Health Policy 117 (2014) 297–310

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Perspectives of physicians practicing in low and middle income countries towards generic medicines: A narrative review Mohamed Azmi Hassali a,∗ , Zhi Yen Wong b , Alian A. Alrasheedy a , Fahad Saleem a , Abdul Haniff Mohamad Yahaya b , Hisham Aljadhey c a Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia b Pharmacy Department, Hospital Teluk Intan, Jalan Changkat Jong, 36000 Teluk Intan, Perak, Malaysia c College of Pharmacy, King Saud University, 11451 Riyadh, Saudi Arabia

a r t i c l e

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Article history: Received 4 June 2013 Received in revised form 16 July 2014 Accepted 24 July 2014 Keywords: Perspective Generic medicines Low and middle income countries Physician Review

a b s t r a c t Objectives: This review was conducted to document published literature related to physicians’ knowledge, attitudes, and perceptions of generic medicines in low- and middleincome countries (LMICs) and to compare the findings with high-income countries. Methods: A systematic search of articles published in peer-reviewed journals from January 2001 to February 2013 was performed. The search comprised nine electronic databases. The search strategy involved using Boolean operators for combinations of the following terms: generic medicines, generic medications, generic drugs, generic, generic substitution, generic prescribing, international non-proprietary, prescribers, doctors, general practitioners, physicians, and specialists. Results: Sixteen articles were included in this review. The majority (n = 11) were from high income countries and five from LMICs. The main difference between high income countries and LMICs is that physicians from high income countries generally have positive views whereas those from LMICs tend to have mixed views regarding generic medicines. Few similarities were identified among different country income groups namely low level of physicians’ knowledge of the basis of bioequivalence testing, cost of generic medicines as an encouraging factor for generic medicine prescribing, physicians’ concerns towards safety and quality of generic medicines and effect of pharmaceutical sales representative on generic medicine prescribing. Conclusion: The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care system and pharmaceutical funding system, medicine policies, the level of educational interventions, and drug information sources in countries of different income levels. © 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction ∗ Corresponding author. Tel.: +60 12 4421605. E-mail addresses: [email protected] (M.A. Hassali), [email protected] (Z.Y. Wong), [email protected] (A.A. Alrasheedy), [email protected] (F. Saleem), [email protected] (A.H. Mohamad Yahaya), [email protected] (H. Aljadhey). http://dx.doi.org/10.1016/j.healthpol.2014.07.014 0168-8510/© 2014 Elsevier Ireland Ltd. All rights reserved.

The major challenge faced by many health care providers and policy makers in the world is the ever escalating health care costs [1,2]. Within this context, the cost of pharmaceuticals constitutes the second largest cost in health care provision after the staffing costs [3].

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There could be many reasons for increased pharmaceutical expenditure, including a rise in disease prevalence, an increase in population risk factors, changes in clinical thresholds for treatment, and the emergence of new medical treatments [4,5]. The situation is worsening in lowand middle-income countries (LMICs) where the household out-of-pocket payments are a higher proportion of the total expenditure than in high income countries [6]. In this challenging scenario of health care provision, one of the mechanisms suggested to minimize the costs of medicines is the encouragement of greater use of generic medicines [7–10]. Generic medicine can be defined in different ways [11–13]. However, generic medicine is commonly understood as defined by World Health Organization (WHO) to mean “a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights.” [14]. Generic medicines are required to have the same active substance, strength, route of administration, identity, quality, purity, efficacy and the same intended use of the brand name medicines [15–18]. However, the generic and brand name formulations of the medicines can have some minor differences, such as the inactive ingredients (e.g., preservatives, flavours), colour, shape, and product packaging [15,17,19]. Despite different regulatory guidance for marketing approval of generic medicines, bioequivalence testing is a fundamental regulatory requirement for approval of generic medicine [12]. Generic products are considered to be bioequivalent only if their rate and extent of absorption do not show a significant difference from the reference product [7]. Moreover, bioequivalence can be waived only if scientifically appropriate based relevant scientific principles and considerations including the Biopharmaceutics Classification system (BCS) [20]. In BCS, medicines are categorized into four categories based on solubility and intestinal permeability [21]. BCS takes into consideration dissolution, solubility and intestinal permeability when granting biowaivers [12]. Thus, bioavailability and bioequivalence studies can be waived if the product is categorized under BCS Class I (i.e. high solubility and high permeability) and if the immediate release formulation exhibits rapid in-vitro dissolution [22]. Moreover, biowaivers can be granted to BCS Class III (i.e. high solubility and low permeability) [23]. Different countries have different health policies and health care systems, as well as different regulations and policies related to generic medicine utilization [24]; hence, it is believed that physicians’ perspectives and knowledge of generic medicine will differ accordingly. Physicians play an important role in improving the generic utilization rate. In fact, in most countries, the physician is the key person in the medicine use process. The physicians start the process by prescribing or ordering medications, and this is normally followed by pharmacists, who will in turn dispense the medications. However, in some countries, physicians are involved in the dispensing role as well [25,26]. Hence, physicians have a great influence on selecting either generic or original-brand medicines for patients. Previous literatures had reported that information given by

prescribing doctors on generic medicines could influence patients’ acceptance and use of these products [27–30]. In addition, physician prescribing practice using international non-proprietary name (INN) is important in encouraging the use of generic medicines among patients [31]. For example, patient confusion over medicine names which was identified as one of the main barriers to the acceptance of generic medicines can be avoided if physicians used an INN in prescribing [32–35]. However, prescribing by INN alone does not stimulate generic medicine use unless accompanied by pharmaceutical policies to encourage the use of generic medicine [36]. The understanding of physicians’ perceptions, knowledge, and attitudes towards generic medicine will have an important influence on patients’ selection of medicines. Therefore, this review was conducted to document the published literature related to physicians’ knowledge, attitudes, and perceptions of generic medicines in LMICs. By understanding physicians’ perspectives in LMICs, researchers and health policy makers can formulate more efficient interventions to increase the rate of generic medicine prescribing in respective countries. 2. Methods An extensive literature search was carried out in several electronic databases available at the authors’ institution library. A systematic search of articles published in peerreviewed journals between January 2001 and February 2013 was performed. The search comprised nine electronic databases including CINAHL Plus with Full Text, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Wiley Online Library, ProQuest, PubMed, and Scopus. The search strategy involved using Boolean operators for combinations of the following terms: generic medicines, generic medications, generic drugs, generic, generic substitution, generic prescribing, international non-proprietary, prescribers, doctors, general practitioners, physicians, and specialists. Equivalent terms in thesauruses or Medical Subject Heading (MeSH) browsers were used whenever possible. In this review, both qualitative and quantitative studies which reported physicians’ knowledge, attitudes, and perceptions towards generic medicines were included. Systematic reviews, case studies, commentaries, essays, legal analyses, consensus statements, and letters to editors were excluded from the review. Studies were excluded if they were written in languages other than English. Articles reporting clinical trials for evaluating the efficacy between generic and branded products were also excluded from this review. Similarly, articles mentioning bio-similar products were also excluded. Each study was reviewed by all authors with disagreement resolved by consensus. A number of variables were assessed, including the study design, the country of origin, the objective, the number of respondents, the outcomes and limitations. A total of 10,588 titles and abstracts were identified from the electronic search of all nine databases. Subsequently, 10,554 titles and abstracts were not related to physicians’ perceptions, attitudes, and knowledge of generic medicine. Duplicated citations were identified and

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Titles and abstracts identified by electronic search of all nine database. (n=10,588)

Title and abstracts not related to physicians’ perception, attitude and knowledge of generic medicine and duplication (n=10,554) Full text of articles retrieved for further assessment (n= 34)

Articles not assessing physicians’ perception, attitude and knowledge of generic medicine but rather largely looking at the clinical effectiveness of generic medicines were excluded (n=18) Studies related to physicians’ perception, attitude and knowledge of generic medicine and which satisfied the selection criteria were included in the review (n=16) Fig. 1. Quorum flow chart of the review process.

excluded. The full texts of 34 articles were retrieved for further evaluation. Lastly, 18 out of the 34 articles that did not really assess physicians’ perceptions, attitudes, and knowledge of generic medicine, but rather looked largely at the clinical effectiveness of generic medicines were excluded from further analysis. The quorum flow chart for selection in this review is shown in Fig. 1. 2.1. Description of included studies The studies discussed in this review article were arranged according to the country income level. According to the World Bank, countries are classified to low-income country, lower-middle income country, upper-middle income country and high-income country using gross national income (GNI) per capita [37]. The GNI per capita is calculated using the Atlas conversion factor with the aim to reduce the impact of exchange rate fluctuations in the cross-country comparison of national incomes [37]. A list of countries included in this review is showed in Table 1. Studies from high income countries were included in the results to allow comparison between findings from LMICs and high income countries. Thirty-four studies were identified but eighteen studies were excluded as they did not fulfil the selection criteria. Subsequently, 16 published studies were included in the review as shown in Table 2. Of the 16, the majority (n = 11) were from high-income countries: United States of America (n = 2), Australia, Finland, Canada, Germany, Italy, Greece, Slovenia, Saudi Arabia and a study conducted in two countries—Greece and Cyprus. Four were from uppermiddle income countries: Malaysia, Turkey, Jamaica, and

Iraq. One was a lower-middle income country—Pakistan. Most of the studies were quantitative, while four studies used qualitative methods. One study took an international perspective, but the focus of each of the rest was an individual country. 2.2. Methodological quality Each study was reviewed by all authors and a consensus meeting was convened to ensure quality assurance. The most prominent pitfall identified was a lack of generalizability of study results to whole populations, as the studies were restricted to certain geographical areas, governorates, or provinces [35,38,39]. There were three studies in which limitations were not mentioned by the authors [26,40,41]. Five studies suffered from low response rate [42–46] and one study suffered from a high number of missing values in some questions although it had a good response rate [47]. Two studies used convenience sampling [48,49] and one study might have a sampling bias [50] which could limit the generalization of their findings. There was one study limited by lack of distinction between primary care and secondary care physicians [51]. 3. Results A summary of studies included in the review investigating physicians’ perception, attitude and knowledge towards generic medicines is shown in detail in Table 2. A summary of the variables that were investigated in the studies is presented in Table 3.

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Table 1 List of countries and GNI per capita [37]. No.

Country

GNIa per capita (2011)

Income groups

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

United States of America Australia Finland Canada Germany Italy Cyprus Greece Slovenia Saudi Arabia Turkey Malaysia Iraq Jamaica Pakistan

50,660 50,130 47,720 46,860 44,670 36,260 28,840 24,940 23,930 21,210 10,510 8,830 4,970 4,800 1,140

High income High income High income High income High income High income High income High income High income High income Upper middle income Upper middle income Upper middle income Upper middle income Lower middle income

a

Gross National Income.

4. Discussion In this review, physicians in LMICs tend to have mixed views of generic medicines whereas physicians in high-income countries generally have positive views. One possible explanation for this finding could be due to the differences in health care and pharmaceutical funding systems and medicine policies among countries [6,31,36,52,53]. However, the difference in study designs and cross-country differences make comparisons of results problematic. Moreover, differences in the findings can be attributed to other factors such as disease prevalence, geographical region and the socio-demographic structure of the country’s population. Complexities in the health care and pharmaceutical funding systems in LMICs may account for the differences in opinions towards generic medicines. Low-income countries have a less reliable collection of tax revenue and subsequent low public spending on health and other social expenditure [6]. As a result of this, low-income countries are heavily dependent on external resources such as private insurance, donor funding, patients’ out-of-pocket payment and the provision of services based on faith-based charities [6]. However, this external dependence poses a major problem in which funding in low-income countries varies from year to year [54]. Such variation poses major planning difficulties in health care allocation [54]. In fact, most of the health care costs are paid out of pocket by patients in LMICs. Thus, in most of the studies reviewed, cost was reported to be the main reason in prescribing generic medicines [35,38,45–47,51]. In contrast, high income countries have developed social health protection that is based on risk pooling system [55]. In this system, funds dedicated for health care are collected through prepayment [55]. However, low-income countries spend proportionately less public funding on health, private insurance plays a minor role and household out-of-pocket payments are a higher proportion of the total expenditure than in middle- and high-income countries [6]. In high-income countries, individuals pay few health care costs directly. The medical expenses are borne mainly by social health insurance or by the government [55]. In high-income countries, use of generic medicine is one of the cost containment measure

that commonly adopted by policy makers and insurance companies [7,31]. As a result of that, earlier exposure to generic medicines and experience in using generic medicine may lead to positive views of generic medicines among physicians in high-income countries. Pharmaceutical financing by health care stakeholders has also been seen as an enabler for generic medicine use in certain countries [56]. In terms of pharmaceutical funding at the population level, there are two main systems, namely the public and private systems. In fully public systems, medicines are financed, procured and distributed by a centralized government unit [53,56]. In a mixed system, public funding from central budgets or social health insurance is used to reimburse patients or private pharmacies [53,56]. The alternative way is that medicines are supplied through government medical stores and health facilities but paid for by patient fees. In fully private systems, patients or private insurance systems bear the whole cost of medicines purchased from private pharmacies and drug sellers [53,56]. Most high income countries (94%) are covered with insurance system [52]. Medicines are covered for reimbursements in all the health insurance systems of all the high-income countries [52]. However, the opposite scenario was observed in LMICs. Only 45% or 18 lowincome countries have medicine benefits in their insurance system [52]. Consequently, patients’ out-of-pocket payments for medicines are higher in low-income countries. In short, physicians in LMICs may be less sensitive towards medicine cost as in LMICs most of the pharmaceutical costs are paid by out-of-pocket payments [52]. Moreover, lack of policies and strategies by government or third party payers that encourage prescribing generic medicines as a cost containment strategy hinders the wide utilization of generic medicines in the health care system in LMICs. However, in most high income countries, there are several policies and initiatives that encourage and support prescribing generic medicines [24,31]. These policies can be categorized into two groups, namely supply-side and demand-side policies [7]. Supply-side policies are related to market entry, pricing and reimbursement issues related to generic medicines [7]. In contrast, demand-side policies are mostly related to interventions at the prescribing and dispensing levels as well as purchasing by consumers

Table 2 A summary of studies in the review investigating physicians’ perception, attitude and knowledge towards generic medicines. Study description

Country

Objective

Outcome

Limitation

Barrett (2005) [44]

Sample size: 2050 Response rate: 21% (n = 425) Sampling: Non-probability sampling Methods: Web survey Target group: Physicians Source of sample: American Medical Association master file of physicians in the United States Funding source: Not mentioned by author(s)

United States of America (high income)

To investigate physicians’ opinions about generic medicines substitution and their pattern of prescribing of generic medicines.

The limitations, similar to other surveys, included non-response bias, wording of questions and order of questions, and use of non-random sampling technique. Thus, the impact of such issues cannot be ruled out with certainty, nor measured.

Pereira et al. (2005) [50]

Sample size: 375 Response rate: 29% (n = 110) Sampling: Random Methods: Mail survey Target group: Physicians Source of sample: College of Physicians and Surgeons of Ontario website Funding source: Father Sean O’Sullivan Research Centre of St Joseph’s Healthcare, Hamilton, Ontario, Canada

Canada (high income)

Kersnik and Peklar (2006) [40]

Sample size: 200 Response rate: 58.5% (n = 117) Sampling: Random Methods: Postal survey Target group: General practitioners Source of sample: National database Funding source: National Health Insurance Institute and research grant from National Research Agency (ARRS)

Slovenia (high income)

To survey Canadian physicians and patients on their attitudes towards generic medicines, importance of bioequivalence to Coumadin© and their perceptions about generic Warfarin. To examine general practitioners’ attitude towards generic prescribing

Perception of physician towards generic medicines: (1) Only 42% of physicians agreed that generic medicines must be therapeutically equivalent to brand innovator drugs. (2) However, 36% of the physicians in this study perceived that therapeutic failures were a serious problem with generic medicines. Physicians’ prescribing practice: Physicians supported generic substitution in most cases (78%). Factors affecting physicians’ choice of medicines: 73% of physicians said they were aware of the price differences between brand innovator drugs and generic medicines. Physicians said they felt pressured by patients, health care plans or insurance companies to prescribe generic medicines. However, they also claimed that a patient’s needs influenced their choice to prescribe brand medicines over generic medicines. Knowledge of BE regulatory requirement: (1) The majority of physicians (90%) stated that they were knowledgeable about generic bioequivalence. (2) Older physicians were more likely to say they knew enough about the bioequivalence of generic medicines. Perceptions of physician towards generic medicines: Respondents held neutral view on generic Warfarin although a minority of them had concerns about it. Physicians’ prescribing practice: (1) 65% of the respondents generally supported generic substitution. (2) 43.6% of respondents agreed or strongly agreed that for narrow therapeutic index drugs, brand innovator drugs should not be substituted with generic equivalents. (3) 44.0% of respondents prefer to prescribe original warfarin for patients starting warfarin therapy. (4) 40.0% of them felt not comfortable about generic substitution of warfarin. (5) 19.4% of them reported difficulties in managing the switch. Knowledge of BE regulatory requirement: Only 14.5% of the respondents were familiar with the specific bioequivalence requirements that are applied to generic warfarin in Canada. Perception of physician towards generic medicines: 88.9% of them perceived generic medicines to have the same effectiveness as original brand medicines. Factors affecting physicians’ choice of medicines: (1) Academic detailing affects respondents’ generic prescribing decision (60.7%) (2) They were willing to switch to cheaper generic versions (96.3%) if prices were lower by 25–35% than brand innovator medicines.

Sampling bias might be limitation of the study, as those physicians with more interest in generic substitution or with some concerns were more likely to have participated. The opinions of all physician specialty groups might not be represented adequately.

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Author

Limitations were not mentioned by the authors.

301

302

Table 2 (Continued) Study description

Country

Objective

Outcome

Limitation

Hassali et al. (2006) [38]

Sample size: 10 Response rate: Not applicable Sampling: Convenience sampling Methods: Qualitative interview Target group: General practitioners (GPs) Source of sample: Advertisement in the weekly newsletter of Division of General Practice, Melbourne Branch Funding source: Not mentioned by author(s).

Australia (high income)

To investigate factors affecting the GPs’ generic medicine prescribing.

The study was an explorative qualitative study conducted with ten general practitioners in one state in Australia (Melbourne). Hence, generalization of results to other parts of the country might be limited.

Heikkilä et al. (2007) [48]

Sample size: 25 general practitioners and 24 specialists Response rate: Not applicable Sampling: Convenience sampling Methods: Structured interview Target group: General practitioners and specialists Source of sample: North Savo and Central Finland Funding source: Not mentioned by author(s) Sample size: 1463 Response rate: 82.3% (n = 1204) Sampling: Stratified sampling Method: Postal survey Target group: Physicians Source of sample: Greek Medical Association directory Funding source: Not mentioned by author(s)

Finland (high income)

To investigate the opinions, attitudes and experiences that physicians and customers have of generic substitution.

Perception of physician towards generic medicines: GPs in Melbourne had mixed attitudes prescribing of generic medicines. Moreover, misconceptions about the safety and efficacy of generic medicines still persist among some GPs. Factors affecting physicians’ choice of medicines: (1) Cost was reported to be the main reason in prescribing generic medicines. (2) Major factors influencing the practice were identified such as the safety profile of the medicine, cost and patient compliance. Effect of pharmaceutical sales representatives on prescribing of generic medicines: Respondents agreed that drug advertising and marketing can influence their choice of medicine brands. Barriers to prescribing of generic medicines: There were three main reasons why GPs opposed generic medicines: patient confusion arising from substitution, concerns over bioequivalence and the risk of less money for research-based companies to discover new drugs. Knowledge of BE requirement: GP had poor knowledge of the bioequivalence standard. Perception of physician towards generic medicines: Most of the physicians interviewed (n = 42, 86%) perceived that generic substitution was a good reform measure. However, more than half of the physicians thought that interchangeable medicines in certain medicine groups are not of the same safety and effectiveness as the original brand medicines. Others: The topics related to generic substitution that were most discussed by patients and physicians during consultations were the lower cost of the generic medicines followed by their side effects. Patients also talked about the efficacy and availability of generic medicines during the consultations.

Greece (high income)

To investigate the prescribing practice of physicians in Greece with a focus on factors that influence their decision on generic prescribing

Tsiantou et al. (2009) [47]

Perception of physician towards generic medicines: Physicians had positive views on the safety, efficacy and quality of generic medicines. Physicians’ prescribing practice: The majority of respondents (70.8%) reported that they did not prescribe generic medicines. Factors affecting physicians’ choice of drug: (1) The appearance of side effects, patients’ insurance coverage, patient income and cost of the drug were identified as important factors that affected their selection of medicines. (2) Participants’ age and their opinion of generic medicines were two factors influencing generic medicines prescribing. Effect of pharmaceutical sales representatives on prescribing of generic medicines: (1) Companies’ sales representatives were considered as the second most important source of information. (2) 74.2% of them claimed that they were not affected by sales representatives.

The participants were conveniently selected from two areas, namely North Savo and Central Finland. Hence, the results of the study were not generalizable to all Finnish physicians. Moreover, the results represented the opinions and views during the first year of mandatory generic substitution implementation. The study was subjected to all the limitations that might happen with similar mail surveys. Moreover, while the survey had a good high response rate, but the high number of missing values in some questions, particularly questions related to the quality, efficacy and effectiveness of generic medicines, might lead to bias in the study findings.

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Author

Theodorou et al. (2009) [51]

Fabiano et al. (2012) [42]

Sample size: 303 Response rate: Not mentioned by author(s) Sampling: Not mentioned by author(s) Methods: Web-survey Target group: Family Paediatrician (FP) Source of sample: All Italian family paediatrician Funding source: Not mentioned by author(s)

Greece and Cyprus (high income)

To investigate attitudes and factors that influence physicians’ prescribing decisions and practice in Greece and Cyprus.

Perception of physician towards generic medicines: (1) The majority of doctors in both countries agreed that the effectiveness, safety and efficacy of generic medicines may not be excellent but they are acceptable. (2) Physicians believed that new drugs are not always better and their high prices are not necessarily justified. Physicians’ prescribing practice: Cypriot physicians prescribed more generic medicines than Greek physicians. Factors affecting physicians’ choice of drug: (1) Clinical effectiveness was the most important factor to be considered in drug selection in both countries. (2) About 60% of physician considered cost of medicines to patients important or highly important when prescribing medicines.

Lack of distinction between primary care and secondary care physicians.

Saudi Arabia (high income)

To examine physicians’ practices, attitudes and other factors influencing prescribing of generic medicines

Limitations were not mentioned by the author.

Italy (high income)

To collect information regarding FP’s perception of generic medicines and generic prescribing

Perception of physician towards generic medicines: (1) Even though most physicians (79%) supported generic substitution, there were certain clinical situations where they preferred to use brand name medicines. Factors affecting physicians’ choice of medicines: (1) 72% of them believed that price difference between generic and original medicines helped them to switch to generic medicines. (2) Physicians did not report significant difference in pressure from patients in prescribing generic or brand medicines. Effect of pharmaceutical sales representatives on prescribing of generic medicines: (1) Physicians reported receiving visits and samples more frequently from representatives of brand name companies. (2) Physician reported that generic drug representatives were their first source of information followed by pharmacists. Knowledge of generic medicines: (1) The majority (96%) of the physicians knew enough about the therapeutic value of generic medicines. (2) 75% of the respondents reported that they knew the price differences. Perception of physician towards generic medicines: The majority of them believed that efficacy of generic medicines were sufficient (33.6%) or good (45.2%). Physicians’ prescribing practice: 13.5% of them declared that generic medicines would always be prescribed when available. Barriers to generic prescribing: Factors that hindered FP prescribing generic medicine were insufficient knowledge of generic medicines (20.4%) and scepticism about the reliability of bioequivalence test and the safety of generic medicines (54.4%). Knowledge of generic medicines: The findings of the study reported that 37.2% and 32.6% of them declared having a sufficient or fairly good knowledge of generic medicines, respectively.

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Alghasham (2009) [41]

Sample size: Greece: 1463 Cyprus: 240 Response rate: Greece: 82.3% (n = 1204) Cyprus: 80.4% (n = 193) Sampling: Proportional stratified sampling Methods: Postal survey Target group: physicians Source of sample: Not mentioned by author(s) Funding source: Not mentioned by author(s) Sample size: 900 Response rate: 85.8% (n = 772) Sampling: Stratified sampling Methods: Self-administered questionnaire Target group: Physician Source of sample: Different setting in central Saudi Arabia Funding source: Not mentioned by author(s)

The major limitation of the study was the small sample size.

303

304

Table 2 (Continued) Study description

Country

Objective

Outcome

Limitation

Hamann et al. (2013) [49]

Sample size: 410 Response rate: Not mentioned by author(s) Sampling: Convenience sampling Methods: Hypothetical decision scenario, structured questionnaire Target group: Psychiatrists Source of sample: Psychiatrists attending annual meeting of the German Psychiatrists’ Association (DGPPN) Funding source: No funding received

Germany (high income)

Perception of physician towards generic medicines: (1) Most of the psychiatrists judged branded drugs were slightly better than generic ones’ with all the potential difference the author asked. (2) The most pronounced difference between generic and branded medicines was placebo effect. Physicians’ prescribing practice: Psychiatrists preferred to use branded drugs for their own use but for patients, they preferred to prescribe generic medicines in the two scenarios of hypothetical depression and schizophrenia. Factors affecting physicians’ choice of medicines: Additional predictors for choosing generic medicines were higher share of outpatients, less negative attitude toward generic medicines and higher uncertainty tolerance.

The study had some limitations. First, a hypothetical decision scenario was used. Second, not all potential factors influencing prescribing habits were studied. Third, Convenience sampling was used. Hence, generalization for all psychiatrists might not be possible.

Shrank et al. (2011) [43]

Sample size: 2764 Response rate: 30.4% (n = 839) Sampling: Stratified random sampling Methods: Web survey Target group: Physician Source of sample: e-Rewards Physician Panel and the American Medical Association (AMA) Physician Master file Funding source: Career development award from National Heart, Lung and Blood Institute (K23HL090505-01) and research grant from CVS Caremark

United States of America (high income)

To display the subjective views of psychiatrists towards generic versus branded psychotropic medicines with special focus on what influences their choice between branded and generic medicines in various clinical situations To evaluate physicians’ perceptions about generic medicines and potential barriers to generic medicine use.

Perception of physician towards generic medicines: (1) About 67% of the respondents somewhat or strongly agreed that generic medicines are as effective as brand innovator medicines. (2) Over 23% of the physicians surveyed expressed negative perceptions about efficacy of generic medicines. (3) However, 50.6% of respondents were concerned about the quality of generic medicines. Physicians’ prescribing practice: More than a quarter preferred not to use generic medicines as the first-line medicines for their family members and themselves. Factors affecting physicians’ choice of medicines: The age of respondents was reported to be associated with physicians’ perception of generic medicine with older physicians showing more negative perceptions towards generic medicines than younger physicians. Effect of pharmaceutical sales representatives on prescribing of generic medicines: Physicians reported that pharmaceutical company representatives were the most common source of information (75%) about the market entry of generic medicines.

The sample size was drawn from a sampling frame that had in it those physicians who were willing to participate in surveys. Thus, they might be different to the majority population. Also, the response rate was very low. Moreover, some age groups (i.e. young physicians) and female physicians were less likely to participate in the study, while those between the age of 55 and 64 were overrepresented. Furthermore, social desirability bias could have biased the results. Moreover, in this study face validity was performed but construct validity of the questions was not.

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Author

Sample size: 325 Response rate: 26.8% (n = 87) Sampling: Convenience sampling Methods: Postal survey Target group: General practitioners (GPs) Source of sample: Private Medical Practice Control Department, Medical Practice Division, Ministry of Health Malaysia, 2007 registry Funding source: Not mentioned by author(s)

Malaysia (upper middle income)

To evaluate general practitioners’ knowledge and perception of generic medicines in Penang, Malaysia.

Toklu et al. (2012) [46]

Sample size: 115 Response rate: 49% (n = 56) Sampling: Convenience sampling Methods: Survey Target group: Prescribers Source of sample: Haydarpasa Numune Education and Training Hospital and Marmara University Hospital Funding source: Not mentioned by author(s). Sample size: 10 Response rate: Not applicable Sampling: Purposive sampling Methods: Qualitative interview Target group: Physicians Source of sample: Central city and rural regions in Basrah Funding source: Not mentioned by author(s)

Turkey (upper middle income)

To investigate the knowledge and attitudes of patients, community pharmacists and physicians regarding the use of generic medicines.

Iraq (upper middle income)

To explore factors affecting generic medicine prescribing in Iraq.

Sharrad et al. (2009) [35]

Perception of physician towards generic medicines: 33% of the respondents had doubts about the efficacy of generic medicines while only 10.3% thought that generic medicines produced more side effects than their counterpart original brand. Physicians’ prescribing practice: 85.1% of the respondents claimed that they actively prescribed generic medicines in their practice. Factors affecting physicians’ choice of drug: Respondents’ age and years of practising were found to be significantly associated with active prescribing of generic medicines. Knowledge of generic medicine: (1) The majority of the GPs thought that generic medicines must be in the same dosage form (65.5%) and dose (81.6%) as the brand name medicines. (2) Only 49.4% of the respondents believed that generic medicines are bioequivalent to brand name medicines. Knowledge of BE regulatory requirement: Only 4.6% of the respondents correctly identified the bioequivalence standard for generic products. Perception of physician towards generic medicines: 32% of the prescribers perceived that generic medicines did not differ from the original brand innovators. Factors affecting physicians’ choice of medicines: Their knowledge and attitude about generic substitution were not related to sex, age or professional experience. For 92% of the prescribers, cost was the most important factor taken into consideration regarding generic substitution. Knowledge of generic medicines: (1) However, 82% of the prescribers were unsure about the bioequivalence of generic medicines. (2) Healthcare providers have insufficient knowledge about generic medicines.

Physicians’ prescribing practice: Mixed reactions when physicians were asked whether they prescribed generic medicine. Factors affecting physicians’ choice of medicines: (1) The major factors affecting physicians’ choice of medicines were drug availability, cost of medicine, safety and quality of the medicine, economic situation of the patient and disease severity. (2) Low cost of the generic medicines was the most common incentive to encourage prescribing of generic medicines. Effect of pharmaceutical sales representatives on prescribing of generic medicines: All physicians agreed that advertising positively influenced their choice of generic medicines. Pharmaceutical industry representatives were one of the main drug information sources. Barriers to generic medicine prescribing: The most common reason why physician opposed generic medicines was potential clinical problems. Other factors that hindered physicians from prescribing generic medicines were patient confusion, concerns about the quality and efficacy of generic medicines, and disease severity. Knowledge of BE regulatory requirement: Physicians had little or no knowledge about bioequivalence criteria required.

The low response rate is one of the limitations of the study. Moreover, the study was conducted in one state (State of Penang). Hence, the generalization of the findings to all GPs in Malaysia is not possible.

The major limitation of the study was the low response rate and the small sample size.

The study was an explorative qualitative study conducted with ten physicians in one city in Iraq (Basrah city). Hence, generalization of results to other parts of the country is limited.

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Chua et al. (2010) [39]

305

306

Table 2 (Continued) Study description

Country

Objective

Outcome

Limitation

GossellWilliams (2007) [45]

Sample size: 100 Response rate: 60% (n = 60) Sampling: Random sampling Methods: Survey by multi channels (i.e. email, fax, by hand, phone) Target group: Physicians Source of sample: Yellow Pages of local telephone directory of 2005 issued by Cable and Wireless Funding source: Not mentioned by author(s) Sample size: 11 Response rate: Not applicable Sampling: Snowball sampling Methods: Qualitative interview Target group: Dispensing doctors Source of sample: Karachi, Pakistan Funding source: Universiti Sains Malaysia

Jamaica (upper middle income)

To investigate attitudes of Jamaican physicians towards generic substitution and issues related to the use of generic medicines.

Physicians’ prescribing practice: Most of the surveyed physicians (49%) had a preference for prescribing generic medicines whereas 29% of the physicians prescribed generic medicines and brand innovator medicines in 50:50 ratios. Factors affecting physicians’ choice of medicines: Cost was the main factor (70%) influencing generic medicines prescribing. 33% of respondents reported clinical problems encountered with specific generic medicines; most of the clinical problems were associated with anti-infective agents. Knowledge of generic medicine: There were doubts about whether the generic medicines are bioequivalent and therapeutically equivalent to the innovator medicines.

Recruitment and having access to contact details of physicians to invite them to participate in the study was a limitation. The use of a directory does not cover all physicians in the country.

Pakistan (lower middle income)

To explore dispensing doctors’ knowledge, perception and attitude towards generic medicines and factors hindering and favouring generic medicine use.

Mixed views and attitude of dispensing doctors towards generic medicines were reported. Thematic content analysis identified five themes: (1) knowledge of generic medicines, (2) perception regarding generic medicines, (3) attitudes towards generic medicine, (4) attitudes towards marketing strategies by industries for original brands and generic medicines, and (5) recommendation to further enhance generic ultilization.

Limitations were not mentioned by the authors.

Jamshed et al. (2011) [26]

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Author

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307

Table 3 A summary of the variables that were investigated in the studies. Study

The variables Perception of physician towards generic medicines

Physicians’ prescribing practice

Factors affecting physicians’ choice of medicines

√a √ √ Barrett (2005) [44] √ √ Pereira et al. (2005) [50] √ √ Kersnik and Peklar (2006) [40] √ √ Hassali et al. (2006) [38] √ Heikkilä et al. (2007) [48] √ √ √ Tsiantou et al. (2009) [47] √ √ √ Theodorou et al. (2009) [51] √ √ Alghasham (2009) [41] √ √ Fabiano et al. (2012) [42] √ √ √ Hamann et al. (2012) [49] √ √ √ Shrank et al. (2011) [43] √ √ √ Chua et al. (2010) [39] √ √ Toklu et al. (2012) [46] √ Jamshed et al. (2011) [26] √ √ Sharrad et al. (2009) [35] √ √ Gossell-Williams (2007) [45] a √ means the particular variable(s) is explored in the respective study.

that include educational interventions to improve knowledge and confidence of physicians in prescribing generic medicines [7]. On contrast, the lack of part or all of these policies especially the educational interventions in LMICs may account for the mixed views of physicians towards generic medicines. Moreover, lack of confidence in the drug registration system, lack of communication between health care professionals and drug regulatory authorities, lack of drug information, guidelines, and regulatory information that document the bioequivalence and therapeutic equivalency contribute to the negative perceptions of generic medicines among physicians [24]. From the present review, there were five articles (i.e. two from middle-income countries [35,39] and three from high-income countries [38,44,50]) in which knowledge of bioequivalence acceptability criteria for generic medicine was accessed. In general, all studies reported that physicians have a low level of knowledge of the basis of bioequivalence testing. Lack of knowledge on the regulatory requirement of generic medicines will result in misconceptions about the quality, safety and efficacy of generic medicines [38,39,57].

Effect of pharmaceutical sales representatives on generic medicine prescribing

Barriers to generic medicine prescribing

Knowledge of bioequivalence regulatory requirement

Knowledge of generic medicines

√ √











√ √



√ √

√ √









√ √ √

The findings from this present review show that the cost of generic medicine was the main factor encouraging physicians to prescribe generic medicines regardless of the country income group. This finding showed that physicians were aware of the escalating health care costs and potential savings that generic medicines can offer. In fact, wide utilization of generic medicines can lead to substantial cost savings to the healthcare system [7–10,42,58]. The money being saved can be better used elsewhere [47,59,60]. Moreover, empowering the physicians with the appropriate knowledge about generic medicines and increasing their prescribing rate of these products will not only lead to cost savings and financial benefits, but it can lead to better health outcomes via improving medicine access and affordability and hence patient adherence to essential medicines [61–63]. Another interesting issue was that physicians, regardless of country income group, expressed concerns over the safety and quality of generic medicines although in many of these countries strict bioequivalence acceptability criteria for generic medicines were set by their respective drug regulatory bodies. One plausible explanation is lack of

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awareness of physicians towards roles and responsibilities of drug regulatory body in respective countries. In addition, the effect of pharmaceutical sales representatives in changing physicians’ prescribing habit should not be neglected. A few papers in this review investigated the roles of pharmaceutical sale representatives in providing drug information [35,43,47]. Physicians mentioned that pharmaceutical sales representatives were among the major sources of drug information and some of them mentioned that visits from these representatives affected their choice of drugs when prescribing [47]. In fact, other studies showed that pharmaceutical sales representative visits had an influence on prescribing patterns [58,64,65]. One study also reported that physicians were not informed with undesirable side effects by pharmaceutical sales representatives [66]. Patients’ health may be negatively affected if physicians are not informed about the side effects. Other than that, physician claimed they received visits mostly from original pharmaceutical companies. This scenario of biased drug information obtained from drug companies, if left unattended may have a negative impact on prescribing of generic medicines. Thus, there is a need for a regulatory body to monitor and audit drug information provided by pharmaceutical sales representatives since they are one of the main drug information sources for physicians [31]. Moreover, it is an important to provide the physicians with evidence-based information about generic medicines and their therapeutic equivalence with their counterpart original brands. This could be done by publishing a formulary of interchangeable medicines that documents the bioequivalence and suitability of generic substitution [67]. 5. Conclusion The present literature review revealed that physicians from LMICs tend to have mixed views regarding generic medicines. This may be due to differences in the health care systems and drug approval and regulatory systems, medicine policies, the level of educational interventions and drug information sources in countries of different income levels. Based on the present review, in order to improve utilization of generic medicines in LMICs, the following recommendations were made. First, more education and promotional efforts should be carried out to promote the bioequivalence acceptability criteria for generic medicines to physicians. Second, evidence-based information is needed to convince the physicians about the safety, quality and efficacy of generic medicines especially those physicians practising in LMICs. Third, drug regulatory bodies need to monitor and audit drug information provided by pharmaceutical sales representatives as they are one of the main drug information sources used by physicians. 6. Limitations The review has a number of limitations. The literature search was carried out based on electronic databases to which the authors’ university library subscribed. As a result, it is possible that some important studies might not have been retrieved. However, the review was not intended

to be exhaustive, but merely an attempt to examine the general perspectives of physicians in LMICs regarding generic medicines. Besides that, papers that were published in languages other than English were excluded from the review. Moreover, the review focused on the recent literature, i.e., from 2001 and onwards. However, this is justified because older studies might not be relevant to current practices. Perceptions and views do change over time, and a large number of generic medicines have been marketed in the last two decades. Moreover, many initiatives, policies, and promotion programs have been introduced in recent years, which might have an effect on physicians’ perceptions and views [68]. Also, information technology and easy access to information about generic medicines (e.g., via the Internet) has become more common in recent years. Thus, including the recent literature makes this review more contemporary and more relevant to today’s practice [68]. Conflicts of interest None. References [1] Borger C, Smith S, Truffer C, Keehan S, Sisko A, Poisal J, et al. Health spending projections through 2015: changes on the horizon. Health Affairs 2006;25:w61–73. [2] Steinwachs DM. Pharmacy benefit plans and prescription drug spending. Journal of the American Medical Association 2002;288:1773–4. [3] Marchildon G, DiMatteo L. Health care cost drivers: the facts. Canadian Institute for Health Information, https://secure.cihi.ca/ 2011 free products/health care cost drivers the facts en.pdf; [accessed 24.04.14]. [4] Thorpe KE. The rise in health care spending and what to do about it. Health Affairs 2005;24:1436–45. [5] Thorpe KE. Factors accounting for the rise in health-care spending in the United States: the role of rising disease prevalence and treatment intensity. Public Health 2006;120:1002–7. [6] Hopkins S. Health expenditure comparisons: low, middle and high income countries. The Open Health Services and Policy Journal 2010;3:111–7. [7] King DR, Kanavos P. Encouraging the use of generic medicines: implications for transition economies. Croatian Medical Journal 2002;43:462–9. [8] Kanavos P. Do generics offer significant savings to the UK National Health Service. Current Medical Research and Opinion 2007;23:105–16. [9] Karim SA, Pillai G, Ziqubu-Page T, Cassimjee M, Morar M. Potential savings from generic prescribing and generic substitution in South Africa. Health Policy and Planning 1996;11:198–202. [10] Haas JS, Phillips KA, Gerstenberger EP, Seger AC. Potential savings from substituting generic drugs for brand-name drugs: medical expenditure panel survey, 1997–2000. Annals of Internal Medicine 2005;142:891–7. [11] Birkett DJ. Generics-equal or not. Australian Prescriber 2003;26:85–6. [12] Davit B, Braddy AC, Conner DP, Yu LX. International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. American Association of Pharmaceutical Scientists (AAPS) Journal 2013;15:974–90. [13] Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology 2013;14:1. [14] World Health Organization. Generic drugs, http://www. who.int/trade/glossary/story034/en/index.html; 2012 [accessed 07.11.12]. [15] US Food and Drug Administration (FDA). FDA Center for Drug Evaluation and Research. Office of Generic Drugs. Facts about generic

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Perspectives of physicians practicing in low and middle income countries towards generic medicines: a narrative review.

This review was conducted to document published literature related to physicians' knowledge, attitudes, and perceptions of generic medicines in low- a...
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