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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 G 2, Masood I 1, Saleem F 1 and Al-Qazaz HK 2 1 Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia 2 Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia 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 G 2, Masood I 1, Saleem F 1 and Al-Qazaz HK 2 1 Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia 2 Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia ABSTRACT 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. Acknowledgement We would like to thank all participants for reviewing the questionnaire, for the GPs for their valuable help in responding to the study survey. INTRODUCTION  With the global escalating healthcare cost, governments in many countries have adopted ongoing series of cost-containment attempts in an effort to spend their limited financial resources efficiently so that equitable access to healthcare can be provided.  One of the many ways to control healthcare expenditure is to promote the use of cheaper generic drugs instead of the more expensive branded equivalents [1–4].  Savings made by using generic medicines allow more patients to be treated with the same amount of money and mobilizes fund to finance other treatment modalities [1–3].  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 have been done to evaluate the understanding and perceptions of GPs in Malaysia on issues surrounding the safety, efficacy, and quality of generic medicines. Study design and population  A postal cross-sectional survey was undertaken between March 1, 2009 and April 30, 2009. Questionnaire  A 23-item questionnaire designed to assess the knowledge and perceptions of GPs towards generic medicines along with an explanatory statement and a prepaid return envelope were sent to 325 GPs registered in Penang, Malaysia (based on Private Medical Practice Control Department, Medical Practice Division, Ministry of Health Malaysia 2007 registry).  Two weeks later, a reminder letter along with the same questionnaire and prepaid return envelope were sent to all non-respondents.  The questionnaire was comprised of three sections: (1) Items to characterize the GPs’ demographics. (2) A question asking GPs to identify the Malaysia’s National Pharmaceutical Control Bureau (NPCB) bioequivalence standard for a generic product and (3) six specific statements to assess their knowledge towards generic medicines. METHODS  Responses to eight statements pertaining to generic medicines utilization using a five-point Likert type scale.  The first draft of the questionnaire was reviewed by a panel of professionals which consist of two pharmacy faculty members with experience in generic medicines and survey- type research.  Its content and construct validity was examined and feedback were provided.  Revisions were made according to suggestions on additions, deletions and ambiguities.  The modified version of the original questionnaire was pilot tested among eight GPs before distribution.  Reliability analysis was performed and the Cronbach’s alpha coefficient was found to be 0.61 and 0.65 for the second and third section of the questionnaire, respectively.  All the data collected were entered into SPSS Version 13.0 for analysis. Fisher’s exact test was used for group comparisons at a significance level of 0.05 METHODS Table 1 : Characteristic of GPs and factors influencing generic prescribing GPS knowledge of generic medicines  Up to 85.1% of the respondents claimed that they actively prescribed generic medicines in their practice (Table 1).  Majority of the GPs thought that a generic medicine must be in the same dosage form (65.5%) and dose (81.6%) as the brand.  Nearly one-third (33%) of the respondents have doubts about the efficacy of generic medicines, while 10.3% thought that generic medicines produced more side effects compared to branded medicines.  Only 4.6% of the respondents correctly identified the NPCB’s bioequivalence standard for generic drug products.  A total of 49.4% respondents believed that a generic medicine is bioequivalent to a brand medicine, whereas 32.2% believed otherwise.  A total of 84% of the GPs believed that a standard guideline is required for both GPs and pharmacists on brand substitution process.  The majority of the GPs (86.2%) agreed that patients should be equipped with adequate information on generic medicines.  Advertisements by drug companies played a role in their prescribing pattern agreed by 45% of GPs RESULTS  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.  Generic medicines are commonly prescribed by GPs in Malaysia. However, reservations still exist regarding the safety and efficacy of generic medicines.  In order to increase the quality use of medicines in Malaysia, GPs need to be educated and reassured about generic products approval system with regards to bioequivalence, quality and safety.  A systematic effort and policy should also be adopted to promote the practice of generic prescribing and substitution in Malaysia. 1- King DR, Kanavos P. Encouraging the use of generic medicines: implications for transition economies. Croatian Medical Journal 2002;43:462–9. 2- Abdool Karim SS, Pillai G, Ziqubu-Page TT, Cassimjee MH, Morar M. Potential savings from generic prescribing an generic substitution in South Africa. Health Policy and Planning 1996;11:198– 205. 3- Kanavos P. Do generics offer significant savings to the UK National Health Service? Current Medical Research and Opinion 2007;23:105–16. 4- Key facts—contribution of generic medicines to the UK. British Generic Manufacturers Association. CONCLUSIONS REFERENCES Corresponding author: Dr. Mohamed Azmi Ahmad Hassali Associate Professor, Discipline of Social and Administrative Pharmacy School of Pharmaceutical Sciences Universiti Sains Malaysia, 11800, Minden, Penang, Malaysia Email: azmihassali@usm.my Characteristic Response rate n (%) Actively prescribing generic medicine P Yes n (%)No n (%) Gender Male Female 71(81.6) 16(18.4) 60(81.1) 14(18.9) 11(84.6) 2(15.4) 1.00 Age (years) 30–40 41–50 51–60 61–70 10(11.5) 29(33.3) 28(32.2) 20(23.0) 8(10.8) 27(36.5) 12(16.2) 2(15.4) 1(7.7) 8(61.5) 0.003* Year of graduation Before 1980 1981–1990 1991–2000 After 2001 41(47.1) 28(32.2) 15(17.2) 3(3.4) 32(43.2) 27(36.5) 12(16.2) 3(4.1) 9(69.2) 1(7.7) 3(23.1) 0 (0) 0.134 No. of years in practice (years) <10 11–20 21–30 31–40 >40 15(17.2) 27(31.0) 25(28.7) 17(19.5) 3(3.4) 12(16.2) 27(36.5) 22(29.7) 12(16.2) 1(1.4) 3(23.1) 0 (0) 3(23.1) 5(38.5) 2(15.4) 0.002* Country of graduation Malaysia India United Kingdom Australia Indonesia Others 32(36.8) 39(44.8) 1(1.1) 4(4.6) 1(1.1) 10(11.5) 30(40.5) 34(45.9) 0 (0) 3(4.1) 1(1.4) 6(8.1) 2(15.4) 5(38.5) 1(7.7) 0 (0) 4(30.8) 0.022* No. of prescription written per day <10 11–20 21–39 >40 4(4.6) 32(36.8) 17(19.5) 34(39.1) 2(2.7) 26(35.1) 15(20.3) 31(41.9) 2(15.4) 6(46.2) 2(15.4) 3(23.1) 0.154 Questionsn (%) SAANDSD A generic medicine is bioequivalent to a brand name medicine. 6 (6.9) 37 (42.5) 16 (18.4) 22 (25.3) 6 (6.9) Generic medicines must be in the same dosage form (e.g. tablet, capsule) as the brand name medicine. 11 (12.6) 46 (52.9) 9 (10.3) 19 (21.8) 2 (2.3) Generic medicines must contain the same dose as the brand name medicines. 18 (20.7) 53 (60.9) 7 (8.0) 7 (8.0) 2 (2.3) Generic medicines are less effective compared to brand name medicines. 6 (6.9) 23 (26.4) 26 (29.9) 26 (29.9) 6 (6.9) Generic medicines produce more side effects compared to brand name medicines. 0.0 (0.0) 9 (10.3) 18 (20.7) 51 (58.6) 9 (10.3) Brand name medicines are required to meet higher safety standards than generic medicines. 12 (13.8) 34 (39.1) 15 (17.2) 21 (24.1) 5 (5.7) Table 2: GPs’ knowledge of generic medicines Fig 1: GPs’ knowledge on the Malaysia’s National Pharmaceutical Control Bureau (NPCB) regulatory limit for bioequivalence Questionsn (%) SAANDSD I believe we need a standard guideline to both GP’s and pharmacist on brand substitution process 26(29.9)47(54.0)10(11.5)3(3.4)1(1.2) In my opinion, quality use of generic medicines among Malaysian consumers can be achieved if both GPs and pharmacist work together 15(17.2)49(56.3)15(17.2)7(8.0)1(1.2) I think patient should be given enough information about generic medicines in order to make sure they really understand about the medicines they take 21(24.1)54(62.1)7(8.0)5(5.7)0(0) I believe advertisement by the drug companies will influence my future prescribing pattern 8(9.2)31(35.6)25(28.7)22(25.3)1(1.2) I need more information on the issues pertaining to the safety and efficacy of generic medicines 28(32.2)49(56.3)8(9.2)2(2.3)0(0) Patient’s socio-economic factor will affect my choice of medicines 37(42.5)46(52.9)1(1.2)3(3.4)0(0) Credibility of the manufactures/suppliers is my concern when prescribing medicines 39(44.8)44(50.6)2(2.3)1(1.2) Pharmaceutical companies’ product bonuses will influence my choice of medicines 4(4.6)28(32.2)18(20.7)29(33.3)10(11) SA= Strongly Agree, A= Agree, N= Neutral, D= Disagree, SD= Strongly Disagree  Only 87 GPs responded to the study questionnaire (26.8%).  Majority of the responding GPs were male (81.6%) and 33% of the respondents were between 41 and 50 years old.  The respondents had been in GP practice for 1–55 years [mean (SD) was 22.5 (11.0 )]. Fisher’s exact test; * P < 0.05 is considered significant Table 3: GPs’ perception on generic medicines utilization in Malaysia SA= Strongly Agree, A= Agree, N= Neutral, D= Disagree, SD= Strongly Disagree