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).
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
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.
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.
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 in comparison to brand medicines as well as generic substitution (12-items) and expectations from the pharmacy curriculum with respect to bioequivalence, safety and efficacy of generic medicines (8-items). The 20-items used a five-point Likert scale (5=strongly agree to 1=strongly disagree) with only one item pertinent to the issue of bioequivalence regulatory limits. In the beginning of questionnaire there was one statement about the definition of bioavailability which was read out to the students by the researcher. The item related to the issue of bioequivalence regulatory limits was read as under:
“The regulatory limits applied are that 90% confidence intervals for the ratios (generic product: brand name product) of areas under plasma drug conc versus time curves & maximum plasma drug conc must fall between….” For this statement six options were given to the respondent. The correct option was 80-125%.
The data was entered into the SPSS version 17.0. Descriptive statistics were applied to summarize the data. In order to explore the normality assumptions descriptive statistics was performed to get skewness and kurtosis. Data was found to be not normally distributed and cross tabulation was done to examine the relationship between the variables. In order to test the association between categorical variables, Chi square was applied. In case, Chi square fails to fit its assumption, then Fisher’s exact test is applied. A p value of less than 0.05 was considered significant.
In order to see how well the items in a construct are of similar quality and dimension, reliability coefficient is calculated by means of computing the value of Cronbach’s alpha (34). In exploratory studies Cronbach Alpha values ranging from 0.50 to 0.60 are considered to be acceptable (35, 36). Moreover, for sample size greater than 100, Cronbach’s alpha coefficient values being greater than 0.40 are acceptable for research purposes (37). In the current research the Cronbach’s Alpha Coefficient was found to be 0.73.
In the present era of spiraling health care costs there is a need of cost-effective generic alternative. The Government of Pakistan endorsed this concept and thus educators of healthcare professionals are liable to teach and train future practitioners about the utilization of cost-effective medicines. Therefore in order to deal with the contemporary issue of underutilization of generic medicines it is imperative that healthcare professionals do demonstrate understanding and sound perception of generic alternatives. In the light of these facts this study is carried out to explore the understanding and perception of pharmacy students towards generic medicine.
Moreover, to the best of our knowledge, the current study is the first of its kind in evaluating final year Pharm D students’ understanding and perception of generic medicines in Pakistan. The current study showed gaps in the understanding of basic concepts of generic medicines in final-year Pharm D students. Nearly half of students ”strongly agreed” and ”agreed” that a generic medicine is bioequivalent to the brand name medicine and that generic medicine must be available in the same dosage form as brand name medicine. Likewise, more than 50% “strongly agreed” or”agreed” that generic medicine must contain the same dose as brand name medicine. A statistically significant difference was noted for all of these responses; however, higher proportions of the responses ”strongly agreed” or ”agreed” were observed from the government-sponsored university. This may be reflective of different styles of teaching in each university, probably due to highly-qualified and experienced teaching staff in government-sponsored universities.
With regard to perception toward generic medicines, the students seem to be positive. In the current study, a large majority of students disagreed that generic medicines are of inferior quality and are less effective than brand name medicines. Nearly half of the students disagreed that generic medicines produce more side effects than brand name medicines. Female students from the government-sponsored university showed higher confidence in dispensing by generic name rather than brand name. Moreover, in the current study, a higher proportion of students from the government- sponsored university showed eagerness to know about bioequivalence tests.
The findings of the current study do not correlate well with the previous studies done in Australia, where more than 80% of the pharmacy pre-registrants considered generic medicines inferior, less effective and having more side effects than brand name medicines (27). Similarly, a comparative study among final-year medical students and pharmacy pre-registrants reported gaps in knowledge about the quality, safety and efficacy of generic medicine (28). The difference in findings in the current study from the Australian study may be due to the generics-dominated local industry in Pakistan, resulting in the sensitization of the faculty toward generic medicines. Furthermore, lectures on generic medicines might have been conducted in the final semester. Moreover, orientation sessions from the local pharmaceutical industries in both pharmacy universities in the final semester may partly contribute to the differences in the understanding and perception of generic medicines when compared to previous Australian studies (27, 28). As highlighted by McGivney training of future pharmacy practitioners in practice sites contributes to better patient care (38). The execution of a similar concept of “hands on training” to future pharmacy practitioners in Pakistan may result in better quality of care from them. Regarding bioequivalence issues, students admitted that they were introduced well to the concepts, but a poor response to questions about bioequivalence limits indicates a lack of understanding of this concept. A similar response was observed in Australian studies (27, 28). These findings reflect the complexity of topics of pharmacokinetics and biopharmaceutics that are difficult for students to understand. As outlined in a previous study in the US a special course emphasizing bioequivalence and bioequivalence testing of generic medicines and highlighting the patients’ needs regarding generic substitution and interchangeability of brands with generic formulations could be helpful for future pharmacy practitioners.
Students’ learning expectations of cost-effective dispensing were higher in government-sponsored university. Although basic principles of economics are taught in second-year PharmD in both the universities, the application of basic concepts of supply and demand, drug pricing, and the merits and disadvantages of brand name medicines and generics are lacking. A study done in the US reported that as compared to pharmacists pharmacy students made more recommendations to curtail healthcare expenses (26) Thus, incorporating case studies in economics course in pharmacy curriculum will help future practitioners to develop into counselors of cost-effective regimens. Moreover, pharmacy students need to have knowledge about the National Drug Policy and the Essential Drug List that contain information on cost-effective medicines. A pharmacoeconomics course which is included as a subject in many pharmacy curricula globally (39, 40) is recommended to be included in the pharmacy curriculum in Pakistan.
General Conclusion and Recommendation
In the current study, gaps in understanding of the basic concepts of generic medicine and their bioequivalence were documented. This should be tackled by pharmacy educators as pharmacists are the core loop in the healthcare chain, and their knowledge of generic medicines can inform both the prescriber and the patient on cost-effective regimens. Interestingly, in relation to perception, pharmacy students showed positive perception towards generic medicines.
With regard to pharmacy curriculum, future strategies should be directed toward one-year pre-registration training or residency in the field of interest such as a hospital or in industry. A Memorandum of Understanding would be signed between the academic institution and the hospital or company to foster evidence-based learning.
Regarding the limitations in the current study the student participants were from two pharmacy institutes only. Due to the semester break in four other universities, the students were not available to participate in the study. As the data is from only two universities, this restricts the extrapolation of findings to other doctor of pharmacy programs in Pakistan.
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