FACILITATORS AND BARRIERS FOR GENERIC DRUG USE AMONG GENERAL PRACTITIONERS IN NORTHERN STATE OF...
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Transcript of FACILITATORS AND BARRIERS FOR GENERIC DRUG USE AMONG GENERAL PRACTITIONERS IN NORTHERN STATE OF...
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: [email protected]
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