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 G2, Masood I1, Saleem F1 and Al-Qazaz HK2

1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia2Department 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 MA1, Shafie AA1, Awaisu A2, Chua G2, Masood I1, Saleem F1 and Al-Qazaz HK2

1Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia2Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

 

School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800, Penang, MalaysiaSchool of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800, 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

REFERENCESCorresponding 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 (%)

GenderMale 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)27(36.5)12(16.2)

2(15.4)2(15.4)1(7.7)8(61.5)

0.003*

Year of graduationBefore 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 graduationMalaysia 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)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

Questions n (%)SA A N D SD

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

Questions n (%)SA A N D SD

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) 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