proceeding book - mnmp

12 8 - 3 0 J u l y 2 0 0 9 • S h e r a t o n S u b a n g H o t e l & T o w e r s , S u b a n g J a y a

N a t i o n a l M e d i c i n e s P o l i c y M i d - T e r m R e v i e w W o r k s h o p

National Medicines PolicyMid-Term Review Workshop

28 ~ 30 July 2009Sheraton Subang Hotel & Towers,

Subang Jaya

Buku kesihatan final.indd 1Buku kesihatan final.indd 1 06/01/2010 15:42:3206/01/2010 15:42:32

2 2 8 - 3 0 J u l y 2 0 0 9 • S h e r a t o n S u b a n g H o t e l & T o w e r s , S u b a n g J a y a


First Printing: December 2009

Copyright © 2009 byPharmaceutical Services Division

Ministry of Health Malaysia,Lot 36, Jalan University, 46350 Petaling Jaya, Selangor

Cover & Book design byAbfas Images Enterprise

All rights reserved. No part of this book may be reproduced in any form or by any electronic or mechanical means including information storage and retrieval systems, without permission in writing from the author. The only exception is by

a reviewer, who may quote short excerpts in a review.

ISBN 978-967-5570-00-1

Printed by:Abfas Images Enterprise,

No. 22 Jalan Meranti Bunga 4, Taman Sri Mewah,Off Jalan Pekan Meru,41056 Klang, Selangor




CONTENT

Welcome Address By Senior Director of Pharmaceutical Services,Ministry of Health Malaysia

Opening Speech By Director-General of Health Malaysia

Overview of Malaysian National Medicines Policy By Senior Director ofPharmaceutical Services, Ministry of Health Malaysia

Plans of Action of DUNAS (Dasar Ubat Nasional / Malaysian National Medicines Policy)

Component 1 - Quality, Safety and Ef� cacy of DrugsComponent 2 - Drug AvailabilityComponent 3 - Drug AffordabilityComponent 4 - Quality Use of DrugsComponent 5 - Human Resources DevelopmentComponent 6 - Research & DevelopmentComponent 7 - Technical Co-operation

Panel Discussion

Appendix • List of Committees • List of Participants • List of Panel Members • Panel Discussion • Curriculum Vitae of Panel Members • Abbreviations • Photo Gallery

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WELCOMING ADDRESS BYSENIOR DIRECTOR OF PHARMACEUTICAL SERVICES,

MINISTRY OF HEALTH MALAYSIA

Y. Bhg. Tan Sri Dato’ Seri Dr. Hj. Mohd Ismail bin MericanDirector - General of Health Malaysia.

Y. Bhg. Datuk Kamarul Zaman bin Md IsaDeputy Secretary-General (Finance)

Y. Berusaha Puan Hasnah Binti IsmailDirector Pharmacy Practice and Development cum Chairperson of Organising Committee National Medicines Policy Mid-Term Review Workshop

Invited guests, participants,

Ladies & Gentlemen,

Assalamualaikum wbth, Salam Sejahtera dan Salam 1Malaysia

On behalf of the Organising Committee, it gives me great pleasure to extend a very warm welcome to all of you to this Opening Ceremony of the National Medicines Policy Mid Term Review Workshop. I would especially like to express our utmost appreciation to Y. Bhg. Tan Sri Dato’ Seri Dr. Hj. Mohd Ismail Merican, Director-General of Health Malaysia for his kind presence to grace the of� cial opening of this workshop despite his very hectic schedule. Indeed, the presence ofY. Bhg. Tan Sri Dato Seri this morning is a testimony of his profound concern and commitment towards the successful implementation of the National Medicines Policy.

I would also like to congratulate the Organising Committee, the Technical Working Committee and the secretariat for the commendable efforts, dedication and contributions in planning and making this 3-day workshop a real success. Alhamdulillah, I am very thankful that despite serious concerns regarding the pandemic In� uenza H1NI and the closures of institutions and schools recently, this workshop can go on as scheduled and hope that it will progress and conclude well.

Allow me � rst to give you a quick snapshot of the current Pharmaceutical Services in Malaysia. As a program under the Ministry of Health Malaysia, the




Pharmaceutical Services operates via 4 main arms namely Pharmacy Practice & Development, Pharmacy Regulatory (NPCB), Pharmacy Enforcement and Pharmacy Management (new arm). From the old perception of merely being in charge of purchasing and often hidden behind mortuary, we are proud that the Pharmaceutical Services has evolved tremendously over several decades, stretching frontiers far and wide, ascending higher and higher as proven by the milestones achieved.

We take pride of the vast recognitions; as the WHO Collaborating Centre for Regulatory Control of Pharmaceuticals, international model for drug regulatory authority, accession into PIC/S, certi� cation of ISO 9001:2008, leader in ASEAN pharmaceutical development, active participation in global regulatory harmonization initiatives and winning international award for innovation like the Pharmacy Drive Thru in Penang Hospital. In tandem with the current focus on key results areas (KRA) and key performance indicators (KPI) and putting Rakyat First, concerted efforts are now driven towards providing � exible medicine supply services at out-patient pharmacies, both at hospitals and health clinics through innovative approaches like the Integrated Medicines Dispensing System,drive-thru counters or the pharmacy appointment system using text sms and Park & Take.

As we look back, it is unbelievable that the strategies and policies laid down have translated into miraculous outcomes and brought transformation we see today. Undoubtedly, the National Medicines Policy (NMP) or its acronym DUNAS (Dasar Ubat Nasional) has steered the direction for ensuring quality, safety, ef� cacy, availability, affordability and quality use of medicines as well as setting a platform for human resources development, research & development and also international cooperation in relevant � elds. DUNAS is a binding force that brings together all major stakeholders in the pharmaceutical sector. DUNAS serves as a compass, providing the framework for activities to be conducted and coordinated and sets the priorities for the medium- and long-term goals of the sector. As the Secretariat to DUNAS, the Pharmaceutical Services Division is very much committed to see that relevant policies and strategies are effectively and ef� ciently implemented to achieve desired outcomes. In this regard, I am very delighted that there was so much enthusiasm shown by many stakeholders to participate in this consultation. We are extremely touched by such an over-whelming response.I was told that there are more than 150 participants attending this workshop. We thank you for the support.

We are fortunate that when DUNAS was approved by the Cabinet and of� cially became a Government policy, we already had the relevant infrastructure in place. Even before DUNAS was published in 2006, we have established a comprehensive regulatory system, promulgated adequate laws and regulations, created a robust




pharmaceutical industry and developed extensive pharmaceutical distribution network. Catalysed by strong political will, DUNAS has galvanized our efforts towards promoting equity to improve the health and well-being of the Rakyat.

In a nutshell, DUNAS has seeped through the entire fabric of pharmaceutical services, resulting in expansion of scope and functions. Let me highlight the current spectrum of key activities that currently underpin DUNAS:

• Pharmacy Practice & Development oversees key areas such as drug procurement, price monitoring, clinical pharmacy practice, hospital pharmacy practice, community pharmacy, drug formulary, medication safety, research & development, drug information and Know Your Medicine campaign.

• Pharmacy Regulatory encompasses product evaluation and registration, analytical testing and certi� cation, post market surveillance, pharmacovigilance, GMP inspections and licensing.

• Pharmacy Enforcement takes charge of legislation, raids, seizures, forensic examinations, investigations, prosecutions, advertisements and consumer protection.

• Pharmacy Management handles policies, human resources development, training, ICT and external collaborations.

Against this diverse backdrop, DUNAS has been implemented and monitored accordingly. Nevertheless, there are threats and challenges that continue to haunt us. The media is rife with pertinent and pressing issues. Dispensing separation, cost containment on drug expenditures, price control, drug substitution therapy, psychotropic abuse and syndicated illegal activities must be dealt with diligently.

Keeping abreast with current global developments, it is timely that DUNAS be reviewed and an appropriate Plan of Action formulated. I am con� dent that through this forum, you will put your hearts, soul and minds together to ensure that the proposed Plan is achievable and can be successfully implemented.

Once again, I would like to thank Y. Bhg. Tan Sri DG for accepting our invitation to be here this morning. Your gracious presence and your precious time meant a lot to all of us. We are indeed grateful for the strong leadership, guidance, support and encouragement, without which the sector, the Pharmaceutical Services and DUNAS may not have charted remarkable success. On that � nal note, I thank all of you for joining us this morning and I wish you a fruitful deliberation over the next few days.

Thank you.




OPENING ADDRESS BYY. BHG. TAN SRI DATO’ SERI DR. HJ. MOHD ISMAIL MERICAN

DIRECTOR GENERAL OF HEALTH MALAYSIA

Y. Bhg. Datuk Kamarul Zaman bin Md IsaDeputy Secretary-General (Finance)

Y. Bhg. Puan Eisah Binti A. Rahman Senior DirectorPharmaceutical Services Division

Y. Berusaha Puan Hasnah Binti IsmailDirector Pharmacy Practice and Development cum Chairman of Organising Committee National Medicines Policy Mid-Term Review Workshop

Distinguished guests,

Ladies and gentlemen,

Good morning to all.

First and foremost I would like to express my sincere gratitude to the Pharmaceutical Services Division, Ministry of Health Malaysia for cordially inviting me to of� ciate this workshop. I am deeply honoured by the kind gesture and it gives me great pleasure to address this meeting.

I would like to take this opportunity to congratulate the Organising Committee for bringing in all healthcare stakeholders together to review the implementation of the Malaysian National Medicines Policy and to deliberate on its Plan of Action. I certainly hope that all delegates will give their commitment towards producing a practical and attainable Plan of Action for the next few years.


Health needs of an individual are a necessity as much as it is a basic human right. Likewise, health is an important asset in the development of a nation. To meet the health needs of the population is no easy feat as the challenges facing health provision and delivery are even more profound in today’s turbulent economic climate.

In the wake of current global uncertainties, the health system faces huge challenges. Changing disease pattern, pandemic outbreaks, rising cost of health care, new drugs and treatment regimes, innovative medical technologies, environmental issues, resource constraints, impacts of globalization and




trade liberalization, are seriously impinging the health system. Rising social expectations regarding health and healthcare is fuelled by greater access to information and improved health literacy. All these factors are driving demand for more people-centred access, better community health protection and more effective participation in decisions that affect health.

In this regard, the Millennium Development Goals Report 2009 shows that the right policies and actions, backed by adequate funding and political commitment can yield positive results. The capacity to frame and implement policies that guide all major stakeholders is fundamental in achieving a stronger health system.


It is indeed very heartening that the Ministry of Health Malaysia as the major healthcare provider has made remarkable progress in improving the health status of the population. Nevertheless, Malaysians desire a system of health and health-related services that will continue to provide protection against disease, promote physical and mental health as well as spiritual and social well-being.

The MOH Vision “A nation working together for better health” regards all stakeholders as partners in ful� lling its commitment towards improving the health status of the population and to continue to provide access to health based on equity, social justice and solidarity.

The future prospects in health and healthcare provision will include the restructuring and strengthening of the health system, focus on primary care and wellness paradigm. Against this backdrop the National Health Policy already in place will provide the direction for all involved in health to plan and implement the respective health activities and unify all efforts towards improving the health status and quality of life of all Malaysians.

In tandem, the Malaysian National Medicines Policy, being an organizational policy pertaining to the pharmaceutical sector serves as an integral component and provides the guiding principle and support to the National Health Policy in achieving its desired objectives.


Deliberate policy decisions are fundamental in order to shape a better and ef� cient healthcare system in the country. In the mid-seventies, the WHO recommended that all countries should formulate and implement a comprehensive National Medicines Policy. The policy is based on the essential drugs concept which is central to a National Health Policy as it promotes equity and helps to set priorities for the health care system.




By 2003, it was reported that 71 developed and developing countries had formulated or updated their NMP. Although many countries have adopted and revised NMPs, not all of them have succeeded in systematically implementing these policies and monitoring them effectively or ensuring that they are tailored to national health priorities.


Since the development of the MNMP, it is encouraging to note that constant efforts have been undertaken to turn this policy into action. Quality, safety and ef� cacy of drugs remain as one of the most fundamental and important public health concern. The Drug Control Authority (DCA) established since 1985 has been entrusted to ensure that pharmaceutical and healthcare products marketed comply with the standards and technical requirements as speci� ed. I am told that to date, there are 6,864 prescription drugs, 4,646 over-the-counter (OTC) products and 11,420 traditional medicines in the registry.

As Chairman of the DCA, I am impressed that progress in the regulatory domain has been tremendous, earning national and international accolades. In tandem with the advancement of biotechnology, Malaysia has been well commended for introducing the guidelines for the registration of biosimilar products. As these guidelines are similar to those used in the EU and other developed countries, a biosimilar product developed in Malaysia which is in compliance with these guidelines should be able to attain marketing authorisation in the foreign markets.

On the international front, Malaysia is a Provisional Member of the OECD Mutual Acceptance Data (MAD) System since October 2008. With this recognition, test data generated in Malaysia will be accepted in OECD countries and all other nations adhering to the system. While promoting foreign investments, it also provides an opportunity for local companies to gain better access to markets and business opportunities in all 30 OECD countries.

In the era of ICT, it is gratifying that a new chapter has emerged in the history of pharmaceutical regulatory. The National Pharmaceutical Control Bureau (NPCB) is among the � rst regulatory agencies in the world to implement the online system for the application of product registration in 2002. The QUEST information system is currently being upgraded to incorporate more and better features to increase ef� ciency. The system enables transactions to be executed 365 days a year, 7 days a week and 24 hours a day, from anywhere in the world.

Recognising the crucial importance of public safety, another strategy in ensuring safety of products is through enforcement of regulations. Concerted efforts have been taken to curb illegal activities and combat counterfeit medicines in the


1 0 2 8 - 3 0 J u l y 2 0 0 9 • S h e r a t o n S u b a n g H o t e l & T o w e r s , S u b a n g J a y a


marketplace. In 2008 alone, values of con� scated products were reported to be about RM29 million.

The eradication of counterfeit medicines and control of diversions, unethical promotion, unscrupulous advertisements and rampant internet sales of prescription medicines pose increasing challenges to the policy implementation to ensure that medicines available to the public are of quality, safe and effective. Hence, closer international collaboration and partnership among healthcare stakeholders are important in tackling these problems.


Globally, the health economy is growing faster than the gross domestic product (GDP), having increased share from 8% to 8.6% of the world’s GDP between 2000 and 2005. This represents a 35% growth in the world’s expenditure on health over a � ve-year period. For 5.6 billion people in low- and middle-income countries, more than half of all healthcare expenditure is through out-of pocket payments. In Malaysia, it is estimated that the increase in healthcare costs is 10% every year, approximately double the in� ation rate. The MOH total drug expenditure hits RM1.5 billion in 2008. This represents an increase of 397% compared to the expenditure in 1998, over a period of 10 years. This works out to about an average of 40% per year.

In light of the increasing healthcare costs, we can count ourselves fortunate for the system to put in place for the bene� t of all Malaysians. However, this situation cautions us to be more prudent with spending and reduce wastage and it would be necessary to introduce certain policies to contain the escalating costs in the near future.


Access to affordable essential medicines is vital in ful� lling the basic health needs of the population. Besides being an important element in WHO’s goal in medicines, access to essential medicines that encompasses equitable � nancing, affordability and delivery of essential medicines is in line with the United Nations’ Millennium Development Goals.

The Malaysian National Formulary contains 1,432 drugs at the end of 2008. Out of these, 288 are listed in the National Essential Drugs List (NEDL), which was launched in 2000 and updated in 2007. Essential drugs are made available at the primary care level to ensure equitable, adequate and continuous availability of quality, safe and ef� cacious drugs. This is strongly supported when a study has




shown that the average availability of key medicines in public health clinics in West Malaysia is 95.4%.

A thriving local pharmaceutical industry can also provide support towards availability of medicines. Up to date, there are 73 licensed pharmaceutical manufacturers producing mainly generics. Increase in locally manufactured drugs can ensure continuous supply and reduce stock-outs. One of the approaches taken is collaboration between domestic manufacturers and multinational pharmaceutical companies. This has resulted in an increase in the number of multi-national company (MNC) brands being contract manufactured locally with some degree of import substitution taking place. The bene� t of such strategic collaboration has led to signi� cant improvements in GMP of local manufacturers with some even in compliance with FDA requirements.


Quality use of drugs is another essential component in strengthening the healthcare system through MNMP. Recognizing such importance, rational use of medicines has been included as an agenda in the 60th World Health Assembly. Irrational use of medicines was given consideration in the context of the threat of antimicrobial resistance to global health security. In addition, the � nancial costs incurred to individuals and governments are unnecessary and often high.

According to the WHO report in 2002, more than 50% of all medicines are prescribed, dispensed or sold inappropriately and it is not surprising when 50% of patients were reported to fail to take their medicines correctly. As such, inappropriate use of drugs has been identi� ed as a major global problem.

It is certainly of great concern that irrational use of medicines does not only occur among consumers and patients but is also common among prescribers and dispensers of drugs. Irrational use of medicines includes over-treatment of a mild illness, inadequate treatment of a serious illness, misuse of anti-infective drugs and over-use of injections. Such irresponsible practice by healthcare providers could happen from lack of knowledge, inadequate training or aggressive promotional in� uence. Several country � gures show that such practices are frequent, and not exclusively in developing countries.

Professionals play a key role in educating consumers towards self-empowerment in the management of their medicines. However, they are the key determinants in the rational use of medicines by practicing rational prescribing and dispensing.

Education and training of health professionals and providers form a major strategy to achieve rational drug use. For this reason, I would like to congratulate the Pharmaceutical Services Division for providing the MTAC (Medication Therapy




Adherence Clinic) services, which provides guidance and counseling to patients about their drugs and conditions. It is encouraging to see that the training in clinical pharmacy has succeeded in producing competent pharmacists to provide this service. This service has enable patients with conditions such as diabetes and hypertension and those requiring special care such as renal and liver transplantation to adhere better to their treatment and reduce drug-related problems. While 71 MTACs have already been set up, I hope that more MTAC can be set up throughout the country.


While human resources development as well as research and development are supporting components of the National Medicines Policy, they are also the supporting goals of the Ninth Malaysia Plan (9MP). From the Mid-term Review of the 9MP, infrastructure development, human resource improvements and expansion of sectors contributing towards new sources of growth will continue to be pursued. In view of their importance, substantial allocation for training and research development has been given under the 9MP.

Under the 9MP also, the Government is targeting the pharmaceutical, medical device and health biotechnology sector as an engine for continuing growth. Key baseline information on the current development of these sectors is necessary for the purpose of informed policy-making. I am pleased to know that major surveys have been conducted to gather baseline information for the pharmaceutical sector including preliminary National Medicines Expenditure Survey, National Medicines Price Survey and the third phase of the National Medicines Use Survey.

These surveys have enabled us to understand more on the utilization of medicines in this country and to support in decision making. From the National Medicines Survey 2006, it was found that the � ve most utilised drugs (in DDD/1000 population/day) are glibenclamide, metoprolol, metformin, nifedipine and atenolol. By therapeutic group, drugs for diabetes are the most utilized followed by beta-blocking agents, calcium channel blockers and agents acting on the renin-angiotensin system.

Interestingly, these � ndings are consistent to those � ndings of the National Health and Morbidity Survey which showed an increasing trend in chronic diseases such as diabetes and hypertension. Relating this to the National Strategic Plan to Combat Non-communicable Disease, the � rst and second-line drugs for these priority conditions are essential medicines and compliance to these drugs are important. Ladies and gentlemen,

The Ministry of Health is making every effort to promote equitable access, rational




use, safe, effective and affordable essential drugs of good quality to ensure better health outcomes of the people through the National Medicines Policy. Although the strategies to implement such policies have been outlined, I would like to urge all parties involved to continually monitor its implementation and further evaluate the contribution it has made towards the progress of the pharmaceutical sector primarily, and the impact on healthcare in this country. To ensure policies are well implemented, key indicators to measure the appropriate outcomes must be identi� ed and monitored. Driven by these policies, premised on sound legal infrastructure and nurtured by best practices, it is rewarding to see how such combinations have translated to great success. Evolving from these policies, we have achieved milestones and set benchmarks in many areas including Good Governance in Medicines, PIC/S Good Manufacturing Practices, Good Clinical Practices, Good Laboratory Practices, Good Regulatory Practices and Quality Management Systems.


In the spirit of smart partnership, all key stakeholders are invited to this workshop because the Ministry of Health values your inputs and contributions. I sincerely hope that over the next few days you can all work together to review and further evaluate the implementation of this MNMP. At the same time, in upholding thethrust, all stakeholders in the public and private sectors need to reaf� rm commitments towards achieving common goals of the pharmaceutical care sector.

As we embark on the 10th Malaysia Plan, it is timely that we conduct this review to make necessary recommendations to further strengthen, improve and advocate the National Medicines Policy for the bene� t and betterment of all. In line with the concept of 1 Malaysia, with emphasis on People First and Performance Now, indeed the National Medicines Policy provides an encompassing framework for caring and protecting public health, promoting a business friendly environment, improving ef� ciency and inculcating best practices, through involvement of partners and players in healthcare.

Despite the gloomy outlook, I am optimistic that the National Medicines Policy will be successfully implemented with concerted and continuing efforts from all stakeholders. At this point, I hope you will make good use of the time to formulate new strategies and chart the future roadmap and I sincerely wish all of you a stimulating and fruitful discussion. On that note, I now have the pleasure to declare this National Medicines Policy Mid Term Review Workshop of� cially open.

Thank you.




OVERVIEW OF MALAYSIAN NATIONAL MEDICINES POLICYBY SENIOR DIRECTOR OF PHARMACEUTICAL SERVICES,

MINISTRY OF HEALTH MALAYSIA

Slide 1

• A National Medicines Policy is a commitment to a goal and a guide to coordination of action by all stakeholders.

• The MOH has instituted various policies over the years which are considered as part and parcel of a Medicines Policy. This of� cial document consolidates the existing policies together with future ones with the strategies for implementation.

Slide 2

• This presentation will deliberate on the National Medicines Policy in general and issues speci� c to the Malaysian policy, and the management of the policy.




Slide 3

• In the global arena, many countries have developed their own medicines policy and even developed countries such as Australia and Turkey have a National Medicines Policy.

• Quite a number of countries have their medicines policy integrated into the countries’ health plan.

Slide 4

• Like many other countries in the world the pharmaceutical sector is inundated with many players, and therefore all stakeholders need to come under one unifying framework. • The experience of other countries has shown that complicated and interdependent problems are best addressed within a common framework.

• NMP de� nes a framework for setting and monitoring medium- to long-term objectives in the public and private pharmaceutical sectors.




Slide 5

• Formulation of NMP was initiated in 2000• Developed through a systematic and consultative process Assisted by WHO consultancy and funding National MNMP Workshops with stakeholders in 2001 & 2003• Formalization of the MNMP as a government policy document• Approved by MOH on 14 June 2006• Submitted ‘Cabinet Memorandum’ for cabinet endorsement in July 2006• Approved by cabinet on 11 October 2006• 2009-mid term review of policy

Slide 6

�

�




Slide 7

Slide 8

• The framework to regulate quality, safety and ef� cacy of drugs has been in place for more than 20 years.




Slide 9 • The setting up of the NPCB in 1985 started off the era of regulation of pharmaceutical products in Malaysia. Together with the enforcement of products and practice, the public is ensured of quality, safe and ef� cacious products. In line with the strategies, through the above activities many policy decisions have been taken by DCA over the years to ensure the quality, safety and ef� cacy of products in the market.

Slide 10

• Procurement mechanism and network for supply and distribution of drugs have been established as well; so that even remote areas are supplied with essential drugs.




Slide 11

• A National Essential Drug List was formulated in 2000, through a collaborative process and has been updated in 2007.

• Traditional medicines (TM) have been an integral part of every day life of many societies in the world. Widespread and growing use of traditional medicines have become a public health challenge to safety, quality, rational use and policy. The policy strategy is to identify safe and effective TM therapies and products and to initiate a TM Formulary.

• Procurement and supply of medicines in the country have been good but can be improved further with new and modern technologies such as bar coding and RFID especially in the public sector.

• There should also be a guideline for emergency and orphan drug supplies and drug donations.




Slide 12

• Malaysia needs to look into the most appropriate � nancing mechanism for pharmaceuticals to provide the population with affordable essential medicines in view of escalating health care costs. Target 8e of Millennium Development Goals acknowledges the need to improve the availability of affordable medicines.

Slide 13

• An af� rmative pricing policy is usually present in high income countries where prices of drugs are transparent to the pricing authorities. Amongst them are reference pricing, mark-up controls or control on pro� ts.

• Prices of drugs should at least be available to patients and consumers at the dispensing level from all providers.

• Generic policy and drug � nancing are policy issues to be considered in health system restructuring and � nancing plan.




Slide 14

• Cooperation and collaboration of various stakeholders in promoting quality use of drugs can lead to a better informed and more knowledgeable society.

Slide 15

• The policy has outlined many different strategies to promote and improve quality use of drugs. While many interventions are already in place, there are some that require more initiatives (e.g. STG development) and strengthening (e.g. DTC and medicines advertisement and promotion).

• Drug information services are provided in all major hospitals and DTCs have been formed at hospitals, districts and state level institution. STGs should be produced for diseases with high morbidity and linked with essential medicines.

• There should be clear distinction between prescribing and dispensing functions, and the roles of health professionals.




Slide 16

• This policy is important so there is suf� cient human resource for all � elds of the pharmaceutical sector, i.e community, secondary care, industry, etc.

Slide 17

• More researches on drug utilization and management are needed to provide greater understanding of drug use and expenditure for informed policy-making.

• Industries should participate more in drug research and development.




Slide 18

• Sharing of information, expertise and provision of human capital development can be strengthened through technical cooperation.

Slide 19

• At present there has been strong technical cooperation and collaboration at national, regional and international level. More could be done in all the areas of the core components, especially at national level.




Slide 20 • Besides policy statements and strategies, a national drug policy must incorporate monitoring and assessment plan to ensure that implementation is carried out to achieve the goals of the policy. • A secretariat has been formed at the PSD to coordinate and monitor the implementation of the NMP.

Slide 21

• The policy process is just as important as the policy document.• Assessment and monitoring of the pharmaceutical situation are vital in order to identify strengths and weaknesses, track progress and determine priority health needs.• While many countries have adopted and revised NMPs, not all have succeeded in systematically implementing these policies and monitoring them effectively. • There are many challenges to its implementation especially in promoting the recognition of access to medicines as a human right (one of the indicators of MDG) and promoting ethical practices.




Slide 22

Slide 23

Slide 24




Slide 25

Slide 26

Slide 27• Routine reports such as QA and KPIs.




Slide 28

• A Manual on WHO indicators and data collection methods has been published. Some of the WHO indicators have been selected for monitoring.

Slide 29

• Level 1 indicators are collected through questionnaires and for Level II through simple, routine surveys. Level III indicators are investigations or in-depth surveys on areas of importance to the country.




Slide 30

Slide 31




Plans of Action of DUNAS(Dasar Ubat Nasional /

Malaysian National Medicines Policy)



N a t i o n a l M e d i c i n e s P o l i c y M i d - T e r m R e v i e w W o r k s h o pN a t i o n a l M e d i c i n e s P o l i c y M i d - T e r m R e v i e w W o r k s h o p





COMPONENT 1: QUALITY, SAFETY AND EFFICACY OF DRUGS

Policy: Only safe, ef� cacious and quality drugs that meet approved standards and speci� cations shall be registered and made available for sale and use in Malaysia.

Aim: To ensure that drugs marketed for patient care are safe, effective and of high quality so as to meet the health needs of the nation.

Strategy: The aim shall be achieved by strengthening the drug regulatory system through a comprehensive drug legislation framework and enhancement of pharmaceutical quality assurance measures.

Part 1: LEGISLATION AND REGULATIONS Strategy 1: Drug Control Authority Strategy 2: Licensing of Premises Strategy 3: Prescription of Drugs Strategy 4: Inspection Strategy 5: Medicines Advertisement and Promotion Strategy 6: Intellectual Property Rights Strategy 7: Counterfeit Drugs

Part 2: PHARMACEUTICAL QUALITY ASSURANCE Strategy 1: Drug Registration Strategy 2: Inspection Strategy 3: Quality Control Strategy 4: Post-Marketing Surveillance




Part 1: LEGISLATION AND REGULATIONS

Strategy 1: Drug Control Authority

Develops and implements the regulations concerning the quality, safety and ef� cacy of drugs

Strategy 2: Licensing of Premises

i) Licensing of Manufacturers, Importers and Wholesalersii) Licensing of retail and dispensing outlets

ImplementationTimelineNo. Activities Indicators Targets Stakeholders

On going1. Review of drug registration guidelines to ensure relevance to current regulatory framework

Constructive feedback from Industry & stakeholders through - surveys - dialogues

Quality of the dossiers submitted - periodic surveys on no. of correspondence

To be determined(TBD)

NPCB; Industry; Relevant Stake-holder

NPCB; Industry;

20082. Enforce Ready-to-dispense pack No of product complaints pertaining to quality for ready to dispense packs.

Review effectiveness of implementation - Expect a downward trend

NPCB; Industry

20103. To review number of dispensed packs used “as is” in dispensing outlets

% of products dispensed in the original packs

Survey in dispensing outlets through random sampling. Target 100%

NPCB; PSD;Industry; MMA; MPS & Academia

20114. To implement use of the PIL (Patient Information Lea� ets) for OTC and selected prescription medicines for chronic diseases such as diabetes, asthma, CVD (cardio-vascular diseases)

No. of products supplied with PIL/ No. of products registered with requirement for PIL

100% of products identi� ed to have PILs

Product registration holders; NPCB; Academia; MPS; ProfessionalAssociations & ConsumerAssociations


Ongoingactivity

1. Licensing of Manufacturers, Importers and Wholesalers

% of premises which require licensing are licensed

100% NPCB

Ongoingactivity

2. Licensing of retail and dispensing outlets

% of premises which require licensing are licensed

100% PSD




Strategy 3: Prescription of Drugs

Strategy 4: Inspection


KIV (To bedetermined

when the new bill is approved by Parliament)

3. Listing of sellers of General Sale List item (OTC & TCM)

TBD TBD PSD


Ongoingactivity

1. Prescribing of Group B Poisons by registered medical, dental practitioners and veterinary surgeons

No. of violations identi� ed/ No. of premises inspected

0 PSD; Professional Bodies

Ongoingactivity

2. Dispensing of Group C Poisons by registered pharmacists

No. of violations identi� ed/ No. of premises inspected

0 PSD; Professional Bodies


Ongoingactivity

1. Licensed manufacturers, importers and wholesalers

No. of licenses withdrawn / no of premises inspected

No. of premises with “weak” GMP status / No of premises inspected

No. of premises which comply to GSP & GDP/ No. of premises inspected

0

0

100%

NPCB; PSD; RelevantAssociations

NPCB;PSD; RelevantAssociations

NPCB; PSD; RelevantAssociations

2. Auditors’ training No. of auditors trained

No. of Auditors/No. of Audits to be done

100%

Based on norms

-

NPCB

Ongoingactivity

3. Inspection of retail pharmacies No. of Punitive actions taken./ No. of premises inspected

0 PSD

Ongoingactivity

4. Inspection of medical, dental and veterinary clinics

No. of Punitive actions taken./ No. of premises inspected

0 PSD

TBD5. Inspection of Listed Sellers of General Sale List Items

TBD TBD PSD




Strategy 5: Medicines Advertisement and Promotion

Regulate all advertisement and promotion of drugs, including traditional medicines, in line with the WHO Ethical Criteria for Medicinal Promotion.

Review and strengthen prevailing legislation, where necessary.

Strategy 6: Intellectual Property Rights


TBD1. Registration of products in accordance with patent laws and TRIPS respects IP and does not allow for infringement of IP

TBD TBD NPCB; Registration holders; MyIPO (Intellectual Property Corporation of Malaysia)

TBD2. Implementation of requirements for Data Exclusivity

TBD TBD NPCB; Product applicants; Relevant parties


Ongoingactivity

1. Regulate all advertisement and promotion of drugs (including health supplements and traditional medicines)

No. of advertisements in violation of regulation/ No screened

0 PSD

2. Review of existing guidelines for Advertisement over the Internet

No. of advertisements in violation of regulation/ No. screened

Constructive feedback from industry & stakeholders through dialogues

PSD

20103. Development of guidelines for Advertisement of selected Group C items such as Nicotine Replacement and Cough Cold products

No. of advertisements in violation of guideline / No. screened

0 PSD

20104. Review the mechanism for the dissemination of scienti� c and new clinical studies in the public domain.

No. of articles in violation/No. screened

No violation reported

PSD

Ongoingactivity

5. Encourage self regulation of OTC/TCM/Health supplements by conducting awareness program for self regulation

No. of dialogues, talks, campaign organised

20106. Increase media education & awareness

No. of dialogues, talks, campaign organised

PSD




Strategy 7: Counterfeit Drugs

Note : * Propose to change to “Counterfeit, Adulterated and Unregistered Drugs”


Ongoingactivity

1. Seizure of counterfeit, adulterated and unregistered drugs

No. of counterfeit, adulterated and unregistered drugs con� scated.

Value of seized products

No. of counterfeit, adulterated and unregistered drugs sold in the market should show adecreasing trend.

Co-operatives and Consumerism); FOMCA; Industry; ConsumerAssociations; other relevant NGOs and Practitioner bodies.

TBD2. Implementation of stricter penalties for persons/companies violating the law

Inclusion of stricter penalties in the Pharmacy Bill

Ongoingactivity

3. Sharing of information domestically and internationally

No. of meetings/discourses with local and international agencies, no. of letters, e-mail sent

0 NPCB; PSD

Ongoingactivity

4. Consumer education No. of education sessions on counterfeits, adulterated and unregistered drugs including dialogues, talks and campaign organised/participated

PSD

Ongoingactivity

5. Issuance of public alerts through the mass media

No. of alerts issued

NPCB; PSD

Ongoingactivity

6. Auditing of security label vendor Compliance to the requirements

100% PSD

Ongoingactivity

7.

8.

Review the impact & usefulness of the current security label

Evaluate alternative/ progressive technology for monitoring & combating counterfeits, adulterated and unregistered drugs

Positive � ndings

Effective & Cost Effective

PSD

PSD; Industry; Professional Associations and ConsumerAssociations




Part 2: PHARMACEUTICAL QUALITY ASSURANCE

Strategy 1: Drug Registration To enhance registration procedures of pharmaceuticals, traditional medicines and cosmetics


20101. Evaluation of active pharmaceutical ingredients

No. of API evaluated

25% NPCB

20102. Registration of veterinary products

No. of Veterinary product registered

100% of existing products

NPCB

Ongoingactivity

3. Training of evaluators, analysts, inspectors

100% achieve CPD points requirement

All competent regulators

NPCB

20124. Evaluating ef� cacy claims for Natural Products as part of their use in mainstream medicine

No. of products registered with data to support ef� cacy claims

TBD NPCB; Traditional Medicine Industry; Academia; Relevant Professional Bodies

Ongoingactivity

5. Fast track approval system for new, innovative life saving and essential drugs

No. of products given priority review registered within 6 months

Ongoingactivity

6. Review of registration procedures and timelines

Constructive feedback from industry & stakeholders through surveys and dialogues

Feedback from the stakeholders

NPCB; Industry; ProfessionalBodies

100% if dossier provided is complete

NPCB; Traditional Medicine Industry; Academia;Relevant Professional Bodies

Ongoingactivity

7. Review of Functional claims for Health Supplements

No. of ingredients with approved functional claims

Increasing no. based on evidence

NPCB; HS (HealthSupplement) Industry; Food Safety and Quality Division; Academia




Strategy 2: Inspection Note : * Propose to change to “Licensing and Inspection”


Ongoingactivity

1. Inspection and licensing of premises (manufacturer, wholesaler and importer)

Inspection of manufacturers: to inspect more than 90% of the total number of scheduled inspections

Licensing of Importers and Wholesalers: all license applications will be processed in accordance to client’s charter

Manufacturer - 200/year

Importer - 800/yearWholesaler - 1000/year

NPCB

Ongoingactivity

2. Clinical Trial Import License (CTIL) Issued

No. of licenses approved

All applications evaluated within 2 months

NPCB

Ongoingactivity

3. Authorization to Manufacture (CTX) Issued

No. of authorizations approved

All applications approved are evaluated

NPCB

20104. GCP Inspection No. of CT sites found to be GCP compliant/ No. of sites inspected

20105. Inspection of Bioequivalence (BE) Centres

No. of compliant BE centres/No. of BE centers inspected

100%; At least once every 2 years

NPCB

100% NPCB

20106. GLP Inspection No. of laboratories compliant/No. of laboratories inspected

At least once every 2 years

NPCB

20117. Good Distribution Practice Inspection

No. of premises which comply to GSP & GDP/ No. of premises inspected

TBD NPCB; PSD; Industry (anyone involved inmarketing drug products)




Strategy 3: Quality Control

Strategy 4: Post-marketing surveillance program Strengthen surveillance activities of pharmaceutical and traditional products.


Ongoingactivity

1. Upgrading of existing QC laboratory

Development of new test methods

As required by current needs

NPCB

20092. Accreditation of NPCB laboratory (Scope – Testing of Traditional Medicine)

Accreditation received

Laboratories accredited to MS ISO/IEC 17025 by 2009

NPCB

20113. Accreditation of private laboratory (Scope – Testing of Traditional Medicine)

No. of accredited labs

TBD NPCB; Academia; TraditionalMedicine Industry

Subject toapproval

Ongoingactivity

4.

5.

Establishment of regional laboratories for purpose of surveillance

Training of analyst

TBD

Refer to the Training records of the Analyst

TBD

All competent analysts

NPCB; Academia; TraditionalMedicine Industry


Ongoingactivity

1. Adverse drug reaction reporting No. of ADR reports received

200 ADR / million population

Healthcare Professionals; Industry; NPCB

Ongoingactivity

2. Reporting of ADR by industry to the DCA

No. of ADR reports submitted by product registration holders

Increasing trend Industry

Ongoingactivity

3. Consumer based reporting of ADR

No. of ADR reports submitted by consumers

Increasing trend Consumers/ Public; ConsumerAssociations; NPCB

Ongoingactivity

4. Recognition of good ADR reporters

No. of reporters who consistently submit ADR reports

NPCB

20105. Annual training for the HCPs to be incorporated as part of CME/ CPD

CME/CPD Points

Ongoingactivity

6. Surveillance of registered products and cosmetics under PMS program

No. of samples taken for conformity assessment

2500/year NPCB; PSD

TBD NPCB; PSD

Ongoingactivity

7. Review of Quality Assurance Programme during GMP/GSP audits

Compliance with the system

No. of product complaints

NPCB; Industry






COMPONENT 2: DRUG AVAILABILITY

Policy: An ef� cient and integrated drug management and supply network shall be maintained.

Aim: To ensure an equitable, adequate and continuous availability of safe, effective and quality essential drugs to the entire population.

Strategy: The aim shall be achieved through the careful selection of medicines, improvement in the management of drug procurement and the supply chain, and through optimal utilization of available � nancial resources.

Part 1: SELECTION OF MEDICINES

Strategy 1: Development of Essential Drugs Programme. NEDL based on STG be used as a guide for i) Public sector drug procurement, distribution and utilization ii) Education and curricula of undergraduate, post-graduate and in-service training of health professionals iii) Advocacy and training in the concept of essential medicines iv) Support to domestic pharmaceutical industry

Strategy 2: Development of Standard Treatment Guidelines.

Strategy 3: Selection of traditional medicines - Formation of Technical Committee comprising of expert and Practitioners.

Part 2: DRUG SUPPLY

Strategy 1: Procurement - Strengthen procurement and supply system of cost effective essential medicines.

Strategy 2: Domestic Medicines Production - Support Development of a viable domestic pharmaceutical industry and manufacturing capacities towards self suf� ciency.

Strategy 3: Distribution, Storage and Disposal - An effective and economical distribution network shall be strengthen to ensure prompt distribution of adequate quantities of quality essential medicines to all healthcare facilities.

Strategy 4: Drug Supplies in emergency situations and drug donations - Shall be based on expressed needs as recommended by the WHO guidelines.




Part 1: SELECTION OF MEDICINES

Strategy 1: Development of Essential Drugs Programme

NEDL based on STG be used as a guide for:i) Public sector drug procurement, distribution and utilization

ii) NEDL based on STG be used as a guide for:Education and curricula of undergraduate, post-graduate and in-service training of health professionals


20081. • Form multisectorial panel to assess and update NEDL according to country’s needs• Publish NEDL and circulate to public facilities• Use NEDL as � rst line reference drugs during budget constraints

Updated list ready • Updated and documented NEDL

• Drugs in NEDL is being used as � rst line in public private sector

• Full reimbursement for all drugs in NEDL

Healthcare Professionals; Industry; NPCB

2010-20122. • Create NEDL awareness with wide NEDL circulation• To conduct a survey on the relevancy of NEDL in the public sector, private practice, Private Hospital, GP and community pharmacies. • NEDL should be reviewed in lieu of any development on health sector reform especially in the aspect of health � nancing and should there be any changes, it should be the management of care at primary and secondary levels. • Panel should include experts consist of clinicians, clinical pharmacists, health economics, pharmacovigilance, pharmacoepidemiology, social pharmacist, and industries reps

• NEDL Circulated• Formation of expert committees• Result of the survey ready

Updated version of NEDL to be made available after the survey

MOHMOHE


On-going1. Undergraduate HCPs to be exposed to the concept of NEDL and National Medicines Policy

• To enhance knowledge capacity at masters and PhD level in order to provide expert advice to the selection committee. (Specialties such as health economics/ epidemiology, Pharmacoepidemiology and pharmaceutical technology/ industry).

Increased number of experts in each specialties

Increased number of experts in the country

• MOHE to create pool of experts and to train.

• PSD to identify candidates and funding.




iii) NEDL based on STG be used as a guide for:Advocacy and training in the concept of essential medicines

iv) NEDL based on STG be used as a guide for:Support to domestic pharmaceutical industry

Strategy 2: Development of Standard Treatment Guidelines


20091. • Conduct CME to healthcare providers and consumer education on Essential Drugs (ED) concept • Circulate updated version of NEDL to private facilities

20102. To make Continuous Professional Development mandatory to all HCPs by making it a criterion for renewal of the professional practicing certi� cates.

• Average CPD points collected by HCP on respective specialty.

• % of professionals engaged in CPD program by individual professions.

Min points required will be set by each professional bodies

MPS; MMA; MDS etc.


• To submit for budget 2010

• To be implemented in

2011

1. • Grant to local industry to do BE studies and make BE as the standard requirement for all generic drugs. • Government MOH work together with industry to identify off-patent imported products from the NEDL that are viable to be manufactured locally. • Abolish all taxes if any on equipments parts, packaging materials and excipients used in local pharmaceutical manufacturing.

• Increase in the number of generics with BE

• Cheaper generics ED in the market

• Increase in % of NEDL drug manufactured locally

Positive growth of domesticmanufacturers

MOPIMOHMITIMIDA (tax)


2010-20121. Review and update MOH Drug Formulary on Paediatric Treatment.

• Identify and list medicines critical for paediatric treatment which are not readily available in the market. • Create standard guideline for extremponeous preparation.

Formulary for pediatric established

Pediatric Formulary ready by 2012

Pediatric institute, HKL

PSD

USM




Strategy 3: Selection of Traditional Medicines

Formation of a Technical Committee comprising of experts and practitioners

Part 2: DRUG SUPPLY

Strategy 1: Procurement – Strengthen procurement and supply system of cost effective essential medicines


2010 - 20121. • Pro-tem committee consisting of TCM practitioners, clinicians, TCM division, pharmaceutical services division, MOSTI, FRIM.

• To acquire expertise in the following � elds: Pharmacognosy, phytochemistry, ethnobotany, pharmaceutical technology and toxicology area. • Establish criteria for selection - Products must be registered with NPCB - For products to be selected in the formulary it has to comply to the standards monograph and pharmacopoeia if available. - Any medical claim must be supported with clinical trials. - Pro-forma for recommendation must come from registered TCM practitioners.• Establish Formulary of Traditional and Complementary Medicines

• Increase in number of experts in the country

• Formation ofpro-term committee

• Formation of the committee

• Criteria of selection have been established

• No. of products listed in the formulary

• Development of a standard List of TCM products identi� ed to be used in hospitals

• Establishment of Malaysian TCM formulary

• TCM division, MOH; NPCB

• MOE

• TCM division, MOH; NPCB


Refer to item 3 ICT below

1. Set up a national database for drug supply for • Use as guidance to encourage domestic production esp. for drugs in NEDL • Use as guidance for proper forecasting, tracking, trending and reduce wastage

Discussion: Will look into drug usage data which will be provided by public sector. (Refer to item 3, on ICT below)

Refer to item 3, on ICT below

2. Incorporate and institutionalize GGM




* De� nition of local manufacture: Manufactured by companies that are registered in Malaysia.

* De� nition of manufacturing: In the Poisons Act 1952:Manufacture and its grammatically variations, means the


3. • To of� cially incorporate element of patent protection for pharmaceutical products in the procurement process.• To incorporate IP requirement in product registration, where MNC to inform & routinely update the patent status during the patent period of the product. ( to seek NPCB’s view in this issue) no liability to NPCB.

Lead: Propose NPCB, with involvement from MyIPO & industry

To discuss with NPCB

N/A NPCB;MOPI;PhAMA

To assess local capacity and

capability

4. • Mandatory for MNCs to out- source the manufacturing to Malaysian-owned manufacturing companies for sales to public sector. • Manufacture of drugs in NEDL (to take into consideration on IP & patent element). * Please � nd de� nition of local manufacturer & manufacturing in the note below

• For off patent product tender item should it be manufactured locally? • Allow PhAMA companies to assess the situation prior to agreement to this proposal.

Assessment on local capacity and capability.Follow-up meeting with PhAMA, MOPI, PSD, Bahagian Perolehan and Pengswastaan


PhAMA; MOPI; PSD

The task force is already in place, led by

NPCB

5. • Development on Guidelines for procurement of orphan drugs• Orphan drugs: drugs for treatment of rare diseases, or drugs that are not used very often• Objective of the guidelines: To facilitate availability of orphan drugs when needed.• Committee to develop the guidelines, to involve personnel in NPCB & PSD & State Pharmacy, 1 from PhAMA & 1 from MOPI to look into: - list of orphan drugs - source of supply - procurement process - allocation of funds - communication to all stakeholders

A guideline for orphan drug will be established by March 2010. The guideline is updated every 2 years


NPCB;PSD;Industry




preparation, compounding, mixing, and making of a pharmaceutical preparation in bulks but does not include the dispensing of a pharmaceutical preparation for a particular individual.

Under Control of Drugs and Cosmetics Regulation 1984: Manufacture, in relation to any products includes a) the making or assembling of a productb) the enclosing or packing of a product in any containers in a form suitable for administration or application and the course of any of the foregoing activities.

Strategy 2: Domestic Medicines Production – Support development of a viable domestic pharmaceutical industry and manufacturing capacities towards self suf� ciency


• According to Industrial

Master Plan 3 (IMP3)

• To assess local capability and capacity

1. • Increase contract manufacturing of MNCs products

• Increase production for drugs in NEDL.

• A need for database for usage of drugs in NEDL.

• MNCs to out-source the manufacturing to Malaysia-based manufacturing companies for sales to public sectors, on contract negotiation basis (e.g. based on the volume of supply).

• Allow PhAMA companies to assess the situation prior to agreement to the proposal.

PhAMA companies to assess local capability and capacity

To assess local capacity and capability

PhAMA; MOPI; PSD; Procurement & PrivatisationDivision, MOH

20112. • Support to domestic industry in terms of training and capacity enhancement on quality. Choice be left to professional judgement based on a number of factors including safety, ef� cacy, quality, bioequivalence, and price.

• Pharmaceutical companies to be given the same/equivalent strategic incentives as to the bionexus companies.

Achieve strategic incentive for pharmaceutical industry by 2011

MIDA

20143. • National self reliance: Drugs in NEDL including antivirals & vaccines.

• Manufacture of vaccines: support from the Government is needed.

• Refer to drug usage database on the quantity & types of vaccine used.

Malaysia is able to produce vaccines in NEDL by 5-7 years time

MOPI;PhAMA;PSD




Strategy 3: Distribution, Storage and Disposal – An effective and economical distribution network shall be strengthen to ensure prompt distribution of adequate quantities of quality essential medicines to all healthcare facilities.


20101. • Shorter lead time -APPL shorter lead time (7 days-in negotiation)• Competition - open tender system• on time renewal of contract (to determine the timeline on initiation of renewal prior to expiry)

• All contracts of NEDL are renewed on time• APPL supply: max 10 working days• No. stock out situation in central procurement/ distribution unit

2010 Procurement & PrivatisationDivision MOH; Pharmaniaga; PSD

10th Malaysian Plan

2. • Establish Information Communication Technology network (for intergrated pharmacy system in the whole country) for all health facilities - on drug consumption: quantity & value - drug delivery period - drug write off due to expiry - drug annual turnover rate etc

• To propose it under the 10th Malaysian Plan

ICT is completed & implemented during the tenure of the 10th Malaysian Plan

10th Malaysian Plan

PSD, withinvolvement from InformationManagementDivision, MOH

N/A - no issue since

enforcementof the act is

Dept ofEnvironment

(DOE)

10th Malaysia Plan

3.

4.

• Develop guideline on drug disposal according to environmental policies for disposal of medicines• Adopt MoH guidelines on “Disposal of Pharmaceutical Waste”, with reference to Enviromental Quality Act 1974.• Dissemination of guidelines to all stakeholders.

National reserve: National warehouse for outbreaks /pandemic, e.g. stockpile for antivirals & PPE (Personal Protective Equipments)

Focused activities will improve ef� ciency

National warehouse is established by 10th Malaysia Plan

Focused activities will improveef� ciency

10th Malaysia Plan

PSD; Pharmacy Practice &DevelopmentDivision, MOH(to coordinatewith Kualiti Alam,Department of Environment, DOE & Engineering Division)




Strategy 4: Drug Supplies in emergency situations and drug donations- shall be based on expressed needs as recommended by the WHO guidelines.


To becompleted by

2010

1. How Malaysia receive drug supplies in emergency situations:• Develop guidelines ( to look into core principles and topics) for the management of drug donation in emergency situations based on WHO Guidelines - WHO/EDM/ PAR/99.4 ( to develop the emergency drug list and antidotes, location and availability & other admin procedures)• Adopt & adapt the WHO Guidelines on “Drug Donation” with reference to Inter-agency emergency health kit 2006, WHO (or latest version)

Guidelines on Drug Supply in Emergency Situation & Drug Donation is established by end of 2010

Guidelines made available by 2010

PSD; Medical Development Division; MITI; MERCY Malaysia; WHO; NGOs; MOF and other stakeholders.





COMPONENT 3: DRUG AFFORDABILITY

Policy: The pharmaceutical industry shall be organized and regulated to create incentives and foster competition in drug prices. Appropriate � nancing mechanisms shall be developed to ensure essential drugs needed for quality healthcare are affordable.

Aim: To ensure continuous access and � nancial sustainability of essential drugs at prices affordable to all.

Strategy: The aim can be achieved by implementing cost-containment measures and developing appropriate and reliable � nancing mechanisms to ensure equitable access to essential drugs for the population. Part 1: PRICE OF DRUGS Strategy 1: Formulation of a Pricing Policy (Medicine Price Monitoring) Strategy 2: Price Information and Sharing

Part 2: GENERIC MEDICINES POLICY Strategy 1: Procurement of Multisource Products by Generic Names Strategy 2: Provide Incentives for Use and Production Strategy 3: Encourage Generic Labeling and Generic Substitution

Part 3: DRUG FINANCING Strategy 1: Establishment of a Reliable Drug Financing Mechanism




Part 1: PRICE OF DRUGS

Strategy 1: Formulation of a Pricing Policy (Medicine Price Monitoring)


20041. To set up a Medicine Price Monitoring Unit for the following activities:

• On-site medicine price data collection from private outlets

• Submission of medicine price data by public premises

• Submission of medicine price data by distributors

• Submission of medicine price data by GPs

• Development of medicine price database

Medicine Price Unit set up and Terms of Reference (TOR) de� ned

Done PSD

2006-on going Data collected 2x per year

Done -ongoing

Done -ongoing

Done -ongoing

PSD; FPMPAM

2010

Data submitted yearly, continuously

Q3 2009Separate GP & specialist data

2009

2008

2. To Develop Price Monitoring for Ensuring Rational Pricing System:

• Consultation on situational analysis & intervention

• Identify current composition of medicine pricing structure

• Identify mechanisms to monitor mark-ups on medicine prices (Note: Separation of prescribing and dispensing would facilitate price structure monitoring)

• Study impact of trade practices on drug pricing

Consultation carried out & report submitted

Done PSD; WHO

Medicine price database developed

2009

2010

Price structure identi� ed for further action & policy development.

Identify suitable and feasible mechanisms to monitor prices of essential medicines

Consultancy completed Q1 09

Data collection commenced for 2009

To commence monitoring based on mechanism proposed by consultant

2010

Data submitted yearly, continuously




Strategy 2: Price Information and Sharing

Part 2: GENERIC MEDICINES POLICY

Strategy 1: Procurement of Multisource Products by Generic Names


End 20091. Implement labeling requirement for Recommended Retail Price (RRP) labeling on ready to dispense packages only at retail pharmacies and private hospitals.

RRP labeling on ready to dispense packages implemented (existing in retail pharmacies).

2009 (with co-operation from otherorganizations)

PSD ; APHM ; FOMCA ; MPS

20092. Enforce itemized billing for each item purchased and / or supplied by retail pharmacies, hospitals and private medical/dental practitioners. (Note: At private medical / dental practice as it is not mandatory for charges below RM 35.00. Available on request at private hospitals. Bills should be itemized 100%).

Itemized billing enforced.

End 2009 PSD; APHM ; FOMCA ; MPS

Early 20093. Accessible medicine price database via web-based sites and web-based bulletin.

Accessible medicine price database

Ongoingactivity

4. Public Education on Consumer Rights to Medicine Price and Itemized Billing.

(Note: Should be carried out with Quality Use of Medicine Group)

Public Education Program on Consumer Rights to Medicine Price and Itemized Billing

End 2009 and ongoing (twice a year)

MOH; MPS; MMA; FOMCA & other NGOs; Academia

Done; for a limited number of medicines. To continually increase number and to include essential drugs in 2010.

USM; MPS; MOH; FOMCA


2009 - Ongoing1. Give preference to generic names in procurement.

(Note: To encourage all sectors. Enhance purchase and use in public sector based on cost effectiveness)

Percentage of increment in use of generic names

All sectors by 2011

MOH; Othergovernment health institutions; APHM




Strategy 2: Provide Incentives for Use and Production

Strategy 3: Encourage Generic Labeling and Generic Substitution

Part 3: DRUG FINANCING

Strategy 1: Establishment of a Reliable Drug Financing Mechanism


Ongoing1. Preference for medicines with generic names to be listed as contract / APPL items

Increase in purchase of local generics

2010 MOH; MOPI


2009 -20101. To consider generic substitution in consultation with prescribers

No of studies; No of institutions

Study / data by 2010

MOH; MPS; MOPI; FPMPAM

20092. Generate list of drugs that are not interchangeable

List developed End of 2009 MOH; PhAMA

Ongoing3. Public health facilities to continue data collection on generic prescribing and reporting to the Drug Therapeutic Committee.

No of reports to DTC

All survey data analysed and reported

MOH; University hospitals; Other governmenthospitals


20101. Development of an ICT system ICT system developed

End 2009 MOH

2010

2009

2.

3.

Develop data on:-

• Drug cost per prescription based on type of care (acute, primary) and by discipline

To develop a Formulary of Essential Drugs applicable for reimbursement for both public and private facilities.

• Formation of a Technical Committee to review the EDL on a regular basis

(Note: Formulary Panel currently reviews the NEDL; need to include others such as Health Economists and Pharmacoeconomists in the Review Panel)

No of study conducted

No of reviews (until 2012)

2010

TechnicalCommittee (with new members) formed and ED Formularydeveloped

MOH

MOH; MMA; PhAMA; MOPI; MOHE; LIAM; FPMPAM





2010

2010

4.

5.

To develop structural capacities for pharmaceutical bene� ts system (PBS) for the National Healthcare Financing Mechanism (NHFM)

• Formation of a Technical Working Group

(NHFM to be identi� ed before structural capacities for PBS can be developed)

Generate approved list of drugs that can be substituted

Structural capacities for PBS identi� ed

Approved list of drugs that can be substituted generated

2010

2010

PIAM; MOH; MPS; PhAMA; MOPI; MOHE; MOF

MOH; FPMDAM; PIAM; LIAM; MOPI; PhAMA




COMPONENT 4: QUALITY USE OF DRUGS

Policy: Quality use of drugs by healthcare providers and consumers shall be promoted. Activities of the government, industry and media in support of informed and appropriate use of drugs by consumers shall be encouraged.

Aim: To contribute towards quality of care and cost-effective therapy.

Strategy: The aim shall be achieved by promoting rational prescribing and appropriate use of medicines by consumers through:- • Training and education• Provision of independent, evidence-based drug information• Establishment of therapeutic committees, development of standard treatment guidelines and standards of professional practice• Ethical promotion of drugs• Provision of relevant legislation

Part 1: TRAINING & EDUCATION – HEALTHCARE PROVIDERS Strategy 1: Training attachments for pharmacists – locally & overseasStrategy 2: Provide adequate theoretical and practical training in drug useStrategy 3: Education and curricula of undergraduate, post-graduate and health professionals undergoing in-service training

Part 2: TRAINING & EDUCATION – GENERAL PUBLIC Strategy 1: Educate general public.

Part 3: DRUG INFORMATIONStrategy 1: Disseminate accurate, unbiased and relevant information on drugsStrategy 2: Provide adequate facilities for drug information disseminationStrategy 3: Networking of Drug Information Centres to optimize resourcesStrategy 4: Regulate drug labelling and facilitate availability of product information lea� et

Part 4: DRUGS AND THERAPEUTIC COMMITTEESStrategy 1: Formulary Panel to coordinate incorporation of NEDL into STGStrategy 2: Enhancement of the role of Drugs and Therapeutic Committees

Part 5: STANDARD TREATMENT GUIDELINES Strategy 1: Establishment of Standard Treatment Guidelines (STG) based on disease prevalence (evidence–based)Strategy 2: Promotion and training on use of STG




Part 6: PRESCRIBING AND DISPENSING PRACTISESStrategy 1: Enforce the use of generic names in prescriptionsStrategy 2: Separate prescribing and dispensing functions

Part 7: ROLE OF PHARMACISTSStrategy 1: To establish the central role of the pharmacist

Part 8: MEDICINES ADVERTISEMENTS AND PROMOTIONS Strategy 1: Establish Good Governance of Medicines and apply it to all industry players and health professionals. Promote ethical promotion of medicines and marketing activities.

Part 1: TRAINING & EDUCATION – HEALTHCARE PROVIDERS

Strategy 1: Attachment training of pharmacists – locally & overseas


10 MP1. Identify new areas for specialization e.g., cardiology, intensive care, pediatrics, oncology, mental health, geriatrics, military pharmacy, transplantation pharmacy, biopharmaceutics, pharmacogenomics & primary care pharmacy.

No. of specialized � elds

No. of pharmacists with postgraduate training in the specialized � elds

No. of hospitals/health facilities offering services in the 4 identi� ed specialized � elds

No. of training centres

No. of specialized pharmacist posts

4 � elds of specialization (to be identi� ed by PSD)

At least 20% of the currently practising pharmacists trained in the 4 identi� ed specialized � elds

To be collected

To be collected

20% of all pharmacist posts

PSD of MOH; Human Resources Division of MOH; Public Services Department (JPA); Academia; MOE; MOHE; MINDEF; Professional Societies (e.g. MPS, MMA), & Academy of Pharmacy

2009

20112. Strengthening existing specialized areas

No. of personnel trained

At least 20% of new personnel will be trained in the 4 identi� ed specialized � elds

2014

2014

3.

4.

Accreditation of training centres

Acquire Credentialing & Privileging in specialized areas for gazettement

No. of accredited training centres

No. of pharmacists credentialed & privileged in specialized areas

100% identi� ed training centres

100% pharmacists nominated

PSD; MPS




Strategy 2: Provide adequate theoretical and practical training in drug use

Strategy 3: Education and curricula of undergraduate, post-graduate and in-service training of health professionals


Ongoingactivity

1. Attend regular multidisciplinary teaching rounds

Set up mechanism for academic detailing activities)

Number of teaching round teams in hospitals which include pharmacists

Are there training centres for academic detailing activities?

How many regional training centres have been set up?

No. of staff sent abroad to be trained as master trainers

100% of teaching rounds in specialized � elds identi� ed by PSD to include pharmacist(s)

Yes

At least 2 regional training centres

At least 5 staff to be sent abroad to be trained as master trainers

2011


20101. Include National Medicines Policy, Essential Medicines concept, Generic Drug Policy, Quality Use of Medicines and Medicine Pricing into Pharmacy and Medical school curricula and CPD activities for healthcare professionals

No. of Pharmacy and Medical schools with curriculum on National Medicines Policy, Essential Medicines concept, Generic Drug Policy, Quality Use of Medicines and Medicine Pricing

100% PSD; Human Resources Division of MOH; Academia; MOE; MOHE; MINDEF; Public Services Department (JPA); Professional Societies (e.g. MPS, MMA) & Academy of Pharmacy

20102. Organize training for pharmacists/doctors in National Medicines Policy, Essential Medicines concept, drug formularies, Quality Use of Medicines (QUM), STGs etc. in collaboration with WHO Development of core curriculum on QUM for allied health providers

No. of training programmes conducted

Has core curriculum on QUM for Allied Health Providers been established?

Do all allied health institutions have core curriculum on QUM?

To be collected

Yes

100% allied health institutions




Part 2: TRAINING AND EDUCATION – GENERAL PUBLIC

Strategy 1: Educate general public:

• On objective and basic information on quality use of medicines• To encourage informed decision-making• To develop discerning attitude towards advertisements & commercial information• To be responsible for self-medication• To be con� dent to interact with healthcare providers


2006

2011

Ongoingactivity

Ongoingactivity

1. Pre-intervention national survey on consumer knowledge and awareness on the quality use of medicines

Post-intervention national survey on consumer knowledge and awareness on the quality use of medicines

Carry out projects and campaigns in collaboration with pharmacies/universities / MPS / NGOs to educate public on the quality use of medicines

Carry out projects and campaigns for secondary schools to educate students on the quality use of medicines

Level of consumer knowledge and awareness on the quality use of medicines gauged?

Increment in level of knowledge and awareness

% of secondary schools covered by projects and campaigns

Baseline level gauged

20% increment in knowledge and awareness

20% secondary schools covered

MOH; MOE; MDTCC; MOPI; MPS etc.

20102. Dissemination of information on the quality use of medicines through exhibitions, seminars, public workshops and forums TOT for community leaders

No. of activities conducted

No. of participants per activity

No. of leaders trained

At least one activity per pharmacy facility per year �30

At least one community leader trained per district.

20073. Establish a dedicated portal on consumer protection and education

Dedicated portal developed

Satisfaction level on web content

Yes

50%




Part 3: DRUG INFORMATION

Strategy 1: Disseminate accurate, unbiased and relevant information on drugs


20111. To enhance the role of drug information centres in hospitals

To raise awareness among members of the public and HCPs on the existence and roles of such centres

Comments/Suggestions:

The location of DIC should be accessible to patients and public Provide accessible service to the public to check on the status of drug registration

To be collected

At least one promotional activity undertaken per facility per year

PSD; MOH; MOE; MDTCC; MOPI; MPS etc.

20062. Dissemination of drug information inclusive of issues on quality use of medicines through:

Website/Internet portal

Patient Counselling

Through patient Counselling

Portal developed

No. of hits

No. of patients/consumers counselled

Frequency of publishing of drug bulletin

No. of types of pamphlets on drugs/issues on drugs developed and circulated

Yes

To be collected (with increment of 10% monthly)

To be decided by PSD of MOH

Drug bulletin published quarterly Publication of 2 pamphlets. Themes to be based on top 40 drugs in NMUS


No. of pharmacists trained in pharmacoinformatic services

No. of promotional activities carried out for public and HCPs




Strategy 2: Provide adequate facilities for drug information dissemination

*Ideally, each facility should be equipped with updated versions of all above mentioned references. However, it is not currently compulsory to keep all.

Strategy 3: Networking of DICs to optimize resources


20121. To equip all hospitals/health centres/community pharmacies with basic updated drug information references

No. of facilities (public and private) with basic updated drug information references*(Online, soft or hardcopies of) Micromedex Healthcare Series, Drug Information Handbook, Martindale: The Complete Drug Reference, BNF, MIMS, The Top 100 Drug Interactions by Hansten & Horn, Meyler’s Side Effects of Drugs.

100% MOH; MOE; MDTCC; MOPI; MPS etc.


20111. Networking among all drug information call centres for exchange of information

Is networking system in place?

Yes MOH; MOE; MDTCC; MOPI; MPS etc.

20112. Corporate licensing of drug database under MOH for hospitals & health clinics

No. of corporate licenses acquired

At least one Corporate license





Strategy 4: Regulate drug labelling and facilitate availability of product information lea� et

Part 4: DRUG AND THERAPEUTIC COMMITTEES

Strategy 1: Formulary Panel to coordinate incorporation of NEDL into STG


20091. • Enforce drug labelling in private pharmacies and GP clinics,

• Distribution of legislation documents

Proportion of inspected premises complying /no. of premises inspected

100% compliance MOH; MOE; MDTCC; MOPI; MPS etc.

20102. Consumer focused labelling guidelines

Are guidelines available for consumer-focused labelling?

Yes MOH; MOE; MDTCC; MOPI; MPS etc.

20113. Improve accessibility of Patient Information Lea� et to HCPs and consumers

No. of medicines (with PIL requirement) with PIL accessible to HCPs and consumers.

100% of registered medicines with PIL requirement

NPCB; Manufacturers; Distributors & Retailers


20101. Pharmacists in local DTCs and STG panels to coordinate and participate in the selection of essential drugs in line with STGs

No. of essential drugs used as � rst line drug treatment

100% MOH; DTCs in public & private sectors




Strategy 2: Enhancement of the role of Drug and Therapeutic Committees (DTC)


20101. Review membership, TOR and activities of DTC at local and national level

All public and private institutions have established DTC

DTC meeting held at least thrice yearly

100%

100%

MOH; Health Care Providers in public & private sectors

Mid 20113. Database for subject matter experts e.g.: evidence-based medicine, disease speci� c experts, pharmacoeconomics, pharmacoepidemiology

No. of expert teams established

Expert teams established for 5 diseases with highest BOD

MOH; Members of DTCs & Healthcare providers

Before end 2009

4. Virtual communication practiced e.g.: online forum discussion

Is virtual communication practiced?

Yes

20102. Local DTCs to develop hospital-based and state-based policies in adopting essential drugs to meet local needs via:

Emphasis on cost effectiveness, disease prevalence & burden of disease, budget impact analysis based on high cost drugs & high volume usage.

Transparency in decision making

Policies developed on STG

No. of evaluations done

Yes

100% evaluation on all new drug requests

MOH; Health Care Providers in public & private sectors

PSD; Members of DTCs; Healthcare providers & Medical DevelopmentDivision of MOH

Members of DTC; Healthcareproviders

Mid 20115. Control of samples used in government health institutions to ensure � nancial ability to continue medication. Adopt and adapt the local (UMMC) and international policy

Comments/Suggestions:

Establish DIC pharmacy as one stop centre for drug sample application.

No. of facilities which have implemented the policy

70% of facilities implemented the policy




Part 5: STANDARD TREATMENT GUIDELINES

Strategy 1: Establishment of Standard Treatment Guidelines (STG) based on disease prevalence (evidence–based)

Strategy 2: Promotion and training in use of STG


Mid 20111. Formulary panel and DTCs to coordinate development of STGs for use in primary healthcare involving most common diseases in adults and children.

Develop STGs based on the 5 diseases of highest burden

No. of STGs produced

5 STGs produced PSD; Healthcare providers in public & private sectors; Medical Development Division of MOH


Mid 20111. To promote and provide training on the use of STGs among HCPs and paramedics.

No. of training sessions held by zone

No. of master trainers No. of echo training sessions

At least once per year

At least 6 MT per zone

At least one per health facility

PSD; Healthcare providers in public & private sectors; Health Promotional Board; Medical Development Division of MOH

Comments/Suggestion:

Highlight incentive issues pertaining to STG implementation e.g. : fee for services, charge per prescription, upgrade of medical record structure, home based medical card, IT facilities

Mid 20112. Disseminate STG:a. Along with Annual Practicing Certi� cate (APC ) b. Email blast


Cost implication

Proportion of HCPs to whom STG disseminated/ APCs renewed

No. of HCPs to whom STG disseminated via e-mail blasts

100% of HCPs who renewed APC received STG

100% HCPs received STG via e-mail blast

Healthcare providers in public & private sectors

Mid 2011

Mid 2011

3.

4.

STGs accessible via MOH, professional & consumer organization websites

Audit on awareness and adherence to STG. Survey in terms of awareness and usage. Survey can be carried out manually or electronically

No. of STGs accessible for public viewing online

No. of STGs accessible for public viewing online

100% of STGs accessible

100% of STGs accessible






Part 6: PRESCRIBING AND DISPENSING PRACTICE

Strategy 1: Enforce the use of generic names in prescriptions

Strategy 2: Separate prescribing and dispensing functions


20101. Consultation on situational analysis and implementation of dispensing separation


Should a poll be conducted?Distance between clinics and pharmacies to be taken into consideration?

Has the consultation been held?

Has a consensus been reached between all stakeholders?Has the ideal ratio of pharmacists-to-population been determined?

Has the ideal distribution of pharmacies been determined?

Has the ideal ratio of pharmacists-to-population been attained?

Has the ideal distribution of pharmacies been attained?

Yes

Yes

Yes

Yes

Yes

PSD, Healthcare providers in public & private sectors, Health Promotional Board; Medical Development Division of MOH

To be determined at consultation

To be determined

post-consultation

2.

3.

Amendment/enactment of legislation for separation of dispensing and prescribing functions [if necessary]

Carry out promotional activities targeting the public and healthcare providers

Is legislation in place to implement separation of dispensing and prescribing functions?

No. of activities held to promote dispensing separation

Yes

To be collected

PSD; AG Chambers

Professional associations; consumer associations & government agencies


When new Bill is enacted

1. Incorporate regulation on use of generic names in prescriptions in New Pharmacy Bill

Is regulation incorporated in New Pharmacy Bill?

Yes PSD; MOH & AG Chambers





BenchmarkingNew premises:

Jan 2010

Existing premises:Dec 2011

4. Benchmarking and accreditation of community pharmacies


Continuous review of benchmarks under Quality Use of Medicines SubcommitteeDiscussion with MSQH is ongoing

Proportion of pharmacies complying with benchmarks.

Frequency of review of benchmarks

Is there an accreditation body?

Proportion of premises accredited

100% compliance

Annually

Yes

10% of community pharmacies accredited by Dec 2010

MOH; MPS; MSQH & PharmacyEnforcement Division of MOH

20095. Mapping of community pharmacies by zones/states to identify areas feasible to commence dispensing separation

Have all the community pharmacies been mapped out?

Frequency of updates to map

Yes

Quarterly

MPS inco-operation with the Pharmacy EnforcementDivision of MOH

To bedetermined

post-consultation

6. Dispensing of medicines to be carried out solely by pharmacists in areas where ideal distribution of pharmacies and ideal ratio of pharmacist-to-population for dispensing separation has been attained

No. of private clinics still dispensing medicines in areas where ideal distribution of pharmacies and ideal ratio of pharmacist-to-population for dispensing separation has been attained

0 Pharmacy Enforcement Division of MOH




Part 7: ROLE OF PHARMACISTS

Strategy 1: To establish the central role of the pharmacist


October2010

1. Strengthen and expand pharmacists’ roles in clinical pharmacy at public/private facilities

Is there at least one clinical pharmacist per specialized � eld?

No. of clinical pharmacist posts in public hospitals.

Is there at least one pharmacist in each private hospital?

No. of clinical pharmacists in private hospitals

No. of pharmacists trained in following specialized areas pharmacoepidemiology, pharmacoeconomics and pharmaco- sociology

�1 clinical pharmacist per specialized � eld

Suf� cient for at least one clinical pharmacist per specialized � eld

Yes

� 1

� 1 pharmacist per specialized area per state

PSD; Pharmacy Enforcement Division of MOH

2015

2010

2. Strengthen and expand pharmacists’ role in the primary care setting


Training for Medication Reviews to be conducted by Academy of Pharmacy. Payment for service to be determined also

Has a Medication Review training module been developed?

No. of pharmacists trained in conducting medication reviews

No. of pharmacists carrying out medication reviews.

No. of community pharmacies involved in Methadone Substitution Therapy

No. of ADR Reports sent in by pharmacists

No. of Health Promotion activities conducted by pharmacists

Yes

50

30

3

To be collected

�2 activities per pharmacist per year

Academy of Pharmacy; MPS; PSD; NPCB & State Health Departments (JKN)




Part 8: MEDICINES ADVERTISEMENTS AND PROMOTIONS

Strategy 1: Establish Good Governance of Medicines and apply it to all industry players and health professionals. Promote ethical promotion of medicines and marketing activities . Refer also to 1.1.5


2009

2010

3. Set up committee to establish counselling guidelines on common diseases for community pharmacists


Cough / cold, hypertension, Diabetes Mellitus, minor ailments, self-medication

Has a committee been set-up to produce counselling guidelines?

No. of guidelines published

Yes

Guidelines for 5 common diseases published

PSD; MOH; MPS; Academy of Pharmacy

20104. Establish and coordinate referrals with General Practitioners


Discuss accessibility of medical records and sharing of information among health professionals.

Has a joint committee been set-up to address operational issues with respect to referrals?

Is there a system in place to ease referrals?

Yes

Yes

MOH, MPS, MMA; Private Medical Practitioners Association


20101. Develop guidelines on GGM

Promote and disseminate guidelines on GGM

Are guidelines on GGM ready?

Awareness about GGM guidelines?

Yes

100% awareness

Government agencies, professional bodies & pharmaceutical industry

20122. Adherence to Code of Conduct on Prescription Products Promotion by:

Manufacturers and distributors

Health Professionals

No. of manufacturers or distributors adhering to the Code of Conduct on Prescription Products Promotion

No. of Health Professionals (medical practitioners, dentists, pharmacists, veterinarians) adhering to Code of Conduct on Prescription Products Promotion

100% adherence

100% adherence

Government agencies, professional bodies & pharmaceutical industry





COMPONENT 5: HUMAN RESOURCES DEVELOPMENT

Policy: The human resource needs of the pharmaceutical sector shall be planned and developed.

Aim: To ensure suf� cient experts, professionals, and trained personnel in the pharmaceutical sector.

Strategy: The aim shall be achieved through manpower planning and training.

Part 1: PLANNING Strategy 1: Implement short and long-term planning of human resources i) Undergraduate Training ii) Compulsory Service Period iii) Postgraduate Training

Part 2: EDUCATION AND TRAINING Strategy 1: Strengthen the quality assurance mechanism of training institutions / Accreditation of Programmes Strategy 2: Training of healthcare providers in line with the principles of the National Medicines Policy

Part 1: PLANNING

Strategy 1: Implement short and long-term planning of human resourcesi) Undergraduate Training


a) 2014 b) 2010

1. Enhance knowledge of graduates by reinforcing existing educational modules or introducing newmodules in the form of; a) electives b) postgraduate diplomas

No. of graduates of modules (i.e. GMP, GLP, GCP, validation, process management)

a) LT: 50% of graduates

b) ST: 10% of graduates

LT: 50% of graduates

Academia; MOPI; PSD

20102. Enhance the soft skills of graduates with regards to communication (spoken & written), leadership & managerial, interpersonal relationships & entrepreneurial skills, professionalism & ethics.

No. of graduates of modules (i.e. communication, entrepreneurship, management)

ST: 50% ofgraduates LT: 100% of graduates

PSD; Academia




ii) Compulsory Service Period

iii) Postgraduate Training


Initiate proposal in 2009

1. Compulsory service: Propose to be reduced to 2 years

Approval given for the service year of 2011

2011 PSD; Academia

20102. To lighten the current burden of industry players on the issue of the shortage of pharmacists/other related critical health personnel during the compulsory service period, these personnel can be engaged in govt./ universities/ research institutes to conduct research, innovation and development through collaborative effort with the pharmaceutical industries

No. of pharmacists /other related critical health personnel involved in the collaborative effort

ST: 2 pharmacists per year

LT: 4 pharmacists per year.

Industries;Academia;ResearchInstitutes; JPA (Public Services Department )


current : 6.7% ST: 8% LT: 10%

1. Ministry of Health to identify needs for postgraduate training and to ensure equitable distribution of post graduate training opportunities

No. of PhD and MSc holders and their areas of specialization.

ST: growth 1.3% (100) LT : growth 2% (460)

PSD ; Training Division, MOH; Academia

current : (e.g.2 from 1 industry)

ST: 10 LT: 100

2. Industry to identify needs in industry, retail, commerce and research (collaborative effort between industry & govt./universities/research institutes

No. of PhD holders produced via this collaborative effort

Current : (e.g. 2 from 1 industry) ST: 10 LT: 100 Disciplines to be de� ned

Industries;Academia ;ResearchInstitutes

2009 3. Communicate and justify with human resource division for allocation of more posts

No. of posts made available

Current total: 4000 ST : additional 2000 (total 6000) LT: Additional 10,000 (total 14000)

Public Services Department (JPA); PSD




Part 2: EDUCATION AND TRAINING

Strategy 1: Strengthen the quality assurance mechanism of training institutions / Accreditation of Programmes

Strategy 2: Training of healthcare providers in line with the principles of the National Medicines Policy


ongoing1. Recognition/accreditation of pharmacy programmes and pharmacy-related programmes

No. of recognized /accredited programmes

All Bachelor of Pharmacyprogrammes to be accredited by the Pharmacy Board

Pharmacy Board; MQA

All Diploma Pharmacy programmes or pharmacy-related programmes (diploma level) to be accredited by MQA

MQA, PSD


20101. Include principles of the National Medicines Policy in curricula of all Pharmacy Programmes

No. of pharmacy programmes that include the NMP in their curricula

100% by 2014 Academia ; PSD

20102. Include principles of the National Medicines Policy in CPD activities for all health care providers

No. of CPD activities that includes the NMP

At least twice a year for both sectors (public & private)

PSD; MPS; MOPI; PhAMA;Other HealthProviders;Associations

20123. Create pharmacist specialists in centres of excellence in hospitals (or other government sites) who are joint appointees of MOH and universities

No. of pharmacists specialists who are joint appointees

Current: Not in practiceST: 1 per category A, tertiary hospital (Clinical Pharmacy) LT: 1 pharmacist specialist perspecialization/sub-specialization per tertiaryhospital.

PSD; Training Division, MOH; Academia; Public Services Department(JPA)




COMPONENT 6 : RESEARCH & DEVELOPMENT

Policy: Research in utilization, management and development of medicines shall be enhanced. Aim: To improve medicines utilization and management and to encourage drug research and development.

Strategy: The aim shall be achieved through partnerships among the policy makers, healthcare providers, industry, academia, research institution, professional bodies, NGOs and consumer association in the following areas:- • Development of capability and capacity for research • Development of trained and competent researchers • Promotion of research culture among healthcare providers • Creation of a conducive environment for research • Integration and enhancement of drug research facilities and capabilities.

Part 1: DRUG UTILIZATION AND MANAGEMENT

Strategy: Conduct research in the following priority areas: • Impact of NMP • Pharmacoeconomics • Issues related to prescribing and dispensing • Behavioural and cultural aspects of drug use Part 2: DRUG RESEARCH AND DEVELOPMENT

Strategy: Encourage research of drugs for common diseases, new and emerging conditions and traditional medicines




Part 1: DRUG UTILIZATION AND MANAGEMENT

Strategy: Conduct research in the following priority areas: • Impact of NMP • Pharmacoeconomics • Issues related to prescribing and dispensing • Behavioural and cultural aspects of drug use


20121. Conduct research based on topics in priority areas and submit proposals to NMRR and any relevant agencies to acquire funding

No. of research completed

No. of priority areas - 6 for 9th Malaysia National Health Plan

Researchcentres/agencies; academia; NIH; MOSTI; MOPI; PhAMA and other industries

20122. Conduct social research in collaboration with the universities, policy makers, health care providers, research institution, industry, professional bodiesNGOs, and consumer association

No. of collaborative research conducted

No. of research completed

Ongoingactivity

3. Provide training in drug utilization and pharmacoeconomic research

No. of personnel trained

No. of research done

Ongoing5. Promote the use of research � ndings for continual improvement in drug utilization and management

Data source: 1. NMRR 2. PSD

No. of policy/ management reviews based on research � ndings/ recommendation

10% of researches done result in policy change

No. of personnel trained No. of research done

2012

2010

4.

6.

Conduct study on the implementation of schemes for the disposal of harmful medicines.

Establish pharmacy services research centre

No. of research conducted

To establish data and resource center:Establishment of a focal point for reference and data

1-2 research (estimated) completed

1 researchcentre

DOE; academia with environmental department / faculty




Part 2: DRUG RESEARCH AND DEVELOPMENT

Strategy: Encourage research of drugs for common diseases, new and emerging conditions and traditional medicines


20121. Provide new incentives to encourage clinical trials

Comply with government policy on Intellectual Property Rights (IPR) pertaining to government-funded R&D

No. of clinical trial conducted & result utilized- depends on the new type of incentives

No. of clinical trials

Research centres/ agencies;academia; NIH and industries

20122. Provide technical assistance to GLP standard

No. of test facility complied

20124. To encourage/ focus on research with outcomes/ output which contribute directly to NMP.

Data source: 1. NMRR 2. MIDA3. MITI4. PhAMA5. MOPI6. Academia7. FRIM, SIRIM, etc8. PSD

No. of innovative drug/ chemical research

No. of technological/ practice research

No. of new pharmaceutical/ medical product or process as a direct outcome of local research

2-3 researches per indicator

10% of test facilities

20123. Encourage basic research i.e. New Chemical Entity, New Biological entity and New Molecular Entity. Cluster research by clinical and non clinical

No. of research conducted

Number of research completed

Research centres / agencies ; Academia ; NIH; MOSTI; MOPI; PhAMA and Other Industries





COMPONENT 7: TECHNICAL CO-OPERATION

Policy: Technical collaboration and co-operation in the implantation and strengthening of relevant areas in the pharmaceutical sector shall be established with various stakeholders at the national, regional and international levels.

Aim: To ensure that relevant technical co-operations are explored, best practices and agreed standards promoted to optimize the effective use of resources and strengthen national and regional policies.

Strategy: The aim shall be achieved by training, sharing of information, expertise, skills and facilities and through harmonization of legislation and guidelines pertaining to medicines at national, regional and international level. Partnership involving various stakeholders and key players in the healthcare sector shall be enhanced to achieve the desired goals, setting strategies and priorities, and implementing policies.

Strategy 1: Training for enhancement of skills in technical expertiseStrategy 2: Sharing and exchange of information–expertise, ADR, Post marketing Surveillance (PMS), noti� cation of adulteration of productsStrategy 3: Sharing and exchange of information on precursors (PEN)

Strategy 1: Training for enhancement of skills in technical expertise


1. Collaborate with established centres for skills training in policy management

No. of training (government regulators in terms of policy management)

Depending on the number ofgraduatesproduced by the local universities

20122. Collaborate and exchange technical expertise with institutions abroad who are expert in speci� c � elds

No. of collaboration

2 experts per year NPCB;Industries




Strategy 2: Sharing and exchange of information – expertise, ADR, Post marketing Surveillance (PMS), noti� cation of adulteration of products

Strategy 3: Sharing and exchange of information on precursors (PEN)


Ongoingactivity

1. • ASEAN Post Market Alert System

• PIC/S rapid alert

No. of alerts issued / received

No. of registered products removed from the market

NPCB

Ongoingactivity

2. Regional and international harmonization of regulatory requirements (ACCSQ)

No. of harmonized area achieved

100% (according to target date)

NPCB;Industries

Ongoingactivity

3. Sharing and exchange of pre-marketing assessment of medicine

No. of products

No. of collaborating centres

100% of allexchange shared

NPCB


Ongoing1. Communicate with other competent authorities for activities involving the importation and exportation of precursors

No. of PEN issued

No. of PEN received

100% of all PEN shared

PSD





PANEL DISCUSSION

Repertoire :1. Dr. Asrul Akmal bin Sha� e (USM)2. Pn. Azura binti Abdullah (NPCB)3. Pn. Saimah binti Mat Noor (PSD)

No. Panel Members Issues Opinions

1. MPS Quality, safety andef� cacy of drugs

• Does not support advertising group C across board. Council suggests relooking at certain product. The outcome of discussion would be relayed later.

• Suggest relooking at security measures to control counterfeit drugs in light of new development and two years experience in implementation. Eg : Review impact on hologram use as security label

• Licensing of premises must also be studied.

• To review registration guideline from time to time, availability of orphan drugs, ready to dispense pack, guidelines on advertisement on the internet, etc.

• Intellectual Property Right must be valued.

Quality Use of Drugs • Dispensing separation issues. ICT changes the landscapes. Government is studying national health � nancing policy. WHO found 50% non compliance to drug use. Prudent use of medicine especially among vulnerable groups.





2.

3.

MMA

Pharmacy Board

Drug Affordability

Human Resources Development

General

General


• MPS run programme awareness in hospital & clinics. Eg : Clean Your Cabinet Campaign.

• Advocate the balance on pro-business measure and at the same time keeping cost affordable.

• Should be looking into National Insurance Policy.

• Pave the way for dialogues with industry and university. To match products with the demands.

• Monitoring of pharmacy education program and information of such education policy and advances should be disseminated to public.

• Strengthen communication and collaboration between all stakeholders.

• Continuously review and ensure roles of stakeholders are informed.

• Delivery of medicines involves doctors to the patients.

• Doctors (government, private and senior consultants) cannot be left out in national medicines policy review.

• Policy says that we should increase the number of accredited institutions of higher learning. Lately, there has been an explosion of institutions offering the pharmacy degree. Now we have 15 institutions. It seems to be saturated.The Pharmacy Board has written to MOHE (Ministry of Higher Education) to stop approving new pharmacy schools, but while waiting, the Pharmacy Board still receives applications to start new programmes. The issue in question is about the resources needed to support the programme, mainly lecturers. Not sure what are the incentives that are causing the increase interest among students to pursue a pharmacy degree.





Pharmacist registration

Research

• Curriculum development: all stakeholders need to be involved. The present multidisciplinary composition might need to be increased. Suggest MOH write to institutions to include NMP & NEDL in the curriculum.

• Might need to include compulsory CPD. Issues such as access should not be a barrier as CPD can be provided online.

• Need to consider the registration of 2 types of pharmacists as practiced in certain parts of Canada whereby registered pharmacists are classi� ed as practicing pharmacists (actively practicing pharmacy and involved in patient care) or as non-practicing pharmacist (e.g. those who are lecturers and administrators). This might be a good practice.

• The use of OSPhE (Objective Structure Pharmaceutical Examinations in the undergraduate curriculum would increase the quality of pharmacy education.

• Need to recognize pharmacist specializing in certain � elds and having certain competencies. Eg : clinical pharmacist, expert in particular areas such as renal, O&G, ICU, etc. The specialist status should be based on demonstrable and measurable competencies and certain skills.

• Mainly done in the universities. There is an increasing emphasis on research in MOH. This is a good trend and stronger collaboration between MOH, IMR and the universities will promote more ef� cient research.

• University’s traditional source of funding is from MOSTI and the expected research output is product oriented. However, for MOSTI, social and clinical oriented research is not a priority. This area is of interest to MOH and funds should be allocated for MOH for this type of research.





4. FOMCA Quality, Safety & Ef� cacy of Drugs

Drug Availability

Drug Affordability

Quality Used of Drugs

• Lots of complaints of unsafe product especially beauty, counterfeit, dubious medicines sold in night market (pasar malam), misleading promotion (� yers, banners, lea� et, poster, billboard etc.)

• FOMCA can play a part in channeling complaints for post marketing surveillance. Structured complaints can be set up.

• Need to ensure all essential drugs available for outbreak or pandemic.

• Disposal of medicines: Consumers not sure how to dispose medicines. Hopefully, consumers can be better informed on how to dispose medicines.

• Lots of complaints of large variations of drug price among private pharmacies – difference of about RM40. Suggests more control on drug pricing.

• Transparency of drug price – no itemized billing for medicines in doctor’s practice and no generic name for medicines in doctor’s practice.

• Health subsidy in Malaysia might not be sustainable. Hope discussion on medicines also includes health � nancing.

• Self medication and self diagnosis before seeing doctor. NMP needs to ensure over the counter traditional medicines are safe.

• Communications of health care providers with patients are lacking. We should educate patients their rights.

• STGs should be included in the training.

• FOMCA also did campaigns for QUM.

• Dispensing medicines using generic names should be enforced.





5.

6.

MOPI

PhAMA


General

General

• Dispensing separation is supported by FOMCA provided the infrastructure is ready and cost is affordable.

• More quali� ed pharmacists should be trained to get better services/information.

• Communication between stakeholders and also with the media are essential.

• Implementation is more challenging than formulation and FOMCA is willing to assist in this regard.

• MOPI is ready to deliver quality medicines. Half billion has been invested to implement GMP/PICS standards etc.

• There should be commitment to implementation.

• Challenges to adding value. Can be done by exporting locally manufactured products to penetrate international market. Need support and more funding (MOF/MIDA).

• It is important to provide access to medicines.

• Promoting timely access to quality medicines.

• Empower consumers for self medication and responsible on medication taken.

• Ethical promotion of medicine should be allowed.

• Intellectual Property Rights (IPR) recognition need to be addressed.

• Disseminate information throughtrainings, CPD, CME.




LIST OF COMMITTEES

Advisor

Mdm Eisah binti A.RahmanSenior Director of Pharmaceutical Services

Ministry of Health

Chairman

Mdm Hasnah binti Ismail Director of Pharmacy Practice and Development Division

Ministry of Health

Organising Commitee

1. Mr. Mohd Hatta bin Ahmad Director of Pharmacy Enforcement Ministry of Health

2. Ms. Siti Aida binti Abdullah Deputy Director of Prevention and Protection Pharmacy Enforcement Division Ministry of Health

3. Ms. Zawiyah binti Mat Johor Deputy Director of Pharmacy Development Pharmacy Practice and Development Division Ministry of Health

4. Dr. Salmah binti Bahri State Health Deputy Director (Pharmacy) WP Kuala Lumpur & Putrajaya Health Department Ministry of Health

5. Ms. Yogeswary a/p V. Markandoo State Health Deputy Director (Pharmacy) Selangor Health Department Ministry of Health

6. Dr. Nour Hanah binti Othman Senior Principal Assistant Director Pharmacy Management Division Ministry of Health

7. Ms. Anis binti Talib Senior Principal Assistant Director National Pharmaceutical Control Bureau Ministry of Health

8. Ms. Bariah binti Abd Rani Senior Principal Assistant Director National Pharmaceutical Control Bureau Ministry of Health

9. Ms. Saimah binti Mat Noor Senior Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health

10. Mr. Mazlan bin Ismail Senior Principal Assistant Director Pharmacy Enforcement Division Ministry of Health

11. Ms. Wan Mohaina binti Wan Mohammad Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health

12. Ms. Salwati binti A. Kadir Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health




13. Ms. Norhayati binti Musa Senior Assistant Director Pharmacy Management Division Ministry of Health

14. Ms. Normawati binti Mohamed Noor Assistant Director Pharmacy Enforcement Division Ministry of Health

15. Mr. Chow Ching Yei Assistant Director Pharmacy Management Division Ministry of Health

16. Mr. Yuhaidy bin Yusof Administrative Assistant Pharmacy Management Division Ministry of Health

17. Mr. John Chang Chiew Pheng Ex-President Malaysian Pharmaceutical Society (MPS)

18. Mr. Lam Kai Kun General Manager Malaysian Pharmaceutical Society (MPS)

19. Mr. Jimmy Piong Teck Onn President Malaysian Organisation of Pharmaceutical Industries (MOPI)

20. Mr. Tong Yew Sum Executive Director Malaysian Organisation of Pharmaceutical Industries (MOPI)

21. Mr. Keh Song Hock Executive Director Pharmaceutical Association of Malaysia (PhAMA)

22. Ms Tan Booi Charn Representative Pharmaceutical Association of Malaysia (PhAMA)

23. Ms. Akalily So� na binti Mohamed Arif Representative Pharmaceutical Association of Malaysia (PhAMA)

24. Prof. Dr. Mohamed Izham bin Mohamed Ibrahim Deputy Dean School of Pharmacy University Science of Malaysia

25. Prof. Dr. Saringat Hj Baie Lecturer School of Pharmacy University Science of Malaysia

26. Dr. Mohd Makmor Bakry Senior Lecturer Faculty of Pharmacy National University of Malaysia

27. Dr. Ng Shiow Fern Senior Lecturer Faculty of Pharmacy National University of Malaysia

28. Prof. Dr Mohamed Mansor bin Manan Lecturer Faculty of Pharmacy University of MARA Technology (UiTM)

29. Ms. Syazwani binti Shaharuddin Lecturer Faculty of Pharmacy University of MARA Technology (UiTM)

30. Ms. Junaidah binti Amir Lecturer Pharmacy Department, Faculty of Medicine University of Malaya

31. Dr. Fariz Abdul Rani Lecturer Pharmacy Department, Faculty of Medicine University of Malaya

32. Dr. Tey Kim Kuan Senior Lecturer School of Pharmacy and Health Sciences International Medical University

33. Dr. Low Bee Yean Lecturer School of Pharmacy and Health Sciences International Medical University




1. Dr. Salmah binti Bahri State Health Deputy Director (Pharmacy) WP Kuala Lumpur & Putrajaya Health Department Ministry of Health

2. Dr. Nour Hanah binti Othman Senior Principal Assistant Director Pharmacy Management Division Ministry of Health

3. Ms. Saimah binti Mat Noor Senior Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health

4. Mr. Mazlan bin Ismail Senior Principal Assistant Director Pharmacy Enforcement Division Ministry of Health

5. Ms. Wan Mohaina binti Wan Mohammad Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health

6. Ms. Salwati binti A. Kadir Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health

7. Ms. Norhayati binti Musa Senior Assistant Director Pharmacy Management Division Ministry of Health

8. Ms. Normawati binti Mohamed Noor Assistant Director Pharmacy Enforcement Division Ministry of Health

9. Ms. Azlina binti Ismail Senior Assistant Director National Pharmaceutical Control Bureau Ministry of Health

10. Mr. Mohammad Rizalmazli bin Salim Assistant Director Pharmacy Enforcement Division Ministry of Health

11. Mr. John Chang Chiew Pheng Ex-President Malaysian Pharmaceutical Society (MPS)

12. Mr. Jimmy Piong Teck Onn President Malaysian Organisation of Pharmaceutical Industries (MOPI)

13. Mr. Keh Song Hock Executive Director Pharmaceutical Association of Malaysia (PhAMA)

14. Prof. Dr. Mohamed Izham bin Mohamed Ibrahim Deputy Dean School of Pharmacy University Science of Malaysia

15. Prof. Dr. Saringat Hj Baie Lecturer School of Pharmacy University Science of Malaysia

16. Dr. Fariz Abdul Rani Lecturer Pharmacy Department, Faculty of Medicine University of Malaya

TECHNICAL WORKING COMMITEE




PUBLICATION WORKING COMMITTEE

LOGISTIC WORKING COMMITTEE

1. Ms. Yogeswary a/p V. Markandoo State Health Deputy Director (Pharmacy) Selangor Health Department Ministry of Health

2. Mr. Chow Ching Yei Assistant Director Pharmacy Management Division Ministry of Health

3. Ms. Hafsah binti Md. Yusof Assistant Director Pharmaceutical Services Division, Selangor

4. Mr. Lam Kai Kun General Manager Malaysian Pharmaceutical Society (MPS)

5. Mr. Tong Yew Sum Executive Director Malaysian Organisation of Pharmaceutical Industries (MOPI)

6. Ms. Tan Booi Charn Representative Pharmaceutical Association of Malaysia (PhAMA)

7. Prof. Dr Mohamed Mansor bin Manan Lecturer Faculty of Pharmacy University of MARA Technology (UiTM)

1. Ms. Anis binti Talib Senior Principal Assistant Director National Pharmaceutical Control Bureau Ministry of Health

2. Ms. Bariah binti Abd Rani Senior Principal Assistant Director National Pharmaceutical Control Bureau Ministry of Health

3. Ms. Syazwani binti Shaharuddin Lecturer Faculty of Pharmacy University of MARA Technology (UiTM)

8. Dr. Ng Shiow Fern Senior Lecturer Faculty of Pharmacy National University of Malaysia

9. Dr. Mohd Makmor Bakry Senior Lecturer Faculty of Pharmacy National University of Malaysia

10. Ms. Junaidah binti Amir Lecturer Pharmacy Department, Faculty of Medicine University of Malaya

4. Ms. Akalily So� na binti Mohamed Arif Representative Pharmaceutical Association of Malaysia (PhAMA)

5. Mr. Yuhaidy bin Yusof Administrative Assistant Pharmacy Management Division Ministry of Health




GROUP LEADER

GROUP 1(QUALITY, SAFETY & EFFICACY OF DRUGS)

Ms. Abida Haq binti Syed M. Haq Deputy Director

Centre of Product RegistrationNational Pharmaceutical Bureau

Ministry of Health

GROUP 2(DRUG AVAILABILITY)

Mr. Mohd Hatta bin AhmadDirector of Pharmacy Enforcement

Ministry of Health

GROUP 3(DRUG AFFORDABILITY)

Ms. Zawiyah binti Mat JohorDeputy Director of Pharmacy Development

Pharmacy Practice and Development DivisionMinistry of Health

GROUP 4(QUALITY USE OF DRUGS)

Dr. Salmah binti BahriState Health Deputy Director (Pharmacy)

WP Kuala Lumpur & Putrajaya Health Department Ministry of Health

GROUP 5

(HUMAN RESOURCES DEVELOPMENT, RESEARCH AND DEVELOPMENT,TECHNICAL CO-OPERATION)

Dr. Faridah Aryani binti Md. YusofPrincipal Assistant Director

Pharmacy Practice and Development DivisionMinistry of Health




GROUP 1: QUALITY, SAFETY & EFFICACY OF DRUGS

Attendance

No Name Designation Stakeholder / Agency/ Organisation Representative

1. Abida Haq Syed M. Haq Deputy Director (U54) National Pharmaceutical Control Bureau (NPCB)

2. Mazuwin Zainal Abidin Principal Assistant Director (U48)

National Pharmaceutical Control Bureau (NPCB)

3. Hasniza Zaidan Principal Assistant Director (U48)


4. Nor Hayati Abdul Rahim Senior Assistant Director (U44)


5. Ahmad Ayob Senior Principal Assistant Director (U52)

Pharmacy Enforcement Division, MOH

6. Nor Aza Hassan Principal Assistant

Director (U48) Pharmacy Enforcement Division, MOH

7. Latifah Haji Idris Principal Assistant Director (U48)


8. Normawati Mohamed Noor

Assistant Director (U41)


9. Dato' Dr. Dorai Raja President, PEPTIM

Pertubuhan Perubatan Tradisional India Malaysia (PEPTIM)

10. Noor Azlina Abdul Rahman

Manager, Pharmaniaga

Malaysian Organisation of Pharmaceutical Industries (MOPI)

11. Yeo Lee Choo Senior Manager, CCM Pharmaceuticals


12. Stephen Sze Kwong Yew CEO, Pharmaniaga Malaysian Organisation of

Pharmaceutical Industries (MOPI) 13. Norsiah Hamid Senior Technical &

Regulatory Executive, Amway

Direct Selling Association of Malaysia (DSAM)

14. Dr. Ariza Zakaria Medical Officer (UD41) Clinical Research Center (CRC) 15. Dr. Asrul Akmal Shafie Lecturer Universiti Sains Malaysia (USM) 16. Prof. Madya Dr.

Mohamed Ibrahim Noordin

Head of Pharmacy Department

Universiti Malaya (UM)

17. Ting Ka Hua General Honorary Secretary

Federation Of Chinese Physicians & Medicines Dealers Associations of Malaysia (FCPMDAM)

LIST OF PARTICIPANTS





18. Prof. Dr. Yeoh Peng Nam

Lecturer, International Medical University (IMU)

Malaysian Pharmaceutical Society (MPS)

19. Lum Wai Hoong Pharmacist Malaysian Pharmaceutical Society (MPS)

20. Ewe Kheng Huat Managing Director Pharmaceutical Association of Malaysia (PhAMA)

21. Sumitha Ganasegaram Regulatory Affairs Director

Pharmaceutical Association of Malaysia (PhAMA)

22. J S Sunitha Devi Shanmugam

Regulatory Affairs & Quality Director


23. Dr. Low Bee Yean Lecturer International Medical University (IMU)

24. Sam Wong

The Federation of Malaysian Consumers Associations (FOMCA)

25. Amy Ding Malaysian Direct Distribution Association (MDDA)

26. Prof. Madya Razak Hj. Lajis Lecturer National Poison Center

Absent (With Apologies)


1. Lawrence Cheah Director Direct Selling Association of Malaysia (DSAM)

2. Dr. Syid Ayob Syid Mustafa Al -Qudsi Malaysian Direct Distribution

Association (MDDA) 3.

Persatuan Pengeluar-Pengeluar Ubat Tradisional Melayu Malaysia (PURBATAMA)

4. Ministry of International Trade and Industry (MITI)

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GROUP 2 : DRUG AVAILABILITY

Attendance


1. Mohd Hatta Ahmad Director of Pharmacy Enforcement


2. Rosminah Mohd Din Senior Principal Assistant Director (U52)

Pharmacy Practice & Development Division, MOH

3. Norhaliza A. Halim Principal Assistant Director (U48)


4. Zainab Md Yusuf Senior Principal Assistant Director (U52)


5. Noor 'Ain Shamsuddin Assistant Director (U41) National Pharmaceutical Control Bureau (NPCB)

6. Dr. Hussain Imam Hj. Mohammad Ismail

Head of Department & Senior Consultant of Pediatric, HKL

Medical Development Division, MOH

7. Ruhaiyem Yahaya TPKN(F) Perak Pharmaceutical Services Division, Perak

8. Wee Suat Bee TPKN(F) Pahang Pharmaceutical Services Division, Pahang

9. Abd. Aziz Dan Manager, Duopharma Malaysian Pharmaceutical Society (MPS)

10. Aileen Chong General Manager, Vitacare Pharmacy


11. Jimmy Piong Managing Director Malaysian Organisation of Pharmaceutical Industries (MOPI)

12. Ch'ng Kien Peng General Manager Malaysian Organisation of Pharmaceutical Industries (MOPI)

13. Abdul Aziz Fazal Mohamad

Senior Manager, Pharmaniaga


14. Mohamed Rosli Abdul Rashid

Senior Principal Assistant Secretary

Policy and International Relations Division, MOH

15. Prof. Madya Dr. Habibah A Wahab Director of Division

Malaysian Institute of Pharmaceutical and Nutraceutical, USM

16. Dr. Nik Musa'adah Mustapa Senior Research Officer Forest Research Institute Malaysia

(FRIM) 17. Prof. Saringat Hj Baie Lecturer Universiti Sains Malaysia (USM) 18. Dr. Tey Kim Kuan Lecturer International Medical University

(IMU) 19. Hisyam Yong Abdullah Principle Assistant

Secretary Procurement and Privatisation Division, MOH

20. Nik Iryani Nik Ahmad Damian Pharmacy Officer (U41) Procurement and Privatisation

Division, MOH 21. Suraiya Abdul Rahman Head of Drug

Regulatory Affairs Pharmaceutical Association of Malaysia (PhAMA)

22. Billy Yau Senior Country Manager






23. Tan Booi Charn Regulatory Affairs and Policy Manager


24. Dr. Wan Nurdiana Zaireen Zainal Abidin

Head, Medical Coordinator, Relief Operation Department

Malaysian Medical Relief Society (MERCY)

25. Hamzah Mahadi Senior Assistant

Director

Ministry of Domestic Trade, Co-Operation and Consumerisms (MDTCC)

26. Zarina Saad Deputy Director Malaysian Industrial Development Authority (MIDA)

27. Malini Sailin Manager Kualiti Alam Sdn Bhd 28. Halisah Kasdi Pharmacy Officer U48 Melaka Hospital



1. Dr. Ng Shiow Fern Lecturer Universiti Kebangsaan Malaysia (UKM)

2. Mohan a/l K.P Gangadharan

Sciences Officer (C54) Ministry of Science, Technology and Innovation (MOSTI)

3. Dr. Neelam Shahab Researcher SIRIM Berhad 4. Malaysian Medical Association

(MMA) 5. Association of Private Hospitals of

Malaysia (APHM) 6. Ministry of International Trade

and Industry (MITI) 7. Economic Planning Unit (EPU) 8. Department of Environmental,

Malaysia (DOE) 9. Finance Division,MOH

10. Engineering Division, MOH

11. Traditional and Complementary Medicine Division, MOH

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11. Traditional and Complementary Medicine Division, MOH

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GROUP 3 : DRUG AFFORDABILITY

Attendance


1. Zawiyah Mat Johor

Deputy Director, Pharmacy Development (U54)


2. Saimah Mat Noor Senior Principal Assistant Director (U52)


3. Fatimah Abd. Rahim Principal Assistant Director (U48)


4. Helina Abdul Halim Principal Assistant Director (U48)


5. Dr. Nour Hanah Othman Senior Principal Assistant Director (U52)

Pharmacy Management Division, MOH

6. Rosilawati Ahmad Principal Assistant

Director (U48) National Pharmaceutical control Bureau (DCA Secretariat)

7. Mariani Ahmad Nizaruddin Pharmacist Malaysian Pharmaceutical Society

(MPS) 8. Wan Hwei Yen GM, Pharmacy Practice,

Guardian Pharmacy Malaysian Pharmaceutical Society (MPS)

9. Dr. Ng Swee Choon

Federation of Private Medical Practitioners’ Associations of Malaysia (FPMPAM)

10. Y. S. Tong Executive Director Malaysian Organisation of Pharmaceutical Industries (MOPI)

11. Ng Su Yee

General Manager, Technical Support & Development


12. Jamaludin Elis Senior General Manager, Pharmaniaga


13. Nathan, Kothandaraman

Director of Government Affairs and Medical Affairs


14. Christopher Dion Henry Commercial Excellence Manager


15. Francis Del-Val General Manager Pharmaceutical Association of Malaysia (PhAMA)

16. Keh Song Hock Pharmaceutical Association of Malaysia (PhAMA)

17. Rohan Talalla Head, Corporate & Government Affairs


18. Narinder Kaur Director, Public Affairs Pharmaceutical Association of Malaysia (PhAMA)

19. Lee Swee Hua Vice President, Health Services, American International Assurance Bhd

General Insurance Association of Malaysia (PIAM)





20. Y. Bhg. Datin Dr. Hjh.

Aziah Ahmad Mahayiddin

Pakar Perunding Kanan Perubatan / Pakar Perubatan Respiratori, HKL


21. Prof. Mohamed Izham Mohamed Ibrahim Deputy Dean Universiti Sains Malaysia (USM)

22. Abdul Aziz Mansor Pharmacist Officer (U48) Selayang Hospital



1. Fatkhiah Abd. Khalil Principal Assistant Director (U48)


2. Dr. Ahmad Razid Salleh Deputy Director Medical Practice Division, MOH 3. Shantini a/p

Thevendran Pharmacist Officer U48 Kajang Hospital

4. Sudha Sivadas Principle Assistant Director

Economic Planning Unit (EPU)

5. Chua Kee Long Senior Principal Assistant Director

Planning and Development Division, MOH

6. Julia Mohamad Saber Senior Assistant Director


7. Malaysian Medical Association (MMA)

8. Association of Private Hospitals of Malaysia (APHM)

9. Finance Division, MOH 10. Family Health Planning Division,

MOH �

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20. Y. Bhg. Datin Dr. Hjh. Aziah Ahmad Mahayiddin

Pakar Perunding Kanan Perubatan / Pakar Perubatan Respiratori, HKL


21. Prof. Mohamed Izham Mohamed Ibrahim Deputy Dean Universiti Sains Malaysia (USM)

22. Abdul Aziz Mansor Pharmacist Officer (U48) Selayang Hospital



1. Fatkhiah Abd. Khalil Principal Assistant Director (U48)


2. Dr. Ahmad Razid Salleh Deputy Director Medical Practice Division, MOH 3. Shantini a/p

Thevendran Pharmacist Officer U48 Kajang Hospital

4. Sudha Sivadas Principle Assistant Director

Economic Planning Unit (EPU)

5. Chua Kee Long Senior Principal Assistant Director


6. Julia Mohamad Saber Senior Assistant Director


7. Malaysian Medical Association (MMA)

8. Association of Private Hospitals of Malaysia (APHM)

9. Finance Division, MOH 10. Family Health Planning Division,

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GROUP 4 : QUALITY USE OF DRUGS

Attendance


1. Dr. Salmah Bahri

TPKN(F), Wilayah Persekutuan Kuala Lumpur dan Putrajaya

Pharmaceutical Services Division, Wilayah Persekutuan Kuala Lumpur dan Putrajaya

2. Yogeswary a/p Markandoo TPKN(F) Selangor Pharmaceutical Services Division,

Selangor 3. Mazlan Ismail Senior Principal

Assistant Director (U52) Pharmacy Enforcement Division, MOH

4. Mohammad Rizalmazli Salim Assistant Director (U41) Pharmacy Enforcement Division,

MOH 5.

Noraini Sa'ari Principal Assistant Director (U48)


6. Siti Aisah Bahri Principal Assistant

Director (U48) Pharmacy Practice & Development Division, MOH

7. Wan Mohaina Wan Mohammad

Principal Assistant Director (U48)


8. Salwati Abd. Kadir Principal Assistant Director (U48)


9. Chow Ching Yei Assistant Director(U41) Pharmacy Management Division, MOH

10. Suhailah Abu Bakar Senior Assistant Director (U44)


11. Bariah Abd Rani Senior Principal Assistant Director (U52)


12. Carolyn Marie Peter Assistant Director (U41) Pharmaceutical Services Division, WP Kuala Lumpur dan Putrajaya

13. Hafsah Md Yusof Assistant Director (U41) Pharmaceutical Services Division, Selangor

14. Prof Dr. P T Thomas Lecturer, UKM Malaysian Pharmaceutical Society (MPS)

15. Lam Kai Kun Malaysian Pharmaceutical Society (MPS)

16. Alex Tan C.J Pharmacist Malaysian Pharmaceutical Society (MPS)

17. Yip Sook Ying Pharmacist Malaysian Pharmaceutical Society (MPS)

18. Usha Rajasingham Pharmacist Malaysian Pharmaceutical Society (MPS)

19. Jeff Kong Pharmacist Malaysian Pharmaceutical Society (MPS)

20. Wong Hooi Fen Chief Pharmacist,

Caring Pharmacy






21. Dr. Steven Chow


22. Dr. Chang Keng Wee


23. Dr. Norlida Abdullah Senior Principal Assistant Director (U52) Oral Health Division, MOH

24. Dr. Samsuddeen Abd. Aziz Assistant Director Ministry of Education

25. Tan Hee Looi Principal Assistant Secretary

Ministry of Information Communication and Culture

26. Dr. Chuah Siew Kee Pakar Perunding Medical Development Division, MOH

27. Faridah Md. Yusof Head of Department UKM Medical Centre 28. Dexter Francis Vandort Assistant Manager UKM Medical Centre 29. Amrahi Buang Pharmacist (U52) UM Medical Centre 30. Dr. Mohamed Azmi

Ahmad Hassali Lecturer Pusat Pengajian Sains Farmasi, USM, Pulau Pinang

31. Dr. Mohd Suhaimi Ab Wahab Lecturer Pusat Pengajian Sains Perubatan,

USM, Kelantan 32. Khoo Joo Lee R&D Manager Malaysian Organisation of

Pharmaceutical Industries (MOPI) 33. Zarina Noordin Senior Manager,

Pharmaniaga Malaysian Organisation of Pharmaceutical Industries (MOPI)

34. Assoc. Prof. Dr. Chua Siew Siang Lecturer Universiti Malaya

35. Prof. Dr. Hjh Samsinah Hj. Hussain

Lecturer Universiti Malaya

36. Dr. Fariz Ab. Rani Pensyarah Universiti Malaya 37. Noormah Mohd Darus Senior Principle

Assistant Director (U52) Health Technology Assessment, MOH

38. Anwar Abdullah Pengarah Farmasi

Bahagian Perkhidmatan Kesihatan, Kementerian Pertahanan

39. Dr. Mohd Gowdh Committee Member Malaysian Medical Association (MMA)

40. Akalily Sofina Mohamed Arif

Associate Regulatory Manager


41. Vong Yuit Meng Head Of Marketing Pharmaceutical Association of Malaysia (PhAMA)

42. Nurzita Ahmad Nasir Pharmacist Officer (U41) College of Allied Health Sciences






1. George Wong Lai Khai TPKN(F) Sarawak Pharmaceutical Services Division, Sarawak

2. Norddin Daud Principal Assistant Director Health Education Division, MOH

3. Lt. Kol. Dr. A Halim Hj. Basari PS 1 Farmasi

Bahagian Perkhidmatan Kesihatan, Kementerian Pertahanan

4. Jaarah Mat Lecturer College of Allied Health Sciences 5. Association of Private Hospitals of

Malaysia (APHM) 6. Malaysian Dental Association

(MDA) 7. National Union of Journalist

Malaysia 8. Kulliyyah of Pharmacy,

International Islamic University Malaysia

9. The School of Pharmacy University of Nottingham Malaysia Campus

10. Faculty of Pharmacy International Medical University

11. Academy of Medicine 12. Economic Planning Unit (EPU) 13. Malaysian Administrative

Modernisation and Management Planning Unit (MAMPU)

14. Family Health Planning Division, MOH

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GROUP 5 : HUMAN RESOURCES DEVELOPMENT, RESEARCH & DEVELOPMENTAND TECHNICAL CO-OPERATION

Attendance


1. Dr. Faridah Aryani Md. Yusuf

Principal Assistant Director (U48)

Pharmacy Practice and Development Division, MOH

2. Siti Aida Abdullah

Deputy Director , Prevention & Protection (U54)


3. Faridah Hanin Ismail Senior Principal Assistant Director (U52)


4. Hasnizan Hasan Principal Assistant Director (U48)


5. Norhayati Musa Senior Assistant Director (U44)


6. Anis Talib Senior Principal

Assistant Director (U52) National Pharmaceutical Control Bureau (NPCB)

7. Dr. Hasenah Ali

Senior Principal Assistant Director (U48)


8. Azura Abdullah Senior Assistant

Director (U44) National Pharmaceutical Control Bureau (NPCB)

9. Baharudin Baba Pharmacist Officer

(U48) Hospital Sultanah Bahiyah, Alor Setar

10. Dr. Lian Lu Ming Pharmacist Officer

(U52) Clinical Research Centre (CRC)

11. Dr. Azizi Ayob Chief Sceintific Officer Malaysian Organisation of Pharmaceutical Industries (MOPI)

12. Mohd Danil Daud Senior Manager,

Pharmaniaga


13. Prof. Dr. Aishah Adam Dean, Faculty of Pharmacy Universiti Teknologi MARA

14. Shazwani Shaharuddin Lecturer� Universiti Teknologi MARA 15. Prof. Madya Mohd Baidi

Bahri Lecturer� Universiti Sains Malaysia

16. Prof. Dr. Mohamed Mansor Manan

Lecturer� Universiti Teknologi MARA

17. Junaidah Amir Lecturer Universiti Malaya 18. Unny Sankar a/l Ravi

Sankar Principal Assistant Secretary

Policy and International Relation Divison, MOH

19. Dr. Rasadah Mat Ali Senior Director, Bhg. Tumbuhan Ubatan

Forest Research Institute Malaysia (FRIM)

20. Mohamad Raya bin Mohd Ali Assistant Secretary

Training Management Division, MOH





21. Maimun Yusoff Deputy Director Human Resource Division, MOH 22. Ramli Zainal Pharmacist Institute for Health Systems

Research (IHSR) 23. Mohd Isa Wasiman Research Officer Institute of Medical Research

(IMR) 24. Terence Tan Yew Chin Pharmacist Officer

(U41) Institute of Medical Research (IMR)

25. Dr. H Krishna Kumar Chairman Malaysian Medical Association (MMA)

26. Norsaedah Mohd Ibrahim Merican

Senior Assistant Director

Malaysian Industrial Development Authority (MIDA)

27. Noor Yang Azwar Kamarudin Senior Manager Pharmaceutical Association of

Malaysia (PhAMA) 28.

Adrian Abdul Ghani Vice Presiden Legal & Regulatory, Strategic & Planning Division

Malaysian Biotechnology Corporation Sdn Bhd



1. Dr. Kamaruzaman Salleh

Senior Principal Assistant Director (U52)


2. Dr. Azizi Ayob Chief Sceintific Officer Malaysian Organisation of Pharmaceutical Industries (MOPI)

3. Prof. Dato' Dr. Mohamed Isa Abdul Majid

Chief Director Institut Farmaseutikal/Neutraseutikal Negara ,USM

4. Dr. S Asmaliza Ismail Chief Secretary NIH Secretariat (IHM) 5. Malaysian Medical Association

(MMA) 6. Malaysian Qualifications

Accreditation (MQA- Pharmacy) 7. Malaysian Industries -

Government Group for High Technology (MIGHT)

8. Faculty of Medical Sciences (Pharmacy), UCSI University

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1. Eisah A. Rahman Senior Director of Pharmaceutical Services

Pharmaceutical Services Division, MOH

2. Prof. Dr. P.T Thomas Lecturer, Universiti Kebangsaan Malaysia Pharmacy Board

3. Datuk Nancy Ho President Malaysian Pharmaceutical Society (MPS)

4. Jimmy Piong President Malaysian Organisation of Pharmaceutical Industries (MOPI)

5. Ewe Kheng Huat President Pharmaceutical Association of Malaysia (PhAMA)

6. Dato' Dr. NKS Tharmaseelan

Honorory General Secretary

Malaysian Medical Association (MMA)

7. Cheah Chee Ho Policy and Research Manager

The Federation of Malaysian Consumers Associations (FOMCA)

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LIST OF PANEL MEMBERS




PANEL DISCUSSION

During this 2 ½ day workshop, all the stakeholders have discussed on the Plan of Action (POA) of the Policy, which include the activities, indicators and targets.

I am told that the presentation has been very interactive and many issues were raised. However, this workshop is not the end of the preparation of the POA, as key indicators, measurable indicators and achievable targets that are crucial to achieving the various components need to be determined. Further work will involve presentation of the POA to the Technical and Monitoring committees set up to oversee the implementation of this Policy. The Steering Committee chaired by Tan Sri Dato’ Seri Dr. Hj. Mohd. Ismail Merican, Director General of Health will be the highest level committee that will endorse the POA.

In order to get the commitment of the various stakeholders, representatives from the various organizations are invited to this workshop to give their input on the contribution and involvement of their organization towards the successful implementation of the National Medicines Policy and the impact of the policy.

Panel Members:

a) Datuk Nancy Malaysian Pharmaceutical Society (MPS) b) Mr. Jimmy Piong Malaysian Organisation of Pharmaceutical Industries (MOPI)

c) En. Ewe Kheng Huat Pharmaceutical Association of Malaysia (PhAMA)

d) Dato’ Dr. NKS Tharmaseelan Malaysian Medical Association

e) Mr. Cheah Chee Ho Federation of Malaysian Consumer Associations (FOMCA)

f) Prof. Dr. P.T. Thomas Pharmacy Board




CURRICULUM VITAE OF PANEL MEMBERS

DATUK NANCY HO (MPS)

Name : Datuk Nancy Ho

Academic Quali� cations : Bachelor of Pharmacy, Unversity of Otago, New Zealand (1982)

Post held in MPS : Vice President (1989-1995) : Deputy President (1995-1996) : Assistant Treasurer (1996-1997) : Assistant Secretary (1997-1999) : Vice President (1999-2001) : Committee member (2001-2004) : Council member (1989-2008) : President (2008-present)

Professional Commitment : Board Director of International Inner Wheel (2009/2010) : President of Sabah Pharmaceutical Society : Member of Advisory Board, City Hall, Kota Kinabalu : Chairman of Malaysian Federation of Sabah San Chiang Association and Sabah Chairman

Work Experience

1. Queen Elizabeth Hospital (1973)2. Sabah Central Medical Store (1979-1981)3. Managing Director - Grace Communication Sdn.Bhd. which include Medical Supplies (Sabah) Sdn.Bhd., Grace Healthcare Sdn.Bhd and Joy Pharmacy Sdn.Bhd which owns three retail outlets called Joy Healthcare Shoppe. (1981-present) Awards

1986 - ‘Ten Outstanding Young Malaysian’ Award1995 - ‘Malaysian Woman Manager of the year’ by Women at work Magazine2001 - ‘Anugerah Tokoh Wanita Cemerlang’ by Jabatan Ketua Menteri Sabah - ‘Tokoh Sukarelawan Kebajikan/Sumbangan Ikhlas Negeri Sabah’ by Majlis Perkhidmatan Masyarakat Sabah2003 - State Award ‘PGDK’ [DATUK]2004 - Outstanding Jaycee Senator of Junior Chamber Malaysia

1.




JIMMY PIONG TECK ONN (MOPI)

Name : Jimmy Piong Teck Onn

Academic Quali� cations : Bachelor of Science in Pharmacy (Honors), University of Wales, Cardiff, UK (1982)

Post held in MOPI : Vice President (2001) : President (2007 - 2009) : Co-Chairman Malaysia’s Industry Master Plan 3 for Pharmaceutical Products (2008)Work Experience

1. Managing Director - Kotra Pharma (1984 - present – 25 years)

EWE KHENG HUAT (PhAMA)

Name : Ewe Kheng Huat

Academic Quali� cations : Bachelor of Science (Honors), UM – 1982

Work Experience

1. Pharmacist – Syalin Enterprise Sdn.Bhd. (1983-1984)2. National Sales Manager – Wellcome (M) Sdn.Bhd (1984-1994)3. Country Manager – Summit Company (M) Sdn.Bhd. (1994)4. Country Manager – MSD Malaysia (1997)5. Managing Director MSD, Malaysia (2002- present)

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DATO’ DR. NKS THARMASEELAN (MMC)

Name : Dato’ Dr.Nks Tharmaseelan

Academic Quali� cations : MBBS (1974), : Homeopathy Medical Sciences, University of Pondicherry (Degree – 1994) : Law Degree with Honors (University of London) : Medical Law, post-graduate (University of Northumbria, UK)

Post held in MMA : Hon. Gen. Secretary (2009-2010) Chairman PPSMMA (2005-2007)

Posts held other medical NGOs : Board Member of Koperasi Doktor Malaysia (2006-2009) : Deputy Secretary of Medico-Legal Society of Malaysia (2001-2007) : Medico-legal Advisor for Medical Protection Society

Work Experience

1. General Hospital Klang (1976)2. Medical Of� cer – Hospital Tanjung Karang3. Registrar in O&G – GH Klang and University Hospital4. Consultant O&G ( GH Kuala Lumpur, Melaka and Seremban)5. Private practice (since 1990)

CHEAH CHEE HO (FOMCA)

Name : Cheah Chee Ho

Academic Quali� cations : Bachelor Sains (Pengajian Makanan) Universiti Putra Malaysia (2004)

Work Experience

1. Manager of policy and research (FOMCA)2. Active in civil society – represented FOMCA in Coalition against the privatization of healthcare3. Active in other NGO Coalitions on drug patents and access to medicines

4.

5.


1 0 0 2 8 - 3 0 J u l y 2 0 0 9 • S h e r a t o n S u b a n g H o t e l & T o w e r s , S u b a n g J a y a


PROF. DR. P. T. THOMAS (PHARMACY BOARD MALAYSIA (PBM)

Name : Prof. Dr. P.T. Thomas

Academic Quali� cations : Bachelor of Pharmacy, Nagpur University, India : Master of Science, University of Texas, Austin, USA : PhD in Pharmacology/Toxicology, University of Texas, Austin, USA

Post held in PBM : Evaluator of pharmacy degree programmes, both local and foreign, and serves on the panel of evaluators for MQA : Member of the subcommittee for Evaluation and Recognition of Pharmacy Degrees of the Pharmacy Board of Malaysia Work Experience

1. 1977 - Hospital Kuala Lumpur / National Pharmaceutical Control Bureau2. Present - Professor of Pharmacy Practice, Faculty of Pharmacy, Universiti Kebangsaan Malaysia.

6.




ABBREVIATIONS

ADR - Adverse Drug ReactionsAG - Attorney GeneralAPC - Annual Practicing Certi� cateAPPL - Approved Products Purchase ListsAPHM - Association of Private Hospitals of MalaysiaBE - BioequivalenceCME - Continuous Medical EducationCPD - Continuing Professional DevelopmentCTIL - Clinical Trial Import LicenseCTX - Clinical Trial ExemptionCVD - Cardiovascular DiseaseDCA - Drug Control AuthorityDIC - Drug Information CentreDOE - Department of EnvironmentDTC - Drug Therapeutic CommitteeEBM - Evidence Based MedicinesED - Essential DrugsFOMCA - Federation of Malaysian Consumers AssociationFPMPAM - Federation of Private Medical Practitioners’ Associations MalaysiaFRIM - Forest Research Institute of MalaysiaGCP - Good Clinical PracticeGGM - Good Governance in MedicinesGLP - Good Laboratory PracticeGMP - Good Manufacturing PracticeGP - General PractitionersHCPs - Healthcare ProvidersHS - Health SupplementsICT - Information and Communication TechnologyIP - Intellectual PropertyJPA - Public Services DepartmentLIAM - Life Insurance Association of MalaysiaLT - Long TermMDG - Millennium Development GoalsMDTCC - Ministry of Domestic Trade, Co-Operatives and ConsumerismMERCY - Malaysian Medical Relief SocietyMIDA - Malaysian Industrial Development AuthorityMINDEF - Ministry of DefenceMITI - Ministry of International Trade and IndustryMMA - Malaysian Medical AssociationsMOE - Ministry of Education




MOF - Ministry of FinanceMOH - Ministry of HealthMOHE - Ministry of Higher EducationMOPI - Malaysian Organization Pharmaceutical IndustryMOSTI - Ministry of Science, Technology & Innovation, MalaysiaMPS - Malaysian Pharmaceutical SocietyMQA - Malaysian Quali� cations AgencyMSQH - Malaysian Society For Quality in HealthMTAC - Medication Therapy Adherence ClinicMyIPO - Intellectual Property Corporation of MalaysiaNEDL - National Essential Drug ListNGOs - Non-Government OrganizationsNHFM - National Healthcare Financing MechanismNHFS - National Health Financing SchemeNIH - National Institute of HealthNMRR - National Medical Research Register NMP - National Medicines PolicyNMUS - National Medicines Use SurveyNPCB - National Pharmaceutical Control Bureau OECD - Organisation for Economic Co-operation and DevelopmentOTC - Over The CounterPBS - Pharmaceutical Bene� ts SystemPhAMA - Pharmaceutical Association of MalaysiaPIAM - General Insurance Association of MalaysiaPEN - Pre- Export Noti� cationPIL - Patient Information Lea� etPMS - Post Marketing SurveillancePSD - Pharmaceutical Services DivisionQC - Quality ControlQ1 - Quarter 1Q3 - Quarter 3R & D - Research & DevelopmentRRP - Recommended Retail PriceSIRIM - Standard and Industrial Research Institute of MalaysiaST - Short termSTG - Standard Treatment GuidelinesTBD - To Be DeterminedTCM - Traditional Complementary MedicinesTOR - Terms of ReferenceTRIPS - Trade Related Intellectual Property RightsUMMC - University Malaya Medical CenterUSM - Universiti Sains MalaysiaWHO - World Health Organisation




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