Transcript 114-Hassali-_b

SCHOOL OF
PHARMACEUTICAL
SCIENCES
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
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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)
SCHOOL OF
PHARMACEUTICAL
SCIENCES
Generic Medicines Policy in
Malaysia
Generic Medicines Policy
•
•
•
•
•
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
Key Findings
By definition, generic medicines equivalent to branded
drugs in terms of:
Dose
Dosage form
Bioequivalence
Efficacy
Side effects
(82.4% GPs strongly agree/agree)
(64.7% GPs strongly agree/agree)
(49.4% GPs strongly agree/agree)
(37.6% GPs strongly agree/agree)
(69.4% GPs strongly agree/agree)
SCHOOL OF
PHARMACEUTICAL
SCIENCES
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
There is a gap in GPs’
• GPs need to be educated
and reassured
about generic
knowledge
and
products approval understanding
system in Malaysia concerning
bioequivalence, quality, and safety.
about generic medicines!
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
Future Research Agenda
• Development of:
1. Educational booklet for
i. Healthcare Providers
ii. Consumers
2. National Guidelines on Brand
Substitution
SCHOOL OF
PHARMACEUTICAL
SCIENCES
Snapshot of Educational
Booklet on Generic Medicine
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
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.
SCHOOL OF
PHARMACEUTICAL
SCIENCES
Thank You
Contact:
Mohamed Azmi Hassali, Ph. D
Programme Chairman,
Discipline of Social and Administrative
Pharmacy
[email protected]