meet the needs of practice nurses and will be made available to all General Practice nurses within both the North and South Edinburgh Community Health Care Partnership Area. Following training audit of practice will be measured against the formulary.

PC-213 Prospective evaluation of 68 wound dressing medical prescriptions

Marie-Christine Monteiro 1, Morgane Ethgen-Bonnet1, Jihane Lemachatti1, Dominique Levêque1, Sandra Wisniewski1, Laurence Beretz1

1Pharmacy, University Hospital, Strasbourg, France

Background and objective Inappropriate clinical management of chronic wounds is responsible for significant delays in healing. The main issue of our study was to analyse the modalities of wound dressing management.

Design Prospective study.

Setting Department of Pharmacy.

Main outcome measures We prospectively reviewed all dressing wound prescriptions between Nov 5, 2006 and Jan 15, 2007. For each prescription, we systematically called the care unit to investigate the wound characteristics, the indication and the frequency of dressing changes. Our questionnaire had previously been validated by an infectious disease specialist.

Results They were 68 wound dressing prescriptions that concerned 42 patients during the study period. Prescriptions were collected from 21 care units (2 external consultations/19 conventional hospitalizations). The general surgery (7 prescriptions), the external intra-abdominal surgery (12 prescriptions) and the dermatology (15 prescriptions) were by ascending order the 3 main prescribing care units. The median number of wound dressing prescriptions per patient was 3 (range 1–6). The most common wound treated was abdominal wound. Eight different dressings were identified: 1 hydrocolloid, 1 hydrocellular, 1 hydrofiber, 2 border dressings, 1 silver dressing, 1 hyaluronic acid dressing, 1 water dressing. The primary dressing used was judged inappropriate in 13 cases out of 68 (19%), 8 cases concerning the healing phase and 5 the infectious status of the wound. Inappropriate dressing affected 9 care units and 8 had used <5 dressings during the last 2 months. Among the 13 inappropriate prescriptions, a modification due to our recommendation was accepted in 5 cases and refused in 3 cases. No alternative could be articulated in 5 cases and 3 concerned silver wound dressings.

Conclusions A significant proportion of wound dressing prescriptions was found inappropriate. The results of this study also highlighted the importance of providing training on wound dressing management for health-care workers. Dressing selection is a vital part of the successful management of wounds. The choice of an appropriate dressing should be based on the wound type and on clinically applicable measures, such as antibacterial action, healing, and exudate handling effects.

Keywords Wound dressing, Prescription, Prospective study

PC-77 Structured patient assessment of quality of medication use in cardiovascular disease in primary care

Thomas Kanis 1, Tobias T. Dreischulte2, John J. J. McAnaw3, Han J. J. de Gier4, Steve S. A. Hudson5

1Groningen Research Institute for Pharmacy and Strathclyde Institute of Pharmacy and Biomedical Sciences, Groningen University and University of Strathclyde, Groningen and Glasgow; 2Strathclyde Institute of Pharmacy and Biomedical Sciences, Groningen University and University of Strathclyde, 3Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom; 4Department of Pharmacotherapy & Pharmaceutical Care, University of Groningen, Groningen, Netherlands; 5Strathclyde Institute of Pharmacy and Biomedical sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To evaluate a tool to measure adherence of medication use to clinical guideline recommendations in primary care.

Design Retrospective case-note survey to field-test a prototype 51-item medication assessment tool (MAT-CVD) derived from earlier studies [1–3].

Setting Patients (n = 60) with coronary heart disease (CHD) from patients recorded as having CHD, heart failure, hypertension or atrial fibrillation and receiving care from a community pharmacist supplementary prescriber (n = 388) having remote access to the electronic records of a general practitioner.

Main outcome measures Adherences to 51 guideline criteria covering coronary heart disease, heart failure, hypertension or atrial fibrillation. Inter-rater agreement between two independent raters.

Results Patients [57% male, mean (SD) age 73 (10) years and 59% had a BMI > 25]. Overall adherence was 73% (CI: 62–84%) to 642 applicable guideline criteria. Inter-rater agreement based on the results from a random sample of 30 patients gave a Cohen’s kappa, к = 0.81 (where к > 0.8 signifies ‘good’ agreement).

Conclusions The MAT-CVD, deserves further study for use in reviewing medicines use against clinical guideline recommendations based on primary care case records. Reliability testing requires further investigation in a larger sample to allow examination of individual criteria.

References

  1. 1.

    Chinwong S, Reid F, McGlynn S, Hudson S, Flapan A. The need for pharmaceutical care in the prevention of coronary heart disease; an exploratory study in acute myocardial infarction patients. Pharmacy World and Science 2004;26:96–101.

  2. 2.

    Ernst A, Kinnear M, Hudson S. Quality of Prescribing: A study of guideline adherence in patients with diabetes mellitus. Practical Diabetes International 2005;22:285–290.

  3. 3.

    Kamyar MR, Johnson BJ, McAnaw JJ, Lemmens-Gruber R, Hudson SA. Evaluation of the implementation of medication guidelines in the prevention of coronary heart disease for patients with type II diabetes mellitus in primary care. Pharmacy World and Science 2007;In Press.

Keyword

Quality prescribing therapy

PC-218 Discharge prescribing patterns for cardiovascular patients in a public and a private hospital in Australia

Alexandra Bennett 1, L. Selim2, I. Davidson3, A. Wardell3, J. Brien4

1Faculty of Pharmacy, The University of Sydney, 2Faculty of Pharmacy, Uppsala University, 3St Vincent s Hospital Campus, The University of Sydney, 4FAculty of Medicine, University of New South Wales, Sydney, Australia

Background and objective Patients may undergo percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in public or private hospitals in Australia. Senior medical officers work in both hospital systems and junior medical officers (JMOs) are based in public hospitals. Evidence-based guidelines provide recommendations for secondary prevention of cardiovascular disease. While funding for inpatient medications differs in public and private hospitals, medication funding and supply do not differ after hospitalisation. Medications begun in hospital are more likely to be continued post-discharge. The purpose of this project was to describe patterns of evidence-based medication (EBM) prescription at discharge in patients post-PCI and post-CABG.

Design Descriptive, observational, retrospective.

Setting Co-located public and private hospital.

Main outcome measures Descriptive statistics including EBM prescription rates at hospital admission and discharge (aspirin, ACE inhibitors/angiotensin II receptor blockers (ACEI/ARBs), beta-blockers, statins).

Results During 2005/2006, data from the medical records of 300 public and 440 private patients were reviewed. The demographics of the 2 hospital populations were similar. 100% of public and 28% of private patients had a presenting diagnosis documented. 84% and 16% of public and 68% and 32% of private patients underwent PCI and CABG, respectively. 63% of public and 99% of private PCI patients received drug-eluting stents. 32% of public and 43% of private patients had some missing data regarding medication use. Information regarding antiplatelet use post-PCI was documented in both catheter reports and discharge letters in the public hospital but only in discharge letters in the private hospital. There was disparity between the catheter report and discharge letter in 10% of public patients. On admission, rates of prescribing of aspirin were 59% (public) and 64% (private), ACEI/ARBs 50% and 48%, beta-blockers 42% and 42%, and statins 60% and 64%. At discharge aspirin was prescribed in 98% (public) and 79% (private), ACEI/ARBs 71% and 59%, beta-blockers 70% and 41% and statins 87% and 79%.

Conclusions Differences in discharge EBM were noted between the 2 hospitals although baseline admission rates were similar. Concordance with EBM recommendations in the public hospital was comparable to published literature. Documentation was poor in the private hospital and may be associated with the availability of JMOs in the public hospital. Transfer of medication information to maintain continuity of care may not be achieved for some patients. Findings of disparity regarding antiplatelet prescription post-PCI have been communicated to public hospital prescribers. The finding that discharge prescribing may be different between the hospital settings suggests further follow-up investigation of these patients after discharge is necessary.

Keywords Evidence-based medication, Discharge, Hospital settings

PC-192 Evaluation of the integration of a pharmacist into the hospital outpatient clinic providing care in rheumatoid arthritis

L. Azzopardi 1, S. Hudson2, L. Perry2, C. Mallia3, A. Serracino-Inglot1, V. F. Camilleri3

1Department of Pharmacy, University of Malta, Malta, Malta; 2Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom; 3Faculty of Medicine and Surgery, University of Malta, Malta, Malta

Background and objective To measure the impact of a clinical pharmacist’s contributions to the care of patients with rheumatoid arthritis.

Design Controlled trial over 11 months with control group crossing over into intervention group to allow pre-test post-test comparisons.

Setting Eighty-eight patients, 72 (82%) female, mean (SD) age 61 (12) years, on methotrexate (MTX), 51 (58%) MTX alone and 37 (42%) MTX with other DMARDs disease-modifying antirheumatic drugs.

Main outcome measures Ratings of general and disease-specific health-related quality of life [Health Assessment Questionnaire (HAQ), the Medical Outcome Short Form Questionnaire (SF36)]; changes in patients’ beliefs about their medication [Beliefs about Medicines Questionnaire (BMQ)]; level of patient satisfaction. Ratings of patients’ desire for information.

Results All data were compared using non-parametric (rank order) comparisons of paired and unpaired data. HAQ showed improvement in activities of daily living in the intervention group compared with control group (P < 0.05) and this improved as the trial progressed. The pharmacist service was associated with changes in patients’ desire for information and their beliefs about their medicines, reflected in reduced ‘concerns’ and greater feelings of ‘necessity’. A total of 106 pharmaceutical care issues were identified and categorised into drug therapy problems (DTPs) of which 72% were actual DTPs and 28% potential DTPs.

Conclusions The use of a pharmaceutical care plan within a rheumatology outpatient clinic was a useful tool for facilitating the pharmacist’s contribution to the health care team. The pharmacist makes a contribution to improving patient outcomes in terms of quality of life measures and their beliefs about their medicines.

References

  1. 1.

    Whalley D, McKenna SP, de Jong Z, van der Heijde D. Quality of life in rheumatoid arthritis Br J Rheumatology 1997;36:884–8.

  2. 2.

    Cipolle RJ, Strand LM, Morely PC, Frakes M. Pharmaceutical Care Practice; the clinician’s guide McGraw Hill: New York; 2004.

  3. 3.

    Horne R, Weinman J, Hankins M. The Beliefs about Medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and Health;1999;14:1–24.

Keywords Rheumatoid arthritis, Methotrexate, Pharmaceutical care

PC-287 Investigation on catheter administration practices in Pontchaillou Hospital—Rennes University Hospital

Fabienne Le Gac 1, Florian Le Maitre1, Pierre-Yves P. Y. Berthier1, Loic Javaudin1

1Pharmacy unit, Pontchaillou Hospital, Rennes, France

Background and objective Drugs are dispensed globally for 2/3 of Pontchaillou Hospital’s 968 beds. To understand prescribers’ approach on pharmaceutical forms and nurses’ practices, we investigated the different methods of drug-administration via a catheter (naso-gastric tube, naso-intestinal tube, gastrostomy tube and jejunal feeding tube) used in our hospital.

Design Our investigation consisted of going into care units and questioning nurses about their practices using a standardized questionnaire. Twenty-three care units were questioned in one day, so that we could draw up an inventory of common habits in care units. At the same moment, we also collected the prescriptions of every patients requiring enteral feeding to analyse their relevance.

Setting Pharmaceutical Unit, Care Units.

Main outcome measures We analysed 28 hard-copy prescriptions of catheterized patients.

Results Of the 594 patients hospitalized in the 23 units, 58 (9.8%) of them had an enteral catheter or tube. Twenty-eight hard-copy prescriptions were analysed, representing 142 actual prescription drugs prescribed (i.e. on average 3.7 prescription drugs per hard-copy prescription).

The investigation shows that 75% of the units have a tablet crusher. Sixty-four percent of them declare that they never call the pharmacy unit to check a drug’s compatibility with enteral catheter administration. Only 32% of nurses look for a drinkable form of the medication. Fifty-nine percent of them still believe that all injectable are drinkable. Seventy-three percent of the nurses think that all caps can be opened, and 86% of them think that all tablets are crushable. Fifty-five percent of units use injectable drugs in place of dry forms. In 91% of cases, water is used as drug vehicle.

Sixty-three percent of prescriptions contained at least one error. Twenty-nine percent of the prescribed drugs were not compatible with catheter administration. In 10% of cases, a drinkable form did exist, but the dry form was administered instead (e.g. Motilium® and Lasilix® in most of the cases). Administration of Inexium® was the most obvious case of misuse. Indeed, it is crushed by 75% of the nurses, whereas its galenical development has been based on the formulation of a soluble tablet used to facilitate enteral tube administration.

Conclusions This investigation was carried out in Pontchaillou Hospital, Rennes, and it highlights a lack in prescribers’ and nurses’ knowledge of galenic. This ignorance could be of concern for patients. To awaken practitioners to the importance of the subject, we are going to write an information sheet summarizing the results of the study and develop good practices guidelines on drug administration by enteral catheter.

Keywords Drug-administration, Catheterized patients, Enteral feeding

PC-80 A study to compare antihypertensive prescribing patterns with the standard treatment guidelines in patents with diabetes

Surarong Chinwong 1, Sunteep Batra1, Sittikorn Jailungka1

1Department of Pharmaceutical Care, Faculty of Pharmacy Chiang Mai University, Chiang Mai, Thailand

Background and objective To study the patterns of antihypertensive drug presentation in diabetic patients and to quantify (i) the achievement of target blood pressure control and (ii) adverse events of antihypertensive drugs.

Design Descriptive cross-sectional study.

Setting Cardiovascular Clinic, Maharaj Nakorn Chiang Mai Hospital, Thailand.

Main outcome measures Prescribing patterns, the achievement of blood pressure control, adverse events and appropriateness of prescribing.

Results A total of 200 out-patients were included in this study. The mean (SD) age was 62.4 (10.4) years and 56.0% were female. Dyslipidaemia and CHD accounted for 79.0% and 53.0% of patients respectively. The mean (SD) number of antihypertensive drugs prescribed was 2.4 (1.0). ACEI/ARB were the most frequently prescribed in 68.0% of patients. The majority of patients were prescribed two-drug combinations. There was no statistically significant association between blood pressure levels, fasting blood glucose level, the achievement of target blood pressure goal (<130/80 mmHg) and number or type of antihypertensive drugs prescribed (P > 0.05). Only 79 (39.5%) of patients had achieved the target blood pressure goal. Almost all patients were appropriately prescribed antihypertensive drugs according to its treatment criteria and antihypertensive drug use. However, the achievement of target blood pressure goal, interval of follow up and the prescribing of heart disease prevention seemed to be less appropriate. Data from 116 patients (58%) who answered the postal questionnaire showed that almost all patients were advised on lifestyle modification especially in reduction of sugar consumption, reduction of consumption of saturated fat and cholesterol-rich diets and increased consumption of high fibre diet. The most common adverse events reported by the patients were urinary frequency, exhaustion, impotence, syncope and chronic cough (70.7%, 63.8%, 50.9%, 41.4% and 39.7%, respectively) The severity of these events were mild to moderate and related to types of antihypertensive drugs prescribed.

Conclusions The present study provided important information on prescribing patterns, blood pressure levels, adverse events and conformity to recommendation on lifestyle modifications in diabetic patients with hypertension. This information is useful to guide and increase awareness of physicians in selection of antihypertensive drugs in this group of patients in order to achieve blood pressure targets and to reduce possible complication.

References

  • Chobanian AV, Bakris GL, et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003;42:1206–52.

  • ADA. Standards of Medical Care in Diabetes-2006. Diabetes Care. 2006;29:S4–42.

Keywords Antihypertensive prescribing patterns, Appropriateness of prescribing, Achievement of blood pressure control

PC-83 Community pharmacy diabetes care: design and evaluation of a model to support continuous professional development

Ailsa Power 1, Steve A. Hudson2, Susan McKellar2

1Pharmacy, NHS Education for Scotland, 2Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To develop a competency-based continuous professional development (CPD) support package based on a workbook of competencies for community pharmacists working with patients with diabetes mellitus type 2 in primary care. To evaluate by means of a pre- and post-measurement of views and attitudes to CPD.

Design (a) Interviews with nineteen health care team members in the design of the package (representing community pharmacists, general medical practitioners, diabetic specialist physicians and diabetic specialist nurses). (b) Eighteen community pharmacists in a consensus building project. (c) Sixty community pharmacists in a controlled study to evaluate the package.

Setting Primary care.

Main outcome measures A documented model of care [1]. Measured consensus on pharmacist activities within a model of care [2]. Information to explain pharmacists priorities in addressing specific competencies. Changes in pharmacist views and attitudes to the CPD support.

Results The findings from interviews and Delphi questionnaire has established an agreed model of care and a set of 51 pharmacist activities. The activities have been linked to nationally agreed multi-professional diabetes competencies, grouped within five competency descriptors [3].

A CPD diabetes workbook was designed using these competencies and has been linked to a package of support (educational sessions, knowledge exchange network and peer support). The evaluation of the CPD support being undertaken in a controlled trial among community pharmacists is due for completion in June 2007.

Conclusions Scottish Community pharmacists extending their role within a Strategy for Pharmaceutical Care and a new community pharmacist contract. CPD is becoming formalised and is a necessary support to the development of new services. This project is using a research approach in diabetes which may offer an exemplar for use in the management of other chronic diseases.

References

  1. 1.

    Power A, Douglas E, McGregor A-M, Hudson S. Pharmaceutical care of the patient with type 2 diabetes mellitus: A multidisciplinary conceptual model to structure continued professional development. International Journal of Pharmacy Practice 2006;14:289–299.

  2. 2.

    Power A, Mc Kellar S, Hudson S. Pharmaceutical care of the patient with type 2 diabetes mellitus: A consensus model for delivery of structured pharmaceutical care by community pharmacists in Scotland. International Journal of Pharmacy Practice (Submitted).

  3. 3.

    NHS Education for Scotland. A competency framework for the care of a person with diabetes. Edinburgh; 2003.

Keywords Community pharmacy, Diabetes mellitus type 2, Continuing Professional Development

PEPI-10 Complexity of treatment of patients with type 2 diabetes

Péter Doró 1, Edit Kosik1, Mária Matuz1, Ria Benkõ1, Gyöngyvér Soós1

1Department of Clinical Pharmacy, University of Szeged, Szeged, Hungary

Background and objective The drug treatment of diabetic patients is not limited to diabetes, but due to the high prevalence of comorbidities and complications of diabetes, more medication than the average population, making their treatment rather complex.

The aim of the present study was to assess the complexity of drug treatment of patients with type 2 diabetes.

Design Retrospective descriptive cohort study.

Setting Csongrád County (430.000 inhabitants), Hungary, period 1998–2004.

Main outcome measures Patient specific data were retrieved from the electronic database of the Hungarian National Health Fund Administration.

Results Prescription medication history of 1350 patients with newly diagnosed type 2 diabetes were analyzed for a 66-month period (6 months prior and 5 years after diagnoses). 18.0% of all prescriptions dispensed during the 5-year period were for medication treating diabetes (ATC A10), and 82.0% were for drugs treating other health concerns. The majority of medication, 42.1%, were from the ATC C main group; 26.1% were from ATC A main group (which include the 18.0% antidiabetic medication); 11.9% were from the ATC N main group; 6.1% were from the ATC M main group; each of the other ATC main groups had a <3% share. During the course of diabetes—with the progression of the disease—a significant increase was found in the number of patients using drugs from ATC C main group (P < 0.001), drugs from ATC B main group (P = 0.001), drugs from ATC M main group (P = 0.021), and drugs from ATC N main group (P < 0.001). No statistically significant changes could be detected in cases of other medication groups. Diabetic patients used much more medication than the average population: they claimed 3 times more prescriptions than the average citizen, and nearly 2 times more than what they had claimed just prior their diagnoses of diabetes. Although diabetic patients used more medication from most of the drug groups than the average population, the increase in the number of prescriptions for cardiovascular drugs (ATC C main group) was the most striking one. During the first year of diabetes males claimed 40.0 prescriptions and females collected 48.3 prescriptions on average. By the fifth year this increased to 54.8 and 62.3 prescriptions, respectively. During the first year males used an average of 10.8 different active ingredients which increased to 12.9 in the fifth year, and females used 13.2 active agents in the first year and 14.5 in the fifth year.

Conclusions The concurrent use of several drugs not only increases the complexity of the treatment and results in higher health care cost, but also raises the risk of adverse drug reactions and drug–drug interactions. As polypharmacy is almost inevitable in diabetic patients, regular reevaluation of the therapy is essential to minimize the risk arising from polypharmacy.

Keywords Diabetes, Hungary, Co-medication

PEPI-163 Quality of life in patients with tuberculosis

Fikret V. Izzettin1, Sude Eminzade1, Sule Apikoglu-Rabus 1, Turan Karagoz2

1Clinical Pharmacy Department, Marmara University Faculty of Pharmacy, 2Department of Chest Diseases, Sureyyapasa Center for Chest Diseases and Thoracic Surgery, Istanbul, Turkey

Background and objective Despite the effective treatment modalities, tuberculosis (TB) is still a persistent problem for the world. Factors including the debilitating nature of the disease as well as the long-term treatment consisting of multiple drugs with potential toxicities seem to affect the TB patients’ quality of life. The aim of this study is to describe the impact of TB on patients’ quality of life by using a validated instrument.

Design The study was conducted on three treatment groups: 1. outpatient TB patients (MDR or non-MDR) [n = 20]; 2. inpatient MDR TB patients [n = 20]; 3. inpatient non-MDR TB patients [n = 20]; and a control group [n = 20]. The control group consisted of non-TB, age and sex matched subjects of similar socioeconomic environment with the TB patients. SF-36 was used for quality of life assessment. The scale was administered via face to face interviewer-mediated sessions. The same interviewer was in charge through the whole study.

Setting Sureyyapasa Center for Chest Diseases and Thoracic Surgery; Istanbul, Turkey.

Main outcome measures The quality of life scores of TB patients.

Results The physical dimension and mental dimension scores for the of SF-36 was highest for the control group (P: 70.86; M: 62.85) where this was followed by the outpatient (P: 68.32; M: 65.53), inpatient non-MDR (P: 60.12; M: 58.91) and inpatient MDR (P: 55.25; M: 51.38) groups, respectively.

Only role-physical, social functioning and role-emotional scales showed a significant statistical difference among the groups. Role-physical scale score was highest for the control group where this was followed by the outpatient, inpatient non-MDR and inpatient MDR groups, respectively. The scores for the social functioning and role-emotional scales were the lowest for the inpatient MDR group; this was followed by the inpatient non-MDR, control and outpatient groups, respectively.

Conclusions Tuberculosis was found to have a negative impact on the physical and mental dimensions of quality of life in general. Especially scales constituting the mental health dimension were the most affected ones. This negative impact was most significant for the inpatients. The clinical pharmacist can help the TB patients improve their quality of life through reducing the drug-related burdens by counseling on medications and coping strategies.

Keywords Tuberculosis, Quality of life, Multi-drug resistant

PEPI-31 Oral high dose dexamethasone: clinical use in patients with multiple myeloma

Nathalie Saurel1, Sophie Calvez1, Yvette Brasseur2, Bernard Do 3, Marie-Pierre Berleur1

1Regulatory, 2Pharmacovigilance, 3Analytical Development Laboratory, Ageps EPHP, Paris, France

Background and objective Multiple myeloma (MM) is a malignant plasma cell disorder. Our objective is to compare oral dexamethasone (DX) therapeutics protocols in patients with MM (previously untreated, refractory or relapsed patients).

Design Literature review.

Setting Assistance publique-Hôpitaux de Paris.

Main outcome measures We searched Medline and the Cochrane library database.

Results Fifty-one papers were identified and analysed. DX can be used alone to treat MM in elderly patients or in patients who cannot tolerate chemotherapy and more frequently in combination with cytotoxic drugs. Drugs combined with DX are mainly vincristine plus adriamycine (VAD protocol), bortezomib, thalidomide and more recently lenalidomide. Treatment strategy is not clearly defined. DX protocols vary on 3 important points: dose (1), dose regimens (2), total number of administration cycles (3).

Daily oral dose ranges from 20 to 40 mg. Dose may also be expressed as a dose per square meter (usually 20 mg/m2).

Cyclic dose regimens are different between protocols: days 1–4, 9–12, 17–20 or days 1–2, 4–5, 8–9, 11–12 or days 1–4 and are repeated every 21–35 days.

Total number of cycles ranges from 2 to 8.

Whatever the protocol, addition of DX to cytotoxic drugs improved clinical responses without prohibitive toxicity (the good tolerance probably being due to intermittent administrations).

Conclusions In conclusion, DX appears to be an effective treatment but a consensus on dose regimens is needed to optimize treatment strategies in MM patients.

References

  1. 1.

    Alexanian R et al. Primary dexamethasone treatment of multiple myeloma. Blood 1992 Aug 15;80(4):887–90.

  2. 2.

    Alexanian R et al. Thalidomide with or whithout dexamethasone or refractory or relapsing multiple myeloma. Semin Hematol 2003 Oct;40(4 Suppl4):3–7.

  3. 3.

    Jagannath S et al. Bortezomib in combination with dexamethasone for the treatment of patients with relapsed/or refractory multiple myeloma with less than optimal response to bortezomib alone. Haematologica 2006 Jul;91(7):929–34.

  4. 4.

    Richardson PG et al. Lenalidomide in multiple myeloma. Expert Rev Anticancer Ther 2006 Aug;6(8):1165–73.

Keywords Dexamethasone, Clinical use, Multiple myeloma

PK-265 Lithium intoxication caused by nimesulide

Sabrina De Winter1, Daniel Knockaert2, Ludo Willems 1

1Pharmacy, 2Internal medicine, University Hospital Leuven, Gasthuisberg, Leuven, Belgium

Background and objective We report the case of a patient admitted with an acute lithium intoxication. The aim of this report is to emphasize the importance of a detailed history of medication use and particularly of occasional drug intake.

Design Case report based on clinical data and literature review.

Setting Emergency Department, University Hospital Leuven, Belgium.

Main outcome measures Reporting a drug-related admission and evaluation of possible contributing pharmacological causes.

Results A 75 year old woman was admitted to the emergency department with symptoms of aphasia, tremor, muscle weakness, muscular rigidity and confusion. A few days prior to the admission she has fallen several times. The medication history taken by the clinical pharmacist in a standardised manner revealed routine use of lithium 350 mg TID for one year, venlafaxine, trazodone, duloxetine, bisoprolol, simvastatine, metformine, alprazolam and zopiclon. Nimesulide 100 mg OD had been prescribed to control her pain symptoms following frequent falls. Laboratory investigation revealed a lithium blood level of 2.16 mmol/l (Reference value 0.40–1.5 mmol/l). The clinical pharmacist at the emergency department suggested nimesulide to be the cause of her intoxication.

Although there are large interindividual differences in lithium clearance associated with different NSAIDs, they all have been associated with lithium toxicity. The exact underlying mechanism of the interaction between lithium and NSAIDs remains unknown. One hypothesis involves the ability of NSAIDs to inhibit the production of endogenous prostaglandins (PG) by the kidney. Reduced PGE2 levels are believed to mediate the sodium retention and would, therefore, be anticipated to increase the lithium reabsorption as well. Alternatively, inhibition of PG synthesis may reduce renal blood flow and glomerular filtration rates. However, aspirin decreases PGE2 levels by 70%, but does not appear to effect lithium clearance to a large extent.

Conclusions In the literature there are several reports of lithium poisoning caused by the use of nimesulide. The authorities even launched a warning about this interaction.

This case-report illustrates the importance of taking in depth drug histories and being aware of drug interactions especially when adding new medications.

Keywords Medication-history, Lithiumintoxication, NSAIDs

PT-242 Non-adherence to guideline of rational antibioticotherapy/prophylaxis of dialysis patients

Radka Vrbecka 1, Vilma V. P. Petrikaite2, Romaldas R. M. Maciulaitis3, Edita E. Z. Ziginskiene4, Vytautas V. K. Kuzminskis4, Jiri J. V. Vlcek5

1Department of Clinical Pharmacology, Clinics of Kaunas Medical University, Pharmaceutical Faculty, Charles University in Prag, 2Department of Pharmaceutical Chemistry and Pharmacognosy, 3Department of Clinical Pharmacology, 4Nephrological Clinic, Kaunas University of Medicine, Kaunas, Lithuania; 5Department of Clinical Pharmacology, Pharmaceutical Faculty, Charles University in Prague, Hradec Kralove, Czech Republic

Background and objective Level of rationality in antibioticotherapy/prophylaxis (ABT/P) in dialysed patients (DP) is unknown therefore needs to be evaluated. This study is aimed at evaluation of cases of non-adherence (NA) to note for guidelines on rational prescribing of antibiotics; comparison of these data with data from general practice (GP); and identification of targeted intervention into NA.

Design Retrospective analysis and comparison of all available ABT/P cases in DP and GP during 2005. Data were processed with SPSS 16.0 using descriptive and comparative statistics for nonparametric values.

Setting 2 out-patient settings: Department of Nephrology (I group) and Clinic of Family Medicine (II group), Clinics of Kaunas Medical University, Lithuania.

Main outcome measures Quantification of NA and comparison between two settings; definition of major areas for improvement.

Results Totally 113 and 1285 patients were available in group I and II. Correspondingly, for I and II groups, the mean age (±SD) were 58.8 ± 18.76 and 45.2 ± 18.91 years; proportions of females were 32.5% and 81.5%. 40/113 (35.4%) of patients experienced 88 cases of ABT/P in I gr. and 65/1285 (5.1%) of patients—71 cases in II gr.

NA rate in I and II gr. was 14/88 (15.9%) and 39/71 (54.9%), correspondingly (P < 0.05, Mann Whitney test). The most frequent NA of ABT/P cases in I gr. were respiratory tract infection (64.3%, with pneumonia in 66.7%); major NA antibiotics–cefuroxime (42.9%) and amoxicillin (28.6%) with tendency for broadening antimicrobial spectrum.

Conclusions The data analysis discloses relatively low rate of NA in DP population that is less comparing to GP population; with majority of NA in case of using cefuroxime and amoxicillin and in treatment of respiratory tract infection, especially pneumonia. These findings define a strategy for targeted intervention in nephrology setting.

Reference

  • KMUK databases.

Keywords Rational drug use, Intervention, Antimicrobial therapy

PT-253 Targeted therapy in hematology and oncology: comparison of different strategies

M. T. Baylatry 1, P. Tilleul1, V. Rathouin1, J. L. Prugnaud1, A. C. Joly1

1Saint-Antoine Hospital AP-HP, Paris – Cedex 12, France

Background and objective To assess and compare the IV targeted anticancer drug use in hematology and oncology clinical practice (clinical trials excepted).

Design Good practice reference guidelines; 2-year retrospective study (2005–2006); statistical method: Chi2 test, P < 0.05.

Setting Hematology, oncology and pharmacy departments in a teaching hospital.

Main outcome measures Assessment criteria: therapeutic strategies involving IV targeted anticancer drugs (combination with conventional anticancer chemotherapy, maintenance therapy, monotherapy, combination of targeted drugs), type of targeted therapy and anticancer drugs involved. A 2-year analysis of the evolution of these criteria.

Results The targeted anticancer drug prescriptions increased between 2005 and 2006 in hematology (28%) and oncology (127%). Of 3,535 hematology and 11,718 oncology prescriptions containing costly anticancer drugs, respectively 79% and 22.5% had at least a targeted anticancer drug (rituximab, alemtuzumab, bortezomib for hematology, bevacizumab, cetuximab, trastuzumab for oncology): 43.5% and 92% polychimiotherapy prescriptions with targeted drugs, 56.5% and 8% mono- or maintenance targeted drug therapy prescriptions.

No statistically significant difference was observed in prescriptions combining chemotherapy with targeted drugs between 2005 and 2006 in hematology. In oncology a major increase was observed (P < 0.001). Mono- or maintenance targeted drug therapy prescriptions between 2005 and 2006 increased significantly in hematology (P < 0.001), no statistically significant difference was observed in oncology. No combination of targeted drugs was observed in oncology over 2 years and in hematology until October 2006, 41 hematology prescriptions combining rituximab and bortezomib were prescribed afterward.

Conclusions The targeted therapy has an increasing role in therapeutic cancer strategies. The place of this therapy is different in the treatment and management of hematology and oncology malignancies. Combinations of targeted drugs with traditional chemotherapy, mono- or maintenance therapy strategies are currently prescribed in daily practice. Multitargeted therapy using combinations of selective drugs is a new approach; these combinations are clinical trial or off-label use prescriptions. Targeted therapy strategies need to be evaluated to optimise their use and control their costs in our health care system.

Keywords Targeted drug, Oncology, Hematology

PT-272 Pharmacist’s intervention on the stress-related mucosal disease prophylaxis: elaborating recommendations, evaluating antiulcerous drug’s utilization and intervention proposal

Elena Florensa 1, Eva Hernández1, Margarita Garau1, Núria Padullés1, Julio Martínez1, Josep Monterde1

1Pharmacy, Hospital Vall Hebron, Barcelona, Spain

Background and objective To elaborate recommendations for the mucous gastrointestinal acute injuries prevention on hospitalized patients, and before disseminating them, to evaluate the utilization of antiulcerous drugs in our hospital according to it’s adequacy to the recommendations. Finally, to design the strategy of pharmacist’s intervention on it’s introduction.

Design A bibliographical research in PUBmed database, National Guideline Clearinghouse and other hospitals protocols was carried out to elaborate the recommendations. A cross sectional randomized study of 124 patients of different units of hospitalization was conducted to evaluate the utilization of antiulcerous drugs.

Setting Pharmacy Department and different units pf hospitalization of a tertiary teaching hospital.

Main outcome measures Patients general information, antiulcerous therapy used and the presence of mucous gastrointestinal acute injuries risk factors to justify this therapy.

Results The recommendations are: Prophylaxis with proton pump inhibitors (PPI) in patients with antiinflamatory therapy that have some risk factor, prophylaxis with PPI in patients with corticosterids or low dose aspirin therapy that have some peptic disease antecedent, and stress ulcer prophylaxis with Histamine2 receptor antagonists (H2RAs) in patients that have some risk factor. Nineteen percent (23/124) of patients didn’t receive any antiulcerous therapy being not needed in any of the cases. Of the 101 remaining ones (81%), two received an H2RAs and the others a PPI. There were found correct prescriptions in forty eight (48%) patients while in the other 53 (52%) an inappropriate utilization was reported.

Conclusions The excessive and incorrect use of antiulcerous drugs has been demonstrated in our hospital, a fact that can cause important side effects and an unnecessary expense. The development, dissemination and the following of some utilization recommendations must increase its cost-efficiency.

PT-275 Prevalence of renal dysfunction in rheumatoid arthritis patients: results of the matrix study

Svetlana Karie1, Frederique Grandjbakhch2, Cam Uyen Mai Ba1, Nicolas Janus 1, Sylvie Rozenberg2, Pierre Bourgeois2, Gilbert Deray1, Vincent Launay-Vacher1

1Nephrology, 2Rheumatology, GH Pitié-Salpêtrière, Paris, France

Background and objective Renal Insufficiency (RI) is a common pathology. However, only few data are available on the prevalence of RI in rheumatoid arthritis (RA) patients. The French MATRIX study (MeThotreXate and Renal Insufficiency) was thus started to estimate the prevalence of RI, proteinuria, abnormal urine sediment, hypertension and diabetes in RA patients.

Design Data were collected for RA patients presenting at the Rheumatology department from April 18 to July 31, 2006: sex, age, weight, serum creatinine (SCr), drugs and theirs dosages. Proteinuria and abnormal urinary sediments were assessed with urinary sticks.

Setting Rheumatology Department and ICAR (A National Medical Advisory Service on “Drugs and the Kidney”) located in the Nephrology Department, Pitié-Salpêtrière Hospital, Paris, France.

Main outcome measures Prevalence of SCr > 110 mol/l was determined. Renal function was estimated with the Cockcroft-Gault (CG) and the abbreviated MDRD (aMDRD) formulae. Prevalence of abnormal urinalysis was also assessed.

Results 129 (109 women, 20 men) patients were included: mean age 55.2 years, weight 66.6 kg, duration of RA 9.5 years. 102 (79.1%) and 99 (76.7%) patients had available data for SCr and urinary sticks, respectively. SCr was normal in 99% of the patients for whom data were available. With CG, GFR < 90 ml/min was observed in 60/99 patients (60.6%). With aMDRD, GFR < 90 ml/min/1.73 m² was observed in 68/102 patients (66.7%). Proteinuria (≥1+), hematuria (≥1+), and leucocyturia (≥1+) were observed in 16/99 (16.2%), 17/99 (17.2%) and 22/99 (22.2%) patients for whom data were available, respectively. Hypertension and diabetes were observed in 24.8% and 7.8% of patients, respectively. Methotrexate (MTX) (mean dose 15.5 mg/week and mean duration 4.6 years) was prescribed in 82.2% of MATRIX patients. When using CG, 20.5% of the patients treated with MTX should have had an adjustment of its dosage (GFR < 60 ml/min). 92.5% of those patients had an adapted dose of MTX according to their renal function.

Conclusions The results of the MATRIX study showed that RI is frequent in RA patients. SCr under-estimates this prevalence. Systematic estimation of renal function with CG or aMDRD formulae is mandatory. Clinicians must be aware of such a high prevalence since it may necessitate adjustment of drugs dosages.

Keywords Renal insufficiency, Rheumatoid arthritis

PT-56 Glutathione for hepatic protection during raltitrexed and oxaliplatin treatment

Lois Pollock 1, Aileen Cameron1, Moira Kinnear1, Ewan Morrison1, Lucy Wall2

1Lothian Pharmacy Practice Unit, 2Edinburgh Cancer Centre, Western General Hospital, Edinburgh, United Kingdom

Background and objective Raltitrexed and oxaliplatin are approved for treating colorectal cancers in the cancer centre. Both agents can cause transient, reversible increases in alanine transaminase, however, hepatotoxicy is greater with concomitant administration (RalOx). Although glutathione (GSH) is known to protect against chemo-toxicities (unlicensed in the UK), its specific role in hepatotoxicity associated with chemotherapy is unclear.

We report the effect of 1.5 g/m2 GSH administered intravenously immediately prior to chemotherapy to allow completion of intended number of cycles.

Design Case reports.

Setting Cancer centre, large teaching hospital.

Main outcome measures Liver function tests (LFTs), additional adverse effects and treatment delays.

Results Patients X and Y received RalOx. Raltitrexed was withheld as per protocol if the alanine transaminase (ALT) was greater than twice the upper limit of normal (2ULN). Range for ALT is 10–50 U/L. Both X & Y experienced 2 treatment delays due to increased ALT and were prescribed GSH as pre-medication on cycle 4 when their ALT had recovered to less than 2ULN. X experienced a 25% dose reduction in ralitrexed at cycle 4 in addition to GSH due ALT of 101 U/L. Both X and Y received GSH prior to all further cycles of RalOx.

Patient Z received raltitrexed. GSH was added at cycle 2 when ALT was 113U/L. To date (third cycle), ALT is within range.

X has completed the course of 8 cycles of chemotherapy with no further treatment delays since adding GSH pre-treatment. Although elevated, ALT remained stable.

Y has received 5 cycles of chemotherapy to date and ALT remains in range since the addition of GSH.

Conclusions These three patients have benefited from being able to continue chemotherapy as a result of using GSH in an unlicensed manner. No additional adverse effects are anticipated with GSH and the preparation has minimal cost implications. Further cases should be reported and reviewed at the Chemotherapy Treatment Advisory Committee before GSH is added to treatment protocols for this patient group.

Keywords Glutathione, Raltitrexed, Hepatotoxicity

PT-87 A medication assessment tool (MAT) for use in identifying patients who are poorly controlled or well-controlled on oral anticoagulants

Kristian Svendsen 1, Syireen Alwi2, Carl Fenelon2, Trude Giverhaug1, Stephen Hudson2

1Institute of Pharmacy, University of Tromsø, Tromsø, Norway; 2Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objectiveTo compare adherence to warfarin guidelines (1–3) using a medication assessment tool (MAT). Examination of MAT as a method for identifying patients who are “well-controlled” or “poorly controlled”.

Design Retrospective case-note survey with the application of a 13-item MAT compared with time spent in range derived from the computerised record of INR history.

Setting Patients with a history of warfarin treatment for at least 2 years, served by two hospital outpatient warfarin clinics (n = 243, n = 119) and a cluster of outreach warfarin clinics (n = 146).

Main outcome measures Adherence to 13 guideline criteria. Estimated time spent within target INR range. Predictive power of the tool to identify poorly controlled patients (<50% time in INR range) and well-controlled patients (>80% time in INR range).

Results A significant difference in adherence between sites was found in eight of thirteen criteria (P < 0.05): Recognised indication for warfarin; appropriate target range of INR; appropriate duration of therapy; INR history with 6 of the last 10 measurements in INR range; 50% of INR measurements within range in the last 2 years; patients admitted to hospital had a follow up INR measurement taken no later than 7 days after discharge; patients with INR > 6.0 had their warfarin withheld until INR < 5.0; and finally patients with high INR had their dose reduced or withheld.

Overall, 16.3% and 16.1% of patients were ‘poorly controlled’ and ‘well-controlled’, respectively. For identifying poorly controlled patients, an abbreviated 7 item tool performed as well as or better than the 13-item original with a sensitivity of 86% (95% confidence interval [CI] 82, 89) and specificity 77% (95% CI 73, 81). For identifying well-controlled patients, the sensitivity was 76% (95% CI 72, 79) and specificity 71% (95% CI 67, 75).

Conclusions The tool detected differences in adherence between the sites in eight of 13 criteria. Comparison showed that a 7 item tool could identify poorly- and well-controlled patients, and offers a means of targeting patients with specific pharmaceutical care needs.

References

  1. 1.

    British Committee for Standards in Haematology. Guidelines on oral anticoagulation: third edition. Br. J. Haematology 1998;101:374–387.

  2. 2.

    British Committee for Standards in Haematology. Guidelines on oral anticoagulation (warfarin): third edition (2005 update). Br. J. Haematology 2006;132:277–285.

  3. 3.

    Scottish Intercollegiate Guidelines Network Guidelines. Antithrombotic therapy. Edinburgh: SIGN 36; 1999.

Keywords Warfarin monitoring, INR, Dose

PT-88 Evaluation of quality of medication use in adult asthma: development and validation of an audit tool

Pei Se Wong 1, Anna Bastos2, Lorraine Perry2, Richard L. C. Loh3, Stephen Hudson2

1Department of Pharmacy, International Medical University, Kuala Lumpur, Malaysia; 2Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom; 3Department of Medicine, International Medical University, Kuala Lumpur, Malaysia

Background and objective To design and validate audit tools for evaluation of medication use in adult asthma patients for international comparison.

Design Literature appraisal and questionnaire design using group interviews among respiratory specialists. Retrospective case note survey to field test the application of the tool in primary care from UK general practitioner records (n = 51) and Malaysian hospital outpatient records (n = 200).

Setting Respiratory pharmacists and physicians at two separate research group sites—in Scotland, UK and in Negeri Seremban, Malaysia.

Main outcome measures Qualifying statements and standards within the criteria of audit tools proposed for separate use in the UK and Malaysian settings. Quantified levels of applicability and adherence to proposed audit tool criteria during the field-testing.

Results Twenty-six criteria for potential inclusion in the audit tools were identified by literature search and initial systematic appraisal of British asthma guidelines [1] and GINA guidelines [2]. Criteria were grouped under five sections in the tool addressing general care, inhaled steroids, add-on therapy, oral steroid use and patient educational needs. After the group interviews and field testing a 23 item tool was derived for use in Malaysia (after sixteen criteria were retained, nine removed, six added and two modified). A 24 item tool was derived for use in the UK which, compared with the Malaysian tool, had seven removed criteria, eight additional and four modified. A set of twelve criteria were common to both UK and Malaysian tools.

Conclusions The audit tools are ready for application in a study to investigate international comparisons in asthma management and to help target pharmacy services in guideline implementation.

References

  1. 1.

    British Thoracic Society and Scottish Intercollegiate Guideline Network. British guideline on the management of asthma. (November 2005 Update). [Accessed via www.brit-thoracic.org.uk].

  2. 2.

    Global Initiative for Asthma (GINA) Guidelines. Workshop Report. Global strategy for asthma management and prevention. 2005 [Accessed via www.ginasthma.com].

Keywords Asthma, Guidelines, Treatment

DI-41 Clinical and economic analysis of antimicrobial therapy of COPD exacerbations

Steven Simoens 1, Marc Decramer2, Sandra De Coster1, Geert Celis2, Gert Laekeman1

1Research Centre for Pharmaceutical Care and Pharmaco-economics, Katholieke Universiteit Leuven, 2Respiratory Division, University Hospitals Leuven, Leuven, Belgium

Background and objective The aim of the study was to analyse clinical and economic indicators of treatment of acute exacerbations of COPD. The study focused specifically on antimicrobial therapy and the use of fluoroquinolones in the management of exacerbations.

Design Data on the consumption of antibiotics to treat exacerbations in ambulatory care were derived from IMS Health. Also, an observational, retrospective analysis was carried out of patients who entered the clinical pathway for COPD exacerbations in University Hospitals Leuven.

Setting Treatment of COPD exacerbations in ambulatory care and in hospital setting.

Main outcome measures Consumption of antibiotics in defined daily dose per 1,000 inhabitants daily; FEV 1% predicted at admission; length of stay; quality of life; costs of medication, hospital stay, diagnostic and laboratory tests.

Results IMS Health data showed that there is a trend towards increasing use of broad-spectrum penicillins and fluoroquinolones, and decreasing use of tetracyclines in the treatment of COPD exacerbations in ambulatory care in Belgium in the first half of the 2000s. The observational analysis enrolled 267 patients who were hospitalized between October 2000 and October 2005 to manage 359 exacerbations according to the clinical pathway. Median length of stay per exacerbation amounted to 10 days. Mean quality of life associated with an exacerbation was 74 using the Chronic Respiratory Disease Questionnaire. Median costs of hospital treatment amounted to 5,514 € (third-party payer reimbursement and patient co-payment) per exacerbation. Treatment costs were driven by hospital stay (75% of total costs), diagnostic and laboratory tests (20%), and medication (5%). Antibiotics played a role in the hospital management of 75% of exacerbations. Fluoroquinolones were used to treat more severe exacerbations.

Conclusions Treatment of acute exacerbations of COPD imposes a significant clinical and economic burden on patients, the healthcare system and society.

Keywords Chronic obstructive pulmonary disease, Exacerbation, Antibiotics

DI-93 Oral drug administration to neurologic handicapped patients: drug therapy optimization

Bich Nga Pham 1, Xavier Simoens1, Jean Pierre Molly2

1Clinical pharmacy, Institut de Cancérologie de la Loire, St Priest en Jarez Cedex, 2Readaptation and Physical Medecine, IMC Loire Association, St Etienne, France

Background and objective Establishments members to IMC Loire Association receive handicapped people (children and adults). They suffer from neurologic disorders due to brain lesions, with swallowing disorders. Nurses and parents are responsible for drug administration. In order to make it easier, and to avoid false passage, they have recourse to techniques not recommended by SPC (Summary of Product Characteristics). They scrub tablets, open capsules, and mix this obtained powder with food, such as compote, stewed fruit, yoghurt or soup. These techniques have the advantages of binding drug bad taste and making big tablets easier to swallow. However it also originates inactivation, or destruction of the agent, leading to a therapeutic failure. To avoid these consequences, it has been necessary to inform personnel and parents of allowed practices.

Design Literature review.

Setting Establishments members to IMC Loire Association, St Etienne, France, partners with ICL pharmacy (Loire Cancerology Institute).

Main outcome measures Non applicable.

Results We have listed all drugs prescribed in establishments, and searched for data concerning administration method, galenic form (delayed or extended-release), solubility, and sensibilities (light, oxidation, acidity), for each drug. We have drawn up a table with name of the medical product, common name, available galenic form and doses, specific administration cautions, and possible alternatives.

This table, intended for doctors and nurses, defines allowed practices, and possible substitutions for doctors.

Conclusions Doctors dealing with patients and their parents and nurses are able to advise them about the way to administer each drug.

Among this kind of patients who receive a lot of drugs, our main preoccupation is to make drug administration as comfortable as possible in order to obtain the best possible observance, in a way to optimize their treatment.

Keywords Handicapped people, Swallowing disorders, Optimization

DI-106 Stability of oxaliplatin solution in 5% dextrose infusion bags

Pascal André1, Anne-Lise Roy1, Lamia Hassani1, Fouad Chiadmi1, Joël Schlatter1, Jean-Eudes Fontan1, Salvatore Cisternino 1

1Pharmacy, University Hospital Jean Verdier—APHP, Bondy, France

Background and objective Oxaliplatin, an antineoplastic drug, must be diluted in 5% dextrose solutions before infusion. Product information recommends storing those solutions no more than 24 h at 5°C or 6 h at ambient temperature. No further information is presently available on the long term chemical stability of oxaliplatin in 5% dextrose. The objective was to assess the chemical stability of oxaliplatin at 0.7 mg/ml, which is an average concentration of oxaliplatin in FOLFOX6 or GEMOX regimens diluted in a 250 ml 5% dextrose infusion bags.

Design Infusion bags containing oxaliplatin solution (0.7 mg/ml) were prepared aseptically. The chemical stability of oxaliplatin was assayed by HPLC-UV method.

Setting Pharmacy Department.

Main outcome measures Oxaliplatin solution (0.7 mg/ml) in 5% dextrose infusion bags were stored in the dark at 5°C (n = 3) or 22°C (n = 3); others were stored at 22°C and not protected from artificial light (n = 3). Samples were taken initially and at various times over 30 days and assayed in duplicate. Appearance and pH were also assessed.

Results The indicating stability of the HPLC method was checked by exposing oxaliplatin to accelerated degradation (acid, base, peroxide, temperature) which produced unidentified products that were not co-eluted with oxaliplatin or the internal standard (IS). The standard curve was constructed by plotting the oxaliplatin concentration against the oxaliplatin/IS peak-to-height ratio. All oxaliplatin solutions in 5% dextrose infusion bags, retained over 90% of their initial concentration throughout the 30-day study regardless of the storage conditions. There was no color change or visible precipitation and the pH remained stable. Neither temperature nor artificial light had any significant effect on the stability of oxaliplatin.

Conclusions Oxaliplatin diluted in 5% dextrose infusion bags to a final concentration of 0.7 mg/ml is chemically stable for at least 30 days at 5°C or at 22°C, with or without exposure to artificial light. Shortened storage time and refrigeration should be considered to limit potential microbiological proliferation.

DI-112 Communication with patient for a better compliance: a Reims experience of a medication information

The Corinne 1, Rauch Sophie1, Buire Anne Claire1, Legrand Maryline1, Gourdier Bertrand1

1Pharmacy, CHU Robert Debre, Reims, France

Background and objective In France some drugs can be dispensed only by hospital pharmacies thanks to a temporary authorization for use (Autorisation Temporaire d’Utilisation—ATU). Besides, pharmaceutical advices concerning these drugs are often restricted. This lack of information is one of the reason why patients fail to comply with their prescription. To improve the knowledge of the treatment and thus, the compliance, a written and oral information was provided to patients by hospital pharmacist.

Design In order to give the best pharmaceutical advice, maximum useful information were collected concerning ATU drugs (the different sources were pharmaceutical companies and internet databases; existing drug informations supports). Thanks to this research a written and oral information was provided to patients treated with two selected ATU drugs (thalidomide or lidocaine patch) and a questionnaire was elaborated to assess the quality of the discussion.

Setting Reims University Hospital—Pharmacy units.

Main outcome measures Quality of (1) the welcome, (2) the reception area, (3) the drug information and (4) the written support.

Results 19 patients, average age 61.8 years (28–90) have participated. The sex ratio was 4/9. 13 treatments involved lidocaine patch and 6 thalidomide.

Before discussion, 19 patients had knowledge of the drug indication and the associated treatments.

According to the questionnaire, all the patients were satisfied with welcome and pharmaceutical team listen. 18 patients were satisfied with the reception area. For one patient the pharmacy was too far away from the hospital entrance.

The 19 patients were satisfied to have an understandable drug information whereas 12 patients really require a written information. According to the 19 patients, the size of the written support was adapted.

Conclusions These results showed a good patient satisfaction. Therefore, an adapted written support will be used to provide an understandable and clear information. A triptic folder was selected as medication information type. In the future this experience could be helpful to elaborate others ATU drugs information supports dispensed in Reims hospital pharmacy.

Keywords Compliance, Medication information

DI-118 Comparison of pharmacovigilance algorithms in reported voriconazole adverse events

Céline Eiden 1, Anaïs Grand1, Hélène Peyrière1, Dominique Hillaire-Buys1

1Medical Pharmacology and Toxicology, Lapeyronie Hospital, Montpellier, France

Background and objective To compare two algorithms in the diagnosis of voriconazole adverse events.

Design We performed a retrospective analysis of all cases of adverse drug effects (ADEs) including voriconazole reported to the French Pharmacovigilance database between 2002 and 2005. Assessment of causality was established using two Pharmacovigilance algorithms: Naranjo probability scale and Begaud method [1, 2].

Setting Department of Medical Pharmacology and Toxicology, Lapeyronie Hospital.

Main outcome measures All cases of ADEs reported in the network of the French Pharmacovigilance centres were collected. Patient’s age, sex, medications, and ADEs description were analysed. Causality assessment method Begaud is based on seven criteria, that are separated in two groups (chronology and symptoms or signs) (1). It carried out independently for each drug taken. These scores result in five final possible causality score: I0 (no imputability), I1 (dubious imputability), I2 (possible imputability), I3 (likely imputability) and I4 (very likely imputability). Naranjo et al. use an algorithm base on ten questions; for each question, three responses are possible: yes, no and don’t know (2). Scores are added up range from −2 to +12. The probability of the effect resulting from drugs is thus definite highly probable (score > 9), probable (scores 5–8), possible (scores 1–4) or doubtful (scores < 0).

Results A total of 227 ADEs cases were reported in 178 adults and 9 children (<12 years) between 2002 and 2005. Men represented 66%. According to Naranjo criteria, 5% of ADEs were notified highly probable, 7% probable, 84% possible and 4% doubtful. According to Begaud et al. method, ADEs were notified I0 for 5%, I1 for 68%, I2 for 20% and I3 for 7% of cases. The concordance between the two algorithms was assessed by the kappa coefficient. I0 + I1 scores of the Begaud algorithm were compared with the “doubtful” score of Naranjo. And the I2 + I3 + I4 scores of the Begaud algorithm to the score > 1 of Naranjo. This grouping was mandatory for the statistical analysis and was reasonable for pharmacologists. No concordance (k = 0.037) was noted between the two methods.

Conclusions Causality assessment methods are used for facilitating database analysis, in our study, no concordance exists between Naranjo algorithm and Begaud algorithm.

References

  1. 1.

    Begaud B, Evreux JC, Jouglard J, Lagier G. Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France. Thérapie 1985;40:115–8.

  2. 2.

    Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239–45.

Keywords Naranjo algorithm, Begaud algorithm, Voriconazole, Adverse events

DI-157 Development of an addendum to the British National Formulary

Lilian M. Azzopardi 1, Anthony Serracino-Inglott1, Maurice Zarb-Adami1, Stephanie Micallef1

1Department of Pharmacy, University of Malta, Msida, Malta

Background and objective The British National Formulary (BNF) which aims to provide healthcare professionals detailed information about drugs available in the United Kingdom (UK), is also used as a major reference source by Maltese healthcare professionals. However there is no formulary which is easily available for products used in Malta which are not available in the UK. The objective was to compile a formulary for products marketed locally that are not listed in the BNF.

Design A list of medicinal products available from the Maltese Medicines Authority (MMA) was used to identify products not listed in the BNF. Data for products included in the addendum were: proprietary name, dosage forms, dosage strength, consumer price, local distributor and dosage regimen. For drug entities that are not listed in the BNF the following data were also included: indications, cautions, contra-indications, side-effects and dose. A copy of the Adverse Drug Reaction (ADR) reporting card developed by the MMA was included. Copies of the addendum were distributed to ten pharmacists, ten medical prescribers and ten pharmacy and medical undergraduate students for evaluation. Permission was sought from the BNF co-publishers to prepare copies of the addendum.

Setting Community pharmacy, general practice.

Main outcome measures Production and evaluation of Addendum.

Results The addendum included 354 preparations. All the members of the evaluation group found the book useful and 22 (73.3%) preferred the book in the A5 size format. They reported that the addendum was user-friendly (26, 86.7%) and presenting up-to-date information (23, 76.7%). All agreed that an ADR reporting card should be included and 23 (76.7%) said that two copies should be included per Addendum.

Conclusions The prepared addendum was reported to be useful, informative and well presented. Such a publication should be prepared on a regular basis. One may consider producing a European Formulary covering medicines which are approved in the European Union (EU) countries.

Keywords Formulary, Drug information, Evaluation

DI-181 Antibiotic management: similarities and divergences between staff members and interns

Pieter-Jan Cortoos 1, Karel De Witte2, Willy Peetermans3, Gert Laekeman1

1Research Centre for Pharmaceutical Care and Pharmaco-economics, 2Centre for Organisation and Personnel Psychology, 3Department of Experimental Medicine, Katholieke Universiteit Leuven, Leuven, Belgium

Background and objective Recent literature on guideline implementation (1) shows the importance of the use of interventions tailored to the local situation and opinion. In order to improve our own antibiotic guideline adherence, we wanted to categorise physicians’ attitudes against antibiotic management and guidelines.

Design Focus group discussions with semi-structured interview guide, tape-recording, verbatim transcription and subsequent qualitative analysis with two independent reviewers.

Setting Internal medicine wards in a large University Hospital.

Main outcome measures Identification and categorisation of attitudes against antibiotic management and differences between interns and staff members.

Results Three focus group discussions were held in November 2006: one for staff members (n = 6) and two for interns (n = 3 + 4). Points of agreement between interns and staff members were the importance of supervisors and opinion leaders as a role model, external control on compliance with guidelines and the need for additional information and motivation in antibiotic prescribing. Points of divergence: interns felt the need for additional guideline content whereas staff members emphasized interpretation of existing guidelines. As feedback on and support of antibiotic prescribing is concerned, the role of the clinical pharmacist was widely accepted by staff members. Interns on the contrary were more reluctant towards a clinical pharmacist monitoring their prescribing behaviour.

Conclusions This qualitative analysis shows similarities as well as divergences in topics of concern between interns and staff members. Interns are more interested in the availability of extended information and support while staff members stress the relative character of guidelines. Staff members show a high approval of the role of the clinical pharmacist on the issue of antibiotic management while interns seem unfamiliar with their role. When increasing the contribution of the pharmacist in our hospital, their potential advantages e.g. as to informational support should be emphasized. In order to improve antibiotic use and guideline adherence in the hospital, the contextual and behavioural topics emerging from these focus groups will be useful in order to design and implement tailored interventions.

Reference

  1. 1.

    Steinman MA, Ranji SR, Shojania KG et al. Improving antibiotic selection: a systematic review and quantitative analysis of quality improvement strategies. Med Care 2006;44:617–628.

Keywords Antibiotic use, Guidelines

DI-184 Pancytopenia and fat overload syndrome due to a total parenteral nutrition overdose: a case report

Gaëlle Breton 1, Laurent Chouchana1, Thibaut Caruba1, Mathilde Neuville2, Christine Lebeller3, Patrice Prognon1, Laurence Weiss2, Brigitte Sabatier1

1Pharmacy, 2Clinical Immunology, 3Pharmacovigilance, European Georges Pompidou Hospital, Paris, France

Background and objective Evaluation of iatrogenic role in a total parenteral nutrition (TPN) overdosage: case report of a 43 years old woman with pancytopenia.

Design Case report with clinical and biological data collected from clinical charts and pharmaceutical records during hospitalization.

Setting Pharmacy and Clinical Immunology Departments, Regional Pharmacovigilance Center.

Main outcome measures Calculus of French imputability score is performed on chronological and semiological criteria combination.

Results Mrs CB, HIV-1 positive was admitted for visceral and cutaneous leishmania, denutrition and general health deterioration. She also suffered from a mycobacterial pneumonia.

At the admission (day 0) she weighted 32 kg and a TPN at the dose of 2000 kcal/day was initiated. At day 14 partial oral nutrition was reintroduced. At day 28, the TPN was reduced to 1600 kcal/day and the patient weighted 40 kg. At day 35, the TPN was stopped and the weight reached 42 kg.

At day 26, she presented fever (40.0°C), diarrhea and abdominal pain with unknown etiologia. The symptoms persisted 9 days with asthenia. The biological results reported a cholestasis (GGT: 109 UI/L; AP: 869UI/L), a low level hepatic cytolysis (AAT: 79 UI/L) and a pancytopenia: anemia (hemoglobin = 7.9 g/dl), neutropenia (neutrophils = 0.46 G/L) and thrombocytopenia (platelets = 113 G/L). No argument was in favor of a leishmania reactivation, a pneumonia aggravation or in favor of prescribed treatments.

Thus, a TPN overdosage was suspected and TPN was immediately stopped. Regional pharmacovigilance center evaluated imputability score of pancytopenia to level 2: clinical 2 and semiological 2. The imputability of the role of TPN was highlighted because the blood cells count increased after discontinuation.

Conclusions According to medical literature analysis, TPN overdosage appeared to be rarely described [1, 2]. Haber et al. suggested the causative role of fat sludging in different organs with micro-embolization [3]. The posology of TPN should have been adapted to oral nutrition intake and monitored to the clinical situation of the patient.

References

  1. 1.

    Heyman MB, Storch S, Ament ME. The fat overload syndrome. Report of a case and literature review. Am J Dis Child. 1981;1335(7):628–30.

  2. 2.

    Cozette P, Laxenaire MC, Borgo J. Fat overload during intake of lipids. Ann Aesthesiol Fr. 1977;18(11):911–5.

  3. 3.

    Haber LM, Hawkins EP, Seilheimer DK, Saleem A. Fat overload syndrome. An autopsy study with evaluation of the coagulopathy. Am J Clin Pathol. 1988;90(2):223–7.

Keywords Pancytopenia, Total parenteral nutrition, Overdosage

DI-203 A new psychiatric adverse effect of rivastigmine?

Claire Gautreau1, François-Xavier Chedhomme 1, Marie-Laure Seux2, Alain Chevallier1

1Pharmacy, 2Gerontology Department, Broca Hospital, Paris, France

Background and objective Rivastigmine is used for its anticholinesterasic properties in the symptomatic treatment of the mild or moderated forms of the Alzheimer disease. Its most frequent undesirable effects are digestive, cardiovascular and neurological. But rivastigmine could also cause severe psychiatric disorders.

Design Case report.

Setting Broca hospital (563 beds) including geriatric short staying and long staying patients.

Main outcome measures Mr G. 82-year-old suffering from a mild form of the Alzheimer disease has been treated first by donepezil (5 mg/day). After 6 months of treatment and a decrease of the cognitive fonctions, donepezil was considered as ineffective and replaced by rivastigmine. The posologic plan has been prescribed by steps to reach the effective dose. This treatment was well tolerated by the patient and stopped the increase of his mesic troubles. After 8 months of treatment, the patient became suddenly aggressive, hyperactive and presented obsessional troubles at the posology of 6 mg/day.

The prescription of antidepressants (citalopram 10 mg and then mianserine 10 mg/day) has been a failure because it caused confusion. Burst of paranoia appeared. Faced with the distress of the family, the doctor decided to stop the rivastigmine. Psychiatric symptoms disappeared in a few days. However, 3 months later, the nearest relations of the patient noted again a psychiatric degradation.

Results The disappearance of the psychiatric troubles after the stop of the treatment can confirm the direct imputability of rivastigmine. The legal mentions of this product do not quote so serious psychiatric side effects. We declared this case to the pharmacovigilance authorities. Only three similar cases have already been described in the literature.

Conclusions As the psychiatric symptoms reappeared, the question is: Are these symptoms attributable to rivastigmine or linked with the evolution of the disease?

This noticed undesirable effect is not really known. It confirms the obligation of a regular evaluation by the doctor in order to preserve the quality of life of the patient and its family. On the other hand, it translates the difficulty to impute a rare undesirable effect to a treatment. This difficulty is as more consequent as the Alzheimer disease is neurodegenerative and complicated in its evolution.

DI-208 Assessment and improvement of the intranet drugs order software Helios in Colmar Hospital

Emmanuel Calfayan 1, Said Melk1, Eric Pelus1, Daniel Roncalez1

1Pharmacy, Colmar Hospital, Colmar, France

Background and objective Helios is a data-processing database available on Colmar Hospital intranet. It is connected to our financial and economic management software, C-PAGE. Helios allows an easy and fast non-personal prescribing drugs order. Moreover, caregivers can use it to look for specialities registered in the therapeutic booklet.

After 3 years, it was necessary to upgrade our order software. Thus, we carried out a study to collect caregivers’ opinions about Helios.

Design A satisfaction study and an optimization of an existent database.

Setting All units of a 1500 beds General hospital.

Main outcome measures Data collected form with four items: advantages, disadvantages, functions need to upgrade and accessibility. One questionnaire by unit and many answers allowed for one topic.

Results Of 100 units, 51 questionnaires (51%) were collected. Instead of a weak computer knowledge (24.6%), Helios satisfied a large majority of caregivers. Main advantages are software easy to use (76.1%), a quick access to the database (62%) and his availability in units (77%). However 48% of units seems to have lack of information on drugs: no International Non-proprietary Name (INN), none therapeutic alternative and a difficult access to Vidal. According to the study’s results, we implemented new functions in Helios to answer caregivers’ requests. Helios allows from now to: look for drugs by INN or branded name; precise INN systematically; open drug’s Vidal page by clicking on branded name; open formulary and put drug in its therapeutic class by clicking on INN; suggest equivalent drugs held in pharmacy stock if required drug not referred; give different information about drug by icons (drug committee’s recommendations, out of stock, restricted indication).

Conclusions The Helios new version is now in function and is favourably received. By answering caregivers’ requests, we optimize our software and, consequently, enter in a process of quality improvement. Its next evolution could be his integration, even his replacement, in the future computerized medical record.

Keywords Order software, Optimization, Drug information

DI-216 Bupropion ZYBAN®lp 150 mg; the Lille poison center experience

Olivier Cougnenc1, Patrick Nisse1

1Centre Antipoison-Toxicovigilance, CHRU de Lille, Lille, France

Background and objective To describe the intoxications by ingestion of bupropion registered by the poison center of Lille.

Design Literature review and retrospective study (2001–2004) on accidental or voluntary intoxications by bupropion ingestion registered at the Lille poison center.

Setting All phone calls received by the poison center of Lille coming from hospitals or private individuals concerning a mono-intoxication by bupropion between 2001 and 2004 were included in this study.

Main outcome measures Attempt of stratification of the toxicological risk, by taking account of the Poisoning Severity Score (PSS), the ingested dose, the age and the antecedents of the patients. Comparison of the adverse events with the data of the literature.

Results Among the 42 calls concerning a mono-intoxication by bupropion (15 men, 22 months–66 years), we count 6 childrens (<15 years) and 36 adults. In 60% of the cases (n = 25) the intoxication remained asymptomatic. The most frequent appeared clinical signs, are reactions cutaneous or allergic, neuropsychiatric disorders (insomnia, distresses or depression), neurological disorders (giddinesses, cephalgias, tremors, one case of hallucination), one case of moderated arterial hypertension and two convulsive states. We note an absence of correlation between the ingested dose and the PSS (Pearson, P = 0.29).

The 4 cases whose PSS reached 2 or 3 (moderate to severe) required a hospitalization of a few days in reanimation. In close to a case of convulsion on two, the patients presented antecedents of convulsions or factors of risk of occurred of convulsions.

The toxic amount is fixed at 600 mg by catch for adults. In the child very taken of bupropion must be regarded as poison.

Conclusions These results come to support data published of pharmacovigilance and consolidates the position of the Agency of European evaluation of the drugs of 2002 which had reaffirmed that the ratio benefit/risk of bupropion (ZYBAN® in France) remained positive in the assistance with nicotinic weaning. However vigilance is of setting, and we insist on the need for respecting the posologies and precaution for use of this drug.

References

  • Tashkin DP, Kanner B, Bailey W, et al. Smoking cessation in patients with chronic obstructive pulmonary disease: A double-blind placebo-controlled randomised trial. Lancet 2001;357:1571–5.

  • Ferry LH, Robbins AS, Scariati PB, et al. Enhancement of smoking cessation using the antidepressant bupropion hydrochloride. Circulation 1992;86:671.

  • Hurt RD, Sachs DPL, Glover EB, et al. A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med 1997;337:1195–202.

  • Jorenby DE, Leischow SJ, Nides MA, et al. A controlled trial of sustained-release bupropion, a nicotine patch or both for smoking cessation. N Engl J Med 1999;340:685–91.

Keyword

Bupropion toxicity pharmacovigilance

DI-256 Stability study of azathioprine solution for pediatric use

Pierre Le Quan1, Sophie Dubouch1, Rozenn Clément1, Marie-catherine Desroches 2, Eric Singlas1

1Pharmacy, Necker-Enfants Malades Hospital, 2Pharmacy, Pitié-Salpêtrière Hospital, Paris, France

Background and objective Azathioprine is an immunosuppressant indicated in prevention of rejection of the graft in organ transplantation and in the autoimmune diseases on a purely curative basis. In paediatric gastroenterology, it is used mainly in Crohn’s disease and ulcerative colitis.

For these two main pathologies, the dosage is 2 mg/kg/day per os, without exceeding 3 mg/kg/day. Currently, the manufactured tablets (25 and 50 mg) of Imurel® were crushed then diluted in water with an aim of administrated to the patient. In absence of speciality adapted to pediatrics, the aim of this work is to study the physical and chemical stability of a drinkable suspension of 5 mg/ml azathioprine.

Design The solution (5 mg/ml) was made by dissolution of tablet in equal orasweet/oraplus® mixture (Inresa).

The stability study was carried out starting from the assay of three batches (drinkable suspensions with 5 mg/ml) at Day 0, 1, 2, 3, 4, 7, 11 and 30, stored at +4°C and conserved in resistant-light containers over 30 days, thanks to a method of azathioprine assay by high performance liquid chromatography.

Setting This study was realized in department of pharmacy of Necker University Hospital (Paris, France).

Main outcome measures With each assay, the measurement of the pH was checked, as well as a visual examination in order to determine an abnormal color. The solution was considered stable as long as azathioprine concentration was within ±5% of the initial concentration (C0) (ICH).

Results The average concentration is in conformity and equal to −4.3% C0. No peak of degradation product appeared, and the pH remained constant (pH = 4.21 ± 0.02). The yellowish aspect of the suspension did not change. Under these conditions, the drinkable suspension is stable stored at +4°C and conserved in resistant-light containers for 30 days.

Conclusions This drinkable suspension makes it possible to adapt dose for the newborn and the children who are unable to swallow the tablets. It improves the taste and the observance of the treatment too. Bacteriological stability must be verified before dispensing the drinkable suspension of azathioprine to the patients.

DI-279 Pregabalin-induced myoclonia in a patient with impaired renal function

Inge Sluyts1, Isabel Spriet1, Sandrina von Winckelmann1, Guido Van Hamme2, Michiel Dumoulin2, Etienne Joosten2, Ludo Willems 1

1Pharmacy Department, 2Geriatric Ward, University Hospital Leuven, Leuven, Belgium

Background and objective Pregabalin, a analogue of GABA reduces the release of excitatory neurotransmitters by modulating calcium channels. It has anticonvulsant, analgesic and anxiolytic activity. Myoclonia have been reported as a relatively common side effect of pregabalin. It appears that a high dose or a rapid titration of pregabalin results in a higher frequency of myoclonia. With this case report we want to illustrate this potential reversible adverse drug event.

Design Case report and literature review.

Setting Geriatric ward, University Hospital Leuven, Belgium.

Main outcome measures Evaluation of pregabalin as a possible cause for myoclonia.

Results A 74-year-old man, with a history of diabetes mellitus complicated with a bilateral limb amputation, was admitted to the acute geriatric ward because of a pneumonia. For the treatment of phantom pain the patient received 150 mg pregabalin BD since 14 days. During the present hospitalisation two episodes of diffuse myoclonic jerks associated with drowsiness has been observed. No epileptic activity, encephalitis, meningitis or acute cerebral vascular disease could be detected. After the first event, the administration of pregabalin, was discontinued. Two days after restarting pregabalin 300 mg the patient experienced a new episode of diffuse myoclonic jerks. It is noteworthy that the renal creatinine clearance was only 11 ml/min the day before the first event and 9 ml/min the day after the second one, whereas 1 week before the creatinine clearance was 49 ml/min.

The most probable explanation for the first event is the accumulation of pregabalin, which is completely excreted by the kidney implicating dose adjustments when renal function deteriorates. The maximum dose for patients with a renal clearance of <15 ml/min is 75 mg OD.

The second event is most likely caused by starting pregabalin in a dose too high without adjustments for the renal function.

For patients with normal renal function the starting dose is 75 mg BD, which can be increased to 150 mg BD within 1 week based on efficacy and tolerability. When after 2–4 weeks the drug is well tolerated but the effect is not optimal, dose may be increased up to 300 mg BD.

The Naranjo score, which estimates the probability of adverse drug reactions, is 6. A score between 5 and 8 indicates a probable relationship between pregabalin and myoclonia.

Conclusions Pregabalin should be titrated carefully and dose adjustments in patients with renal impairment are necessary to prevent severe adverse events. Clinical pharmacists can advise appropriate dosing regimes.

Keywords Pregabalin, Myoclonia, Impaired renal function

DI-316 Overestimation of the risk for ADR’s due to the presentation in the package leaflets

Mai Lindström1, Eva Tärning2, Anders Ekedahl 3

1Department of Health Sciences, Luleå University of Technology, Lulea, 2Department of Pharmacology, Faculty of Health Sciences, Linköping University, Linkoping, 3R and D, National Corp. of Swedish Pharmacies and School of Pure and Applied Natural Sciences, University of Kalmar, Sweden

Background and objective Assessing the risk of drug treatment is important in the decision making by patients and is linked to compliance. Patients’ interpretation and estimation of risk depend on how the information is presented and may play a role for how the receiver understands and interprets the information as well as the acceptance or denial of risk.

It has been known for long that we tend to overestimate the risk for unusual and underestimate the risk for common events. Presentation of the risk for adverse drug reactions in verbal form is associated with large individual differences and overestimation of the risk, and increase negative perceptions of the medicine that may increase non-compliant behaviour.

Objective: To study how the risk for adverse drug reactions is presented in patient information leaflets (PIL).

Design PIL for betablockers; opioids; anxiolytics; antihistamines and NSAID’s were collected at http://www.lakemedelsverket.se (the Swedish Medical Product Agency).

Setting Sweden.

Main outcome measures Which adverse drug reactions are mentioned and how the risk is expressed—verbally, numerically or both.

Results On two-thirds of the 123 PIL, the risk for adverse drug reaction was expressed both verbally and numerically. On one-fifth verbal expressions only were used, and for about as many the risk was sometimes expressed numerically, sometimes verbally only and sometimes in a mix. For substances, where several brands are available on the market, the ADR’s mentioned in the patient information leaflets varied from 23% (3/13) to 93% (37/40) of those found in the Summary of product Characteristics (SPC).

Conclusions There is a large variation for the adverse drug reactions mentioned and how the risk is expressed. When assessing the benefit-risk ratio of a drug treatment, the presentation of the risk for ADR’s in patient information leaflets may lead to patients’ overestimate the risk and contribute to non-compliant behaviour.

References

  1. 1.

    Halpern DF, Blackman S, Salzman B Using statistical risk information to assess oral-contraceptive safety. Applied Cognitive Psychology 1989;3:251–60.

  2. 2.

    Kahneman D, Tversky A. Choice, values and frames. American Psychologist 1984;39:341–50.

  3. 3.

    Kahneman D, Tversky A: Prospect theory: An analysis of decisions under risk. Econometrica 1979;47:313–27.

  4. 4.

    Berry DC, Raynor DK, Knapp P, Bersellini E. Patients’ understanding of risk associated with medication use: impact of European Commission guidelines and other risk scales. Drug Saf. 2003;26(1):1–11. Review.

  5. 5.

    Berry DC, Knapp P, Raynor DK. Provision of information about side-effects to patients. Lancet 2002;359:853–4.

  6. 6.

    Knapp P, DK Raynor, DC Berry. Comparison of two methods of presenting risk information to patients about the side effects of medicines. Qual Saf Health Care 2004;13:176–80.

Keywords Drug information, Package leaflets, Adverse drug reactions

EDU-15 Successful approach to the development of an integrated outcome-based curriculum

Claude Mailhot 1, Pierre Moreau1, Chantal Pharand1, Johanne Vinet1, Francoise Crevier1

1Faculte de Pharmacie, Universite de Montreal, Montreal, Canada

Background and objective Based on a relevance and feasibility study involving major stakeholders, the Faculté de pharmacie of the Université de Montréal engaged in the development of an integrated outcome-based curriculum. Our relevance study confirmed the following: population needs for services related to drug use are unmet; drug use is increasing and a need exists for interdisciplinary seamless care.

Design Literature review, focus groups, professional associations’ consultations, faculty member teamwork.

Setting Faculté de pharmacie, Université de Montréal.

Main outcome measures Program development steps; curriculum content; program architecture and design.

Results Program development involved several steps with constant interaction between clinicians and Faculty members. First, we determined fundamental program characteristics including: an outcome-based curriculum; the migration to active learning strategies, the integration of knowledge from different disciplines; the creation of interdisciplinary activities; and a more intense experiential program which includes early experiential activities. Next, we defined the competency profile of the future pharmacist. We identified the following nine outcomes (general and professional) to be mastered by pharmacy graduates: professionalism; communication; teamwork and interdisciplinarity; scientific reasoning and critical thinking; self-directed learning abilities; leadership; pharmaceutical care; community services; and finally management and operations. The next step was to make an inventory of all cognitive material essential for each outcome development including knowledge units, skills and attitudes. This material was then reorganised as follows: annual themes were identified. Knowledge mapping procedure was used to design learning modules. The 5 modules span over nine trimesters and integrate several disciplines: Module 1: Drugs and man; Module 2: Drugs and society; Module 3: Skills laboratories; Module 4: Integrative activities; and Module 5: Clerkships. Program architecture has been profoundly redesigned and now integrates externships and internships.

Instructional design for each integrated course will be performed by multidisciplinary teams which includes a clinical pharmacist. Delivery of courses is done by the same multidisciplinary teams. Educational approaches selected will promote significant involvement of students through active learning strategies. Use of portable computers is mandatory.

Conclusions The new program has been recognized by the Quebec Board of pharmacy and graduates will have immediate practice privileges. Our successful and structured approach to program development was based on active participation of Faculty members and clinicians working in multidisciplinary teams.

Keywords Pharmacy program development, Clinical pharmacy curriculum

EDU-47 Improving the awareness of inpatient nursing staff about medication errors: the clinical pharmacist’s perspective

Dr. Asim Elnour 1, Dr. Nagy N. H. Ellahham1, Huria H. I. Al Qassas2

1Pharmacy, 2Nursing, Al Ain Hospital, Al Ain, United Arab Emirates

Background and objective This study describes the inpatient nursing staff perceptions, attitudes and practices on medication errors. The main objective is to raise the awareness of the inpatient nursing staff about medication errors. The study demonstrates the benefits of a program encompassing continuing education and training of inpatient nursing staff on a computerized medication safety program (Med Safe® Tool) with regard to reporting medication errors.

Design A systematic sample of the inpatient nursing staff in the Al Ain hospital (n = 370) was included in the study and completed a self-reported questionnaire about medication errors. A structured program was developed and used by the clinical pharmacists to identify the underlying nursing attitudes and practices on medication errors and other medication related safety issues. The program consisted of a pre/post self-reported questionnaire, a training service and an educational material (successive presentations and handouts). The self-reported questionnaire included 20 open ended questions asking the nurses their opinions about medication errors. A training program on medication safety (Med Safe® tool) was carried out by the [clinical pharmacy team (n = 2) and the quality coordinator nurse (n = 1)], for each group of 10 nurses. An oral presentation was performed during the training program. An educational booklet was developed by the clinical pharmacists and was distributed (post baseline questionnaire) to the nursing staff.

Setting The study site was Al Ain Hospital, a teaching hospital in the Al Ain, United Arab Emirates (UAE).

Main outcome measures The questionnaire results at baseline and post intervention.

Results Findings revealed that there were differences in the perceptions of nurses about the causes and reporting of medication errors. There were statistically significant differences in responses across the participant’s years of experience and the current clinical working area. The participant’s responses improved significantly post interventions (P < 0.05).

Conclusions The clinical pharmacy services on medication errors and medication related safety issues were perceived to be very fruitful. The clinical pharmacist’s structured program has provided benefits in terms of raising the awareness of the inpatient nursing staff about medication errors and about electronic reporting of medication errors.

References

  1. 1.

    Institute of Medicine. (1999) To Err is Human: Building a safer health system. Washington DC: National Academy Press.

  2. 2.

    Mayo AM and Duncan D. (2004) Nurse perceptions of medication errors: What we need to know for patient safety. J Nurs Care Qual, 19(3), 209–217.

Keyword Clinical errors pharmacist

EDU-50 Evaluation of drugs administrated by gastric enteral feeding in neuro-paediatrics unit

Elodie Garric 1, Rachel Favreau1, Delphine Pozzi1, Maryvonne Villart1

1Pharmacy, University Hospital R. Poincaré, Garches, France

Background and objective Neuro-paediatrics unit of University Hospital R. Poincaré (45 beds) accommodates children suffering from dysphagia (encephalopathy, myasthenia, tetraplegia…). More than 50% of them are fed by gastric enteral feeding tube or from gastrostomy, which can involve problems of drugs administration. In order to better know nurses daily practices, pharmacy set up an evaluation of drugs administration by gastric enteral feeding tube in this service.

Design Prospective open study lasting 15 days.

Setting Neuro-paediatrics unit.

Main outcome measures An observation of drugs preparation and administration to gastric enteral feeding patients was carried out and a data of pharmaceutical information that could be given to nurses has been realized. Also, an evaluation of storage conditions of oral solutions after opening was carried out.

Results Every drugs of one patient are crushed and mixed in a mortar (tablets, oral solutions, injectable solutions…) with mineral water and administrated next by gastric enteral feeding tube in only once.

Started oral solutions are all stored at ambient temperature and 42% of the bottles do not have opening date indicated. Nurses do not have concept on conservation conditions of different oral solutions.

Conclusions All these practices could involve drugs errors by effectiveness reduction and toxicity. To improve drug safety, an administration guide intended for doctors and nurses was worked out by pharmacy, with pharmaceutical laboratories help.

It gathers information about galenic formal amendment, eventual substitution by forms adapted (oral solutions, dispersives tablets…) and oral solutions stability durations after opening. A protocol of drugs preparation for gastric enteral feeding tube will be set up soon as well as a training to nurses on site.

Keywords Gastric enteral feeding tube, Drug administration, Drug safety

EDU-67 Using e-learning to promote interprofessional working between pharmacy and medical students

Michael Gibson1, Lorna McHattie1, Laura Binnie1, Lesley Diack 1

1School of Pharmacy, The Robert Gordon University, Aberdeen, United Kingdom

Background and objective The use of e-technology to deliver undergraduate education is becoming increasingly recognised. Such delivery methods can overcome many logistical issues associated with interprofessional education (IPE). The aim of this project was to develop and evaluate a web-based virtual learning environment (VLE) IPE module. The objectives were to identify a topic of study relevant to the professional groups involved, to develop the course including the use of web based video content and to evaluate the attitudes and experiences of the students involved.

Design A VLE module on the topic of diabetes was developed and delivered to Year 3 pharmacy and medical students using the Robert Gordon University’s Virtual Campus. At the start of the module the students attended an introductory session outlining the course content and instructions on how to use the VLE. The students then took part in a series of online sessions over a period of 5 weeks using a range of information including electronic patient notes and online videos to jointly develop a clinical management plan. Focus groups and a quantitative survey were conducted to elicit information about the students’ needs, attitudes and experiences of the module. The data from the focus groups were transcribed and analysed using N-Vivo. The quantitative questionnaire included key themes identified in the focus groups as well as questions based on the Readiness for Inter-Professional Learning Scale (RIPLS) [1].

Setting Aberdeen.

Main outcome measures Attitudes towards e-learning as a method of delivering IPE and course evaluation.

Results Despite a majority of respondents indicating that face-to-face interaction was preferable (77.8%) a number (33.3%) agreed that the course was likely to increase their future interprofessional communication. A large majority of respondents agreed that learning with other students will make them a more effective member of a health care team (88.9%) and indeed would welcome the opportunity to share some generic lectures and tutorials with other health care students (77.8%). The response rate to the questionnaire was 33%. Key themes arising from the focus groups included an appreciation of the potential benefits of interprofessional education and the importance of face-to-face and non-verbal communication.

Conclusions Both sets of students finished the pilot course with a deeper appreciation and understanding of the other’s roles and responsibilities demonstrating that two interprofessional groups can successfully study together and that this can be achieved online. The module has now been embedded into the curriculum and has now been rolled out to all Year 3 pharmacy students.

Reference

  1. 1.

    Parsell G, Spalding R & Bligh J. (1998) Shared goals, shared learning: evaluation of a multiprofessional course for undergraduate students Medical Education 32:304–310.

Keywords Interprofessional education, e-Learning

EDU-70 Evaluation of pharmacist interventions on a computerized physician order entry (CPOE) system

Audrey Toledano1, Stéphanie Castagnet1, Zahira Benabadji1, Fouad Chiadmi1, Salvatore Cisternino 1, Joel Schlatter1, Olivier Fain2, Jean-Eudes Fontan1

1Pharmacy, 2Internal Medicine, Jean Verdier, Bondy, France

Background and objective A computerized physician order entry system (PHEDRA®) has been implemented in the internal medicine unit and the pharmacy since May 2006 in order to increase the safe use of medications and to improve the patient safety. All the drug prescriptions of this unit are reviewed and analyzed by a pharmacist. The aim of this study is the evaluation of this activity by accurate indicators.

Design 10 week retrospective evaluation of prescription orders and pharmacist interventions.

Setting Department of Pharmacy, Department of Internal Medicine, University Hospital of Jean Verdier.

Main outcome measures We reviewed all the medication orders during 2.5 months. Drug-related problems and pharmacist interventions were collected and analysed according to the pharmaceutical interventions classification of the French Society of Clinical Pharmacy (SFPC).

Results 1731 orders resulted in 241 drug-related problems (14%) and 206 pharmacist interventions (11.9%). Of 241 drug-related problems, 70 (28%) were categorized as error of drug dose unit (i.e. mg vs. ml), 35 (15%) as non-conformity to guidelines or contra-indication, 30 (13%) as lack of data in prescription, 30 (13%) as lack of monitoring, 22 (9%) as drug schedule error, 20 (8%) as overdosage, 14 (6%) as inappropriate drug route or administration, 9 (4%) as drug interaction, 7 (3%) as useless drug and 2 (1%) as underdose. Of 206 pharmacist interventions, 101 (49%) were classified as drug schedule modification, 38 (18%) as therapeutic monitoring, 33 (16%) as drug substitution, 12 (6%) as administration schedule optimisation, 12 (6%) as prescription breaking off, 6 (3%) as drug schedule adaptation and 4 (2%) as completion of data prescription.

Conclusions Most of pharmaceutical interventions are due to drug schedule errors but these could be partially explained by the lack of experience of residents using this CPOE system.

As the order analysis by the pharmacist can’t detect drug administration errors, the presence of a pharmacist in the medical unit remains useful for drug error prevention.

Keywords Computerized Physician Order Entry system, Pharmacist interventions, Drug-related problems

EDU-76 Providing pharmaceutical care—academic development of a professional competency

Chantal Pharand 1, Louise Mallet1, Johanne Vinet1, Céline Léveillé-Imbeault1, Julie Couture1, Judith Choquette1, Françoise Crevier1

1Faculty of Pharmacy, Université de Montréal, Montreal, Canada

Background and objective One of the main professional competencies that a pharmacy student must acquire throughout his pharmacy program is the ability to provide pharmaceutical care. In the context of transforming our bachelor’s degree into a professional doctorate in pharmacy (PharmD), it was decided that this competency would be the “pivot” or at the center of the 14 Pharmaceutical Care courses. In order to provide a uniform language amongst faculty and students, the pharmaceutical care process was reviewed. An integrated approach using different disciplines (pathophysiology, biopharmaceutics, pharmacology, pharmacotherapy, etc.) will be used in the new program. These courses will be organised according to the various biological systems (cardiology, nephrology, etc.). We describe herein how the pharmaceutical care process was mapped and used to create an interactive teaching tool for all 14 courses.

Design This process was developed in three steps by a team of Faculty members: (a) systematic analysis of the competency; (b) development of a teaching tool prototype; (c) elaboration of Pharmaceutical Care courses.

Setting Faculté de Pharmacie, Université de Montréal.

Main outcome measures A team of 6 community and hospital pharmacists, along with an instructional designer, developed a detailed map of the cognitive process involved in providing pharmaceutical care using software specifically designed for that purpose (MotPlus®). Then, using a simplified version of the cognitive process, the prototype of an interactive teaching tool of pharmaceutical care was developed.

Results Mapping of the cognitive process in providing pharmaceutical care resulted in 295 knowledge units. To facilitate the implementation of this active learning strategy, the prototype will be used to develop a Web tool that will allow students to “travel” throughout the process, to listen to audio capsules or to watch videos attached to the different knowledge units. This Web tool will be used in four different modes: consultation, problem solving, observation, and authoring. The simplified version of the pharmaceutical care process knowledge map will also be used by students in Pharmaceutical Care courses by our students to analyze and solve problems in order to acquire the necessary knowledge and gradually develop the competency.

Conclusions By making explicit this complex pharmaceutical care process by the use of a validated knowledge map and applying it throughout the different courses of the new program, the students’ learning process will be facilitated and allow a better development of the competency.

Reference

  • Making explicit this complex process by the use of a validated knowledge map and applying it throughout.

Keywords Pharmaceutical care, Knowledge map, Competency

EDU-101 Non applicable

Claire Guisset1, Sophie Perriat 1, Laurent Giraudon1, Nanaz Afifi1, Christine Blondin1

1Pharmacy, CHIBT, Sète, France

Background and objective Compliance of Health Care Centers to Recommendations for antibiotic treatment issued by the Anti-Infective Committee is a pre-requisite for harmonization of practice across centers, improvement of the quality of antibiotic treatments, and better control of bacterial resistance.

Evaluation of local compliance to Recommendations for antibiotic treatment appeared necessary in order to optimize the actions of Anti-Infective Committee.

Design Two-month observational prospective study to evaluate how Recommendations were applied.

Setting We analyzed, in three departments (medicine, surgery, geriatric), the conformity of antibiotic treatment used in urinary tract infections to Recommendations established in 2002 in collaboration with the doctors.

Main outcome measures Type of urinary infections, antibiotics prescribed, treatment duration, germ involved and level of compliance to Recommendations….

Results The study was conducted on 60 patients with mean age of 60.3 years. 58% of them had been hospitalised due to urinary infection. Observed pathologies were mainly uncomplicated pyelonephritis (40%) and cystitis (35%). An ECBU was systematically performed at initiation of the antibiotic treatment, as recommended, and it was contributive in 87% of cases. The germ that was most frequently found was E. coli, in 46% of total isolated germs. 26% of these E. coli were resistant to penicillin A and 19% were resistant to both penicillin A and fluoroquinolones. 72% of therapeutic strategies employed by different departments were found non compliant to the Recommendations. The main non-compliant events observed were:

  • An un-adapted treatment duration (48%).

  • An un-adapted strategy (28%). Notably, 52% of cystitis cases received a bi-therapy instead of the recommended mono-therapy.

  • An adapted strategy using molecules outside the list issued by the Anti-Infective Committee. Strikingly, 97% of the bi-therapies used in pyelonephritis were association of ofloxacine and cefotaxime or ceftriaxone (no valid molecules) instead of recommended associations: C3G + aminoside or Ofloxacine + aminoside.

Conclusions Our observations illustrate difficulties of distribution and assimilation of information by clinicians. They also highlight the need for education during the implementation of Recommendations. Due to their strategic place in the medication circuit, pharmacist should actively participate in this education, specifically when validating antibiotic prescriptions. Based on the results of present study, the Anti-Infective Committee has decided to reinforce training of doctors by:

  • Communicating present results to the concerned departments.

  • Accompanying the distribution of the new Recommendations that were established after enquiry, by using support defined with clinicians and Renewing information on the Recommendations’ objectives upon arrival of new medical staff members (residents…).

EDU-117 The attitudes of pharmacy students in Scotland and Ghana to patients with HIV/AIDS

Scott Cunningham 1, Ruth Edwards1, Derek Stewart1, Lesley Diack1, Mahama Duwiejua2

1School of Pharmacy, The Robert Gordon University, Aberdeen, United Kingdom; 2Faculty of Pharmacy, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana

Background and objective Sub-Saharan Africa is the area in the world most affected by HIV/AIDS [1] and resistance to antiretroviral therapy is increasing in the UK [2]. Such therapy improves outcomes but full benefit requires near-perfect adherence. This may be enhanced through patient counselling [3]. Understanding attitudes of pharmacy students to patients with HIV/AIDS will help develop effective education for pharmacists. This study investigated differences in and factors that may influence the attitudes of first year pharmacy students in Ghana and Scotland to patients with HIV/AIDS.

Design Pre-piloted anonymised questionnaires were distributed to first year pharmacy students at each institution (RGU n = 134 and KNUST n = 139). Mann–Whitney U test in SPSS for Windows version 13 (SPSS Inc.) was used to test for differences in attitude scores using an 18 item validated instrument with a 6 point scale (1 = strongly disagree and 6 = strongly agree).

Setting Schools of Pharmacy in Scotland and Ghana.

Main outcome measures Demographic characteristics and statistical analysis of item scores.

Results Response rates were RGU; 45.5% (61/134) and Ghana; 91.4% (127/139). Respondents; between 18 and 20 years old—RGU 63.9% (39/61)/Ghana 81.9% (104/127), female—RGU 67.2%, (41/61)/Ghana 43.3%, (55/127) and had never worked in a pharmacy practice setting—RGU 52.5% (32/61)/Ghana 84.2% (107/127). Preferred practice setting for the majority on qualification was; community pharmacy at RGU (57.4%, 35/61) and industrial pharmacy in Ghana (55.1%, 70/127). Statistical analysis showed that there was no significant difference between students at each institution in the total score (median Ghana, 79.24 vs. RGU, 79.1; P = 0.776) for the 18 items on the instrument. However, there was a significant difference in each of the sub-themes relating to ‘working with’ (Median Ghana 35.67 vs. RGU 38.97; P = 0.001) and ‘emotion toward’ (Median Ghana 43 vs. RGU 40.1; P < 0.001) patients with HIV/AIDS.

Conclusions Conclusions are limited by differences in response rates but this study indicates that pharmacy student attitudes to patients with HIV/AIDS may differ due to a variety of factors including demographics, preferred practice setting and practice experience. Understanding these factors will facilitate the development of effective education programmes for pharmacists.

References

  1. 1.

    Anon. Greater HIV prevention needed to slow epidemic. Pharmaceutical Journal 2005;275:656.

  2. 2.

    UK Group on Transmitted HIV Drug Resistance. Time trends in primary resistance to HIV drugs in the United Kingdom: multicentre observational study. British Medical Journal 2005;331:1368.

  3. 3.

    Haddad M, Inch C, Glazier RH, Wilkins AL, Bayoumi A, Rourke S. Patient support and education for promoting adherence to highly active antiretroviral therapy for HIV/AIDS. The Cochrane Database of Systematic Reviews 2000;Issue 3.

Keywords HIV/AIDS, Pharmacy student attitudes, Factors influencing

EDU-190 Good use of medicines contract: chemotherapy prescriptions evaluation

Delphine Baylot 1, Isabelle Moullet2, Philippe Ardisson2, Armelle Jarrige1

1Pharmacy, 2Oncology, Clinique de la Sauvegarde, Lyon, France

Background and objective For the “good use of medicines contract”, our health system has defined for each expensive drug a special indication that must be respected. In oncology, using expensive drugs, each establishment has settled a list of protocols, ranked by groups, functions of indications. They must be international standards as much as possible, or in case of control by the Health System, we must refund the cost of unjustified treatments.

Design Determination of the group for each protocol and statistical study on 4 weeks (December 2006).

Setting Oncology day hospitalization department in private clinic.

Main outcome measures Categorization into group 1; 2a; 2b; 2c and 3 of each chemotherapy prescription for respectively protocols with validated indications or international standards (folfox 4 in adjuvant colorectal cancer); scientifically validated protocols by serious and concordant publications (gemcitabine-carboplatin in advanced bladder cancer); little number of reported cases needing an evaluation (vinorelbine in metastatic prostate cancer); logical indications without publications (gemcitabine-topotecan in second line ovary cancer); unrecognized indications (cetuximab-oxaliplatin in second line for metastatic colorectal cancer).

Results 236 patients were treated, 409 protocols done, group 1 = 66.5% (272), group 2a = 20.5% (84), group 2b = 0.5% (2), group 2c = 0.5% (2), group 3 = 12% (49). Breast oncology represents 28.1% (115) of the protocols: group 1 = 67.8% (78), group 2a = 25.2% (29), group 3 = 7% (8). Digestive oncology represents 25.4% (104) of the protocols: group 1 = 55.8% (58), group 2a = 21.2% (22), group 2b = 1.9% (2), group 3 = 21.2% (22). Urologic oncology represents 13.9% (57) of the protocols: group 1 = 64.9% (37), group 2a = 19.3% (11), group 3 = 15.8% (9). Gynecologic oncology represents 9.3% (38) of the protocols: group 1 = 63.2% (24), group 2a = 21.1% (8), group 2c = 5.3% (2), group 3 = 10.5% (4). Thoracic oncology represents 7.3% (30) of the protocols: group 1 = 40% (12), group 2a = 40% (12), group 3 = 20% (6). Hematological and head and neck oncology represent respectively 11% (45) and 4.4% (18) of protocols, only in group 1.

Conclusions 66.5% of our protocols are in group 1, but it could be up to 70% if we consider that 22.5% (11/49) of group 3 protocols are irinotecan-bevacizumab (a continuity of folfiri-bevacizumab for fragile patients). And more, a huge part of 2a protocols are group 1 protocols adapted for a better tolerance (cisplatyl switched by carboplatin). Although most of group 3 protocols are third lines chemotherapy for patients without others therapeutic alternatives, we must now avoid prescribing unrecognized protocols to give to patients chances to be cured with demonstrated efficiency treatments, and we must keep on prescribing as many group 1 protocols as possible, not to refund the treatment cost to our Health System.

EDU-227 Evaluation of methods for teaching and assessing undergraduate pharmacy students in a clinical placement

Annette Freidank 1, Steve Hudson2, Moira Kinnear2, Julienne Johnson2, Roland Radziwill1

1Pharmacy, Klinikum Fulda, Fulda, Germany; 2University of Strathclyde, Glasgow, United Kingdom

Background and objective Since 2000 Clinical Pharmacy has been part of the curriculum of Pharmacy Education in Germany. The subject Clinical Pharmacy should be taught in seminars or workshops with suitable assessment methods. This project evaluated different methods for teaching and assessing undergraduate pharmacy students in a clinical placement. A three day intensive clinical pharmacy teaching programme had been delivered to a group of pharmacy students. The outcome of the students with different assessment methods had been evaluated.

Design Some 24 students of the Philipps-University in Marburg attending the eighth semester opted for the project and were assigned by random to four groups, including one control group. After one introduction day at the university in Marburg, the students of the intervention groups were attached for one day to a ward at the hospital in Fulda. Afterwards each student had to write a pharmaceutical care plan, judged by a clinical pharmacist.

All 24 students attended an objective structured clinical examination (OSCE) in Fulda and a final written examination at university, which is mandatory. The OSCE included 10 stations, 6 theoretical stations and 4 with a role-play-station with an interview of a simulated patient or doctor.

Setting The Clinical placement was held at the Klinikum Fulda, located 120 km from Marburg. The hospital is a teaching hospital of the Philipps-University in Marburg with 950 acute beds. The students had been attached to the neurological ward, the orthopaedic clinic or the day cancer clinic.

Main outcome measures The OSCE had been tested for reliability. The OSCE and the final written exam had been compared for the ranking of the students. The outcome of the students of the intervention and the control group had been compared. The students view had been evaluated by questionnaires and a focus group discussion.

Results The reliability of the OSCE had been proved with Cronbach’s alpha (0.639), which could be improved if the final written examinations had been included (Cronbachs alpha 0.726). There was a mean correlation of the results within the OSCE and the final written examination. There was no difference in the outcome of the students of the intervention and the control group. The students improved their problem-solving and analytical skills, benefit from the day at the ward and felt the OSCE to be a good method to practice and prove their theoretical knowledge and practical skills.

Conclusions The teaching of Clinical Pharmacy within small groups, the opportunity to work with real patients and the assessment by suitable methods should be implemented into the curriculum. To verify these results another course has been offered once more. The course with 16 students will be finished in February. The results will be presented.

Keywords Clinical pharmacy, Education, OSCE

EDU-229 Communication and ethics skills course at the Faculty of Pharmacy, Bratislava, Slovakia

Anna Olearova 1, Alena Fekarova1

1Department of Organization and Management in Pharmacy, Faculty of Pharmacy, Comenius University, Bratislava, Slovakia

Background and objective Good communication skills in pharmacy practice are very important part of successful treatment of patients. Pharmacy students in Bratislava, Slovakia have possibility to improve the communication skills during their pharmacy study.

Design Evaluative study and report.

Setting The course called “Basics of Pharmaceutical Ethics and Psychology” is set in Faculty of Pharmacy for undergraduate students in eighth semester of their study. The questionnaire was designed for students to observe their communication skills before and after the course.

Main outcome measures Quantitative and qualitative evaluation of communication skills improvement in pharmacy students before and after the “Basics of Pharmaceutical Ethics and Psychology” course.

Results The course is design as complex of lectures and workshops for undergraduate pharmacy students when they are in the first semester of the fourth year of their studies. Within the scope of course, student through simulations and discussions are able:

  • to find personality types

  • to use and know the value of non-verbal communication

  • to learn how to communicate with difficult patients (aggressive, rude, elderly, confused, chronic patient…)

  • to solve conflicts with colleagues, patients, and other health care providers

  • to learn how to fight with stress

  • to find basics of ethics codex in pharmacy

Students (n = 210) were satisfied in 95% with quality and content of the course at the end. Students were able to know their personality type in 56% before, and in 98% after the course. Using and knowing of non-verbal communication was known by 42% of students before and by 93% after the course. Students thought they would know communicate with difficult patients in 27% before and in 87% after the course. Ethics codex of the pharmacists was known in 19% of students before and in 92% after the course.

Conclusions “Basics of Pharmaceutical Ethics and Psychology” course improved communication and ethics skills in pharmacy students. Further developing of this useful programme and cooperation with a psychologist and communication expert is going on.

Keywords Communication skills, Pregraduate course, Slovakia

EDU-320 National survey on clinical pharmacy practices by residents in France

Maxime Detavernier1, Fabien Calcagno2, Matthieu Roustit 1, Thierry Romanet1, Pierrick Bedouch1, Benoît Allenet1, Jean Calop1

1Pharmacie, CHU Grenoble, Grenoble; 2Pharmacie, Pitié Salpétrière, Paris, France

Background and objective French Clinical Pharmacy (CP) started in 1984 after the reform of pharmaceutical studies. The main tasks carried out by clinical pharmacists in hospitals were originally the purchasing and distribution of medication. For the last 10 years, they have become aware of the importance of bringing together the various care units in a hospital in order to improve the use of medication. Nevertheless, this practice is not yet widespread in French hospitals. Residency is probably an ideal way to get the skills needed in CP.

The aim of our study was to consult all the residents being trained in France in order to collect information about their practices, their needs and their expectations about CP.

Design We realized a questionnaire to assess: residents practices and knowledge on CP; CP activities according to Bond et al. [1]; actual means and training; residents expectations towards the practice of CP.

This questionnaire was distributed nationally.

Setting French hospitals.

Results Eighty-eight residents answered the survey. Among them, 38% were assigned to a clinical unit: 80% of them spent <25% of their working time in clinical units. Sixty-two residents (70%) practiced at least one of CP activities according to Bond et al.: 1. information about medications (33%); 2. prescribing evaluation (28%); 3. adverse events management (18%). 70% are unsatisfied with their practical training and 90% expect CP courses during their Pharmacy degree.

Conclusions The definition of CP is well understood by residents. Access to CP is still limited, but there is a positive evolution in its development. Of interest, CP activities are mainly focused on drug management and not patient-centered. In addition, French residents report a lack of practical and theoretical teaching of CP. This may represent a limiting factor to its development. Therefore, a systematic and practical teaching of Clinical Pharmacy should be a key to improve and standardize practices.

Reference

  1. 1.

    Bond CA, Raehl CL, Franke T.Clinical pharmacy services and hospital mortality rates. Pharmacotherapy, 1999.19(5):p. 556–64.

Keywords Clinical pharmacy, Residents, University of pharmacy

EDU-323 The importance of clinical pharmacy practices in clinical settings for the undergraduate pharmacy students (An Evaluative Study)

Emel Mashaki Ceyhan 1, Philip M. Clark2

1Clinical Pharmacy-Pharmacovigilance, Bristol-Myers Squibb, 2Pharmacology, Yeditepe Üniversity-Faculty of Pharmacy, Istanbul, Turkey

Background and objective To evaluate and measure the importance and benefits of having a clinical pharmacy practice course within the curricula conducted in the clinical settings for the undergraduate pharmacy students.

Design Literature review, study of other universities clinical pharmacy practical courses, design a 1 year course for the undergraduate level, setting three different hospitals, selecting the convenient wards and evaluating the feed backs of students and the outcomes through a questionnaire.

Setting Yeditepe University Hospital (different wards)

A public Hospital-Göztepe Research & Teaching Hospital (internal, Surgery, Pediatrics, Infection, Dermatology wards)

A private Hospital-Anatolian Hospital (Oncology, Intensive Care Unit, cardiology wards)

Main outcome measures Determining the advantages of having such a practical course for students or the disadvantages, determining the most effective wards and using the SPSS data evaluating program to reveal the outcomes of this pilot study.

Results Of 20 undergraduate students year of pharmacy 88.8% confirmed the educative role of clinical pharmacy practices and 66% of the students indicated the effect of such courses on their patient oriented attitude and 72% declared that such courses enhanced their collaboration with the other health care professionals. The results also revealed that 61% of the students preferred public hospitals where more cases can be followed-up. However, infection disease 61% and pediatrics 50% were the most selected wards by students.

Conclusions Introducing a clinical pharmacy practice course in clinical settings and percent hospitals within the undergraduate curricula of pharmacy which matches the theoretical courses enables the students to better understand the concept of clinical and patient-oriented pharmacy, it helps in the integration of the future pharmacists in the health care system and helps in the development of clinical pharmacy within the hospitals.

References

  • Hanning Lyn et al. A New Approach To Clinical Pharmacy Practice Teaching in the Four-Year Degree Course. The Pharmaceutical Journal, Vol. 269, p. 164, 3 August, 2002.

  • Hepler CD, Strand LM. Opportunities and Responsibilities in Pharmaceutical Care. Am J Hosp. Pharm. 1990;47:533–43.

  • Currie D. Jay, et al. A Practical Guide to Pharmaceutical Care. 2nd edition, Amazon, USA, 2003, Chapter 1, p. 3–5.

Keywords Clinical pharmacy, Education

NUTR-42 Stability of vitamins in parenteral nutrition admixtures intented for newborn, infants and children

Raphaël Vazquez 1, Sophie Calvez2, My Dung Le Hoang1, Melissa Benmeziani1, Dominique Pradeau1, Bernard Do1

1Analytical Development Laboratory, 2Regulatory, AGEPS, 75005, France

Background and objective The use of vitamins is recommended at the first day for any parenteral nutrition. However, vitamins miss in the binary admixtures intended for newborn and children developed by the Paris hospitals and so must be added before the perfusion. The aim of this study was to assess the stability of vitamins during 24 h (duration of an infusion) on these admixtures.

Design Three independent tests were carried out on three different mixtures.

Setting This study takes place in the public establishment of Paris hospitals.

Main outcome measures The follow-up of the content of vitamins (10 among the 12 present in the solution) and the formation of potential products of degradation in the mixture was investigated by a method associating HPLC/UV/MS. The technique was developed and was validated at the laboratory and allows analyses the liposoluble and water-soluble vitamins simultaneously, with sufficient sensibility and specificity.

Results After 24 h, no significant difference was noted concerning the aspect, the colouring and the limpidity of the solutions. The chromatographic profiles at T0 and T24 were identical. For all admixtures the vitamins stability remained within acceptable ranges except ascorbic acid. In the G15 and G25 children admixtures the rate of ascorbic acid was respectively 82.6 ± 4.9% and 87.0 ± 2.5% compared to the solutions at T0. In the G15 child mixture the lower limit of the confidence interval of dexpanthenol is near the limit of acceptability: 97.1 ± 7.6%.

Conclusions Thus, after 24 h, it was not observed major matrix effect on the stability of the vitamins. On the chromatographic profiles it was not appeared other compounds after the introduction of these vitamins. Lastly, there were no significant interactions of the container towards the contents. This study confirms the possible addition of vitamins in these parenteral nutrition admixtures.

Reference

  • Koletzko B et al. Vitamins. J Pediatr Gastr Nutr 2005 Nov;41(Suppl 2):S54–S62.

Keywords Parenteral nutrition, Vitamins, Stability

NUTR-74 A 12 year survey of home parenteral nutrition in a French approved centre

Amélie Rousseaux 1, Adeline Danielou1, Vanessa Palascak2, Dominique Leveque1, Laurence Beretz1, René Baumann2

1Pharmacy, 2Hepatogastroenterology, Hôpital de Hautepierre, Strasbourg, France

Background and objective In France, home parenteral nutrition (HPN) is provided by regionalized approved centres located in teaching hospitals. The aim of our study was to review the profile of adult patients receiving HPN, since the creation of the centre in 1994.

Design Retrospective study.

Setting Approved centre of HPN for adults in Strasbourg.

Main outcome measures Data were retrospectively collected (1994–2005) from medical and pharmaceutical records of all patients followed by our HPN centre.

Results Fifty-three patients (mean age: 48.8 years, range 13.1–79.7 years) were included, and were given 56 HPN treatments. The major indications were short bowel syndrome (71%), and chronic pseudo-obstruction or occlusion (13%). The underlying diseases in patients with short bowel mainly were Crohn’s disease (32%) and mesenteric ischemia (40%). Nutritive mixtures were tailored preparations that were provided with disposable equipment and infusion pumps by the hospital pharmacy. Nutritional mixtures were mainly (57%) delivered through tunnellized catheters and the regimen of perfusion was nocturnal in all patients. The mean duration of HPN was 3.3 years (range 2 months–10 years). The mean number of nutritional bags were 4.8/week (range 1–7) at the beginning of HPN treatment Two hundred and 57 hospitalizations occured for 47 patients, mainly in relation with catheter related infections (55%) and nutritional assessment (13%). Parenteral nutrition was withdrawn during 61.5% of the hospitalizations. At the end of the survey (December 31, 2005), 18 (34%) patients continued HPN, 13 (38%) had stopped and 18 (34%) had died. Four deaths were related to parenteral nutrition and resulted from sepsis.

Conclusions This study is the second French survey on long term HPN patients [1]. The characteristics of our data are the absence of patients with cancer, the long duration of HPN (3.3 years vs. 11 months), and the type of nutritive mixtures (only personalized) [1].

Reference

  • Nutrition parentérale à domicile: bilan de 14 ans d’activité d’un centre agréé. F Gonzales et al. Nutr Clin Metabol 2001;15:16–22.

NUTR-291 Study of polyvalent intravenous immunoglobulins indication in neurology over 2006

Anouk Bernard 1, Latifa Haddad1, Angélique Leroy-Cotteau1, Elise Toguyeni1, Monique Yilmaz1

1Pharmacy, CHRU, Lille, France

Background and objective Polyvalent intravenous immunoglobulins (Ig IV) are widely prescribed in neurology. To avoid an increasing use of Ig IV, it seems important to assess the good practice.

The aim of the study is to list patients with intravenous immunoglobulin treatment and their indication over 2006.

Design A list of patients is extracted from PROSANG® from January to December 2006. Indication and tolerance to treatment were checked off in each patient file. The pharmacy department has bought intravenous immunoglobulins TEGELINE®, GAMMAGARD® and ENDOBULINE® which has been switched with OCTAGAM® since August 2006.

Setting Neurology Department of University Hospital of Lille.

Main outcome measures Number of patients per indication.

Results The patients are 79 adults and 11 children. 86 of them are treated by TEGELINE® four are instituted with ENDOBULINE® and three continue with OCTAGAM® 94% of the indications belong to label: chronic inflammatory demyelinating polyneuropathy (35%), acute myasthenia (23%), Guillain-Barré syndrome of adult (17%). 6% of the indications are off label: polyneuropathy associated with monoclonal gammopathy Ig M anti MAG (1%), intractable epilepsy of child (1%) and Guillain-Barré syndrome of child (4%).

Conclusions TEGELINE® is well tolerated. Only 4 patients required Ig IV with a weak rate of Ig A (ENDOBULINE® or OCTAGAM®) and no patient needed GAMMAGARD®.

Although few indications are off label, they were ratified by scientific recommendations emitted by the CEDIT. Moreover each off label indication was validated by pharmacists. Immunoglobulins are dispensed within the framework of a Contract of Good Practice. At last our referential was reviewed, thus positioning new indications in the Contract of Good Practice, such as multifocal motor neuropathy with persistent conduction blocks and Guillain-Barré syndrome of child.

Reference

  • Recommendations de bon usage des Immunoglobulines IntraVeineuses polyvalentes. CEDIT November 2006 (available on http://cedit.aphp.fr).

Keywords Polyvalent intravenous immunoglobulins, Neurology, Indication

PC-8 Survey of drug-related problems identified by community pharmacies during 1 week of documentation

Nina Griese1, Andrea Hämmerlein1, Martin Schulz 1

1Center for Drug Information and Pharmacy Practice, ABDA, Berlin, Germany

Background and objective A drug-related problem (DRP) is defined as an event or circumstance involving drug therapy that actually or potentially interferes with desired health outcomes. DRP can lead to an ineffective pharmacotherapy and may cause drug-related morbidity and mortality [1]. Most DRP are avoidable and community pharmacies (CP) are assuming an active role in preventing and solving DRP.

The primary objectives of this study were to demonstrate the pharmacists’ performed counselling services concerning the prevention and solution of DRP as well as the spectrum of DRP.

Design Between February and May 2005, a nationwide survey was conducted in CP to record all identified DRP. Participating CP had the freedom to choose 1 week of documentation within the given time period. Each CP was requested to record basic data concerning pharmacy structure e.g., number of customers, prescriptions and dispensed drugs per week. All identified DRP were documented separately on a standardized documentation sheet. Besides patient-specific data like age and gender, drug-related data Rx or OTC, first-time or repeated prescription, problem description and solution were recorded. For a qualitative evaluation, DRP were categorised using a modified PI-Doc classification system [2].

Setting All CP in Germany (21,476) were invited to participate.

Main outcome measures Number, nature, and relative frequency of DRP and time spent to detect and solve a DRP.

Results 1,146 CP participated and documented in total 10,427 DRP (9.1 DRP/CP/week). A broad spectrum of DRP was detected with 9/10 DRP pertaining to prescribed medicines. Three levels could be differentiated where DRP can arise: the prescription-, the patient- and the delivery level. Overall, drug-drug interactions were the most frequently reported DRP (8.6%). According to CP, more than 80% of identified DRP could be solved. Thereby, the prescribing physician was contacted in 61% of all cases. Median (mean) time for detecting and solving a DRP was 5 (10) min.

Conclusions CP play an important role in the identification, assessment, and prevention of DRP and provide a valuable contribution for an effective pharmacotherapy and improved drug safety. A follow-up study should evaluate the prevalence of DRP in daily CP practice.

References

  1. 1.

    Johnson JA, Bootman JL. Drug-related morbidity and mortality and the economic impact of pharmaceutical care. Am J Health-Syst Pharm. 1997;54:554–6.

  2. 2.

    Schaefer M. Discussing basic principles for a coding system of drug-related problems: the case of PI-Doc. Pharm World Sci. 2002;24:120–7.

Keywords Drug-related problem, Community pharmacy, Pharmaceutical care

PC-11 Impact of pharmacist’s intervention on generic prescription at hospital discharge

Marga Gassó 1, David Campany1, Emili Vallvé1, Elena Florensa1, Carme Alerany1, Ferran Sala1, Josep Monterde1

1Pharmacy, Hospital Vall d Hebron, Barcelona, Spain

Background and objective In recent years, Spanish Public Health System policy promotes the use of generic drugs instead of brand-name drugs [1].

The main objective is to evaluate the impact of pharmacist’s intervention on generic drug substitution in discharged patients from the hospital. A secondary objective is to analyse the economic impact on public health system.

Design The Pharmacy Department (PD) validates the pharmacotherapy of discharged patients from the Internal Medicine Unit (IMU). At discharge, the pharmacist generates an individualized report (InfoWin®v3.0) including the medication that patient must take at home in order to improve therapy compliance. The same software application generates the official public health system prescriptions required to dispense the patient medicines in a community pharmacy. During this process, whenever a generic alternative drug is commercially available, all prescribed brand-name drugs are substituted by the pharmacist.

We analyzed the impact of pharmacist’s intervention during 6 months.

Setting PD and IMU of a tertiary teaching hospital.

Main outcome measures Percentage of validated prescriptions, percentage of generic drugs, economic saving due to the substitution.

Results Seventy-six percent (251/331) of the discharged patients prescriptions from the IMU were validated by the PD. Pharmacist took part in 114/251 discharge prescriptions (45.41%) in order to change brand-names drugs for generic drugs. Out of the total dispensed prescriptions, 39.03% were generic drugs. Regarding to the total of public health system prescriptions, a difference of the 20.5% has been documented (39.03% vs. 18.51%).

The pharmacist substitution means a monthly decrease of 7.58% on average in medicines acquisition cost. In chronic treatments, this measure can mean a saving of 364 €/patient/year.

Conclusions The pharmacist implication in the IMU multidisciplinary team facilitates generic drugs dispensation to patients who must continue their pharmacological therapy after hospital discharge. The economic impact of this intervention is, quantitatively, limited. Probably, this may be due to the decreased cost of brand-name drugs after the approving of generic drugs.

Reference

  1. 1.

    Haas JS et al. Potential savings from substituting generic drugs for brand-name drugs: medical expenditure panel survey, 1997–2000. Ann Intern Med. 2005 Jun 7;142(11):891–7.

Keywords Generic drug, Intervention, Drug substitution

PC-16 Pharmaceutical care needs of haematology out-patients receiving cytotoxic chemotherapy

Maggie Hamill 1, Heather Dalrymple1, Moira Kinnear2

1Lothian Pharmacy Practice Unit, Western General Hospital, Edinburgh; 2Pharmaceutical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To identify pharmaceutical care needs in haematology out-patients receiving cytotoxic chemotherapy through characterisation of pharmaceutical care issues and seeking opinions about the pharmaceutical service from patients and healthcare professionals.

Design Retrospective review of records and categorisation of pharmaceutical care issues in 24 patients. Semi-structured interviews were audio-taped with all five haematology consultants, as were two focus groups with seven nursing staff. Consistent codes were used to analyse the transcripts into themes. Questionnaires handed to 100 haematology patients or carers (41% response) On which they were asked to select which medicines they received, difficulties encountered when taking medicines, further medicine information needs and preferred source, potential services from clinical pharmacists, satisfaction with current pharmacy service and expected waiting times for medicines given the safety checks which must be undertaken.

Setting Haematology outpatient clinic within cancer centre of large teaching hospital.

Main outcome measures Number and type of pharmaceutical care issues recorded. Opinions of doctors, nurses and patients about pharmaceutical service needs.

Results The mean (SD) age was 69 (11.8) years and 17 (71%) were male. Review of patients with; chronic lymphocytic leukaemia, chronic myeloid leukaemia, acute myeloid leukaemia, essential thrombocythaemia, polycythaemia vera, non-hodgkin’s lymphoma and multiple myeloma identified 241 pharmaceutical care issues as potential drug related problems, of which 172 (71%) addressed adverse drug reactions, 30 (12%) identified additional medication needs, 24 (10%) identified unnecessary medication use, 9 (4%) identified doses suspected of being too low, 4 (2%) identified doses suspected of being too high and 2 (1%) concerned prescription of an ineffective drug. Checks or patient monitoring issues were largely due to safety enquiries (75%) and also included medication needs enquiries (22%) and effectiveness enquiries (3%).

Most patients reported satisfaction with the pharmacy service, 4 (10%) had unrealistic expectations of waiting <15 min for their prescription. Healthcare professionals reported the need for better team education, communication and systems to target patients receiving complex regimens and those who are elderly and easily confused. Patients (29%) reported problems with compliance which was confirmed by nurses. Proposed solutions to patient waiting times identified doctors’ and nurses’ lack of awareness of guidelines for the safe dispensing of chemotherapy.

Conclusions The care issues confirmed that patients are at risk of adverse drug reactions and interactions between medicines for co-morbidities and their chemotherapy. Pharmaceutical care should address these care issues, identify the need for supportive therapy and confirm chemotherapy doses to minimise clinical risk. Improved communication and referral systems are required and educational needs of patients and healthcare professionals have been identified and will be addressed in development of the pharmacy service to meet patient need.

Keywords Haematology, Pharmaceutical care

PC-36 Benefit of an antibiotic prophylaxis in therapeutic use of medicinal leeches

Nicolas Arlicot 1, Virginie Bonnin1, Pascale De Calbiac1, Nelly Viratelle1, Sylvie Froger1, Jacqueline Grassin1

1Pharmacy Department, University Hospital of Tours, Tours, France

Background and objective Back from Antiquity, therapeutic use of living medicinal leeches, Hirudo medicinal, is commonly indicated in plastic, reconstructive and orthopaedic surgery to improve microvascularization of flaps and to relieve post-traumatic venous congestion. Nevertheless, it remains associated to an infectious risk related to an endosymbiotic bacterium of leech: Aeromonas hydrophila. In 2005, a case of nosocomial infection due to A. hydrophila in a patient treated with leeches has been reported by the Microbiology Department. We aimed to identify, and if possible to correct, the cause of this infection associated with leech therapy.

Design One-year retrospective study based on the analysis of both literature about medicinal leech-related infections (PubMed—Medline), and medical files of patients treated with leeches and/or with a positive bacteriological culture of A. hydrophyla in 2005.

Setting Pharmacy, Plastic and Orthopaedic surgery Departments.

Main outcome measures (1) Identification of complications associated with leech therapy; (2) Determination of the number and types of patients treated with leeches; (3) Inspection of leeches supply, cleaning and dispensation stages within the pharmacy then confronted with the practice reported from five other teaching hospitals.

Results Infection associated with leech therapy is a documented complication of leech application, with reported incidences ranging from 2.4% to 20% [1]. Leeches progress within the pharmacy is wholly and clearly defined by written procedures: storage between 4 and 8°C, in identified aquariums (batch number) filled with spring water weekly replaced [2]. Dispensation is carried out in spring water added to 20 mg of gentamicin. After use, leeches follow the infected waste elimination process to be incinerated. Other 5 hospital pharmacies questioned all had comparable delivery process, but none which added antibiotic in the dispensation flask. Aside, the analysis of the 6 patient’s files treated with medicinal leeches in 2005 (4 in orthopaedic surgery (hand surgery), 2 in plastic surgery (venous congestion after mastectomy) revealed that only the infected one did not receive any oral antibiotic prophylaxis (fluoroquinolones, aminoglycosides), which is recognized to be the most efficient prevention against leech-related infections [3].

Conclusions The Pharmacy Department proposed a new protocol, systematically including an oral antibiotic prophylaxis (ofloxacin 200 mg, 3 doses/day), for prescription and dispensation of medicinal leeches, and submitted this protocol to the local Committee of Infection survey for validation, before its delivery to the concerned surgery units.

References

  1. 1.

    De Chalain TM. Exploring the use of the medicinal leech: a clinical risk-benefit analysis. J Reconstr Microsurg 1996;12(3):165–72.

  2. 2.

    Sartor C et al. Nosocomial infections with Aeromonas hydrophila from leeches. Clin Infect Dis. 2002;35(1):E1–5.

  3. 3.

    Mackay DR et al. Aeromonas species isolated from medicinal leeches. Ann Plast Surg. 1999;42(3):275–79.

Keywords Medicinal leeches, Antibiotic prophylaxis

PC-44 Optimising drug-therapy for patients to reduce hospital admissions

Ulrika Gillespie 1, Anna A. A. Alassaad1, Astrid A. F. Forsström1, Henrik H. T. Toss2, Anna A. F. Finquist3, Dan D. H. Henrohn2, Claes C. M. Mörlin2

1Pharmacy Department, 2Acute-Medicine Division, The Academic Hospital, 3Division of Pharmacokinetics and Drugtherapy, Uppsala University, Uppsala, Sweden

Background and objective Studies have shown that pharmacists involvement can reduce the number of acute hospital admissions and improve quality of drug-use [1].

The Objectives are to optimise drug-treatment and reduce the number of hospital admissions in patients 80-years old or older.

Design AA randomised, controlled trial including 400 patients (200 + 200) Patients in the intervention group (I) received a patient interview on admission, counselling on discharge and a drug review—all performed by a clinical pharmacist. Patients in the control group (C) received standard care, without pharmacists’ involvement.

Patients were included between Oct 2005 and June 2006.

Setting Two wards at the Division of Acute-Medicine at the Academic Hospital in Uppsala, Sweden.

Main outcome measures Readmission rate 12 months after last included patient.

Quality of prescribing using Medication Appropriateness Index (MAI) for (I) and (C)

Drug-related problems in (I)

Prescribing errors in (I)

Number of drugs and drug costs, before and after admission, in (I) and (C)

Results The result on readmissions will come through in June 2007

MAI decreased for 66% of the patients in (I) compared to 31% in (C) (P = 0.004).MAI was reduced for (I) by 2.9 ± 4.9 points compared to 0.3 ± 2.7 points in (C) (P = 0.0012) (A low score indicates high quality in prescribing.)

476 DRPs were recorded for 157 patients. 75% of the suggestions were accepted and acted upon.

At 31 admissions and 9 discharges from hospital, there were mistakes made of major clinical importance

Number of drugs, before and after admission, were increased by 0.5 drugs/patient in (I) and by 1.3 drugs/patient in (C). Drug costs did not increase significantly in (I) but by approximately 0.5 €/patient/day for (C).

Conclusions These results indicate that pharmacists involvement in the healthcare team can improve quality of prescribing, patient safety and drug utilisation for patients.

Reference

  1. 1.

    Hogg A. Length of stay and readmission down in NI medicines management project. The Pharmaceutical Journal 272:329–330 (2004).

Keywords Hospital admissions, MAI, Drug-related problems, Prescribing errors

PC-52 Installation of a quality system in Cytotoxics Centralized Reconstitution Unit (URCC)

Rachel Favreau 1, Muriel Afif1, Sandrine Baucher1, Alexandra Smet1, Maryvonne Villart1, Delphine Pozzi1

1Pharmacy, University Hospital R. Poincar, Garches, France

Background and objective Following oncology paediatric unit’s creation in University Hospital R. Poincaré, URCC has been created to reconstitute drugs under insulator.

URCC at once fell under a step quality assurance with for objective homogenization and optimization of practices in order to guarantee the safety of patient and units staff as well as manufacture of quality product.

Design Review of documentation set up in URCC.

Setting URCC—Pharmacy Department.

Main outcome measures URCC’s pharmacists and preparers has listed documentation existing on handling, centralization and cytotoxics risks, in particular documents relating to legislation of cytotoxics and preparations in general, with good practices and recommendations in force, and any laboratory information on products used—defined 4 sectors of quality assurance: Functional unit, Production, Customer and Quality—bench the list of procedures (P), instructions of work (T), printed recording (I) and various documents (D) to realize for each sector.

Results Three months after its creation, 5 procedures, 23 instructions of work, 14 printed recording and 15 various documents were compiled and validated. URCC privileged Production sector initially since it describes all the cytotoxics’ preparation methods ones: prescription analysis to dispensation in unit, this in order to formalize the practices.

In parallel, an instruction manual of computerized prescriptions software was elaborate making it possible to allow pharmacists taking obligations in URCC to be correctly formed. Lastly, a reference frame of handled products including indications, dosage, stability durations after reconstitution then after dilution.

Conclusions This work allowed constitution of a handbook quality assurance placed at the disposal of the various speakers within pharmacy. An evaluation of the application of handbook work instructions will be carried out later on.

Keywords Cytotoxics Centralized Reconstitution Unit, Quality assurance, Optimization of practices

PC-66 Evaluation of medication guidelines’ adherence in the prevention of coronary heart disease for patients with type 2 diabetes mellitus in the United Arab Emirates (UAE)

Naseeba Alozaibi 1, Julienne B. Johnson2, Stephen A. Hudson2

1Pharmacy Department, ADNOC Medical Services Division, Abu Dhabi, United Arab Emirates; 2Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective To evaluate adherence of prescribed medication in UAE to internationally recognised guideline criteria.

Design Retrospective case-note survey with the application of a validated 31-item tool (MAT-CHD) [1, 2].

Setting Two medical centres’ database records of 218 type 2 diabetes outpatients aged 20–74 years, receiving medication for hypertension, with or without a history of ischaemic heart disease (n = 60, n = 158).

Main outcome measures Investigation of overall and individual adherences to 31 guideline criteria in primary (n = 158) and secondary prevention (n = 60) subgroups. Quantification of documented reasons for non-adherence.

Results Patients (49.5% male) had mean (SD) age of 53.3(8.1) years and mean (SD) BMI of 33.0 (8.1) kg/m2. A total of 4455 guideline criteria were applied with an overall adherence of 74.8% (CI: 62.9, 86.7).

The criteria with low adherence (<50%) were use of: gemfibrozil in secondary prevention (33.3%, CI: 20.4, 46.3); sublingual glyceryl trinitrate in secondary prevention (4.8%, CI: 0.0, 10.6); ACE-I post MI (26.1%, CI: 14.0, 38.1); ACE-I in patients with micro-albuminuria (36.8%, CI: 23.6, 50.0); ACE-I or β-blockers in patients <55 years of age and non-black (41.0% CI: 27.5, 54.5); ACE-I in patients with risk factors (35.1%, CI: 22.0, 48.2).

The criteria with the high adherences (≥70%) were use of: aspirin in secondary and primary prevention; appropriate dose of aspirin; aspirin safely in primary prevention; statin in secondary prevention; statin in primary prevention; antihypertensive therapy; ACE-I to achieve target dose in patients with no left ventricular dysfunction; β-blockers and other anti-anginal agents; metformin in overweight patients; advice on smoking cessation; achievement of target total cholesterol level; ARBs in patients with micro-albuminuria as an ACE-I substitute.

Conclusions The MAT-CHD highlighted areas for review and possible improvement in the absence of locally generated guidelines. With minor amendments the tool can be used in primary care from case record examination.

References

  1. 1.

    Scottish Intelligence Guidelines Network (SIGN). Management of Diabetes: A national clinical guideline. Edinburgh: SIGN (SIGN publication No. 55).

  2. 2.

    Ernst A, Kinnear M, Hudson S. Quality of Prescribing: A study of guideline adherence in patients with diabetes mellitus. Practical Diabetes International 2005;22:285–290.

PC-79 Epidemiology and treatment options for postherpetic neuralgia in a pain management center

Anne Claire Buire 1, Emilie Prévost1, Catherine Mennesson1, Jean Pierre Concé2, Olivier Bredeau2, Bertrand Gourdier1

1Pharmacy, 2Pain Management Center, Reims Teaching Hospital, Reims, France

Background and objective Postherpetic neuralgia (PHN) is a neuropathic pain syndrome defined as significant pain or dysesthesia present 3 months after the herpes zoster’s dermatomal rash has healed. The aim of this study was to research PHN risk factors and characteristics and to assess treatment’s strategies and tolerability.

Design Retrospective study included all patients consulted in pain management center for PHN from January 2005 to December 2006 in Reims hospital.

Setting Pain management center in a teaching hospital.

Main outcome measures From the medical records, a report sheet was set up with the following items: risk factors (age, pathologies and associated treatment, zoster localisation and treatment in critical phase, pain description), treatments chronology and tolerability.

Results 15 of 352 patients who have been treated in pain management center since 2 years suffered from PHN. The average age is 72 years old. Main pain were intercostal, continuous and paroxystic. Autoimmune diseases were associated for 6/15 patients. Bi-therapy is generally adopted in first line: anticonvulsants are used in continuous pain and tricyclics antidepressants in paroxystic pain. Gabapentine and now pregabline are indicated in both cases. Previous treatment (before pain consultation): most of them (7/15) had profited from two different molecules, gabapentine most often, then amitryptiline and clonazepam. Others treatments are put in place in pain management center: lidocaine patches (13/15), Transcutaneous Electrical Nerve Stimulation (TENS) (5/15), cryotherapy (2/15) or others molecules such as carbamazepine and oxcarbamazepine (2/15). Topical treatment with lidocaine patch is of benefit in many patients, while TENS and cryotherapy may be effective in some cases but often temporary. The study could not show superiority of efficiency between molecules. Treatment tolerability depends on the drugs used: Amitriptyline is the less best tolerated because of drowsiness and weight gain while gabapentine is well tolered. Two patients had developed irritated skin to patches’ glue and one patient to TENS electrodes. Reasons of treatment cessation were firstly inefficiency and secondly bad tolerability.

Conclusions No risk factors could be proposed in this study. PHN management appears very complex, because each drug offer variable levels of efficiency or tolerance and depend on the patient. A better comprehension of the pain would make it possible to better apprehend it. Also, after this study, an informative card was written and will be filled out during each consultation pain.

PC-82 Development of a pharmacist-managed cardiovascular risk reduction clinic

Chantal Pharand 1, Jean G. Diodati2

1Pharmacy Department, 2Division of Cardiology, Hôpital du Sacré-Coeur de Montréal, Montreal, Canada

Background and objective Cardiovascular disease is one the major causes of death in the industrialized world. Around 80% of all patients evaluated in cardiology at our center present 2–4 risk factors and 50–60% of patients do not reach target values in terms of their lipid profile. Our objective was to develop a risk reduction clinic that would improve attainment of target values for 6 risk factors: dyslipidemia, hypertension, diabetes, smoking, obesity, physical inactivity.

Design All patients discharged with acute coronary syndrome are referred to the clinic. The first visit is planned about 4 weeks after the post-discharge visit with a cardiologist, which should occur 2 months after discharge.

Setting Outpatient cardiology clinic, Hôpital du Sacré-Cœur de Montréal.

Main outcome measures The main objective of this clinic is to inform patients and general practitioners of the patient risk and treatment objectives, as well as to help them reach these goals. Our clinic is composed of a cardiologist, a pharmacist, and a nurse. When needed, we refer patients to a nutritionist, an endocrinologist, a smoking cessation program, or a specialised fitness center.

Results In anticipation of visits to a cardiologist and the risk reduction clinic, blood is drawn to assess lipid profile, glycemia, A1c, electrolytes, BUN, and creatinine 6 weeks after discharge. At the initial clinic visit, patients meet the clinic cardiologist and pharmacist together, who evaluate risk factors, decide on treatment goals, initiate a treatment plan, and schedule a follow-up visit. At follow-up visits, patients meet only with the pharmacist, who is responsible for monitoring therapy and adjusting the medications in order to reach the established goals, based on treatment protocols approved by the institution. The nurse insures that all appointments are taken and answers patient calls. A combined cardiologist/pharmacist visit is planned once a year.

Conclusions A risk reduction clinic was developed to address a lack in our patient management system resulting in many patients not being treated to target. Patient visit to our clinic should result in an optimization of their therapy and hopefully a reduction in cardiovascular events.

Keywords Risk factors, Outpatient clinic, Pharmaceutical care

PC-85 Determining lay attitudes on the prescribing of medicines for dementia

Denise Taylor 1, Marjorie C. Weiss1

1Pharmacy and Pharmacology, University of Bath, Bath, United Kingdom

Background and objective Many people will hold a belief about how medication may affect their medical condition [1]. For people diagnosed with probable Alzheimer’s disease NICE [2] has suggested that a cessation point of treatment is agreed between the patient, carer and prescriber, before prescribing commences. In 2004 the Alzheimer Society [3], reported that carers of people taking antidementia agents described the positive effects of these medicines as: “seems brighter/happier/more aware/more active” to “calmer/less aggressive.” The end points of successful treatment seem at odds with those proposed by NICE [2]. It is therefore important to explore lay perspectives of medicines for dementia.

The aim of this research was to explore attitudes and concerns about medicines prescribed for dementia held by people who take these medicines and their carers. The objectives were to explore issues around compliance, decision-making; perceived efficacy, stopping treatment and provision of information.

Design MREC approval was attained for a muliticentred qualitative study inviting people taking antidementia agents and their carer to either a focus group or semistructured interview.

Setting Four Alzheimer’s Society branches in South West England.

Main outcome measures Exploring attitudes and viewpoints of the prescribing and efficacy of medicines for dementia.

Results Three focus groups (n = 18 participants) and 11 semi-structured interviews were completed. Interpretative phenomenological approach to analysis produced a subset of concerns, broadly falling into the following categories:

Effects of the medicines prescribed for dementia

Concerns about consultation etiquettes

Concerns about the quality of information received

Conclusions People who take medicines for dementia and their carers seem to hold different criteria for success of treatment compared to accepted bio-medical viewpoints. This is important when clinicians review cessation points and for consideration in future research when tools that measure efficacy are developed.

References

  1. 1.

    Horne R, Weinman J. patient’s beliefs about prescribed medicines and their role in adherence to treatment in chronic illness. J Psychosom 1999;47(6):555–567.

  2. 2.

    HTA No. 19. Guidance on the use of donepezil, rivastigmine and galantamine for the treatment of Alzheimer’s disease. NICE 2001.

  3. 3.

    Alzheimer Society Report, June 2004. Drugs for the treatment of Alzheimer’s disease. Submission to NICE.

Keywords Dementia, Attitudes, Prescribing

PC-91 Characterisation and quantification of pharmaceutical care delivery to hospital inpatients

Helge Ovesen 1, Carl Fenelon2, Thrina Loennechen1, Stephen Hudson2

1Institute of Pharmacy, University of Tromsø, Tromsø, Norway; 2Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom

Background and objective The UK government through the NHS in 2000 proposed the implementation of the medicine management. The redesign of the service was to deliver a more effective and patient-centered service. The pharmacy staff on the ward became part of a multidisciplinary care team [1]. This project was to validate and compare hospital clinical pharmacy inpatient process maps of services and characterise ward prescribing and pharmaceutical care activity using a defined set of parameters [1].

Design Descriptive cohort study. Comparison of process maps across ward-based services in seven different clinical settings [2, 3].

Setting Two groups of 94 patients were recruited for the survey of prescribing activity and generation of the pharmaceutical care profile. The study site was a hospital acute receiving ward.

Main outcome measures Generation of pharmaceutical care profiles of the acute receiving ward [1]. Recorded activity at the receiving ward compared with other clinical settings.

Results The patients (42% male) for the characterisation of prescribing activity had mean (SD, range) age of 63 (19, 15–93) years and mean (SD) duration of stay was 1.2 (0.8) days. The total number of courses prescribed was 799; the mean (SD) number of courses was 8.5 (3.5) per patient, and 81% of all daily prescriptions were newly prescribed.

For the pharmaceutical care profile the patients (38% male) had mean (SD, range) age 60 (20, 14–92) years were recruited. The total number of care issues was 185; the mean (SD) was 2.3 (1.4) per patient representing 0.27 care issues per estimated course. Of the total care issues, 42 (22.7%) were recorded as checks and 143 (77.3%) were recorded as changes.

Conclusions The characterisation of the acute receiving ward has highlighted differences in the service provided from other wards featured in the ‘medicines management’ redesign; in particular the high prescription activity. The total level of activity required for the pharmacist at the acute receiving ward is much greater due to the high patient turnover. However the delivery of pharmaceutical care in terms of care activities per patient was comparable to that in other clinical settings. The findings inform the service redesign to this patient group.

References

  1. 1.

    Audit Commission. A Spoonful of Sugare. Medicines Management in NHS hospitals. 2002 February.

  2. 2.

    Log T. A study of the implementation of a redesigned medicines usage and supply system. Thesis (MPharm)—University of Tromsø; 2005.

  3. 3.

    Tuffaha HW. Implementation and validation of a method for characterising prescribing activity and associated pharmaceutical activity in haematology setting. Thesis (MSc) University of Strathclyde; 2005.

Keyword Medicines management

PC-94 Pharmaceutical care for patients on infliximab—a multidisciplinary team approach

Louise A. Azzopardi 1, Franco Camilleri Vassallo2, Carmel Mallia2, Paul J. Cassar2, Karen Cassar2, Bernard Coleiro2, Mark L. Zammit1, Josette Sciberras1, Doris Aquilina3

1Department of Clinical Pharmacy, 2Department of Rheumatology, 3Department of Nursing Services, St Luke’s Hospital, Guardamangia, Malta

Background and objective To develop guidelines on infliximab administration and patient management care with the aim of introducing other health care professionals such as medical doctors and nursing staff on the medical wards to infliximab therapy.

Design A literature review on administration of infliximab and patient management care was carried out. The guidelines which were prepared by the rheumatology clinic pharmacist were divided into two parts, reconstitution protocol and administration and monitoring protocol. The reconstitution protocol offered a stepwise guide to reconstitution of the drug. The administration and monitoring protocol offered a stepwise approach to the calculation of the dose and the monitoring of the patient, before, during and after the infliximab therapy. The guidelines incorporated a documentation sheet of the dose and the monitoring parameters together with signatures of the respective health care professional carrying out the reconstitution and the monitoring of the patient. The guidelines were reviewed by an expert panel consisting of 2 Consultant Rheumatologists and their three Rheumatology Senior Registrars, a Principal Pharmacist specialised in Medicines Information and the Head of the Pharmacy Department at St Luke’s Hospital.

Setting Medical wards at St Luke’s Hospital, Malta.

Main outcome measures Formalisation of guidelines on infliximab administration and patient management.

Results The expert panel agreed with the general contents of the guidelines. The guidelines were published on the local hospital network for easy access by health care professionals on the wards. The response from the nursing point of view and junior medical doctors in view of these guidelines is still being evaluated.

Conclusions Developing such guidelines help health care professionals on the wards to become acquainted with the drug they are administering. Providing a step by step guide on how to reconstitute, administer and monitor the drug before, during and after the infliximab therapy tends to decrease potential medication or omission errors. Thus in a way the guidelines also serve as a quality assurance check during the infliximab therapy leading to an improved quality of service offered to patients.

Keywords Infliximab, Patient care, Quality assurance, Guidelines

PC-99 Use of tumour necrosis factor inhibitors: prescribing and monitoring practices

Louise A. Azzopardi 1, Carmel Mallia2, Franco Camilleri Vassallo2, Bernard Coleiro2, Paul J. Cassar2, Karen Cassar2, Doris Aquilina3

1Department of Clinical Pharmacy, 2Department of Rheumatology, 3Department of Nursing Services, St Luke’s Hospital, Guardamangia, Malta

Background and objective Etanercept and infliximab are the tumour necrosis factor (TNF) inhibitors available for use on the national health scheme at St Luke’s Hospital. All rheumatoid arthritis patients are followed up at the Rheumatology Out-Patient Clinic by two Consultant Rheumatologists and their 3 Rheumatology Senior Registrars. The objective of the study was to determine the prescribing, monitoring and assessment practices.

Design A panel discussion was carried out with the five medical practitioners, the Rheumatology Nurse Specialist and the rheumatology clinic pharmacist.

Setting Rheumatology Out-Patient Clinic, St Luke’s Hospital, Malta.

Main outcome measures Adherence with local protocol, identifying prescribing, monitoring and assessment practices.

Results The response rate was 100%. All members of the team prescribe etanercept as first line TNF inhibitor and infliximab to patients who are intolerant to etanercept or in whom there is no adequate response to etanercept therapy. They prescribe methotrexate where possible in conjunction with either TNF inhibitor. Two prescribers (40%) request a purified tuberculin skin test (PPD) and a chest X-ray prior to starting treatment with a TNF inhibitor. Three prescribers (60%) did not carry out the PPD test on the basis that patients eligible for TNF inhibitors are failed methotrexate users for whom a PPD test would already have been carried out. A disease activity score, ESR, early morning stiffness, pain score and global assessment are carried out at baseline and during visits to the clinic by all practitioners. The pharmacist carries out a Health Assessment Questionnaire at baseline and at each visit to the clinic. Patients are screened by the nurse specialist prior to the administration of a TNF inhibitor. Where necessary, in the case of adverse reactions to TNF inhibitors patients are prescribed an antihistamine and a steroid prior to the administration of the TNF inhibitor and where appropriate the rate of infusion is slowed down.

Conclusions Prescribers tend to follow strictly the local protocol for prescribing a TNF inhibitor. Patients on TNF inhibitors are closely followed up the multidisciplinary team. Prescribing, assessment and monitoring trends adopted by the team mirror trends outlined by the British Society for Rheumatology.

References

  • British Society for Rheumatology. Guidelines for prescribing TNF alpha blockers in adults with rheumatoid arthritis. London: British Society for Rheumatology, 2001.

  • British Society for Rheumatology. Updated BSR Guidelines for prescribing TNF alpha blockers in adults with rheumatoid arthritis. London: British Society for Rheumatology, 2004.

Keywords Infliximab, Etanercept, Tumour necrosis factor inhibitors, Prescribing practices, Monitoring practices

PC-105 Case report: medication error leading to an overdosing of baclofen for a one-year old child: is our computerized physician order entry responsible for this incident?

Sonia Touati 1, Frédérique Bouchand1, Catherine Bouiri1, Linda Benchikh1, Rachel Favreau1, Maryvonne Villart1

1Pharmacy, Hôpital Raymond Poincaré, Garches, France

Background and objective After an overdosing incident with baclofen (10 times normal dose) prescribed on a computerized physician order entry (CPOE) for a 1-year-old child, pharmacists tried to find out the potential sources of this incident in order to make drug circuit more secure from prescription to administration.

Design Case report.

Setting Pediatric clinical Department of a teaching hospital.

Main outcome measures Case report.

Results In our hospital, since 2006, prescriptions have been entered by physicians on the CPOE Phedra® and analysed by pharmacists. A daily administration plan, in accordance with prescription, is printed by nurses for each patient. For this one-year old patient, the physician prescribed baclofen at the dose of 3 mg, 3 times a day (tid). But this child received 3 tablets of 10 mg tid. The analysis of this incident reveals errors at each step of the drug circuit:

  • On our CPOE, physician prescribed baclofen as from the commercialised drug form, baclofen tablets of 10 mg: 3 mg, tid,

  • After analysis of the prescription, the pharmacist prepared nominative baclofen capsules of 3 mg, but did not notice the prescription error,

  • One nurse of the pediatric department took 3 tablets of the commercialised drug form, instead of one capsule of 3 mg, first because prescription appeared with the commercialised drug form, and also because the unit of prescription (mg) was printed only to the very left of the sheet.

CPOE Phedra® was incriminated by the pediatric department for this incident.

Discussion From the pharmacist’s point of view, several causes leaded to this incident: lack of rigorousness concerning prescription and pharmaceutical analysis on Phedra®, most likely due to a deficient training for new staff, but also failures of our CPOE concerning the intelligibility of administration plans.

Pharmacists decided to elaborate good practices of prescription and administration on Phedra®, which were diffused to all departments. They also made it possible to prescribe magistral preparations and decided to alert physicians if prescribed in the wrong way (commercialised drug form).

The Phedra® training team was asked by pharmacists to improve the design of administration plans and to organize more training sessions in the hospital.

Conclusions Introduction of CPOE in a hospital can lead to serious errors, if users are not correctly trained. With such a prescription support, more rigorousness is expected and pharmacists have a major role to avoid any type of error.

Keywords Medication error, CPOE, Pediatric use

PC-107 A prescribing and delivering path for drugs and medical devices to patients affected by thalassemia

Fabbrocini Michelangela 1, Cuzzolino Maria Laura1

1Territorial Pharmaceutical Care, ASL NA 1, Napoli, Italy

Background and objective Thalassemias are a heterogeneous group of hereditary hemolytic anemias that have in common a decreased synthesis of one or more hemoglobin polypeptide chains and are classified according to the chain involved in á, â and ä; the two major categories are á- and â-thalassemia. Patients suffering all Major forms of thalassemia receive frequent blood transfusions that lead to iron overload which make necessary iron chelation treatment in order to prevent damage to the internal organs.

Objective of the study is the realization of a Local Health Authority’s path for the prescription and delivery of drugs and medical devices used in the treatment of thalassemia.

Design Consult of National and Regional laws inherent thalassemia, EMEA’s Scientific Discussions inherent drugs used in the treatment of thalassemia and Pub Med.

Setting ASL NA 1 has 1.000.000 inhabitants and covers the city centre of Naples; thalassemic patients are 45.

Main outcome measures The development of a unique path for thalassemic patients that includes those medical devices not expected in National or Regional laws.

Results The National law in force inherent thalassemia was made in 1996 and it established that thalassemic patients could receive drugs and medical devices from the Pharmaceutical Department as each Director of the ASL had arranged. A Regional law has identified the Prescribing Centres. Recent rules established that deferoxamine and deferiprone, according to their classification, are distributed respectively by Territorial and Hospital Pharmacies. Since 1996, new medical devices have developed, such as vertical needles and special filters for subcutaneous infusions, but their distribution is not scheduled in any law.

In ASL NA 1 there is only one Centre of distribution for infusion pumps, while needles and materials for medication are withdrawn in one of the 10 Territorial Pharmacies. When vertical needles and filters for subcutaneous infusion are prescribed, they need an additional motivation letter.

Conclusions The most common complaint by patients is that it is difficult to comply with the intravenous chelation treatments because they are painful and inconvenient. Lack of compliance interferes with patient’s long term survival; however, many patients do not keep up with it or abandon treatment. Oral chelation is less effective than the ev/sc one and associated with more side-effects.

The prescribing and delivering path elaborated in ASL NA 1 has given patients the opportunity to approach easily to a more compliant therapy that improves their QoL. However it is necessary a national update that considers the new medical devices for subcutaneous infusion of deferoxamine in order to assure more compliance and equal the different distribution paths.

Reference

  • EMEA’s Scientific Discussion—Pub Med—Dorland’s Illustrated Medical Dictionary, 29th Edition—Cooley’s Anemia Foundation, Inc.

Keywords Thalassemia, Pharmaceutical care, Rare diseases

PC-113 General practitioners’ opinions of cardiovascular disease risk assessment by community pharmacists: a Scotland perspective

Scott Cunningham 1, Denise Hansford1, Dai N. John2, Dorothy J. McCaig1, Kim Munro1, James McLay3, Derek Stewart1

1School of Pharmacy, The Robert Gordon University, Aberdeen; 2Welsh School of Pharmacy, Welsh School of Pharmacy, Cardiff University, Cardiff; 3Department of Medicine & Therapeutics, University of Aberdeen, Aberdeen, United Kingdom

Background and objective Community pharmacist (CP) involvement in cardiovascular disease (CVD) risk assessment is likely to increase [1]. CP practice guidance issued following reclassification of simvastatin requires a limited risk assessment before over-the-counter (OTC) simvastatin sale [2]. The objective of this study was to determine the opinions of general medical practitioners (GPs) in Scotland toward the role of the CPs in the process of CVD risk assessment.

Design A prepiloted postal questionnaire was sent to all primary care medical practices in Scotland (1010, excluding 40 pilot practices) during the winter of 2005. The questionnaire was directed to a senior GP or one with a special interest in cardiovascular medicine (CVM). Grampian Research Ethics Committee advised that NHS ethical approval was unnecessary. Data were coded and entered into SPSS for Windows version 13 (SPSS Inc.) and analysed using descriptive statistics.

Setting Primary care medical practices in Scotland.

Main outcome measures Responses to closed questions on experiences and opinions of GPs towards CP involvement in CVD risk assessment.

Results A total of 462 questionnaires were returned (45.7%); a third (32.9%) were female, 157 (34.0%) indicated a special interest in CVM. Only 11.5% (53) indicated a CP had referred a patient for full CVD risk assessment. Concerning GP-CP communication; only 9.1% (42) had discussed the general management of CVD risk assessment and lipid lowering therapy, 9.1% (42) sharing cholesterol test results and 9.5% (44) local policies for referral for a full CVD risk assessment. Two-thirds (62.6%, 289) disagreed that ‘CPs should have access to information in the medical records to allow them to assess CVD risk’. In contrast, 86.8% (401) felt CPs should inform GPs of the results of any pharmacy based risk assessment. GPs however did believe that CPs should be involved in monitoring; blood pressure, 61.0% (282), cholesterol, 70.8% (327), ADRs/drug interactions 83.3% (385) and compliance 75.5% (349).

Conclusions CPs are encouraged to discuss local CVD risk assessment policies with GPs [2] but our results show that such discussion is not widespread. GPs responding agreed that CPs should do monitoring of patients on OTC simvastatin. CVD risk assessment and monitoring needs access to information in medical records. GPs reluctance for such access will need to be overcome.

Acknowledgements The input of the following individuals is acknowledged: AJ McGibbon, V Scott, S Wall and L Adams.

References

  1. 1.

    Anon. NICE appraises statins. MeReC Extra 2006;21.

  2. 2.

    Anon. Practice Guidance: OTC simvastatin 10 mg. Pharm J 2004;273:169–170.

Keywords Cardiovascular, Risk, Assessment

PC-114 Scottish general practitioners’ awareness, experiences and views of over-the-counter simvastatin

Denise Hansford 1, Scott Cunningham1, Dai John2, Dorothy McCaig1, Kim Munro1, James McLay3, Derek Stewart1

1School of Pharmacy, The Robert Gordon University, Aberdeen; 2Welsh School of Pharmacy, Cardiff University, Cardiff; 3Medicine & Therapeutics, University of Aberdeen, Aberdeen, United Kingdom

Background and objective Simvastatin became available over-the-counter (OTC) in Great Britain in 2004: concerns were expressed regarding the evidence base, risk assessment and side effects.[1] General medical practitioners (GPs) concerns regarding OTC medicines for chronic conditions include monitoring.[2] The objectives were to determine the awareness, experiences and views of Scottish GPs of OTC simvastatin.

Design A questionnaire, piloted in 40 Scottish primary medical care practices, mailed to the practice manager at the remaining 1010 in winter 2005. The questionnaire, which included a letter outlining the study, and a freepost envelope was to be passed to a senior GP or one with a special interest in cardiovascular medicine (CVM).

Setting Primary care medical practices in Scotland.

Main outcome measures GPs’ awareness and views of appropriateness of licenced indications, dose, cost and required tests for supply of OTC simvastatin; experiences with OTC simvastatin; and demographics.

Results The response rate was 45.7% (462/1010). Most were male (66.7%). 60% had been a GP for 16 years or more. 34.0% (157) indicated a special interest in CVM. Most (428, 92.6%) were aware of the licensed indication for OTC simvastatin; 55.6% (257) felt it inappropriate. 85.3% (394) were aware of the OTC licensed dose; 46.3% (214) felt it inappropriate. A third (33.1%, 153) were aware of the cost. 45.2% (209) were aware that cholesterol and 34.8% (161) blood pressure (BP) measurement is not required prior to OTC sale. Many felt this inappropriate; cholesterol, 56.7% (262,111 missing), BP 57.8% (267,109 missing). Few GPs (7.8%, 36) had encountered patients on OTC simvastatin; the majority (95.9%, 443) had never recommended purchase. 31.8% (147) indicated an increase in patient demand for statins.

Conclusions GPs showed high awareness of but low support for OTC simvastatin and low awareness that no full cardiovascular risk assessment is required, reflecting previous concerns [1, 2]. Few had patients using OTC simvastatin or had recommended it. GPs had perceived increased demand for statins which may reflect general advertising. Some GPs indicated awareness of aspects of OTC simvastatin supply but did not give a view on appropriateness.

References

  1. 1.

    Editorial. OTC statins: a bad decision for public health. Lancet 2004;363:9422.

  2. 2.

    Bayliss E and Rutter P. GPs’ views on recent and proposed medicine switches from POM to P. Pharm J 2004; 273:819–821.

Acknowledgements We thank all respondents and acknowledge the contribution of A Bowbyes, AJ McGibbon, V Scott, S Wall and L Adams.

Keywords General Practitioners, Over-The-Counter, Simvastatin

PC-115 Analysis of aseptic preparations of investigational medicinal products in a hospital pharmacy

Sophie Perriat 1, Pierrejean Aragon1, Sylvie Hansel1

1Pharmacy, Lapeyronie-Arnaud de Villeneuve Hospital, Montpellier, France

Background and objective 160 clinical trials are currently ongoing in our hospital and among them, 15 require aseptic preparations of Investigational Medicinal Products (IMP), realised in respect with european directives 2001/20/EC and 2003/94/EC, concerning Good Manufacturing Practices. This activity has increased since 2003, so we evaluated it more precisely. Considering technical constraints (isolator without fridge, no fax in the sector) and time constraints (sterilization and randomisation times can’t be reduced), we propose measures to improve our efficiency.

Design Qualitative and quantitative analysis of aseptic preparations considering activity report since 4 years and using a report sheet during 2 months: June and July 2006.

Setting Pharmacy of Lapeyronie-Arnaud de Villeneuve teaching hospital, Montpellier, France.

Main outcome measures Characteristics of the clinical trials and of the drugs involved in aseptic preparations and evolution of this activity (number, preparation time).

Results 420 aseptic preparations of IMP have been realized in 2003 and 506 in 2006 (20% more). In 2006, 15 phase III trials promoted by pharmaceutical companies generate 16 aseptic preparations concerning rheumatology (12 trials in rheumatoid arthritis, 64% patients), Nephrology (1 trial in post-graft immunosuppressive therapy, 4% patients) and Haematology (2 trials in malignancies, 32% patients).

5 of the 8 IMP prepared are monoclonal antibodies, 2 are proteins, 1 is a small molecule. 3 drugs are administered subcutaneously and 5 intravenously. All the drugs except one must be stored in a fridge (5) or in a freezer (2), which prevents advanced sterilization, since there’s no fridge in our isolator. Post reconstitution stability ranges from 2 to 72 h but randomization process must be done after patient examination so, even for long-term stable drugs, preparation can’t be anticipated, which is a second technical constraint.

During the 2 months analysis, 82 preparations were realized (Mean/day: 1.95, 2 h work): 77% in rheumatology, 18% in haematology, 5% in nephrology. Mean time between prescription reception and drug delivery is 1 h 40, including 45 min sterilisation and 10 min IVRS randomisation in 55% of cases. Double control, effective in 77% cases, needs 1 h more work per day.

Conclusions Most aseptic preparations concern rheumatology trials. To improve the safety of our work, double control must be generalised thanks to a better staff planning management. To reduce the delay of preparation and the patient expectation, we propose several measures:

  • Installation of a small fridge in the isolator

  • Installation of a new sterilisation system needing only 25 min

  • Acquisition of a fax to receive directly the prescription in the sector

Limiting constraints will allow us to take in charge the preparations more fastly and to improve our efficiency.

Keyword Investigational drugs preparation

PC-126 Evaluation of an assessment tool for adherence to medication guideline criteria in cancer pain management

Ann Lisbeth Torbergsen 1, Gro D. Håkonsen2, Stephen Hudson1, Thrina Loennechen2, Derna Campbell1

1Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom; 2Institute of Pharmacy, University of Tromsø, Tromsø, Norway

Background and objective To test, revise and apply an audit tool for assessment of medication prescribing to guideline criteria in cancer pain management for potential use in Scottish clinical settings [1, 2].

Design Retrospective case-note survey to validate a 38-item medication assessment tool for cancer pain management (MAT-CP).

Setting Cancer patients experiencing pain and/or on analgesics aged 18 years or older who were admitted to one of three participating centres (two hospitals and one hospice).

Main outcome measures Percent adherences to 38 guideline criteria. Inter-rater reliability of the overall tool using Cohen’s kappa statistics.

Results The revised MAT-CP was applied to 101 cancer patients (55% male), mean (SD) age of 69 (14) years. Overall adherence was 69% (CI: 68%–71%) to 1954 applied guideline criteria. Overall inter-rater reliability assessed by two independent raters (n = 30 patients) was к = 0.92, which signifies good agreement.

The criteria with low adherence (<50%) included: most criteria relating to patient assessment and start of opioid treatment; follow-up assessment of pain intensity; assessment of need for adjuvant treatment of bone pain.

The criteria with the highest rate of overall adherence (≥75%) were: criterion relating to pain assessment, documentation of location of pain; most criteria regarding current continuous analgesia, current intermittent analgesia and follow-up of pain therapy; treatment of nausea/vomiting, sleep disturbance, neuropathic pain and anxiety/depression respectively.

Conclusions The MAT-CP highlighted areas for review and possible improvement. The MAT-CP is a potential outcome measure for future service developments which requires further testing and possible abbreviation to focus on commonly applicable criteria.

References

  1. 1.

    WHO. Cancer pain relief: With a guide to opioid availability. 2 ed. Geneva: World Health Organization;1996.

  2. 2.

    Scottish Intercollegiate Guidelines Network (SIGN): Guideline No.44: Control of pain in patients with cancer: SIGN; 2000.

Keywords Cancer, Pain, Guidelines

PC-127 Inpatients medication reconciliation process in a traumatology ward

Juan Francisco Marquez Peiro 1, Blanca Gomez Correcher1, Begoña Porta Oltra1, Ma Angeles M. A. Lopez-Montenegro Soria1, Monica Climente Marti1

1Pharmacy, Hospital Universitario Dr. Peset, Valencia, Spain

Background and objective To identified and resolve medication reconciliation errors (MRE) in hospitalised patients.

Design A transversal and observational study in a terciary university hospital. Period: One and a half months between December 2006 and January 2007. Inclusion criteria: adult patients admitted to Traumatology ward.

Setting Medication reconciliation process was performed after the implantation of a descentralised program of pharmaceutical care in a Traumatology ward (36 beds; 1363 patients/year).

Main Outcome Measures

To identified MRE pharmacist carried out an interview to patient or caregiver focused on ambulatory treatment (drug name, dose, dosage interval, route of administration and indication). This information was compared with the information obtained by nurse in the admission process. When a MRE was detected a pharmacist intervention (PhI) was performed. Variables: MRE (overall and per patient); Drugs involved in MRE; PhI (overall, level of acceptance and significance (1)); Initial severity of MRE (2). We studied the frequency of appearance of this variables.

Results 113 patients were admitted in Traumatology ward in this period and 70 patients (62%) were included (age: 61.6 ± 19.2; %male/female: 36/64) with an average of 4 drugs per patient. 14.3% (n = 10) of patients presented MRE, with 2.5 MRE per patient (IC95%: 1.7 a 3.2). Class of MRE (n; %): (a) Omitted drug: diuretics (4;18.2%); antidepressant (2;9.1%); antiarrhytmics (2;9.1%); other drugs (5;22.7%). (b) Wrong drug: antidepressant (2;9.1%); (c) Wrong dose: antihypertensives (4;18.2%); other drugs (3;13.6%).

Initial severity of MRE: 52.2% required increased monitoring or change in treatment. A total of 21 PhI were performed (start treatment: 12; clarification of treatment: 9). 90.5% of PhI were accepted (n = 19), with moderate significance in all cases.

Conclusions MRE were identified in 14% of patients included. Pharmacist interventions solve 86.4% of MRE and reduce severity of these errors without harm to patient. It is necessary to carry out future studies to evaluate the effectiveness of the medication reconciliation process.

References

  1. 1.

    Schneider PJ, Gift MG, Lee YP, et al. Cost of medication-related problems at a university hospital. Am J Health-Syst Pharm 1995;52:2415.

  2. 2.

    Brown BL, Williamson SE. A system for documentation of pharmacist interventions with incorporation into performance and quality improvements plans. Hosp Pharm 1993;28:1083–88.

Keywords Medication reconciliation, Pharmacist interventions, Descentralised pharmaceutical care

PC-137 Evaluation of physicochemical compatibilities during intravenous drug administration in two paediatric inpatient and outpatient oncology units

Ermindo R. Di Paolo 1, Vivian Därr1, Catherine Ansermoz2, Nicolas von der Weid2, Maja Beck Popovic2, André Pannatier1

1Pharmacy Department, 2Paediatric Department, University Hospital CHUV, Lausanne, Switzerland

Background and objective Chemotherapeutic agents and other intravenous (iv) drugs are often administered to paediatric oncology patients through a unique implantable vascular access port. Drug administration and compatibility charts are available in the paediatric oncology units of our hospital. The aim of this study was to identify the iv drug associations used in children and adolescents and to determine if the drugs were injected or infused according to known compatibility data.

Design Anonymous observational prospective study during a 6-month period.

Setting Two paediatric inpatient and outpatient oncology units of a university hospital.

Main outcome measures Compatibilities between drugs administered through the same iv line: drug-drug and drug-solute associations in the same infusion (mixture) and through Y-site.

Results Twenty inpatients and 20 outpatients were included in our study during 52 days of observation. Their median age was 7.1 years (range 0.8–21.5). Twenty chemotherapeutic agents, 25 other iv drugs and 7 solutes were prescribed, with a mean of 4.3 drugs per patient and per day. All the 236 associations between drugs and solutes were compatible according to the literature. Of 12 drug-drug mixture associations, 11 were compatible; of 19 drug-drug Y-site associations, 13 were compatible. No data was available for the seven remaining associations. No drugs were administered simultaneously to outpatients through Y-sites.

Conclusions Even if a doubt remained on drug associations with no compatibility data, this study showed that (1) few drugs were administered simultaneously through the same iv line, and (2) the problem of drug incompatibilities could be mostly avoided with the planning of infusions during prescription and the respect of good nursing practice.

Keywords Chemotherapeutic agents, Intravenous, Compatibility

PC-139 Community pharmacies in south wales: service provision for drug users

Karen Hodson 1, Elin Gwyn1, Sarah L. Benney1, David K. Luscombe1, Neil Jones2, Arwel Thomas2, Robert D. Sewell1, Paul N. Deslandes3

1Welsh School of Pharmacy, Cardiff University, 2Community Addiction Unit, 3Pharmacy Department, Cardiff and Vale NHS Trust, Cardiff, United Kingdom

Background and objective In 2000, research was conducted in South Wales on pharmacists’ service provision for drug users [1]. This study therefore aimed to determine the current involvement of community pharmacists in these services.

Design Minor amendments were made to the questionnaire designed by McBride et al. [1]. After it was piloted, the questionnaire, covering letter and pre-paid envelope were hand delivered to each community pharmacy. The pharmacist either completed the questionnaire whilst the researcher waited or returned it by post. Non-responders were followed-up after 2 weeks. After a further 2 weeks, the data was analysed using SPSS 12.

Setting All community pharmacies in four Local Health Boards (LHBs) in South Wales.

Main outcome measures The percentage of pharmacies in each LHB dispensing controlled drugs (CDs) for drug misuse treatment; the type of treatment dispensed; mean number of clients per pharmacy and the range of prescription installments. The percentage of pharmacies supervising consumption and the number which were commissioned to provide these services under the New Pharmacy Contract.

Results The response rate was 79% (n = 139/175). 70% (n = 96/137) of pharmacists dispensed CDs for drug misuse treatment to 805 people; 59%, 70%, 79% and 88% in the four LHBs. The mean number of individuals per pharmacy receiving treatment was 8.7 (range 1–60, n = 88). 73% of prescriptions were for daily installments. More opioid than amphetamine prescriptions were dispensed (89% vs. 19% respectively). Fifty-seven percent of pharmacists supervised daily methadone consumption; 41% buprenorphine. The main reason for not providing this service was lack of demand. Only 14% (n = 17/124) of responders had been commissioned to provide these services.

Conclusions Since the research undertaken in 2000, the number of pharmacies dispensing CDs for treatment of drug misuse has risen by 15.7%. The number of people dispensed opiates has tripled. The community pharmacist is uniquely positioned and willing to provide existing and further services to this group of patients. However appropriate reimbursement for these services should be fair and equitable.

Reference

  1. 1.

    McBride AJ, Pates R et al. Service provisions for drug users: a survey of community pharmacies in a South Wales health authority. Pharmaceutical Journal 2001;267:820–823.

Keywords Community pharmacy, Community pharmacists, Drug misusers, Methadone, Buprenorphine

PC-141 Community pharmacies in south wales: misuse of over-the-counter medicines

Karen Hodson 1, Sarah L. Benney1, Elin Gwyn1, David K. Luscombe1, Neil Jones2, Arwel Thomas3, Robert D. Sewell1, Paul N. Deslandes4

1Welsh School of Pharmacy, Cardiff University, 2Community Addiction Unit, 3Community Addiction Unit, 4Pharmacy Department, Cardiff and Vale NHS Trust, Cardiff, United Kingdom

Background and objective In 2000, research was undertaken in South Wales on the prevalence of over-the-counter (OTC) medicines misuse [1]. This study therefore aimed to determine what OTC medicines are currently being misused and how the community pharmacist manages the situation.

Design Minor amendments were made to the questionnaire designed by McBride and Pates [1, 2]. After the questionnaire was piloted, the questionnaire, covering letter and pre-paid envelope were hand delivered to each community pharmacy. The pharmacist either completed the questionnaire whilst the researcher waited or returned it by post. Non-responders were followed-up after 2 weeks. After a further 2 weeks, the data was analysed using SPSS 12.

Setting All community pharmacies in four Local Health Boards (LHBs) in South Wales.

Main outcome measures

The percentage of pharmacists who believed that OTC medicines were being misused. The type of medicines being misused and the methods used by pharmacists when OTC misuse was suspected.

Results The response rate was 79% (n = 139/175). 73% of respondents (n = 101/138) thought there was a problem with OTC misuse in their area. The number of cases in the week preceding the survey, ranged from 0 to 18 (mean 3.1, n = 85). The type of products suspected of being misused were opioid containing products (n = 81), antihistamine containing sleeping aid (n = 70), laxatives (n = 57), cough and cold remedies (n = 40) and others (n = 13). Factors which commonly alerted pharmacists to possible OTC misuse were frequent requests for the product (n = 97/101), alerted by the counter staff (n = 69/101), a person’s behaviour (n = 41/101) or their appearance (n = 33/101). Methods to deal with suspected misuse were reported as: question customer (n = 71/101), counsel customer (n = 66/101), refuse a sale (n = 58/101), supervise the sale (n = 58/101), keep product out of sight (n = 50/101) and/or say it was out of stock (n = 38/101).

Conclusions Suspected OTC misuse has increased since 2000; however the identified products have not changed. Although improvements have been made, co-operation between all pharmacists is required to ensure that these clients are not visiting several pharmacies to purchase their OTC medicines.

References

  1. 1.

    Pates R, McBride AJ et al. Misuse of over-the-counter medicines: a survey of community pharmacies in a South Wales health authority. Pharmaceutical Journal 2002;268:179–183.

  2. 2.

    McBride AJ, Pates R et al. Service provision for drug users: a survey of community pharmacies in a South Wales health authority. Pharmaceutical Journal 2001;267:820–823.

Keywords Community pharmacy, Community pharmacist, Over the counter medicines, Drug misuse

PC-142 Evaluation of intravenous immunoglobulin utilization at King Khalid University Hospital, Riyadh, Saudi Arabia

Abdullah A. Al-Angari1, Mohammed H. Abutaleb2, Ahmed A. Albarraq 3, Abdullatif A. Al-Dhowailie4

1Pediatrics, King Khalid University Hospital, 2Clinical pharmacy Department, College of Pharmacy, King Saud University, 3Pharmaceutical Services Department, King Khalid University Hospital, 4Clinical Pharmacy, College of Pharmacy, KSU, Riyadh, Saudi Arabia

Background and objective Intravenous immunoglobulin (IVIG) is a plasma product that has many important therapeutic uses. There are only 6 FDA approved indications for IVIG use. However, it is used to treat a wide variety of other clinical conditions. Different studies in developed countries showed high rate of inappropriate utilization of IVIG.

Objectives To study the utilization of IVIG in terms of pattern of prescription, amount used, side effects, and cost.

Design We performed a retrospective study to evaluate IVIG utilization at King Khalid University Hospital. Patients who received IVIG in the period form January 2003 to December 2005 were identified using the hospital computer system. The medical records of those patients were reviewed. The collected data included demographics, indication of use, dose regimen, physician specialty, and adverse effects. Based on clinical evidence and common experience, indications were categorized into 4 different categories; (A) FDA-labeled indications, (B) off-labeled recommended indications, (C) off-labeled recommended as alternative, and (D) off-labeled not recommended.

Setting King Khalid University Hospital, an 850 bed teaching tertiary center.

Main outcome measures Describing the pattern of prescription, amount used, side effects, and cost.

Results We identified a total of 311 patients. Among them 284 (91.3%) had there files available for review and for 27 (8.7%) patients limited information were obtained from electronic records. The total amount of IVIG that was consumed during the study period was 43.5 kg with total cost of approximately 6.65 Million Saudi Riyals. Of all patients 35.1% received IVIG for category (A) indications, 9.5% for category (B), 27.3% for category (C), and 28.1% for category (D). In regard to the prescribing physician; 41.2% were pediatricians, 34.1% internists, 18.7% neurologists, and 6% other specialties. Side effects to IVIG infusion were noted in only 30 patients (11%). Most of them were mild with fever being the most frequent (7.2%). One patient developed anaphylaxis.

Conclusions IVIG was mostly prescribed for non-recommended or weakly recommended indications. It was generally safe. The over utilization of such an expensive medication should be better controlled. Studies of different methods to ensure more appropriate IVIG use are warranted.

Keywords Intravenous Immunoglobulin utilization, Intravenous Immune globulin use evaluation

PC-143 Drug preparation errors in a medical department: a short study

Patrick Le Garlantezec 1, Leslie Lefeuvre1, Olivier Aupee1, Helene Mullot1, Laurent Simon1, Xavier Bohand1

1Pharmacy, Military Hospital Percy, Clamart, France

Background and objective The aim of this observational study was to evaluate in a French military hospital the rate of oral drug preparation errors (DPEs) in a medical unit (MU) which is provided with a ward stock distribution system, and to classify the DPEs.

Design Every day and during 2 weeks, a pharmacist checked the pill-boxes prepared in a MU by nurses, by using an undisguised observation technique. The pill-boxes preparation was compared to their prescriptions.

Setting Internal medical department.

Main outcome measures DPEs were classified according to the definitions of the American Society of Health-System Pharmacist.

Results A total of 117 pill-boxes with an average of 5.1 oral drugs per prescription were checked. 82.1% of pill-boxes contained at least one error for a total of 173 errors (averaging to 1.5 errors per pill-box). The observed errors have been classified as follows: deteriorated drug errors (including unidentifiable or without unit packaging drugs) (56.1%), omission errors (14.5%), improper dose errors (13.3%), unauthorized drug errors (11.6%), patient identification errors (including pill-box without label) (3.5%), wrong time errors (1.2%). No wrong dosage-form error was observed.

Conclusions Although the recorded error rate is high, in most cases, the consequences wouldn’t be of serious concerned to the patients. However, some of the errors like doses errors (some of them concerning oral anticoagulative treatments) and lack of identification (nurses preparing and those administrating drugs being different) could lead to serious iatrogenesis and worsen the security of drug use process. Unfortunately the checking step during the administration by nurses is not efficient enough, when no unit packaging exists. The literature data show that the DPEs rate is lower when pill-boxes are prepared with an unit dose drug dispensing system (UDDDS) centralized in the pharmacy department and errors detected are corrected before the dispensing step. UDDDS applying a unit dose and a patient-labelled system would contribute to decrease the iatrogenesis risk. This short study could confirm the pharmacist role in preventing iatrogenesis. Our hospital has since introduced the application of UDDDS for 60% of patients.

Keywords Drug preparation errors, Study, Iatrogenesis risk

PC-144 Antivitamin k iatrogenesis in the context of behavioural troubles: an elderly case report

Patrick Le Garlantezec 1, Renaud Dullou1, Eric Blondet1, Helene Mullot1, Olivier Aupee1, Laurent Simon1, Xavier Bohand1

1Pharmacy, Military Hospital Percy, Clamart, France

Background and objective Anticoagulative treatment use with Antivitamin K (AVK) needs a close monitoring, using the International Normalized Ratio (INR). The therapeutic range varies according to the affection requiring anticoagulation. Excess complications from bleeding (frequently found in elderly patients) are associated with high INR values. We report a case of an elderly patient who presented with AVK excess in relation with behavioural troubles, resulting in acute spinal subdural haemorrhage (SSH).

Design Case report.

Setting Neurosurgery department.

Main outcome measures Follow-up of the patient’s state and clinical assessment.

Results A 78 year-old woman was admitted because of recurrent falls with temporospatial disorientation and difficulties ambulating after her son’s suicide a few days earlier. Past medical history included valvular prosthesis requiring previscian for 8 years. On examination, there was confused with slowed thought process. The INR was five and cerebral CT-scan showed subarachnoid haemorrhage. AVK was then replaced by heparin. Progressively the patient developed partial motor deficit of the inferior limbs. A first neurosurgical opinion was required in the absence of clinical amelioration but no surgery was hold. The deficit worsened and a MR scan confirmed the diagnosis of SSH and require an emergency decompressive surgery, performed in an another neurosurgical department. The clinical state, first improved, worsened 2 weeks later because of anaemia (resulting of an ulcer). Secondary ischemic cerebral vascular injury (related to anaemia) is resolved with blood transfusion. Ten months later, the patient still presented complete sensitivomotor paraplegia.

Conclusions This case recalls that anticoagulative treatments, even when supervised, have many bleeding risks and must be closely monitored during some more delicate periods, as the initiation period of treatment or the change in the drug therapy consecutive of an intercurrent disease. In this case report, AVK excess (probably resulting from taking the wrong dose of AVK tablets) may be related to the attention troubles. The resulting SSH is difficult to treat especially because it is a rare pathology, difficult to diagnosis and without treatment’s guidelines. For the elderly, a more frequent INR follow-up should be advised to avoid iatrogenesis.

References

  1. 1.

    Domenicucci M, Ramieri A, et al. Spinal subarachnoïd hematomas: our experience and literature review. Acta Neurochir 2005;(147):741–50.

  2. 2.

    Miller DR, Ray A, et al. Spinal subdural haematoma: how relevant is the INR? Spinal Cord 2004; (42):477–80.

Keywords Antivitamin K, Iatrogenesis event, Elderly

PC-152 Home blood glucose monitoring: meters and advice provided by community pharmacists in Lothian

Pauline Westwood 1, Natalie Dudgeon2, Ian Brown3, Aileen Thomson2, Catherine Kelly4

1Edinburgh Community Health Partnership, 2Clinical Effectiveness Team, 3Colinton Pharmacy, 4Community Pharmacy Development, NHS Lothian, Edinburgh, United Kingdom

Background and objective The Lothian Joint Formulary (LJF) recently included a list of preferred Home Blood Glucose Monitoring (HBGM) meters and guidance on frequency of monitoring. The objectives of this project were to identify: brands of HBGM meters stocked by community pharmacists; the type and frequency of advice on HBGM provided; and awareness of the current formulary guidance.

Design Baseline audit using postal questionnaire sent one per community pharmacy. Responses were anonymous.

Setting Community pharmacies in NHS Lothian health board area.

Main outcome measures Brands of HBGM meters stocked and influences on this,

  • Type and frequency of advice on HBGM,

  • Information sources on HBGM

Results Ninety-one responses received from 182 questionnaires (50%). Seventy-four (81%) stocked meters, 22 (30%) of which had meters other than the formulary recommendations. Most common influence on meter choice was pharmacy company policy 46(51%). The meters listed in the LJF influenced stock held by 7(8%) respondents. Advice most commonly given was how to use the meter 72(79%) and frequency of testing 43(47%). Seventy-five (82%) reported giving advice when dispensing HBGM test strips to patients. The most common information source used for advice was the HBGM meter manufacturers’ literature 78 (86%). Fifty-one (56%) used the LJF for advice. Thirty-two (35%) were aware of the recent guidance on HBGM in the LJF.

Conclusions Community pharmacists play an important role in choice of meter purchased and in providing general advice on HBGM. Plans to raise awareness of the local formulary guidance include: a training session on HBGM meters included in the LJF; liaising with representatives from multiple retail pharmacy companies; and developing an aide memoir to assist community pharmacists in providing advice. The questionnaire will then be reissued to community pharmacists.

Keywords Diabetes, Monitoring, Pharmacy

PC-153 How do community-based nurses select appropriate inhaler devices for their patients?

Gillian Hall 1, P. Westwood1, M. Reid1, M. Kinnear1

1Pharmacy, NHS Lothian, Edinburgh, United Kingdom

Background and objective Local data indicates prescribing of a broad range of inhaler devices despite national guidance and local formulary first line recommendations to use a metered dose inhaler (MDI) with or without a spacer device. Practice nurses play a major role in the management of respiratory disease in primary care. Although an assessment tool is used to support inhaler device selection in hospitalised patients, it seems that no such tool exists for use by nurses in the community setting. This study aimed to identify factors considered important by practice nurses in selection of inhaler devices; and gather views on the introduction of an assessment tool.

Design Postal questionnaire sent to 299 practice nurses.

Setting General practices within one geographical health board area.

Main outcome measures Factors considered important in selection of inhaler device.

  • Level of demand for a standardised assessment tool

  • Extent to which MDI is used as first line treatment

  • Guidelines used in practice

Results 161 (54% response) questionnaires were returned, 112 of which were from nurses involved in inhaler selection for patients. Fifty-seven (52%) indicated they used an MDI first line, nearly always or frequently. Fifteen of 21 listed factors influencing inhaler choice were classed as important or very important by more than 70% respondents. One hundred (90%) respondents did not use an assessment tool. Fifty-five (49%) would be willing to if one was available, 7(6%) would not, and 48 (43%) didn’t know. Sixty-one (54%) used the local formulary and 102 (91%) used national guidelines as a reference source.

Conclusions The factors considered important by practice nurses in device selection do not help explain the wide variations in prescribing practice. Further work is required to ascertain reasons for this, such as nurse inhaler technique or differing patient demographics. A large number of nurses indicated that they would like support with device selection.

Keywords Inhaler, Assessment tool, Device selection

PC-155 Repeat prescribing systems and waste

Elaine Lawrie 1, James Arkley1, Damien Keane1, Sandra McNaughton1, Carol Philip1, Moira Kinnear1

1Lothian Pharmacy Practice Unit, Department of Pharmacy NHS Lothian, Edinburgh, United Kingdom

Background and objective Annually an estimated £15 million (Euro 23 million) of unused medications are returned to community pharmacies for disposal [1]. Repeat prescribing in primary care allows patients with chronic diseases to collect prescriptions every 56 days without medical review although review must be undertaken annually. Repeat prescribing accounts for approximately 75% of prescriptions. National standards exist to promote safe and efficient repeat prescribing systems [2]. The study aimed to define the patient pathway through the system in one medical practice and identify medicines management processes that could be improved with the aim of reducing medicines waste.

Design Observation of staff procedures mapped the process. Medical records for the previous year were reviewed for 81 patients (Group A, < 65, n = 41; Group B, > 65, n = 40) randomly selected from the disease register for ischaemic heart disease. A previously validated questionnaire was sent to these patients to gain insight into their awareness of the repeat prescribing system.

Setting One general medical practice (14,200 patients).

Main outcome measures Proportion of synchronised medicine supplies, medicines ordered to set timescale, annual medication review, patient questionnaire responses.

Results The nationally recommended ordering process was not followed—a telephone ordering system was in place with potential for error and allowed ordering of acute medicines without direct consultation with the doctor. This was the preferred method of ordering reported by 18/39 (46%) patients. Medicine supplies were synchronised within 2 days for 95% of patients in group A and 78% in group B (overall 86%, target = 90%). Most patients (69%) were aware of the 48 h notice policy for ordering prescriptions. Overall 56 (69%, target = 90%) of patients ordered medicines to the set timescale (64% group A, 74% group B). Overall 36 (44%, target = 90%) had their medicines recorded as reviewed within one year (54% group A, 35% group B). Of the 39 (48% response rate) questionnaire respondents, 16 (41%) reported having received a review within the last year.

Conclusions The repeat prescription ordering process did not adhere to national guidance and should be reviewed. Synchronisation of medicines was not identified as a problem but there is need to improve the frequency and/or recording of medication review. Implementation of the Chronic Medication Service section of the New Community Pharmacy Contract has the potential to improve performance against these standards and reduce waste generation.

References

  1. 1.

    The Scottish Executive. The Right Medicine; a strategy for pharmaceutical care in Scotland. Edinburgh: Scottish Executive 2002.

  2. 2.

    National Prescribing Centre. Saving time, helping patients: a good practice guide to quality repeat prescribing. Liverpool 2004.

Keywords Medicines Waste, Repeat Prescribing System

PC-161 Pharmacists’ interventions: cost saving and return on investment from “parenteral to oral switch” and “drug discontinuation”

Rose Francois-Xavier 1, Escofier Laurence2, Juste Michel3, Roubille Renaud4, Charpiat Bruno5, Conort Ornella6, Allenet Benoit7, Bedouch Pierrick7

1Clinical Pharmacy, Rennes University Hospital, Rennes; 2Clinical Pharmacy, Nord Mayenne Hospital, Mayenne; 3Clinical Pharmacy, Auban Moet Hospital, Epernay; 4Clinical Pharmacy, Lucien Hussel Hospital, Vienne; 5Clinical Pharmacy, Croix Rousse Hospital HCL, Lyon; 6Clinical Pharmacy, Cochin Hospital APHP, Paris; 7Clinical Pharmacy, Grenoble University Hospital, Grenoble, France

Background and objective The special interest group (SIG) “standardisation and valorisation of clinical pharmacy activities” (French Society of Clinical Pharmacy) developed an instrument to describe the daily routine documentation of pharmacists’ interventions on drug prescription [1].

We used documented interventions to calculate cost saving and return on investment (ROI) from two kinds of interventions: change of drug administration route (parenteral to oral switch) and actual drug discontinuation.

Design A prospective multicenter study was conducted from January to September 2004 to collect 1800 pharmacists’ interventions (among those made by the SIG). We used the method developed by Simoens et al. to calculate the financial benefits of pharmacists’ interventions [2]. We calculated the financial benefit arising from improved drug therapy for one day. This one day benefit was then multiplied by the number of days with a maintained impact: impact during 1 day (scenario 1), 3.5 and 7 days (scenario 2 or 3: corresponding to respective durations of inpatient stays). The cost of these interventions was evaluated considering that each intervention needed 5 min.

Setting Units of Clinical Pharmacy in 6 different French hospitals.

Main outcome measures Cost saving and return on investment of pharmacists’ intervention.

Results Among 1800 interventions, 321 consisted in “parenteral to oral switch” and “drug discontinuation” and cost 847 euros. Cost saving was 1060 euros (scenario 1), 3289 euros (scenario 2) and 6410 euros (scenario 3). The ROI was 1.25 euros (scenario 1), 2.88 euros (scenario 2) and 6.56 euros (scenario 3) for every spent euro.

Conclusions Clinical pharmacy can reduce costs of hospital care without affecting clinical outcomes.

References

  1. 1.

    Allenet B, Bedouch P, Rose FX, Escofier L, Roubille R, Charpiat B, Juste M, Conort O. Validation of an instrument for the documentation of clinical pharmacists’ interventions. Pharm World Sci 2006;28:181–188.

  2. 2.

    Simoens S, Broothaers K, Willems L, Lakeman L. Financial benefits of pharmacy interventions. Clinical Pharmacy Europe Spring 2006;2:42–4.

Keywords Cost-saving, Parenteral/oral switch, Drug discontinuation

PC-172 Audit of subcutaneous insulin prescription and administration in NHS Lanarkshire

Ruth Waters 1, Sandra Crawford2, Elizabeth A. McIntyre3

1Pharmacy Department, Wishaw General Hospital, Wishaw, 2Other, NHS Lanarkshire, Lanarkshire, 3Bracco House Diabetes Centre, Monklands Hospital, Airdire, United Kingdom

Background and objective Following a number of clinical incidents within NHS Lanarkshire (NHSL) a review of the prescribing and administration of subcutaneous insulin was undertaken. A key development, following the review has been the pilot implementation of a newly designed insulin prescription/administration chart supported by prescribing and administration guidelines. The objective was to assess adherence to NHS Lanarkshire (NHSL) Insulin Prescribing and Administration Guidelines following the pilot implementation of a newly designed insulin prescription/administration chart.

Design Staff training for the use of the new chart was provided by clinical pharmacists, diabetes specialist nurses and diabetologists prior to the pilot. A 2 weeks insulin chart/medicine cardex audit was then carried out by pharmacists, assessing all aspects of the prescription and administration of subcutaneous insulin as specified in the NHSL Insulin Prescribing and Administration Guidelines. All patients prescribed subcutaneous insulin in designated wards were included in the audit. The audit standard set for this study was 100% compliance with the guidelines.

Setting The audit was carried out in designated wards across all three acute hospital sites within NHSL. The wards included three medical/diabetic wards and a surgical ward.

Main outcome measures It was demonstrated that 100% compliance with the guidelines was not achieved across all three acute hospital sites. This highlighted that further education and training for nursing and medical staff was essential to improve the prescription and administration of subcutaneous insulin.

Results A total of 22 in-patients were included in the audit. The charts were checked on 93 occasions on all designated wards during the audit. Results for each question in the audit schedule (18 in total) were ranked in order of percentage compliance with the guidance. Results were analysed and compared according to ward and hospital site. Following a multidisciplinary meeting after data collection, agreed action points were assigned to those outcomes ranked as highest priority to improve patient safety. Revisions to the pilot insulin chart were suggested and the final insulin chart was compiled.

Conclusions The outcome of this study has highlighted that there are key areas for improvement in practice concerning the prescription and administration of subcutaneous insulin within NHSL. Education and training for medical and nursing staff is currently being planned. A further review of the final insulin chart is also planned following its full implementation and roll out within all wards of the acute sector of NHS Lanarkshire.

Keywords Insulin, Chart, Audit

PC-194 Pharmacist’s interventions during dispensation for improvement of safety treatment

Josef Maly 1, Michal Hojny2, Jitka Novakova2, Jiri Vlcek1

1Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Kralove, 2Hospital pharmacy, Institute of Clinical and Experimental Medicine, Prague, Czech Republic

Background and objective The adverse drug events and medication errors occur often and so decrease quality of health care. To manage the problems connected with it and to reduce the risks requires team-work. A pharmacist is a minor, but important element of health care system in the Czech Republic. Medication errors may be caused by many factors from prescription to administration of drugs. The aim of this study was to describe and evaluate pharmacist’s role in detecting and solving the problems during dispensing of drugs.

Design Nine pharmacists recorded their interventions during a six-month period of dispensing care. The following data were collected: patient and prescriber characteristics, prescribed drugs, and the result in form of pharmacist’s intervention. Basic characteristic of pharmacists: mean age was 29.7; mean length of pharmaceutical practice was 6.3 years. Five of them got first level of accreditation (by 4 years of working experience and by passing exams). All data were processed by descriptive statistics.

Setting The Hospital pharmacy of the Institute of Clinical and Experimental Medicine in Prague (Czech Republic).

Main outcome measures Type and frequency of pharmacist’s interventions, according to different medication errors.

Results During a six-month period there were 338 interventions of pharmacist, out of 71 146 prescriptions. We evaluated the following interventions: 8 cases of drugs prescribed to wrong patient (2.4% of total interventions), 5 cases of duplications of therapy (1.5%), 42 cases of wrongly prescribed drugs or strengths of medication (12.4%), 8 cases of inappropriately prescribed strength of medication causing inconvenient administration (2.4%), 23 cases of inappropriate dosage forms (6.8%), 26 cases of prescribed drugs unavailable on the Czech market (7.7%), 58 cases of possible instabilities of specific dosage forms as dividing sustained release tablets (17.1%), 4 cases of incorrect indication and 4 cases of wrongly prescribed drugs to patients with hypersensitivity in anamnesis on the same (1.2%). Most frequently, in 160 cases, pharmacists intervened in dosages of drugs (47.3% of total interventions). The insufficient dosing, overdosing and other problems with dosages were evaluated.

Conclusions Our study pointed out errors that pharmacists can identify, and are relevant to adverse drug events, occurring from prescription to dispensation of drugs. It is important to establish documentation and record pharmacist’s interventions in order to minimize adverse drug events.

Keywords Medication errors, Hospital pharmacy service, Pharmaceutical care

PC-210 Harmonization of the quality of chemotherapy preparations: impact of a certification process

D. Boulay 1, S. Bauer2, A. De Laguerenne3, V. André3, J. F. Tournamille3, S. Froger2, A. Rouleau3, J. Grassin2

1Pharmacy, Clocheville Hospital, 2Pharmacy, Trousseau Hospital, 3Pharmacy, Bretonneau Hospital, Tours, France

Background and objective The units for centralized chemotherapy preparation of University Hospital of Tours realize 22.000 preparations of cytotoxic drugs yearly. This activity is carried out within two geographically distinct locations. These units face constraints of productivity and must attend to the conformity, a high quality level of the preparations and concurrently secure handling of these hazardous drugs. This activity requires precise quality management according to principles described in the Standard ISO 9001 version 2000. Its application permits quality to be improved continuously towards the patients’care and so obtain their confidence.

Design This voluntary certification process has involved the development of a quality policy centered on the deployment of ISO management quality system.

Setting Unités de Biopharmacie Clinique Oncologique, University Hospital of Tours.

Main outcome measures This development requires:

  • Organization supported by written supports (Quality Manual, procedures)

  • adapted equipments and locations

  • highly trained staff working

  • safety implying computerization of the data and prescriptions

  • good communication with the patients and care units

  • constitution of working groups and regular meetings. A self evaluation compared to the standard was carried out to consider actions which could be undertaken.

Results An important investment in duration and an involvement of the staff permit the establishment of:

  • setting up of the conformity of the practices in the two locations

  • quality controls at different times of the preparation

  • internal audit producing 12 recommendations

  • satisfaction survey for which 32% of answers

  • second self evaluation with 13% variations in comparison with the standard

  • trainings and evaluations of the staff

  • meetings implicating management every 6 months

  • charts by extraction of 30 validated French national pharmacy indicators (Société Française de Pharmacie Clinique 2006) to facilitate a harmonization of the practices extended to all the French hospital pharmacists. A visit of the experts of the certification body will proceed in April 2007.

Conclusions Obtaining certification will testify the capacity to realize products in conformity with the medical prescriptions, permit recognition and valorisation of know-how. Its preservation will fall under a continuous improvement with a control of all the drug circuit.

Reference

  • Standard NF EN ISO 9001. Quality Management systems: requirements. AFNOR, 2000.

Keywords Chemotherapy, Medical care, Certification

PC-214 Evaluation of antimicrobial therapy management of 23 patients with secondary peritonitis in a surgical intra-abdominal care unit

Marie-Christine Monteiro 1, Adeline Danielou1, Serge Rohr2, Yves Piemont3, Steinmetz Jean-Philippe2, Remy Veronique4, Dominique Levêque1, Laurence Beretz1

1Pharmacy, 2Department of Surgical Intra-abdominal Care, 3Department of Microbiology, 4Department of Infectious Diseases, University Hospital, Strasbourg, France

Background and objective Secondary peritonitis remains a major cause of mortality. Although, early surgical intervention is the basis of treatment, appropriate antimicrobial treatment is essential. The main issue of this study was to evaluate antimicrobial therapy management of secondary peritonitis in a surgical intra-abdominal care unit.

Design Retrospective study (Jan–Dec 2005).

Setting Department of surgical intra-abdominal care in a teaching hospital.

Main outcome measures The following items were recorded in patient’s medical files: patient’s characteristics, microbiologic data, antibiotic management including discharge prescriptions.

Results Twenty-three patients with a median age of 64 years (range: 27–98 years) were included. Peritonitis was nosocomial in 5 cases. Two patients, with community-acquired secondary peritonitis, died within hospitalization. Peri-operative intra-abdominal samples were noted for 9 patients (all positive). The median number of bacterial species isolated per patient was 2 (range 1–5). Escherichia coli and Bacteroides spp. were the most common species isolated (respectively for 5/9 and 3/9 patients). Sixteen blood cultures were noted (all negative). The median duration of hospital stay was 17 days (range: 7–42 days).

Peri-operative empirical antimicrobial treatment was initiated in 22 patients. Ten different regimens were used and they contained 2 or 3 agents. Most of the patients (6/22) received ticarcillin/clavulanic acid with an aminoglycoside and metronidazole. During the post-operative period, all patients received antimicrobial agents. This treatment was modified for 6 of 23 patients between the peri and post-operative periods. The total average duration of antimicrobial treatment (inpatient and ambulatory settings) was 24.5 days (range: 6–49 days). Fifteen patients received orally antimicrobial treatment after hospital discharge.

Conclusions Peri-operative intra-abdominal samples were not performed in 60, 9% of our patients which raises the question of antibiotic susceptibility testing of bacterial isolates obtained from peritoneal infections. The mean duration of antimicrobial treatment is marketedly longer than that recommended in the French guidelines [1]. In addition, the number of antimicrobial associations used is too high and the association of metronidazole and ticarcilline/clavulanic acid is redundant. This supports the need to develop local recommendations with the different experts (surgeon, microbiologist, infectious disease specialist, pharmacist).

Reference

  1. 1.

    Société française d’anesthesie et de réanimation. Conférence de consensus. Prise en charge des péritonites communautaires. 16 juin 2000. www.sfar.org/pdf/peritonites.pdf.

Keywords Secondary peritonitis, Antimicrobial therapy management

PC-215 Withdrawal of a patient addicted to tianeptine: collaboration between doctors, psychiatrists and pharmacists

Catherine Hua 1, Amandine Lagoutte1, Laurent Theveniaud1, Jean-François Cannard2, Laetitia Dalle2, Christine Meyer2, Jean-Michel Petit2, Véronique Jost1, Marie-Hélène Guignard1

1Pharmacy, Dijon Hospital University Centre, 2General Medicine and Psychiatry, Dijon Remand Centre, Dijon, France

Background and objective Tianeptine is usually indicated in the treatment of major depressions. The posology is two to three tablets of 12.5 mg/day. Following one case of overdose on tianeptine, the drug addictive profile has been examined.

Design Case study of an addiction to tianeptine and evaluation of the efficacy of the patient’s management.

Setting Department of General Medicine and of Psychiatry at Dijon Remand Centre, France.

Main outcome measures A 35 year-old man took fluctuating doses of tianeptine for about 10 years and up to 150 tablets of 12.5 mg of tianeptine per day. He regularly took 30–40 tablets per day for the last 4 years. He doesn’t suffer from depression but has a disabling neurosis. He has no history of addiction to opiates, psychoactive drugs and alcohol. He tried to stop taking tianeptine by himself several times. This lead to anxiety, shaking, abdominal pain and the need to take tianeptine again. The side effect which was associated with the overdose was a mydriasis. The patient did not show any sign of liver and cardiovascular toxicity. A withdrawal protocol which is based on 2 mg of clonazepam at the posology of three times a day has been established. The posology of clonazepam is maintained at 6 mg/day during the whole withdrawal treatment. The aim is to progressively and rapidly reduce the dose of tianeptine. The withdrawal is associated with a daily psychiatric follow-up. The dose of tianeptine has been decreased from 20 to 15, 9, 3 and 0 tablets a day within about ten days. Afterwards, the posology of clonazepam has been progressively decreased. In addition, the patient took some alimemazine to help him to sleep.

Results The association between tianeptine and clonazepam showed rapid benefits within a few days. The withdrawal signs which were observed when the patient entered the remand centre and before the treatment have considerably decreased. He does not feel anymore the desire to take tianeptine. However, the psychiatric follow-up has to be continued.

Conclusions The management of the patient has been a success. Even though tianeptine has usually shown to be safe, it would be recommended to avoid prescribing it to patients who are likely to develop a strong addiction to psychoactive drugs. This would avoid a withdrawal treatment which also requires the patient to have a psychiatric follow-up.

References

  • Guillem E. et al. Does addiction to antidepressants exist? Encephale 2003 Sep-Oct;29(5):456–9.

  • Saatcioglu O. et al. A case of tianeptine abuse. Turk Psikiyatri Derg. 2006 Spring;17(1):72–5.

Keywords Tianeptine, Addiction, Withdrawal, Management, Efficacy

PC-219 Inquiry into home parenteral chemotherapy requirements

Sebastian Hochart1, Anoul Bernard1, Marie-Cécile Boulliat1, Monique Yilmaz1

1Pharmacy Department of the Lille Regional University Hospital, Lille, France

Background and objective The Lille University Regional Hospital (CHU) plans to set up in its pharmacy parenteral anti-cancer chemotherapies reconstitution for home administration. For this project implementation, our pharmacy must evaluate the needs for chemotherapies home passage.

Design We carried out a questionnaire to the attention of chemotherapy prescribers.

Setting This questionnaire was addressed to the medical oncology, the blood, the urology, the pediatry, the pneumology, the dermatology and the neurology departments of the Lille CHU.

Main outcome measures The questionnaire asks the physicians on their current home chemotherapy practices, and their needs to come.

Results Here formulated needs: home parenteral administrations of bortézomib, fluoro-uracil, cytarabine with weak dose, vincristine, etoposide, fludarabine, cyclophosphamide except to high dose, azacitidine, and alemtuzumab IV.

Conclusions Etoposide and alemtuzumab IV, which can cause anaphylactic reactions, are noneligible products with home chemotherapy according to the home anti-cancer chemotherapy patient’s eligibility criteria professional consensus published by the French Health Accreditation and Evaluation National Agency (ANAES) in September 2003. The very short ambient temperature stability of azacitidine after reconstitution makes difficult its home use. Cyclophosphamide and fludarabine are available in tablets. In conclusion, only uses of fluoro-uracil, cytarabine, vincristine and bortézomib are considered by pharmacy for the moment. The results of this investigation are a good dialogue base between our establishment’s professionals. Important work remains to be carried out concerning the formalization of cancerology local networks, chemotherapy transport methods, and home’s cytotoxic waste elimination.

Keywords Home, Parenteral, Chemotherapy

PC-220 A study of prescribing patterns and applying evidence based medicine for primary and secondary prevention of cardiovascular diseases and stroke for diabetic patients

Mohammed Al-Jamal 1

1Pharmacy, RMH, Riyadh, Saudi Arabia

Background and objective Prescribing is one of the most important activities practiced by physicians in the clinical settings in all health care levels. A number of factors influence prescribing patterns and variations in prescribing rates have been identified.

Cardiovascular disease is one of the main causes of death world wide. Many risk factors are associated with cardiovascular disease. It is now well established that diabetes mellitus is an extremely common disorder in Saudi Arabia. Recently published surveys indicate that nearly one Saudi Arabian in 5 (20%) beyond the age of 30 has diabetes mellitus. A number of large clinical trials have established statins as effective agents in the prevention of both primary and secondary coronary heart disease (CHD). The American Diabetes Association (ADA) in 1997 recommended aspirin (ASA) therapy for the primary and secondary prevention of cardiovascular events in patients with DM. This recommendation is partially based on the results of four major clinical trials showing that ASA prophylaxis reduced the risk of major cardiovascular (CV) events in patients with DM. Hence, this problem needs urgent study, in sufficient depth, to delineate the factors associated with inappropriate prescribing patterns as a prerequisite for effective and cost-effective intervention strategies. This proposed project attempts to address these concerns.

Design This study has three main stages. A cross sectional study to study prescribing patterns of antidiabetic agents, antihypertensive, statins, and antiplatelets that prescribed for diabetic patients. Diabetic patients admitted to accident and emergency have been also evaluated.

Setting Emergency and outpatient clinics of atertiary hospital.

Main outcome measures The Number of diabetic patient who require statins and antiplatelets but not taking.

Results The preliminary results of this ongoing study that include about two million prescriptions have been analyzed. Eight percent were for diabetic patients. Less than 20% are taking antiplatelets and about 15% on statins. More than 1500 case of stroke have been received by accident and emergency department. Seventy percent of these are diabetic or have co-morbid disease such as hypertension. Only 25% are taking aspirin and about 20% taking statins for primary and secondary prevention of stroke.

Conclusions Although there is overwhelming evidence that patients with diabetes benefit from antiplatelets and LDL-cholesterol lowering with statins, a large number of diabetic patient need the addition of antiplatelets and statins to there medications. Both adopted evidence based guidelines and policies should recommend the use of statins and antiplatelets in the primary prevention of CHD and stoke. Diabetics are highly utilizing health care services. Those patients require special education program designed for the disease and its complications such as cardiovascular diseases and stroke and strategies to prevent these complications.

Keywords Diabetes, Prescribing, Statins, Antiplatelets, Aspirin

PC-223 Pharmaceutical care of COPD patients in a hospital setting

Nils Keiner1, Marion Schaefer 2

1Hospital Pharmacy, HELIOS Klinikum, Erfurt, 2Clinical Pharmacology, Charite, Berlin, Germany

Background and objective To evaluate a pharmaceutical care programme for COPD patients in a hospital setting including patient education.

Design Prospective study during hospital stay (average 7.6 days).

Follow up using a questionnaire 6 months after release form hospital.

Setting Medical admission unit, pneumonological ward, patients in ambulatory care in community pharmacies.

Main outcome measures Effects of pharmaceutical care including quality of life, patient knowledge, inhalation technique and reduction of hospital days as well as number of re-admissions.

Results 105 patients (47 male, 58 female, mean age 69.9, SD 6.6) who had received a structured pharmaceutical care programme including three training sessions with a total of 83 min on average and covering the disease itself, drug therapy, breathing exercises, nutrition and in some cases smoking cessation showed improved scores in a pre-post comparison with regard to knowledge, self management, inhalation techniques and quality of life. Compared with data from a pneumonological ward and all other hospital units the number of hospital days as well as the number of re-admissions were significantly lower for the study population. The follow-up 6 months after hospital release revealed that the level of knowledge was difficult to maintain especially for those patients who did not receive pharmaceutical care in their community pharmacy.

Conclusions Structured pharmaceutical care programmes are effective even during a short stay in hospital with regard to several outcome parameters. However, the results can only be maintained when there is an outreach into ambulatory care through community pharmacies.

Reference

  • Keiner N, Schaefer M: Was Pharmazeutische Betreuung bei COPD-Patienten leisten kann. Pharm Ztg 152 (2007);2:24–28.

Keywords Pharmaceutical care, COPD patients, Reduction of hospital days and re-admissions

PC-224 A study of prescribing patterns and errors in a Saudi hospital

Ahmed Al-Jamal1, Mohammed Al-Jamal 2

1Pharmacy, PSH, MOH, 2Pharmacy, RMH, Riyadh, Saudi Arabia

Background and objective There are no standard definitions or methodologies for prescribing patterns or prescribing errors studies which make the comparison between studies or health care services impossible. The practice of polypharmacy is a concern medically, socially, and economically as well as in terms of morbidity and mortality. In the clinical literature, the incidence of prescribing errors ranges between 0.5% and 18.8%.

Design A prospective study of all prescriptions in a three-month period (June–August 2003) in a tertiary hospital has been analyzed. The hospital provides both primary and secondary levels of care. Criteria used include frequency of selected prescribed drugs, average number of items per prescription, compliance to the hospital formulary, frequency of prescriptions for antibiotics and parenterals, generic prescribing and diagnosis. All prescribing errors were defined as deviation of the standard prescribing procedures (right patient, right drug, right dose and right duration). All prescribing errors were identified and documented in a special form. The incidence of prescribing errors was calculated by dividing the number of errors identified by the total number of prescriptions. The prescribing patterns and the incidence of prescribing errors were performed for selected specialties or clinics.

Setting A secondary care Hospital prescriptions.

Main outcome measures The incidence of prescribing errors. What do physicians prescribe for diagnosed disease?

Results Total number of prescriptions for the three-month study was 24,404. Emergency Room (ER) and primary care have the highest number of prescriptions (37.1%). The average number of items per prescription is 2.1. The most prescribed drugs by primary care (25.3% errors), emergency are antibiotics (28.2%), medicine (3.7), ophthalmology (22.3), gynecology (7.8), and pediatrics (17.8). The incidence of prescribing errors was 18.8%. The prescription errors were 13.6% in primary care and 22.3% in emergency department.

Conclusions Total Prescription errors are related to frequency of prescribing antibiotics. There was a relation between prescribing of antibiotics and prescribing of trade names (P < 0.01), compliance to the hospital formulary (P < 0.001), frequency of injection use (P < 0.001) and the incidence of medication errors and the average number of items per prescription. Several factors influence prescribing patterns and variations in prescribing rates has been identified. These include general physician behavior, differences in morbidity and mortality patterns, social perception toward illness, and physician clinical skills, experience and qualification, as well as physician continuing education and training. Special antibiotic prescribing guidelines and restrictions should target primary care and emergency department physicians.

Keywords Prescribing, Errors, Patterns

PC-226 Drug presentation and dispensation errors

C. Beuzon 1, A. Fseil1, S. Weber1, C. Doreau1

1Pharmacy Outpatient Unit, AGEPS, AP-HP, Paris, France

Background and objective Confusion between drugs with similar conditioning (look alike) or with an ambiguous dose designation on package is a reason of medication errors. This is even more important with hospital preparations; their presentation is seldom adapted for outpatients. This study evaluates in an outpatient hospital pharmacy the evolution of dispensing errors concerning the proportion of FLUDROCORTISONE AP-HP 10 g (F10) and 50 g (F50) after a change in presentation. 100 tablets boxes with similar colour for both dosage forms were replaced by 30 tablets boxes with a specific colour for each dosage form. A 30 tablet box was more appropriate to most prescriptions.

Design Each dispensing error concerning F10 and F50 was filed on a non-conformity form. The study covered the same time period before and after the packaging change. For F50, the survey was conducted over a 24 months period (packaging change on 15/12/05) and over a 14 months period for F10 (packaging change on 17/05/06).

Setting Pharmacy outpatient unit.

Main outcome measures Counting dispensing errors of F10 and F50. Statistical interpretation was done by counting the reduced split (Normal distribution) with 5% risk.

Results F50: 6 934 deliveries with 18 errors noted before the change (error ratio = 0.26%) and 6 742 deliveries with 1 error noted after the change (error ratio = 0.01%). The decrease was highly significant (P < 0.01). F10: 408 deliveries with 15 errors were noted before the change (error ratio = 3.68%) and 415 deliveries with 7 errors after the change (error ratio = 1.69%). The decrease was significant (P < 0.05). Results were more noticeable for F50 than for F10. This might be explained by a higher delivery frequency of the 50 g which encourages the dispensation of this dosage form by habit.

Conclusions High significant decrease in medication errors was noted when switching to new dosage forms of F10 and F50. We assume this decrease was due to the colour difference in each packaging. We can also think that dispensing the medicine in boxes instead of blisters contributes to reduce the error risk. We suggest the manufacturer could extend similar policy for other hospital preparations. A more specific package for each drug and each dosage form would certainly reduce delivery errors and enhance the safety of the medicine delivery process.

Reference

  • Fseil A et al. Erreurs de prescription medicale et de dispensation dans un service de dispensation aux patients externes. Abstract, SNPHPU 2004.

Keywords Drug presentation, Dispensation, Errors

PC-231 Can be patients’ compliance improved by the active pharmacist intervention? A pilot study in hypertension patients

Anna Olearova 1, Ivana Drinkova1, Lucia Krempaska2

1Department of Organization and Management in Pharmacy, Faculty of Pharmacy, Comenius University, 2Pharmacy Libra, Bratislava, Slovakia

Background and objective Polypragmatic cardiovascular patients meet drug related problems in interaction, risk of health state impairment and non-compliance with drug regimes. The role of the community pharmacist is legislative given and may be advanced to advice giving and counselling in drugs, drug related problems and strengthening of the pharmacist position in therapy process. The aim of this study was to evaluate pharmaceutical care of individual patient in a community pharmacy, to identify drug interaction and adverse effects, and to monitor of patients compliance.

Design Patients involved into the study (n = 184) were observed and contacted during 2 years by the community pharmacist. All patients were treated on hypertension and another co-morbidity, and used three or more drugs. There was a questionnaire filled out face-to-face direct by the pharmacist to obtain information of health state, using drugs, (non)compliance and life style of the patients.

Setting The study was set in community pharmacies in Slovakia, six pharmacists, one pharmacy assistant and one practising student were collaborating. Pharmacists were trained in two days session in counselling, drug regimes preparing, drug interaction identifying and healthy lifestyle advising.

Main outcome measures The pharmacist prepared drug regimes for patients, counselled using of drugs, interaction with food and other drugs, and advised in changing of life style. The patients described the level of their compliance, adherence and persistence and their internal opinion of the health state through the simple questionnaire.

Results The compliance of patients was very short at the beginning of the study. It was improved in 5 months, and continued in adherence and persistence in following 19 months such as patients’ satisfaction with pharmaceutical care and services in community pharmacy as well. The intervention of the pharmacist led to improving of compliance and led to persistence and disease knowledge, and also to improving of patients’ satisfaction in pharmacy services.

Conclusions The effectiveness and safety of drugs, and patients’ compliance, adherence and persistence were improved by pharmacist intervention.

The expert and human state of the community pharmacist in the therapy process and pharmaceutical care in polypragmatic and chronic cardiovascular patients was supported.

Our work suggest that patients’ compliance and persistence can be improved by the active and systematic pharmacist intervention in a community pharmacy.

Keywords Pharmacist intervention, Hypertension, Slovakia

PC-237 Drug history taking, identification of drug therapy problems and quality of patients own drugs (PODs)

Asta Fridriksdottir 1, Anna I. Gunnarsdottir2, Thorunn K. Gudmundsdottir2, Anna B. Almarsdottir3

1Hospital Pharmacy and Faculty of Pharmacy, Landspitali University Hospital and University of Iceland, 2Hospital Pharmacy, Landspitali University Hospital, 3Faculty of Pharmacy, University of Iceland, Reykjavik, Iceland

Background and objective A good and accurate drug history is extremely important. Studies show that pharmacists take more accurate drug histories than physicians, are more likely to identify drug therapy problems and reduce prescription errors, which may lead to more accurate drug therapy [1]. One way of documenting drug history is to examine patients own drugs. In some countries PODs are used during hospital stay and studies show that their overall quality is very good [2]. Use of PODs also significantly reduce drug wastage and hospital costs [2, 3]. The objectives of this study were to (a) compare drug histories taken by a pharmacist to those taken by physicians; (b) identify and analyze drug therapy problems; (c) examine PODs in relation to their usability during hospital stay.

Design A cross-sectional design was employed where the researcher took drug histories from patients post-op and compared with those taken by physicians in a preadmission clinic. Comparisons were made using t-tests and chi-squared statistics in SPSS 13.0.

Setting Four surgical units at Landspitali University Hospital, Reykjavík, Iceland.

Main outcome measures Comparison of the drug history taken by the researcher and by physicians in the preadmission clinic. Categorization of identified drug therapy problems. Examination of PODs in relation to their usability during hospital stay.

Results A total of 134 patients were interviewed. Comparison of drug histories taken respectively by the researcher and the physician revealed 804 discrepancies, 331 of those were in prescription medicines. The quality of PODs was good and 90.6% suitable for use. Drug therapy problems identified were 165 in 79 patients, the majority due to adverse drug reactions (39%) and noncompliance (16%).

Conclusions The results indicate that a drug history taken by a pharmacist is more accurate regarding prescription medicines, natural medicines, natural products and OTCs. Quality of PODs is generally good and usable during hospital stay. Around half of the patients experienced drug therapy problems, mostly adverse drug reactions, which emphasizes the importance of pharmaceutical care.

References

  1. 1.

    Hospital pharmacists group (2004). Providing pharmacy services to medical admissions units, Hospital Pharmacist, 11:72–73.

  2. 2.

    Fradgley S, Pryce A (2002). An investigation into the clinical risks in the use of patients own drugs on surgical wards, The Pharmaceutical Journal, 268:63–67.

  3. 3.

    Semple JS, (1995). The effect of self-administration and reuse of patients own drugs on a hospital pharmacy, The Pharmaceutical Journal, 255:124–126.

Keywords Drug history discrepancies, PODs, Drug therapy problems

PC-238 At sun-up and sun-down: pharmacists’ contribution to medical post-take ward rounds

C. Alice Oborne 1, S. J. Hill1, Kim Richmond2, Patricia Duthiel2

1Pharmacy, Guy s and St Thomas NHS Foundation Trust, 2Pharmacy, St Georges Hospital, London, United Kingdom

Background and objective UK pharmacists have recently started attending medical post-take ward rounds (PTWRs), when the consultant reviews newly admitted patients for the first time [1]. The objectives of this work included describing the type, frequency and impact of pharmacists contributions.

Design Prospective data collection. Data were collected over 22 months on all PTWR. A 20% random sample of contributions, were analysed.

Setting Morning and night PTWR in two teaching hospitals.

Main outcome measures Duration of activities, type of contribution, completion of drug histories, drugs involved, acceptance of contribution.

Results Ward rounds took 2.5–3.5 h, median 12 patients per PTWR. Drug histories were fully completed for 48% patients and partly completed for 17% patients during the PTWR. A median of 15 contributions were made per PTWR (excluding drug histories and drug supply). Pharmacists’ PTWR attendance differed between sites but data from 1604 PTWRs and 5006 contributions was similar. A wide range of contributions was made. Pharmacists initiated 81% contributions, doctors 18%. Drugs most commonly involved were heparins (15%), aspirin (4.5%), cephalosporins (3.3%), B vitamins (3.2%), opiates (3.2%). Reasons for contributions included new item prescribed (16.3%), unintentional omission (14%), evidence-based medicine (13%), prescribing error (12%). Body system affected by contributions included cardiac (23%), CNS (18%), respiratory (14%).

Pharmacists’ advice was accepted (90%), partially accepted (3.7%), not applicable (3.5%). The impact on the patient was estimated as major (1.9%), moderate (47%), minor (36%), none (5.6%).

Type of contribution varied: advise specific regimen, 25%; recommend start drug, 18%; swap drug to another, 7%; recommend stop drug, 8%.

Conclusions Pharmacists’ PTWR clinical contributions varied widely in type and drug. Pharmacists actively offer advice and one-fifth contributions recommended starting new therapy.

Pharmacists make valuables contributions to the care of acutely admitted patients outside usual ward pharmacy hours. Almost all are accepted.

Reference

  1. 1.

    Bednall R et al. A prospective evaluation of pharmacy contributions to post-take ward rounds. Pharm J 2003;271:22–23.

Keywords Pharmacist, Ward round, Advice

PC-240 Centralization of cytotoxic drug preparations for home hospitalization: which drugs and which protocols for which circuit?

Frédéric Benizri 1, Anne Laure Ferrio1, Virginie Korb2, Danièle Marande3, Louis Joyeux1, Patrice Prognon2, Brigitte Bonan2

1Pharmacy, Hospitalisation à domicile, Assistance Publique Hôpitaux de Paris APHP, 2Pharmacy, Georges Pompidou European Hospital APHP, 3Care unit, Hospitalisation à domicile, APHP, Paris, France

Background and objective APHP home medical care covers Paris area (including 126 cities). Oncologists are spread among APHP hospitals. Nowadays, injectable cytotoxic drugs are prepared by nurses at patient’s home. The aim of this study is to determine the measurements to setup the centralization of cytotoxic drug prescriptions within the context of home hospitalization.

Design Analysis of cytotoxic drug consumption during 18 months. Prospective analysis of injectable cytotoxic drug prescriptions during 33 days.

Setting Home hospitalization, APHP, Paris, France.

Main outcome measures The following outcomes are evaluated: injectable cytotoxic drug conservation and their stability after dilution.

Results During 18 months, 35 different cytotoxic drugs were used for home hospitalization. The drug stability after dilution was under 24 h (low stability) for 5 drugs (alemtuzumab, bortezomib, azacitidine, chlormethine, cetuximab) and between 24 h and 48 h (intermediary stability) for 2 others (oxaliplatin and cladribine). During 33 days, 91 medical precriptions were dispensed. There were 28 different protocols: 10 of them contained one drug only. 18 drugs were used and included 374 chemotherapies (11.3 per days). The low and intermediary drug stability represented respectively 17.6% (bortezomib and azacitidine) and 1.6% of the whole chemotherapies. 37.7% of them had to be conserved at a temperature between 2°C and 4°C.

Conclusions Circuit of injectable cytotoxic drugs is complicated. In fact, centralization required a network software accessible to oncologists, pharmacists and nurses from care units of home hospitalization. The centralization of injectable cytotoxic drugs raised several problems: the use of drugs that have a stability under 48 h, the cold chain traceability for cytotoxic drugs preserved between +2°C and +4°C and the disposal of cytotoxic drugs. In front of this report, it seemed important to us to carry out a reflexion on the stability of cytotoxic drugs by implying pharmaceutical laboratories on the home medical care situation. In conclusion, the choice of drugs and protocols for home hospitalization must be decided by multidisciplinary teams who will respect several criteria: stability, toxicity, time of perfusion.

Keywords Centralization, Cytotoxic drugs, Home hospitalization

PC-241 Assessment of potential drug–drug interactions in inpatients on cardiology intensive care unit—pilot study

Martina Marikova 1, Jiri Kotlar1, Karel Macek2, Miroslav Solar3, Jiri Vlcek4

1Hospital Pharmacy, 2Dept. of Clinical Pharmacology, 31st Internal Clinic, Teaching Hospital, 4Dept. of Social and Clinical Pharmacy, Faculty of Pharmacy, Hradec Kralove, Czech Republic

Background and objective We provided preliminary surveillance of potential drug—drug interactions (DDIs) in inpatients on cardiology intensive care unit (ICU) in Teaching hospital and assessed their potential risk and role of pharmacists on the ward.

Design Pharmacotherapy of 50 consecutive patients was screened by pharmacists in last two days of their stay in ICU. The risk of DDIs was checked by software “Control module of drug—drug interactions version 2, 2006” produced and spread between pharmacists in Czech republic by INFOPHARM company. According this program particular pairs of drugs were classified from 0 to 5. “0” means evidence of no DDI (DDI0), “1” means low and “5” very serious risk of DDI (DDI1—DDI5).

Setting Cardiology ICU, 1st Internal Clinic of Teaching Hospital Hradec Kralove.

Main outcome measures A rate of different serious DDIs.

Results The average age of patients was 62 years. The patients were treated with 393 drugs (7.86 drugs/per patients). In 26% of patients we didn’t discovery any DDI0–DDI5. In 74% of patients were detected 143 DDIs. The rate of DDIs0 to DDIs4 was 21.6%, 33.6%, 27.3%, 15.3% and 2.1% of all DDIs respectively. Occurrence of DDI’s 3.4 were 22 and 3, respectively. DDI5 wasn’t detected. Warfarin (46.8%) and aspirin (9.8%) were most frequently interacting drugs. Majority of identified DDIs by particular patient made clinical benefit or should be under the control (e.g. INR by particular warfarin DDIs)—we have to collect this data as well.

Conclusions The incidence of potential DDIs is relatively low and their clinical meaning is not too serious. The project stimulate cooperation physicians on ICU and pharmacists and improve training of clinical pharmacists in DDIs management.

PC-243 Management of hypersensitivity to oxaliplatin at the Paul Brousse hospital pharmacy department: desensitization protocol and clinical impact

Hélène Habert 1, Vincent Castagne1

1Pharmacy-Pharmacology, Hospital Paul Brousse, Villejuif, France

Background and objective Oxaliplatin, a DACH—platinum complex, has a wild neoplastic activity spectrum, mostly without cross-linked resistance with other platinum compounds nor cross-reactivity. Intravenous oxaliplatin is mainly used in combination with fluorouracil/leucovorin in metastatic colorectal cancer. Oxaliplatin most frequent adverse effects (acute sensory peripheral neuropathy, haematological or gastro-intestinal disorders) are reversible and of mild to moderate intensity. Oxaliplatin can also cause rare but limiting adverse events: cumulative neurological toxicity or type I hypersensitivity (1%). Allergic patients who do not experience neurological toxicity can benefit from desensitization. We report 14 cases of desensitization in 34 patients with type I hypersensitivity to oxaliplatin (LOHP).

Design Retrospective study between 2004 and 2007. 34 patients experiencing at least 1 episode of hypersensitivity to LOHP. Chemotherapy: mostly FOLFOX, GEMOX …

Setting Anti-cancer Chemotherapies Reconstitution Unit (ACRU) of the Paul Brousse hospital (Villejuif, France).

Main outcome measures ELOXATINE® 5 mg/ml 20 ml.

4-h desensitization protocol: 4 10-fold dilutions of 100 ml of 10% of full dose. Titration from 1:10,000 1:1,000 1:100 to 1:10. Administration: 1 h each.

Results Type I hypersensitivity symptoms described in 16/34 patients: respiratory (chest tightness, cough, choc…), dermatological (urticaria/erythema, facial swelling …), neurological (swarming …) or gastro—intestinal (nausea, vomiting …). Not determined in 18/34 patients.

Outcome: 14/34 patients underwent the desensitization protocol. 7/14 completed the desensitization, 7/14 experienced a reaction during the protocol or when receiving the 90% of full dose bag. At least one LOHP course was continued in 10/34 patients (LOHP was pursued in 3 patients without any desensitization protocol). Hypersensitivity symptoms reoccured at the next course or at the course after in 2/7 patients who underwent desensitization successfully. Therefore, desensitization protocol avoided premature LOHP discontinuation in 5/14 patients.

Conclusions Risk factors of hypersensitivity to LOHP such as age, cancer localization, chemotherapy combination, cumulative dosage/course number, intensity/nature of the reaction and risk factors of desensitization failure are discussed. Nevertheless, after successful desensitization, risk of susceptibility to LOHP remains. Therefore a desensitization protocol may be implemented at each additional LOHP course.

Keywords Hypersensitivity, Oxaliplatin, Desensitization

PC-247 Community pharmacists’ opinion on pharmaceutical care practice in Turkey

Mesut Sancar 1, Betul Okuyan1, Sule Apikoglu Rabus1, Fikret V. Izzettin1

1Clinical Pharmacy Department, Marmara Univ. Faculty of Pharmacy, Istanbul, Turkey

Background and objective To assess community pharmacists’ points of view about pharmaceutical care practice in Turkey.

Design A self-administered questionnaire was designed.

Setting Data was collected from community pharmacists representing seven geographic areas of Turkey (total of 385).

Main outcome measures All data were expressed as percentage.

Results Most pharmacists (94.8%) were willing to provide pharmaceutical care services and also 78.9% of them considered these services as pharmacists’ duty. Participants stated that the major problems while providing services were as follows: limited availability of information on drug, disease and technical issues and the lack of communication with physicians and stationary works related to state’s regulatory issues consuming lots of time. Communication with patients, the physical conditions of the pharmacy and reaching the information were not barriers for the pharmacist in providing pharmaceutical care. The participants were divided into two groups: the pharmacist with over 15 years of experience (51.7%) and those with <15 years of experience (48.3%), no difference was found in pharmacists’ point of view about the pharmaceutical care practice according to their professional experiences. 57.4% of participants claimed that they had provided pharmaceutical care services; but in fact they were mainly providing some kind of patient counseling services. Among those who claimed to provide the pharmaceutical care services, only 22.5% counseled patients for more than 6 min. While 61.9% and 15.6% counseled for 3–6 min and <3 min, respectively. Participants’ opinions indicated that pharmaceutical care was more necessary for antiasthmatic, antidiabetic, coronary heart disease, antihypertensive drugs and antibiotics than over the counter drugs.

Conclusions Our study indicated that pharmacists were willing to provide pharmaceutical care practices and also most of the participants consider lack of information as the major obstruct for providing the services. Hence, increasing the availability of patient oriented education programs and promoting graduate degree programs might improve the quality of the pharmaceutical care practices and related services.

Keywords Pharmaceutical care, Clinical pharmacy services, Patient oriented

PC-252 Guidelines for pharmacists advising ranitidine

Lidija Pavlovic 1, Natasa N. Cater1

1Lekarna Zalec, Community Pharmacy Zalec, Zalec, Slovenia

Background and objective To find out which patients could be treated with ranitidine, if a patient has gastroesophageal reflux disease (GERD) or dyspeptic problems and to determine a time when a patient has to visit a doctor with those problems.

Design Literature review: about ranitidine, GERD, dyspepsia, 6 months prospective study.

Very important is to indicate the “alarm signs”, such us bleeding in a stomach, nausea, vomiting, stomach pain, painful swallowing. These signs mean serious illness and pharmacist must advise a patient to visit a doctor as soon as possible. Also if those signs don’t occur and the pain comes without any reason or a pain occurs often, patient is again advised to visit a doctor. When a pharmacist eliminates those “alarm” symptoms, patients could be treated by a pharmacist. We advise about life style, drugs and self-medication rules.

Setting Community Pharmacy Zalec.

Main outcome measures To select patients with GERD, dyspepsia, other diseases, counting patients, statistic evaluation.

Results A Community Pharmacy Zalec has participated in a preparing of the national protocol about the self-medication with ranitidine. If the patient feels pain in the upper side of stomach, pharmacist must find out if that could be GERD of dyspepsia.

In a Community Pharmacy Zalec a research is in progress to see how many people have stomach problems and how many of them need to be treated by ranitidine. In 6 months until now 650 patients have suffered because of stomach pains. 82% of them have come to us and have told us their problems, stomach pains… and others have come in the pharmacy just to buy a ranitidine. All of them have been asked by pharmacists some questions from the self-medication protocol to determine if they could have GERD of dyspepsia. 12% of people have had no typical symptoms for GERD or dyspepsia. 3% of patients have been advised to visit a doctor. Among others 78% have been detected as GERD patients and 22% have had dyspepsia. They have been advised to take ranitidine for a treatment and to change their life-style.

Conclusions Dyspepsia and GERD are very common illnesses caused by unhealthy food, stress, side effects of drugs.

Pharmacists could advice changing life-style and a treatment with ranitidine and other drugs. The self-medication must be limited on max 2 weeks. In that time problems must be treated unless a patient must visit a doctor.

If symptoms of GERD or dyspepsia occur by a patient three to four times per year, a patient must be treated by a doctor.

Keywords Ranitidine, Gastroesophageal reflux disease (GERD), Dyspepsia

PC-259 The quality of life and pharmaceutical care requirements of the hypertension patients in a community pharmacy

Fikret Vehbi Izzettin 1, V. Sumeyra Nakiboglu1, Mesut Sancar1

1Clinical Pharmacy Department, Marmara Univ. Faculty of Pharmacy, Istanbul, Turkey

Background and objective Hypertension is remaining one of the major factors for many chronic diseases and effecting quality of life of the patients. Pharmaceutical care may be an option to improve blood pressure control and better outcomes for most of these patients. In this study we aimed to monitor the blood pressure, measure the quality of life and evaluate the pharmaceutical care requirements of hypertension patients in a community pharmacy.

Design The study was carried out with 30 hypertensive patients. During 3 months of the study period systolic and diastolic pressures was measured in 15 days intervals. Quality of life was assessed prospectively using the SF-36 questionnaire. Also patient profile was used as a database for determining the pharmaceutical care requirements.

Setting The study was performed by a clinical pharmacist in her own community pharmacy located in Bostancı, Istanbul, Turkey.

Main outcome measures

Systolic and diastolic pressures, Quality of life scores for both hypertensive patient group (n = 30) and healthy (control) group (n = 30), patients’ knowledge on hypertension, drug related problems.

Results The mean ± standard deviation of systolic blood pressure of patients in 15 days intervals (day 15, 30, 45, 60, 75 and 90) were found to be 134.70 ± 17.49; 132.83 ± 12.62; 132.00 ± 13.05; 129.50 ± 10.23 and 126.70 ± 10.11 mmHg; diastolic blood pressure were found to be 85.40 ± 10.78; 83.83 ± 8.66; 82.93 ± 6.61; 83.20 ± 5.79; 81.30 ± 7.14 and 81.03 ± 3.63 mmHg, respectively. Statistically significant decreases were seen between the first and the sixth measures of the blood pressure (P < 0.05). There was no significant difference between the mean scores of quality of life of hypertensive patients and control group (P > 0.05). Also we observed an increase in patients’ knowledge and drug compliance at the end of the study.

Conclusions We can conclude that in hypertension, as in other chronic diseases, clinical pharmacist should provide patient education service, monitor the patients and define the pharmaceutical care requirements of the patients with the cooperation of physician and other health care team members to increase the compliance of the patients and their quality of life.

Keywords Hypertension, Pharmaceutical care, Quality of life

PC-260 Spontaneous reporting of medication errors and active observations of the drug process: results 2006

Annemie Somers 1, Marijke Van Hooreweghe1, Johan Vandenbroucke1, Hugo Robays1

1Pharmacy, Ghent University Hospital, Ghent, Belgium

Background and objective Since several years it is the aim of the pharmacy to set up a hospital wide system for reporting (near) misses in the drug process. Within the pharmacy, reports are collected since many years, and since 2006, those reports are discussed within the Drug Safety Committee, as well as the results of active observations. Hence, actions for improvement are proposed to the P&T Committee.

Design Reporting errors in prescribing, delivering, compounding, or administration of drugs.

Observation of several steps in the drug process.

Setting Pharmacy, Ghent University Hospital, Belgium.

Main Outcome Measures:

Number and type of reported errors

Observation of:

  • the completeness and accuracy of medication orders;

  • transcription errors;

  • the administration of drugs

Results Spontaneous reporting: 171 reports in 2006: 98 prescribing errors, 23 delivery errors, 37 compounding errors, 13 administration errors (reached the patient). Level of severity (according to NCCMERP taxonomy): 4 × C, 6 × D, 1 × E, 1 × F, 1 × H

Active observation: 1000 drug orders, at three wards:

  • 1.2% incorrect orders (mostly drug dose)

  • 5.2% transcription errors (mostly drug frequency and drug dose)

  • 1% incorrect administration

Conclusions Spontaneous reporting of errors is useful for setting up actions in order to improve the drug process. This encomprises specific actions (e.g. change of drug supplier, provision of drug information), and more general actions (e.g. implementation of electronic prescribing, clinical pharmacy, …). Regular active observations can reveal problems in communication and organisation. The combination of reporting and observation is useful for ongoing vigilance of the drug process; feedback of the results is a tool for preventing errors.

Keywords Medication errors, Spontaneous reporting, Active observations

PC-266 Misuse of antibiotics in public and private hospitals in Sana’a city of Yemen

Hussien O. Alkadi 1, Majed A. Nooman2

1Pharmacology and Therapeutics Department, 2Pharmaceutical and Industrial Pharmacy Department, Faculty of Medicine and Health Sciences, Sanaa, Yemen

Background and objective The number of antibiotics continues to increase annually. This has been accompanied by an increase usage often in situation where such chemotherapy’s either inappropriate or of doubtful value. Also, antibiotics constituted about 25% of all prescribed drugs with inappropriate prescribing habits [1, 2]. The aim of this study is to evaluate antibiotics misuse in public and private hospitals in Sana’a city of Yemen.

Design The present work was done in three public and five private hospitals department of internal medicine and pediatrics. Data were collected over an 4-week period, from 1 November to 30 November 2005. The medical record analysis was used to compare the misuse of antibiotics in public and private hospital. The significant difference was calculated using the chi-square test (Epi-info, a prior level of significance 0.05).

Setting Sana’a city of Yemen.

Main outcome measures Number Main outcome measuresand percentage of type of antibiotics and antibiotics misuse prescribing recorded and analysed.

Results Two thousands prescription was collected. The total prescriptions of antibiotics were 800 in public while 1200 in private hospitals. The total misuse prescription of antibiotics was 550 in public, while 872 in private hospitals. There was significant misuse antibiotics in private as compared with public hospitals. The percentage of misuse prescription of antibiotics as prescribed for chicken box (0.72%) pylonephritis (1.08%), otitis media(0.36%), acute gastroenteritis (1.26%), malaria and vertigo (0.54%) in public were significantly high as compare with private hospitals, while the percentage of misuse prescriptions as prescribed for pharingitis (0.91) dry cough (1.03%), vomiting (1.38%), epilepsy (0.11%), jaundice (1.95%) and chronic cough (2.645%) in private were found highly significant as compared with public hospitals. No significant difference in misuse of antibiotics as prescribed for influenza and common cold in both public and private hospitals.

Conclusions This study is indicate that there are high significant hospitals misuse of antibiotics in both public and private hospitals in Sana’a city of Yemen.

References

  1. 1.

    Gjelstad S, Fetveit A, Straand J, Dalen I, Rognstad S, Lindbaek M.: Can antibiotic prescriptions in respiratory tract infections be improved? A cluster randomized educational intervention in general practice—The Prescription Peer Academic Detailing (Rx-PAD); Study Health Serv Res. 2006 Jun 15;6(1):75.

  2. 2.

    Watson R.: European group targets overuse of antibiotics. BMJ. 2006 Mar 25;332(7543):686.

PC-270 Developing the role of a ward based pharmacy technician in facilitation of admission and discharge of elderly patients

Jane Scott 1, Carol Lumsden2, Janis Taylor2, Garry Todd1

1Pharmacy, Roodlands Hospital, Haddington, 2Pharmacy, Lothian Primary Care NHS Organisation, East Lothian, United Kingdom

Background and objective The interface pharmacy technician (IPT) was funded to facilitate the admission and discharge process and improve pharmaceutical care for elderly patients admitted to Roodlands Hospital.

This post recognises the need for pharmacy staff to work across the interface of elderly care and supports recommendations made in ‘The Right Medicine—a strategy for pharmaceutical care in Scotland’ [1].

Design Patient Medication Profile designed to record information of patients admitted and discharged. Data collated to evaluate and report the activities undertaken by the IPT for a one-year period.

Setting Care of Elderly wards in small general hospital.

Main outcome measures Activities include taking patient medication histories; identifying patients’ community pharmacists and ability to manage their own medicines; assessing patients’ own drugs for re-use; assisting in one-stop dispensing and self medication process; identifying and responding to medicine related issues, referring to clinical pharmacist where appropriate; counselling patients and their carers; assisting in education and training of health care professionals and collection of data.

Results During the period of April 2004 to March 2005, 482 patients were screened by the IPT and the majority (n = 452) had their drug history checked. There were (n = 333) female and (n = 149) male, with an age range of 59 years to 103 years. A total of 389 pharmaceutical care issues were identified at admission, during stay and at discharge, of these, eighteen known drug sensitivities were found omitted from patient drug charts, while 74 discrepancies were found on discharge prescriptions. Thirty-five issues were passed to the clinical pharmacist. Eighty-five health care professionals were contacted on admission, mainly community pharmacists (n = 79) to notify them that a patient they provide a compliance aid device to, has been admitted to hospital. Twenty-one patients started self medicating on the ward. Of a possible 340 discharges to home 92% (n = 314) were checked by the IPT and 80% (n = 274) of patients or their carers were counselled. Community pharmacists received discharge information on 81 occasions and 9 patients who were referred by the IPT received follow up from the Integrated Care Pharmacist at home.

Conclusions This post has integrated well with the multidisciplinary team. There has been an increase in: Pharmaceutical care issues highlighted, patients self-medicating, discharge counselling and transfer of medicine information to community pharmacists and other health care professionals.

Reference

  1. 1.

    Scottish Executive. The Right Medicine: A strategy of Pharmaceutical Care in Scotland. 2002.

Keywords Interface, Clinical, Technician

PC-276 Bedside pharmaceutical interventions in a nephrology department in a French hospital

Reak-Smey Torng1, Nicolas Janus 1, Svetlana Karie1, Elena Ledneva1, Gilbert Deray1, Vincent Launay-Vacher1

1Nephrology, Groupe Hospitalier Pitié-Salpêtrière, Paris, France

Background and objective Nephrologists are most frequently faced with questions regarding drug prescription such as drug–drug interactions (DDI) or drugs dosage adjustment (DDA) in their patients with renal insufficiency or patients with kidney transplant. The French physicians’ desk reference book (Vidal dictionary) is widely used as source of information. However, it may not be sufficient to find clear and practical answers and searching the international literature is often mandatory in order do find a solution. The aim of this study was to assess the impact of pharmaceutical interventions at bedside in a department of nephrology using both the Vidal dictionary and the international literature.

Design For 1 month, a pharmacy student has been included in the medical staff. Patients data were collected (Sex, age, serum creatinine (Scr) medical history, drugs and their dosages) for every patient. Prescriptions were elaborated by both the physician and the pharmacist, regarding the choice of the drug and its dosage, according to renal function and DDI.

Setting Nephrology Department and ICAR (A National Medical Advisory Service on “Drugs and the Kidney” (DDA/DDI/Renal toxicity)—Pitié-Salpêtrière Hospital.

Main outcome measures Number of pharmaceutical interventions, DDA and DDI. Comparison between information found in the Vidal Dictionary and the international literature.

Results 21 patients (14 men, 7 women, mean age 62.8) were included. 18 had RI, 1 had a renal transplant, 1 had kidney damage (proteinuria, abnormal urinary sediment) without RI and 1 had renal artery stenosis. On 206 interventions, 49.5% consisted of DDA in RI patients and 49% were DDI. No information was found in the Vidal Dictionary for 61.8% of DDA interventions whereas data were available in the international literature in 95.1% of cases. No DDI was mentioned in the Vidal Dictionary in 82.2% of the 83 DDI questions. However, 25.3% potential DDI were found when using the international literature even when the Vidal dictionary did not report any.

Conclusions The Vidal dictionary, which provides a collection of drugs Summaries of Product Characteristics is not appropriate for daily drug prescription in Nephrology patients. However, French physicians use it as a prescription tool, for which it is not designed for. As a result, information is often lacking as compared to available data in the international literature, when adequately searched for and analyzed. Providing Clinical Pharmacy services at bedside is a crucial help to improve patient care and drugs handling in those patients, even when the pharmacists is not particularly trained or experienced. Benefits should even be greater with experienced and/or specifically trained senior pharmacists. However, Pharmacy students already provide a significant help, leading to global improvement of patient care.

Keywords Pharmaceutical interventions, Renal insufficiency, Drug–drug interactions

PC-278 Treatment of recurrent sinusal papillomatosis with intravenous cidofovir (Vistide®)

Alexandre Cariou 1, Eugenie E. Bultey1, Marie-Antoinette M. A. Lester1, Loic L. Javaudin1, Christian C. Michelet2

1Pharmaceutical Unit, 2Department of Infectious Diseases, Pontchaillou Hospital, CHU Rennes, Rennes, France

Background and objective Sinusal papillomatosis, caused by human papillomavirus, is a rare disease with certain aggressive features because of frequent relapses and the high probability of malignant degeneration. The standard of care is surgical excision of the lesions. The effectiveness of intralesional injections of cidofovir has been investigated in the off-label use in various studies since 1995. Cidofovir is a nucleoside analog antiviral agent approved in cytomegalovirus retinitis, active as a potent inhibitor of viral DNA polymerase. Recent studies report successful treatment with intravenous cidofovir in respiratory papillomatosis.

Design Evaluation of efficacy and safety of intravenous Cidofovir (Vistide®) in a patient with a recurrent active sinusal papillomatosis (HPV 6/11) after six courses of treatment.

Setting Pharmaceutical unit; Department of Infectious Diseases, Pontchaillou Hospital, CHU Rennes, France.

Main outcome measures Delay of relapse, creatinine clearance, safety of cidofovir, evolution of lesions.

Results The patient is a 39-year-old man with recurrent sinusal papillomatosis requiring multiple ablations since in his teenage. After the failure of a cidofovir aerosoltherapy he underwent a bilateral excision of nasal papillomas with a septum excision. Nevertheless, in January 2006 an evolutive relapse of the papillomatosis with encephalic extension has been diagnosed. Then it was decided to treat the patient with surgical conservative measures and cidofovir both intralesional and intravenous. From July 2006, according to literature data on laryngeal papillomatosis, he received 6 courses of treatment with intravenous cidofovir, 5 mg/kg/j, in conjunction with probenecid in order to diminish nephrotoxicity (creatinine clearance ranged from 100 to 90 ml/mn). During the treatment period no side effects occurred and no renal toxicity could be detected.

Conclusions In October 2006 after 6 injections of cidofovir, nasal papillomatosis remained stable. Moreover, the treatment was well tolerated with no incidence on renal function. Unfortunately, cidofovir didn’t seem to have any activity on the encephalic extension of the papillomatosis but a local radiotherapy could be beneficial.

References

  • Van Valckenborgh I. and al., Systemic cidofovir in papillomatosis. Clinical Infectious Diseases 2001;32:62–4.

  • Shemen L.J. and al., Office-based intralesional cidofovir injections for nasal septal papilloma: a pilot study. Otolaryngology-head and neck surgery 2006;135:149–151.

Keywords Cidofovir, Papillomatosis, Intravenous, Sinusal

PC-282 Food-drug interactions: the role of the clinical pharmacist

Anna Carollo1, P. Marrone2, P. Pollidori1, F. Venuti1, A. Provenzani1, S. Bavetta1, R. Di Stefano1, M. Sidoti1, V. Zampardi1, S. Cammarata1, M. J. Romano1

1Clinical Pharmacy, ISMETT, 2Nutrition Service, Civico Hospital, Palermo, Italy

Background and objective It is of common knowledge that the bioavailability of many drugs is influenced by nutrition, thus causing “interactions” which translate into a reduction or potentiation of the drug’s therapeutic effects. Pharmacodynamic interactions lead to changes in the pharmacological activity if no changes are made to the drug’s pharmacokinetics or nutrients’ availability.

Pharmacokinetic interactions influence, on the other hand, the bioavailability of drugs and nutrients, by interfering with the specific pharmacokinetic processes of absorption, distribution, metabolism and elimination.

Design During hospital ward rounds the clinical pharmacist provides all necessary information to patients and clinical staff to manage their therapy in accordance with their nutritional needs. The clinical pharmacist also provides in patients at high risk, since their therapy includes more than one medication, with a table containing most common food-drug interactions.

Setting ISMETT is a 90-bed facility primarily dedicated to solid organ transplantation and is a specialty hospital managed and operated by the University of Pittsburgh Medical Center (UPMC). The pharmacy has a centralized unit dose distribution system and an intravenous admixture program.

Main outcome measures Our objective is to describe the contribution of the clinical pharmacist to improve patient care in the management of therapy as compared to patient nutrition.

Results Since 2004 all relevant corrective measures taken by clinicians have been recorded in an excel spreadsheet. Over 2006 period pharmacists provided 4898 interventions. Of these, 56% were drug information issues, of which 21% were related to nutrition (food-drug interactions, total parenteral nutrition formula and enteral nutrition formula). The majority of interventions were reported by the pharmacy staff assigned to the intensive care unit.

Conclusions The peculiarity and complexity of the matter require a multidisciplinary approach, with the clinical pharmacist helping the clinician in predicting and preventing potential food-drug interactions.

References

Keywords Food, Drugs, Interactions

PC-283 Pharmacists and JACIE

Anaïs Grand 1, Céline Eiden1, Delphine Raylet2, Nathalie Fegueux3, Laurence Vergely2

1Pharmacy, Lapeyronie Hospital, 2Pharmacy, Arnaud de Villeneuve, 3Hematology, Lapeyronie, Montpellier, France

Background and objective The Joint Accreditation Committee-ISCT and EBMT (JACIE) is an organization established for the purposes of assessment and accreditation in Haematopoietic Cell Transplantation (HCT). It promotes quality in patient care and laboratory performance in HCT centres. European HCT centres have to be accredited. Pharmacists as health care professionals are also involved with this accreditation programme. They help the HCT unit to prepare accreditation visit by participation to the implementation of a quality system.

Design Quality system implementation.

Setting Pharmacy and HCT adult and pediatric units of an university hospital.

Main outcome measures Several pharmacists have been integrated in multidisciplinary work group for implementation of a quality system. It included multidisciplinary concentration seminars, methodological assistance, HCT unit practices analyze, bibliography research and guidelines review. All of the quality system is based on JACIE standards.

Results We chose to present three examples of written procedures, 2 about prophylaxis and treatment of graft-versus-host disease and 1 about adult and pediatric allogeneic conditioning programmes. They have been written using a standardized model diffused by quality department of the hospital and approved by every members of JACIE group. Their objectives are to describe treatments prescribed for graft-versus-host disease and for conditioning regimens in order to establish “internal” guidelines regarding JACIE standards. They also allow adult and pediatric practices standardization.

After their implementation in HCT unit, it has been decided to conduct an audit for evaluation of graft-versus-host disease prophylaxis and treatment. Results would be presented for the congress.

Conclusions JACIE represents an example for collaboration between every health care professional involved with HCT. It’s a quality system which guarantee patient care in accredited centres. Pharmacist are actors of this programme as they can promote good use of medications, treatment optimization and evaluation.

JACIE programme is recognized by French National Authority of Health and is taken into account for Professional Practices Evaluation.

PC-286 Attitudes of Serbian general practitioners and pharmacists towards utilisation of clinical practice guidelines

Jan Komrska 1, Branislava Miljkovic2

1HIV-AIDS Health Center, UNICEF Supply Division, Copenhagen, Denmark; 2Department of Pharmacokinetics, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia

Background and objective Use of the clinical practice guidelines has been found to promote positive health outcomes, reduce variations and errors in care, minimize health care costs, and reduce resource utilization. The objective of present study was to evaluate the attitude of Serbian general practitioners (GP) and pharmacist to clinical practice guidelines (GPG) specifically developed, designed and disseminated in the period of 2004–2006.

Design A qualitative research. Anonymous questionnaire was administered to general practitioners and pharmacists participating at the dissemination seminars in January–February 2006.

Setting General practitioners and pharmacists participating in CPG dissemination seminars in Belgrade region.

Main outcome measures Reasons for and against CPGs utilisation of general practitioners and pharmacists.

Results 217 questionnaires filled by general practitioners (out of 576 distributed) and 90 questionnaires filled by pharmacists (out of 188 distributed) were analysed.

Reasons for guidelines utilisation among Serbian general practitioners are: their concise form, the drive for standardisation and uniformity in treatment approaches, their applicability and reliability as a source of updated information. On the other hand pharmacists consider guidelines as a mean to enhance their continuous professional development; source of new information on treatment strategies and new drugs. Pharmacists also think CPGs facilitate collaboration with GPs and improve quality of care and services.

Majority of Serbian GPs and pharmacists think there is no reason why CPGs should not be implemented. However GPs would not follow CPGs because they exclude possibility of individual approach towards the patients and because some of the recommended diagnostic and therapeutic procedures are not available to them. They also fear of their creativity being limited and because the CPGs are not in line with their experience and current practice. Pharmacist observed that available CPGs are more for general practitioners than for themselves, and are not precise or they recommend non registered medicines.

Conclusions The strong support for the utilisation of CPGs was found among Serbian general practitioners and pharmacists. The research underline qualities and attributes of available guidelines and points out certain weaknesses which should be in the future process of guideline development avoided (recommendation of non available diagnostic procedures and treatments…).

Reference

  • Langley, C., Faulkner, A., Watkins, C., Gray, S., Harvey, I., 1998. Use of guidelines in primary are—practitioners’ perspective. Family Practice 15(2), pp. 105–111.

Keywords Clinical practice guidelines, General practitioners, Pharmacists, Attitudes

PC-288 First assessment of drug–drug interactions in a centralized cytotoxic preparation unit: detection and feedback to prescribers

Caroline Planus 1, Lise L. D. Delbecque1, Vérane V. S. Schwiertz1, Cécile C. B. Bonnevay1, Florence F. R. Ranchon1, Magali M. H. Hellot1, Anaïs A. P. Papon1, Benoit B. Y. You2, Laurence L. G. Gérinière3, Jean J. D. Doucet4, Catherine C. R. Rioufol1

1Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud, 2EA 3738, Ciblage Thérapeutique en Oncologie, Université Claude Bernard Lyon I, 3Service de Pneumologie, 4Service Pharmaceutique, Centre Hospitalier Lyon Sud, Lyon, France

Background and objective Cancer patients are at particular high risk of adverse drug–drug interactions because they commonly receive multiple medications, including cytotoxic chemotherapy, supportive care drugs and other medications unrelated to chemotherapy. Furthermore, drug interactions in oncology are at particular importance owing to the narrow therapeutic index and the inherent toxicity of anticancer agents. Unfortunately, limited data exist on their frequency and clinical consequences. The aim of this study was to identify the nature and frequency of drug interactions related to chemotherapy in cancer patients admitted to oncology and pneumology clinical wards and to define recommendations to prescribers in order to optimize and individualize chemotherapy. Only unadvised associations and contraindications were communicated to prescribers.

Design 487 computerized prescriptions of cancer patients hospitalized in oncology unit (10 beds) and pneumology unit (35 beds) were reviewed (February 2006 to January 2007). Drug-drug interactions were screened using the summary of product characteristics and the French Health Products Safety Agency (AFSSaPS) thesaurus.

Setting University Hospital specialized in Cancerology, with a centralized cytotoxic preparation.

Main outcome measures Analysis of nature and frequency of interactions between cytotoxic and non cytotoxic drugs.

Results 37 drug interactions were detected (7.6% of the prescriptions). These interactions needed precautions for use or were to take into account; none were contraindications. We detected 25 interactions between cytotoxic agents and oral anticoagulants. Other interactions were pemetrexed and nonsteroidal anti-inflammatory medication (NSAID) (n = 6), Irinotecan and aprepitant (n = 4), Carboplatine and amikacine (= 1), Methotrexate and valaciclovir (n = 1). These interactions didn’t lead to prescriptions changes but were used to provide recommendations to prescribers.

Conclusions This study was the first assessment of drug interactions and should be extended to all medical units. It emphasizes that clinical pharmacy can contribute to the prevention of therapeutic iatropathology by increasing the prescribers’ awareness on drugs interactions (choosing appropriate drugs and monitoring for signs of interactions).

Keywords Drug–drug interactions, Chemotherapy, Recommendations

PC-292 Medication errors reporting system in Czech pharmacies

Josef Maly 1, Michal Hojny2, Jiri Vlcek1

1Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Kralove, 2Hospital pharmacy, Institute of Clinical and Experimental Medicine, Prague, Czech Republic

Background and objective There are many factors, in the health care system, which cause medication errors. Both health care professionals and patients make medication errors. Pharmacist is an expert on medication properties and is mainly the last health care professional who deals with drugs before their administration to the patient. He or she can identify any errors in pharmacotherapy of certain patient. To prevent medication errors effectively it is necessary to identify, record and notice the cause’s of errors. The target of a study was to prepare and test reporting system which will serve to record medication errors identified by pharmacists in Czech pharmacies.

Design Pharmacists identify and record all medication errors in a web questionnaire during their dispensing activities in the pharmacy. The pharmacists collect following pieces of information: types and causes of errors, pharmacist’s interventions, patient details, drugs and time concerning errors and subjects making errors. The recorded interventions are evaluated and analyzed by expert group consisting of clinical pharmacists, pharmacists, clinical pharmacologists and physicians.

Setting Hospital and community pharmacies in the Czech Republic.

Main outcome measures Collecting data on pharmacists’ interventions on the web site.

Results We prepared a questionnaire on the web site. This reporting system is open to all Czech pharmacists and it is possible to record all medication errors. Most of the categories of medication errors are evaluated as for example: indications of drugs, duplications of therapy, dosages of drugs, names of drugs, strengths of drugs, dosage forms and routes of administration of drugs. During a four-month period 40 pharmacists registered on this web site and recorded identified medication errors. 17 of them worked in the hospital pharmacy and 23 of them in the community pharmacy. There are 7236 pharmacists in the Czech Republic (year 2006).

Conclusions It seems that this reporting system of medication errors is good way of recording. This reporting system stimulates development of clinical pharmacy activities in the hospital and community pharmacies in the Czech Republic.

Keywords Medication errors, Pharmaceutical care, Pharmacy

PC-293 Analysis of pharmacist interventions

Anh-Thu Phung-Nguyen 1, Leila Achour1, Robert Ratiney1

1Pharmacy, Rene Muret Bigottini Hospital, Sevran, France

Background and objective Medication error harmed 1–2% admitted patients and causes substantial mortality, morbidity and additional healthcare costs [1]. Prescribing error is the most common type of medication error in these settings. Pharmacist interventions on prescriptions have been found to improve quality of care and have a positive effect on patient outcome [2, 3].

The objectives of this study were to describe the nature and the frequency of pharmaceutical interventions in a geriatric hospital, and to evaluate the impact on physician prescribing behaviour.

Design During 3 months, from November 2006 to January 2007, 6515 validations were made by pharmacists on prescriptions for in-patients. All inadequacies of drug prescription or administration were recorded.

Setting Rene Muret Bigottini is a Geriatric University Hospital (554 beds), with a computerized prescription for all patients. 22090 pharmaceutical validations are made annually.

Main outcome measures Medication unit, length of therapy, dose, drug interactions.

Results 222 medication errors were recorded for 930 patients admitted. The most common interventions were prescription of non-stock drugs (17%), length of therapy (14%) and error of medication unit (14%). 9% concerned prescriptions of incorrect dose and 8% related to duplicated drug therapy. Contraindicated drug interactions represented 5% of interventions. The pharmacist’s recommendation was accepted in 90% cases. Moreover, an important improvement in physician prescribing behaviour was observed at the third month.

Conclusions Analysis of prescriptions by a pharmacist is useful for medical teams: it helps to modify common attitudes towards prescribing drugs and contributes to their appropriate use and to prevention of iatrogenic events.

References

  1. 1.

    Maidment ID, Lelliott P, Paton C, Qual Saf Health Care 2005;15:409–13.

  2. 2.

    Strong DK, Tsang GW, Can J Hosp Pharm 1993;46:101–8.

  3. 3.

    Hatoum HT, Hutchinson RA, Witte KW and al., Drug Intell Clin Pharm 1988;22:252–9.

Keywords Pharmacist intervention, Medication error, Iatrogeny

PC-295 Impact of pharmaceutical involvment in multi-disciplinary medical team meetings to improve patient care in cancer chemotherapy

Lise Delbecque1, Caroline C. P. Planus 1, Cécile C. B. Bonnevay1, Vérane V. S. Schwiertz1, Magali M. H. Hellot1, Anaïs A. P. Papon1, Claire C. F. Falandry2, Jean J. D. Doucet1, Catherine C. R. Rioufol1

1Unité de Pharmacie Clinique Oncologique, 2Service D’Oncologie Médicale, Centre Hospitalier Lyon Sud, Pierre Bénite, France

Background and objective To optimize pharmaceutical care in cancerology, a clinical pharmacist participates to weekly multi-disciplinary medical team meetings (MDTM) in oncology ward.

The aim of this study was to assess the clinical interest of this pharmaceutical integration in MDTM mainly on pharmaceutical prescriptions analysis, information about the patients, their treatment and significant side adverse events (SAE).

Design A prospective study to determine the impact of the pharmacist’s integration in MDTM on clinical practice and patient care. During MDTM, clinical data were collected on a standardized registered form and were further compared with the prescription to detect discordances.

Setting Teaching Hospital specialized in Cancerology, with a centralized cytotoxic preparation department.

Main outcome measures Set up a registered form to record clinical data during the MDTM: informations about the patients, medical decisions about the treatment, SAE, and pharmaceutical interventions. Analyse of the collected data, frequency, nature and clinical impact over a 5 months period (August–December 2006).

Results Pharmacists participated to 17 MDTM in the oncology unit during the study. 179 patients care were discussed.

Clinical data were collected. The pharmaceutical patient file was completed for 47% of the patients already registered at the Clinical Pharmacy Oncology Unit (n = 85) and created for 16% of the patients (n = 29). MDTM decisions concerned an initiation of treatment (37%), a prescription of another line because of disease progression (20%) or because of side adverse events (8%).

For 9% of the patients, discordance between the MDTM decision and the prescription was detected by pharmacists during pharmaceutical prescriptions analysis. One case consisted in a medical error. Other prescriptions were at last in accordance with the medical examination of the patient after MDTM. 4 SAE were detected and noticed.

Conclusions The integration of a clinical pharmacist in MDTM led to complete information about the patient and his treatment, to detect side adverse events and to optimize pharmaceutical analysis of chemotherapy prescription, in order to avoid discordances. This integration seems to be major in our clinical pharmacy practice and patient care.

Keywords MDTM, Pharmaceutical care, Cancer chemotherapy

PC-307 Polytrauma and toxicology: results from a cohort study of 80 patients from Bicetre’ Hospital

Alexandre Duchaussoy 1, D. Dupond1, A. M. Taburet1, J. Duranteau2, V. Furlan1

1Clinical Pharmacy and Toxicological Laboratory, 2Surgery and Trauma Intensive Care Unit, Bicetre Hospital, Le Kremlin Bicêtre, France

Background and objective Bicetre Hospital is one of Paris referring hospital for the management of polytraumatized patients. Each year, about 150 polytraumatized patients are treated in Surgery and Trauma Intensive Care Unit (ICU). On admittance, licite and illicite drugs in plasma or urine were performed for each patient. The purpose of this study was to evaluate toxicology screenings for 80 polytraumatised patients admitted in ICU and to establish the interest of theses toxicological analysis.

Design 80 polytraumatised patients were investigated between March and July 2006. Blood and/or urines samples were collected the day of the admission. Ethanol, drugs of abuse, and pharmaceuticals (benzodiazepines, antipressants, phenobarbital, meprobamate) were screened in plasma by routine analytical procedures involving immunoassays (benzodiazepines, antidepressants, drugs of abuses), gaz chromatography (ethanol), HPLC (phenobarbital) and thin layer chromatography (meprobamate).

Setting Department of Clinical Pharmacy, Surgery Intensive Care Unit, Bicetre’ Hospital, AP-HP, Paris, France.

Main outcome measures Toxicology screenings for 80 polytraumatised patients admitted in ICU.

Results Blood samples were collected from all patient and urine samples for 62% of patients. No drugs were detected in blood in 25/80 patients (45%), and in urine in 28/50 patients (56%). Licit drugs (60%), or ethanol (20%) and opioids (26%) were the compounds the most frequently detected. For 15% of patients identification of several compounds were observed. Ethanol concentrations ranged from 0.1 to 4 g/l. For pharmaceuticals, benzodiazepines, phenobarbital, meprobamate and antidepressants (3%) were respectively found in 50%, 7%, 4% and 3% of the patients. Drugs of abuse were detected in 20/50 cases (40%) mainly cannabis (18%) and opioids (26%). Positive results for opioids and benzodiazepines could be explained by sufentanil and midazolam administration before admission.

Conclusions Our results showed that the identified substances were not involved in the trauma. The major part of positive results concerning benzodiazepines and opioids had a therapeutic explanation. By consequent, the decision of clinicians is to limit the toxicological screening in these patients to an ethanol concentration and drug of abuse screening.

PC-327 Clinical monitoring of pharmaceutical care done from dose dispensing system unit

Marta Caja 1, Raul Ferrando2, Beatriz Martinez2, Javier Milara2, Inmaculada Seguí2, Enrique Soler2

1Pharmacy, Arnau de Vilanova Hospital, 2Pharmacy, Arnau de Vilanova, Valencia, Spain

Background and objective To investigate the clinical monitoring of pharmaceutical care done from dose dispensing system unit at Pharmacy Service.

Design In 2005, all drugs related problems (DRP) which caused pharmaceutical interventions in writing and clinical monitoring of those whereby its repercussion on following medical prescriptions (MP), were registered in a data base.

Setting Pharmacy Department (Dose Dispensing System Unit).

Main outcome measures Drugs related problems, pharmaceutical interventions, the result of our interventions in the later MP.

Results 99% of admitted patients (296 beds) are attended to by a system of medicaments dispensing in unit doses.

In 2005 4.264 DRP were detected, which were notified in writing filling in a standardized form which is includes:

  • DRP of indication (95%): this kind of pharmaceutical care has no subsequent repercussion in MP in an 85.4% of changes of brand and/or pharmaceutic form, 83.1% of direct changes to therapeutic equivalents and 61.5% of change recommendations or suspension of drugs not included in pharmacotherapeutic guide (GFH).

  • DRP of security (2.7%) and effectiveness (2.3%): directs changes of doses and/or posological interval, as well as recommendations of those because of DRP of overdosing or underdosing, did have more repercussion and success in following MP, 78% y 66.7% respectively. In case of DRP that have an excessive duration of medical treatment, the recommendation of suspending it was the 75% of MP.

Conclusions The pharmaceutical care derived of security and effectiveness problems have had a confirmation and success much more important in later medical prescriptions (70%). However, changes of brand, pharmaceutic form, or therapeutic equivalents were just 20% of following prescriptions.

References None.

Keywords Pharmaceutical care, Drugs related problems, Pharmaceutical intervention

PC-332 The balanced scorecard as a model to evaluate the pharmaceutical treatment within the hospital

Fotoula Stathoulopoulou 1, Maria Kotrotsou1

1Pharmacy Dpt., KAT Hospital Athens-Greece, Athens, Greece

Background and objective The Balanced Scorecard (BSC) methodology is developed by Robert Kaplan and David Norton and has been used in enterprises of the private section. The characteristic of BSC—that differentiates it from other quality management systems—is that it is measuring business performance from the perspective of strategy implementation rather than relying simply on financial results.

Design The business strategy in a contemporary hospital pharmacy department is expected to be aligned with the social needs for a qualitative pharmaceutical treatment in an environment of restricted economic resources.

Therefore the pharmacists have to transform their professional roles, move from the drug-centered option to the patient-centered option and develop their competencies as effective partners within the healthcare team.

However the pharmaceutical policy and the decision making process that dominate the Greek Hospitals are controversial and obscure the strategic goal for a cost-effective pharmaceutical treatment.

Setting The implementation of BSC could become highly influential in helping pharmacists think about their identity, purpose and the fundamental features of their strategy (values, mission, vision). In addition the development of measuring competency can add value at the level of pharmacy department.

Balancing a set of strategic and financial goals the BSC allows the strategy of pharmacy department to be linked with the creation of shareholder value while providing a set of measurable targets to guide this process.

Main outcome measures The performance measures combine the answers to 4 questions:

  • The economic consequences of pharmaceutical services?

  • How do customers see us (patients, medical staff, nursing staff, pharmaceutical industry representatives, hospital manager)?

  • What must we excel at (internal processes)?

  • Can we continue to improve and create value (learning and growth)?

Results The implementation of BSC in the department of KAT hospital has led to the formation of a strategic map that relates people and processes to the quality of pharmaceutical treatment. The first indicative results are impending.

Reference

  • Kaplan R., Norton D. Using the Balanced Scorecard as a strategic management system. Harvard Business Review, Jan–Feb 1996.

PEC-25 At home immunoglobulin: intravenous or subcutaneous

Latifa Haddad1, Marie Perrinet 1, Damien Parent1, Elise Toguyeni1, Eric Hachulla2

1Pharmacy, 2Internal Medicine, Lille Hospital University, Lille, France

Background and objective Intravenous (IV) and subcutaneous (SC) immunoglobulin (Ig) administration is a safe and efficious treatment in patients with IgG deficiency. Home administration of IV Ig and SC Ig is approved in France since few times. Most of the patients treated at hospital ask for home treatment. Some patients prefer monthly IV administration, others weekly SC administration.

Design We evaluated in details the cost of these 2 practices.

Setting Lille University Hospital.

Main outcome measures With national cost scale date, we evaluated the overall cost of the 2 treatments (SC Ig and IV Ig), using the information system medical program, starting from homogenous group of hospital stay, including drugs and material prices (we currently use for both IV and SC administration electric pumps which are fixed to the patient given a complete freedom and mobility), nurses cost and price of patients’ travel to hospital.

Results For 20 g administrated per 4 weeks, the total cost of home treatment is of 1.518 € with SC Ig and 1.033 € with IV Ig while the cost of hospital treatment is 2908 € with SC Ig and 1192 € with IV Ig. For 40 g administrated per 4 weeks, the total cost of home treatment is of 2.507 to 2.729 € with SC Ig and 2.034 € with IV Ig. The difference is mainly explained by the cost of the electric pumps rent and by the cost of furniture for SC administration.

Conclusions The choice of at home Ig substitution must be given to all patient receiving treatment at hospital. Home IV and home SC perfusions are two possible options with for each different convenient and inconvenient. The cost of each procedure must be known by the medical staff.

Keywords Subcutaneous immunoglobulin, Evaluation cost, At home treatment

PEC-108 Change in antipsychotic pharmacotherapy in Estonia—international comparisons and economic consequences change in antipsychotic pharmacotherapy in Estonia—international comparisons and economic consequences

Merje Ambo 1, Piia Kuslap2, Alar Irs3

1Department of Human Medicines, 2Quality Control Laboratory, Estonian State Agency of Medicines, 3Division of Clinical Pharmacology, Tartu University, Tartu, Estonia

Background and objective There have been several major developments in psychopharmacotherapy in the last decade. Main driver for these has been the arrival of new drugs of better tolerance. Atypical antipsychotics have changed the therapy of psychoses and account now for more than 50% of volume in most developed countries.

The aim of the study was to describe the shift in antipsychotic therapy in Estonia, compare it to neighbouring Nordic countries and to analyse the economic and access consequences of the change.

Design We carried out a retrospective drug utilisation and prescription database study. The period studied was 2000–2005. We used national level wholesale data from Estonia and published drug utilisation data of Nordic countries for time-trend and international comparison. Estonian Health Insurance prescription database was used to evaluate the number of users and economic indicators.

Setting National level drug utilisation study in public health insurance setting.

Main outcome measures ATC/DDD methodology is used in drug utilisation analyses, changes in patient numbers and treatment costs are reported for prescription database study.

Results The total use of antipsychotics changed little during the study period (3.6 DDD/1000/d in 2000, 4.4 DDD/1000/d in 2005, increase of 18%). The use of atypical antipsychotics rose 6.5 times during the same period and this subgroup counted for 20% in total use by the end of 2005. The corresponding proportion of atypicals in the Nordic countries was 50–60%.

The total wholesale value of antipsychotic group increased 2 times and the increase was solely determined by the increase in atypical segment, which counted for 60% of total value in 2005. Considering the utilisation comparison with the Nordic countries, this expenditure is expected to further increase 2–3 times.

Health Insurance data indicated that the introduction of new drugs has not affected the total patient numbers receiving the reimbursed antipsychotics. The proportion of patients getting the atypical antipsychotics had reached 40 by 2005, a result somewhat contradictory to the national level wholesale analysis and indicating the use in practice of doses lower than the DDD.

Conclusions The change in antipsychotic therapy in Estonia resembles that of developed European countries, but happens considerably later. Introduction of atypical agents has not increased the total use of antipsychotics, but has had a considerable impact on treatment costs. As the increase has been dramatically bigger than the increase in total health budget, it is expected to have a negative influence on access to other health services.

Keywords Pharmacoeconomics, Antipsychotics, Psychopharmacotherapy

PEC-140 Economic evaluation of the TNF-alpha antagonist’s role in the hospital

Gonzalo Rodriguez Torne 1, Maria Carmen Iranzu Aperte1, Maria Antonia Berrocal Javato1, Milagros Gomez-Serranillos Reus1

1Pharmacy Service, Hospital Ntra. Sra. del Prado, Toledo, Spain

Background and objective To know the degree of use of the TNF-alpha antagonists in our hospital and to analyse the effect on cost minimization.

Design Retrospective observational study of patients who have been treated with TNF-alpha antagonists at the Nuestra Señora del Prado of Talavera de la Reina in 2006. A literature review.

Setting Rheumatology Department, Medical Admission Department, Hospital Pharmacy.

Main outcome measures The doses and frequency of drugs administration were taken from the medical prescription charts and their cost was the acquisition price by the Hospital Pharmacy.

Results 80 patients were in the study. 78.57% of patients with infliximab had ankylosis spondylitis, while 76.31% of patients with etanercept and 85.31% of the ones with adalimumab had rheumatoid arthritis. Out of the 14 patients on infliximab, one patient received 3 mg/kg every 6 weeks, three received increasing doses from 3 to 5 mg/kg every 8 weeks, and the rest received 5 mg/kg every 8 weeks. 15 of the patients on etanercept had been on infliximab previously but it had been withdrawn due to non-effectiveness (7 cases), toxivity (6 cases) or unknown reasons (2 cases). One of the patients on etanercept had to be changed to infliximab due to toxicity. In 4 of the 38 patients on etanercept the favourable drug response allowed the reduction of drug doses to once weekly. This also happened in 2 of the patients on adalimumab.

Total cost includes direct and indirect cost. Monthly costs were 1.479,68 € for infliximab, 943,68 € for etanercept and 1.055, 07 € for adalimumab.

Conclusions Unlike other studies, the use of infliximab is more expensive than other alpha-antagonists, especially in ankylosing spondylitis. In our Hospital the most frequently used drugs in rheumatoid arthritis are etanercept and adalimumab.

References

  1. 1.

    Carmona L, Ballina J, Gabriel R, Laffon A. The burden of musculoskeletal diseases in the general population of Spain: results from a national survey. Ann Rheum Dis 2001;60:1040–1045.

  2. 2.

    Van Jaarsveld CHM, Jacobs JWG, Van der Veen MJ et al. Aggressive treatment in early rheumatoid arthritis: a randomized controlled trial. Ann Rheum Dis 2000;59:468–477.

  3. 3.

    Mottenen T, Hannonen P, Korpela M, et al.: Delay in institution of therapy of remission using single-drug or combination-disease-modifying antirheumatic drug therapy in early rheumatoid arthritis. Arthritis Rheum 2002;46:894–8.

Keywords (TNF)-Alpha antagonist, Cost-minimization analysis, Pharmacoeconomisc

PEC-170 Cost analysis of kidney transplantation

N. Chaumard 1, P. Fagnoni1, V. Nerich1, S. Limat1, A. Dussaucy2, H. Bittard3, J. M. Chalopin4, M. C. Woronoff-Lemsi1

1Pharmacy Practice Unit, 2Medical Information Unit, 3Urology Unit, 4Nephrology Unit, University Hospital, Besançon, France

Background and objective Kidney graft can actually be considered as a cost-effective therapy for patients with end-stage renal disease ESRD versus haemodialysis [1, 2]. However, hospital medical costs are not accurately known. The aim of this study is to examine the costs of the first hospital stay for kidney transplantation.

Design This retrospective study included all patients who received a renal transplant at the University hospital of Besançon, between January 2004 and December 2005. This study was performed from the French Public Health Insurance perspective, restricted to hospital costs. All resource consumptions were recorded for each patient’s primary hospitalisation stay. Direct medical costs were calculated according to four different approaches: local costs through the analytic accounting system of our hospital, national costs through the French Diagnosis Related Group (DRG) hospital cost databases (readjusted, or not, to actual length of hospital stay), and national rates from the new French DRG prospective hospital payment system. The average costs were compared side by side with Student test. Each patient was observing himself.

Setting Urology and Nephrology units, University hospital of Besançon.

Main outcome measures Costs differences between the four approaches studied were analyzed.

Results Data was collected from 77 patients. The average duration of hospital stay was 19.4 days. Mean cost of renal transplant valued through the analytic accounting system of our hospital is 14,100 €. A significant difference was observed between our cost price and the other national valuation methods. Costs valued through these other approaches were significantly higher: 16,389 € (P = 0.025) through DRG hospital cost databases, 16,114 € (P = 0.033) when we readjusted to actual length of hospital stay and 17,369 € (P < 10−3) through official rates from the new French DRG prospective payment system. There was no significant difference between mean costs of each national methods and official rates.

Conclusions Specific rate for kidney transplant through the new French DRG prospective payment system covers the committed expenditure by our hospital. These results are interesting, but in opposition to the management of other pathologies, especially in haematology. For acute myeloid leukaemia (AML), all the national valuation methods and official rates resulted in a two- to four-fold underestimation of local costs [3]. Finally, we have to consider this new French DRG prospective hospital payment system and the hospital budget as a whole, to take into account balancing between favourable and unfavourable DRG rates.

References

  1. 1.

    Am J Kidney Dis 2003;42(6):1228–38.

  2. 2.

    Pharmacoeconomics 2004;22(18):1217–34.

  3. 3.

    Bull Cancer 2006;93(8):13–9.

Keywords Kidney transplantation, Valuation, Hospital costs

PEC-199 Should we still wash our incontinent patients? No-rinse foam cleansing is better and cheaper than soap-and-water washing

Jacques Douchamps 1, Vincent Douchamps2, Jocelyne Adant1, Frederique Brockaert3

1Pharmacy, CHU de Charleroi, Montigny-Le-Tilleul, Belgium; 2Institute of Psychology, University of Leeds, Leeds, United Kingdom; 3Nursing, CHU de Charleroi, Montigny-Le-Tilleul, Belgium

Background and objective Caring for the skin of bedridden patients with incontinence is an essential activity for preventing the emergence of pressure ulcers. The present prospective study was set up (1) to compare the efficacy and safety advantages of three no-rinse multifunctional cleansing foams over soap and water, (2) to calculate, by means of a microcost analysis, if they were cheaper care alternatives and (3) to evaluate satisfaction of both patients and nurses.

Design Four groups of 10 bedridden patients with either urinary, faecal or dual incontinence were randomly assigned to either a standard care regimen (soap and water cleansing) or one of three skin cleansing mousses: Abena, Menalind and Tena. Patients were treated with a single product container, for circa 10 days. Forty-three registered nurses participated according to a care protocol strictly standardized.

Setting Rehabilitation and geriatric long-term wards in a teaching general hospital.

Main outcome measures The number of incontinence episodes, their type of soilings, degree of effort to care and time duration were recorded. On every care occurrence, the nurse was also required to score on subjective 5-point Likert’s scales the cleansing quality, safety, degree of skin hydration, ease of use and time gain as well as patient’s satisfaction. Problematic skin conditions were recorded. Statistical comparisons were made with Kruskall–Wallis non parametric tests. A microcost analysis was performed using a 15-years seniority nurse basic pay and official purchase prices of products.

Results The standard protocol was definitely more time-consuming, less efficient for washing and for moisturizing and less safe for preserving a skin functional status. It was less easy and less appreciated by the patient than foam cleansing (all P < 0.001). The latter technique was also lower in cost, with a gain ranging from 1.0 to 1.8 euro per care occurrence, i.e. sparing between 22813 and 41063 euros per year in a 25-bed rehabilitation ward with half of the patients being incontinent. Ward nursing time saving amounted to 3 h/day. Selecting one foam for daily routine was not straightforward as they were globally comparable, with a slight preference for Tena.

Conclusions Replacement of soap and water washing by foam cleansing should be recommended because it (1) reduces health care costs, (2) positively influences psychological and physiological aspects of incontinent, often bedridden, patients’ quality of life and (3) facilitates the caregiver’s work.

Keywords Washing foam, Pressure ulcer, Incontinence

PEC-255 Therapeutic and economic differences in prescriptions for hypertension: a study from a community pharmacy

Görkem Sunal1, Rümeysa Demirdamar1

1Faculty of Pharmacy, Department of Pharmacology, Near East University, Lefkosa, TRCyprus

Background and objective Depending on the institution the prescriptions are obtained, and the insurance system the patient is covered by, there are differences in the medication in prescriptions.

The aim of our study was to investigate these differences and evaluate in terms of the cost of each prescription versus the outcomes of the patient in Hypertension Patients in a Community Pharmacy.

Design In Turkey there are four insurance systems that cover health and medical expenses. (a) Retirement foundation (Emekli Sandığı), (b) Social Securities System, (c) Independent ınstitution (Bağ-Kur) and (d) Private Insurance. They differ in the amount they pay for medication and the therapy they cover. Moreover pharmaceutical company visits and benefits offered may change drugs preferred.

Setting Since a Community Pharmacy is a very good setting to conduct a pilot study we chose a community pharmacy located in an area where prescriptions from patients of all above mentioned four insurance systems come. The pharmacy hypertension patient prescriptions from October 2006 to January 2007 were evaluated.

Main outcome measures A total of 8732 prescriptions were evaluated. 26.7% of these were from patients with hypertension diagnosis. Our results show that the difference in generic or original drugs in these prescriptions were significant. The clinics these prescriptions came from varied too. The cost of each prescription could start from a couple of euros up to hundreds.

Results Our results reveal that there are differences in the medication used and the cost of the treatment of hypertension patients, a change in medication was observed for 2% in these 4 months. Patients obtained these prescriptions not only from a cardiologist or an internal medicine specialist but even from infection disease clinics. 81.3% had only one antihypertensive drug, while the rest had other CV drugs.

Conclusions Our results indicate there is a great difference in the drugs and the cost of medication, therefore a more extended study should be conducted.

Keywords Community pharmacy, Hypertension prescriptions, Cost of treatment

PEC-267 The economic impact of a generic substitution based reimbursement system for type-2 diabetes

Sule Apikoglu-Rabus1, Sinem P. Yurtseven2, Omer Guler2, Basak Soydeger 1, Murat B. Rabus3, Seda A. Demircioglu1, Fikret V. Izzettin1

1Clinical Pharmacy Department, 2Clinical Pharmacy Student Research Group, Marmara University Faculty of Pharmacy, 3Department of Cardiovascular Surgery, Kosuyolu Heart and Research Hospital, Istanbul, Turkey

Background and objective Diabetes, as a chronic condition with potential comorbidities accounts for a large percentage of healthcare expenditures. Generic substitution-based reimbursement system is one of the options of decreasing these expenditures for the patients who benefit from the Government’s social security systems. The purpose of this study is to assess the economic impact of a generic substitution-based reimbursement system (which reimburses only the amount of the generic drug with the lowest price) for diabetes and related conditions from the Government’s perspective.

Design Cross-sectional medical record evaluation. A total of 181 records of patients randomly chosen from those who have been receiving diabetes-care from the outpatient diabetes clinics for at least 1 year were evaluated. The annual medication histories were assessed from these records and the annual medication costs were calculated. All the medications (of diabetes and the comorbid conditions) that the patients were prescribed were taken into account. The amount to be reimbursed (using a generic substitution-based reimbursement system) was also calculated. The annual savings were calculated separately for the patients using insulin (INS) and patients who are not (no-INS).

Setting Outpatient diabetes clinics of a ‘governmental hospital’ and a ‘university hospital’.

Main outcome measures The mean annual saving per patient resulting from a generic substitution-based reimbursement system.

Results The mean annual cost per patient was 1316.95 Turkish Liras [YTL] (€715.10) for the INS and 819.18 YTL (€444.82) for the no-INS group. The mean annual saving per patient was calculated as 77.92 YTL (€42.31) for the INS and 97.47 YTL (€52.93) for the no-INS group. These annual savings per patient, was found to be roughly equivalent to the cost of a diabetic patient’s 1 month medication (of diabetes and the comorbid conditions) supply for the INS group, while it was equivalent to the cost of 2 months medication (of diabetes and the comorbid conditions) supply for the no-INS group.

Conclusions While a generic substitution-based reimbursement system can reduce the medication costs; the bio-equivalency of some specific drugs should be ensured and the patients should be educated on the generic drug concept.

PEC-281 Economic evaluation advancement in pharmacy: discrete choice experiments (DCEs)

Michela Tinelli 1

1General Practice and Primary Care, University of Aberdeen, Aberdeen, United Kingdom

Background and objective Discrete Choice Experiments (DCEs) [1] are an attribute-based technique to elicit preferences. When a price proxy is included, willingness to pay (WTP) can be estimated for both marginal changes in service characteristics and changes in the overall service. The last 15 years has seen an increased use of DCEs in health care [1], with more recent applications in pharmacy [2]. However, there has been limited application within the cost benefit analysis (CBA) framework [3]. This study addresses the application of DCEs within a CBA framework, applied to introducing a community pharmacy-led medicines management service [4, 5].

Design The DCE [6] offered three options: the current scenario; a novel community pharmacist and general practitioner review of medicines (CPGP); and a GP only medicines review (GP). WTP in moving from the current situation to ‘CPGP’ or ‘GP’ were estimated. Results were compared across 3 groups (‘intervention still receiving the treatment’, ‘intervention all’ and ‘control’).

Setting England.

Main outcome measures Willingness to pay (WTP).

Results The CPGP model of care was preferred for the ‘intervention still receiving the treatment’, whereas the GP model was preferred for the other two groups. Welfare estimates differed across groups. For example, in moving from the ‘current’ to ‘CPGP’, respondents in the ‘intervention still receiving the treatment’ were willing to pay £50 whereas those in the other groups would have been worse off.

Conclusions Extra costs of delivering the pharmacy led medicines management service were partially offset by increased patients’ value. The DCE methodology is useful within a CBA for use in pharmacy policy decision making.

References

  1. 1.

    Ryan M and Gerard K. Using discrete choice experiments to value health care: current practice and future prospects. Applied Health Economics and Policy Analysis. 2003;2:55–64.

  2. 2.

    Payne K, Elliott R. Using discrete choice experiments to value preferences for pharmacy services. IJPP 2005;13:9–20.

  3. 3.

    McIntosh E. Using discrete choice experiments within a cost-benefit analysis framework: some considerations. Pharmacoeconomics 2006;24:855–868.

  4. 4.

    The Community Pharmacy Medicines Management Project Evaluation Team. Community Pharmacy-led Medicines Management: A randomised controlled trial in patients with CHD. Family Practice (Forthcoming).

  5. 5.

    Scott T, Tinelli M, Bond C on behalf of the Community Pharmacy Medicines Management Project Evaluation Team. A community pharmacist-led medicines management service for patients with coronary heart disease (CHD): cost minimization analysis. Pharmacoeconomics (Forthcoming).

  6. 6.

    Tinelli M, Ryan M, Bond C. A Patient-Centred Approach to Policy Development: A Pharmacy-Led Medicines Management Service. Supplement to the International Journal of Pharmacy Practice 2006;14: B71–72.

Keywords Pharmacy, Willingness to pay, Discrete choice experiments

PEC-308 Pharmacotherapy cost and drug utilization among indigent outpatients in Greece

Despina Makridaki 1, Calliope Allagianni1, Leonidas Tzimis2

1Pharmacy Department, Sismanoglio General Hospital, Athens; 2Pharmacy Department, Chania General Hospital, Chania, Crete, Greece

Background and objective To examine pharmaceutical needs, prescribed drugs and the cost of pharmacotherapy among Social Care indigent outpatients. The indigent patients receive their drugs free of charge only from Pharmacy departments of public hospitals of Greek National Health System.

Design We compare the data of the indigent outpatients’ pharmacotherapy visited Sismanoglio hospital of Athens and Chania hospital of Crete during the year 2004.

Setting Chania county (population = 150000) and Athens, the capital of Greece (population = 5000000).

Main outcome measures The prescription data concerning the drug utilization and pharmacotherapy cost among the indigent outpatients visiting two general hospitals of Greece.

Results The percentage of cost among the various drug categories prescribed for the indigent outpatients visited Sismanoglio hospital of Athens versus Chania hospital of Crete, were: for gastrointestinal and metabolism 3.10% vs. 19.64% (statistical significance, P < 0.05), cardiovascular system 9.53% vs. 21.13% (P < 0.05), dermatological drugs 0.14% vs. 0.60%, urinogenital and hormones 0.67% vs. 0.76%, hormones except sex-hormones 2.85% vs. 7.12%, antibiotics 2.30% vs. 7.63%, musculoskeletal system 1.22% vs. 4.55%, nervous system 37.50% vs. 9.43% (P < 0.05), respiratory system 5.09% vs. 9.69% and sensorial organs 0.23% vs. 2.35%.

Conclusions The present study indicated that there were significant differences in the pharmacotherapy cost among the indigent outpatients living in Athens and those living in the county of Chania in the island of Crete. We are very impressed with the differences in the category of gastrointestinal and metabolism, cardiovascular system and nervous system drugs. In our presentation we focus on differences and similarities, try to find their origins and finally explain the need of interventive measures to optimize the pharmacoeconomical profile of each hospital in the area of the indigent outpatients. Our final goal is to explore the possibility of a common set of proposals suitable for both county public hospitals and the central ones.

References

  1. 1.

    Tzimis L, Katsantonis N, Leledaki A, Vasilomanolakis K, Kafatos A. Prescribed medication and nutrition of social care patients in Crete, Greece. Public Health 1996;110:361–367.

  2. 2.

    Tzimis L, Kafatos A. Drug utilization and health behaviors among indigent elderly patients. Pharmacoepidemiology and drug safety 1999;8:105–114.

  3. 3.

    Tzimis L, Kafatos A Drug utilisation and nutrition patterns among children from indigent and emigrant families in Crete, Greece. Public Health 2000;114:393–397

Keywords Pharmacotherapy, Drug cost, Indigent outpatients

PEPI-13 Drug use practices in teaching hospitals of Khartoum State, Sudan

Abdelmoneim A. I. Awad1, Hossam Himad 2

1Pharmacy Practice, Faculty of Pharmacy, Kuwait University, Kuwait, Kuwait; 2Pharmacy Practice, The Academy of Medical Sciences and Technology, Khartoum, Sudan

Background and objective The present study was carried out to investigate current prescribing and dispensing practices in the largest two teaching hospitals in Sudan and compare these with those of published studies in developing countries.

Design A descriptive, quantitative and cross-sectional study was conducted in the hospital outpatient.

Setting The sample size was selected using systematic random sampling. Prescribing indicators were investigated through a collection of 100 patient encounters, determination of consultation time, dispensing time and interview of 100 patients for the evaluation of dispensing practices.

Main outcome measures The current findings highlight the existing irrational prescribing and dispensing practices at the largest two teaching hospitals in Sudan, and show that the concept of rational drug use is poorly utilized.

Results The present findings showed that 96% (95% CI: 92.0–98.1%) of patient encounters did not include one or more necessary elements. Strength of drug and the quantity to be dispensed were omitted in 57.5% (95% CI: 50.3–64.4%) and 91% (95% CI: 85.9–94.4%) of patient encounters, respectively. Other variables measured per patient encounter were mean (SD) number of drugs prescribed, 1.9 (0.9); percentage prescribed by generic name, 43.6% (95% CI: 38.6–48.8%); percentage of patient encounters involving an antibiotic, 65.0% (95% CI: 57.9–71.5%); percentage of patient encounters with an injection prescribed, 10.5% (95% CI: 6.5–15.8%). The mean (SD) consultation and dispensing times were 4.5 (2.8) min and 46.3 (21.8) s, respectively. The percentages of dispensed drugs that were adequately labeled was 37.6% (95% CI: 33.1–41.8%), whilst adequate patient knowledge was demonstrated for 37.2% (95% CI: 32.3–42.0%) of drugs.

Conclusions Cost-effective, multifaceted interventions are needed to improve current prescribing and dispensing practices at the teaching hospitals in Khartoum State, Sudan.

References

  1. 1.

    World Health Organization (1985). The rational use of drugs. Report of conference of experts;Nairobi.

  2. 2.

    World Health Organization (2002). Promoting rational use of medicines: WHO Policy Perspectives on Medicines.

  3. 3.

    World Health Organization (1993). How to investigate drug use in health facilities: Selected drug use indicators

Keywords Prescribing, Dispensing, Drug use, Teaching hospital, Sudan

PEPI-30 Safety of intermittent oral high dose dexamethasone in multiple myeloma

Nathalie Saurel1, Sophie Calvez1, Yvette Brasseur2, Bernard Do 3, Marie-Pierre Berleur1

1Regulatory, 2Pharmacovigilance, 3Analytical Development Laboratory, Ageps EPHP, Paris, France

Background and objective Multiple myeloma (MM) is an incurable haematological malignancy of B-cell origin. High dose dexamethasone (DX) is an effective treatment of MM. Our objective is to outline the safety of intermittent oral high doses of DX in MM patients.

Design Literature review.

Setting Assistance publique-Hôpitaux de Paris.

Main outcome measures We searched Medline and the Cochrane library database about dexamethasone safety.

Results Fifty-one papers were identified and analysed. Most adverse events (AE) reported during clinical trials are mild to moderate in severity and are usually not responsible of treatment discontinuation. Serious AE can be often managed by reducing doses of DX.

When DX is used alone most frequent (>20%) AE reported were: cushingoid features, fatigue, gastroduodenal effects, peripheral neuropathy, insomnia and anemia. No bone marrow toxicity was reported. Fatal outcomes were associated with serious bleedings and infections. When combined with other cytotoxic drugs, DX did not appear to induce severe additional toxicity. The AE of bortezomib (BZ, 1.3 mg/m2)-dexamethasone (20 mg/day) combination were fatigue, nausea, diarrhea (50 per cent less frequent than with BZ alone at the same dose, P < 0.01) and arthralgia and pyrexia (more frequently than with BZ alone at the same dose). The most frequent AE with thalidomide-dexamethasone combination were deep-vein thrombosis, neurologic side effects, fatigue, rash/dry skin and edema. Authors concluded that DX combined with thalidomide induced low incidence of serious irreversible toxicity.

Conclusions In conclusion, high doses dexamethasone AE are manageable when given at sufficient intervals and by lowing dose to prevent severe toxicity, and don’t usually lead to treatment discontinuation in MM patients.

References

  1. 1.

    Jagannath et al. Bortezomib in combination with dexamethasone for the treatment of patients with relapsed and/or refractory multiple myeloma with less than optimal response to bortezomib alone. Haematologica 2006 Jul;91(7):929–34.

  2. 2.

    Weber et al. Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. J Clinical Oncol 2003 Jan;21(1):16–9.

Keywords Dexamethasone, Safety, Myeloma multiple

PEPI-33 How to manage the quality of medication use in nursing homes: a literature review

Charlotte Verrue 1, Els Mehuys1, Jean-Paul Remon2, Robert Vander Stichele3

1Pharmaceutical Care Unit, 2Pharmaceutical Technology, 3Heymans Institute, Ghent University, Gent, Belgium

Background and objective For the past decades, concern is growing about the appropriateness of medication prescription and utilisation in nursing homes (NHs). The objective of this literature review is to explore the effectiveness of interventions aimed at improving the quality of medication use in NHs.

Design A computerized literature search was carried out using Medline, International Pharmaceutical Abstracts (IPA) and Web of Science. Publications from the past 20 years were retrieved and on basis of the selected publications, a “cited references” search was also conducted.

Setting Non applicable.

Main outcome measures Non applicable.

Results A total of 192 titles were found. 4 main strategies to improve the quality of drug use in NHs could be identified: use of a drug formulary, informatisation of the medication process, pharmacist involvement and multidisciplinary case conferences. These strategies can both influence the quality of prescribing and the quality of medication usage. Drug formularies (standard lists with affordable, safe and active medicines for the most frequently occurring diseases) are not widely implemented in NHs, despite their long use and acceptation in hospital settings. They can theoretically increase the quality of prescribing and reduce costs of drug therapy, however studies evaluating their efficacy are lacking. The use of a Computerised Physician Order Entry-system (CPOE) equipped with a Clinical Decision Support module also is a powerful tool to prevent medication errors and is already successfully implemented in hospital settings. Studies in NHs agreed that CPOE is a promising technology that may be very useful. Pharmacist involvement (mainly medication reviews) and multidisciplinary approaches are more common, especially in the United States, where they have proven to be very effective, both on medication costs and quality of the medication usage.

Conclusions Despite promising strategies, the quality of medication use in NHs still needs to be improved. The best results seem to be obtained with pharmaceutical care and multidisciplinary interventions involving the whole team of caregivers.

Keywords Nursing homes, Medication usage, Quality

PEPI-35 A new, “hazardous-drug” containment system

Yaakov Cass 1, Menachem Kraus2

1Regional Pharmacy, Ministry of Health, Ramle, 2R and D, Teva Medical, Ashdod, Israel

Background and objective Cytotoxics have been in clinical use for decades and are of great importance in the treatment of cancer. Recently, the US National Institute for Occupational Safety and Health (NIOSH) issued a detailed alert stating that chemotherapy drugs are carcinogenic and despite current safety provisions they still pose a risk to nurses, pharmacists and others handling them. Teva Medical developed a new containment system, Tevadaptor, for the safe handling of hazardous drugs. It was designed to prevent the ingress of environmental contaminants into drug containers, and the spread of hazardous drugs (solid, liquid, aerosol or vapour) into the environment.

Design Laboratory tests were performed evaluating the safety and efficiency of Tevadaptor in Israel and Sweden.

Setting Laboratory and environmental testing was performed by Analyst laboratories, Israel using LC/MS/MS. Sterility testing was performed by Aminolab, Israel. Environmental contamination was determined using a Tc99 radioactive tracer at Norrlands Universitetssjukhus, Umeå, Sweden.

Main outcome measures The device was tested for sterility maintenance and its ability to prevent the spread of hazardous drugs into the environment.

Results Vial and bag sterility maintenance demonstrated solution sterility for at least 14 days. 12 Tevadaptor vial adaptors were challenged with cyclophosphamide vapour by passing 90 l of nitrogen through a cyclophosphamide containing vial equipped with a Tevadaptor; at a rate of 0.5 l/min. Tevadaptor units were tested after three differing sterilization conditions. In two control units without filtration systems, there was a passage of 28 and 32 ng of cyclophosphamide/90 l of nitrogen, whilst in all the Tevadaptor test units there was zero passage of cyclophosphamide. 75 Tevadaptors were used in an environmental contamination test. Vial contents were spiked with Tc99 for radioactive analysis of possible liquid spill. Used gloves and pads were wiped and tested for radioactivity using scintillation counting. All units were within the local standard of 100 nl per preparation (1 drop equals 50,000 nl).

Conclusions The results indicate that Tevadaptor achieves its stated aims. A combination of a unique vented containment system together with an innovative connect/disconnect mechanism makes for a safe and user-friendly system; conducive to high user compliance. Tevadaptor fully complies with both the published NIOSH guidelines for closed, hazardous-drug handling systems and a future International Society of Oncology Pharmacy Practitioners (ISOPP) guideline.

Reference

  • Preventing occupational exposure to antineoplastic and other hazardous drugs in Health Care Settings. NIOSH publication No. 2004–16.5. ISOPP Web Site. Retrieved from http://isopp.org. January 2007.

Keywords Cytotoxics, Environmental contamination, Tevadaptor

PEPI-119 Impact of smoking warning pictures on behaviour and attitude in smoking cessation: a case study at Chiang Mai University

Surarong Chinwong1, Dujrudee Chinwong 1, Kasamaporn Noomphan1, Chiranwadee Inkham1, Pairaya Sriboon1

1Department of Pharmaceutical Care, Faculty of Pharmacy Chiang Mai University, Chiang Mai, Thailand

Background and objective After May 2005, six picture-based cigarette package warnings have been required on tobacco products selling in Thailand. This study aimed to assess impacts of these warning pictures on behaviours and attitudes toward smoking amongst current smoking students at Chiang Mai University.

Design A descriptive survey study was conducted. Self-administered questionnaires were used for data collection conducted between 1 December 2005 and 15 January 2006.

Setting Subjects were smoking students studying at Chiang Mai University, Thailand selected by using the snowball sampling technique.

Main outcome measures Behaviours and attitudes.

Results Of 380 respondents from 16 faculties completing the questionnaire, most were male (84.7%), 18–30 years old (21.1 ± 1.47), most were from the Faculty of Engineering (18.4%), most were in year 4 (40.6%). About half (47%) started smoking at the age of 18 years. Most of the respondents smoked daily and smoked <10 cigarettes/day (43.8% and 85.3%, respectively). In general, the warning labels had some impact on smoking behaviours of students; although 61% still had the same frequency and number of cigarette consumption. Twenty-nine percent of respondents avoided seeing the warnings in various ways. The warnings mentally affected most respondents’ attitudes toward smoking e.g., “smoking harms one’s health”, “smoking makes you look bad”. Amongst six cigarette package warnings, “Cigarette smoke causes lung cancer” and “Smoking leads to COPD death” might be the most effective labels for reducing and/or quitting smoking. On the other hand, “Smoking makes you look older” might be the least effective. Most respondents suggested that demonstrating the dangers of smoking and using more terrible/disgusting pictures might increase the success of smoking cessation campaign. Moreover, 60.3% advised that information on how to quit smoking should be available on the package.

Conclusions The prevent study demonstrated that the current cigarette package warning have some effects on behaviours and attitudes of smoking students.

References

  • World Health Organization. Smoking Statistics. [online]. Available from: http://www.wpro.who.int/media_centre/fact_sheets/fs_20020528.htm [Accessed June 2005].

  • Goodall CE. Modifying smoking behaviour through public service announcements and cigarette package warning labels: A comparison of Canada and the United States. Department of Communication. Ohio: The Ohio State University, 2005:135.

Keywords Smoking cessation, Cigarette package warning, Behaviours and attitudes, Students, Thailand

PEPI-124 Palivizumab prophylaxis impact: retrospective study in Calais’ Hospital

Emmeline Janvier 1, Fabrice Monard1, Sylvie Joron1

1Pharmacy, Calais’ Hospital, Calais, France

Background and objective To determine and evaluate the effect of Palivizumb in prevention of Respiratory Syncitial Virus (RSV) infections for the pre-term children hospitalized in neonatalogy in Calais’Hospital.

This antibody has been licensed for prevention of RSV disease for preterm children (<32 weeks) under 6 months old at the beginning of the epidemic period, or for children under 2 years old at the beginning of the epidemic period, born in the term lower or equal to 32 weeks and who required a treatment for bronchopulmonary dysplasy during the last 6 months; or children under 2 years old, suffering from congenital cardiopathy.

Design Retrospective study concerning the 37 preterm who were born in the term lower or equal to 32 weeks and who received Palivizumab between 2004 and 2006: for each of these children, we studied the number of administration of Palivizumab (whether respecting or not the administration therapeutic programme) and whether they where or not hospitalised during the epidemic period for RSV infections or respiratory infections.

Setting Pharmacy for the census of the patient having received the Palivizumab and follow-up of the dispensations, service of neonatalogy to consult patients history.

Main outcome measures Comparison of these results with the results observed at Calais’ Hospital and with those of the French cohort (longitudinal study PrimeVeReS) which included 3636 preterm children.

Results 37 preterm children received Palivizumab between 2004 and 2006. 32.4% (N = 12) were hospitalised for respiratory diseases despite the injections. 8.1% (n = 3) presented a RSV infection.

Conclusions The results are similar with those of the PrimVeRes study which concluded the efficiency of Palivizumab treatment. They are better than those observed for the preterm children who received the Synagis between 2000 and 2002 at Calais’ Hospital (32% of rehospitalizations for RSV infections). Those bad results were then explained by a bad observance. Here the administration programme has been respected in 64% of the cases which could be explained these better results.

References

  • Avis de la commission de la transparence du 13 October 2004 et du 8 November 2006.

  • Document de synthèse PrimeVèReS, Juillet 2002

Keywords Palivizumab, Retrospective study, Efficacity

PEPI-147 Antidepressants and antipsychotics: from the analysis of prescriptions to an active drug control path. The experience of ASL 7, Chivasso (Turin—Italy)

Clara Pietraru 1, Raffaella Baroetto Parisi1, Giuseppe Tibaldi2, Abdoulaye Diarassouba1

1S.C. Assistenza Farmaceutica Territoriale, A.S.L. 7 Chivasso, Chivasso; 2Centro Studi e Ricerche in Psichiatria, A.S.L. 4 Torino, Torino, Italy

Background and objective Depression and Psychosis are important public health problems. Patients often discontinue medication with antidepressant (AD) and antipsychotic (AP) drugs because of adverse effects. In Italy, most patients are receiving their therapy from a general practitioner (GP).

A better knowledge and ability to manage adverse effects by doctors, patients, and families may improve outcome.

Design The objectives of this study are:

  1. 1.

    Describing the epidemiology of patients at ASL 7 treated with AD/AP in 2004.

  2. 2.

    Identifying a GPs group involved with the psychotic/depressed patient problems to implementing active drug control.

Setting From the 2004 drug prescriptions database we selected:

  • Patients receiving at least one AD/AP prescription;

  • 22/150 GPs whose AD/AP prescriptions incidence is higher than the ASL 7 average (Case-control methodology).

Main outcome measures 91.8% of AD/AP prescriptions were by GPs.

The selected 22 GPs show an incidence of patients AD/AP treated higher than the ASL 7 average (47.6‰ AD and 13.3‰ AP). GPs “case”:

  • received scientific material on AD/AP,

  • received personalized reports,

  • participated in a group with psychiatrists, nurses, patients and families on topics of AD/AP therapy.

Results The data analysis of prescriptions promoted discussion, practitioners’ direct motivation on different therapeutic approaches.

The necessity of coordination between GPs and psychiatric service in communication about managing patients was stressed.

Conclusions Patients establishing a steady dialogue with GPs show less fear towards their own disturbances, towards following pharmacological therapies in a more positive way. However, a non-pharmacological therapies to support the overall management, emerged as a primary necessity for patients and families.

Keywords Antidepressant, Antipsychotic, Analysis of prescriptions

PEPI-176 Patients with lowest perceived necessity of inhaled corticosteroids report nonadherence more truthfully

Tanja Menckeberg1, Marcel L. Bouvy 1, Madelon Bracke1, Ad Kaptein2, Rob Horne3, Bert G. M. Leufkens1, Jan A. M. Raaijmakers1

1Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht; 2Department of Psychology, Leiden University Medical Center, Leiden, Netherlands; 3Centre for Behavioural Medicine, The School of Pharmacy, London, United Kingdom

Background and objective In search of an easy to use and readily available screening tool, studies evaluating the accuracy of patients’ self-report to identify non-adherent patients by comparison to prescription refill adherence, have found low agreement. Patients’ beliefs have been shown to correlate with self-reported adherence. Therefore, we aimed to investigate the accuracy of self-report to identify non-adherent patients by prescription refill adherence stratified by patients’ beliefs.

Design A cross-sectional study in which current-users of ICS were sent a mailed questionnaire.

Setting 11 community pharmacies in the Netherlands.

Main outcome measures Patients’ beliefs about inhaled corticosteroids (ICS) by use of the Beliefs about Medicines Questionnaire and self-reported adherence by the Medication Self-reported Adherence Scale (MARS) was assessed. ICS prescription refill adherence during one year prior to the survey was assessed as a Continuous Measure of Medication Acquisition (CMA). Both the MARS (a score of at least 4 on each item) and adherence (cut-off of 80%) were dichotomised and the positive predictive value (PPV) was calculated for the total sample.

For clinical applicability both belief dimensions were split at the scale midpoints and consequently the PPVs for these groups were calculated.

Results Questionnaires were returned by 238 patients (51.1%). Two-third of the sample (66.9%) considered themselves non-adherent. More than half of the patients, 143 (61.4%), were considered nonadherent according to pharmacy records. The proportion of the total sample that was nonadherent according to both methods was 47.2% and overall PPV was 70.5%. For patients with scores lower than scale midpoint on necessity (n = 108) the PPV was 83.1%, for those with high necessity 56.1% (n = 125). For patients expressing a low level of concerns towards the use of ICS, the PPV was 69.4% (n = 133) and for those with a high level of concerns 71.1% (n = 100).

Conclusions Patients with low perceived necessity towards the chronic use of ICS reported nonadherence more truthfully than patients with high necessity to use ICS chronically. Stratification according to the level of concerns did not yield higher PPVs. Clinicians can identify patients with lowest adherence by means of self-report on adherence and the necessity to use ICS and subsequently target their outspoken barriers towards ICS use.

PEPI-186 Tacrolimus induced neurotoxicity: a case report of cerebellar ataxia in an allograft transplant recipient

Stéphanie Berthet1, Nathalie Sylvoz 1, Céline Villier1, Benoît Allenet2, Delphine Bourneau3, Olivier Epaulard4, Michel Mallaret1

1Regional Pharmacovigilance Center, Grenoble University Hospital, 2Department of Pharmacy, Grenoble University Hospital, Laboratory ThEMAS TIMC UMR CNRS 5225, Joseph Fourier University, 3Department of Pharmacy, 4Infectious Diseases Department, Grenoble University Hospital, Grenoble, France

Background and objective Tacrolimus is an effective macrolide immunosuppressive agent in the prevention of organ transplant rejection. Neurotoxicity in transplant recipients treated with tacrolimus has been well documented. The most common symptoms of neurotoxicity associated with tacrolimus include tremor, headache, insomnia, hyperesthesias, and itching, also severe neurologic complications including seizures, coma, dysarthria, and encephalopathy, have been reported. We report a case of cerebellar ataxia induced by tacrolimus in a stem cell allograft recipient.

Design Case report.

Setting Grenoble University Hospital.

Main outcome measures A 54 year-old allograft recipient for follicular lymphoma received cyclosporine and mycophenolic acid for immunosuppression. Five weeks later, he presented tremor which was reversible upon discontinuing cyclosporine and he then started tacrolimus. Thirteen days later, he presented cerebellar ataxia with an unsteady walk and balance. Laboratory findings were normal (negatives tests results for Toxoplasmosis, Cytomegalovirus, Epsteinbarr virus, Cryptocococcus, Aspergillus, Rickettsis and Koch Bacillus). Computed tomography scan, magnetic resonance imaging (MRI) of the brain and the cerebrospinal fluid analysis were normal. Tacrolimus was discontinued. His symptoms improved over the next ten days. He was then only treated by mycophenolic acid.

Results We report a reversible cerebellar ataxia induced by tacrolimus in a stem cell allograft recipient. Neurotoxicity like tremors has been also reported with cyclosporine. These neurological complications are usually reversible after withdrawal of cyclosporine. The endothelial damage caused by cyclosporine may contribute to ischemia in the brain. The mechanism of tacrolimus induced neurotoxicity still remains unknown. It has been suggested that high levels of tacrolimus may contribute to drug-associated neurotoxicity. However, in our case tacrolimus levels were within the normal range. Surprisingly, brain MRI did not show abnormal signals as in a case previously reported of subacute cerebellar ataxia related to tacrolimus.

Conclusions Physicians should be aware of potential neurotoxicity of tacrolimus even if MRI of the brain and tacrolimus level are normal. In our case, the patient presented symptoms with both cyclosporine and tacrolimus. We cannot exclude a common mechanism of neurotoxicity. Therefore in case of neurotoxicity with either cyclosporine or tacrolimus, withdrawal of the drug and replacement by the other should be cautious.

Keywords Tacrolimus, Neurotoxicity, Cerebellar ataxia

PEPI-205 Sudden respiratory and cardiac arrest after varicose veins sclerosis with polidocanol: a case report

Nathalie Sylvoz 1, Stéphanie Berthet1, Céline Villier1, Benoît Allenet2, Sylvaine Robin3, Michel Mallaret1

1Regional Pharmacovigilance Center, Grenoble University Hospital, 2Department of Pharmacy, Grenoble University Hospital, Laboratory ThEMAS TIMC UMR CNRS 5225, Joseph Fourier University, 3Department of Anesthesiology and Reanimation, Grenoble University Hospital, Grenoble, France

Background and objective

Polidocanol sclerotherapy is a well-established therapeutic modality for the treatment of varicose veins. This solution is highly valued by clinicians because of its high efficacy and excellent safety profile, which has been documented in large case series and a single randomised controlled trial. Systemic adverse effects are rare and are represented by allergic reactions and transient neurologic disorders. Feied et al. (1994) have previously reported an incidence of systemic allergic reaction of 0.3%. Some life-threatening reactions such as reversible cardiac arrests have been reported. We report a case of cardiac arrest after a first injection sclerotherapy for the treatment of varicose veins.

Design Case report.

Setting Grenoble University Hospital; BP 217; 38043 Grenoble, France.

Main outcome measures A 48-year-old woman, undergoing sclerotherapy for a symptomatic lower limb varicose, developed a malaise with tetraparesis, 5 min after 2% polidocanol injections (total of 7 ml). Her medical history included De Quervain’s subacute thyroiditis and an atypical thoracic pain a few days before for which she had seen a cardiologist. The patient did not take any medication. Sudden respiratory and cardiac arrest occurred within minutes after the symptoms appeared. Cardiopulmonary resuscitation was immediately started and continuously performed for 15 min, before restoration of pulses. Electrocardiogram and echocardiography were performed, which showed a ST-segment elevation and a normal Left Ventricular Ejection Fraction (LVEF) of about 60–70%. Because of a persistent hemodynamic instability, the patient was transferred to intensive care unit, where epinephrine and intra-aortic balloon counterpulsation were used without success. Coronarography showed normal coronary arteries but echocardiography monitoring revealed a decrease in LVEF to 20%. The patient was finally connected to an extracorporeal circulation. After five days of intensive therapy, she recovered.

Results In the absence of any other obvious etiology, this episode of cardiac arrest should be attributed to polidocanol. Because of the delayed LVEF fall, we suppose a myocardial toxic mechanism rather than an anaphylactic mechanism. As received doses were higher than the authorised doses, we wonder about a dose-dependant toxicity. Initial transient neurological disorders and ST modification suggest a vasospastic mechanism.

Conclusions Our report describes a rare complication of polidocanol sclerotherapy. Clinicians should be aware of the possibility of uncommon but life threatening adverse effects.

Keywords Polidocanol, Sclerotherapy, Cardiac arrest

PEPI-206 Assessment of quality of life—SF-36- in Portuguese hypertensive patients in a community pharmacy survey

Esperanca Silva 1, Margarida Caramona2, Rita Figueirinha3, Emanuel Ponciano3

1Community Pharmacy, Farmacia Rocha, 2Pharmacology, Faculty of Pharmacy, 3Ibili, Faculty of Medicine, Coimbra, Portugal

Background and objective The SF-36 has become one of the most widely used generic measures of subjective health status. It has frequently been used to measure health related quality of life in hypertension. This study assess the impact of a pharmacy-based intervention program on hypertensive individuals served as background for this study.

Design A prospective survey was carried out where 3 standardised questionnaires (HYPER 29, SF-36, clinical data) were sent to each pharmacy and filled only once by the patient in the pharmacy or at home.

Setting In the study have been involved 47 community pharmacies from Portugal.

Main outcome measures The quality of life and epidemiological data of hypertensive patients.

Results 285 subjects, 112 males (mean age 59.72 ± 12.00) and 170 females (mean age 62.36 ± 13.86) participated in this study filing the Hyper 29 and SF-36 at Portuguese community pharmacies.

A factor analyzed symptoms group results on a physical and emotional dimensions. These were correlated with the 8 dimensions of the SF-36. Both, physical and emotional dimensions correlates negatively with the 8 dimensions of SF-36 and strong correlations were found on physical dimension on both genders. A significant correlation between the duration of hypertension diagnostic was only found with physical dimension. Physical and emotional dimensions are intimately related with the 8 dimension of quality of life measured by SF-36 questionnaire on hypertensive patients.

Conclusions The influence of hypertension is more deleterious on physical than emotional components. The longer the diagnostic of hypertension is present stronger evidence of physical deleterious effects are present. Therefore the way to improve quality of life has to be by improvement in quality of care, so the community pharmacist is in great place to develop and deliver services to measure and improve quality of life of their patients.

Keywords Quality of life, SF-36, Hypertension

PEPI-212 Primary therapy of invasive aspergillosis: a retrospective review of 271 cases over 9 years.

Yasmine Nivoix 1, Katy-Anna Phai Phang1, Valérie Letscher-Bru2, Ana Berceanu3, Pierre Bories3, Lynn Rob3, Philippe Lutun4, Dominique Levêque1, Jean-claude Koffel1, Laurence Beretz1, Raoul Herbrecht3

1Pharmacy, 2Mycology, 3Hematology and Oncology, 4Intensive Care, Hôpitaux Universitaires de Strasbourg, Strasbourg, France

Background and objective Invasive aspergillosis (IA) is a major cause of death in patients (pts) with a haematological malignancy and in haematopoietic stem cell transplant (HSCT) recipients. Two classes of antifungals—the polyenes, and the extended spectrum azoles—are available for primary therapy of IA.

Design We reviewed retrospectively the outcome of 271 cases of IA observed in adult oncohaematological pts since January 1997 and treated in first line with a polyene, itraconazole or voriconazole.

Setting Department of Hematology and Oncology, Intensive care.

Main outcome measures Response to treatment and survival were assessed at week 12.

Results Underlying condition included allogeneic HSCT (37), autologous HSCT (24), solid organ transplantation (9), acute leukaemia (87), other haematological malignancy (73), solid tumor (22) or non-malignant haematological disease (19). Sixty-one percent of the pts were neutropenic at time of initiation of treatment. Antifungal therapy was administered for a median duration of 44.0 day (range 1–1191 days). Overall, 143 (52.8%) achieved a favourable response (CR in 125, PR in 18) at week 12. Twelve-week overall survival was 53.9%. Voriconazole-treated pts had a better outcome than amphotericin B treated pts. We did not see any difference in response and survival rates in patients receiving amphotericin B deoxycholate compared to pts receiving a lipid-amphotericin B.

 

First line No

Survival P value (%)

Favourable P value (%)

Antifungal ratea

Responsea

AmB

127

47.2

0.009

45.7

0.02

Lipid-AmB

51

47.1

47.1

  

Itra

31

61.3

61.3

  

Vori

62

69.4

67.7

  
  1. AmB—amphotericine B
  2. Itra—Itraconazole
  3. Vori—Voriconazole
  4. aAt week 12

Conclusions Our data are in accordance with published results of better efficacy of voriconazole over amphotericin B deoxycholate in primary therapy of IA (Herbrecht et al. N Eng J Med, 2002). Survival in lipid-amphotericin B treated pts is lower than in recently presented data on liposomal amphotericin B (Cornely et al. Am. Soc. Hematol, 2005).

Keywords Invasive aspergillosis, Antifungal treatment, Survival, Response

PEPI-239 Multidisciplinary assessment of prescribing errors

Graciela Calle 1, Marcela M. S. Rousseau1, Norma Sberna1, Mariel Perez1, Beatriz B. M. Marciano2, Erika E. H. Hammermuller2, Nora N. D. Dackiewicz2

1Pharmacy, 2Clinical Paediatric, Hospital de Pediatria Prof. Dr. J. P. Garrahan, Buenos Aires, Argentina

Background and objective Children present major differences in age, weight and development, in addition there is lack of information about medicines use in children making them vulnerable to medication errors. In Argentina there is no National o Institutional Programme to report Medication errors. Our Pharmacy department has recorded medication errors at different stages, and this has proved a challenge as it means also a cultural change in our Institution. These records revealed the need of a multidisciplinary working party approach to achieve better. Objective: To identify and classify paediatric errors develop strategies in order to avoid further occurrence.

Design Prospective observational study for one year 2004–2005.

Data collected by 5 pharmacists and reviewed with 3 pediatricians. Data was recorded using Microsoft Excel version 1998, classified by type of prescription error (dose, frequency, route of administration, wrong patient, lack of patient data, abbreviations, units, use of brand names), and evaluated by their potential severity in three levels: fatal, serious and significant.

Setting The study was carried out in 8, general and high dependency care units at Garrahan Paediatric Hospital in Buenos Aires, Argentina. This is a 600 beds tertiary public hospital providing complex care to children and we provide clinical pharmacy service to all the wards.

Main outcome measures Quantify and classify prescribing errors.

Results Total of prescriptions reviewed: 6208. Total of errors identified 1701 (27%). Potentially significant 99.9% and 0.1% potentially serious. Lack of patient demographic data 17%. Use of brand names 28%. Abbreviations 15%. Wrong route 12%, wrong frequency 10%. Classification of drugs by therapeutic group: gastrointestinal 23%, minerals and electrolytes 17% and anti-infectious 11%.

Conclusions This study has limitations as it was the first time a multidisciplinary approach has been given to this topic in our setting. Use of brand names and abbreviations were the most frequent type of error. In Argentina the generic name must be used when prescribing, brand names or abbreviations can cause confusion and lead to the wrong drug being administered. Lack of demographic patient data, can make difficult for pharmacists evaluate dosage and nurses administer the wrong drug to wrong patient. The rest of errors were related to lack or wrong instructions on how to give drugs and this can potentially have serious consequences. As a result of this study we designed prescribing guidelines, approved by the hospital Risk Management Committee. Continuous monitoring is done ever since.

References

  • Brennan TA, Leape LL, Laird NM, et al. New Engl Jour of Med. 1991;324(6):377–384.

  • Stucky ER. Pediatrics 2003 Aug;112(2):431–6.

  • Bauman AN, Pedersen CA, et al. Am J Health-Syst Pharm 2001;58(12):1120–1125.

  • Lesar TS, Briceland L, Stein DS. JAMA, 1997;277:312–7.

Keywords Paediatric, Prescribing, Error

PEPI-254 Fair access to medicines in Lothian: supporting excellent prescribing in primary care

David Crookes 1, Mandy Allison2, Walter Jamieson2, Anne Gilchrist1

1Primary Care Medicines Management Team, 2Craigmillar Medical Practice, Edinburgh, United Kingdom

Background and objective To establish and develop a system and to ensure best outcomes for patients by providing good prescribing support tools and fair and equitable drug budgets. The Lothian Joint Formulary (LJF [1]) was developed in 2001 to promote safe, effective, and economic prescribing in both hospital and general practice. The medicines included provide appropriate treatment for the vast majority of patients. The LJF is available in many formats, including web, electronic version for primary care prescribing (eLJF-GPASS), abbreviated list and more recently a Minor Ailments Formulary to support the Minor Ailment Service (eMAS) element of the new community pharmacy contract in Scotland. The drugs budget in Scotland is based on a national ‘fair shares for all’ formula which takes account of many factors, including deprivation, population characteristics and rurality are taken into account when drug budgets are set for primary care across Scotland [2]. Systems have been developed to ensure that prescribers are regularly informed of their prescribing patterns and expenditure, using the LJF as a benchmark.

Design

  • Use of the Lothian Joint Formulary as the core prescribing tool to support evidence based and cost effective prescribing in the Lothian region of Scotland.

  • Measurement of adherence to the LJF in a practice in a deprived geographical area, examining specific examples, e.g. smoking cessation, substance misuse, cardiovascular disease.

Setting A primary care medical practice in a deprived area of the city of Edinburgh.

Main Outcome Measures

  • Level of use of the LJF and associated support materials by prescribers in the practice.

  • LJF adherence across number of disease areas.

Results Data demonstrates a good level of adherence to the LJF across a range of therapeutic disease areas.

Conclusions Adoption of the LJF along with clear information on allocated drug budget, along with regular monitoring of prescribing and feedback to prescribers provides an excellent support system for fair and consistent patient care.

References

  1. 1.

    The Lothian Joint Formulary. NHS Lothian. www.ljf.scot.nhs.uk

  2. 2.

    Fair Shares For All. Final Report of the National Review of Resource Allocation for the NHS in Scotland ‘The Arbuthnott Report’. Scottish Executive. September 2000. http://www.scotland.gov.uk/fairshares/docs/fsfg-00.asp

Keyword Prescribing formulary equality

PEPI-262 Antidepressants and seizures: a prospective study in emergency medical service

Nathalie Sylvoz 1, Emilie Tudela-lopez2, Claire Louis2, Gwénaël Milin2, Céline Villier1, Benoît Allenet3, Gérard Besson4, Michel Mallaret1

1Regional Pharmacovigilance Center, 2Department of Pharmacy, Grenoble University Hospital, 3Department of Pharmacy, Grenoble University Hospital, Laboratory ThEMAS TIMC UMR CNRS 5225, Joseph Fourier University, 4Department of Neurology, Grenoble University Hospital, Grenoble, France

Background and objective Depression is a major public health problem because of its frequency and its economic and psychosocial impact. Previous studies estimate its prevalence around 16% of the population. Said to be effective and well tolerated, antidepressants are more and more prescribed nowadays. Nevertheless, seizure is one of the adverse effects of antidepressant treatment that occurs rarely. We proposed a prospective study to assess the impact of antidepressants prescriptions on seizures appearance.

Design Prospective study.

Setting Grenoble University Hospital; BP 217-38043 Grenoble Cedex 09, France.

Main outcome measures A six-month prospective study was performed in emergency medical service. Patients who came to hospital because of seizure and/or taking antidepressant drug were selected. Medical history, treatment, compliance, alcohol intake, biochemical tests, brain imaging, EEG, and benzodiazepine withdrawal syndrome were investigated.

Results A total of 8813 patients went to emergency medical service over the 6 months period. 296 of them had taken antidepressants. 114 cases of seizure were documented among which 31 were linked to antidepressants. Our findings showed an excess risk of seizure associated with antidepressants (Odds ratio 11.9; 95% confidence interval 7.75–18.25). Furthermore, in our study, seizures were significantly more frequent with tricyclic antidepressant than with Selective Serotonin Reuptake Inhibitors (P < 0.01). Moreover, in most of the cases, antidepressants facilitated seizures in patients with other risk factors such as epileptic patients (who correspond to 45% of convulsing patients with antidepressants), patients taking both antidepressant drugs and agents lowering seizure threshold, and those with predisposing factors such as alcohol intake, benzodiazepine withdrawal, acute renal failure and diabetic decompensation.

Conclusions Therefore, all antidepressant agents can lower the seizure threshold. Tricyclic antidepressants would be more frequently associated with a clinical risk of seizure than newer antidepressants. Clinicians should be cautious when prescribing antidepressant in patients with risk factors such as epilepsy, alcoholism, antipsychotic treatment, and should avoid the prescription of two antidepressant drugs at the same time.

Keywords Antidepressants, Seizures, Prospective study

PEPI-263 Evaluation of the quality of the postoperative pain management in the surgical wards of the North Estonia Regional Hospital.

Julia Zingel 1, Valdo Toome2, Helen Valk2, Jana Lass1

1Pharmacy Department, 2Anaesthesiology Department, North Estonia Regional Hospital, Tallinn, Estonia

Background and objective The treatment of acute pain is important in the postoperative period [1] and the provision of safe and effective pain management is a quality issue that addresses the needs and expectations of patients. The aim of the study was to evaluate the quality of postoperative pain management in surgical wards by assessing the use of analgesics in the postoperative period in terms of adherence to the WHO Good Pain Management (GPM) standards [2].

Design A retrospective audit was carried out on medical records of patients hospitalised onto the surgical wards of North Estonia Regional Hospital (NERH) and had surgery during November 2006.

Setting Postoperative periods (n = 243) within urology, orthopaedic and oncology wards of NERH.

Main outcome measures Percentage (95% confidence interval [CI]) of adherences to quality criteria of pain management in concordance with WHO GPM standards including: assessment of pain, administration of analgesics, prevention/management of analgesic adverse effects, clinically significant interactions.

Results Of the postoperative periods identified (n = 243), pain was measured by numeric rating scale in the wards 27/243 (11% [CI 7.8, 15.7]). The audit was unable to include 117/243 (48% [CI 42.0, 54.4]) postoperative periods due to various reasons including; poor or incomplete documentation in 29/243 (12% [CI 8.5, 16.6]) in the medical records of the oncological surgery ward; day surgery patients constituted 74/243 (31% [CI 25.0, 36.5]) and were excluded since they provided inadequate follow-up opportunity to make assessment and this group needs a special approach. Some 14/126 cases (11% [CI 6.8, 17.8]) had no record of analgesics being administered during the postoperative period and the further evaluation of the quality of pain management was impossible. The following findings indicated issues requiring to be addressed. Of 126 postoperative periods included in the final analysis, analgesics were administered regularly in 59/126 (47% [CI 38.3, 55.5]), analgesics were administered orally in 53/126 (42% [CI 33.3, 50.8]) although 91/126 (72% [CI 63.8, 79.3]) were able to take oral medicines. While 58/126 (46% [CI 37.6, 54.7]) of patients needed drugs for the management or prevention of adverse effects only 46/58 (79% [CI 67.2, 87.7]) of patients received these drugs.

Conclusions The audit results indicate a rather low adherence to established GPM criteria and they have highlighted the need for further study. The audit method requires further development to be able to address problems such as incomplete documentation and shortness of stay. The clinical pharmacist has a role in the prospective evaluation of pain management and a prospective approach would enable direct interaction with prescribers as a means of obtaining more accurate information from prescribers themselves.

References

  1. 1.

    Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth 2001; 87: 62–72

  2. 2.

    WHO Good Pain Management standards http://www.whocancerpain.wisc.edu/eng/19_1/19_1.html Accessed 15.12.2006

Keywords Postoperative pain management, WHO guidelines, Pharmaceutical care

PEPI-268 The adherence of antihypertensive therapy to national guidelines—the experience of primary health care in Serbia

Branka Stojanovic 1, Branislava Miljkovic2, Daliborka Jovanovic3

1Medical Department, Pfizer, 2Pharmacokinetics, Faculty of Pharmacy, University of Belgrade, Belgrade; 3Hospital Pharmacy, General Hospital Jagodina, Jagodina, Serbia

Background and objective Hypertension is one of the most significantly contributing factor to cardiovascular morbidity and mortality. The estimated prevalence of hypertension is 20% (up to 50%) among woman and 25% (up to 60%) among man in developing countries. The prevalence in Serbia is similar (20–25%). Clinical trials of blood pressure lowering have convincingly shown that the risks associated with hypertension can be substantially reduced: stroke, coronary heart diseases and heart failure. The objective of the present study was to compare prescription policy of hypertension treatment with national guidelines and to evaluate the percent of patient with target blood pressure.

Design Prospective study The pool sample included all patients who visited primary health care facilities within the period of 1 month (November 2006). Data needed for evaluation were obtained from the patients medical notes.

Setting Primary Health Care, in Jagodina, Serbia. All (seven) general practice health facilities.

Main outcome measures Demographic data: age, gender, BMI, lipid status, blood pressure, blood sugar, diagnosis (% of patients with hypertension, % of patients with hypertension and % of patients with hypertension and comorbidity), prescribed drug therapy (the most frequent antihypertensive, % of patient on mono/combined antihypertensive drug, % of patients with target blood pressure. Percentage of treatment according to national guidelines (assessed by Drug and therapeutic Committee).

Results Among 2304 patients who have come to visit primary health care facilities there were: male (44%), aged 51(21–89) and female 56%, aged 54(19–87). Hypertension was secondary (after respiratory disease) reason for visiting primary care settings. Among all patients: 32% have had hypertension, 6.5% have had hypertension and diabetes, 5.5% hypertension and coronary heart disease, 2.% hypertension and heart failure, 9% have had hyperlipidemia, 65% have had BMI > 25. The most frequent prescribed antihypertensive was as follows: Ca blockers (52%), diuretics (46%), beta-blockers (25%), ACE Inhibitors (35%). 37% of patients has been on monotherapy, 33% has been on two antihypertensive drugs, 23% on three, and 7% on more than three antihypertensives. Target blood pressure has been achieved in 15% of patients. The percentage of patients treated in accordance with guidelines was 65%.

Conclusions Although, the results indicate the high level of compliance with national guidelines, target blood pressure has been achieved in only 15% of patients, that highlight the importance of patients counseling and need for evaluation of adherence to prescribed therapy.

Reference

  1. 1.

    Arterial Hypertension. National Guidelines for primary health care. Expert commission for National Guidelines, November 2005.

Keywords Hypertension, Guidelines, Primary health care

PEPI-273 Self-medication with antibiotics by the community of AbuDhabi Emirate, United Arab Emirates (UAE)

Abubakr Abasaeed 1, Vlcek Jiri1, Mohammed Abuelkhair2

1Social and Clinical Pharmacy, Faculty of Pharmacy-Charles University, Hradec Kralove, Czech Republic; 2Pharmacy Department, General Authority for Health Services, AbuDhabi, United Arab Emirates

Background and objective Self-medication with antibiotics may increase the risk of inappropriate use and the selection of resistant bacteria. The aim of the study is to estimate the prevalence of self medication with antibiotics in Abu Dhabi.

Design A systematic randomized, descriptive, cross-sectional survey. Designed questionnaire was used to collect data. Data were analyzed using Chi-Square Test.

Setting The survey was conducted from a sample of 1000 visitors to Abu Dhabi International Book Fair.

Main outcome measures Number of visitors using antibiotics within the past year. The association between the educational levels of the visitors and the way they use to obtain and use the antibiotics was measured.

Results Eight hundreds sixty questionnaires were filled (86%) It included 65.8% males and 34.2% females with average age of 36.2 years. Among the 860 visitors, 485(56.3%) reported antibiotics use within the last year. Amoxicillin was the antibiotics most commonly used (46.3%).The survey showed a significant association between the antibiotic’s use and the source (P < 0.001) which is highly significant with the age groups(P < 0.001). 393(45.6%) would consider self-medication with antibiotics without a medical consultation, which significantly affected by the educational levels of the 0.001). 214(24.8%) were storing antibiotics home, that mostly < visitors (P < 0.001)  acquired from the community pharmacies without prescriptions.

Conclusions The results of the study confirmed that antibiotic self-medication is relatively frequent problem in UAE and interventions are required in order to reduce the frequency of antibiotics misuse. Mandatory Health Insurance scheme will play an important role to diminish this problem.

PEPI-322 Analyse of levofloxacin prescription in a general hospital

Benjamin Lagraulet 1, Etienne Cousein1, Nadia Kdouh1, Marie-Agnes Urbina1

1Pharmacy, Ch Valenciennes, Valenciennes, France

Background and objective Promoting antibiotics good use is an essential axis in the struggle against nosocomial infectious diseases. In our establishment, we dispose of a nominative prescription and dispensations system for broad spectrum and/or expensive antibiotic, of which is levofloxacin (LEV). A pharmaceutical analysis of prescriptions were done in order to assess the usage pattern of this molecule.

Design Data were collected during 10 months in 2006, involving 8 medical and chirurgical units.

Setting A 1900 beds hospital in north of France.

Main outcome measures Levofloxacin prescription and agreement with our local recommendations.

Results We analysed 253 files containing levofloxacin prescriptions for 240 patients. There was no bacteriological data for 80% of the files, respiratory disease was the most frequent disease reported and was documented in 13% of the cases.

In that indication, co-prescribed molecules were, among antibiotics under nominative prescription: others fluoroquinolons: 46%, glycopeptides: 19%, penicillins: 19%, cephalosporins: 4%, aminosides: 4%.

When taking into account collected data from units, it is to say antibiotics under global prescription, distribution became: others fluoroquinolons: 23%, glycopeptides: 10%, penicillins: 35%, cephalosporins: 21%, aminosides: 4% (other: 4%).

Among penicillins and cephalosporins there was amoxicillin/clavulanic acid and ceftriaxone or cefotaxime. These 3 molecules were associated to LEV in 25% of the cases, and this association was done at the beginning of the treatment in 21% of files. IV to oral route switch was done in half cases. LEV usage did not depend on the bacteriological documentation, only ciprofloxacin (IV or oral) prescription was related to documentation (P = 0.03).

Conclusions LEV usage is in accordance with local recommendations for respiratory diseases, and is in 75% of the cases in monotherapy. Nevertheless, we underlined an unjustified co-prescription, given the fact that reanimation unit was not included in our study. At last, despite our prescription/dispensation system, it is important to widen our survey to other “non nominatives” molecules, in order to get the whole prescription and to ensure the good use of antibiotics in our hospital.

Keywords Antibiotics, Prescription

PK-160 Correct interpretation of total phenytoin and valproate concentrations in critically ill patients with hypoalbuminemia

Sandrina von Winckelmann1, Ludo Willems 1

1Pharmacy Department, University Hospital Leuven, Leuven, Belgium

Background and objective Theoretically one could assume that in the presence of a low albumin serum level the free drug concentration of highly protein bound drugs is elevated although the total drug serum concentration remains in the therapeutic range. Theoretical formulas and methods for free drug measurements have been developed and applied without consensus on their overall use and clinical relevance. Our case report illustrates this problem and was the onset of an in depth literature review.

Design Case report and literature review.

Setting Medical Intensive Care (MICU), University Hospital Leuven, Belgium.

Main outcome measures Recommendations for a correct interpretation of total phenytoin and valproate concentrations.

Results A 58-year old patient with a complex medical history including peritoneal dialysis developed status epilepticus after surgical repair of a peritoneal leak. He was treated with lorazepam and phenytoin. Valproate was associated as no neurological improvement was seen. Over the next few days an obvious diminished consciousness and rigidity of the four limbs was observed. The neurologists proposed to correct the measured total drug levels of phenytoin and valproate for the patient’s hypoalbuminemia (22.5 g/l) using the Sheiner-Tozer equation (corrected total concentration = observed total concentration/[(0.2 x serum albumin level) + 0.1]) for phenytoin [1] and the equation of Hermida-Tutor(normalized total concentration = free fraction(in accordance with serum albumin of patient) x observed total concentration/6.5) for valproate [2].No free drug serum measurements were available. After calculation the total phenytoin level was 37 instead of 22.2 mg/l which is above the therapeutic range. The corrected total valproate level was 98 instead of 24 mg/l. The symptoms were interpreted as compatible with phenytoin intoxication and phenytoin administration was stopped. Nevertheless there was no improvement of the patient’s neurological state and finally he died.

Conclusions A correct interpretation of total phenytoin and valproate serum concentrations is difficult in the presence of hypoalbuminemia, renal failure and other highly protein bound drugs. In order to avoid unnecessary dose adjustments in a vulnerable population as critically ill patients the above mentioned corrections seem to be worth applying. Nevertheless further research is necessary to evaluate whether these corrected total drug levels are better correlated with toxicity and if this approach should become standard of care in therapeutic drug monitoring of these anti-epileptic drugs.

References

  1. 1.

    ME Winter’s Basic Clinical Pharmacokinetics 3rd edition. Applied Therapeutics, Inc, Vancouver, WA 1994, p. 312–348

  2. 2.

    Hermida J, Tutor JA. Theoretical method for normalizing total serum valproic acid concentration in hypoalbuminemic patients. J Pharmacol Sci 2005;97(4):489–493

Keywords Phenytoin, Valproate, Hypoalbuminemia

PK-165 Evaluation of needs for pharmacokinetic monitoring of gentamicin and vancomycin in tertiary hospital.

Omar Mneimneh 1, Romaldas Maciulaitis1, Birute Varanaviciene2, Gene Tautkuviene3

1Department of Basic and Clinical Pharmacology, 2Department of Pharmacy, 3Laboratory of Clinical Chemistry and Hematology, Kaunas Medical University Hospital, Kaunas, Lithuania

Background and objective Tendencies in Drug Use (DU) of highly toxic drugs-such as Gentamicin (G) and Vancomycin (V) and level of Rational Drug Use (RDU) is unknown in Lithuania. Our goal was to evaluate the first experiences in serum concentration measurements (Sc) of V&G and explore the practicality of using defined daily dose (DDD) in measuring G&V consumption tendencies.

Design DU study based on hospital pharmacy and hospital administrative databases; consumption in DDD per 100 occupied bed daily (100OBD) during 2004–6 and highest consumers of V&G in 2006. Evaluation of all Sc in 2006. Data were processed with SPSS 16.0 using descriptive and comparative statistics for nonparametric values (Mann Whitney test).

Setting Tertiary hospital, 2600 beds.

Main outcome measures Annual consumptions according to DDD/100OBD; intensity of G&V monitoring (as per number of DDDs) and proportions of abnormal Sc.

Results Mean (± SD) DDD/100OBD values of G (240 mg) were 3.67 ± 5.12 (median 1.31; CI 95% 2.32–5.02) in 2004; 4.53 ± 14.86 (median 0.86; CI 95% 0.86–8.20) in 2005, and 4.24 ± 5.88 (median 1.05; CI 95% 2.84–5.64) in 2006. Corresponding values of V (2 g) were 0.55 ± 1.2 (median 0.10; CI 95% 0.22–0.88) in 2004, 0.50 ± 0.96 (median 0.16; CI 95% 0.22–0.78) in 2005, and 0.53 ± 1.07 (median 0.11; CI 95% 0.27–0.80) in 2006. Numerical changes during 3 years period statistically were not significantly different.

Intensity of Sc were 1/84 DDDs for G and 1/1516 DDDs for V. Sc V: 3/28 (11%) too low, 10/28 (36%) normal, and 15/28 (53%) too high; Sc G: 5/17 (30%) too low, 5/17 (30%) normal, and 7/17 (40%) too high.

In 2006 highest consumer of G were General Surgery, Pediatric Surgery, Hematology and Pulmonology-immunology (37.24% of total DU) while for V-Cardiosurgery, Head-brain Surgery, Central reanimation and Cardiology II (40.78% of total DU).

Conclusions Intensity of G and V consumption does not change essentially during last 3 years with clear insufficiency in Sc. 60–70% of improper G&V dosing reveals high need for intensifying Sc starting from highest consumers.

Reference

  • KMUC databases.

Keywords Rationality, Defined daily dose, Occupied bed daily, Intervention, Antimicrobial therapy

PK-193 Therapeutic drug monitoring of everolimus in combination with cyclosporine therapy in cardiac transplant recipients

Aude Jacob1, Alice Richard1, Marie-Catherine Desroches 1, Julie Damasse1, Shaida Varnous2, Christine Fernandez1, Robert Farinotti1

1Laboratory of Therapeutic Drug Monitoring, Pharmacokinetics and Toxicology, Department of Pharmacy, 2Cardiology Department, Pitie Salpetriere Hospital APHP, Paris, France

Background and objective Everolimus is a novel immunosuppressant indicated in combination with cyclosporine for the prevention of cardiac allograft rejection following heart transplantation. The aim of this study is to investigate whether therapeutic drug monitoring (TDM) of everolimus would benefit patients undergoing this treatment.

Design The data analysed included that of 43 patients (30 M/13F) over a period of 9 months recovered in a cardiac transplant and surgery unit.

For each patient: date of transplantation, date of initiation of treatment, daily dose and concomitant medications were recorded by the physician.

Everolimus residual concentration (Co) were monitored in whole blood via a fluorescence polarization immunoassay (FPIA) by TDx/FLx (Abbott) using the Seradyn’s Innofluor Certican Assay by Biomedical Diagnostic.

Setting Department of pharmacy, Pitié-Salpetrière Hospital (GHPS APHP), Paris, France.

Main outcome measures The results are interpreted in correlation with those of cyclosporine (CsA Co) and the recommended therapeutic range for everolimus is 3 to 8 ng/ml.

Results The average daily dose of everolimus is 1.5 ± 0.48 mg (in two divided doses). A total of 315 quantifications were carried out for these patients (0.8 measure/month/patient). The average Co was 6.0 ± 2.7 ng/ml. 26% of measurements were out of the therapeutic range (10% down and 16% up). In 41% of cases, measurements led to dosage modification of one of the immunosuppressive agents. The association with calcium channel blockers (verapamil, nicardipin) which interact with CYP450, Pgp and the progressive decrease of CsA dosage were the main causes of inter-individual variability.

Conclusions The lack of correlation between dosage and Co in the studied population has shown that TDM is essential to adapt treatment because of the inter-individual pharmacokinetic variability and many drug interactions. It allows for the optimisation of immunosuppressive efficacy and the reduction of treatment-related toxicity.

PK-198 Quantification of caspofungin plasma levels in a patient with child b liver cirrhosis.

Isabel Spriet1, Alexander Wilmer2, Ludo Willems 1

1Pharmacy Dpt., 2Medical Intensive Care Unit, University Hospital of Leuven, Leuven, Belgium

Background and objective Caspofungin belongs to a new class of antifungal drugs, the echinocandins, which are frequently used to treat invasive fungal infections caused by Candida and Aspergillus spp. in immunocompromised patients. It is metabolized in the liver independently of the CYP450 system. A reduction of the caspofungin maintenance dose to 35 mg OD is recommended in cases of moderate hepatic dysfunction (Child B).

Design Case report.

Setting Medical Intensive Care Unit, University Hospital of Leuven.

Main outcome measures Quantification and assessment of trough and peak levels of caspofungin in a patient with Child B liver cirrhosis.

Results A 53-year old man with AML was hospitalised for his second course of chemotherapy with cytarabine. On day 21, he was transferred to the MICU because of neutropenic fever and progressive dyspnea due to pneumonia and spontaneous bacterial peritonitis. He was mechanically ventilated and intermittent hemodialysis was started because of acute renal failure. Meropenem 1 g OD was associated for bacteremia with Bacteroides fragilis. A progressively increasing serum Aspergillus antigen test and a CT scan of the chest was compatible with invasive pulmonary aspergillosis for which he was treated with caspofungin 70 mg OD. Last year, a liver biopsy revealed postalcoholic liver cirrhosis, which was classified as Child B9. Upon admission, total bilirubin level was 3.54 mg/dl and AST and ALT were respectively 104 and 140 U/L. As mentioned in the package insert of Cancidas, caspofungin dose should be reduced to 35 mg OD in patients with moderate liver failure due to a substantially higher Cmax and AUC found in this population. However, given the poor prognosis of invasive aspergillosis and good safety profile of caspofungin, it was decided to administer the full dose. Caspofungin plasma levels (trough and peak levels taken on day 13 and 14 of caspofungin therapy) were monitored using HPLC (Agilent Zorbax 300SB-C8 column) followed by UV detection at 215 nm. Trough levels were 3.81 and 3.88 μg/ml, peak levels were 8.01 and 9.07 μg/ml, which are within the expected therapeutic range [1]. Possible explanations for this result are pharmacokinetic alterations caused by critical illness e.g. capillary leak leading to a higher distribution volume or low albumin levels leading to a more rapidly elimination by the kidney or hemodialysis.

Conclusions In critically ill patients with life-threatening invasive fungal infections, benefits and risks of adjusting caspofungin dose in accordance to chronic liver failure have to be carefully considered. Therapeutic drug monitoring can assist in preventing drug related toxicity or underdosing leading to therapeutic failure.

Reference

  1. 1.

    Caspofungin Acetate. FDA Advisory Committee Meeting Background. http://www.fda.gov/ohrms/dockets/ac/01/briefing/3676b1_02.pdf

Keywords Caspofungin, Dose adjustments, Liver cirrhosis

PK-211 Molecular determinants on drug-drug interactions of systemic triazole antifungals

Yasmine Nivoix 1, Dominique Levêque1, Raoul Herbrecht2, Jean-Claude Koffel1, Laurence Beretz1, Geneviève Ubeaud-Sequier1

1Pharmacy, 2Hematology and Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg, France

Background and objective Drug-drug interactions are a common and recurring problem in immunocompromised patients treated with triazole antifungals. While the introduction of new antifungals has expanded opportunities for lowering drug toxicity, virtually all antifungal regimens still carry the risk for pharmacokinetic interaction.

Design This paper presents the published data regarding the molecular determinants (enzymes, transporters, orphan nuclear receptors) of systemic triazole antifungals pharmacokinetics in humans, including itraconazole, fluconazole, voriconazole and posaconazole.

Setting Pharmacy Department.

Main outcome measures Literature review based on PubMed search.

Results All available triazole antifungals are cytochrome P450 substrates to varying degrees, except to the posaconazole which is not metabolized to a significant extent through the cytochrome P450 enzyme system. The limited metabolism of posaconazole is mediated predominantly through phase 2 biotransformations via UDP Glucuronosyltransferase (UGT) enzyme pathways. Nevertheless, all these drugs inhibit CYP3A4. This CYP3A4 inhibition seems to be a class effect of the triazoles and is possibly related to a common mechanisms of action. The systemic azoles are inhibitors of CYP isoenzymes (fluconazole and voriconazole versus CYP2C9, CYP2C19 and CYP3A4, itraconazole and posaconazole versus CYP3A4). Posaconazole does inhibit only CYP3A4, so a limited spectrum of drug-drug interactions could be expected for posaconazole. Some of these drugs also inhibit activity of other enzymes. Then, UGT inhibition has also been demonstrated with fluconazole. Moreover, some of these drugs are also substrates (itraconazole, fluconazole and posaconazole) and/or inhibitor (itraconazole) of P-glycoprotein, a transport protein which can also be involved in drug-drug interactions.

Conclusions The mechanisms of triazole antifungals interactions regarding the molecular determinants can be divided into three following categories: (i) additive dangerous interactions; (ii) modifications of antifungals kinetics by other drugs; and (iii) modifications of other drugs kinetics by antifungals. These features are the basis for most of the interactions occurring during triazole antifungals therapy (e.g., in severe ill patients in the hospital who are treated with multiple drugs) and could contribute to a more effective prediction of interactions.

Keywords Antifungal azoles, CYP450, Drug–drug interactions

PK-246 Bioavailabilities of two ubidecarenone products in korean healthy volunteers

Hyesun Gwak 1, Inkoo Chun2, Kyungso Chun3, Eunyoung Kang1

1College of Pharmacy, Ewha Woman University, 2College of Pharmacy, Dongduk Womens University, 3Department of Laboratory Medicine, Hanil Hospital, Seoul, South Korea

Background and objective To evaluate the bioavailabilities of two ubidecarenone (CoQ10) products using healthy volunteers, which are being marketed in Korea, and compare them with their dissolution profiles.

Design Parallel study design for pharmacokinetic study and repeated ANOVA test for comparing the intrinsic CoQ10 levels for 3 days between groups.

Setting Department of Laboratory Medicine in a Korean Hospital.

Main outcome measures Pharmacokinetic parameters and dissolution profiles of two CoQ10 products by a validated analytical method.

Results Chromatographic peaks of CoQ10 and IS were well-resolved at 6.8 and 5.3 min. The relation between CoQ10 concentrations and peak height ratio of CoQ10 to IS was linear from 50 to 4000 ng/ml (y = 0.6723x + 0.0192, r 2 = 0.9997). The intra- and inter-day RSD (%) was within 7.8% and the accuracy ranged between 85.8% and 108.2% including the limit of quantitation of 50 ng/ml. The extraction recovery of CoQ10 at concentrations of 200 and 2000 ng/ml was 98.2 ± 7.9 and 99.8 ± 6.4%, respectively, while for IS at concentration of 2000 ng/ml it was 105.2 ± 3.1%. The dissolution rates of product A and B after 3 hr were 0.35 ± 0.09% and 1.27 ± 0.16%, respectively. The intrinsic CoQ10 concentrations were ranged between 0.68 and 0.79, and there was no statistically significant difference between groups. From the adjusted concentration-time curve by subtracting mean individual level of intrinsic CoQ10 from individual CoQ10 concentration assayed after administration of products, the AUC, Cmax, and Tmax were calculated to be 11.51 ± 5.76 μg h/ml, 0.32 ± 0.1 μg/ml and 7.9 hr in Group B, respectively, while in Group A the plasma concentration after administration of CoQ10 was not higher than intrinsic level indicating that there was no significant drug absorption occurred.

Conclusions There were significantly different pharmacokinetic characteristics found according to pharmaceutical products of CoQ10 and dissolution rate was considered as one of the main factors affecting CoQ10 bioavailability.

References

  • Tang PH, Miles MV, et al. HPLC analysis of reduced and oxidized coenzyme Q10 in human plasma. Clin Chem 2001;47:256–265.

  • Chopra RK, Goldman R, et al. Relative bioavailbility of coenzyme Q10 formulations in human subjects. Int J Vitam Nutr Res 1998;68:109–113.

Keywords Ubidecarenone, CoQ10, Bioavailability, Dissolution rate

PK-251 No effect of gender on carbamazepine elimination—population approach

Katarina Vucicevic1, Branislava Miljkovic 1, Marija Petronijevic1, Milena Pokrajac1, Ruzica Velickovic2, Ales Mrhar3, Iztok Grabnar3

1Department of Pharmacokinetics, Faculty of Pharmacy, University of Belgrade, 2Institute of Mental Health, Belgrade, Serbia; 3Faculty of Pharmacy, University of Ljubljana, Ljubljana, Slovenia

Background and objective Cytochrome P450 (CYP 450) metabolize carbamazepine (CBZ) via 3A4 (predominant pathway), 1A2 and 2C8 (minor pathways) isoenzymes. One of the possible factors that can contribute to interindividual variability in response to an administered drug is patients’ gender. Gender differences in drug-metabolizing enzymes have been observed for CYP 1A2, 2D6 and 3A isoenzymes activity but these data are controversial. Therefore, the objective of this study was to describe the possible effect of gender on the CBZ elimination.

Design In total 379 epileptic outpatients’ data were retrospectively collected (2 years period) from routine therapeutic drug monitoring. Patients were on mono or polytherapy, and 1–2 concentrations per patient were available. In the modelling building set, there was practically equal presence of male and female patients (50.9–49.1%). The pharmacokinetic analysis was carried out by a population modelling approach using software NONMEM (Version V, level 1.1, GloboMax LLC, USA) and Visual-NM (Version V, R.D.P·P., France) assuming a one-compartmental model with first-order absorption and elimination. The first order method (FO) was used for the estimation.

Setting The study was conducted at the Institute of Mental Health, Belgrade, Faculty of Pharmacy University of Belgrade, Faculty of Pharmacy University of Ljubljana.

Main outcome measures Demographic characteristics: weight, age, gender, smoking status, information on allergy, biochemical parameters, CBZ tablets formulation, dosing regimen, schedule of blood sampling, concentrations and concomitant therapy were collected for the population included in the study.

Results Interindividual variability of CBZ clearance (CL/F) was best described by exponential error model, while additive error model most adequately characterized residual variability in CBZ concentration. Effect of patient’s gender (GEN) as categorical covariates (where GEN is 0 = male, 1 = female) was described by the following model: TVCL = THETA(1)*(THETA(2))**GEN; resulting THETA(1) = 4.44 (3.89–4.99) and THETA(2) = 1.13 (0.92–1.34), while OBJ decreased 3.494.

Conclusions In the present study, inclusion of patient’s gender in the base model did not significantly improve data fitting. Hence, the results showed that patients’ gender is not the reason for interindividual variability of CBZ elimination.

Keywords Carbamazepine, Gender, Population pharmacokinetics, NONMEM

PT-9 Review of erythropoietin usage for treatment of chronic renal failure-associated anaemia in a Singapore hospital

Ian Wee 1, Xinyu Yap2

1Department of Pharmacy, Changi General Hospital, 2Department of Biosciences, Temasek Polytechnic, Singapore, Singapore

Background and objective To: (1) examine the usage and prescribing patterns of recombinant human erythropoietin (rhEPO) in Changi General Hospital, and (2) assess the efficacy of rhEPO in increasing haemoglobin (Hb) and haematocrit (Hct) levels in patients with chronic renal failure (CRF).

Design One-year retrospective review of case notes of all patients (aged 18 years and older) with CRF who received rhEPO during a hospital admission lasting 1 week or longer.

Setting Large, secondary teaching hospital.

Main outcome measures Patient demographics; choice and dosing regimen of rhEPO; changes in Hb and Hct levels between baseline and 3 months later; nature and incidence of adverse effects.

Results Of 104 patients identified as recipients of rhEPO in the 1-year study period, 63 (average age 68.3 ± 14.3 years) fit the inclusion criteria for evaluation. Approximately two-thirds of the patients were admitted for fluid overload secondary to CRF. Their average length of stay was 22.1 ± 24.9 days (range: 7–56 days) during which the patients received an average of 4.7 ± 6.6 doses of rhEPO. However, at admission, 8 patients (12.7%) were not receiving rhEPO while a further 37 patients (58.7%) were found to have not received or were receiving inadequate iron supplementation (i.e., <200 mg/day of elemental iron) despite being regular recipients of rhEPO. The majority of patients received subcutaneous EPO-beta at a median dose of 4000 units/week. Mean increases in Hb and Hct levels between baseline and end of the study period were 0.5 ± 1.3 g/dl and 1.3 ± 2.1%, respectively. Only 2 patients (3.2%) were found to have achieved Hb and Hct levels of 11–12 g/dl and 33–36%, respectively. No major adverse effects were detected amongst rhEPO.

Conclusions Recombinant human erythropoietin appeared to modestly increase the Hb and HCt in patients with CRF-associated anaemia. However, in order to achieve desired levels of Hb and Hct in this group of patients, it will be necessary to increase the average doses of rhEPO and iron supplements.

Keywords Erythropoietin, Review, Chronic renal failure

PT-22 Characterization of proton inhibitors, omeprazole, lansoprazole and rabeprazole by monitoring bioactive peptides

Masaharu Takeyama 1, Fumihiko Katagiri1, Hiroki Itoh1

1Department of Pharmacy, Oita University Hospital, Oita, Japan

Background and objective Proton pump inhibitors (PPIs), widely used in the treatment of gastric and duodenal ulcer, gastroesophageal reflux disease and the Zollinger-Ellison syndrome, have not only gastric antisecretory but also mucosal protective actions. Except for inhibition of gastric acid secretion, the mechanism is not well understood. So we examined the effects of three PPIs (omeprazole (OME), lansoprazole (LAN) and rabeprazole (RAB)) on plasma levels of gastrin, somatostatin, motilin, vasoactive intestinal peptide (VIP), substance P and calcitonine gene-related peptide (CGRP).

Design OME (20 mg), LAN (30 mg), RAB (20 mg) or placebo was orally administered in five healthy male volunteers aged 25–30 years. Venous blood samples were taken before and after administration. Comparison of the mean peptide levels in plasma was made by analysis of variance.

Setting Department of pharmacy, Oita university hospital.

Main outcome measures Plasma peptide levels were measured by using a sensitive enzyme immunoassay developed by us.

Results OME caused significant (P < 0.05) increase in somatostatin-immunoreactive substance (IS) and motilin-IS at 60–240 min, and 120–180 min compared with the response of the placebo, respectively. OME significantly suppressed temporary elevation (30 min) of placebo gastrin-IS levels. OME had no effect on plasma VIP-IS, substance P-IS and CGRP-IS levels compared with the placebo. Compared with the placebo, LAN caused significant increase in somatostatin-IS, VIP-IS, substance P-IS and CGRP-IS at 120 min, 120 min, 90–240 min and 120 min, respectively. Similarly to OME, LAN significantly inhibited temporary elevation of placebo gastrin-IS levels. LAN had no effect on plasma motilin-IS levels. Single oral administration of RAB caused significant increase of gastrin-IS at 360 min and significantly decrease of motilin-IS at 180 min, but did not alter the other peptides.

Conclusions Somatostatin is known that it not only inhibits other hormone release but also regulates gastric motility in the stomach and stimulates peristalsis in the intestine (1). Both of CGRP and substance P are vasoactive substances, which are released from the sensory afferent nerve endings against gastric mucosal injury in the stomach (2). Considering the result, we hypothesized that except for potent gastric antisecretory, OME might promote peristaltic reflex that might be useful to treat constipation, LAN might have gastro protective effect by increase of mucosal blood flow.

References

  1. 1.

    Grider J. R. (2003) Neurotransmitters mediating the intestinal peristaltic reflex in the mouse. J Pharmacol Exp Ther. 307, 460–467.

  2. 2.

    Holzer P. (1998) Neural emergency system in the stomach. Gastroenterology 114, 823–839.

Keywords Proton pump inhibitor, Mucosal protective neuropeptide, Gut-regulatory peptide

PT-24 Use of complementary and alternative medicine in association with conventional therapy in patients affected by multiple sclerosis

Adele Gallo 1, Maria Rita Badagliacca1, Antonella Pieratti2, Achille P. Caputi2, Gioacchino Calapai2

1Department of Pharmacy, Clinical Pharmacy Azienda USL2, Caltanissetta, 2Department of Clinical and Experimental Medicine and Pharmacology, University of Messina, Messina, Italy

Background and objective Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system, its etiology is not known and the immunitary system plays an important pathogenetic role. Substantial evidences show that people affected by sclerosis multiple are treated with complementary and alternative therapies in association with conventional therapy (medicines-CAM)in order to improve health conditions according to the symptoms of the disease [1, 2].

Design The survey is conducted through a questionnaire containing several questions on the kind of CAM and/or substances used, rationale for use, communication with doctors, perceived effectiveness and changes in relapses or remissions.

Setting All the subjects interviewed were treated with the licensed drugs for the therapy of multiple sclerosis interferon beta 1a, interferon beta 1b or glatiramer. Here we show results of 73 patients. Women were 75% of the sample.

Main outcome measures The aim is that to evaluate the prevalence and the way of the use of complementary and alternative medicines, and in particular of herbal remedies in human beings with relapsing/remitting multiple sclerosis treated with conventional therapy, we are conducting a survey on a sample of sicilian people (Italy) affected by this disease.

Results Results of the study point out that about 52% (29F 11 M) of patients of the sample were treated with herbal remedies for the basic pathology or for related symptoms. The average age is 36 years (range 19–55) with this qualification: diploma middle school 29%, diploma high school 32%, diploma university 24%, university students 16%. Many patients use more CAM. Herbal remedies by 50%, vitamins were used by 42%, massage by 39.5%, homeopathy by 31.6%, Minerals by 15.8%, special diets and fatty acids by 13.15%. Bach Flowers by 13.2%. More cited plants were: escholtzia, aloe, echinacea. A good effectiveness was perceived by 79% of CAM users. A conscious analysis shows the existence of incongruences and some of herbal remedies used could counteract the activity of conventional therapy. About 77% of patients don’t inform in a complete form his doctor about alternative products used.

Conclusions These data confirm that CAM are widely used by patients with multiple sclerosis in association with conventional therapy and that this kind of medication needs attention by specialists through more complete communication with patients.

References

  1. 1.

    Shinto L. et al., Complementary and alternative medicine in multiple sclerosis: survey of licensed naturopaths. J Altern Complement Med. 2004;10:891–7.

  2. 2.

    Page SA., et al., The use of complementary and alternative therapies by people with multiple sclerosis. Chronic Dis Can. 2003;24:75–9.

Keywords SM, CAM

PT-29 Development, implementation and assessment of the guideline for treatment of postoperative pain in the orthopaedic ward of the North Estonia Regional Hospital

Jana Lass 1, Helen Valk2, Valdo Toome2, Aleksei Baburin3, Toomas Marandi4

1Pharmacy, North Estonia Regional Hospital, Queens University Belfast, 2Anaesthesiology Department, North Estonia Regional Hospital, 3Department of Epidemiology and Biostatistics, National Institute for Health Development, 4Quality Department, North Estonia Regional Hospital, Tallinn, Estonia

Background and objective To develop a guideline for the treatment of postoperative pain in the orthopaedic wards, implement it into the routine clinical practice to increase the quality of pain management and measure prospectively and comparatively the quality of pain management as assessed by patients and influence of the guideline on the drug utilisation parameters.

Design Prospective, controlled single-blind interventional study. The quality of pain management in the control and intervention wards was measured at baseline (pre-intervention period) and as an outcome assessed at follow up (after implementation of the guideline). Treatment in the intervention ward in the post-intervention period was based on the guideline, treatment in the control ward was performed according to the current clinical practice.

Pain scores were compared by Mann–Whitney U-test and linear regression analysis. Chi-square test was used to compare the categorical data.

Setting Orthopaedic wards of North Estonia Regional Hospital.

Main outcome measures Primary endpoint Mean reported pain intensity as measured by numeric rating scale (NRS 0–10).

Secondary endpoints Proportion of patients with NRS pain intensity score <3.

Change in the utilisation and selection of analgesic drugs.

Results 206 patients with elective orthopaedic procedures (102 in control group, 104 in intervention group) were included into analyse.

Average pain intensity decreased in the intervention ward after the implementation of the guideline (4.8 (2.5)–3.8 (2.1) P = 0.032 vs. control ward 4.5 (2.5)–4.8 (2.3) P = 0.509). Number of patients with NRS scores <3 increased in the intervention ward after implementation of the guideline. According to the adjusted regression analysis the changes between the pre- and post-intervention mean pain intensities were larger and more positively directed in the intervention group.

The proportion of intramuscular (im) and peroral (po) analgesics changed in the intervention group after implementation of the guideline (65% of analgesics were administered im at pre-intervention period, 5% at the post-intervention period).

Conclusions There is a positive effect of postoperative pain treatment guidelines on the quality of pain management, measured as a decrease in pain intensity and improvement of analgesics prescription patterns. Still the effect of the guideline on the intensity of pain seen in the study can be considered modest.

The impact was seen more clearly in the selection and use of analgesics than changes in the intensity of pain.

References

  1. 1.

    Dolin, S.J., Cashman, J.N., Bland, J.M. (2002) Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anesthesia 89 (suppl 3) 409–423.

  2. 2.

    JCAHO (2005). Pain management standards for hospitals. www.jcaho.org accessed 08.05.2006.

Keywords Postoperative analgesia, Acute pain, Clinical guidelines

PT-34 Substrate reduction therapy in patients with mild-to-moderate type i gaucher disease

Cristina Vicente 1, Mª Jose Agustin1, Herminia Navarro1, Estibaliz Picaza1, Mercedes Arenere1, Angela Idoipe1

1Pharmacy Service, University Hospital Miguel Servet, Zaragoza, Spain

Background and objective To study the use, effectiveness and safety of miglustat in patients with mild-to-moderate type I Gaucher disease.

Design Retrospective review of patient records in treatment with miglustat during 2004–2005.

Setting Pharmacy service of a 1300-bed tertiary-care hospital.

Main outcome measures Platelet count, chitotriosidase activity, adverse effects, marrow infiltrates and liver and spleen organ volumes.

Results 3 patients (100% female) have received miglustat 100 mg/8 h.

Patient 1: diagnosed at age of 19 of TIGD and were subjected to splenectomy at the same age.

  • At the age of 51 she initiated treatment due to hepatomegaly, thrombocytopenia, moderate anaemia and extensive marrow infiltrate.

  • After a year of treatment:·pathological marrow infiltrate decreased.

    • chitotriosidase activity diminished from 5870 to 4435 nM/ml.h

    • platelet count increased 120 to 136.103 /mcl.

  • Adverse effects: at the beginning reported transient loss of weight and diarrhoea that resolved spontaneously.

Patient 2: diagnosed at 59 years old by thrombocytopenia. She hasn’t been subjected to splenectomy.

  • The oral treatment began when she was 61 years old.

  • At 10 months (last dates of assessment of treatment) improves of disease:

    • chitotriosidase activity decreased from 4443 to 3507 nM/ml h.

    • platelet count increased from 73 to 113.103 /mcl.

  • As adverse effects she only reported a slight tremor.

Patient 3: diagnosed at the age of 53 by a big hepatomegaly and subjected to splenectomy at 55.

  • At the age of 68, she began treatment due to extensive marrow infiltrates.

  • After a year of treatment: improvement in marrow infiltrates.

    • reduction of chitotriosidase activity from 11791 to 7453 nM/ml h.

    • haematological and visceral parameters stable.

  • Adverse effects: at first, loss of weight (6 kg).

    • constipation and abdominal distension.

    • at 10 months, tremor.

    • at 6 months, paraesthesias in fingers and that still stays.

Conclusions The oral treatment with miglustat appears to be effective and well tolerated in patients studied with mild-to-moderate TIGD, all the patients have improved.

  • the most frequent adverse effects have been gastrointestinal and loss of weight.

Keywords Gaucher disease, Miglustat, Drug’s use

PT-43 Procaine stability in injectable solution (CP1B), a hospital preparation used in cardioplegia.

Melissa Benmeziani 1, My Dung Le Hoang1, Yasmine Ait Yahia1, Herve Graffard1, Dominique Pradeau1, Bernard Do1

1Analytical Development Laboratory, AGEPS, Paris, France

Background and objective CP1B, a hospital preparation, is an aqueous sterile solution containing procaine (10 mmol l−1) used in heart surgery to induce a heart arrest. It is the only formulation which provides procaine as an injectable solution. During the manufacturing process, ampoules are sterilized by autoclaving. It is known that heat accelerates procaine hydrolysis in para-amino-benzoic acid (PABA), the main degradation product, and diaminoethanol.

Therefore, this work intends to study procaine stability after autoclaving and in a long-term storage. It consists in quantifying procaine after autoclaving and identifying its potential degradation products.

Design First, a long-term stability study was performed on sterilized ampoules, stored at 25°C and analyzed after 4, 10 and 18 months. Second, stress testing was conducted by studying the influence of light, temperature and oxidative agent on CP1B in order to clarify the degradation pathways.

Setting This study takes place in the public pharmaceutical establishment of Paris Hospitals.

Main outcome measures Procaine was quantified by HPLC-UV. Impurities detected after autoclaving and those generated under stress conditions were analyzed by HPLC-UV-MS and HPLC-UV-MS².

The analytical methods for the quantification of procaine and PABA were validated in compliance with ICH guidelines.

Results After autoclaving, a slight yellowing of the solution is observed and only PABA is detected (about 10%).

In a long-term storage, an intensification of the colour is noticed. Chromophoric impurities are detected and could be responsible of this event.

Under stress conditions, the most influent parameter inducing the detection of the latter impurities is the oxidative agent. Besides, temperature seems to accelerate the degradation reaction kinetic.

While PABA rate remains stable during time, a yellowing is observed. This event may be correlated to chromophoric impurities which could derive from procaine oxidation.

Conclusions The drug shelf-date must be limited to reduce the amount of degradation impurities. Furthermore, the manufacturing process has to be modified. First, nitrogen gas may be used in order to inert the solution and limit oxidation. Second, another unheated way of sterilization should be used, aseptic filtration for example, in order to slow down procaine degradation.

Reference

  • Ph Galais, C. Dauphin, D. Pradeau, A. Chevallier-Assay of para-aminobenzoic acid formed by hydrolysis of procaine in CP1B solution Chromatographia, 2000 (52), p. 115–119.

Keywords Procaine, Stability, Cardioplegia

PT-53 Iatrogenic acute digoxin intoxications in the emergency room. three case reports.

Meritxell Pujal 1, Dolors Soy1, Santi Nogué2, Miquel Sánchez3

1Pharmacy Service, 2Clinical Toxicology Department, 3Emergency Department, Hospital Clínic, Barcelona, Spain

Background and objective International guidelines recommend digoxin IV administration for treatment of atrial fibrilation (AF) in heart failure patients. Digoxin shows a long elimination half-life, thus a loading dose regimen is required to achieve early therapeutic blood concentrations (0.8–2 ng/ml) [1, 2].

We aimed to report 3 clinical cases of iatrogenic acute digoxin intoxication.

Design Case reports.

Setting Geriatric patients. Emergency Room (ER). University Hospital.

Main outcome measures Patient demographics, clinical records, creatinine clearance (Cockcroft-Gault: CrCLCG), kalemia, digoxin dosage and blood concentrations.

Results Three women (90, 83 and 82 years-old) were diagnosed of AF with high ventricular frequency in the ER and were treated with a digoxin loading regimen. Nausea, vomiting and bradycardia were observed in all cases while digoxin blood concentrations were >2.5 ng/ml.

  • Case 1: The digoxin dose prescribed was 1.25 mg as follows: 0.5, 0.25, 0.25, 0.25 mg, 6 h apart. The CrCLCG was 44.3 ml/min and the digoxin blood concentrations at 5, 9 and 17 h after the last dose were 11.96, 6.95 and 5.7 ng/ml, respectively.

  • Case 2: The digoxin dose administered was 1 mg divided in 3 administrations every 6 h (0.5, 0.25, 0.25 mg). The CrCLCG was 38.7 ml/min and the digoxin blood concentrations at 5 and 14 h after the last administration were 3.49 and 2.93 ng/ml, respectively.

  • Case 3: The digoxin dose administered was 0.75 mg divided in two doses 6 h apart (0.5, 0.25 mg). The CrCLCG was 19.8 ml/min attributable to chronic renal failure and the digoxin blood concentrations 14 h after the last dose was 4.61 ng/ml.

Kalemia was normal in all cases (5.1, 4.5 and 4.5 mEq/l), respectively.

The three patients presented satisfactory clinical outcome after IV hydration, electrolyte correction and symptomatic support. It is noteworthy to point out that case 3 presented life-threatening manifestations and required digoxin-specific antibody fragments due to the lack of response to the conventional treatment.

Conclusions These 3 case reports demonstrate that the risk of digoxin intoxication is increased if the digoxin loading regimen is not adjusted based on CrCL in geriatric patients with moderate-severe renal failure. Based on these results, new guidelines regarding digoxin loading dosage according to the patient renal function are being developed in our Institution by a multidisciplinary team.

References

  1. 1.

    ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines. J Am Coll Cardiol. 2006; 48(4):854–906.

  2. 2.

    Evans WE, Schentag JJ, Jusko WJ. Applied pharmacokinetics: principles of therapeutic drug monitoring, 3rd Edition. Vancouver, Applied Therapeutics, Inc. 1992.

Keywords Digoxin, Drug overdose, Adverse effects, Pharmacokinetics, Geriatric patients

PT-54 Oxidative stress does not contribute to aspirin resistance in coronary disease patients

Chantal Pharand 1, Marie Lordkipanidzé1, Donald A. Palisaitis1, Jacques Turgeon2, Erick Schampaert1, Jean G. Diodati1

1Research Center, Hôpital du Sacré-Coeur de Montréal, 2Faculty of Pharmacy, Université de Montréal, Montreal, Canada

Background and objective To evaluate whether pre-selected demographic, hematological or biochemical parameters, particularly oxidative stress, are associated with the presence of aspirin resistance in patients with stable coronary artery disease chronically treated with aspirin.

Design Prospective observational study.

Setting Outpatient cardiology clinic.

Main outcome measures Platelet aggregation was measured by optical aggregometry after stimulation of platelet rich plasma with 1.6 mM of arachidonic acid. Resistance was defined as residual platelet aggregation ≥20%. Blood samples were used for routine clinical testing and morning urinary samples were tested for isoprostanes (8-iso-PGF2α), using an enzyme immunoassay.

Results Of the 201 coronary artery disease subjects tested, 8 were aspirin resistant. They presented higher platelet counts (318 ± 73 vs. 224 ± 53, 109/l, P < 0.0001) and lower daily aspirin dose (80 ± 0 vs. 187 ± 145 mg daily, P = 0.04) when compared to aspirin sensitive subjects, suggesting that platelet turnover was increased and aspirin dosage was sub-optimal. Levels of C-reactive protein (CRP, 5.4 ± 3.3 vs. 3.5 ± 2.7 mg/ml, P = 0.07) were also higher in resistant patients, suggesting an underlying inflammatory process. However, oxidative stress levels, as measured by urinary 8-iso-PGF2alpha concentrations, were similar between aspirin-resistant and sensitive subjects (86.4 ± 33.4 vs. 81.4 ± 72.9 ng/mmol of creatinine, P = 0.85). In a simple univariate logistic regression model, the following factors were found to be predictive of aspirin resistance (P < 0.1): alcohol use, platelet count, CRP level; while prior revascularization was protective. However, only platelet count remained significant in a multiple logistic regression model (P = 0.002).

Conclusions Isoprostane formation, a marker of oxidative stress, does not appear to contribute to aspirin resistance in stable coronary artery disease patients; however, increased platelet counts, possibly via increased platelet turnover, may do so. Future research should evaluate whether increasing aspirin administration to twice daily would counteract apparent platelet resistance to aspirin.

Keywords Aspirin, Resistance, Isoprostane

PT-64 Effect of four different clopidogrel doses given before PCI on platelet function

Chantal Pharand 1, Thuy Anh Nguyen2, Marie Lordkipanidzé1, Donald A. Palisaitis1, Jacques Turgeon3, Erick Schampaert1, Jean G. Diodati1

1Research Center, 2Pharmacy Department, Hopital du Sacré-Coeur de Montréal, 3Faculty of Pharmacy, Université de Montréal, Montréal, Canada

Background and objective Effective platelet inhibition at the time of percutaneous coronary intervention (PCI) reduces the risk of periprocedural thrombosis. In patients with stable angina who undergo elective PCI, the issue of optimal loading dose and timing of clopidogrel administration remains controversial. We evaluated the effect of four different dosing regimens of clopidogrel on platelet aggregation in patients undergoing elective coronary angiography ± PCI.

Design One hundred and twenty patients were prospectively randomized in a double-blind, placebo-controlled fashion to one of four clopidogrel dosing regimens 1 week prior to the procedure (A-300 mg or B-600 mg on the day prior to the intervention, C-300 mg followed by 75 mg daily started 1 week before, D-300 mg followed by 150 mg daily started 1 week before).

Setting Outpatient investigation clinic and Catheterization Laboratory.

Main outcome measures Platelet function was assessed at baseline, at the time of diagnostic coronary angiography, and 2 h after stenting (when applicable) by optical aggregometry (LTA), using platelet rich plasma stimulated with adenosine disphosphate 20 μM.

Results All regimens significantly reduced platelet aggregation at the time of angiography, as well as 2 h following stenting when compared to baseline (P < 0.0001). Regimen D showed the greatest inhibition of platelet aggregation, while Regimen A resulted in the least inhibition, an absolute difference of 30% at the time of angiography (P = 0.007), which increased to 36% 2 h post-stenting (P = 0.007).

Conclusions In choosing a clopidogrel regimen, it is important to effectively inhibit platelet aggregation and block the surge in platelet activity induced by PCI. The 300 mg bolus and 150 mg daily regimen seemed most effective in achieving and maintaining such a level of platelet inhibition.

Keywords Clopidogrel, Percutaneous coronary intervention, Platelet aggregation

PT-75 Aerosolized cidofovir: a new therapeutic alternative?

Vanida Brunie1, Mélanie Paysant1, Sandrine Roy 1, Caroline Monchaud2, Natacha Teissier3, Francoise Brion1

1Pharmacy, 2Pharmacology, 3Otorhinolaryngology, Robert Debré, Paris, France

Background and objective Human papilloma virus can cause recurrent respiratory papillomatosis that can degenerate in pulmonary metastasis (PM) and eventually, death. The gold standard treatment is intravenous cidofovir. However, its principal adverse effect is tubular nephropathy.

Design Case report. Evaluation of pulmonary and renal tolerance of aerosolized cidofovir. Plasmatic and urinary pharmacokinetics of cidofovir.

Setting Otorhinolaryngology department.

A ten-year-old female was diagnosed with distal tracheal papillomatosis, and treated by cidofovir local injection. Later, PM was discovered and the treatment was switched to continuous infusion of cidofovir. Despite concomitant administration of probenecid, a renal protector, she developped a major tubular nephropathy and intravenous cidofovir had to be stopped.

Main outcome measures Measure of pH and osmolarity of cidofovir’s solution, follow-up of creatinine level, proteinuria and glycosuria, plasmatic and urinary cidofovir levels.

Results Administration of aerosolized cidofovir was started at 1 mg/kg every 2 weeks [1, 2]. Cidofovir inhalation tolerability was confirmed by measuring pH and osmolarity of the solution, respectively 7.4 and 313 mOsm/l. Renal function was monitored by creatinine levels (68–76 mmol/l) and research of proteinuria (0.13–0.14 g/l) and glycosuria (0.3–0.6 mmol/l) in order to confirm tolerance of the medication. Plasmatic and urinary cidofovir levels allowed to evaluate the drug passage into the blood and to stop probenecid administration, if possible, as she suffered from important vomiting when she received it. Cidofovir plasmatic concentration was undetectable, whereas 25% of the inhaled dose was found unchanged in the 12-h urinary sample. These results confirmed the passage of inhaled cidofovir into the blood and its early renal elimination. To date, renal toxicity has never been observed when cidofovir is administered IV at 1 mg/kg [3]. Based on this information, oral adjuvant probenecid was stopped. This was benefic to the patient’s compliance, because stopping oral probenecid prevented her from vomiting.

Conclusions A CT-scan is carried out every month to assess treatment efficiency. If no improvement is noticed, cidofovir dosage may be increased up to 5 mg/kg every week, but probenecid would have to be reintroduced, given the absence of data on potential renal failure.

References

  1. 1.

    M. Bray et al., Antivir Res, 2002; 54: 129.

  2. 2.

    C.J. Roy et al., Antimicrob Agents Chemother, 2003; 47: 2933.

  3. 3.

    Vidal 2006

Keywords Aerosolized cidofovir, Recurrent respiratory papillomatosis

PT-90 Evaluation of quality of medication use in chronic obstructive pulmonary disease (COPD): development and validation of an audit tool

Pei Se Wong 1, Frida Eliasson2, Lorraine Perry2, Richard L. C. Loh3, Stephen Hudson2

1Department of Pharmacy, International Medical University, Kuala Lumpur, Malaysia; 2Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom; 3Department of Medicine, International Medical University, Kuala Lumpur, Malaysia

Background and objective To design and validate audit tools for evaluation of medication use in chronic obstructive pulmonary disease patients for international comparison.

Design Literature appraisal and questionnaire design using group interviews among respiratory specialists. Retrospective case note survey to field test the application of the tool in hospitalised patients with COPD (n = 13) and Malaysian hospital outpatient records (n = 50).

Setting Respiratory pharmacists and physicians at two separate research group sites—in Scotland, UK and in Negeri Seremban, Malaysia.

Main outcome measures Qualifying statements and standards within the criteria of audit tools proposed for separate use in the UK and Malaysian settings. Quantified levels of applicability and adherence to proposed audit tool criteria during the field-testing.

Results Twenty-two criteria for potential inclusion in the audit tools were identified by literature search and initial systematic appraisal of NICE guidelines 1 and GOLD guidelines 2. Criteria were grouped under seven sections in the tool addressing general care, smoking cessation, inhaled bronchodilator, combination therapy, corticosteroids, specific conditions, and patient educational needs. After the group interviews and field testing a 24 item tool was derived for use in Malaysia (after thirteen criteria were retained, four removed, nine added and two modified). A 31 item tool was derived for use in the UK which, compared with the Malaysian tool, had ten removed criteria, seventeen additional and three modified. A set of eleven criteria were common to both UK and Malaysian tools.

Conclusions The audit tools are ready for application in a study to investigate international comparisons in asthma management and to help target pharmacy services in guideline implementation.

References

  1. 1.

    National Institute for Clinical Excellence (NICE). Clinical Guideline 12: Chronic obstructive pulmonary disease management of chronic obstructive pulmonary disease in adults in primary and secondary care. 2004.

  2. 2.

    Global initiative for chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease 2005.

Keywords Asthma, Guidelines, Management

PT-92 Off-label use of proton pump inhibitors: impact of hospital stays on prescribing

Emilie Moreau1, Sébastien Magne1, Christelle Deveaux1, Vanessa Demontoux1, Juliette Petitcolot1, Isabelle Tersen1, Yvonnick Bezie 1

1Pharmacy, Hopital Saint-Joseph, Paris, France

Background and objective There is growing concern with the rapid increase in prescribing proton pump inhibitor drugs (PPIs) for a variety of gastrointestinal disorders, and the escalating costs associated with this trend. Our aim was to examine the use of PPIs in patients at our hospital to determine the appropriateness of the therapy according to published guidelines and to explore how PPIs prescribing changes following hospitalisation.

Design The appropriateness of prescription and relevant investigations were identified by interview of patients with a pre-filled questionnaire and review of patient records. Data were collected during a period of 6 months.

Setting 450-bed metropolitan general private hospital.

Main outcome measures

Indications and duration of PPIs therapy.

Results The 56 patients (26 men and 46 women) had a mean age of 67 years old on average [27–97 years]. Among these patients, 58 were already treated by PPIs before hospitalisation. These treatments were mainly prescribed by GPs (n = 21), gastroenterologists (n = 14) and rheumatologists (n = 8). The median duration of PPIs therapy for patients already receiving one of the drugs was 27 months, 40% of them treated for more than a year. The prescribing of PPIs satisfied the approved indications in only 18 cases. Indeed, prevention of gastritis were made without suspicion of infection with helicobacter pylori. 21 of 25 prescriptions of PPIs for prevention of digestive toxicity of NSAID or mild/moderate oesophagitis concerned patients without risk factor (age < in 65 years and/or any gastric ulcer antecedent). Patients treated with weak daily dosage of aspirin or coxibe benefited also of a useless prevention of digestive toxicity by IPP. New treatments established in the hospital aimed to treat gastric ulcer, but only one 1 patient on 12 PPI treatments established had undergone endoscopy. No treatment by PPI was stopped during hospitalisation.

Conclusions Our data indicated widespread use of PPIs outside current prescribing guidelines and not modified or stopped during hospitalisation. This poses economic and safety concerns, particularly in light of the suggestion that these drugs could delay the diagnosis of gastric cancer. These results have increased pharmaceutical implication about that concern during the patients’ hospitalisation in our hospital.

Keywords Proton pump inhibitor drugs, Hospital stay, Off-label use

PT-95 Prospective study of the prescriptions of proton pump inhibitors in a paediatric hospital

Sandrine Roy 1, Marc Bellaiche2, Ariane Blanc1, Françoise Brion1, Olivier Bourdon1

1Pharmacy, 2Gastroenterology, Robert Debré, Paris, France

Background and objective Hospitalized patients who received proton pump inhibitors (PPI) were approximatly a quarter of Robert Debre hospital’s patients. Three PPI were available: omeprazole and esomeprazole for oral administration and pantoprazole for intravenous administration.

Design This prospective study was based on the analysis of the indications, dosages and dosing intervals of each patient’s PPI treatments.

Setting All clinical units of Robert Debre hospital were included.

Results 313 prescriptions were analyzed. Patient’s age ranged from 1 day to 21 years (median age was 1.3 years). Patients were principally hospitalized in intensive care (24%), neonatalogy (15%), internal medicine (12.5%), haematology (11.5%), gastroenterology (10.2%) and surgery (9.6%) units. Intravenous pantoprazole was prescribed in 37% of cases whereas oral omeprazole and esomeprazole represented 63% of prescriptions. Prevention of stress ulcer and prophylaxis-NSAID/SAID-associated gastropathy represented 66% of the indications. 34% of all prescriptions had a curative purpose (12% for suspicion of gastro-oesophageal reflux disease, 5 and 10% for gastro-oesophageal reflux respectively with and without oesophagitis, 3% for gastritis and 4% for another indication). According to age bracket, the prescribed doses were 1.8 ± 0.5, 1.9 ± 0.5, 1.0 ± 0.4 and 0.7 ± 0.4 mg/kg/d respectively for patients under 1 month old, from 1 month to 1 year old, from 1 to 14 years old, and over 15 years old. Variability of prescribed dosages increased according to the considered age bracket from 28%, children under 1 month old, to 54%, patients over 15 years old. Once-a-day administration represented 99.3% of prescriptions.

Conclusions Prescribing habits and prescription recommendations differ greatly. Most indications of prescriptions (70%) are off-label use. This proportion is by far exceeding previously reported values (30 to 40% [1]). These medical practices are hard to change, especially in the case of hospitalized patients. Moreover, the absence of recommendations causes a high variability in PPI doses which should thus be standardised. Given the potential risk factor represented by prolonged PPI treatments (acute gastroenteritis and community-acquired pneumonia [2]), the present survey is being pursued to determine whether hospital PPI prescriptions are maintained after hospitalisation.

References

  1. 1.

    D. Schroder-Bernhardi, K. Roth, G. Dietlein. Int J Clin Pharmacol, 2004;11:581–8.

  2. 2.

    R. Berni Canani, P. Cirillo, P. Roggero et al. Pediatrics, 2006;117:817–20.

Keywords Proton pump inhibitors, Indications

PT-96 Effectiveness and safety of lamivudine in patients with chronic hepatitis b (chb)

Pilar Flox 1, Luis Margusino1, Isabel Herranz1

1Pharmacy, Juan Canalejo Hospital, La Coruña, Spain

Background and objective Drugs approved in Spain for treatment of chronic hepatitis B in Spain are Interferon alpha (1992), Lamivudine (1999), Adefovir (2003) and PegInterferon alpha-2a (2004). Since 2001, Lamivudine is the first line treatment in chronic hepatitis B in our hospital. Adefovir and Peg-Interferon alpha are second line treatment

Objective To evaluate effectiveness and safety of Lamivudine in chronic hepatitis B virus infected patients.

Design Observational retrospective study. Chronic hepatitis B virus infected patients who started with Lamivudine from 2001 to 2005. Exclusión criteria: low treatment adherence, hepatitis C, hepatitis D and VIH coinfection, hepatic pre and post-transplantation, previous treatment with IFN, exitus and pediatrics. Statistical analysis: McNemar’s method (95%; ±22%).

Setting General hospital (1400 beds). Medicine General Service and Hepatology Service.

Main outcome measures The primary effectiveness end point was end of therapy based on secondary effectiveness end point: negative HBV-DNA, normalize ALT levels, HBsAg or HBeAg seroconversion. Primary safety end point: treatment interruption for adverse effects.

Results Twenty-three patients (19 men; 4 women), age 52, 56 SD 15, 59 years. Positive HBV-DNA: 95%; elevated ALT: 91%; positive HBsAg y negative antiHBsAg: 100%; positive HBeAg and negative antiHBeAg: 28%. By week 48, negative HBV-DNA: 42% (P = 0.008); normal ALT levels: 76% (P < 0.001); HBsAg seroconversion: 0% (ns); HBeAg seroconversion: 33% (ns). No patient stopped treatment by week 48. By week 72: negative HBV-DNA: 31% (ns); normal ALT levels: 71% (P = 0.02); HBsAg seroconversion HBsAg: 0% (ns); HBeAg serocoversion: 33% (ns). No patient stopped treatment due to adverse effects at week 48 and 72. 22% patients finished treatment when they were considered recovered by the physician (length of the treatment 26 SD 8,58 months): negative HBV-DNA: 40%; normal ALT levels: 100%; HBsAg seroconversion: 20%; HBeAg seroconversion: 50%.

Conclusions Lamivudine shows a limited effectiveness at length of treatment recommended, although it shows normal ALT levels and negative HBV-DNA by week 48 and 72. HBsAg and HBeAg seroconversion was less than expected by week 48 and p 72. Lamivudine was a safe drug in the treatment of chronic hepatitis B.

Keywords Lamivudine, Chronic hepatitis B, Drug use evaluation

PT-103 Bacteriophages—alternative antibiotics of xxi century

Rusudan Jashi 1, Leila Kalandarishvili2, Irma Ochigava2

1Department of Pharmacology, Iv. Javachishvili Tbilisi State University, 2LtD “Biopharm-L”, Tbilisi, Georgia

Background and objective Bacterial resistance towards antibiotics became a world-wide problem. In this direction bacteriophages—specific viruses for bacteria are more actual throughout the world. The bacteriophages were discovered 100 years ago by Frederik Twort and Felix d’Herelle. Bacteriophages or phages are bacterial viruses that invade bacterial cells, disrupt bacterial metabolism and cause the bacterium to lyse using the bacterial components for their own multiplication. The Georgian scientist Giorgi Eliava laid foundation for bacteriophagology in Georgia, in 1923 together with Felixd’ Herelle he founded a world know Research Enterprise of bacteriology, bacteriophagology, vaccines and sera, which later became know as Research-and-Enterprise Amalgamation “Bacteriophage”.LtD “Biopharm-L” (Georgia) produce phage cocktails: Piobacteriofagum liquidum and Intestibacteriofagum. From biotechnological point of view the specificity of bacteriophages are challenge and the phagecocktails are more useful for the therapeutic purposes. Piobacteriofagum liquidum (P2815) is a mixture of sterile filtrates of phagolysates of staphylococcal, streptococcal, pseudomonas, E. coli and proteus—phages. It is used for management and prevention of skin, mucous viscelear organs purulent infections caused by the following bacteria: Staphylococci, Streptococci, E. coli, Pseudomonas auroginosa, Proteus vulgaris. Intestibacteriofagum (P2817) contains the mixture of following bacteriophages: shigella, E. coli; proteus, salmonella, enterococcal, pseudomoal, streptococcal, staphylococcal bacteriophages. Is available as liquid as solid (tablets) form of this preparation. It is using to cure gastrointestinal infection diseases. Such as dysentery, salmonelosis, colitis and enterocolitis.

Design Retrospective study.

Setting LtD “Biopharm-L”, IV. Javachishvili Tbilisi State University, Scientific Research Institute of Pedeatrics.

Main outcome measures Analysis of infected materials, isolation of bacteriophages specific for the virulent bacteria.

Results Why the phage therapy: The phages have been reported to be more effective therapeutic agent than antibiotics in treating certain infections in humans and experimentally infected animals. Bacteriophage taxonomy is based on their shape and size as well as on their nucleic acid. Most bacteriophages have ds DNA, however, some have ss DNA, ds RNA or ss RNA. Upon infection of bacterial host different phages can have quite different fates. Some phages follow the lytic infection cycle whereby they multiply in the bacterial cell and lyse the bacterial cell at the end of the cycle to release newly formed phage particles. Some phages may use the lysogenic pathway where the phage genome will integrate as part of host genome, replicate as part of the host genome and stay in a dormant state as a prophage for extended periods of time. The following phases can be distinguished in the lytic bacteriophage developmental cycle: 1. Adsorption of phage on the bacterial cell by binding to a specific receptor; 2. Injection of the nucleic acid into the bacterium; 3. Expression of the phage early genes, synthesis of early proteins, most involved in the shutting down of the host bacterium systems and phage genome replication; 4. Replication of the phage genome; 5. Expression of the phage late proteins involved in the formation of new phage particles and lysis of the host bacterium; 6. Assembly of the phage heads and tails and packaging of the genome; 7. Lysis of the host bacterium and release of the new phage progeny. Bacteriophage host range is determined primarily by the surface structures that phages use as receptors to dock on bacteria; both carbohydrate and protein receptors are known. Phage-associated side effects are uncommon since phages or their products do not affect eukaryotic cells. In addition, the cost of developing a phage system is cheaper than that of developing a new antibiotic. Up to now more than 1000 scientific article were published by Georgian scientist to the issue of bacteriophagology. (i) non-creation of secondary resistance of microbe strains; (ii) high specific mode of action; this specificy was made broad by making the “phage-cocktails”, using this way the phagopreparations received ability to kill more than one bacterial host (iii) no side effects and complication, the phages do not rise the disbacteriosis; (iv) Conformity with other therapeutic means, including antibiotics—they are main exallancy of phages (Black 2004) Safety. From a clinical standpoint, phages are bio-drugs which appear to be innocuous. In Eastern Europe and the former Soviet Union, phages have been administered to humans (i) orally, in tablet or liquid formulations; (ii) rectally, (iii) locally (skin, eye, ear, nasal mucosa, etc.), in tampons, rinses, and creams, (iv) as aerosols or intrapleural injections, and (v) intravenously in the following case: pus—infected wound, cistitis, prostates, colecistites, pielitis, during and post operated, colites, enterocolites and by all kind of bacterial infection. The benefits listed above also hold true in the prophylactic treatment of food products: phages will not harm necessary bacteria in food (e.g., starter cultures), or accompanying bacterial flora in the environment. Moreover, since phages are generally composed entirely of proteins and nucleic acids, their eventual breakdown products consist exclusively of amino acids and nucleic acids. Thus, they are not xenobiotics, and unlike antibiotics and antiseptic agent, their introduction into and distribution within a given environment may be seen as a natural process (Carltoen et al. 2005).Recent in vitro and in vivo phage studies. There are excellent recent reviews on the phage therapy viable (Shkurnik et al 2006; Bradbury 2004; Projan 2004; Thacker 2003; Weber-Debrowska et al. 2002; Kalandarishvili et al. 1985; Matsuzaki et al. 2003).Surprisingly little detailed research has been performed on the fate of phages in animals and humans. Pharmacocinetics are complicated due to the selfreplicating nature of phage. The use of phages as drugs may differ dramatically from pharmaceuticals/antibiotics due to differences in the phage pharmacokinetics (Payne and Jansen 2003).

Conclusions Bacteriophages are the antibiotics of XXI century, than they are (i) highly specific and very effective in lysing targeted pathogenic bacteria, (ii) safe, as underscored by their extensive clinical use as in human as in animals (iii) rapidly modifiable to combat the emergence of newly arising bacterial threats.

References

  • JG Black—Microbiology, principles and exploration. 6th edition, John Wiley, INC. 2004.

  • Carlton RM, Noordman WH, Biswas B et al. (2005). Bacteriophage P100 for control of Listeria monocytogenes in foods: genome sequence, bioinformatic analyses, oral toxicity study, and application. Regul Toxicol Pharmacol 43:301–312.

  • Skurnik M, Strauch E—REVIEW Phage therapy: Facts and Fiction, IJMM 296 (2006) 5–14.

  • Bradbury, J., 2004. My enemy’s enemy is my friend. Using phages to fight bacteria. Lancet 363, 624–625.

  • Projan, S., 2004. Phage-inspired antibiotics? Nat. Biotechnol. 22, 167–168.

  • Thacker, P.D., 2003. Set a microbe to kill a microbe: drug resistance renews interest in phage therapy. JAMA 290, 3183–3185.

  • Weber-Dabrowska, B., Mulczyk, M., Gorski, A., 2003. Bacteriophages as an eficient therapy for antibioticresistant septicemia in man. Transplant. Proc. 35, 1385–1386.

  • Matsuzaki, S., Yasuda, M., Nishikawa, H., Kuroda, M., Ujihara, T., Shuin, T., Shen, Y., Jin, Z., Fujimoto, S., Nasimuzzaman, M.D., Wakiguchi, H., Sugihara, S., Sugiura, T., Koda, S., Muraoka, A., Imai, S., 2003. Experimental protection of mice against lethal Staphylococcus aureus infection by novel bacteriophage fMR11. J. Infect. Dis. 187, 613–624.

  • Payne, R.J., Jansen, V.A., 2003. Pharmacokinetic principles of bacteriophage therapy. Clin. Pharmacokinet. 42, 315–325.

Keywords Bacteriophages, Therapy

PT-104 Study of granulocyte colony-stimulating factor use in an onco-haematology unit

M. Alvarez 1, C. Lezcano2, J. L. Pontón2, X. Bonafont1

1Pharmacy Department, Hospital Germans Trias i Pujol, 2Pharmacy Department, Institut Català d’Oncologia-Badalona, Badalona, Spain

Background and objective To describe G-CSF (granocyte colony-stimulating factor) use and to identify cytostatic agents frequently associated with the use of these drugs.

Design Retrospective study of patients receiving G-CSF from September to November 2006. Analysis of chemotherapy and G-CSF received for these patients from August 2005 to December 2006. The data was obtained from the Pharmacy Department databases. Quantitative variables have been described by mean and standard deviation.

Setting Onco-Haematology Unit.

Main outcome measures Indication, number of cycles, dose and days of G-CSF use; cytostatic agents associated with G-CSF use.

Results 195 episodes of G-CSF use were identified in 121 patients (mean age 55.9 [13.0], 66 women [54.5%]). There were 58 episodes (29.7%) of secondary prophylaxis, 57 (29.2%) of treatment, 43 (22.1%) of primary prophylaxis, 17 (8.7%) of mobilization, 16 (8.2%) of post-bone marrow transplantation (BMT) and 4 (2.1%) of others. Filgrastim was used for 2.3 (1.3) cycles during 6.4 (1.6) days as secondary prophylaxis; 1.2 (0.5) cycles during 5.9 (4.8) days as treatment; 2.4 (1.3) cycles during 8.2 (3.7) days as primary prophylaxis and during 7.2 (4.8) days as post-BMT; mean dose 300 μg daily. Pegfilgrastim was used for 1.8 (0.9) cycles as secondary prophylaxis, 2.3 (1.5) as treatment and 2.8 (1.8) as primary prophylaxis, during 1 day per episode and 6 mg unique dose. Cytostatic agents most frequently associated with G-CSF use were cyclophosphamide in 17 episodes (29.3%), fluorouracil and doxorubicin in 15 (25.9%) each one for secondary prophylaxis; etoposide in 14 (24.6%), cisplatin in 13 (22.8%) and doxorubicin in 12 (21.1%) for treatment; cyclophosphamide in 13 (30.2%), doxorubicin and cytarabine in 12 (27.9%) each one for primary prophylaxis.

Conclusions 15.7% of the patients undergo chemotherapy treatment received G-CSF. Filgrastim was used in 84.6% of episodes and the main indication was secondary prophylaxis. The mean number of cycles and days of G-CSF use was bigger for primary prophylaxis than the rest of indications. Doxorubicin and cyclophosphamide were the most commonly cytostatic agents associated to the use of G-CSF.

Keywords Filgastrim, Chemotherapy, Pegfilgrastrim

PT-109 Evaluation of the use of antifungal treatments in neutropenic patients in an onco-haematology adult care unit at the University Hospital of Montpellier

Ludmilla Tatem1, Flora Mérenna1, Nicolas Terrail 1, Yolande Marhuenda1, Sylvie Hansel-Esteller1

1Pharmacy Lapeyronie, CHU Montpellier, Montpellier, France

Background and objective Incidence of fungal infections is regularly increasing for 20 years and has become a major cause of infection-related mortality in neutropenic patients treated for a cancer. The 2004 consensus 1 describe invasive candidiasis and aspergillosis treatments recommended in France. New antifungal prophylactic strategies have been extensively developed.

The aim of this study is to evaluate the clinical use of antifungal drugs to implement new guidelines in our hospital.

Design A retrospective survey on neutropenic patients hospitalized in onco-haematology care unit in 2006.

Setting Onco-haematology care unit and hospital pharmacy in an university hospital.

Main outcome measures Categorisation of patients and analysis of first line antifungal treatments and their alternatives.

Results 74 patients were included: 44 (59%) men and 30 (41%) women, with a mean age of 49 years (range 17–71). 31 (42%) were treated with fluconazole (400 mg/day) and as second line with caspofungin (70 mg the first day, then 50 mg/day). 10 (13%) were treated with fluconazole, then with voriconazole (400 mg bid the first day, then 200 mg bid), 13 (18%) with caspofungin, 7 (9%) with caspofungin then voriconazole, 4 (5%) only with voriconazole, 5 (7%) with voriconazole than caspofungin, and 4 (5%) with liposomal amphotericin B (3 mg/kg).

Conclusions Fluconazole is the most used molecule as first line prophylactic treatments in neutropenic patients, although consensus conference [1] recommend to use caspofungin or liposomal amphotericin B. Then clinicians often use caspofungin, which is less nephrotoxic than liposomal amphotericin B, as second line treatment. Oral voriconazole is currently used as a prophylactic treatment, particularly for outpatients.

Reference

  1. 1.

    French guidelines: “Prise en charge des candidoses et aspergilloses invasives de l’adulte avec la participation de la Société Française d’Hématologie, de la société Française de Mycologie Médicale et de la société Française de Greffe de Moelle,13 mai 2004. Institut Pasteur, Paris.”

Keywords Antifungal treatments, Neutropenic patients, Onco-haematology

PT-116 Evaluation of the use of darunavir in a cohort of multiresistant HIV outpatients at the university hospital of Montpellier

Sophie Perriat1, Nicolas Terrail 1, Jean-Charles Tenon1, Sylvie Hansel-Esteller1

1Pharmacy Lapeyronie, CHU Montpellier, Montpellier, France

Background and objective In January 2007, darunavir is not marketed in France. It has been made available in May 2006 in an early access program.

To evaluate prescriptions of darunavir and their first results in a cohort of outpatients treated for a HIV infection and resistant to others protease inhibitors.

Design A prospective study on medical files of 12 patients included in the French expanded access program of darunavir.

Setting Infectious and tropical diseases unit and hospital pharmacy outpatients setting in a teaching hospital.

Main outcome measures Categorisation of patients, analysis of antiretroviral treatments used before and in association with darunavir, immunovirological response, and tolerance data.

Results From May to August 2006, 12 patients were included in the expanded access program: 10 (83%) male and 2 (17%) female with a mean age of 42 years (range 14–56). 1 patient died during the study and results are presented for 11 patients.

Before starting darunavir, all patients were on therapeutic failure (CD4 < 200/mm3, viral load > 30000 copies/ml). Previous treatment was a tritherapy for 73% of patients, a multitherapy of 4 or more molecules for 9%, and 18% of patients received a mono or bitherapy of nucleoside reverse transcriptase inhibitor (NRTI) just to keep viruses muted with a lower replication activity.

In the last treatment line before inclusion, a boosted protease inhibitor (BPI) was associated for 9 (82%) patients: lopinavir for 5 (45%), fosamprenavir for 2 (18%) and atazanavir or saquinavir for 1 patient. Tipranavir was used in previous treatment lines and only for 3 (27%) patients.

Darunavir was associated to 1 or more molecules: 6 (50%) patients received enfuvirtide or the NRTI association of emtricitabine and tenofovir (Truvada(c)), and 4 (67%) received both enfuvirtide and Truvada(c).

Darunavir was well tolerated, but 2 patients developed a mild cutaneous toxidermy which resolved spontaneously.

Darunavir showed significant immunovirological efficacy in treatment-experienced patients: CD4 increased for 90% of patients (mean + 70) and viral load decreased for 70% (mean—2.97 log) during the 3 months follow-up.

Conclusions Darunavir showed good efficacy and safety in treatment-experienced patients resistant to the others PI. It will represent, associated with other molecules and with new classes of antiretrovirals, a good alternative for patients on therapeutic failure.

Keywords Darunavir, HIV, Protease inhibitor, Antiretroviral

PT-121 Risk of drug interactions in population of patients with inflammatory bowel disease

Petr Cerveny 1, Jiri Vlcek1, Milan Lukas2, Martin Bortlik2

1Dept. of Social and Clinical Pharmacy, Charles University in Prague, Faculty of Pharmacy in Hradec Kralove, Hradec Kralove, 2Gastroenterological Unit, IVth Internal Clinic, Prague, Czech Republic

Background and objective Concurrent use of multiple drugs often increases therapeutic effectiveness, but very often may also pose a risk for drug interactions. These may result in severe clinical manifestation, if they are not paid an attention and unproperly managed. In this work we assessed percentage of potential drug interactions in the population of patients with diagnosis of inflammatory bowel disease (IBD) and suggested their management.

Design The complete pharmacotherapy (prescribed medicines, over the counter drugs and dietary supplements) of 573 patients (284 males, 289 females) with diagnosis of IBD (327 Crohn’s disease, 246 ulcerative colitis) was analysed by Thomson MICROMEDEX DRUG-REAX® System. Drug interactions of any severity were identified. All the identified drug interactions were taken as potential. There was no prove if patient was harmed by them.

Setting The complete medication was gained from IBD patients, followed up in 11 gastroenterological units in the Czech Republic, by means of interview or questionnaire.

Main outcome measures Percentage and character of potential drug interactions of any severity (minor, moderate, major), identified by proceeding patient’s medications.

Results Number of prescribed medicines increases with patient’s age. In the examined cohort, 53 patients (9.2%) were exposed to minimally one potential drug interaction. Overall 81 potential drug interactions of any severity were identified. 8 (9.8%) drug interactions were classified as minor, 52 (64.3%) as moderate and 21 (25.9%) drug interactions were classified as major.

Occurrence risk of the potential drug interaction, classified as “major”, increases with patient’s age.

In the group of drug interactions classified as “major”, unsuitable combination of angiotenzine converting enzyme inhibitor and kalium sparing diuretic was the most frequent. This combination may cause severe hyperkalemia.

The most often interaction classified as “moderate” was combination of iron containing medicines with proton pump inhibitor omeprazole, which may cause significant reduction in absorption of iron.

Conclusions Drug interactions may be a serious clinical problem. In our examined cohort, almost one tenth of the patients was exposed to minimally one potential drug interaction.

A pharmacist can be very important in the process of drug interactions detection. He is educated in the problematics of drug interactions and his knowledge should be intensively improved during postgradual education.

This study does not deal only with a description of identified drug interactions. It is also focused on their management from the point of view of a physician and a pharmacist.

Keywords Drug interactions, Inflammatory bowel disease, Crohn’s disease, Ulcerative colitis

PT-125 Analgesic infusions in a general hospital—old habits and tradition or drug therapy on evidence-based standards? development of prescribing guidelines for intravenous combinations in the treatment of pain

Karin Nemec 1, Petra Cihal2, Evgeny Timin2, Rosa Lemmens-Gruber2, Majid Reza Kamyar2

1Hospital Pharmacy, Donauspital, 2Department of Pharmacology and Toxicology, University of Vienna, Vienna, Austria

Background and objective To survey all ward specific, bedside prepared infusions (two or more drugs within one vehicle) for the treatment of pain. To evaluate appropriate vehicles and acceptable drug combinations in analgesic infusions with regard to evidence-based therapy.

Design Literature review; computer simulation of pharmacokinetics with MATLAB 6.5; evaluation of pharmacokinetic or pharmacodynamic interactions and dose regimens.

Setting Twenty-nine infusion combinations (n = 29, mean 2.6 drugs per infusion) used for the management of pain and identified in 7 out of 37 wards at the 1000-bed general hospital Donauspital (Vienna).

Main outcome measures Categorisation of infusion combinations into acceptable and questionable combinations of infusion components in terms of quality assurance evaluation.

Results Analgesic drugs such as diclofenac (75 mg/250 or 500 ml, n = 15), metamizole (1 mg/100 or 250 ml, n = 5; and 2.5 mg/250 or 500 ml, n = 6), tramadol (100 and 200 mg/250 or 500 ml, n = 8) and acetylsalicylic acid (1 g/250 or 500 ml, n = 3) were combined with diazepam (5 mg/250 or 500 ml, n = 8) and/or B-vitamins (n = 11), lidocaine (100 mg/500 ml, n = 1), triflupromazine (10 mg/250 ml, n = 1), metoclopramide (10 and 20 mg/100, 250 or 500 ml, n = 8) and pantoprazole (40 mg/250 or 500 ml, n = 3). The vehicles were Ringer solution (n = 7), Ringer lactate solution (n = 7) or 0.9% NaCl solution (n = 12). In two infusions diazepam (5 and 10 mg) was dissolved in 250 ml Neodolpasse® (n = 2), an infusion solution containing diclofenc and orphenadrine citrate. In 45% of the infusions the used vehicle was not one recommended by the manufacturer. The drug combinations diclofenac or tramadol with diazepam induced a long lasting (>11 h) sedative effect by diazepam and its metabolite, but only a moderate duration (approx. 7 h) of analgesia. The combination of the two analgesic drugs diclofenac and metamizole with or without vitamin B was acceptable as long as metamizole was used at 2.5 g/100, 250 or 500 ml. At the lower dosage of metamizole the duration of analgesia was shortened. The necessity of pantoprazole during short-term application of diclofenac in patients without any risk factor for gastrointestinal bleeding is questionable. With the administered doses of metoclopramide and lidocaine, therapeutic plasma levels would apparently not be reached, but sufficient data for safe and effective dosage are lacking. The only infusion combination which might be harmful to patients consisted of tramadol, metoclopramide and triflupromazine, and is no longer used.

Conclusions In 45% of the 29 bedside prepared infusions the vehicle was not suitable. For all of the drug combinations in use no interactions of clinical relevance were observed. However, changing of infusion regimens might achieve optimisation of pain treatment in respect of duration of analgesia and sedation. The combination of analgesic drugs was in accordance with evidence-based medicine.

PT-132 Gb pharmacists’ perceptions and attitudes towards supplementary prescribing training

Derek Stewart 1, Johnson George1, David Pfleger1, Christine Bond2, Lesley Diack1, Scott Cunningham1, Kim Munro1, Anne Watson3, Dorothy McCaig1

1School of Pharmacy, The Robert Gordon University, 2Department of General Practice and Primary Care, University of Aberdeen, Aberdeen; 3Pharmacy, NHS Education for Scotland, Glasgow, United Kingdom

Background and objective Pharmacist supplementary prescribing (SP) was introduced in GB in 2002 and pharmacists are now practising SP [1]. To inform further implementation of SP, the views of pharmacists need to be known. The objectives were to investigate pharmacists’ perceptions of and planned participation in SP training and attitudes towards pharmacist SP.

Design A pre-piloted questionnaire mailed in November 2005 to a random sample of 4,300 registered pharmacists provided by the Royal Pharmaceutical Society of Great Britain (approximately 10% of members) [2].

Setting Great Britain—Primary, secondary and tertiary care.

Main outcome measures Awareness of SP training; actions taken relating to SP training; 5 point Likert scales measuring attitudes towards SP; and demographics.

Results The response rate was 55.1% (2371/4300). 235 were either non-practising or due to retire thus excluded. The majority of respondents were female (1262, 59.1%), had been registered >15 years (1119, 52.4%) and worked in community pharmacy (1325, 62.0%). Of the 1816 reporting patient contact, 63 (3.5%) were prescribers and 46 (2.5%) had undertaken training. Of those (1707) who had not yet undertaken training, 1276 (74.8%) were aware of SP courses, largely via the Pharmaceutical Journal (845, 64.8%). 645/1707 (37.8%) stated they were more likely to undertake training courses covering both SP and independent prescribing. 612/1707 (35.9%) were aware of colleagues who had completed or were undertaking training. 413 (24.2%) had never thought about training whilst 1028 (60.2%) had thought about training but had not yet explored options. The majority (1115, 65.3%) strongly agreed/agreed that practising as an SP would improve patient care.

Conclusions Despite awareness of SP courses, few had taken any action in terms of training. The level of interest in combined SP and independent prescribing training may indicate an opportunity to expand uptake in the future. Policy makers and providers should consider how they expand awareness of SP courses and facilitate the implementation of SP.

References

  1. 1.

    George J, McCaig D, Bond C, Cunningham S, Diack L, Watson A, Stewart D. Supplementary prescribing: early experiences of RPSGB registered prescribers. Annals of Pharmacotherapy 2006;40:1843–1850.

  2. 2.

    Hassell K, Eden M. Workforce update—joiners, leavers, and practising and non-practising pharmacists on the 2005 register. Pharmaceutical Journal 2006;276:40–42.

Keywords Prescribing, Training, Plans

PT-133 Rituximab, a new alternative treatment for refractory thyroid-associated ophtalmopathy

Raphaelle Fanciullino 1, Laurent Chiche2, Charléric Bornet1, Stéphanie Branger2, Albert Darque1, Rodolphe Jean2, Sophie Gensollen1, Jean-Marc Durand2, Marie-Claude Bongrand1

1Pharmacy, 2Internal Medecine, Hospital Conception, Marseille, France

Background and objective Rituximab, a humanized monoclonal antibody against the B-cell antigen CD20, has been successfully used in many autoimmune diseases. Graves’disease is an autoimmune disease characterized by hyperthyroidism. The role of B lymphocytes in thyroidal and extrathyroidal Graves’disease is established. Thus, some authors proposed that treatment with Rituximab may become a clinically relevant treatment option to prevent a possible dramatic evolution of Graves’disease [1].

Design We report the benefit of Rituximab in a patient presenting a refractory form of thyroid-associated ophtalmopathy.

Setting Internal medicine unit and Pharmacy department

Main outcome measures In 1998, a 53 year-old woman was addressed to Internal Medicine Unit for bilateral exophtalmy associated with diplopia. A Graves’ disease diagnosis was established for this patient. She recovered on 1 mg/kg/day of prednisone. But steroids had to be discontinued because of psychiatric adverse effects and cyclosporine was started as a steroid-sparing agent. After 2 years, treatment was withdrawn, but exophtalmy and diplopia recurred, with a decreased visual acuity linked to a compression of her right optic nerve. High dose of steroids associated with eye muscle and optic nerve decompression surgery led to remission. During the five following years, permanent low dose of prednisone was necessary. Eight years after the onset of the disease, a new recurrence failed to respond to steroids as well as to Azathioprine. The patient refused a new surgery and radiotherapy.

Results In this context, Physicians and Pharmacists decided after discussion to establish a treatment including Rituximab. Patient received four weekly pulses of 375 mg/m² of Rituximab with a spectacular clinical response concomitantly to the fall of her B-lymphocytes blood count (2/mm3). One strengthening pulse was given 3 months after initial pulses. No adverse event was mentioned. Five months after the first rituximab pulse, the patient is doing well without receiving prednisone.

Conclusions In thyroid-associated ophtalmopathy, both humoral and cellular immunity are involved. Rituximab, since it induces B cell depletion, probably participates in autoantibody production decrease, and in cellular orbitrary infiltration inhibition. We report the case of a patient with thyroid-associated ophtalmopathy resistant to conventional treatment, successfully treated with Rituximab which might be a new therapeutic option in the management of these selected situations.

Reference

  1. 1.

    El Fassi, et al. The rationale for B lymphocyte depletion in Graves’ disease. Monoclonal anti-CD20 antibody therapy as a novel treatment option. Eur J of Endocrinol. 2006;154:623–632.

Keywords Rituximab, Autoimmune disease, Thyroid-associated ophtalmopathy

PT-134 Initial evaluation of a website to enhance the period of learning in practice of pharmacist supplementary prescribing training

Derek Stewart 1, Johnson George1, Lesley Diack1, Laura Binnie1, Brian Addison1, Christine Bond2, Scott Cunningham1, Dorothy McCaig1, Jennifer Cleland2

1School of Pharmacy, The Robert Gordon University, 2Department of General Practice and Primary Care, University of Aberdeen, Aberdeen, United Kingdom

Background and objective Pharmacist supplementary prescribing (SP) was introduced in Great Britain in 2002. Training involves 25 days (200 h) of university tuition and 12 days experiential learning under medical supervision (termed the Period of Learning in Practice—PLP) [1]. During the PLP, a designated medical practitioner (DMP) supervises the trainee. A website to support the PLP for the SP course at The Robert Gordon University (RGU), Scotland, was designed using information from focus groups of pharmacists and in-depth interviews with DMPs. This website was hosted on the RGU Virtual Campus and included: a welcome message; quotes from previous pharmacist SP trainees and DMPs; frequently asked questions (FAQs); discussion forum; and a contact point. The objective of this research was to evaluate the PLP website.

Design A questionnaire mailed to the first cohort of 27 pharmacists enrolled in the SP course at RGU and their DMPs given access to the website.

Setting Scotland, primary, secondary and tertiary care.

Main outcome measures Views and experiences in relation to the website: use of the website; PLP setting, patient groups/therapeutic areas of study; pharmacist and DMP demographics.

Results Responses were received from 20/27 (74.1%) pharmacists and 14/27 (51.9%) DMPs. More than half the pharmacists (11, 55.0%) worked in community and half of the DMPs were general medical practitioners. ‘Cardiovascular’ and ‘respiratory’ were the most common therapeutic areas. Eleven (55.0%) pharmacists reported accessing the PLP website using broadband internet connection. None had to download additional software. Nine (45.0%) reported printing material from the PLP area. The trainees perceived the FAQs to be the most useful, followed by the handbook, and quotes from pharmacists and DMPs. Of those 11 pharmacists accessing the PLP website, most either agreed or strongly agreed that: it was easy to access the PLP pages (9); the PLP area was well laid out (9); and that the material was easy to read (9). At the time of the study, none of the DMPs had used the PLP website using the login and password provided.

Conclusions Although many of the pharmacists had used the PLP website and had positive views, none of the DMPs had accessed the site. Further research is required to evaluate the website in larger numbers of pharmacists, to determine the extent to which the website can meet educational needs and to explore methods of facilitating DMP use.

Reference

  1. 1.

    Royal Pharmaceutical Society of Great Britain. Outline Curriculum for Training Programmes to prepare Pharmacist Supplementary Prescribers. London, 2002. http://www.rpsgb.org.uk/pdfs/supplprescphoutlcurric.pdf accessed on 06/06/06

Keywords Pharmacist, Prescribing, Network

PT-138 Retrospective analysis of benefit/risk ratio of aprotinin in cardiac surgery

Céline Chu 1, Emilie Moreau1, Maryline Chauffert2, Yvonnick Bezie1, Yves Fromes3

1Pharmacy, 2Biology, 3Cardiac surgery, Hôpital Saint-Joseph, Paris, France

Background and objective Administration of antifibrinolytic drugs during cardiac surgical procedures has been recommended to prevent bleeding under cardiopulmonary bypass assistance. Aprotinin (Trasylol®; Bayer Pharma) is widely used in this indication. However, its efficacy and harmlessness has recently been discussed. Indeed, Mangano et al. have described an increase of cardiovascular mortality and renal dysfunction with aprotinin use without obvious improvement on bleeding compared to tranexamic acid (TA)1. Our aim was to analyze the effectiveness and toxicity of the aprotinin in cardiac surgery.

Design A retrospective study of benefit risk ratio of aprotinin in adult cardiac surgery.

Aprotinin was compared with TA according to the type of surgery: coronary artery bypass or valve surgery.

Setting A French general hospital of 450 acute beds.

Main outcome measures Mortality and spontaneous declaration of adverse drug effects. Blood loss and hematocrit during the first 24 h after intervention.

Results 676 patients were included in our study. Incidence and type of adverse effects were not different between aprotinin and TA. For coronary artery bypass, aprotinin was more effective than TA to reduce blood loss after intervention (719 ± 435 ml; n = 171 patients vs. 947 ± 586 ml; n = 244 patients P < 0.001). Nevertheless, no difference of post-operative bleeding was 745; ± observed between the two anti-fibrinolytic drugs for valve surgery (825 605; tranexamic acid; n = 127 P = 0.426). Per operative ± aprotinin; n = 134 vs. 809 variations of hematocrit were identical between the two drugs and independent of the surgical process. The drugs’ cost per CPB was respectively of 50€ for TA and 240€ for aprotinin.

Conclusions Our preliminary results indicate that tolerance to aprotinin is as good as for tranexamic acid. Concerning its effectiveness, results differ according to the type of surgery. Aprotinin is more effective than TA to reduce blood loss for coronary artery bypass surgery. In valve surgery, our data suggest that TA, as effective and much less expensive than aprotinin, should be recommended.

Reference

  1. 1.

    Mangano DT, Tudor IC, Dietzel C. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006 Jan 26;354(4):353–65

Keywords Aprotinin, Cardiac surgery, Antifibrinolytic agents

PT-148 Tacrolimus-clarithromycin interaction in a paediatric liver transplant with severe diarrhea: a case report

Pieter De Cock 1, Myriam Van Winckel2, Ann Verrijckt3, Annick De Jaeger3, Marijke Van Hooreweghe1, Hugo Robays1

1Pharmacy Dpt., 2Paediatric Gastro-enterology Dpt, 3Paediatric Intensive Care Dpt., University Hospital, Ghent, Belgium

Background and objective Tacrolimus is a potent immunosuppressant widely used in paediatric solid organ transplantation. We report a tacrolimus-clarithromycin pharmacokinetic interaction in a paediatric liver transplant patient with severe diarrhoea.

Design Case report.

Main outcome measures Evaluation of a possible iatrogenic cause to a patient’s morbidity.

Setting Clinical pharmacy activities at the Paediatric Intensive Care Dpt., Ghent University Hospital, Belgium.

Results A 15-year old girl received a liver transplant at the age of 2 and was retransplanted at our institution at the age of 10 because of chronic rejection. Immunosuppression was maintained on tacrolimus (FK506) monotherapy (therapeutic whole blood trough level range: 5–10 ng/ml; MEIA). For H. Pylori gastritis treatment, oral eradication tritherapy with amoxicillin, omeprazole and clarithromycin was initiated. Seven days hereafter, the patient presented in our hospital with seizures, oliguria, diarrhoea, vomiting and overall signs of dehydration. Lab monitoring revealed a six to seven-fold increase in tacrolimus blood trough levels affecting renal function. More than plausible explanation for the rise in blood FK 506 levels was a pharmacokinetic interaction between tacrolimus, a substrate for cytochrome CYP3A4 mediated metabolism in liver and gut and the potent CYP 3A4 inhibitor, clarithromycin. As reported by few case reports, exacerbating factors were probably an increased absorption of tacrolimus—resulting from a decreased P-glycoprotein P mediated efflux in the damaged gut—and secondly, hemoconcentration due to dehydration. Clarithromycin was promptly discontinued and replaced by metronidazole (weak CYP3A4 inhibitor). Tacrolimus was withheld until therapeutic blood levels were reached and titrated within the therapeutic range with no further problems. Renal function and lab values all returned to normal.

Conclusions These observations describe a clinically significant pharmacokinetic interaction between tacrolimus and clarithromycin in the liver and gut. Awareness of potential drug-drug interactions before starting new medications is very important, especially in patients taking drugs with a narrow therapeutic-toxic range like tacrolimus.

Keywords Tacrolimus, Clarithromycin, Drug interaction

PT-149 Safety of short-acting nifedipine in children: a literature review

Pieter De Cock 1, Luc Van Bortel2, Ann Raes3, Johan Vandewalle3, Annick De Jaeger4, Hugo Robays1

1Pharmacy Dpt., 2Clinical Pharmacology Dpt., 3Paediatric Nephrology Dpt., 4Paediatric Intensive Care Dpt., University Hospital, Ghent, Belgium

Background and objective Short-acting nifedipine has been abandoned for treatment of hypertensive crises in adults as a result of significant adverse events. This literature review will assess the safety of short-acting (SA) nifedipine in paediatrics.

Design Literature review.

Setting Department of Paediatrics.

Main outcome measures Guideline for safe use.

Results A Pubmed search revealed three large retrospective series specifically addressing the safety of use of SA nifedipine in children.

First retrospective series reported that a ≥25% precipitous reduction in mean arterial pressure (MAP) was observed in 35% of given doses. MAP reduction significantly correlated with nifedipine dose adjusted for weight. A dose of 0.25 mg/kg or less did not lead to precipitous MAP reduction. No patients experienced cardiovascular or central nervous system side effects.

A similar chart review reported a mean blood pressure reduction of 17% for systolic blood pressure and 28% for diastolic blood pressure. Adverse drug events occurred in 9.6% of patients and included neurological events, symptomatic hypotension and oxygen desaturation. In most neurological events and all patients with symptomatic hypotension a blood pressure reduction of >20% was observed. 33% of neurological events occurred in patients with acute central nervous system (CNS) injury.

5.1% minor adverse events probably related to SA nifedipine administration were recorded in a third review and mainly included edema, nausea and vomiting and gastro-intestinal pain. A serious adverse event of blood pressure reduction >40% occurred in two patients but neither was symptomatic and all recovered spontaneously within 2 h.

Conclusions Based on available literature, a consensus in our hospital was gathered for continued use of short-acting nifedipine in hospitalized children, except in those with acute CNS damage. However, it should only be used on wards with extensive patient monitoring and at a dose below 0.25 mg/kg.

Keywords Nifedipine, Safety, Children

PT-151 Effectiveness of infliximab in a patient with Behcet’s disease refractory to immunosuppressive therapy

Ángeles Tacoronte 1, Diana González1, Miriam Sánchez1, Francisco Moreno1, Yolanda Larrubia1, Elena Villamañán1, Esperanza Jiménez1

1Pharmacy, University Hospital La Paz, Madrid, Spain

Background and objective Effectiveness of infliximab in a patient diagnosed with Behcet’s disease (BD) who had been refractory to previous immunosuppressive therapy.

Design Retrospective study of a case of BD.

Setting Rheumathology, Ophthalmology, Dermatology and Pharmacy Departments. University Hospital La Paz. Madrid. Spain.

Main outcome measures Visual Acuity, Finger counting level, Tyndall and arthritis symptoms.

Results A 29-year-old male diagnosed with Behcet’s disease in March 2005. His main symptoms were panuveitis on his right eye, recurrent orogenital ulcers and arthritis. The uveitis had been refractory to prednisone (1 mg/kg/day), cyclosporine (5 mg/kg/day) and methotrexate. Due to the high risk of getting blind, a new treatment with infliximab 5 mg/kg at weeks 0, 2, 6 and then every 8 weeks is begun as a Compasionate Use. Concomitant treatment with methotrexate 7.5 mg/week was taken. Before this treatment began the ophthalmological examination showed the following measures: Finger counting level 75 cm, Tyndall(+) on anterior chamber, Tyndall(+) in vitreum and retinal infiltrates. First dose was given in October 2005 being reported an improvement in symptoms. At date, the patient has received 7 doses without any side effects being reported, although exacerbation of mucocutaneous, ocular and arthritis symptoms occurred during the treatment period.

Conclusions Using in a long-term infliximab seems to be a useful therapeutic approach to prevent relapses in patients with BD refractory to previous immunosuppressive therapy.

BD is a recidivate disease so this could explain the exacerbation of symptoms. In addition, this patient did not show good adherence because he did not come on programmed dates. There are needed more studies to determine the efficacy of infliximab and the importance of good adherence to this treatment.

References

  • Merino G et al. Effectiveness of infliximab in patients with Behcet syndrome and severe uveoretinitis. Report of five cases. Rev Med Chile 2006;134:875–882.

  • Gulli S et al. Remission of Behcet’s disease with anti-tumor necrosis factor monoclonal antibody therapy: a case report. BMC Musculoskelet Disord. 2003 Aug 28;4:19.

Keywords Infliximab, Behcet, Adherence

PT-159 Quality of life and gastro-oesophageal reflux disease management

Maurice Zarb-Adami 1, Anthony Serracino-Inglott1, Lilian M. Azzopardi1, Melanie Foden1

1Department of Pharmacy, University of Malta, Msida, Malta

Background and objective Gastro-oesophageal reflux disease (GORD) encompasses a heterogenous group of patients. The objective was to evaluate quality of life changes after treatment in patients diagnosed with GORD.

Design The quality of life of patients awaiting a gastroscopy was assessed using a disease-specific tool, the Gastro-intestinal Symptom Rating Scale (GSRS) and a non-disease specific tool, the Short Form-36 (SF-36) (baseline reading). The GSRS was re-administered 4 weeks after commencing treatment. Patients were classified into non-erosive GORD patients who were prescribed ranitidine 150 mg twice daily, erosive GORD patients who were prescribed omeprazole 20 mg twice daily, and patients with Helicobacter pylori who were prescribed amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily and omeprazole 20 mg twice daily. Statistical analysis was carried out using the Statistical Package for Social Sciences (SPSS). The paired samples t-test and the one-way ANOVA test were carried out.

Setting Endoscopy Unit, St Luke’s Hospital.

Main outcome measures Classification of GORD, quality of life before and after treatment.

Results Fifty-six patients participated in the study. The non-erosive GORD was the most common presentation (31, 55.4%) followed by the erosive GORD group (24, 42.9%). In the non-erosive GORD group, 16 (51.6%) were female, the mean age was 49 years, the mean body weight was 79 kg for males and 66 kg for females, 6 (19.4%) were smokers and 10 (32.3%) had hiatus hernia. In the erosive GORD patients, 10 (41.7%) were female, the mean age was 51 years, the mean body weight was 75 kg for males and 65 kg for females, 4 (16.7%) were smokers and 5 (20.8%) had hiatus hernia. At baseline the non-erosive GORD patients had the highest quality of life scores. However, no statistically significant difference was found between the three groups in the quality of life scores (P > 0.05). Following 4 weeks of treatment, the paired samples t-test indicated that the quality of life had improved (P = 0.004) for all patients.

Conclusions An increase in quality of life was detected in all groups confirming the effectiveness of the treatment protocols that are adopted at the Endoscopy Unit of St Luke’s. The study has also indicated the usefulness of the SF-36 and the GSRS as tools that can be used by the pharmacist to monitor treatment outcomes.

Keywords Gastro-oesophageal reflux disease, Quality of life, Gastroscopy

PT-166 Retrospective study of cetuximab tolerance: cases reports in NBPV and in CHU of Reims

Emilie Prevost 1, Anne Claire Buire1, Anne Laure Lepetit1, Olivier Bouche2, Thierry Trenque3, Bertrand Goudier1

1Pharmacy, 2Gastroenterology, 3Pharmacovigilance, Reims University Hospital, Reims, France

Background and objective Cetuximab is a chimerical monoclonal antibody that is indicated in association with Irinotecan in metastatic colorectal cancer. Cetuximab is known to induce side effects such as cutaneous effects which may be reported to the Regional Centre of Pharmacovigilance (RCPV).

The aim of the study was to assess Cetuximab tolerance and evaluate the rate of adverse effects notified to RCPV.

Design After analysing cases reported in the National Bank of Pharmacovigilance (NBPV) from June 2004 to June 2006, we studied Cetuximab prescriptions in gastroenterology department and carried out a retrospective research of side effects which had not been notified (national versus local level).

Setting RCPV. Gastroenterology department—Reims University Hospital.

Main outcome measures Analysis of simplified cards given by NBPV.

Consultation of the patients’ files in gastroenterology department (type, time, severity of side effects; number of notification to the RCPV).

Results 103 cases were notified in the NBPV: 32% were light or moderate reactions of over-sensitiveness, 23% were severe reactions of over-sensitiveness, 32% were cutaneous reactions, 4% were dyspnea and 22% of others side effects. 51% were considered without gravity and 66% did not cause any sequelae. 2 cases only were collected by spontaneous notification in RCPV of Reims.

Among the patient who received Cetuximab in our hospital (41 patients), six patients developed important side effects (severe, persisting all the treatment). It was after the first administration for three patients (1 anaphylactoid choc, 1 cutaneous reaction, 1 diarrhoea). Administration of the drug was continued for five patients who presented others adverse events after the following courses: dyspnea (1/5), acneiform eruptions (4/5), paronychia (3/5) and trichomegaly of the eyelashes (1/5). Among the six patients, none had been notified to the RCPV.

Conclusions The side effects are those described in literature except trichomegaly.

This study reports that many adverse effects are never reported. The under-reporting seems more frequent for chemotherapeutic agents because adverse effect are known and it’s difficult to differentiate adverse effects from the disease’s evolution. Pharmacists should be more present in medical departments to incite physicians to report all the cases of adverse effect (known or not, severe or not) and organise a relationship between the RCPV and the medical departments to optimize the patients’ management.

Keywords Cetuximab, Side effects, Pharmacovigilance

PT-171 Corticosteroid therapy and osteoporosis in children: use of pamidronate

Virginie Bonnin 1, Jerome Aubert1, Agnès Rousseau-Gautier1, Géraldine Senon1, Philippe Meunier1

1Pharmacy, Clocheville Hospital, University Hospital of Tours, Tours, France

Background and objective To describe and evaluate the interest of the use of pamidronate without marketing authorization for the treatment of bone demineralization in children.

Design Literature review; case report: we report a case of an 8 years old girl, 28 kg, suffering from a lymphoblastic acute leukaemia of the B line. The chemotherapy treatment began in June 2004; she received a repeated corticosteroid therapy (prednisone and dexamethasone). In November 2005, the patient presented lumbar pains and the X-Ray showed a compressing of the L2 vertebra. The bone mineral density (BMD) was performed by dual energy X-ray absorptiometry (DEXA) on the lumbar spine. The lumbar spine Z-score was −1.2 SD (correct mineralization correspond to a Z-score > −1.0 SD, moderate demineralization: −1.0 < Z-score < −2.0, severe demineralization: Z-score < −2.0 SD) [1].

A treatment by pamidronate was started: 1 mg/kg IV during 3 days the first month then 1 mg/kg IV once a month.

Setting Oncology pediatric unit.

Main outcome measures Criteria of evaluation of the pamidronate therapeutic effectiveness: bone pains, BMD measured by osteodensitometry, calculation of Z-score Criteria of tolerance of the drug (fever during the injection, hypersensibility…).

Results After 11 months, the results obtained were a reduction in the bone pains and a standardization of the Z-score (−1.2 SD in November 2005, 0.3 SD in November 2006). The treatment by pamidronate was stopped. During this period, there was no problem of tolerance of the drug.

Conclusions For this child, there has been quite an improvement of the BMD with pamidronate treatment. The biphosphonates have been already successfully used in children in others bone disorders like osteogenesis imperfecta [2]. However, the use of an adult presentation is not satisfactory and shows the gap of the pharmaceutical industry in pediatrics.

References

  1. 1.

    P. Moulin, I. Gennero, M. Tauber, JP Salles. Ostéoporose en pédiatrie: place des biphosphonates. Medecine et enfance.

  2. 2.

    T.Srivastava, U.S Alon. The role of biphosphonates in diseases of childhood. Eur J Pediatr (2003) 162:735–751.

Keywords Biphosphonates, Children, Osteoporosis

PT-177 analysis of non-adherence to guidelines on rational antibiotic prescribing

Vitalija Butkyte 1, Romaldas R. M. Maciulaitis1, Evaldas E. B. Bogusis1

1Clinical Pharmacology, Kaunas University of Medicine, Kaunas, Lithuania

Background and objective Non-rational and excessive use of antimicrobial agents increases resistance to these preparations. The main goal of our study was to evaluate non-adherence (NA) to guidelines (NfG) on rational antibiotic therapy and prophylaxis (ABT/P).

Design A cross-sectional study was performed in order to collect the data for patients receiving prescriptions for antimicrobial agents in January, 2006. Descriptive and comparative data were processed and evaluated using Graph Pad Prism 4 statistics program.

Setting Tertiary KMU Hospital, 2600 beds, 34 departments.

Main outcome measures The evaluation of NA to NfG. Analysis of the NA events according to profile of department, prescribing purpose (treatment or prophylaxis), selection (empirical or based on bacteriological tests), dosing features (too low/high) and spectrum (too broad/narrow).

Results 331/1110 (29.82%) patients received antibiotics prescription. The significant correlation between the profile of department and the NA (r = − 0.9259, P = 0.0239, Pearson correlation coefficient). 206/331 (62.24%) cases of ABT/P were assessed as NA. Excluding Ocular department 91 NA cases were evaluated further.

In NA cases mean (±SD) age was 49.27 (27.24%). NA cases consisted 34/76 (44.74%) cases in the departments of therapeutic profile; 30/56 (53.57%) in surgical profile; 23/61 (37.7%) in paediatric profile; and 0/6 (0%) in the intensive therapy profile. NA cases were considered in 58/160 (36.25%) in case of treatment and 33/49 (67.73%) in case of prophylaxis. The dependence between the NA and the type of the scope of antimicrobial prescribing (treatment or prophylaxis) was statistically significant (P = 0.0001, chi-square test). NA rate was 55/100 (55%) events in cases of empirical choice and 3/60 (5%) in case of treatment based on bacteriological tests.

NA case analysis revealed too high dose prescribed in 27/91 (29.67%) cases, too low dose—in 21/91 (23.08%) cases; too broad spectrum in 17/29 (58%) cases, too narrow—in 8/29 (27.59%), and in 4/29 (13.79%) case as unsafe.

Conclusions Proportions of NA cases were ranging from 0% to 54% among surgical, therapeutic, paediatric, and intensive care departments of tertiary hospital. NA proportions were higher in case of prophylaxis comparing to treatment and in case of empirical treatment comparing to treatment according to bacteriological tests. Too high and too low dosages comprised half of NA cases. Tendencies for higher comparing to lower spectrum were considered. These findings define more targeted intervention to be implemented.

Reference

  • Maciulaitis R., Miciuleviciene J., Stirbiene. Rational use of antimicrobial agents. Vilnius, 2004.

Keywords Non-adherence, Rational antibiticotherapy

PT-201 Count interindividual variability of biometric parameters to dose individualization?

Ma Ángeles López-Montenegro1, Elida Vila Torres1, Juan Gonzalez Valdivieso1, Juan Marquez Peiró 1, N. Victor Jimenez Torres1

1Pharmacy, Hospital Universitario Dr. Peset, Valencia, Spain

Background and objective To identify statistical differences of interindividual variability (IIV) in morphometric measures to dosage the drugs and elimination parameters in adult cancer patients treated with antineoplastic drugs.

Design A transversal retrospective observational study from January 2004 to December 2006.

Setting Individualization of antineoplastic drugs is established by body size measurement. In spite of this high toxicity and efficacy variability are met among patients. We analyzed morphometric measure and renal clearance of the cancer patients because majority of these drugs have renal excretion. Cancer type, Weight-W (kg), Height-H (cm), Body Surface Area-BSA (m2), Body Mass Index-BMI (kg/m2) and plasmatic creatinine clearance-ClCr (ml/min) were collected from electronic database (OncofarmTM). BSA, BMI and ClCr were calculated by Dubois and Dubois, Weight/Height2 and Cockroft-Gault formula, respectively. Statistical analysis: T-test.

Main outcome measures Interindividual variability (IIV) was estimated by means of coefficient of variation (CV) between different cancer type of BSA, IMC and ClCr.

Results A total of 1788 patients were in treatment (47% women, 53% men) with a mean age of 61.8 (CI 95%: 61.1–62.5). The cancer type distribution was 27% gastrointestinal, 20% lung, 15% breast, 14% genitourinary, 8% lymphoma, 4% head and neck, 4% myeloma, 3% leukaemia and 5% others. Cancer type groups with less number of patients (100) were excluded. IIV (CI 95%): W 17.76 kg (15.93–19.59); BSA 9.48 m2 (8.51–10.45); BMI 17.16 kg/m2 (15.84–18.48); ClCr 35.80 ml/min (33.79–37.81). The difference between morphometric measures (Weight, BSA, BMI) and ClCr was statistical significant (P < 0.05).

Conclusions The important interindividual variability suggest it translation to the exposure to the antineoplastic drugs. Consequently, due to the narrow therapeutic index of these drugs, adaptative dose methods could be a way to improve therapeutic outcomes because they become more predictable.

PT-225 Initiation of oral anticoagulant therapy (oat) with acenocoumarol in two internal medicine departments: a practice survey

C. ZAugg1, V. Amos1, C. Fournier2, J.-Ph. Reymond2, P. Y. Lovey3, Johnny Beney 1

1Pharmacie, 2Département de Médecine Interne CHCVs, 3Division D’hématologie, ICHV, Sion, Switzerland

Background and objective Initiation of OAT is challenging due to a narrow therapeutic window and considerable individual dose responsiveness. For a rapid anticoagulation effect, e.g. after venous thromoboembolism (VTE), a concurrent administration of unfractionated or low molecular weight heparin (UFH, LMWH) is required until the International Normalised Ratio (INR) has been in the therapeutic range for at least two days (stabilised OAT) [1]. In our setting, OAT is initiated empirically and adapted likewise according to INR. We wanted to evaluate the present practice.

Design Retrospective cohort study (01.06.2005 to 31.05.2006). Patients were included if the target range of INR was between 2 and 3.

Setting CHCVs.

Main outcome measures

  1. 1.

    Number of patients with stabilised OAT or concomitant UFH/LMWH prescription at discharge.

  2. 2.

    time to stabilise OAT.

  3. 3.

    occurrences of INR > 4.

  4. 4.

    number of haemorrhages.

Results

  • 69 patients were included.

  • 47 patients (68.5%) were discharged either with concomitant UFH/LMWH (8 patients) or stabilised OAT (39 patients).

  • Time to stabilise OAT was 6.5 ± 2.3 days for these latters.

  • 21 patients (30.4%) left hospital without stabilised OAT and without prescription of concomitant UFH/LMWH while at least 6 (8.7%) among them having an indication for it (4 pulmonary embolism and 2 deep vein thrombosis).

  • OAT was stopped in 1 patient.

  • There were 10 occurrences of INR > 4.

  • 2 patients had an haemorrhage (1 therapeutic, 1 elevated INR).

Conclusions Most patients (68.5%) were discharged either with a stabilised OAT or with UFH/LMWH associated. There is room for improvement for patients treated for VTE. Application of official recommendations [1] regarding the time span of concomitant use of UFH or LMWH at the initiation of OAT for different indications must be reinforced.

Reference

  1. 1.

    Ansell J, Hirsh J et al. The pharmacology and management of the vitamin K antagonists. Chest. 2004 Sep;126(3 Suppl):204S–233S

Keywords Acenocoumarol, Oral anticoagulant

PT-233 Safety profile of erlotinib: a survey of eight months in Godinot Institute and in Reims University hospital

Sophie Rauch 1

1Pharmacy, CHU Robert Debré, Reims, France

Background and objective Erlotinib is a specific reversible and ATP-competitive inhibitor of tumor-cell epidermal growth factor receptor (EGFR) tyrosine-kinase. Erlotinib (TARCEVA®, an oral treatment) is indicated for treatment of locally advanced or metastatic non small cell lung cancer after failure of at least on prior chemotherapy. According to the monography, the most frequent adverse events (skin toxicity and diarrhoea) can lead in some cases to treatment interruption; nevertheless no notification has been reported to the Regional Centre of Pharmacovigilance.

Therefore the aim of this study was to assess tolerance of erlotinib in a population with a non small cell lung cancer.

Design The study consisted of an eight-months retrospective study between January and September 2006 based on erlotinib prescriptions in pneumology departments.

Setting Pharmacy and Pneumology departments, Godinot Institute and University Hospital, Reims, France.

Main outcome measures Patients receiving erlotinib for the period January 2006- September 2006 were identified from the pharmaceutical records and erlotinib adverse drug reactions (ADRs) were analysed in the patients’ files (type, time and evolution).

Results 13 patients, average age 56.2 years (45–76) were treated by erlotinib. The sex-ratio was 8/5. For 46% of patients TARCEVA® was used as third-line treatment.

The related adverse events were rash (69%), diarrhoea (46%), asthenia (23%), anorexia (15%), abdominal pain (15%) and mucite (7%). 61% of the 24 ADRs observed were reported within the first week of treatment.

Concerning the most frequent-related adverse events, the evolution was more favourable for diarrhoea (54%) which could usually be managed with loperamide than for skin toxicity (38%) which requires sometimes dose reductions. Erlotinib was definitively withdrawn in 11 patients and for three cases ADRs were at least partially implicated.

Conclusions In this study no previously unrecognised ADRs have been identified. Diarhhoea and cutaneous reactions are the principal adverse reactions of erlotinib and can in a few cases lead to discontinuation. In collaboration with physicians pharmacists have so an important role to play in ADRs notification and consequently in patient treatment management.

Reference

  • Sheperd F., Pereira J. R., Ciuleanu T. Erlotinib in previously treated non-small lung cancer The New England Journal of Medicine 2005 July; 353 (2):123–132.

Keywords Erlotinib, Adverse drug reactions

PT-236 “Empirical treatment of newborns from colonized mothers or not by group b streptococci”

I. Blanco Barca 1, A. Concheiro Guisan2, C. Cadarso Suarez3, E. Pedrido Reino1, S. González Costas1, I. Arias Santos1

1Pharmacy, 2Neonatology, Complejo Hospitalario Universitario de Vigo, Vigo, 3Statistic, Medicine Faculty, Santiago de Compostela, Spain

Background and objective To compare results of two action protocols: “Empirical treatment of newborns from colonized mothers or not by group B Streptococci” in order to improve the use of antibiotics in case of neonatal sepsis risk. In children with risk of infection blood account and cultures were practised. In the first protocol, based on the hemogram, antibiotherapy was given while awaiting negative blood culture analyzing several parameters. In the new protocol, in effect since 2004, new more precise decision trees were designed.

Design Retrospective studies 1999 and 2004, in which newborns were included ≥2 kg at birth with suspected risk of infection due to: maternal colonization, prolonged rupture of membranes, maternal fever during delivery, suspected corioamnionitis. Final sample mothers-newborns: 411 (1999) versus 419 (2004). Statistical analysis: SPSS version 10.0 programme used (Fischer test/Yates correction).

Setting Department of Pharmacy and Neonatology.

Main outcome measures Maternal colonization. Prophylaxis during delivery. Antibiotherapy and blood cultures on newborns.

Results

  1. 1.

    Analysis of fulfilment: (1999: final sample 406 pairs of mothers-newborns *5 newborns unable to evaluate) 57% (1999) vs. 94.75% (2004)of the studied were correctly treated. 5.3% (1999) vs. 0.24% (2004) of newborns who should have received treatment were not treated. An excess of 37.7% (1999) (it’s associated significantly (P < 0.001) to the positive result or ignorance of maternal colonization even without risk factors) versus 5.01% (2004) of newborns were treated.

  2. 2.

    Maternal colonization third term: negative (1999:228; 2004:176) unknown (1999:14; 2004:53) positive (1999:169; 2004:190).

  3. 3.

    Prophylaxis during delivery: not carried out or incomplete (1999:297; 2004:302) complete (1999:114; 2004:117).

  4. 4.

    Newborn antibiotherapy: 1999: 326 (80.3%) YES-80 (19.7%) NO. 2004:34 (8.2%) YES-385 (91.9%) NO.

  5. 5.

    Newborn positive blood cultures: 1999: 4 (0.97%); 2004: 7 (1.7%) No cases of infection.

Conclusions In the first protocol four children had positive blood cultures indicating pathogenic bacterias, but none developed infection. Two were treated when the protocol indicated that no treatment was necessary which questions the validity of the protocol. The cases of positive or unknown maternal colonization can be associated to the lack of fulfilment because of excess of treatment.

These conclusions resulted in the implantation of a new protocol in May 2004.3- Data of maternal colonization and prophylaxis during delivery are comparable in both protocols, however the implantation of the new protocol resulted in a best fulfilment and a significant reduction in antibiotherapy in newborns without causing a significant increase in positive blood cultures. There weren’t clinic infections.

PT-280 Rational use of fluoroquinolones in treating urinary and pulmonary infections

Anne Lise Pouliquen 1, Cécile Raignoux1, Marie Hélène Fiévet1, Robert Farinotti1

1Pharmacy, Pitié Salpêtrière, Paris, France

Background and objective As antimicrobial resistance is steadily increasing, our local therapeutic committee has recommended guidelines for a rational antibiotic policy. Fluoroquinolones (FQ) account for a substantial proportion of hospital antibiotics consumption, with a particularly high risk of bacterial resistance development. Thus the committee set up a pre-printed prescription formulary for FQ displaying recommendations. The pharmacy department performed a study to assess their current use and compare them with these guidelines published few years ago.

Design The study has been conducted over 1 month at the pharmacy department in interplay with the bacteriology department. All prescriptions were collected, and those for urinary tract or pulmonary infections were especially analyzed. Information on prescription was completed by telephone survey.

Setting University Hospital, Paris, France (2000 beds).

Main outcome measures Our study has been undertaken to examine specific patients’ factors: clinical (indication, drug association, administration route and total planned duration of therapy) and bacteriological data (germs responsible and antibiogram) facing the FQ prescribed.

Results A total of 611 prescriptions for an overall of 301 patients were collected, mostly for urinary tract (25.9%) and pulmonary (17.6%) infections. Most prescribed FQ were ciprofloxacin (50.1%), ofloxacin (39.9%), followed by norfloxacin (7.0%).

78 patients (median age: 60.5 years; urinary catheter required for 32%) were treated for urinary tract infections (UTI). Acute cystitis were managed in 41 cases, 14 were asymptomatic. Bacteria were isolated in 49 UTI (71.4% Escherichia coli). Ofloxacin was the most prescribed FQ (64.1%) in UTI, in accordance with the number of E coli susceptible to all FQ (60%). FQ were prescribed in monotherapy for 55 patients (70.5%), and administered orally in 85.9% of cases. Concerning the planned treatment duration, only 43.6% of the prescriptions were shorter than 10 days.

39 patients (median age: 63 years; intubated and ventilator assisted 23.1%; immunosuppressed 28.2%) were treated for pulmonary infections, mainly for pneumopathies (14 nosocomial, 8 community-acquired, 11 others). Prescription of ciprofloxacin account for 69.2% although only 33.3% of infections were caused by Pseudomonas aeruginosa. Most FQ were prescribed in association (79.5%), and, for initial administration, intra-veinously (61.5%). The intended treatment duration was shorter than 10 days in merely 48.7% of the prescriptions.

Conclusions This study shows that, despite the availability of guidelines, prescriptions of FQ remain largely empirical, not always in accordance with the germ or the indication. Furthermore duration of treatment is sometimes excessive. Eventually this study highlights that the strict follow-up of treatments allows the pharmacist’s involvement in antibiotics rational use.

Keywords Fluoroquinolones, Clinical practice

PT-289 Ulcerative oral mucositis: towards the identification of the major risk factors to target the use of palifermin

Sandrine Philippe 1, Catherine Ollivier1, Oumedaly Reman2

1Pharmacy Unit, 2Haematology Unit, CHRU, Caen, France

Background and objective Palifermin, the first recombinant human keratinocyte growth factor is indicated for the prevention and treatment of oral mucositis (OM) in patients with haematological cancers undergoing myeloablative therapy, which suppresses bone marrow activity. The severe OM prevalence can vary from 28% to 100%*, the most important rates are encountered by patients who receive intensive treatments, particularly the conditioning regimen by BEAM (80%) and total body irradiation (99%). In the literature, no predictive factors for OM are clearly reported. In this context, we wanted to determine factors to optimize the use of palifermin targeting more precisely a population to be treated.

Design A retrospective study over 8 years included all patients with lymphomas receiving a myeloablative conditioning regimen by BEAM and haematopoietic progenitor cells rescue.

Setting Haematology unit.

Main outcome measures The studied patients were classified in 3 groups: Group A patients without OM, Group B patients with OM of moderate grades (1–2 grades**) and Group C, patients with severe OM (3–4 grades**). For each patient, 10 factors were analyzed: sex, age over 60, initial disease diagnostic, previous chemotherapies, nutritional condition, dental condition, active smoking, nauseas and vomiting frequency (NVF), positive herpetic serology and the used of drugs causing an oral dryness.

Results 39 patients were included (22 males, 17 females). The mean age was 47.4 (range 20–66 year). 77% patients developed OM: 9 patients were included in the group A (23%), 19 patients in the group B (49%) and 11 patients in the group C (28%). In the analysis, the OM appearance seems to support by 2 factors (A vs. B–C): average or severe NVF (P = 0.029) and the used of drugs supporting an oral dryness (P = 0.007). Moreover OM aggravation factors were distinguished (A–B vs. C): female sex (P = 0.022), age over 60 (P = 0.006) and average or severe NVF (P = 0.05). The analysis showed also that, among these elements, a single factor was not sufficient to develop severe OM and the association of several factors increased the risk: in the group A, only 2 patients associated 2 or 3 factors while in the group C, 9 patients had more than 2 factors. The other analyzed factors (initial diagnostic, previous chemotherapies…) didn’t present any impact on OM.

Conclusions Some factors seem to be involved, with variable degrees, in the appearance and the aggravation of OM. The results of this pilot study will permit to set up a prospective analysis to refine these factors: the emetic risk must be estimated during the previous chemotherapies in order to protect with appropriated anti-emetics the patients who are emetic high risk and, the used of drugs causing an oral dryness must be argued before the BEAM chemotherapy.

References

  • * British Journal of Haematology, 2000, 110, 292–99.

  • ** The World Health Organization (WHO) classification.

Keywords Mucositis, Factors, Palifermin

PT-290 The necessity for deep venous thrombosis prophylaxis after splenectomy: a case report.

Sabine Deryckere 1, Hugo Robays1, Marijke Van Hooreweghe1

1Pharmacy Department, University Hospital of Ghent, Ghent, Belgium

Background and objective The pathogenesis of idiopathic thrombocytopenic purpura (ITP) is presumed to be related to the presence of platelet-specific auto-antibodies. Splenectomy is the traditional second-line therapy for ITP when glucocorticoids fail.The platelet count typically increases within the first 2 weeks after splenectomy [1]. Some patients have an immediate post-operative major increase [2]. This prompt response is consistent with the theory that the spleen is the major site of destruction of antibody-covered platelets. Furthermore, an increased risk of thrombosis has also been reported for patients following splenectomy due to procoagulant platelet microparticles which cannot be filtered anymore by the spleen after a splenectomy [3]. Because of these two reasons prophylaxis for deep venous thrombosis (DVT) cannot be omitted.

With this case report we want to communicate the necessity for DVT prophylaxis after a splenectomy when executed because of ITP.

Design Case report, clinical intervention based on clinical data and literature review.

Setting General and hepatobiliary surgery ward at the Ghent University Hospital, Belgium.

Main outcome measures Evaluation of platelet count in serum before and after splenectomy.

Results A 43-year old woman with a history of mammacarcinoma and spinocellular rectumcarcinoma was diagnosed with ITP. Platelet count at the time of diagnosis was 40 × 103/μl (range: 149–409 × 103/μl).

Initial treatment with methylprednisolon and intravenous immunoglobulins was unsuccessful. Therefore, a laparoscopic splenectomy was performed. Platelet count at the time of surgery was 91 × 103/μl. The day after surgery the clinical pharmacist on the ward checked the patient’s medication chart for the first time. The medication did not include DVT prophylaxis. Therefore, the clinical pharmacist proposed to start enoxaparin 40 mg subcutaneous once daily. A few hours after the splenectomy the patient’s platelet count was 121 × 103/μl, 12 h after surgery 164 × 103/μl, 4 days later 284 × 103/μl. The patient is in complete remission.

Conclusions This case report shows that clinicians and clinical pharmacists should keep in mind the necessity for DVT prophylaxis after splenectomy executed because of ITP, despite a low platelet count before surgery.

References

  1. 1.

    Kojouri K et al. Splenectomy for adult patients with idiopathic thrombocytopenic purpura: a systematic review to assess long-term platelet count responses, prediction of response, and surgical complications. Blood. 2004,104(9):2623–2634.

  2. 2.

    Wu JM et al. Laparoscopic splenectomy for idiopathic thrombocytopenic purpura. Am J Surg. 2004, 187:720.

  3. 3.

    Tiede MP et al. Life-threatening hypercoaguable state following splenectomy in ITP: successful management with aggressive antithrombotic therapy and danazol. Clin Appl Thrombosis/Hemostasis. 2005, 11(3):347–352.

Keywords ITP, Splenectomy, DVT

PT-296 Pharmacist interventions in antimicrobial therapy: clinical and microbiological features of these patients

David Conde Estévez 1, Sonia Luque Pardos1, Santiago Grau Cerrato1, Nuria Berenguer Torrijo1, Xavier Mateu-de Antonio1, Pere Ortiz Sagrista2, Olivia Ferrandez Quirante1, Jordi Fernández Morato1, Esther Salas1

1Pharmacy, Hospital del Mar, 2Pharmacy, Hospital Esperança, Barcelona, Spain

Background and objective Antibiotics are one of the most frequently prescribed class of drugs. Widespread and inappropriate use of antibiotics increases health care costs and contributes to antibiotic resistance. One important task of clinical pharmacists are to perform interventions to optimize antimicrobial treatments. Computer programs have been developed to help pharmacists to make efficiently this work.

The objective of this study was to compare the clinical and microbiological features between patients with an accepted vs. a non-accepted pharmacist intervention accomplished by an integrated computer program.

Design Retrospective study carried out in all patients with antimicrobial pharmacist interventions during January 2006. Physicians received interventions through an integrated computer program. In statistical analysis Fischer exact test for dichotomic variables and “U” Mann Whitney test for continuous variables were employed.

Setting A 450-bed university hospital.

Main outcome measures Total interventions, interventions in antibiotic therapies, accepted antimicrobial interventions; type of interventions: antibiotic discontinuation, new prescription, dose adjustments, de-escalation to narrower spectrum antibiotics, pharmacokinetics’ monitoring, adverse effects, drug interactions, contraindications or resistance to isolated microorganisms.

Clinical features: demographics; ward, main diagnosis; type of antibiotic, total length of hospital stay, days of antimicrobial treatment, length of stay before the acceptance of the intervention, length of stay after the intervention.

Microbiological parameters: isolated microorganism (Micr) related to infection or colonization, site of infection, type of culture, antimicrobial susceptibility pattern; and crude mortality.

Results Total interventions: 267; interventions in antibiotic therapies: 50 (18.72%); accepted: 37 (74%) vs. no accepted 13 (26%); age: 67.7 (95% IC: 62.1–73.3) vs. 75.4 (95% IC: 70.7–80.1); age < 65 years: 14(37.8%) vs. 1(5.8%) (P = 0.076); Micr: enterococci 1(2.7%) vs. 5(38.5%) (P = 0.003); this last significant difference was lost when colonizations were excluded: 1(2.7%) vs. 1(5.8%) (P = 0.456).

No differences were observed in the remaining variables.

Conclusions Interventions in antibiotic therapies represents nearly the fifth part of the total pharmacist interventions.

This study shows a trend to a pharmacist intervention acceptance in patients younger than 65 years.

Enterococci isolation from cultures were related to a not acceptance of interventions because these microorganisms were considered colonizations by physicians.

No differences were observed in any antimicrobial agent group in relation to interventions’ results.

Keywords Interventions, Antimicrobial, Pharmacotherapy

PT-297 Analysis of rituximab prescriptions over 2006 in Lille hospital

Cecile Combis 1, Cecile C. C. Combis1, Chloe C. R. Rousseliere1, Camille C. P. Potey1, Maxime M. M. Mutombo1, Angelique A. L. Leroy1, Dominique D. L. Lecoutre1, Monique M. Y. Yilmaz1

1Pharmacy, Chru, Lille, France

Background and objective Rituximab is a humanized monoclonal anti-CD20 antibody, widely used in various pathologies. In France, Health Authorities require hospitals to control the use of expansive drugs like antibodies. Pharmacists check prescriptions according to the Good Practice Contract. The aim of this study is to evaluate the utilization of Rituximab in Lille University Hospital over 2006.

Design Indications are collected from prescriptions for every patient and classified in three groups: label indications (group 1)-off label indications with scientific recommendations (group 2) and without scientific recommendations (group 3)5 categories of indications are identified: haematological, rheumatologic, nephrologic, neurological and autoimmune diseases.

Setting Lille university hospital.

Main outcome measures Number of Rituximab prescriptions per indications.

Results 277 patients received Rituximab in 2006. Proportions of various groups of indications for every speciality are: haematological (69%), rheumatologic (12%), nephrologic (7%), neurological (2%) and autoimmune diseases (10%) 60% of indications belong to group 1, 27% to group 2% and 13% to group 3. The rheumatologic practices are in label group. The neurological, nephrologic and autoimmune diseases prescriptions are off label.

Conclusions More and more, Rituximab treatment is tried out in various medical areas, and in different indications in clinical pathologies. One-third of the prescriptions contain off label indications. These results underline the necessity To analyse utilizations in off label indications. This will enable to validate these utilizations, and to include them in the Good Practice Contract defined by the Health Authorities.

Keywords Rituximab, Good practices, Indications

PT-299 Severe mercuric cyanide intoxication treated by dimercaptosuccinic acid (DMSA): one case report

Chloé Rousselière 1, Cécile Combis1, Stéphanie Ledoux2, Angélique Leroy-Cotteau1, Patrick Nisse3, Annie D’haveloose1, Monique Yilmaz1

1Pharmacy, 2Medical Reanimation, 3Poison Control Centre, CHRU, Lille, France

Background and objective Mercuric intoxication is rare but serious. The main cause of acute intoxication is suicide. Mercuric intoxication can be treated by chelator molecules: dimercaprol, dimercaptopropane sulfonate (DMPS, unregistered in France) and DMSA (only available in hospitals in France) associate with haemodialysis or hemoperfusion. We report one original case of DMSA and hemoperfusion using.

Design A 53 years-old man committes suicide by taking three tablets of mercuric cyanide. Few hours later he presents digestive troubles characterized by bloody vomiting, epigastralgia and diarrhoea associate with acute renal failure. The first line therapy by hydroxocobalamin and dimercaprol isn’t well tolerated by the patient. In fact he develops an allergy to dimercaprol. Haemodialysis is effective but the patient makes a cardiorespiratory failure. As consequence DMSA therapy 120 mg 3 times per day associates with colestyramin 4 g 4 times daily and four courses of charcoal hemoperfusion are started.

Setting Department of medical reanimation, Lille University Hospital, France.

Main outcome measures The consequences of intoxication are evaluated by creatininaemia rate (N: 5–12 mg/l). The efficiency of therapy is monitored by plasma mercury level.

Results At the admission, mercury plasma level is 3050 μg/l (toxic zone >5 μg/l) and creatininaemia plasma level increases to 47 mg/l. At day 24, when DMSA therapy is started, mercury plasma level is 793 μg/l and creatininaemia up to 59 mg/l. After first course of DMSA-colestyramin and one hemoperfusion session, mercury plasma rate decreases to 366 μg/l and creatininaemia to 40 mg/l. After 8 days of therapy and 2 courses of hemoperfusion mercury plasma level decreases around 200 μg/l and continues to fall slowly. Serum creatininaemia level decreases and normalizes after 18 days of therapy. The patient goes out, after 32 days of DMSA therapy.

Conclusions This case shows efficiency of an oral chelator molecule in association with hemoperfusion. Treatment recommendations vary and the effectiveness of chelation therapy is controversial. DMSA can be an alternative of dimercaprol especially in mercuric intoxication when dimercaprol is unwell tolerated and for patient with renal failure.

Keywords Mercuric intoxication, DMSA, Case report

PT-300 The role of nitric oxide in changes in arterial reactivity after exposure to contrast medium.

Leszek Szadujkis-Szadurski 1, Grzegorz Grzesk1, Katarzyna Szadujkis-Szadurska1, Elzbieta Grzesk2, Rafal Szadujkis-Szadurski1

1Department of Pharmacology and Therapeutics, 2Department of Pediatrics and Oncology, Collegium Medicum Nicolaus Copernicus University, Bydgoszcz, Poland

Background and objective The most important physicochemical features of water-soluble, iodinated contrast medium (CM) are their solubility, the viscosity and osmolality of their solutions, the lipophilic or hydrophilic qualities, their electrical charge but little is known about their interactions with cellular receptor systems. We investigated the changes in reactivity of small resistance artery after exposure to CM: ionic (iCM) and non-ionic CM (niCM).

Design Experiments were performed on isolated and perfused male Wistar rats’ tail artery.

Setting We investigated the contractility after stimulation of vasopressin receptor with arg-vasopressin (AVP) and stimulation of alpha1-adrenoceptor with phenylephrine after short (repeated twice) and prolonged (repeated ten times) exposure to CM in comparison to controls. The contractility of iCM and niCM pretreated arteries was compared to controls.

Main outcome measures The constriction of the rat tail artery in response to PHE and AVP was measured as an increase of perfusion pressure at a constant flow of the perfusion fluid (about 1 ml/min.).

Results Significant decrease in reactivity of smooth muscle in iCM and niCM group vs. control was observed. Control EC50 for PHE was 7.42 (±0.76) × 10e−8, for AVP 5.45 (±0.85) × 10e−9. In the presence of niCM-2 min the EC50 for PHE and AVP was 7.64 (±0.56) × 10e−8 (ns.) and 8.50 (±0.80) × 10e−9 (P < 0.05). In the presence of iCM-2 min the EC50 for PHE and AVP was 8.42 (±0.67) × 10e−8 (P < 0.05) and 1.32 (±0.92) × 10e−8 (P < 0.05). This effect was significantly reduced by indomethacine (the cyclooxigenase inhibitor) and after short exposure by NO synthase inhibitors (N-omega-nitro-L-arginine-methyl ester). The calculated KA values for PHE and for AVP in groups did not differ significantly, but KA/ED50 significantly decreased.

Conclusions Our results suggest that the both iCM and niCM promote decrease in contractility as a result of increase in production of prostanoids and after short exposure—prostanoids and nitric oxide.

PT-302 The influence of ischemia/reperfusion on the smooth muscle cells contractility induced by angiotensin 2

Leszek Szadujkis-Szadurski 1, Katarzyna Szadujkis-Szadurska1, Rafal Szadujkis-Szadurski1, Grzegorz Grzesk1

1Department of Pharmacology and Therapeutics, Collegium Medicum Nicolaus Copernicus University, Bydgoszcz, Poland

Background and objective Reactive oxygen species act as second messengers that may play a physiological role in vascular tone, and a pathophysiological role in ischemia-reperfusion and hypertension. The aim of this study was to examine the effects of ischemia/reperfusion (I/R) on reactivity of arteries to angiotensin II (ANG II) and to determine the role of antioxidative system in this condition.

Design Experiments were performed on isolated and perfused male Wistar rats’ tail artery.

Setting The effects of ANG II on vascular tone after 30 min of ischemia and 30, 60 and 90 min of reperfusion were investigated. The results were then compared with reactions performed in the presence of catalase or aminotriazole.

Main outcome measures

The constriction of the rat tail artery in response to ANG II was measured as an increase of perfusion pressure at a constant flow of the perfusion fluid (about 1 ml/min.).

Results After ischemia CRC for ANG II was shifted to the right with reduction in maximal response, while after 30, 60 and 90 min of reperfusion CRCs were shifted to the left with increasion in maximal responses. EC50 for ANG II were 1.22 (±0.23) × 10e−8, after ischemia 2.89 (±0.33) × 10e−8, after 90 min of reperfusion 2.17 (±0.22) × 10e−9. In the presence of catalase calculated EC50 values were higher, while in the presence of amonotriazole EC50 values were lower. EC50 for ANG II in the presence of catalase were 8.26 (±0.29) × 10e−8, after ischemia 1.29 (±0.31) × 10e−7, after 90 min of reperfusion 5.57 (±0.24) × 10e−9.

Conclusions Results suggest that vascular contraction induced by ANG II is modulated by antioxidative system, and reperfusion impairs the balance between antioxidants and the production of reactive oxygen species.

PT-304 Drug use evaluation of cetuximab in patients with metastatic colorectal cancer

Maria Josep Carreras1, Marta Parera2, Nuria Padulles 1, Elena Tomas1, Josep Tabernero2, Josep Monterde1

1Pharmacy, 2Oncology, Hospital Vall d’Hebron, Barcelona, Spain

Background and objective Cetuximab is a chimeric monoclonal antibody that binds to the epidermal growth factor receptor (EGFR) and thereby inhibits cell proliferation. It has demonstrated activity in monotherapy and in combination with Irinotecan (CPT-11) in EGFR-expressing metastasic colorectal cancer (mCRC) refractory to CPT-11-based chemotherapy. The aim of this study is to analyse the use of cetuximab in mCRC in an assistencial setting.

Design Retrospective study in 36 patients with mCRC (treated with cetuximab from 10/2003 to 09/2006. Demographic, pathological and pharmacological variables were recorded.

Setting mCRC patients treated with cetuximab in an assistencial setting.

Main outcome measures Time-to-progression (TTP), tumour response and adverse reactions.

Results Mean age was 62 (range, 37–81); 29 mean/7 women; 29 colon/7 rectum. Metastasis location: 87% liver, 43% lungs, 19% peritoneal and 9% bone. Previous chemotherapy for mCRC: 100% 5-fluorouracil (5FU)-based, 100% CPT-11-based and 41.7% oxaliplatin-based. Only one patient received cetuximab in combination with FOLFOX in the first-line setting in a compassionate use procedure, and this patient was excluded from the analysis. EGFR-expression: 80% in 85%. Mean CEA/CA19-9 levels before and ≥ positive in 95%. Karnovsky index after cetuximab were 38/83 and 24/50, respectively. Patients were treated with cetuximab (400 mg/m2 loading dose, then 250 mg/m2 weekly) combined with CPT-11 (73%) or CPT-11 + 5FU-Leucovorin (27%). Median cycles received 10 (range 1–30). Treatment was applied as 2nd to 7th line (2nd 26%, 3rd 40%, 4th 30%). Best response to treatment: 5 (14%) objective response, 18 (50%) stable disease and 13 (36%) progressive disease. Median TTP was 3.9 months (range, 1.4–8.6). The most common adverse event was acneiform rash, in 27 patients (grade 1, 46%; grade 2, 40%; grade 3, 14%), followed by diarrhoea in 11. Dose reductions and interruptions were done in 6 patients.

Conclusions The activity and the safety profile used in the approved indication by the EMEA translates in a moderate activity with an acceptable safety profile in this refractory population. The results of this study in the assistencial setting support this treatment option. Ongoing studies are developing cetuximab in an earlier stage of the disease.

Keywords Cetuximab, Metastasic colorectal cancer, Assistencial setting

PT-305 Acetylation status has no impact on the hemodynamic effects of levosimendan

Rajendra Pradhan 1, Peter Noertersheuser2, Wenhui Zhang1, Walid Awni1

1Clinical Pharmcokinetics, Abbott Labs, Abbott Park, IL, United States; 2Clinical Pharmcokinetics, Abbott Labs, Ludwigshafen, Germany

Background and objective Levosimendan is an intravenous treatment under evaluation for acute heart failure (AHF). The hemodynamic effects seen after levosimendan administration are due to the pharmacological activity of levosimendan and its metabolites. Levosimendan is reduced to OR-1855 in the gastrointestinal tract by intestinal bacteria. After absorption, the reduction product OR-1855 is further acetylated by N-acetyltransferase 2 (NAT2) enzyme to form OR-1896. NAT2, involved in the formation of OR-1896 metabolite and the equilibrium between OR-1855 and OR-1896 metabolites, is a polymorphically distributed enzyme. Involvement of the NAT-2 polymorphism in disposition of levosimendan was evaluated with a population pharmacokinetic/pharmacodynamic (PK/PD) model. Additionally, the impact of the NAT2 polymorphism on the hemodynamic response of levosimendan was evaluated.

Design A population PK/PD model was constructed using data in patients with NYHA Classes II-IV congestive heart failure from eight clinical studies. The combined dataset included infusion of various doses (0.25–70.6 mg), rates (0.05–0.6 mcg/kg/min) and durations (5 min–7 days), with or without an initial loading dose. A pop-PK mixture model allowing different inter-conversion rates between OR-1855 and OR-1896 for rapid and slow acetylators was used to accommodate the NAT2 polymorphism. The robustness of model parameter estimates and the observed-versus-model predicted concentration diagnostic plots for Levosimendan, OR-1855 and OR-1896 were used to test the goodness-of-fit. Hemodynamic responses from rapid and slow acetylators were compared.

Setting Global Pharmaceutical Research and Development, Abbott Laboratories.

Main outcome measures The hemodynamic response parameters were pulmonary capillary wedge pressure (PCWP), heart rate (HR).

Results The mean post-hoc inter-compartmental clearance (CL23), describing the relationship between OR-1855 and OR-1896, was approximately 3-times greater for rapid acetylators than for slow acetylators (58.4 vs. 21.9 l/h), illustrating the NAT2 polymorphism. The OR-1855 exposure was greater in slow acetylators and the OR-1896 exposure was greater in rapid acetylators. However, these PK differences did not result in different hemodynamic responses in slow and rapid acetylators.

Conclusions Patient’s acetylation status (NAT2 polymorphism) has no impact on the hemodynamic effects of levosimendan. Thus, dose adjustment is not necessary based on acetylation status.

Keywords Levosimendan, NAT2 polymorphism, Population PK/PD.

PT-311 Drug use evaluation of oxaliplatin and irinotecan in metastatic colorectal cancer

Pilar Llopis-Salvia 1, Gema Sarrio-Montes1, Agueda Sanchez-Castellon1

1Pharmacy Department, Hospital de la Ribera, Alzira, Spain

Drug use evaluation of FOLFOX and FOLFIRI as first-line palliative treatment is reviewed.

Design Type of study: Retrospective review.

Period: January 2000–October 2006.

Inclusion criteria: Unselected patients diagnosed with metastatic colorectal cancer who received FOLFOX (oxaliplatin, leucovorin and fluorouracil every 14 days) or FOLFIRI (irinotecan, leucovorin and fluorouracil every 14 days) as first-line palliative treatment.

Exclusion criteria: FOLFOX or FOLFIRI administered as induction treatment before scheduled surgery of metastases or adjuvant chemotherapy administered after scheduled surgery of metastases.

Procedure: Review of pharmacy antineoplastic drug preparation database. Variables recorded: sex, age, weight, type of neoplasm, chemotherapeutic regimen, dosage and dates of administration.

Setting Oncology outpatient setting at a tertiary centre.

Main outcome measures Number of cycles administered, length of treatment (LT), time to treatment discontinuation due to disease progression (DP) or adverse drug reactions (ADRs). Percentage of patients who experienced dosage reductions (dosage <85%) or delay in treatment administration was also recorded (time >50%).

Results 67 patients received FOLFIRI (51) and FOLFOX (16) as palliative treatment. Mean age was 62.8 (10.2) years, 40 were male (60%) and 27 (40%) were female. Mean weigh was 72.6 (14.4) kg. 45 (67%) patients were diagnosed with colon cancer whereas 22 (33%) patients suffered rectum cancer. 5 patients in the FOLFIRI group were lost for evaluation due catheter infection (2), death (2) not related with the antineoplastic treatment and treatment rejection (1).

3 (6.5%) patients in the FOLFIRI group and 2 (12.5%) in the FOLFOX discontinued treatment due to complete response.

Median number of cycles administered was 12.0 (1.5) and 16.0 (3.8) and LT in each group was 9.6 (4.5) and 7.5 (2.2) months for FOLFIRI and FOLFOX respectively (P > 0.05). Treatment discontinuation was due to progression in 38 (82.6%) and 9 (56.3%) patients in the FOLFIRI and FOLFOX group respectively. 5 patients in each group (10.9% FOLFIRI and 31.3% FOLFOX) discontinued treatment due to de following ADRs: haematological (2), gastrointestinal (3) for FOLFIRI and haema-tological (3), neuropathy (1) and allergic (1) in the case of FOLFOX.

Compliance with the planned dosage was high: 89% and 87% whereas compliance with scheduled dates was low: 39% and 47% higher than the period of time planned for FOLFIRI and FOLFOX respectively (P > 0.05).

Conclusions Although the number of patients evaluated is low, particularly in the FOLFOX arm, effectiveness and tolerance in terms of dose received and treatment discontinuation is comparable between both treatments. Continuous assessment of effectiveness and safety of antineoplastic chemotherapy in clinical practice provides information of treatment results under real conditions.

PT-324 Levosimendan affects hemodynamic responses in a simple e-max and dose-dependent manner in patients with acute heart failure

Rajendra Pradhan 1, Wenhui Zhang1, Peter Noertersheuser2, Roopal Thakkar3, Walid Awni1

1Clinical Pharmcokinetics, Abbott Labs, Abbott Park, IL, United States; 2Clinical Pharmcokinetics, Abbott Labs, Ludwigshafen, Germany; 3Levosimendan Global Clinical Team, Abbott Labs, Abbott Park, IL, United States

Background and objective Levosimendan is an intravenous treatment under evaluation for acute heart failure (AHF). Therapeutic objectives for AHF vary based on patient’s clinical status. The hemodynamic effects seen after levosimendan administration are due to the pharmacological activity of levosimendan and its metabolites. REVIVE II and SURVIVE, the Phase III trials, loading doses were 6–12 mcg/kg for 10 min, followed by 0.1 mcg/kg/min for 50 min, then 0.2 mcg/kg/min for the remaining 23 h. A PK/PD model was constructed using the available data and used to explore hemodynamic effects of 24 h infusion rates that were <0.2 mcg/kg/min.

Design A population PK/PD model was constructed using data in patients with NYHA Classes II-IV congestive heart failure from eight clinical studies. The combined dataset included infusion of various doses (0.25–70.6 mg), rates (0.05–0.6 mcg/kg/min) and durations (5 min–7 days), with or without an initial loading dose. The PK/PD models described the relationships of the exposures of LS and its metabolites and the hemodynamic variables.

Setting Global Pharmaceutical Research and Development, Abbott Laboratories.

Main outcome measures Hemodynamic response variables were pulmonary capillary wedge pressure (PCWP) and heart rate (HR).

Results The model-based simulations demonstrated that levosimendan affects hemodynamic response in an E-max and dose-dependent manner. At the end of the infusion (24 h), the effects on PCWP (change from baseline) at doses of 0.05 and 0.1 mcg/kg/min were approximately 70% and 87% of those observed at 0.2 mcg/kg/min, respectively. The corresponding values at Day 5 following the initiation of infusion were 81% and 92%, respectively, suggesting the difference narrowed further out in time. The lower infusion rates (0.05 and 0.1 mcg/kg/min) were predicted to cause much less of an increase in HR compared to that observed at 0.2 mcg/kg/min. At 24 h, the effect on HR (changes from baseline) at infusion rates of 0.05 and 0.1 mcg/kg/min were approximately 44% and 69% of that observed at 0.2 mcg/kg/min. The corresponding values at day 5 were 60% and 79%, respectively.

Conclusions The simulations predict that Levosimendan decreases PCWP and increases HR in a differential and dose-dependent manner. Furthermore, these dose-dependent relationships had a simple E-max profile. Thus, lower infusion rates can attenuate HR increases while preserving PCWP effects.

Keywords Levosimendan, Hemodynamic response, Emax model

PT-325 Levosimendan population pharmacokinetic/pharmacodynamic model predicts hemodynamic responses in patients with acute heart failure

Rajendra Pradhan 1, Peter Noertersheuser2, Wenhui Zhang1, Leticia Delgado-Herrera3, Roopal Thakkar3, Walid Awni1

1Clinical Pharmcokinetics, Abbott Labs, Abbott Park, IL, United States; 2Clinical Pharmcokinetics, Abbott Labs, Ludwigshafen, Germany; 3Levosimendan Global Clinical Team, Abbott Labs, Abbott Park, IL, United States

Background and objective Levosimendan is an intravenous treatment under evaluation for acute heart failure (AHF). A population pharmacokinetic/pharmacodynamic (PK/PD) model was developed for levosimendan and hemodynamic data from patients with AHF in 2 Phase 3 studies (REVIVE II, N = 600 and SURVIVE, N = 1327) were used to validate the model.

Design A population PK/PD model was constructed using data in patients with NYHA Classes II-IV congestive heart failure from eight Phase 2 clinical studies. The combined dataset included infusion of various doses (0.25–70.6 mg), rates (0.05–0.6 mcg/kg/min) and durations (5 min–7 days), with or without an initial loading dose. The model was used to predict the hemodynamic responses for the validation dataset based on patient’s dosing history and covariates. In REVIVE II and SURVIVE trials (the validation dataset) loading doses were 6–12 mcg/kg for 10 min, followed by 0.1 mcg/kg/min for 50 min, then 0.2 mcg/kg/min for the remaining 23 h.

Setting Global Pharmaceutical Research and Development, Abbott Laboratories.

Main outcome measures The hemodynamic response variables were heart rate (HR), systolic blood pressure (SBP) (all averaged using time–windows of 12 h each over 120 h).

Results The mean predicted time courses of HR and SBP responses followed a similar trend as the mean observed time courses of HR and SBP responses for the REVIVE II trial. The mean predicted and observed HR changes from baseline slowly increased and reached steady state by Day 3. The mean predicted and observed peak HR responses were approximately 7 beats/min (bpm). The mean predicted and observed SBP changes from baseline rapidly decreased within the first 24 h and reached the maximal effect by Day 2. The mean predicted and observed peak SBP responses were approximately −7 mmHg. Similarly, the model provided reasonable predictions for HR and SBP in the SURVIVE trial. The mean predicted and observed peak HR responses were approximately 5 to 6 bpm. The mean predicted and observed peak SBP responses were approximately −5 to −6 mmHg.

Conclusions The model validation exercise showed that the PK-PD model developed using the Phase II data was successful in predicting the average time course and magnitude of hemodynamic responses (HR and SBP) from 2 Phase 3 trials in patients with AHF.

Keywords Levosimendan, PK/PD model validation

PT-326 The hemodynamic impact of a loading dose preceding a 24-h continuous infusion of levosimendan in patients with acute heart failure

Wenhui Zhang 1, Rajendra Pradhan1, Roopal Thakkar2, Walid Awni1

1Clinical Pharmcokinetics, 2Levosimendan Global Clinical Team, Abbott Labs, Abbott Park, IL, United States

Background and objective Levosimendan is an intravenous treatment under evaluation for acute heart failure (AHF). The elimination half-life of levosimendan is about 1 h and steady state is achieved in about 4–5 h following the start of a continuous infusion. A loading dose along with continuous infusion has been used to reduce the time taken to reach PK steady state. A population pharmacokinetic and pharmacodynamic (PK/PD) model was developed to evaluate the effect of a levosimendan loading dose vs. no loading dose on hemodynamic variables.

Design A population PK/PD model was constructed using data in patients with NYHA Classes II-IV congestive heart failure from eight clinical studies. The combined dataset included infusion of various doses (0.25– 0.6 mg), rates (0.05–0.6 mcg/kg/min) and durations (5 min–7 days), with or without an initial loading dose. Relationships of the exposures of levosimendan and its metabolites and the hemodynamic response variables were used to simulate the hemodynamic response at infusion dosing regimens of 0.2 mcg/kg/min for 24 h with and without loading infusion dose of 12 mcg/kg (administered over 10 min).

Setting Global Pharmaceutical Research and Development, Abbott Laboratories.

Main outcome measures Hemodynamic response parameters were pulmonary capillary wedge pressure (PCWP), heart rate (HR) and systolic blood pressure (SBP).

Results The maximum predicted hemodynamic response difference due to the loading infusion dose of 12 mcg/kg was −1.5 mmHg, −1.4 mmHg and +1.5 bpm for PCWP, SBP and HR at 1, 1 and 2 h, respectively. At 6 h, the hemodynamic response differences between the two regimens (with and without loading dose) were negligible.

Conclusions Simulations predict that a loading dose prior to a continuous infusion has minimal effects on PCWP, HR or SBP, during the first 6 h after dosing compared to a continuous infusion not preceded by a loading dose.

Keywords Levosimendan, Loading dose, Hemodynamic effect.

PT-328 Atypical case of CNS fungal infection caused by mucor species in a child

György Valent 1, Edit Bereg2, László Tiszlavicz2

1Department of Pediatrics, University of Szeged Faculty of General Medicine, Szeged, Hungary; 2Department of Pathology, University of Szeged Faculty of General Medicine, Szeged, Hungary

Background and objective Mucormycosis is a fungal infection reported rarely in scientific literature. Thus we have poor therapeutic experience in this field.

Design This case well demonstrates the difficulty of establishing the diagnosis and choose adequate therapy in such atypical cases.

Setting Department of pediatrics, pediatric neurology ward.

A 9-year-old boy was admitted to our hospital who has had persistent headache and fatigue for a year. Cranial CT and MR imaging showed hydrocephalus, CSF passage problem and intracranial abscess. Ventriculo-peritoneal shunt implanted by neurosurgeons solved the problem of increased intracranial pressure. Protein level of cranial CSF proved to be 34 times higher than lumbar CSF which suggested obstruction of CSF circulation. Spinal MRI represented a mass 20–25 mm in diameter at the level of the second lumbar vertebra causing obstruction of the vertebral canal. Histological sample was taken by biopsy. According to microscopy and staining in the background of obstruction there was a special fungal structure which proved to be a rare Mucor species. It is important to note that he had a history of frequently recurring sinusitis and upper airway infections.

Main outcome measures Adequate drug that penetrates into CNS (conventional amphotericin B intrathecally or intramedullary as an off-lable route, or to give lipid-based amphotericin B agent iv., or other drug). Effectiveness of antifungal therapy. Clinical outcome of the patient.

Results Although culture and polimerase chain reaction were negative, we started 5 mg/kg/day amphotericin B lipid complex iv. (according to therapeutic guidelines) for 15 days. During the therapy the patient had temperature, leucopenia and decreasing creatinine clearance which were transient. According to literature, posaconazole—a new oral triazole agent—also has anti-mucor activity thus it could have been applied as an alternative therapy. As a result of shunt implantation and iv. drug therapy, the child recovered.

Conclusions We are convinced that the above case raised from sinusitis caused by a Mucor species so-called, “rhinocerebral mucormycosis”. The case is special because of the following: we couldn’t have diagnosed this rare infection without the complication of obstruction, as there was no sign of CNS infection or inflammation.

In such a case administration of amphotericin B lipid complex or posaconazole should be considered.

Keywords Mucormycosis, Fungal infection, Amphotericin B

DI-37 Stability of injectable drugs in infusion. 25 years of literature review

Jean-Daniel Hecq 1

1Hospital Pharmacy, Cliniques Universitaires UCL de Mont-Godinne, Yvoir, Belgium

Background and objective In 2007, was distributed the new edition of a CD-Rom intitled “Stability of injectable drugs in infusion”. This CD is the product of 25 years of literature review on the stability and (in)compatibilities of commonly used hospital drugs alone or in mixture in different types of containers (bags, bottle, syringe, ambulatory devices, …).

Design 25 years of literature review on the stability and (in)compatibilities of commonly used hospital drugs.

Setting Cliniques Universitaires UCL de Mont-Godinne, 5530, Yvoir, Belgium.

Main outcome measures In 1981, a special interest group (SIG) of the Belgian Association of Hospital Pharmacist (BAHP) published the first edition of a “Guide for the administration of drugs by infusion”. 20 drugs are described with the following topics: administration (push iv, intermittent or continuous infusion), stability, compatibilities and incompatibilies with iv solutions or other drugs. New members join the SIG in 1982. A new edition is distributed in 1987 and is followed by 3 up-to-date. Recording of the papers is made manually in a first time, by electronic way in a second time. In December 1991, is distributed the first of eleven editions of a manual entitled “Stability of injectable drugs in infusion”, the new title of the Guide. The Manual give only stability data. The working group was vanished and it is now a personal work. The number of reviewed drugs raise to 195. The up-to-date contains more than 500 pages. In 2000, start the publication of a CD, more practical.

Results The edition 2007 furnish 44.200 data on the stability and (in)compatibilties of 385 drugs alone or in mixture in different types of containers (bags, bottle, syringe, ambulatory devices, …), based on 2.489 references available in the international literature. A review of the stability after microwave freeze-thaw treatment complete the review.

Conclusions A new edition is available each year and it is the seventh that is published at now. It is the result of 25 years of literature review. The CD contribute to the knowledge of stability of intravenous drugs by Belgian hospital pharmacist and contribute to the quality of patient care.

PC-180 Implementation of clinical pharmacy on a neurosurgery and a neurology ward.

Sarah Mertens1, Isabel Spriet1, Ludo Willems 1

1Pharmacy Dpt., University Hospital Leuven, Leuven, Belgium

Background and objective Although clinical pharmacy on a neurosurgery or a neurology ward is not common [1], a new project of clinical pharmacy have recently been set up on these two wards. The aim of this project is to evaluate the added value of a clinical pharmacist.

Design Since 3 months a pharmacist has been attached to the team of neurosurgeons and neurologists. The clinical pharmacist evaluates patients’ pharmacotherapy and gives advice in accordance to the local guidelines, based on pathology and lab results. The interventions are discussed during daily ward rounds.

Setting Neurosurgery (28 beds) and neurology ward (28 beds) in the 1900-bed University Hospital of Leuven, Belgium.

Main outcome measures Improvement of quality of individual drug therapy and standardisation of general drug management.

Results Although the general way of working is similar on both wards, the focus differs. Regarding the experience of clinical pharmacy on a traumatology ward [2], basic aspects of pharmacotherapy on the neurosurgery ward are similar: pain management, peri-operative anticoagulant management, follow up of postoperative infections and continuation of patients’ regular medication during admission. On the other hand clinical pharmacy on a neurology ward requires a specific knowledge about neurological drugs and pathology to interpret whether the prescribed drug therapy is adequate.

In a 2 months period the clinical pharmacist registered 113 interventions. Most interventions were initiated by the pharmacist (78), but in 28 cases the physician and in 6 cases the nurses asked the pharmacist for advice. Rate of acceptance was 88%. Most common interventions are: giving information about dosing and administration (28%), discontinuation (21%) and association (16%) of drugs. The most common involved drug classes are antibiotics (20%), pain medication (12%) and anti-ulcer drugs (11%).

Besides the daily follow up of patients’ pharmacotherapy, the pharmacist completes some projects to standardise general drug management. Among other things the pharmacist optimises the implementation of guidelines concerning pain management and administration of drugs in patients with swallowing difficulties.

Conclusions Although neurosurgery and neurology are unusual wards to attach a clinical pharmacist, we believe that our project illustrates the additive value to the quality of pharmacotherapy.

References

  1. 1.

    Welty T. Neurology and neurosurgery clinical pharmacy practice: ignorance, phobia or progress? Ann Pharmacother 2006;40:2235–7.

  2. 2.

    De Troy E., Willems L. Implementation of clinical pharmacy at a traumatology service. Abstract PC-130 presented at the 2nd ACCP-ESCP congress, 28–30 April 2004, Paris-France

Keywords Neurology, Neurosurgery, Clinical pharmacy

PC-196 Audit of medication incidents recorded by clinical pharmacists

Paula Crawford1, Aine McCoy 1

1Pharmacy, Musgrave Park, Belfast, United Kingdom

Background and objective A snapshot analysis of medication incidents in Musgrave Park Hospital was conducted in January 2006. Clinical pharmacists working on four orthopaedic surgical and rehabilitation wards recorded medication incidents occurring over a two-week period. Clinical pharmacists in Greenpark routinely record medication incidents observed on the ward however this information is not analysed. The objective of this study was to analyse the information gathered with regard to the type of incident occurring, severity and potential future risk and to determine if any trends were occurring.

Design A data collection form was designed using tick boxes for ease of completion. Medication incidents were broken down into six main categories, patient details, allergy status, prescribing, drug history, administration and miscellaneous. Incidents were graded using a severity matrix [1]. Over the study period clinical pharmacists recorded all medication incidents identified at ward level. One clinical pharmacist graded the incidents using the severity matrix to ensure consistency. Grading was peer-reviewed by a second clinical pharmacist.

Setting The audit was conducted in four orthopaedic surgical and rehabilitation wards totalling 70 beds.

Main outcome measures

  1. 1.

    To obtain the total number of medication incidents over the study period.

  2. 2.

    To grade incidents according to severity.

  3. 3.

    To determine which drug or drug groups were involved in medication incidents.

Results Over the study period a total of 121 incidents were recorded. Of these 83 (68.6%) were categorised as prescribing incidents. Incidents involving allergy status and drug history accounted for 14 (11.6%) respectively of the total. The total number of incidents involving named medicines was 83, of these warfarin was involved in 10 (12.1%), antihypertensive medicines were involved in 6 (7.2%). A wide range of medicines involved in incidents was identified during the audit.

Conclusions The audit provided information about medication incidents, which occur within the trust, and individual medicines involved. Further analysis of the information recorded will allow training needs of medical and nursing staff to be identified which will be addressed by clinical pharmacists.

Reference

  1. 1.

    Doing less harm, Department of Health and National Patient Safety Agency, 2001

Keywords Incident, Pharmacist, Medication