IJPP 2005, 13: 257264 2005 The Authors Received March 25, 2005 Accepted July 28, 2005

5 DOI 10.1211/ijpp.13.4.0004 ISSN 0961-7671

Generic medicines: perceptions of consumers in Melbourne, Australia

Abstract
Objective The objective of this study was to explore consumers perceptions and opinions of generic medicines and to identify barriers to their use of generic medicines. Method A qualitative approach was used. A purposive sample of consumers, aged 2280 years, living in the Melbourne, Australia, metropolitan area were interviewed using a semi-structured interview guide. Key findings Sixteen consumers were interviewed. Thematic content analysis of the interviews identified four major themes: knowledge about generic medicines, acceptance of generics, nonacceptance of generics, and education needs pertaining to generic medicine use. In terms of knowledge, some consumers were not familiar with the term generic medicines, but were more familiar with the term cheaper brand of medicine. The major reason for acceptance of generic medicines among the consumers interviewed was cost. Positive encouragement from the healthcare providers was seen to influence generic medicine uptake by consumers. The major barriers to acceptance included influence from medical practitioners, side-effects from generic brands, and confusion that may arise from using different brands. To encourage future uptake of generics by consumers, some of the respondents recommended that education strategies be implemented by healthcare practitioners and governmental agencies to educate people on the safety and efficacy of generic medicines. Conclusions This study indicated that consumers interviewed generally had positive attitudes towards the use of generic medicines. The findings also suggest that direct patient education by the healthcare providers on issues relating to safety and efficacy of generic medicines could further enhance their uptake.

Department of Pharmacy Practice, Victorian College of Pharmacy, Monash University, Victoria, Australia Mohamed Azmi Hassali, PhD candidate David C.M. Kong, lecturer Kay Stewart, senior lecturer Clinical Research and Education, Pharmacy Department, The Alfred Hospital, Melbourne, Victoria, Australia David C.M. Kong, head

Introduction
In recent years, the use of generic medicines has been steadily increasing internationally, as a result of economic pressure on medicines budgets.13 The term generic medicine refers to a pharmaceutical product, usually intended to be interchangeable with the innovator product, marketed after the expiry of patent or other exclusivity rights.4 Generic medicines may be marketed either under the non-proprietary approved name or under a new brand (proprietary) name. In some countries, they may be marketed in dosage forms and/or strengths different from that of innovator products.4 The savings made by using generic medicines have been quoted to be between 37% and 50% in various countries, with most estimates being around 40%.57 In many countries throughout the world, the practice of generic prescribing and substitution is strongly supported by health authorities, and Australia is no exception. In Australia, increasing cost to the Pharmaceutical Benefits Scheme (PBS), which is a unique comprehensive system for subsidy of prescription drugs covering the whole population, has resulted in attempts by the Commonwealth Government to encourage the use of generic drugs.811 Although generic medicines have been available in Australia since the 1950s, they were largely used in hospitals as a consequence of competitive tendering.11 The challenge to brand-name products in terms of supply under the PBS only began in the 1990s.11 Key policy junctures with regard to this

Correspondence: Dr Kay Stewart, Senior Lecturer, Department of Pharmacy Practice, Victorian College of Pharmacy, Monash University, 381 Royal Parade, Parkville, VIC 3052, Australia. E-mail: Kay.Stewart@ vcp.monash.edu.au Acknowledgements: The authors would like to thank Dr Christine Walker, Chief Executive Officer of Chronic Illness Alliance Inc, Melbourne and Mr Graham Sweet, Pharmacist, Dandenong Division of General Practice, for their help in the recruitment of participants for this study.

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include the Brand Premium Policy (BPP) introduced in 1991 and the legalisation of brand substitution three years later.11 The BPP was introduced with the intention of increasing price competition by allowing different brands of the same medicine to be included on the Schedule of Pharmaceutical Benefits at different prices.8 The subsidy amount is determined from the lowest priced brand, the so-called benchmark brand, and the consumer pays the difference (premium) if a more expensive brand is prescribed. Benchmark pricing for PBS medicines means that at any given time, the price paid by the government for all brands of the same medicine is the same; therefore, there is no direct benefit to the government in relation to the brand prescribed by the doctor or used by the consumer. Savings to the PBS accrue as a result of normal market forces acting to reduce the negotiated price to government over the longer term through competition between brands. Savings to consumers occur when prices of different brands differ and a less expensive generically equivalent brand is used. As at June 30, 2003, the average brand premium was A$3.06, and premiums ranged from A$0.06 to A$79.48. The majority of brand premiums were in the range of A$1.00 to A$2.25.12 Further encouragement was provided in 1994 in the form of the Brand Substitution Policy (BSP).10,13 Under this policy, a pharmacist can supply a proven generic equivalent product under the PBS, with the consent of the patient, in place of the one prescribed, provided the prescriber does not preclude this. Furthermore, starting from February 1, 2003, the government regulated to ensure that computer-prescribing programs used by medical practitioners default to allowing generic substitution.14 The prescribing doctor must consciously choose to indicate if they require the patient to receive the original brand name product. It is estimated that this will result in savings of A$111 million over four years.14 All of these measures were taken in order to curb the rising cost of the PBS, which currently costs the federal government more than A$5 billion per year.15 In spite of an increased tendency towards generic medicine use and prescribing in recent years, generic medicines as a whole still represent only a small portion of the nations medicine budget. Indeed, compared to other developed countries around the world, such as the US, Canada, the UK and Germany, where the share of generic medicines in the prescription medicines markets exceeds 40%, the share in Australia is only 18%.11 One of the barriers to uptake of generic medicines in Australia is probably consumers lack of awareness of the availability of generic medicines. A previous Australian study, with 20 consumers in a single pharmacy in Brisbane, supports this argument.16 In this study, the author used a self-completed questionnaire with five questions related to generic substitution, which revealed that up to 40% of consumers did not know that there were less expensive brands of medication available. In the same study, about 18% of the consumers felt that the more expensive brands were of better quality, and 36% preferred to use exactly what the doctor had prescribed. This small study is the

only published work of its kind in the Australian setting and its findings cannot therefore be extrapolated to the Australian population at that time nor to the current situation, due to increases in the availability of generic medicines in the market and the level of patient copayment for prescription medicines under the PBS scheme over the years. Furthermore, since 2003, advertising of generic medicines by some of the manufacturers in the mass media, such as television, might have changed the current perceptions and knowledge of consumers in Australia about generic medicines. In addition, this initial study failed to highlight some of the issues pertaining to generic medicines use, such as consumers personal experiences with generic medicines, their confidence with the local drug regulatory body in registering generic medicines, and labelling of generic medicines. Although a few studies have looked at some of these issues in the worlds leading market for generic medicines, the US, it is difficult to extrapolate these findings to the Australian situation due to the major differences in the healthcare system, especially the way in which pharmaceuticals are funded.1719 An understanding of consumers views is important to the overall planning of educational interventions, to further enhance the utilisation of generic medicines in Australia. Therefore the aim of this study was to explore consumers perceptions and opinions of generic medicines and to identify barriers to their use of generic medicines.

Methods
Since little research has been carried out in Australia to identify consumers perceptions of generic medicines, qualitative methods were used to gain understanding.2022 The qualitative approach was adopted because it allows a flexible exploration of respondents attitudes and experiences.2022 Upon institutional ethics committee approval, the study took place in Melbourne in the state of Victoria, Australia from February 2003 until June 2003. Using a semi-structured questionnaire, interviews were conducted with a convenience sample of consumers until saturation was reached. The semi-structured questionnaire was developed after reviewing the literature and consulting with selected representatives from consumer organisations. Of the 16 informants, 10 were recruited through a Melbourne-based consumers organisation, the Chronic Illness Alliance Incorporated (CIA). CIA is a non-governmental organisation representing over 40 consumer and advocacy groups throughout the state of Victoria, Australia. Consumers from CIA member groups were informed about this study via their emails and their respective organisation newsletters. Consumers interested in the study were asked to contact the researchers directly via phone or email to make interview arrangements. In order to explore a range of views from chronic medicine users and non-chronic medicine users, and from people not associated with consumer organisations, a further six consumers were recruited by snowball sampling through contacts of the researchers.23 This approach also enabled targeting of consumers from specific groups, including the

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elderly. Participants were financially reimbursed for time and travel expenses. Written informed consent was obtained from each participant prior to their participation in the interviews. Participants demographic data were collected using a self-completed questionnaire that was attached with the consent form. The interviews focused on the following issues: knowledge and experience of generic medicines, safety and quality issues surrounding generic medicines, and information sources regarding generic medicines. Appropriate probing questions were used when necessary. To draw out more complete ideas from the participants, they were given freedom to express additional views on the topic at the end of the interview session. Each interview, of approximately 20 to 30 minutes, was conducted at a place and time convenient for the consumer by the first author, who is a foreign-trained pharmacist with experience of the Australian healthcare system. The interviews were audiotaped and transcribed verbatim. All the authors then listened to the tapes, and the first author analysed the transcripts line by line for relevant content and themes using the qualitative data management software, NVivo (QSR NVivo version 2.0.161 19992002 QSR International Pty. Ltd. Melbourne, Australia). The identified themes were verified by discussion among all the researchers.

Table 1 Consumer demographic characteristics Descriptions Sex Male Female Annual household income per year (AUD) 10 00014 999 15 00024 999 25 00034 999 35 00045 999 46 00055 999 56 000 Types of chronic diseases suffered Diabetes, hypertension, angina and hyperlipidaemia Renal failure Diabetes and glaucoma Rhuematoid arthritis Crohns disease Asthma n

8 8 2 3 4 3 2 2 5 2 1 1 1 1

Well, I see generic medicines as medication where the active ingredients are the same but prepared by a different company and usually referred to as a cheaper brand. (Con 09)

Results
Characteristics of participants

Theme 2: acceptance of generics

Sixteen medicines consumers aged from 21 to 80 years (mode age range 50 to 59, n 4) were interviewed. Eleven of the consumers interviewed were living with a chronic condition. The average number of prescription medications used by consumers with chronic diseases was four. Six of the consumers had finished their secondary school education and the remaining nine had completed a bachelors or postgraduate degree. Two interviews were conducted at the Victorian College of Pharmacy, Monash University and the rest were conducted at the consumers homes. Other characteristics for the consumers interviewed are shown in Table 1. Thematic content analysis of the interviews identified four major themes: knowledge about generic medicines, acceptance of generics, non-acceptance of generics and education needs pertaining to generic medicine use. Descriptions of each theme with illustrative excerpts from the consumers transcripts are set out below.
Theme 1: understanding of the term generic medicine

The major reason for acceptance of generic medicine use among the consumers interviewed was cost.
Its more based on cost factors because, you know, I have a lot of medication, so Im trying to reduce my medication cost involved. (Con 01) Im on a lot of medications and those medications cost me a lot of money. For instance, Renitec (enalapril) is very expensive when you compare it to the generic. Its quite a few dollars difference in between the prices. (Con 08)

In addition to the cost factor, trust in healthcare providers was seen to influence generic medicine uptake.
Well I feel very confident about the pharmacists Im dealing with. I trust them. Therefore Im sure they are giving me a good-quality product. (Con 03) I will rely on my doctor to tell me, or my pharmacist to tell me, about the generic medicines before deciding whether its good to take them. (Con 06)

To investigate the familiarity of consumers with the term generic medicine, they were asked about their understanding of the term. All the informants were aware of the availability of generic medicines; however, the term generic was not commonly used by them. Almost all the informants used the term cheaper brand instead of the term generic medicine.
My understanding of generic medicine is a medicine that is similar to a brand name but it is cheaper. (Con 01)

Besides trust in their healthcare providers, experience of patients who had used generics before also influenced consumers decisions to use a generic medicine.
When generic medicines started coming on the market I was completely against them but I think that was because there was an element of fear, fear of I guess, the unknown. Also Im thinking, because it is cheaper is it likely to be inferior. And . . . I was very scared because Ive had my kidney transplant for 31 years. But after talking to my healthcare provider and other patients who had tried generics and found out they

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The International Journal of Pharmacy Practice, December 2005 Personally I do not have any confusion with what Im currently taking but I think there would probably be quite a few people who would. I have a couple of friends who have just been diagnosed with dementia and it will hard for them to remember all the brands of medication that they are taking and even worse if you try to change brands. From my personal experience with my mother, she also had dementia and she would simply take anything didnt matter what it was. (Con 15, 68 year-old female on five medications)

do not have any problem, I started to try it. After taking them without any problems, I stick with them. (Con 01)

Safety and efficacy was also seen as an important factor for accepting generic medicines.
It is something that I have to trust the government. If they licensed them, then Ive got to take their word for it that theyre safe. (Con 10) Oh! I just think that if it has been approved in Australia, I take it on as it has to be good. I guess you cant introduce a drug without testing them. (Con 11) Theme 3: non-acceptance of generics

Two of the respondents highlighted the importance of fostering a consumer-focused approach in the labelling of medicines in Australia to avoid confusion when changing brands of medications.
Look, if every medication was labelled generically in big enough letters so that people can see, if they are given a different brand they can see at least the generic name is there. It is up to the pharmacists to actually educate people how to read medicine labels. I think its crucial for people to know what is the difference between a generic and a brand name so that they can avoid taking wrong doses of the same medication in future. (Con 15) From my experience in South Africa for instance the drug that Im currently on is diclofenac sodium. The word diclofenac sodium must be the main name of the label whereas the brand name Voltaren comes under this word and it is half of the size of the generic name, and Ive been taught by the pharmacist from there what the difference between these two names is. This will eventually avoid any potential confusion because the generic name is widely used worldwide. (Con 16, 68 year old on four medications)

Barriers to acceptance of generics included:

scribed brand of medicine:

It depends on what type of medication. If . . . I had used [it] for ages it will be difficult for me to give a try to another brand because I had already been stabilised with it; but if it is for treating simple things like cold, I will give it a try. (Con 11) I have a trust in the brand of the medication that I have taken so far, since it does the job for me and I dont want to risk my current condition by changing to any other brands. (Con 12)
. concern about adverse effects:

For my salbutamol inhaler, for example, I dont touch the generic brand because Ive had a bad experience, so I request that the doctor prescribes the Ventolin. (Con 09) In one particular instance, for example with the glaucoma eye drops, the carrier that the drug is in irritates my eye. Ive got quite sensitive eyes, so I need the particular one. (Con 15)
. confusion that may arise from using different brands:

For some elderly consumers, their reliance on their pharmacists advice was seen to prevent any potential confusion that might arise from changing brands of medication.
The issue of confusion doesnt exist with me because I try to stick to one pharmacy and the pharmacist there knows which brand Im taking at the moment. There are a few occasions where the pharmacy ran out of the normal brand that I took, but as long as I got a good assurance from my pharmacist, I do not have any problems with changing it. (Con 08, 68-year-old female currently on four medications) I have my chemists who are very good in sorting out things for me and this is usually done when you get any new medicine or any new brands and this really helps me. (Con 12, 70year-old female on five medications)
. Lack of information on generic medicines:

I know I will get confused with different brands, thats why I just stick to one brand and I do not like to change it. Besides that, I feel safe with my doctors choice. (Con 13, 80 year-old female on four chronic medications)

To gain more insight into the issue of confusion with the use of different brands of medicines, five of the respondents over 65 years of age were asked whether they had had any problems in changing brands.
Not with me, its not confusing. I know my mother used to get very confused with different medications. She was on lot more things than Ive ever been on. She died at 74, which to me . . . seemed quite old. Im 70 (now) and I dont feel old like that. So I dont feel as confused but I think probably the 70 year olds today are a little bit more educated than our mothers were. (Con 14, 70-year-old female on four chronic medications)

I think the uptake of generics is slow because there is no adequate information available to the public. Sometimes the healthcare professionals are too busy to explain about medication to their patients and there will be some who miss out on the information they are providing. (Con 02) I think we need to restructure the way society understands things across the board. It will be hard to convince the current society of the benefits of generics if there is not enough information. (Con 03)

December 2005, The International Journal of Pharmacy Practice Theme 4: education needs pertaining to generic medicine use

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Some consumers pointed out the need for direct educational intervention by both healthcare professionals and government agencies to increase future uptake of generics.
It would be nice if there was more exposure that generic medicines are safe and that they actually do go through vigorous testing. (Con 10) I have never seen a table of comparisons with generic and well-known brands in the form that older people would see and understand, and perhaps do something about to bring down the overall cost to the government. Our generation was brought up to be budget conscious and economical, so one just needs to appeal to them in this way and ask for their help. We have to get over the obstacle of thinking generic brands are inferior because they are cheaper. (Con 14)

Most of respondents felt that information on generic medicines should be relayed to them by their healthcare professional rather than by pamphlets and other publications.
I think its still a part of the responsibility of both the pharmacists and the medical practitioners to let us, the consumer know about it because verbal communication for me is much better compared to just giving the pamphlets, which sometimes end up in the bin. (Con 03) I prefer the information relayed to me by the pharmacist since he is well equipped with the knowledge of the drug formulations. I had some problems with some of the GPs [general practitioners] whereby they dont have time to explain. They are just too busy. (Con 05) I dont believe in pamphlets because its more on promotion, but information from doctors are [sic] better and this is due to the knowledge. They have better knowledge than the pamphlets. Besides that, you can ask them if you have any doubts. (Con 07)

Discussion
In the debate over the use of brand name versus generic medicines, the voice of the patient or consumer, for whom the medication is prescribed, often goes unheard.24 Though generic substitution for brand name medications has long been an accepted standard of practice by health bodies across the world, many patients remain under the impression that generics are less expensive than brand name medication because they are inferior and less effective.19,2527 In contrast with the previous Australian study,16 the consumers we interviewed were aware of the availability of generic medicines. Reasons for this finding may include an increase in promotional activities at the pharmacy level with respect to generic medicines, and active promotion in the mass media in recent years. In Australia, both consumers and pharmacists tend to use the terms less expensive or cheaper brand because discussions about generic medicines occur in the context

of the PBS. The perception of price as the distinguishing feature of generic medicines in the minds of consumers is accurate in this context. On the issue of safety and quality of generic medicines, consumers interviewed generally held favourable attitudes towards the safety and quality of generic products marketed in Australia. They believed that the government drug regulatory body plays an important role in assessing the standards of the medicines before they are registered. Consumers confidence in taking generic medicines was also explored in this study. Most of the consumers were confident in taking generic medicine provided they were given assurance either from their GP or their pharmacist. There is a similarity between this study and two studies conducted in US, which concluded that up to 95% of consumers stated they would feel confident with generic medicines if they were prescribed by physicians and 90% would be confident if generics were recommended by pharmacists.17,28 Good communication between medical practitioners and consumers, and between pharmacists and consumers, is vital if optimal health and economic outcomes are to be achieved through the use generic medicines. While the interviews revealed that consumers undertake different decision-making processes before they are willing to try generic medicines, virtually all wanted to be informed about and participate in making decisions about their preferred brand of medication, to some degree. Some take a passive approach and choose to let the doctor decide, while others wish to be much more active and to receive detailed information about their medicines. Some consumers preferred to stay with the brand that they were currently using, and this opinion was prominent among the elderly consumers who are not used to changing their medications. Some consumers only choose a generic brand for the treatment of acute illness. This finding corresponds with two previous studies reported by Podulka et al.17 and Ganther and Kreling,29 which concluded that consumers acceptance of a generic medicine was found to be related to the degree of risk they attached to it, and this risk is dependent upon the seriousness of the disease state and not the medication itself. Although consumers in these two studies knew what generic medicines are and were positively predisposed toward them, they were less likely to want to use them for chronic or serious conditions where the possibility of ineffectiveness might have serious consequences. In this study, confidence in taking a generic medicines was also affected for consumers who had experienced worsening of their medical condition or side-effects after substituting their previous brand name medication with the generic alternative. Some attributed this to differences in the excipients used in formulation. Two previous studies demonstrated that some patients respond differently to inactive excipients used in generic medicine formulations for non-narrow therapeutic index medicines.30,31 Thus, it is recommended that formal comparative studies be performed on different formulations of the same medicine in clinical populations to address these issues.32 Analysis of the transcripts indicated that consumers on multiple chronic medications cited cost factors as the main

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reason for selecting generic medicines. Even though the savings on individual items are relatively small compared to a brand name medicine in Australia (an average of A$2 for each item in a prescription), over time there are substantial savings for high users of medicines.33,34 Although consumers with chronic conditions receive subsidised medicines through the PBS, the patients copayment for the subsidised medicines becomes a barrier when their total health costs, such as special diets, allied health services and the costs of medical care are considered.33 Consumers cited various sources that they use to obtain information about generic medicines. Most of the consumers said they obtained their information from pharmacists. Some consumers believe that pharmacists are the easiest people to access and receive information from pertaining to medicines. Lack of information on generic medicine was also perceived as a barrier to their uptake by some consumers. To overcome these problems, some participants suggested that educational efforts should be directed to consumers to increase their knowledge and awareness about generic medications and to encourage consumers to take an active role in managing their medical conditions. There was a preference among the consumers interviewed for information to be relayed verbally by their healthcare providers, suggesting that consumers trust their healthcare providers. It is likely that adequate information enables consumers to make better decisions about treatment.3537 The issue of confusion with the use of generics was also explored among the elderly consumers in this study due to widely expressed concerns that changing brands of medication can cause confusion among this subgroup and therefore increase the risk of medication error. Different brands of the same medicine sometimes are physically different.38 The tablets or capsules may be a different colour, different shape, or have different markings or score lines on them, and this leads to potential confusion, with a particular risk of multiple dosing, among some patients especially the elderly.3840 In our study, all of the elderly consumers were confident about their medications, however personal experience with their family members confirmed that confusion does occur, especially for those who are cognitively impaired. The responsibility for avoiding confusion after a change of medicine brand lies principally with the prescribing medical practitioner and the dispensing pharmacist.21 Both should use their professional judgment when addressing this issue, even in the non-elderly patient population. If necessary, they should involve patients carers. This is crucial because some patients are unaware when their brand of medication has been changed, as highlighted by a general practice survey in the UK, which showed that 22% of patients were unaware of changes made to their medicines from brand name products to the generic equivalent.41 On the issue of medicine labelling, some consumers raised concerns about the importance of knowing what was written or printed on medicine box labels. Furthermore, consumers commented on inconsistency in terms of medicine labelling across pharmacies. Some of the consumers were well educated by their pharmacists

about interpreting medicine labelling. An earlier Australian study showed that patients identify 81% of medicines by using trade names.42 In another study, consumers did not understand the difference between the generic and trade name of their medication labels in 29% of cases.43 It is important to educate patients about the differences between a trade name and generic name because of the proliferation of branded generics in the Australian market.44,45 A common example of this is ranitidine tablets, where there are currently nine brands available in Australia.46 Furthermore, the generic names are sometimes printed very small on the package and some consumers, especially the elderly, might not be able to read them. To achieve optimal outcomes with generic medicines use, consumers must not only receive appropriate treatment, but also have the knowledge and skills to use their medicines to best effect. Healthcare practitioners have a vital role to play in promoting safe and appropriate use of medicines through good treatment choices, good communication with consumers, and collaboration between professions.47,48 While healthcare professionals are ultimately responsible for implementing the best therapeutic options for their patients, consumers should be included in the decision-making process, so that their beliefs and wishes can be taken into consideration. Through such partnerships, optimal and cost-effective therapy can be delivered.
Limitations of the study

There are several limitations to this study. Firstly, this study was conducted only with consumers in Melbourne and the findings therefore may not be confidently extrapolated to consumers residing in other states. However, since all Australian citizens qualify to receive their medication under the PBS system, it is likely that consumers from other parts of the nation would have similar perceptions towards generic medicines. Secondly, none of the consumers interviewed reported having had problems with confusion due to changing brands. Despite our continued efforts we were unable to recruit anyone who had personally experienced confusion when changing medication brands. Thirdly, we were unable to include consumers from non-English-speaking backgrounds in the interviews, due to limited funding to employ trained translators. Anecdotal reports have indicated that confusion when changing brands of medications can happen within this population of patients.
Conclusion

This paper reports some issues that have not been previously discussed, including consumers understanding of the term generic medicines, concerns about the labelling of generic medicines, and consumers personal experience of generic medicines in the Australian context. Because of the variation in healthcare systems, this adds to knowledge of the topic beyond the US perspective. Consumers in this qualitative study generally had a positive attitude towards generic medicines.

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The findings suggested that cost was a common reason for choosing generic medicines. Furthermore, this study suggests that consumers rely on advice from medical practitioners and pharmacists when making decisions about choosing generic medicines. The insights gained from consumers in this study will be useful to health organisations and policy makers to design programmes to increase consumer awareness of generic medicines. It is hoped that through the provision of information and educational programmes regarding the role of generics, health professionals and consumers may develop a better understanding of brand choice issues and will be able to use medicines more cost-effectively.

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