A Study on How Industrial Pharmacists Rank Competences for Pharmacy Practice: A Case for Industrial Pharmacy Specialization

This paper looks at the way in which industrial pharmacists rank the fundamental competences for pharmacy practice. European industrial pharmacists (n = 135) ranked 68 competences for practice, arranged into 13 clusters of two types (personal and patient care). Results show that, compared to community pharmacists (n = 258), industrial pharmacists rank competences centering on research, development and production of drugs higher, and those centering on patient care lower. Competences centering on values, communication skills, etc. were ranked similarly by the two groups of pharmacists. These results are discussed in the light of the existence or not of an “industrial pharmacy” specialization.


Introduction
Graduates with a pharmacy degree are employed in a variety of positions, the most important (in terms of numbers) being community, hospital and industrial pharmacy. The discussion on whether these three domains require specific skills with a specific education has long been contentious. Industrial pharmacy as a university discipline is recognized by some European pharmacy departments. The PHARMINE study (Pharmacy Education in Europe) reported that pharmacy departments in 10/31 European countries give elective pre-graduate courses in industrial pharmacy, and 11/31 departments give post-graduate industrial pharmacy courses [1]. Most of the graduates from such courses go on to to work in an industrial setting. The PHARMINE study reported that a substantial number (37,308) of European pharmacists (6% of the industrial workforce) work in the pharmaceutical industry [2]; this is similar to the worldwide figure of 10% given by the International Pharmaceutical Federation [3].
In some European countries the status of the industrial pharmacist is officially recognized. In France, the profession of "industrial pharmacist" is defined by national law and the statutes of the pharmacy professional body [4]. On the global European level, this is not the case. In the European Union (EU), the 1985 EU directive on the profession of pharmacy [5], and the 2013 update [6], do not recognize any specialization in pharmacy (although these are recognized in medicine).
There is a second EU directive that is relevant in this case, however, and that is the EU directive on qualified persons working in the pharmaceutical industry [7]. In some EU member states, such as Germany [8], only those with a pharmacy degree meet the requirements set down in the qualified persons directive.
It appears, therefore, that the argument is equivocal for the existence of a specialized pharmacy job description of "industrial pharmacist" (i.e., a pharmacist working in industry) that is different from that of other specialties such as community pharmacy. This paper looks at one aspect of this discussion: whether industrial pharmacists rank competences for practice differently than do community pharmacists. It is possible that pharmacists working within such specialties view the pharmacy profession differently. Within this context we investigated, therefore, whether the ranking by industrial pharmacists of competences for practice is different from that of community pharmacists.
In the PHAR-QA ("Quality Assurance in European PHARmacy Education and Training") project [9], we asked community and industrial pharmacists to rank competences for pharmacy practice. This paper describes the similarities and differences between the ways in which European industrial and community pharmacists respectively rank competences for pharmacy practice.

Experimental Section
Ranking data on competences for practice were obtained using the PHAR-QA surveymonkey [10] questionnaire that was available online from 14 February 2014 to 1 November 2014, i.e., 8.5 months [11]. Respondents came from 36/49 countries of the European Higher Education Area [12].
The first six questions were on the profile of the respondent (duration of practice, country of residence, current occupation (industrial, community . . . pharmacist)). There was also a question on the job title. This allowed a subdivision of industrial pharmacists according to their experience/activity: regulatory affairs, research and development, etc. A similar subdivision of the activities of community pharmacists was not possible, as all respondents in this group were involved in some form of dispensation to patients.
Questions 7 through 19 asked about 13 clusters of 68 competences (see Appendix A). Questions in clusters 7 to 11 were concerned with personal competences, and in clusters 12 to 19 with patient care competences.
Respondents were asked to rank the proposals for competences on a 4-point Likert scale: (1) Not important = Can be ignored; (2) Quite important =Valuable but not obligatory; (3) Very important = Obligatory, with exceptions depending upon field of pharmacy practice; (4) Essential = Obligatory.
There was also a "cannot rank" possibility as well as that of leaving the answer blank. Results are presented in the form of "scores" calculated as follows: Ranking score = (frequency rank 3 + frequency rank 4) as % of total frequency, which represents the percentage of respondents that considered a given competence as "obligatory". This calculation is based on a similar calculation made by the MEDINE consortium that studied the ranking of competences for medical practice [13]. Such scores are used for descriptive purposes only, and no conclusions on statistical differences amongst groups are based on scores.
Leik ordinal consensus [14] was calculated as an indication of the dispersion of the data using an Excel spreadsheet. The original Leik paper cited previously gives an explicit mathematical example of the calculation of ordinal consensus. Responses for consensus were arbitrarily classified as: < 0.2 poor, 0.21-0.4 fair, 0.41-0.6 moderate, 0.61-0.8 substantial, > 0.81 good, according to the scale used in MEDINE study.
The statistical significance of differences between rankings of competences or between rankings by different categories of respondents was tested by the chi-square test (confidence level 95%). Statistical tests were performed using GraphPad software [15].
Results are presented at 2 levels: that of the 13 clusters and that of the 68 competences.
Respondents could also add their comments on the different clusters. An attempt was made to analyze comments using the NVivo10 program [16] for the semi-quantitative analysis of unstructured data. It was found that the numbers involved were too small to draw significant conclusions.

Results and Discussion
The distribution by duration of practice of the groups is given in Table 1. Most respondents had less than 20 years of experience, thus in both cases a relatively "young" population was involved. This may be due to the higher motivation of a younger population to reply to a questionnaire.
Respondents came from 36 European countries. Nineteen countries provided 5 or more respondents to one or both groups; they were: Belgium, Croatia, Czech Republic, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Macedonia, Montenegro, Norway, Romania, Slovenia, Spain, Switzerland, The Netherlands, and the United Kingdom.
The numbers of industrial pharmacy respondents arranged according to experience/activity are given in Table 2.  Table 2 shows that, while some respondents work in a typically "pharmaceutical" environment (such as regulatory affairs and pharmaceutical technology), many others work in more "generic" environments (such as management and quality assurance). If we consider that industrial surroundings correspond to 4 groups/stages, namely (1) research and development; (2) production; (3) analyses and quality assurance; and (4) marketing and sales, it appears that not all pharmacists employed in marketing and sales feel that they are industrial pharmacists. Indeed, marketing and sales representatives of "big pharma" are sometimes very far from classical industrial surroundings, even though they are employed in industry. Table 3 shows the overall distribution of rankings by industrial and community pharmacists. Notes: Chi-square test on distribution of ranks for industrial versus community pharmacists: p < 0.05 (degrees of freedom = 3, ((4 ranks´1)ˆ(2 groups´1)).
All but 7-11% of respondents were able to rank all competences. This suggests that the majority in both groups of respondents believed that they were sufficiently informed to reply to almost all the questions asked.
As judged from the Leik ordinal consensus values, dispersion was low. This suggests that both groups were relatively homogeneous and that subgroups with responses significantly different from the overall group do not exist. Similar values for ordinal consensus have been reported by the MEDINE consortium.
Overall ranking by industrial pharmacists was significantly lower (72%) than that by community pharmacists (77%). This raises the question of whether industrial pharmacists globally believed that the competence framework was less applicable; however, the global score was high with almost 3/4 of industrial pharmacists considering the competences "obligatory". The global lower score of industrial pharmacists was weighted by the low scores they gave to patient care competences (see later). Figures 1 and 2 show the results for analysis by clusters. In Figure 1, the values for Leik ordinal consensus are shown.
Leik ordinal consensus was higher for industrial pharmacists in 10/13 clusters including cluster 11 that dealt with competences for industrial pharmacy.
Scores for personal competences (clusters 7 to 11) were similar in industrial and community pharmacists, except for cluster 11, dealing with industrial pharmacy, for which industrial pharmacists scored higher. Scores for clusters dealing with patient care competences (clusters 12 to 19) were lower for industrial pharmacists.       Overall, the ordinal consensus values were higher for industrial than for community pharmacists. This was especially true for competences 6 (research), 18 (development, production of medicines), 28 (analytical chemistry), 38 (design, synthesis, etc. of active substances), 40 (EU directive on qualified persons), and 41 (drug registration, licensing and marketing). For all these competences, the consensus for industrial pharmacists was higher than community pharmacists (Figure 4 and  Overall, the ordinal consensus values were higher for industrial than for community pharmacists. This was especially true for competences 6 (research), 18 (development, production of medicines), 28 (analytical chemistry), 38 (design, synthesis, etc. of active substances), 40 (EU directive on qualified persons), and 41 (drug registration, licensing and marketing). For all these competences, the consensus for industrial pharmacists was higher than community pharmacists (Figure 4 and Overall, the ordinal consensus values were higher for industrial than for community pharmacists. This was especially true for competences 6 (research), 18 (development, production of medicines), 28 (analytical chemistry), 38 (design, synthesis, etc. of active substances), 40 (EU directive on qualified persons), and 41 (drug registration, licensing and marketing). For all these competences, the consensus for industrial pharmacists was higher than community pharmacists (Figure 4 and Appendix A). For competences 31 (microbiology) and 44 (diagnostic tests) the ordinal consensus for community pharmacists was higher than that for industrial pharmacists, as were the scores (Figure 4 and Appendix A).
Scores for the 68 competences are given in Figure 4 and the Appendix A. This graph shows that competences on the right-hand side concerned with personal values, subject matters and industrial pharmacy were often ranked higher by industrial pharmacists. Competences on the left-hand side concerned with patient care were often ranked higher by community pharmacists. A proviso must be added here; through a comparison between Figure 4 with Figure 3, it is obvious that, for competences scoring low (e.g., 24 and 25), consensus was low. Thus, the low ranking was far from unanimous.
Going into more detail, Table 4 shows the competences for which industrial pharmacist ranked higher (upper) and for which community pharmacists ranked higher (lower). Ability to recognise when referral to another member of the healthcare team is needed because a potential clinical problem is identified (pharmaceutical, medical, psychological or social) 46 Retrieval and interpretation of relevant information on the patient's clinical background 47 Retrieval and interpretation of an accurate and comprehensive drug history if and when required 48 Identification of non-adherence and implementation of appropriate patient intervention 49 Ability to advise to physicians and, in some cases, prescribe medication 50 Identification, understanding and prioritization of drug-drug interactions at a molecular level (e.g., use of codeine with paracetamol) 51 Identification, understanding, and prioritization of drug-patient interactions, including those that preclude or require the use of a specific drug (e.g., trastuzumab for treatment of breast cancer in women with HER2 overexpression) 52 Identification, understanding, and prioritization of drug-disease interactions (e.g., NSAIDs in heart failure) 55 Critical evaluation of the prescription to ensure that it is clinically appropriate and legal 56 Familiarity with the supply chain of medicines and the ability to ensure timely flow of drug products to the patient Provision of appropriate advice on resistance to antibiotics and similar public health issues 61 Ability to use effective consultations to identify the patient's need for information 62 Provision of accurate and appropriate information on prescription medicines 63 Provision of informed support for patients in selection and use of non-prescription medicines for minor ailments (e.g., cough remedies)

64
Identification and prioritization of problems in the management of medicines in a timely manner and with sufficient efficacy to ensure patient safety 66 Undertaking of a critical evaluation of prescribed medicines to confirm that current clinical guidelines are appropriately applied 67 Assessment of outcomes on the monitoring of patient care and follow-up interventions 68 Evaluation of cost effectiveness of treatment The competences ranked higher by industrial pharmacists fall into three groups with, firstly, competences 4, 6 and 18 on evaluation of scientific data, research, and production of medicines. Scores for community pharmacists on 2 of these competences (6,18) were less than 50%. The second group was concerned with the subject matters physics (25) 33%, analytical chemistry (28) 67%, and pharmaceutical technology (34) 84%. Subject matters were included because they figure in the EU directive on the sectoral profession of pharmacy. The authors recognize that they are not competences but part of the foundation of competences. Having said that, it should be noted that community pharmacists ranked these elements very low, with a score of 22% for physics and 42% for analytical chemistry. Thus, the general message that all the subject matters cited in the EU directive are essential for science-based pharmacy practice is not understood, as concerns subjects such as physics.
In the lower part of Table 4, the competences that are ranked higher by community pharmacists are shown. Four of these concern subject areas (24, 30, 33, and 36), but the majority concern patient care competences. For the latter community pharmacists scored significantly higher than industrial pharmacists for all but five competences. This is not to say that industrial pharmacists scored low for patient care competences, as almost all of their scores were between 60% and 80%. Thus, they do recognize the need for information relating to the pharmacist as a medicine specialist (see also comments below).
Overall, the observations in the previous paragraphs suggest that the two groups are often ranking in the context of their own specific activity and, following on from this, that certain competences are needed for certain specializations. Continuing this argument further, certain competences could thus be part of an "industrial pharmacy-oriented" degree course, and others part of a "community pharmacy-oriented" degree course (taking for example, those in Table 4). An alternative argument is that this is in favor of "amplifying" different clusters in different specializations within a single curriculum, rather than "separating" competences into different curricula for the two activities.
Comments were made by 15/138 (11%) of industrial pharmacist and 23/258 (9%) of community pharmacist respondents. Our initial objective was to evaluate whether comments were in line with scoring, but the low numbers of comments received did not permit a satisfactory analysis using semi-quantitative analysis of unstructured data (results not shown). Comments are reported here, therefore, in a "raw data" form.
Comments are grouped into areas in Table 5. There were several comments on the English phraseology and the construction of the questions, and these have been taken into consideration in the production of the revised version of the questionnaire. Others pointed to the esoteric nature of certain competences and the recognition of specialization, be it industrial or community. Of interest also is the fact that industrial pharmacists recognized the necessity of all competences, including patient care competences, and the nature of the pharmacist as a "medicines specialist". Globally, the comments leave a subjective impression of backing up the scores, but, as explained in Section 2, no solid conclusions can be drawn.

Conclusions
Competences centering on values, communication skills, etc. were ranked similarly by the two groups of pharmacists (industrial and community). In other areas, such as (1) drug research, development and production, and (2) patient care, scores suggest that the groups appeared to be ranking in the context of their own specific activity. These results are discussed in the light of the existence of, or need for, an "industrial pharmacy" specialization based on a specific competence framework. The latter is provided by the PHAR-QA framework.
The pharmacists' perception of their profession is primarily determined within the context of their specific activities in their line of work. The split in opinion lies between "hard sciences" and "patient care." The truth is that the pharmacy service that best serves the population at large involves both. Pharmacy students seldom know in advance whether they will end up working as industrial or as community pharmacists. Taking this into account, one could argue that a pharmacist should receive a balanced education involving the two areas and then specialize in one of the two as his/her professional career advances, post-registration. On the other hand, if the degree of specialization necessary is so profound that it would be best to start it from the educational phase, the specialty-oriented program may be the better solution. The discussion on this dilemma continues.

Perspectives
In light of the rankings and comments, a revised version of the competence framework will be sent out for survey. This will be followed by the proposal of a PHAR-QA competence framework for pharmacy practice.
Future papers will deal with results for hospital pharmacists, and academics. These papers, as does the present paper, will deal with the implications of the results obtained, thus contributing to the ongoing debate on the perceptions of professional identity of a pharmacist [17], in this case, with contributions that are backed up by hard data.  Notes: Competences in bold are those showing a statistically significant difference in distribution of rankings between groups (chi-square, p < 0.05).