Exploring community pharmacists’ views on generic medicines: a nationwide study from Malaysia
- 328 Downloads
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.
KeywordsBioequivalence Community pharmacist Generic medicine Malaysia Views
The authors acknowledge the pharmacists who voluntarily participated in this study.
Conflicts of interest
The authors declare no conflict of interest in connection with this paper.
- 2.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.
- 5.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.
- 8.Gossell-Williams M, Harriott K. Generic substitution in Jamaica: challenges to improving effectiveness. WHO Drug Info. 2007;21(4):294–9.Google Scholar
- 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.Google Scholar
- 11.Ministry of Health Malaysia. National medicines policy of Malaysia. Putrajaya: ministry of health Malaysia; 2007. (ISBN 978-983-3433-15-5).Google Scholar
- 12.Ministry of Health Malaysia. Malaysian guidelines for the conduct of bioavailability and bioequivalence studies. Kuala Lumpur: ministry of health Malaysia. http://188.8.131.52/bpfk/index.cfm?menuid=51&parentid=50 (2000). Accessed 29 June 2009.
- 13.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://184.108.40.206/bpfk/aeimages//File/BE/1st_generic_immediate_release.pdf (1999). Accessed 29 June 2009.
- 14.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://220.127.116.11/bpfk/aeimages//File/BE/7th_generic_immediate_release.pdf (2008). Accessed 29 June 2009.
- 15.Pearce GA, McLachlan AJ, Ramzan I. Bioequivalence: how, why, and what does it really mean? J Pharm Pract Res. 2004;34(3):195–200.Google Scholar
- 17.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.
- 20.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.Google Scholar
- 23.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.
- 25.Malaysian Pharmaceutical Society (MPS). Pharmacy schools in Malaysia. i—Bulletin 030620. Kuala Lumpur: MPS. http://18.104.22.168/new_mps/cfm/announcement_view.cfm?id=509 (2003). Accessed 28 Oct 2008.
- 26.Dighe SV. A review of the safety of generic drugs. Transplant Proc. 1999;31(suppl. 3A):S23–S24.Google Scholar
- 27.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.
- 32.National Prescribing Service Limited (NPS). Generic medicines: safe & appropriate use. Inpharmation special edition; December 2007. Curtin: NPS; 2007.Google Scholar
- 33.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.
- 34.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.