Understanding of Generic Medicines in Pharmacy Students

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Understanding of Generic Medicines in Pharmacy Students

Aging population and expensive medicines are the hallmarks of any healthcare system globally(1-3) and, in fact, the contributory role of medicaments in population health has been an adjunct to escalating pharmaceutical expenditure, which in turn leads to extra burden on health care expenditure(4). Healthcare workforce, which refers to physicians, pharmacists, nurses, and dentists(5) is the backbone of respective healthcare system(6). In order to strengthen the healthcare system the role of pharmacist , in particular, is evolved from a dispenser to a counselor and caregiver(7). Whether in the developed or developing nations, pharmacists are generally the direct and first line of contact with the patients(8, 9), thus symbolized as health information professional expected to give advice ranging from dosage regimen to side effects, adverse effects, drug-drug interactions, etc.(10-12). Studies from both developed and developing countries highlighted pharmacists’ attitudes, perceptions, and willingness to counsel in health-related issues, pharmaceutical care(10) as well as involvement in hospital rotations to improve patient care and decrease drug costs to patients.(12) Pharmacists are also involved in suggesting brand substitutes to patients, promoting cost effective generic alternatives and their knowledge and views about generic medicine use were reported previously in the literature (13-15).

Pakistan is considered to be a politically chaotic state. With 77% of medicine expenditures as out-of-pocket payment and more than 50% of the population lives below the poverty line, the recent medicine price hike (16) addresses the need of a cost-effective alternative for large majority of population. The present government continuously promotes the concept of generic medicine by addressing the healthcare professionals to prescribe and dispense. Because of generally first point of contact with the consumers and patients, pharmacist is positioned in an improved situation to advise the healthcare professionals as well as consumers. Previous studies highlighted that transforming prescribing and/or dispensing behavior is an ardent task (17, 18) .Therefore the pharmacists, right from the stage of their academic and professional training needs to be well equipped to suggest cheaper generic alternatives. To be precise, pharmacy students are future practitioners and their knowledge and attitude can play an important role to promote quality use of medicines (19).

Literature Review

Previous studies demonstrated future practitioners’ interventional skills in areas of drug information right from dosage regimen to adverse effects and drug-drug interactions (20-24). Only a couple of interventional studies reported reduction in medication-related costs (15, 22, 25). In one of the study conducted by Freml and associates future pharmacy practitioners suggested more cost-saving recommendations as well as generic substitution and even alternate brands than pharmacy practitioners (26). Thus, in order to reduce healthcare expenditures, these recommendations contribute to encourage more future practitioners being utilized in different healthcare settings (26).

Regarding understanding and perception on generic medicines, only a couple of studies have been conducted so far among medical and pharmacy students (27, 28). In a national web-based survey in Australia more than 80% of the pharmacy pre-registrants’ considered generics medicines inferior and less effective with more side effects when compared to brand name medicines (27). Likewise, a national web based survey between final year medical students and pharmacy pre-registrants showed sparse knowledge about the quality, safety and efficacy of generic medicine in both the groups (28). In a study done in US the comparative risk perceptions associated with eight categories of brand and generic drugs were evaluated in 165 pharmacy students (29). In this study Holmes and Dennison (1992) reported that the perception of students’ pharmacists about the effectiveness and probability for harmful effects were the most likely determinants to recommend a branded or generic product (29).

It seems from the above mentioned literature review that interventions done by pharmacy students are sparse but the reported ones highlighted that pharmacy students are helping the patients by offering them cost-effective regimens with maximum therapeutic benefits. An exploration of the understanding and perception of future pharmacy practitioners towards generic medicine issues including the bioavailability and bioequivalence concepts and the attempt to incorporate those concepts in their academic training can make them sensitize for cost-effective dispensing, right before the start of their professional career.

Justification of the Study

In Pakistan where the local pharmaceutical industry is responsible for an estimated 70-85% of the total market by volume and around 55% by value (30), this current research is important as some major innovators will face patent expiry in the coming years and the generics- dominated local pharmaceutical industry is likely to benefit more. In Pakistan at the time of registration of new generic molecules, effective bioequivalence data is not required.

In Pakistan the criteria for generic version to demonstrate bioequivalence is that the generic version must deliver the same account of active ingredients into a patient’s bloodstream in the same amount of time as the original source

Thus, future practitioners need to be well equipped to counsel both the prescriber and the patients about cost-effective generic alternatives.

To be precise underutilization of generic medicines and the factors affecting underutilization are neglected areas in Pakistan. Although there have been several studies from developed and developing countries addressing the factors responsible for underutilization of generic medicines, none has specifically concentrated in the context of Pakistan. With local pharmaceutical industry holds more than 50% of market share by volume coupled with the market of Pakistan flooded with branded generics, research into the factors affecting the contemporary issue of underutilization of generics is imperative.

On the other hand, government policies consider risk perceptions, and the perception of different stakeholders towards the efficacy and safety of products can affect the development and application of regulatory framework.

In the light of this fact it is imperative to ascertain the understanding and perception of future practitioners which could only practice as knowledgeable and competent pharmacists provided their academic training is in alignment with the curricular contents such as clerkships and clinical rotations.

Objectives of the Study

The objectives of this study were to:

  • To evaluate the understanding and perception of pharmacy students regarding generic medicines
  • To explore the expectations of the pharmacy students from the pharmacy curriculum

Methodology

There is paucity of research evidences from developing countries regarding understanding and perception of future pharmacy practitioners towards generic medicine. In order to explore the research objectives both in depth and in breadth, mixed method research is the best suitable option in the current study as it employs both qualitative and quantitative methods (31, 32). Thus, as mentioned by Tashakkori and Teddlie (33) this current research also used a combination of data collection methods and data analysis in sequential phases. Therefore, in the light of the methodological design the study was conducted in two phases; i.e. qualitative (first phase) and quantitative (second phase). The first part of the qualitative study is published elsewhere.

Quantitative Method

As mentioned in the earlier section the current study used mixed-method approach, and thus quantitative instrument design, quantitative data collection and analysis were followed subsequently after the completion of qualitative phase (first phase).

Study Setting and Sample

This study was performed among pharmacy students at two pharmacy institutes in Karachi, Pakistan from January 2009-February 2009. The researcher identified six pharmacy institutes in Karachi, Pakistan. On the basis of pioneers in pharmacy education one government-sponsored and one privately-funded pharmacy institute were purposively selected for this study. Final year Pharm D students from government-sponsored (n=85) and privately funded institute (n=151) were invited to participate in the study during their lecture session. In this study the students were recruited and informed through an official notification from the Dean. The office order stated the objectives of the study and displayed at the notice board of the faculty of pharmacy. Participation was voluntary; however all final year Pharm D students participated in the study. As no personal identification was required the students did not ask to fill the consent form. The questionnaire was administered in the last week of final semester after which the students would have to appear for the final examination.

Survey Instrument

As the main purpose of qualitative phase is to develop a background for the layout of quantitative survey instrument, the questionnaire used by Hassali et al. was modified in the light of qualitative analysis (27). The modified 24-item questionnaire was subjected to face validity and content validity with six pharmacy practitioners who gave feedback on the appropriateness of items. The questionnaire was then subjected to pilot testing with six newly graduated pharmacists. The 24-item questionnaire consists of three sections i.e. demographic information of students (3-items); understanding and perception of the students regarding the bioequivalence, safety, and efficacy profile of generic medicines