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

Highlights

• A review of physicians’ views of generic medicines in low- and middle-income countries (LMICs).

• Physicians from LMICs have mixed views about generic medicines.

• In LMICs, there is a lack of coherent policies that encourage wide utilization of generic medicines.

Abstract

Objectives

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

Introduction

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]. 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 low- and 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], [8], [9], [10].

Generic medicine can be defined in different ways [11], [12], [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], [16], [17], [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], [28], [29], [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], [33], [34], [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.