Assessment of current prescribing practices using World Health Organization core drug use and complementary indicators in selected rural community pharmacies in Southern India

Due to the lack of clear, comprehensive, and rational drug policy, the production of pharmaceutical preparations in India is distorted for the most part. Indian markets are flooded with more than 70,000 formulations, compared to approximately 350 formulations listed in the World Health Organization (WHO) Essential Drug List. Studies have indicated that majority of prescriptions in India are of drugs of “doubtful efficacy.” To promote rational drug use in developing countries, assessment of drug use patterns with the WHO drug use indicators is becoming increasingly necessary. The aim of this study was to assess the patterns of drug use by using WHO core drug use and complementary indicators. One thousand fifty-two patients were prospectively interviewed and their prescriptions analyzed according to WHO guideline five randomly selected busy community pharmacies in northern district of the State of Tamil Nadu, South India to analyze the WHO core drug use and complementary indicators using an investigator-administered data collection form. The main outcome measured is patterns of drug use measured using WHO core drug use and complementary indicators. The data obtained showed that, out of total drugs prescribed (3936), only 2.5 % (100) drugs were prescribed by generic name. Mean number of drugs per encounter was 3.7. Use of antibiotics was 22 %, percentage of encounters with an injection was 7.2 %, and the percentage of drugs prescribed from formulary was 99.8 %. Brand name prescribing is dominated even in rural India. There is a need to improve the availability of essential guidelines and key drugs in the stock in rural areas of India. Prescriptions studied were conforming to most indicators of WHO except the number of drugs prescribed & generic name prescription practice, which deviated. In India the healthcare is dominated by private practitioners at the primary level. Prescription practices of the individual community-based clinician needs consistent monitoring with respect to generic name prescribing habits as well as the number of drugs prescribed. The WHO drug use indicator guidelines need to be promoted amidst the primary care clinicians and should not be just limited to hospitals having a formulary. The data collected by this study can be used by policymakers to monitor and improve the prescribing and consumption of pharmaceutical products in Southern India.


Background
World Health Organization (WHO) defined rational use of drugs as "patients receive medicines appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, at the lowest cost to them and their community [1]." Due to the lack of clear, comprehensive, and rational drug policy, the production of pharmaceutical preparations in India is distorted for the most part. Indian markets are flooded with more than 70,000 formulations. Thousands of drug companies operate in India and they manufacture generic preparations with different brand names. Huge number of vitamins, tonics, and multi-drug combinations that are unique to Indian market are also manufactured and marketed here. This entails the drug manufacturers to enter into fierce competition, which makes them to encourage the prescribers to prescribe branded medicines, often in exchange of small favor. This benefits the manufacturing companies, but it also results in drugs being prescribed without any necessity and combinations that are not rational [2,3]. A concerted effort is needed to readjust pharmaceutical actions and practices aiming at the rational use of medications. WHO developed Medication Use Indicators, including Prescription Indicators with an aim to evaluate the services provided to the population in regards to medications [4]. Prescription Indicators allow the therapeutic actions taken in similar institutions to be ascertained, enabling subsequent comparison of parameters between them, and to evaluate the population's medication needs and determine the most frequently used medications in a given place [4]. In addition, these indicators enable the investigator to identify the prescription profile and quality of services offered to the population. The prescription Indicators are as follows [4]:

Average number of drugs per medical prescription
This indicator helps in investigating poly-medication, which is a major factor contributing to adverse drug reactions (ADRs) and drug-drug interactions (DDIs). The educational quality informational level of the prescriber may also be observed [4].

Percentage of drugs prescribed by generic name
This indicator enables the investigator to calculate the number of prescriptions in which the drugs are prescribed by the generic name. This helps in controlling drug costs in the health service. It also evaluates the marketing influence on the person prescribing drugs [4].

Percentage of drugs prescribed from essential drug list or formulary
This indicator helps in measuring the degree to which practices conform to the current National Drug Policy (NDP) of October 1998. By following essential drug list, it guarantees the treatment of the principal diseases of the population besides controlling overall cost of medications.

Percentage of encounters with an antibiotic prescribed
This indicator evaluates the use of antibiotics in excess which contributes to bacterial dissemination and resistance [4].

Percentage of prescribed injectable drugs
This indicator helps to evaluate the injectables in excess, administration of which may have serious consequences when prescribed or applied wrongly, such as in the event of anaphylactic reactions, adverse reactions, necrosis, etc. [4]. Even though, this indicator helps in evaluation of attention given to health swiftly, these indicators do not quantify all the important aspects of drug use [4].
Studies have indicated that majority of prescriptions in India are of drugs of "doubtful efficacy" [5][6][7]. Due to high cost of inappropriate use of drugs, developing countries face more problems due to limited economic resources and lack of organized drug policy [8]. To promote rational drug use in developing countries, assessment of drug use patterns with the WHO drug use indicators is becoming increasingly necessary [9,10].

The current status of drug use pattern in South India
All evidences available indicate that observations have been made only in hospitals and not in the private clinics that cater to the majority of the population in this part of the country. Even those observations reveal that the prescription pattern is not in line with the WHO drug use guidelines. Though there is a guideline stating that the durgs should be prescribed using the generic names, adherence to that can hardly be observed across this subcontinent [6,7].

Aim of the study
To assess the patterns of drug use by using WHO prescribing, health facility, and complementary indicators in selected community pharmacies in Southern India.

Study design
A prospective, cross-sectional survey was carried out in five randomly selected busy community pharmacies from different cities in a northern district of State of Tamil Nadu, South India. The study was conducted between June 2014 and May 2015 in order to consider the prescriptions that flow through all seasonal periods. The study sample comprised of all the medication prescriptions made out of those five selected pharmacies.

Data collection
Two well-trained clinical pharmacists collected data on prescribing, health facility, and complementary indicators by observing the prescriptions and interviewing the patients. A data collection form prepared exclusively for this study was used to collect data. Information obtained included prescribing date, gender identity, age, and BMI of the patients, educational qualification of patients, physician specialty, prescription-related information such as dosage forms and the number of medicines per prescription, and WHO core drug prescription indicators and complementary indicators. According to a document by WHO "How to investigate drug use in health facilities," at least 600 prescription encounters should be included in cross-sectional survey to describe the current prescription pattern [10]. The sample selected was by systematic random sampling method. The sampling unit was patient encounters taking place at selected five community pharmacies.

Prescribing indicators measurement
The WHO prescribing indicators were pretested and slight modification was made to make it applicable in Indian scenario before using in this study. The formula adopted from the WHO's manual for the assessment prescribing indicators used in this study are as follows:

Patient care indicators measurement
Patient care indicators measured were consultation time, dispensing time, and percentage of drugs actually dispensed. Consultation and dispensing times were divided in three categories viz., ≤ 5 min, 6-10 min, and 11-15 min. Percentage of drugs actually dispensed was calculated by dividing the number of drugs actually dispensed at each of the community pharmacy by the total number of drugs prescribed multiplied by 100.

Health facility indicators measurement
Health facility indicators measured were drugs available in the formulary and drugs not available in formulary. It can be measured by subtracting drugs not available in the formulation from total amount of drugs prescribed × 100.

Complementary indicators measurement
Complementary indicators analyzed were number of patients treated without drug, number of patient treated with drugs, cost of injections prescribed, and the ratio of drugs prescribed versus drugs dispensed. These were expressed in percentage.

Data analysis
All data in the data collection form were analyzed using Microsoft Excel 2007. The indicators are reported as means and proportions. From five community pharmacies 218, 215, 197, 220 and 202 prescriptions were analyzed respectively.

Results
Out of 1052 patient encounters assessed during the study period, 447 (42.5 %) were males and 605 (57.5 %) were females with a mean age of 28.37 years. The classification of patient encounters based on BMI shows that most of the patients fell in the overweight BMI range 25 to 29.9 (35.4 %) followed by normal BMI range of 18.5 to 24.9 (32.8 %). The educational status of the patient encounters reveals that 40.2 % of the patients (N = 423) have finished at least undergraduate studies. This is shown in Table 1.
Highest number of prescriptions encountered were from consultant physicians (N = 271, 25.8 %) followed by the pediatricians (N = 205, 19.5 %), general practitioner (N = 180, 17.1 %), gynecologist (N = 139, 13.2 %) followed by ENT, orthopedic, and the dentist (N = 119, 78, and 41; 11.3, 7.4 and 3.9 % respectively). The dermatologists and the civil surgeons contributed together to 12.5 % of prescriptions in total. The consultant physician was the first choice for the patients as majority of the prescriptions encountered were that of adults, followed by the pediatrician and the general practitioner. The civil surgeon was the last choice for the patients. We could also see from the prescriptions that the non-pediatric patients were also treated by the pediatrician. The indication wise distribution of data shows that up to 40 % of the total prescriptions were given for indications like cough/cold/ congestion/fever/headache. Acute infections and the allergic reactions were the major cause for the patients to come to the clinics. This can be shown in Table 2.
The distribution of drug prescription indicators shows that more than 53.2 % of the encounters contained four drugs with an average number of drugs per encounter of 3.7, which should always be maintained as low as possible to reduce adverse effect and patient medication cost. Almost 92 % of the prescription encounters contained no drugs prescribed by their generic names and about 58.8 % of prescriptions contained at least one antibiotic and 24.3 % contained at least one injection. Surprisingly, all the drugs dispensed through those 1052 prescriptions were present in essential drug list. The community pharmacies ensure that any prescription is dispensed in full. In the rural areas, when a patient returns with an incompletely filled prescription, he may not return to the pharmacy for any future need as he/she may perceive the pharmacy as one that's inadequately stocked. At least the community pharmacy owners and the counter managers or the pharmacists ensure that the generic equivalent, whether it is bio-equivalent or not, is substituted for what is prescribed by the physician. So, the availability of drugs from the formulary was 100 %. This can be clearly seen in Table 3.
The patient care indicators consisted of three components such as consultation time, dispensing time and percentage of drug actually dispensed. Maximum number of patients (N = 822, 78.1 %), had anywhere between the 6-10 min of consulting time with a physician with an average time of 8 min. The dispensing time required for 82.5 % of the prescription encounters fell between 6 and 10 min range. The dispensing time taken in rural areas was low when compared to another department of other hospital because prescription consists mainly   Number of drugs prescribed from essential drug list tablets and capsules, which are prescribed in different doses, but at regular intervals. So, pharmacists required less time for the dispensing. In 1052 prescriptions, 3936 drugs were prescribed and the percentage of actual drug dispensed was 99.8 %. This is depicted in Table 4. A total of 3936 drugs were prescribed from 1052 prescription encounters, in which, 3927 drugs was available in the formulary. 99.8 % of drugs prescribed were dispensed by the community pharmacies. The formulary concept is totally alien to the community pharmacies and is not even followed in many hospitals here. But, for a reference, the prescriptions were catered from the available stock and so we mean the stock of the individual retailer as the formularythe retailers know about the prescription habits of the physicians in the vicinity and so they could cater to all prescribed brands or its generic substitutes. The data obtained also shows that all patients were treated with drugs and no patient was treated without a drug. We also analyzed injection drug cost per prescription as a complementary indicator. The data obtained shows that most of the injections prescribed (N = 195, 80.2 %) fell in the cost range of below Rs. 25. The details of health facility indicator and complementary indicator can be seen in Table 5. Table 6 shows the details of drugs prescribed out of 1052 prescriptions. A total of 3936 drugs were prescribed from 1052 prescriptions. Antimicrobials agents was most commonly prescribed drugs (N = 977, 24. Antibiotics are used both as single and as fixed dose combination and prescribed orally. NSAIDS are also prescribed in tablet form in double dose combination.

Limitations of the study
Only 1052 prescription encounters were sampled for this study and a higher number of prescription encounters are required for better result. This cannot be generalized to overall prescribing practice of all private practitioners. Prescribing indicators based drug utilization study in health facilities is not an exhaustive tool to identify all problems related to prescribing and rationality of the drug use, as they do not exactly explain why drugs are prescribed. The WHO prescribing indicators measure aspects of outpatient treatment. They are designed for use in health centers, dispensaries or hospital outpatient

Discussion
In this study, 91.4 % prescriptions did not contain even a single drug prescribed in its generic name. A similar study conducted in Goa, the western part of India has similar observations where only 0.05 % of the drugs out of 1842 products prescribed were in generic name [10]. This study showed that, in the community pharmacies, where this study was conducted, most of the indicators analyzed were in agreement with the WHO's recommendations, except for the mean number of drugs per encounter and percentage of medications prescribed by generic name which should be ≤2 and 100 %, respectively [4,9]. Fixed dose combinations (FDCs) are one of the strategies to reduce the number of drugs prescribed and improve medication compliance. Increasing requirement of drugs in patients with more than one disease justifies the use of FDCs [11,12]. But with the recent ban on 344 FDCs, a question arises on how many prescribed during the study were rational? A similar study highlights the practice of poly-pharmacy, low usage of generic drugs, injudicious usage of antibiotics and injections and low usage of drugs from essential drugs list in other parts of this region in India [13].

Conclusion
The study indicates a clear need for a guideline by the policy making bodies directing the prescription habits of all clinicians in this part of India. The rules are defined and available even today, but the practice is yet to change is the sad part of the story. Unless strict enforcement of the guidelines happen with consistent monitoring, adherence by clinicians leading to better healthcare services cannot be guaranteed in this part of India.