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Hassali MA 1 , Shafie AA 1 , Awaisu A 2 , Chua GN 1 , Masood I 1 , Saleem F 1 and Al-Qazaz HK 2

Facilitators And Barriers For Generic Drug Use Among General Practitioners In Northern State Of Malaysia: Findings From A Cross Sectional Mail Survey. Hassali MA 1 , Shafie AA 1 , Awaisu A 2 , Chua GN 1 , Masood I 1 , Saleem F 1 and Al-Qazaz HK 2

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Hassali MA 1 , Shafie AA 1 , Awaisu A 2 , Chua GN 1 , Masood I 1 , Saleem F 1 and Al-Qazaz HK 2

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  1. Facilitators And Barriers For Generic Drug Use Among General Practitioners In Northern State Of Malaysia: Findings From A Cross Sectional Mail Survey Hassali MA1, Shafie AA1, Awaisu A2, Chua GN1, Masood I1, Saleem F1 and Al-Qazaz HK2 1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia 2Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

  2. Overview of Malaysian Healthcare System • Population of 28.2 million (Dept. of Statistic 2010) • Ministry of Health via their network of 131 hospitals and 2,833 primary health clinics are the major provider health care services. • Private health-sector financing is based on out of pocket fee-for service and third party payers who reimburse employees. • There are about 209 licensed private hospitals, which are located mainly in urban areas. • Private medical practitioners (GPs) are registered doctors who provide services through private clinics. • In 2010, there are 6307 private general practitioners clinics compared to only around 1900 community pharmacies in the country.

  3. Malaysia Pharmaceutical Market and Regulation • The Malaysian drug market valued at USD 1.40 bn in 2010 with generic drugs market valued at USD 0.37 bn (Business Monitor International 2011) • Local producers concentrate on generics and OTC medicines, with output mainly intended for domestic consumption. • Malaysian Organisation of Pharmaceutical Industries (MOPI): Local manufacturers can produce 80% of the drugs on the Malaysian National Essential Drugs List (NEDL) • Pharmaceutical are regulated by the National Pharmaceutical Control Bureau (NPCB) and the Drug Control Authority (DCA)

  4. Generic Medicines Policy in Malaysia • Procurement of multi-source products by generic names shall be promoted to foster healthy competition in drug pricing. • Appropriate incentives to promote the use of generic drugs and their production in the country shall be introduced. • A formulary of interchangeable generic drugs and the list of products that cannot be substituted shall be made available. • All dispensed drugs shall be labelled with the generic (INN) name of the medicine with or without the brand name. • Generic prescribing and labelling should be encouraged, and generic substitution permitted and eventually legislated, in order to improve affordability of medicines. Generic Medicines Policy

  5. Justification For The Conduct of The Study • In the context of Malaysia’s healthcare system, where currently no separation of dispensing has been implemented, the GPs are important players in the medication distribution chain as their core activities revolve around prescribing as well as dispensing of medications. • To date, no studies had been conducted to evaluate the understanding and perceptions of GPs in Malaysia on issues surrounding the safety, efficacy, and quality of generic medicines.

  6. Study Methodology • A postal cross-sectional survey was undertaken between March 1 and April 30 2009 • Survey was sent (2 mailing attempts) to all 325 GPs registered in Penang, Malaysia (based on Private Medical Practice Control Department, Medical Practice Division, Ministry of Health Malaysia 2008 registry). • The questionnaire comprised of three sections: • Items to characterize the GPs’ demographics. • A question asking GPs to identify the Malaysia’s National Pharmaceutical Control Bureau (NPCB) bioequivalence standard for a generic product & 6 specific statements to assess their knowledge towards generic medicines. • Eight statements to assess GPs’ perception on generic medicines utilization in Malaysia

  7. Key Findings • Eighty-seven GPs responded to the survey (response rate 26.8%) • The majority of the respondents (85.1%) claimed that they actively prescribed generic medicines in their practice. • Only 4.6% of the respondents correctly identified the Malaysia’s National Pharmaceutical Control Bureau’s bioequivalence standard for generic products • As many as 51.8% of the respondents thought that manufacturing standards for generic medicines were not as stringent as for branded products.

  8. Key Findings By definition, generic medicines equivalent to branded drugs in terms of: • Dose (82.4% GPs strongly agree/agree) • Dosage form (64.7% GPs strongly agree/agree) • Bioequivalence (49.4%GPs strongly agree/agree) • Efficacy (37.6% GPs strongly agree/agree) • Side effects (69.4% GPs strongly agree/agree)

  9. Key Lessons • 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. There is a gap in GPs’ knowledge and understanding about generic medicines!

  10. Implications • The findings from this study will be useful to health organizations, regulatory & professional bodies to design program to educate GPs on the role of generic medicines & the issue of BE requirements. • Education on the issue of generic medicines can also be extended to medical students. • It is hoped that by empowering health care professionals it will facilitate the transfer of awareness to consumers alike.

  11. Future Research Agenda • Development of: • Educational booklet for • Healthcare Providers • Consumers • National Guidelines on Brand Substitution

  12. Snapshot of Educational Booklet on Generic Medicine

  13. List of published studies by DSAP generic research group • Hassali MA, Kong DCM, Stewart K. Utilisation of Generic Medicines in the Australian Healthcare System. Journal of Generic Medicines 2004; 2(1): 42-52. • Hassali MA, Kong DCM, Stewart K. Quality use of generic medicine. Australian Prescriber 2004; 27: 80-81. • Hassali MA, Kong DCM, Stewart K. Generic Medicines: Perceptions of community pharmacists in Melbourne, Australia. Journal of Pharmaceutical Finance, Economics & Policy 2005; 14(3): 27-45. • Hassali MA, Kong DCM, Stewart K. Generic Medicines: Perceptions of consumers in Melbourne, Australia. International Journal of Pharmacy Practice 2005; 13: 257- 264. • Hassali MA, Kong DCM, Stewart K. Generic Medicines: Perceptions of general practitioners in Melbourne, Australia. Journal of Generic Medicines 2006; 3(3):214-224. • Hassali MA, Kong DCM, Stewart K. Knowledge and perceptions of recent pharmacy graduates about generic medicines. Pharmacy Education 2007; 7(1): 89-95. • Hassali MA, Kong DCM, Stewart K. A comparison between senior medical students’ and pharmacy pre-registrants’ knowledge and perceptions of generic medicines. Medical Education 2007; 41(7): 703-710. • Hassali MA. Quality use of generic medicines in Malaysia. Journal of Pharmacy Practice and Research 2007; 37(4):334.

  14. List of published studies by DSAP generic research group • Ping CC, Bahari MB, Hassali MA. A pilot study on generic medicine substitution practices among community pharmacists in the State of Penang, Malaysia. Pharmacoepidemiology and Drug Safety 2008; 17(1):82-89. • Hassali MA, Kong DCM, Stewart K. A national survey on knowledge and perceptions of senior medical students about generic medicines in Australia. Medical Journal of Australia 2008; 188 (2): 123-124. • Gedadi NA, Hassali MA. Pharmacists’ views on generic medicines: a review of the literature. Journal of Generic Medicines 2008; 5 (3): 209-218. • Gedadi NA, Hassali MA, Shafie AA. A pilot survey on perceptions and knowledge of generic medicines among consumers in Penang, Malaysia. Pharmacy Practice 2008;6(2):93-97. • Shafie AA, Hassali MA. Price comparison between innovator and generic medicines sold by community pharmacists in the State of Penang. Journal of Generic Medicines 2008; 6(1):35-42. • Hassali MA, Shafie AA, Jamshed S, Ibrahim MI, Awaisu A. Consumer’s view on generic medicines: A review of literature. International Journal of Pharmacy Practice 2009; 17:79-88. • Jamshed S, Babar ZU, Ibrahim MI , Hassali MA. Generic medicines as a way to improve access and affordability: A proposed framework for Pakistan. Journal of Clinical and Diagnostic Research 2009; 3(3): 1596-1600.

  15. List of published studies by DSAP generic research group • Hassali MA. Quality use of generic medicines in developing countries: a way forward. The Journal of Medicine Use in Developing Countries 2009; 1(2):1-2. • Sharrad AK, Hassali MA, Shafie AA. Generic medicines: Perception of Physicians in Basrah, Iraq. Australasian Medical Journal 2009; 1(8): 58-64. • Jamshed S, Hassali MA, Ibrahim MI, Babar Z. Knowledge attitude and perception of dispensing doctors regarding generic medicines in Karachi, Pakistan: A qualitative study. J Pak Med Assoc 2011; 61(1):80-83. • Hassali MA, Shafie AA. Status of generic medicine use in Malaysia. Journal of Pharmacy Practice and Research 2009; 39(4):329. • Hassali MA, Shafie AA, Awaisu A, Chong CP, Ibrahim MI, Jamshed S. Physicians’ view on generic medicines: A narrative review. Journal of Generic Medicines 2010; 7(1): 30-39. • Chua GN, Hassali MA, Shafie AA, Awaisu A. A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia. Health Policy 2010; 95(2-3):229-235. • Sharrad AK, Hassali MA, Shafie AA. Generic medicines: Perceptions of Pharmacists in Basrah, Iraq. HealthMED 2010; 4(1):38-44. • Jamshed S, Hassali MA, Ibrahim MA, Shafie AA, Babar Z. Knowledge, Perception and Attitude of Community Pharmacists towards Generic Medicines in Karachi, Pakistan: A Qualitative Insight. Tropical Journal of Pharmaceutical Research, August 2010; 9 (4): 409-415.

  16. List of published studies by DSAP generic research group • Chong CP, Hassali MA, Bahari MB, Shafie AA. Generic medicine substitution practices among community pharmacists: a nationwide study from Malaysia. J Public Health 2010. • Chong CP, March G, Clark A, Gilbert A, Hassali MA, Bahari MB. A nationwide study on generic medicines substitution practices of Australian community pharmacists and patient acceptance. Health Policy 2010. • Chong CP, March G, Clark A, Gilbert A, Hassali MA, Bahari MB. A web-based survey on Australian community pharmacists’ perceptions and practices of generic substitution. Journal of Generic Medicines 2010;7(4):342-353. • Jamshed S, Ibrahim MI, Hassali MA. Generic medicines in Pakistan: a questionable boon. Int J Clin Pharm 2011. DOI 10.1007/s11096-010-9463-0. • Chong CP, Hassali MA, Bahari MB, Shafie AA. Exploring community pharmacists’ views on generic medicines: a nationwide study from Malaysia. Int J Clin Pharm 2011. DOI 10.1007/s11096-010-9470-1. • Sharrad AK, Hassali MA. Consumer perception on generic medicines in Basrah, Iraq. Preliminary findings from a qualitative study. Research in Social and Administrative Pharmacy 2011;7(1):108-12. • Jamshed SQ, Ibrahim MI, Shafie AA, Hassali MA, Babar Z. Generic medicines in Pakistan: a viable cost-effective option for consumers. Eur J Clin Pharmacol 2011. DOI 10.1007/s00228-011-1032-5.

  17. Thank You Contact: Mohamed Azmi Hassali, Ph. D Programme Chairman, Discipline of Social and Administrative Pharmacyazmihassali@usm.my

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