OBJECTIVES: To review the literature on consumers' knowledge, attitudes and opinions of the use of generic medicines.
METHOD: A narrative review of studies conducted from 1970 to 2008 on consumers perceptions and views towards generic medicines was performed. An extensive literature search was undertaken using indexing services available at the authors' institution library. The following keywords were used for the search: brand, generic, multisource, medications, medicines, drugs, pharmaceuticals and consumers, customers, and patients. Electronic databases searched were Medline, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Proquest, Ebsco Host and Google Scholar. These electronic databases were searched for full text papers published in English from 1970 to October 2008.
KEY FINDINGS: Twenty studies were identified. Eleven were from the USA, four were from Europe, two were from Canada and one each was from Australia, Brazil and Malaysia. In general, consumers showed mixed reactions towards the use of generic medicines. This was evident from the divergence of views observed by country development level, consumers' socioeconomic characteristics, drug product characteristics, pharmaceutical reimbursement system, policy environment, contact with health care professionals, past experience with medications, and knowledge of the seriousness of a medical condition.
CONCLUSIONS: Patient confidence and knowledge pertaining to generic medicines use have increased over the past four decades, especially in developed countries. Mass educational efforts, financial incentives, and greater communication among patients and health care professionals were seen as major drivers to the uptake of generic medicines among consumers.
A prevalence study was conducted, measuring drug cost and prescribing patterns of clinicians treating cardiovascular patients in UKM Hospital (HUKM). One Hundred and thirty-five patients' case-notes were selected from the Case-Mix database of HUKM. The average and median number of drugs prescribed per patient was 7.56 (+/- 3.37) and 7.0 (+/- 3) respectively. Generic drug prescription rate was still low (45.2%). Significant relationship was observed between generic drug prescriptions with age of patients, types of wards and different levels of clinicians' training. Younger patients, admitted to Coronary Care Unit (CCU) and Cardiology Rehabilitation Ward (CRW) were more likely to be prescribed with branded drugs. Lower generic drugs prescription and higher cost of drugs were mostly practised by Consultants. CCU and CRW wards were the only predictor to having low generic drugs prescriptions. Ninety-nine percent of the total RM28,879.25 drug cost was used to purchase branded drugs. Mean drug cost for a patient is RM213.92 (+/- RM333.36) and median cost is RM102.46 (+/- RM240.51). Higher drug cost and its' predictors were patients with severity level II and III, length of stay of > or = 6 days, number of drugs types of > or = 7, generic drugs prescription rate < 50% and patients admitted in CCU and CRW wards. This study is important for short and long-term decision-making, controlling of providers behaviour and resources.
Matched MeSH terms: Drugs, Generic/therapeutic use
The development of biological products has experienced continuous growth over the past three decades. The expiration of patent protection for many biological medicines has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilar drugs and covers their therapeutic status, clinical trials, approved biosimilars, and regulatory guidelines in Japan, South Korea, and Malaysia. The literature suggests that biosimilars are comparable but not identical to the reference product. They are not a generic version of an innovative product and do not ensure therapeutic equivalence. Biosimilars present more challenges than conventional generics and their marketing approval is also much more complicated. Guidelines for biosimilars were published in Japan in July 2009 by the Ministry of Health, Labour and Welfare (MHLW), in South Korea in March 2009 by the Ministry of Food and Drug Safety (MFDS), and in Malaysia in July 2008 by the National Pharmaceutical Control Bureau (NPCB).
A multicentre study was conducted to assess the long term efficacy and safety of a generic atorvastatin in the treatment of primary hypercholesterolaemia. Eighty five patients who received 10mg or 20 mg of atorvastatin for 8 weeks depending on target cholesterol goal were followed up by their own physicians and had final evaluation at 52 weeks. Reduction in mean low density Lipoprotein (LDL-C) was 36.5%, 37.9% and 32.2% at weeks 4, 8 and 52 respectively. LDL-C target was maintained in 81% and 69% of patients at week 8 and 52 respectively without drug related serious adverse events. Generic atorvastatin is safe and effective in usual clinical care setting.
BACKGROUND: The use of generic medicines has been increasing steadily internationally, primarily because of cost concerns. Knowledge and use patterns of generic medicines in Iraq have not yet been measured.
OBJECTIVE: This study aimed to explore consumers' perception and knowledge on issues relating to generic medicine use in Basrah, Iraq.
METHODS: A qualitative approach was used to gather information from consumers in Basrah, Iraq. A purposive sample of 14 consumers in Basrah was interviewed face-to-face using a semistructured interview guide.
RESULTS: Thematic analysis of the interviews identified 5 major themes: understanding of the term "generic medicine," preference for generic medicine, refusal of generic medicine, generic substitution, and education on the use of generic medicines. Not all the consumers were familiar with the term "generic medicine;" they were familiar with the term "commercial medicine." Most of the participants understood that generics cost less compared with their branded counterparts. Most of the consumers said that their physicians and pharmacists had given them information on generics.
CONCLUSION: Knowledge of generic medicines may be lacking among consumers in Iraq. Development of consumer education on generics by health care providers is required to support the implementation of the policy on generic medicines in Iraq.
A multicenter study was conducted to assess the efficacy of a generic form of Atorvastatin (Ranbaxy's Storvas) in the treatment of Primary Hypercholesterolemia. One hundred and nineteen patients were given 10 mg of Storvas for four weeks and increased to 20 mg if target LDL-Cholesterol was not achieved. LDL-Cholesterol was reduced by 36.6% at four weeks and 37.5% at eight weeks from baseline. Total cholesterol and triglycerides were significantly reduced. There were no drug-related serious adverse events. We conclude that the generic atorvastatin is safe and effective in the treatment of primary hypercholesterolaemia and the results are comparable to published data on innovator atorvastatin.
This study evaluated Australian community pharmacists' rate of generic medicine substitution, patient acceptance of generic substitution and cost-savings achieved for patients from substitution.
OBJECTIVES: The objective of this study was to evaluate the general practitioners' (GPs') knowledge and perceptions towards generic medicines in a northern state of Malaysia.
METHOD: A postal cross-sectional survey involving registered GPs in Penang, Malaysia was undertaken. A 23-item questionnaire was developed, validated and administered on the GPs. Eighty-seven GPs responded to the survey (response rate 26.8%).
RESULTS: The majority of the respondents (85.1%) claimed that they actively prescribed generic medicines in their practice. On the other hand, only 4.6% of the respondents correctly identified the Malaysia's National Pharmaceutical Control Bureau's bioequivalence standard for generic products. There were misconceptions among the respondents about the concepts of "bioequivalence", "efficacy", "safety", and "manufacturing standards" of generic medicines. GPs in this survey believed that a standard guideline on brand substitution process, collaboration with pharmacists, patient education and information on safety and efficacy of generic medicines were necessary to ensure quality use of generics. Furthermore, advertisements and product bonuses offered by pharmaceutical companies, patient's socio-economic factors as well as credibility of manufacturers were factors reported to influence their choice of medicine.
CONCLUSION: Although it appeared that GPs have largely accepted the use of generic medicines, they still have concerns regarding the reliability and quality of such products. GPs need to be educated and reassured about generic products approval system in Malaysia concerning bioequivalence, quality, and safety. The current findings have important implications in establishing generic medicines policy in Malaysia.
This study aims to provide baseline data to support the implementation of generic substitution policy in Malaysia by evaluating the community pharmacists' perceptions and opinions on generic substitution and current substitution practices.