Abstract
Objective To evaluate the Malaysian community pharmacists’ views on generic medicines. Setting A sample of 1419 Malaysian community pharmacies with resident pharmacists. Method A cross-sectional nationwide survey using a self-completed mailing questionnaire. Main outcome measure Pharmacists’ views on generic medicines including issues surrounding efficacy, safety, quality and bioequivalence. Results Responses were received from 219 pharmacies (response rate 15.4%). Only 50.2% of the surveyed pharmacists agreed that all products that are approved as generic equivalents can be considered therapeutically equivalent with the innovator medicines. Around 76% of respondents indicated that generic substitution of narrow therapeutic index medicines is inappropriate. The majority of the pharmacists understood that a generic medicine must contain the same amount of active ingredient (84.5%) and must be in the same dosage form as the innovator brand (71.7%). About 21% of respondents though that generic medicines are of inferior quality compared to innovator medicines. Most of the pharmacists (61.6%) disagreed that generic medicines produce more side-effects than innovator brand. Pharmacists graduated from Malaysian universities, twinning program and overseas universities were not differed significantly in their views on generic medicines. Additionally, the respondents appeared to have difficulty in ascertaining the bioequivalent status of the marketed generic products in Malaysia. Conclusion The Malaysian pharmacists’ have lack of information and/or trust in the generic manufacturing and/or approval system in Malaysia. This issue should be addressed by pharmacy educators and relevant government agencies.
Similar content being viewed by others
References
McManus P, Birkett DJ, Dudley J, Stevens A. Impact of the minimum pricing policy and introduction of brand (generic) substitution into the pharmaceutical benefits scheme in Australia. Pharmacoepidemiol Drug Saf. 2001;10(4):295–300.
Simoens S, De Coster S. Sustaining generic medicines markets in Europe. Belgia: research centre for pharmaceutical care and pharmaco-economics. Katholieke Universiteit Leuven. http://www.bvsde.paho.org/bvsacd/cd65/simoens-report.pdf (2006). Accessed 29 June 2009.
Homedes N, Ugalde A. Multisource drug policies in Latin America: survey of 10 countries. Bull World Health Organ. 2005;83(1):64–70.
Gossell-Williams M. Generic substitution: a 2005 survey of the acceptance and perceptions of physicians in Jamaica. West Indian Med J. 2007;56(5):458–63.
Beecroft G. Generic drug policy in Australia: a community pharmacy perspective. Aust N Z Health Policy. 2007;4:7. doi:10.1186/1743-8462-4-7.
Hassali MA, Kong DCM, Stewart K. Generic medicines: perceptions of consumers in Melbourne, Australia. Int J Pharm Pract. 2005;13(4):257–64.
Kjoenniksen I, Lindbaek M. Patients’ attitudes towards and experiences of generic drug substitution in Norway. Pharm World Sci. 2006;28(5):284–9.
Gossell-Williams M, Harriott K. Generic substitution in Jamaica: challenges to improving effectiveness. WHO Drug Info. 2007;21(4):294–9.
Leach RH, Wakeman A. An evaluation of the effectiveness of community pharmacists working with GPs to increase the cost-effectiveness of prescribing. Pharm J. 1999;263(7057):206–9.
Braybrook S, Walker R. Influencing NSAID prescribing in primary care using different feedback strategies. Pharm World Sci. 2000;22(2):39–46.
Ministry of Health Malaysia. National medicines policy of Malaysia. Putrajaya: ministry of health Malaysia; 2007. (ISBN 978-983-3433-15-5).
Ministry of Health Malaysia. Malaysian guidelines for the conduct of bioavailability and bioequivalence studies. Kuala Lumpur: ministry of health Malaysia. http://110.74.134.250/bpfk/index.cfm?menuid=51&parentid=50 (2000). Accessed 29 June 2009.
Drug Controlled Authority (DCA) Malaysia. List of test products, comparator products and effective submission date for bioequivalence study report for year 1999-2000 (1st List). Petaling Jaya: DCA Malaysia. http://110.74.134.250/bpfk/aeimages//File/BE/1st_generic_immediate_release.pdf (1999). Accessed 29 June 2009.
Drug Controlled Authority (DCA) Malaysia list of test products, comparator products and effective submission date for bioequivalence study report for year 2008–2009 (7th List). Petaling Jaya: DCA Malaysia. http://110.74.134.250/bpfk/aeimages//File/BE/7th_generic_immediate_release.pdf (2008). Accessed 29 June 2009.
Pearce GA, McLachlan AJ, Ramzan I. Bioequivalence: how, why, and what does it really mean? J Pharm Pract Res. 2004;34(3):195–200.
Peter JR, Hixon DR, Conner DP, Davit BM, Catterson DM, Parise CM. Generic drugs—safe, effective, and affordable. Dermatol Ther. 2009;22:229–40.
Australian Department of Health and Ageing (DoHA). Schedule of pharmaceutical benefits. Effective 1 September 2009–30 September 2009. Canberra: DoHA. http://www.pbs.gov.au/html/healthpro/publication/view?date=20090901&type=FlashPaper&name=general-schedule (2009). Accessed 17 Sept 2009.
Nightingale SL, Morrison JC. Generic drugs and the prescribing physician. J Am Med Assoc. 1987;258(9):1200–4.
Nightingale SL. From the food and drug administration: generic substitution. J Am Med Assoc. 1998;279:645.
Kirking DM, Gaither CA, Ascione FJ, Welage LS. Pharmacists’ individual and organizational views on generic medications. J Am Pharm Assoc. 2001;41(5):723–8.
Allenet B, Barry H. Opinion and behaviour of pharmacists towards the substitution of branded drugs by generic drugs: survey of 1, 000 French community pharmacists. Pharm World Sci. 2003;25(5):197–202.
Al-Gedadi NA, Hassali MA. Pharmacists’ views on generic medicines: a review of the literature. J Generic Med. 2008;5(3):209–18.
Ministry of Health Malaysia. Malaysian national essential drug list. Putrajaya: ministry of health Malaysia. http://www.pharmacy.gov.my/index.cfm?menuid=6 (2008). Accessed 8 July 2010.
Chong CP, Bahari MB, Hassali MA. A pilot study on generic medicine substitution practices among community pharmacists in the State of Penang, Malaysia. Pharmacoepidemiol Drug Saf. 2008;17(1):82–9.
Malaysian Pharmaceutical Society (MPS). Pharmacy schools in Malaysia. i—Bulletin 030620. Kuala Lumpur: MPS. http://202.144.202.76/new_mps/cfm/announcement_view.cfm?id=509 (2003). Accessed 28 Oct 2008.
Dighe SV. A review of the safety of generic drugs. Transplant Proc. 1999;31(suppl. 3A):S23–S24.
US Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations (Orange Book). Rockville: US FDA. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf (2009). Accessed 17 Sept 2009.
Crawford P, Feely M, Guberman A, Kramer G. Are there potential problems with generic substitution of antiepileptic drugs? A review of issues. Seizure. 2006;15(3):165–76.
Hansen RN, Campbell JD, Sullivan SD. Association between antiepileptic drug switching and epilepsy-related events. Epilepsy Behav. 2009;15(4):481–5.
Van Paesschen W, Hauman H, Lagae L. The use of generic medication in epilepsy: a review of potential issues and challenges. Eur J Paediatr Neurol. 2009;13(2):87–92.
Hassali MA, Yuen KH, Ibrahim MIM, Wong JW, Ng BH, Ho DSS. Malaysian pharmaceutical industry: opportunities & challenges. J Generic Med. 2009;6:246–52.
National Prescribing Service Limited (NPS). Generic medicines: safe & appropriate use. Inpharmation special edition; December 2007. Curtin: NPS; 2007.
National Prescribing Service Limited (NPS). Generic medicines are an equal choice campaign launch. NPS media release; October 20, 2008. http://www.nps.org.au/__data/assets/pdf_file/0008/64169/NPS_Generic_medicines_campaign.pdf (2008). Accessed 23 Jan 2009.
National Prescribing Service Limited (NPS). Generic medicines training kit: safe and appropriate use of generic medicines. http://www.nps.org.au/health_professionals/activities/pharmacy_assistants_kit (2008) Accessed 24 Jan 2009.
Acknowledgments
The authors acknowledge the pharmacists who voluntarily participated in this study.
Funding
None.
Conflicts of interest
The authors declare no conflict of interest in connection with this paper.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Chong, C.P., Hassali, M.A., Bahari, M.B. et al. Exploring community pharmacists’ views on generic medicines: a nationwide study from Malaysia. Int J Clin Pharm 33, 124–131 (2011). https://doi.org/10.1007/s11096-010-9470-1
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11096-010-9470-1