Proceeding Book - MNMP

National Medicines Polic y Mid-Term Review Workshop
National Medicines Policy Mid-Term Review Workshop

28 ~ 30 July 2009 Sheraton Subang Hotel & Towers, Subang Jaya
28-30 July 2009 S heraton S ubang Hotel & Towers, S ubang Jaya
Buku kesihatan final.indd 1
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First Printing: December 2009
Copyright 2009 by Pharmaceutical Services Division Ministry of Health Malaysia, Lot 36, Jalan University, 46350 Petaling Jaya, Selangor Cover & Book design by Abfas 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
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CONTENT
Welcome Address By Senior Director of Pharmaceutical Services, Ministry of Health Malaysia ................................................................................. 4 Opening Speech By Director-General of Health Malaysia .................................. 7 Overview of Malaysian National Medicines Policy By Senior Director of Pharmaceutical Services, Ministry of Health Malaysia ..................................... 14 Plans of Action of DUNAS (Dasar Ubat Nasional / Malaysian National Medicines Policy) Component 1 - Quality, Safety and Efcacy of Drugs ........................... 31 Component 2 - Drug Availability ............................................................ 39 Component 3 - Drug Affordability .......................................................... 47 Component 4 - Quality Use of Drugs .................................................... 52 Component 5 - Human Resources Development ................................. 65 Component 6 - Research & Development ............................................ 68 Component 7 - Technical Co-operation ................................................ 71 Panel Discussion .............................................................................................. 73 Appendix List of Committees .................................................................... 79 List of Participants .................................................................... 84 List of Panel Members .............................................................. 95 Panel Discussion ...................................................................... 96 Curriculum Vitae of Panel Members ......................................... 97 Abbreviations ...........................................................................101 Photo Gallery .......................................................................... 103
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WELCOMING ADDRESS BY SENIOR DIRECTOR OF PHARMACEUTICAL SERVICES, MINISTRY OF HEALTH MALAYSIA
Y. Bhg. Tan Sri Dato Seri Dr. Hj. Mohd Ismail bin Merican Director - General of Health Malaysia. Y. Bhg. Datuk Kamarul Zaman bin Md Isa Deputy Secretary-General (Finance) Y. Berusaha Puan Hasnah Binti Ismail Director 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 ofcial opening of this workshop despite his very hectic schedule. Indeed, the presence of Y. 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 Inuenza 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
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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, certication 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, efcacy, 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 efciently 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 ofcially 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
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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 certication, 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 development, training, ICT and external collaborations. resources
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 condent 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. 6
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OPENING ADDRESS BY Y. BHG. TAN SRI DATO SERI DR. HJ. MOHD ISMAIL MERICAN DIRECTOR GENERAL OF HEALTH MALAYSIA Y. Bhg. Datuk Kamarul Zaman bin Md Isa Deputy Secretary-General (Finance) Y. Bhg. Puan Eisah Binti A. Rahman Senior Director Pharmaceutical Services Division Y. Berusaha Puan Hasnah Binti Ismail Director 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 ofciate 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. Ladies and gentlemen, 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 todays 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
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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. Ladies and gentlemen, 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 healthrelated 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 fullling 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. Ladies and gentlemen, Deliberate policy decisions are fundamental in order to shape a better and efcient 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.
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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. Ladies and gentlemen, 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 efcacy 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 specied. 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 efciency. 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
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marketplace. In 2008 alone, values of conscated 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. Ladies and gentlemen, Globally, the health economy is growing faster than the gross domestic product (GDP), having increased share from 8% to 8.6% of the worlds GDP between 2000 and 2005. This represents a 35% growth in the worlds 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 ination 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 benet 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. Ladies and gentlemen, Access to affordable essential medicines is vital in fullling the basic health needs of the population. Besides being an important element in WHOs 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 efcacious drugs. This is strongly supported when a study has
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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 benet of such strategic collaboration has led to signicant improvements in GMP of local manufacturers with some even in compliance with FDA requirements. Ladies and gentlemen, 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 identied 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 inuence. 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
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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. Ladies and gentlemen, 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
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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 identied 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. Ladies and gentlemen, 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 the thrust, all stakeholders in the public and private sectors need to reafrm 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 benet 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 efciency 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 ofcially open. Thank you.
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OVERVIEW OF MALAYSIAN NATIONAL MEDICINES POLICY BY 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 ofcial 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 specic to the Malaysian policy, and the management of the policy.
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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 denes a framework for setting and monitoring medium- to long-term objectives in the public and private pharmaceutical sectors.
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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
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Slide 7
Slide 8 The framework to regulate quality, safety and efcacy of drugs has been in place for more than 20 years.
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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 efcacious 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 efcacy 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.
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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.
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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 afrmative 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 prots. 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. 20
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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.
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Slide 16 This policy is important so there is sufcient 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.
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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.
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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. 24
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Slide 22
Slide 23
Slide 24
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Slide 25
Slide 26
Slide 27 Routine reports such as QA and KPIs. 26

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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.
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Slide 30
Slide 31
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Plans of Action of DUNAS

(Dasar Ubat Nasional / Malaysian National Medicines Policy)
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COMPONENT 1: QUALITY, SAFETY AND EFFICACY OF DRUGS
Policy: Only safe, efcacious and quality drugs that meet approved standards and specications 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: Strategy 2: Strategy 3: Strategy 4: Strategy 5: Strategy 6: Strategy 7: Drug Control Authority Licensing of Premises Prescription of Drugs Inspection Medicines Advertisement and Promotion Intellectual Property Rights Counterfeit Drugs
Part 2: PHARMACEUTICAL QUALITY ASSURANCE Strategy 1: Strategy 2: Strategy 3: Strategy 4: Drug Registration Inspection Quality Control Post-Marketing Surveillance
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Part 1: LEGISLATION AND REGULATIONS Strategy 1: Drug Control Authority Develops and implements the regulations concerning the quality, safety and efcacy of drugs
No. 1. Activities Review of drug registration guidelines to ensure relevance to current regulatory framework Implementation Timeline On going Indicators Targets Stakeholders NPCB; Industry; Relevant Stakeholder
Constructive To be determined feedback from (TBD) Industry & stakeholders through - surveys dialogues Quality of the dossiers submitted - periodic surveys on no. of correspondence
NPCB; Industry;
2.
Enforce Ready-to-dispense pack
2008
No of product complaints pertaining to quality for ready to dispense packs. % of products dispensed in the original packs
Review effectiveness of implementation - Expect a downward trend Survey in dispensing outlets through random sampling. Target 100%
NPCB; Industry
3.
To review number of dispensed packs used as is in dispensing outlets
2010
NPCB; PSD; Industry; MMA; MPS & Academia
4.
To implement use of the PIL (Patient Information Leaets) for OTC and selected prescription medicines for chronic diseases such as diabetes, asthma, CVD (cardio-vascular diseases)
2011
No. of products 100% of products supplied with PIL/ identied to have No. of products PILs registered with requirement for PIL
Product registration holders; NPCB; Academia; MPS; Professional Associations & Consumer Associations
Strategy 2: Licensing of Premises i) Licensing of Manufacturers, Importers and Wholesalers ii) Licensing of retail and dispensing outlets
No. 1. Activities Licensing of Manufacturers, Importers and Wholesalers Implementation Timeline Ongoing activity Indicators % of premises which require licensing are licensed % of premises which require licensing are licensed Targets 100% Stakeholders NPCB
2.
Licensing of retail and dispensing outlets
Ongoing activity
100%
PSD
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No. 3.
Activities Listing of sellers of General Sale List item (OTC & TCM)
Implementation Timeline KIV (To be determined when the new bill is approved by Parliament)
Indicators TBD
Targets TBD
Stakeholders PSD
Strategy 3: Prescription of Drugs

No. 1. Activities Prescribing of Group B Poisons by registered medical, dental practitioners and veterinary surgeons Dispensing of Group C Poisons by registered pharmacists Implementation Timeline Ongoing activity Indicators No. of violations identied/ No. of premises inspected No. of violations identied/ No. of premises inspected Targets 0 Stakeholders PSD; Professional Bodies
2.
Ongoing activity
PSD; Professional Bodies
Strategy 4: Inspection
No. 1. Activities Licensed manufacturers, importers and wholesalers Implementation Timeline Ongoing activity Indicators 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 2. Auditors training No. of auditors trained No. of Auditors/ No. of Audits to be done 3. Inspection of retail pharmacies Ongoing activity No. of Punitive actions taken./ No. of premises inspected No. of Punitive actions taken./ No. of premises inspected TBD Targets 0 Stakeholders NPCB; PSD; Relevant Associations
NPCB;PSD; Relevant Associations
100%
NPCB; PSD; Relevant Associations
100%
Based on norms
NPCB
PSD
4.
Inspection of medical, dental and veterinary clinics
Ongoing activity
PSD
5.
Inspection of Listed Sellers of General Sale List Items
TBD
TBD
PSD
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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.
No. 1. Activities Regulate all advertisement and promotion of drugs (including health supplements and traditional medicines) Implementation Timeline Ongoing activity Indicators No. of advertisements in violation of regulation/ No screened No. of advertisements in violation of regulation/ No. screened Targets 0 Stakeholders PSD
2.
Review of existing guidelines for Advertisement over the Internet
Constructive feedback from industry & stakeholders through dialogues 0
PSD
3.
Development of guidelines for Advertisement of selected Group C items such as Nicotine Replacement and Cough Cold products Review the mechanism for the dissemination of scientic and new clinical studies in the public domain. Encourage self regulation of OTC/TCM/Health supplements by conducting awareness program for self regulation Increase media education & awareness
2010
No. of advertisements in violation of guideline / No. screened No. of articles in violation/No. screened
PSD
4.
2010
No violation reported
PSD
5.
Ongoing activity
No. of dialogues, talks, campaign organised
6.
2010
No. of dialogues, talks, campaign organised
PSD
Strategy 6: Intellectual Property Rights

No. 1. Activities Registration of products in accordance with patent laws and TRIPS respects IP and does not allow for infringement of IP Implementation Timeline TBD Indicators TBD Targets TBD Stakeholders NPCB; Registration holders; MyIPO (Intellectual Property Corporation of Malaysia) NPCB; Product applicants; Relevant parties
2.
Implementation of requirements for Data Exclusivity
TBD
TBD
TBD
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Strategy 7: Counterfeit Drugs Note : * Propose to change to Counterfeit, Adulterated and Unregistered Drugs
No. 1. Activities Seizure of counterfeit, adulterated and unregistered drugs Implementation Timeline Ongoing activity Indicators No. of counterfeit, adulterated and unregistered drugs conscated. Targets No. of counterfeit, adulterated and unregistered drugs sold in the market should show a decreasing trend. Stakeholders Co-operatives and Consumerism); FOMCA; Industry; Consumer Associations; other relevant NGOs and Practitioner bodies.
Value of seized products 2. Implementation of stricter penalties for persons/companies violating the law Sharing of information domestically and internationally TBD Inclusion of stricter penalties in the Pharmacy Bill No. of meetings/ discourses with local and international agencies, no. of letters, e-mail sent 0 NPCB; PSD
3.
Ongoing activity
4.
Consumer education
Ongoing activity
No. of education sessions on counterfeits, adulterated and unregistered drugs including dialogues, talks and campaign organised/ participated No. of alerts issued Compliance to the requirements Positive ndings 100%
PSD
5.
Issuance of public alerts through the mass media Auditing of security label vendor
Ongoing activity Ongoing activity Ongoing activity
NPCB; PSD
6.
PSD
7.
Review the impact & usefulness of the current security label Evaluate alternative/ progressive technology for monitoring & combating counterfeits, adulterated and unregistered drugs
PSD
8.
Effective & Cost Effective
PSD; Industry; Professional Associations and Consumer Associations
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Part 2: PHARMACEUTICAL QUALITY ASSURANCE Strategy 1: Drug Registration To enhance registration procedures of pharmaceuticals, traditional medicines and cosmetics
No. 1. Activities Evaluation of active pharmaceutical ingredients Implementation Timeline 2010 Indicators No. of API evaluated Targets 25% Stakeholders NPCB
2.
Registration of veterinary products
2010
No. of Veterinary product registered
100% of existing products
NPCB
3.
Training of evaluators, analysts, inspectors
Ongoing activity
100% achieve CPD points requirement
All competent regulators
NPCB
4.
Evaluating efcacy claims for Natural Products as part of their use in mainstream medicine
2012
No. of products registered with data to support efcacy claims
TBD
NPCB; Traditional Medicine Industry; Academia; Relevant Professional Bodies
5.
Fast track approval system for new, innovative life saving and essential drugs
Ongoing activity
No. of products given priority review registered within 6 months
100% if dossier provided is complete
NPCB; Traditional Medicine Industry; Academia; Relevant Professional Bodies
6.
Review of registration procedures and timelines
Ongoing activity
Constructive feedback from industry & stakeholders through surveys and dialogues No. of ingredients with approved functional claims
Feedback from the stakeholders
NPCB; Industry; Professional Bodies
7.
Review of Functional claims for Health Supplements
Ongoing activity
Increasing no. based on evidence
NPCB; HS (Health Supplement) Industry; Food Safety and Quality Division; Academia
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Strategy 2: Inspection Note : * Propose to change to Licensing and Inspection

No. 1. Activities Inspection and licensing of premises (manufacturer, wholesaler and importer) Implementation Timeline Ongoing activity Indicators Targets Stakeholders NPCB
Inspection of Manufacturer manufacturers: to 200/year inspect more than 90% of the total number of scheduled inspections Licensing of Importer - 800/year Wholesaler Importers and Wholesalers: all 1000/year license applications will be processed in accordance to clients charter
2.
Clinical Trial Import License (CTIL) Issued
Ongoing activity
No. of licenses approved
All applications evaluated within 2 months All applications approved are evaluated 100%
NPCB
3.
Authorization to Manufacture (CTX) Issued
Ongoing activity
No. of authorizations approved No. of CT sites found to be GCP compliant/ No. of sites inspected No. of compliant BE centres/No. of BE centers inspected No. of laboratories compliant/No. of laboratories inspected No. of premises which comply to GSP & GDP/ No. of premises inspected
NPCB
4.
GCP Inspection
2010
NPCB
5.
Inspection of Bioequivalence (BE) Centres
2010
100%; At least once every 2 years
NPCB
6.
GLP Inspection
2010
At least once every 2 years
NPCB
7.
Good Distribution Practice Inspection
2011
TBD
NPCB; PSD; Industry (anyone involved in marketing drug products)
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Strategy 3: Quality Control

No. 1. Activities Upgrading of existing QC laboratory Implementation Timeline Ongoing activity Indicators Development of new test methods Targets As required by current needs Stakeholders NPCB
2.
Accreditation of NPCB laboratory (Scope Testing of Traditional Medicine)
2009
Accreditation received
Laboratories accredited to MS ISO/IEC 17025 by 2009 TBD
NPCB
3.
Accreditation of private laboratory (Scope Testing of Traditional Medicine) Establishment of regional laboratories for purpose of surveillance Training of analyst
2011
No. of accredited labs TBD
NPCB; Academia; Traditional Medicine Industry NPCB; Academia; Traditional Medicine Industry
4.
Subject to approval
TBD
5.
Ongoing activity
Refer to the Training records of the Analyst
All competent analysts
Strategy 4: Post-marketing surveillance program Strengthen surveillance activities of pharmaceutical and traditional products.
No. 1. Activities Adverse drug reaction reporting Implementation Timeline Ongoing activity Indicators Targets Stakeholders Healthcare Professionals; Industry; NPCB Industry
No. of ADR reports 200 ADR / million received population
2.
Reporting of ADR by industry to the DCA
Ongoing activity
No. of ADR Increasing trend reports submitted by product registration holders No. of ADR reports Increasing trend submitted by consumers No. of reporters who consistently submit ADR reports CME/CPD Points TBD
3.
Consumer based reporting of ADR
Ongoing activity
Consumers/ Public; Consumer Associations; NPCB NPCB
4.
Recognition of good ADR reporters
Ongoing activity
5.
Annual training for the HCPs to be incorporated as part of CME/ CPD Surveillance of registered products and cosmetics under PMS program
2010
NPCB; PSD
6.
Ongoing activity
No. of samples taken for conformity assessment Compliance with the system
2500/year
NPCB; PSD
7.
Review of Quality Assurance Programme during GMP/GSP audits
Ongoing activity
No. of product complaints
NPCB; Industry
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COMPONENT 2: DRUG AVAILABILITY Policy: An efcient 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 Development of Standard Treatment Guidelines. Selection of traditional medicines - Formation of Technical Committee comprising of expert and Practitioners.
Strategy 2: Strategy 3:
Part 2: DRUG SUPPLY Strategy 1: Procurement - Strengthen procurement and supply system of cost effective essential medicines. Domestic Medicines Production - Support Development of a viable domestic pharmaceutical industry and manufacturing capacities towards self sufciency. 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. Drug Supplies in emergency situations and drug donations - Shall be based on expressed needs as recommended by the WHO guidelines.
Strategy 2:
Strategy 3:
Strategy 4:
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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
No. 1. Activities Form multisectorial panel to assess and update NEDL according to countrys needs Publish NEDL and circulate to public facilities Use NEDL as rst line reference drugs during budget constraints Implementation Timeline 2008 Indicators Updated list ready Targets Stakeholders
Updated and Healthcare documented Professionals; NEDL Industry; NPCB Drugs in NEDL is being used as rst line in public private sector Full reimbursement for all drugs in NEDL Updated version of NEDL to be made available after the survey MOH MOHE
2.
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
2010-2012
NEDL Circulated Formation of expert committees Result of the survey ready
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
No. 1. Activities 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). Implementation Timeline On-going Indicators Increased number of experts in each specialties Targets Increased number of experts in the country Stakeholders MOHE to create pool of experts and to train. PSD to identify candidates and funding.
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iii) NEDL based on STG be used as a guide for: Advocacy and training in the concept of essential medicines
No. 1. Activities Conduct CME to healthcare providers and consumer education on Essential Drugs (ED) concept Circulate updated version of NEDL to private facilities To make Continuous Professional Development mandatory to all HCPs by making it a criterion for renewal of the professional practicing certicates. Implementation Timeline 2009 Indicators Targets Stakeholders
2.
2010
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.
iv) NEDL based on STG be used as a guide for: Support to domestic pharmaceutical industry
No. 1. Activities Implementation Timeline Indicators Targets Stakeholders MOPI MOH MITI MIDA (tax)
Grant to local industry to do To submit for Increase in Positive growth of BE studies and make BE as budget 2010 the number of domestic the standard requirement for all To be generics with BE manufacturers generic drugs. implemented in Cheaper generics ED in the market Government MOH work 2011 Increase in % together with industry to identify off-patent imported products of NEDL drug from the NEDL that are viable to manufactured be manufactured locally. locally Abolish all taxes if any on equipments parts, packaging materials and excipients used in local pharmaceutical manufacturing.
Strategy 2: Development of Standard Treatment Guidelines

No. 1. Activities 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. Implementation Timeline 2010-2012 Indicators Formulary for pediatric established Targets Stakeholders
Pediatric Formulary Pediatric institute, ready by 2012 HKL PSD USM
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Strategy 3: Selection of Traditional Medicines Formation of a Technical Committee comprising of experts and practitioners
No. 1. Activities 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 Implementation Timeline 2010 - 2012 Indicators Targets Stakeholders
Increase in Development of TCM division, a standard List MOH; NPCB number of experts in the of TCM products MOE identied to be country Formation of used in hospitals pro-term committee Establishment of TCM division, MOH; NPCB Formation of the Malaysian TCM formulary committee Criteria of selection have been established No. of products listed in the formulary
Part 2: DRUG SUPPLY Strategy 1: Procurement Strengthen procurement and supply system of cost effective essential medicines
Implementation Timeline Refer to item 3 ICT below
No. 1.
Activities 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)
Indicators
Targets
Stakeholders
Refer to item 3, on ICT below
2.
Incorporate and institutionalize GGM
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No. 3.
Activities To ofcially 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 NPCBs view in this issue) no liability to NPCB. Lead: Propose NPCB, with involvement from MyIPO & industry
Implementation Timeline
Indicators N/A
Targets
Stakeholders NPCB; MOPI; PhAMA
To discuss with NPCB
4.
Mandatory for MNCs to outTo assess local source the manufacturing to capacity and Malaysian-owned manufacturing capability companies for sales to public sector. Manufacture of drugs in NEDL (to take into consideration on IP & patent element). * Please nd denition 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
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
The task force is already in place, led by NPCB
A guideline for orphan drug will be established by March 2010. The guideline is updated every 2 years
NPCB; PSD; Industry
* Denition of local manufacture: Manufactured by companies that are registered in Malaysia. * Denition of manufacturing: In the Poisons Act 1952:Manufacture and its grammatically variations, means the
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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 product b) 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 sufciency
No. 1.
Activities
Indicators
Targets
Stakeholders PhAMA; MOPI; PSD; Procurement & Privatisation Division, MOH
Increase contract manufacturing According of MNCs products to Industrial Increase production for drugs in Master Plan 3 NEDL. (IMP3) A need for database for usage of To assess drugs in NEDL. local capability and capacity 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 to assess local capacity and capability and capability capacity
2.
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, efcacy, quality, bioequivalence, and price. Pharmaceutical companies to be given the same/equivalent strategic incentives as to the bionexus companies.
2011
Achieve strategic incentive for pharmaceutical industry by 2011
MIDA
3.
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.
2014
Malaysia is able to produce vaccines in NEDL by 5-7 years time
MOPI; PhAMA; PSD
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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.
Implementation Timeline 2010
No. 1.
Activities 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)
Indicators All contracts of 2010 NEDL are renewed on time APPL supply: max 10 working days No. stock out situation in central procurement/ distribution unit
Targets
Stakeholders Procurement & Privatisation Division MOH; Pharmaniaga; PSD
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
10th Malaysian ICT is completed & implemented Plan during the tenure of the 10th Malaysian Plan
10th Malaysian Plan
PSD, with involvement from Information Management Division, MOH
3.
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)
N/A - no issue Focused activities since will improve enforcement efciency of the act is Dept of Environment (DOE)
Focused activities will improve efciency
PSD; Pharmacy Practice & Development Division, MOH (to coordinate with Kualiti Alam, Department of Environment, DOE & Engineering Division)
4.
10th Malaysia National 10th Malaysia Plan Plan warehouse is established by 10th Malaysia Plan
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Strategy 4: Drug Supplies in emergency situations and drug donations- shall be based on expressed needs as recommended by the WHO guidelines.
Implementation Timeline To be completed by 2010
No. 1.
Activities 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)
Indicators
Targets
Stakeholders PSD; Medical Development Division; MITI; MERCY Malaysia; WHO; NGOs; MOF and other stakeholders.
Guidelines on Guidelines made Drug Supply available by 2010 in Emergency Situation & Drug Donation is established by end of 2010
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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
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Part 1: PRICE OF DRUGS Strategy 1:

No. 1.
Formulation of a Pricing Policy (Medicine Price Monitoring)

Activities Implementation Timeline 2004 Indicators Medicine Price Unit set up and Terms of Reference (TOR) dened Done Targets Stakeholders PSD
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 2. To Develop Price Monitoring for Ensuring Rational Pricing System: Consultation on situational analysis & intervention
2006-on going Data collected 2x per year
Done -ongoing
PSD; FPMPAM
Done -ongoing Data submitted yearly, continuously Data submitted yearly, continuously 2010 Separate GP & specialist data Done -ongoing
Q3 2009
Medicine price 2009 database developed
2008
Consultation carried out & report submitted
Done
PSD; WHO
Identify current composition of medicine pricing structure
2009
Price structure Consultancy identied for further completed Q1 09 action & policy development. Identify suitable and feasible mechanisms to monitor prices of essential medicines Data collection commenced for 2009
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
2010
2010
To commence monitoring based on mechanism proposed by consultant
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Strategy 2:
No. 1.
Price Information and Sharing

Activities Implementation Timeline End 2009 Indicators RRP labeling on ready to dispense packages implemented (existing in retail pharmacies). Itemized billing enforced. Targets 2009 (with cooperation from other organizations) Stakeholders PSD ; APHM ; FOMCA ; MPS
Implement labeling requirement for Recommended Retail Price (RRP) labeling on ready to dispense packages only at retail pharmacies and private hospitals.
2.
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%). Accessible medicine price database via web-based sites and web-based bulletin.
2009
End 2009
PSD; APHM ; FOMCA ; MPS
3.
Early 2009
Accessible medicine price database
Done; for a USM; MPS; MOH; FOMCA limited number of medicines. To continually increase number and to include essential drugs in 2010. End 2009 and ongoing (twice a year) MOH; MPS; MMA; FOMCA & other NGOs; Academia
4.
Public Education on Consumer Rights to Medicine Price and Itemized Billing. (Note: Should be carried out with Quality Use of Medicine Group)
Ongoing activity
Public Education Program on Consumer Rights to Medicine Price and Itemized Billing
Part 2: GENERIC MEDICINES POLICY Strategy 1:

No. 1.
Procurement of Multisource Products by Generic Names

Activities Implementation Timeline Indicators Targets Stakeholders MOH; Other government health institutions; APHM
Give preference to generic names 2009 - Ongoing Percentage of All sectors by in procurement. increment in use of 2011 generic names (Note: To encourage all sectors. Enhance purchase and use in public sector based on cost effectiveness)
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Strategy 2:
No. 1.
Provide Incentives for Use and Production

Activities Implementation Timeline Ongoing Indicators Increase in purchase of local generics 2010 Targets Stakeholders MOH; MOPI
Preference for medicines with generic names to be listed as contract / APPL items
Strategy 3:
No. 1.
Encourage Generic Labeling and Generic Substitution

Activities Implementation Timeline 2009 -2010 Indicators No of studies; No of institutions List developed Targets Study / data by 2010 End of 2009 Stakeholders MOH; MPS; MOPI; FPMPAM MOH; PhAMA
To consider generic substitution in consultation with prescribers Generate list of drugs that are not interchangeable Public health facilities to continue data collection on generic prescribing and reporting to the Drug Therapeutic Committee.
2.
2009
3.
Ongoing
No of reports to DTC
All survey data analysed and reported
MOH; University hospitals; Other government hospitals
Part 3: DRUG FINANCING Strategy 1:

No. 1.
Establishment of a Reliable Drug Financing Mechanism

Activities Implementation Timeline 2010 Indicators ICT system developed No of study conducted Targets End 2009 Stakeholders MOH
Development of an ICT system
2.
Develop data on: Drug cost per prescription based on type of care (acute, primary) and by discipline
2010
2010
MOH
3.
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)
2009
No of reviews (until Technical 2012) Committee (with new members) formed and ED Formulary developed
MOH; MMA; PhAMA; MOPI; MOHE; LIAM; FPMPAM
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No. 4.
Activities To develop structural capacities for pharmaceutical benets system (PBS) for the National Healthcare Financing Mechanism (NHFM) Formation of a Technical Working Group (NHFM to be identied before structural capacities for PBS can be developed)
Indicators Structural 2010 capacities for PBS identied
Targets
Stakeholders PIAM; MOH; MPS; PhAMA; MOPI; MOHE; MOF
5.
Generate approved list of drugs that can be substituted
2010
Approved list of drugs that can be substituted generated
2010
MOH; FPMDAM; PIAM; LIAM; MOPI; PhAMA
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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 & overseas Strategy 2: Provide adequate theoretical and practical training in drug use Strategy 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 INFORMATION Strategy 1: Disseminate accurate, unbiased and relevant information on drugs Strategy 2: Provide adequate facilities for drug information dissemination Strategy 3: Networking of Drug Information Centres to optimize resources Strategy 4: Regulate drug labelling and facilitate availability of product information leaet Part 4: DRUGS AND THERAPEUTIC COMMITTEES Strategy 1: Formulary Panel to coordinate incorporation of NEDL into STG Strategy 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 (evidencebased) Strategy 2: Promotion and training on use of STG
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Part 6: PRESCRIBING AND DISPENSING PRACTISES Strategy 1: Enforce the use of generic names in prescriptions Strategy 2: Separate prescribing and dispensing functions Part 7: ROLE OF PHARMACISTS Strategy 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
No. 1. Activities Identify new areas for specialization e.g., cardiology, intensive care, pediatrics, oncology, mental health, geriatrics, military pharmacy, transplantation pharmacy, biopharmaceutics, pharmacogenomics & primary care pharmacy. Implementation Timeline 10 MP Indicators No. of specialized elds Targets 4 elds of specialization (to be identied by PSD) At least 20% of the currently practising pharmacists trained in the 4 identied specialized elds To be collected Stakeholders 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
No. of pharmacists with postgraduate training in the specialized elds
No. of hospitals/ health facilities offering services in the 4 identied specialized elds No. of training centres No. of specialized pharmacist posts 2. Strengthening existing specialized areas 2011 No. of personnel trained
To be collected
20% of all pharmacist posts At least 20% of new personnel will be trained in the 4 identied specialized elds 100% identied training centres PSD; MPS
3.
Accreditation of training centres
2014
No. of accredited training centres
4.
Acquire Credentialing & Privileging in specialized areas for gazettement
2014
No. of pharmacists 100% credentialed pharmacists & privileged in nominated specialized areas
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Strategy 2: Provide adequate theoretical and practical training in drug use

No. 1. Activities Attend regular multidisciplinary teaching rounds Implementation Timeline Ongoing activity Indicators Number of teaching round teams in hospitals which include pharmacists Targets 100% of teaching rounds in specialized elds identied by PSD to include pharmacist(s) Stakeholders
Set up mechanism for academic detailing activities)
2011
Are there training Yes centres for academic detailing activities? How many At least 2 regional regional training training centres centres have been set up? No. of staff sent abroad to be trained as master trainers At least 5 staff to be sent abroad to be trained as master trainers
Strategy 3: Education and curricula of undergraduate, post-graduate and in-service training of health professionals
No. 1. Activities 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 Implementation Timeline 2010 Indicators 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 No. of training programmes conducted Has core curriculum on QUM for Allied Health Providers been established? Targets 100% Stakeholders PSD; Human Resources Division of MOH; Academia; MOE; MOHE; MINDEF; Public Services Department (JPA); Professional Societies (e.g. MPS, MMA) & Academy of Pharmacy
2.
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
2010
To be collected
Yes
Do all allied health 100% allied health institutions have institutions core curriculum on QUM?
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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 condent to interact with healthcare providers
No. 1. Activities Pre-intervention national survey on consumer knowledge and awareness on the quality use of medicines Implementation Timeline 2006 Indicators Targets Stakeholders MOH; MOE; MDTCC; MOPI; MPS etc.
Level of consumer Baseline level knowledge and gauged awareness on the quality use of medicines gauged? Increment in level of knowledge and awareness 20% increment in knowledge and awareness
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
2011
Ongoing activity
Ongoing activity
% of secondary schools covered by projects and campaigns
20% secondary schools covered
2.
Dissemination of information on the quality use of medicines through exhibitions, seminars, public workshops and forums TOT for community leaders
2010
No. of activities conducted
At least one activity per pharmacy facility per year 30
No. of participants per activity No. of leaders trained
At least one community leader trained per district. Yes
3.
Establish a dedicated portal on consumer protection and education
2007
Dedicated portal developed Satisfaction level on web content
50%
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Part 3: DRUG INFORMATION Strategy 1: Disseminate accurate, unbiased and relevant information on drugs
No. 1.
Activities To enhance the role of drug information centres in hospitals
Indicators
Targets
Stakeholders PSD; MOH; MOE; MDTCC; MOPI; MPS etc.
No. of pharmacists To be collected trained in pharmacoinformatic services No. of promotional activities carried At least one out for public and promotional HCPs activity undertaken per facility per year
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 2. Dissemination of drug information inclusive of issues on quality use of medicines through: Website/Internet portal 2006
MOH; MOE; MDTCC; MOPI; MPS etc. Portal developed No. of hits Yes To be collected (with increment of 10% monthly) To be decided by PSD of MOH
Patient Counselling
No. of patients/ consumers counselled Frequency of publishing of drug bulletin No. of types of pamphlets on drugs/issues on drugs developed and circulated
Through patient Counselling
Drug bulletin published quarterly Publication of 2 pamphlets. Themes to be based on top 40 drugs in NMUS
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Strategy 2: Provide adequate facilities for drug information dissemination

No. 1. Activities To equip all hospitals/health centres/community pharmacies with basic updated drug information references Implementation Timeline 2012 Indicators 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, Meylers Side Effects of Drugs. Targets 100% Stakeholders MOH; MOE; MDTCC; MOPI; MPS etc.
*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

No. 1. Activities Networking among all drug information call centres for exchange of information Corporate licensing of drug database under MOH for hospitals & health clinics Implementation Timeline 2011 Indicators Is networking system in place? Targets Yes Stakeholders MOH; MOE; MDTCC; MOPI; MPS etc.
2.
2011
No. of corporate licenses acquired
At least one MOH; MOE; Corporate license MDTCC; MOPI; MPS etc.
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Strategy 4: Regulate drug labelling and facilitate availability of product information leaet
No. 1.
Activities Enforce drug labelling in private pharmacies and GP clinics, Distribution of legislation documents
Indicators Proportion of inspected premises complying / no. of premises inspected
Targets
Stakeholders
100% compliance MOH; MOE; MDTCC; MOPI; MPS etc.
2.
Consumer focused labelling guidelines
2010
Are guidelines Yes available for consumer-focused labelling? No. of medicines (with PIL requirement) with PIL accessible to HCPs and consumers. 100% of registered medicines with PIL requirement
MOH; MOE; MDTCC; MOPI; MPS etc.
3.
Improve accessibility of Patient Information Leaet to HCPs and consumers
2011
NPCB; Manufacturers; Distributors & Retailers
Part 4: DRUG AND THERAPEUTIC COMMITTEES Strategy 1: Formulary Panel to coordinate incorporation of NEDL into STG
No. 1.
Activities Pharmacists in local DTCs and STG panels to coordinate and participate in the selection of essential drugs in line with STGs
Indicators No. of essential drugs used as rst line drug treatment
Targets 100%
Stakeholders MOH; DTCs in public & private sectors
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Strategy 2: Enhancement of the role of Drug and Therapeutic Committees (DTC)

No. 1.
Activities Review membership, TOR and activities of DTC at local and national level
Indicators All public and private institutions have established DTC DTC meeting held at least thrice yearly
Targets 100%
Stakeholders MOH; Health Care Providers in public & private sectors
100%
2.
Local DTCs to develop hospitalbased 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
2010
Policies developed Yes on STG No. of evaluations done 100% evaluation on all new drug requests
MOH; Health Care Providers in public & private sectors
3.
Database for subject matter experts e.g.: evidence-based medicine, disease specic experts, pharmacoeconomics, pharmacoepidemiology Virtual communication practiced e.g.: online forum discussion
Mid 2011
No. of expert teams established
Expert teams established for 5 diseases with highest BOD
MOH; Members of DTCs & Healthcare providers
4.
Before end 2009
Is virtual communication practiced?
Yes
PSD; Members of DTCs; Healthcare providers & Medical Development Division of MOH
5.
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.
Mid 2011
No. of facilities which have implemented the policy
70% of facilities implemented the policy
Members of DTC; Healthcare providers
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Part 5: STANDARD TREATMENT GUIDELINES Strategy 1: Establishment of Standard Treatment Guidelines (STG) based on disease prevalence (evidencebased)
No. 1. Activities 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 Implementation Timeline Mid 2011 Indicators No. of STGs produced Targets 5 STGs produced Stakeholders PSD; Healthcare providers in public & private sectors; Medical Development Division of MOH
Strategy 2: Promotion and training in use of STG

No. 1. Activities To promote and provide training on the use of STGs among HCPs and paramedics. Implementation Timeline Mid 2011 Indicators No. of training sessions held by zone No. of master trainers No. of echo training sessions 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 2. Disseminate STG: a. Along with Annual Practicing Certicate (APC ) b. Email blast Comments/Suggestion: Cost implication Mid 2011 Proportion of HCPs to whom STG disseminated/ APCs renewed No. of HCPs to whom STG disseminated via e-mail blasts Mid 2011 No. of STGs accessible for public viewing online No. of STGs accessible for public viewing online 100% of HCPs who renewed APC received STG 100% HCPs received STG via e-mail blast Healthcare providers in public & private sectors Targets At least once per year Stakeholders PSD; Healthcare providers in public & private sectors; Health Promotional Board; Medical Development Division of MOH
At least 6 MT per zone At least one per health facility
3.
STGs accessible via MOH, professional & consumer organization websites
100% of STGs accessible
Healthcare providers in public & private sectors
4.
Audit on awareness and adherence to STG. Survey in terms of awareness and usage. Survey can be carried out manually or electronically
Mid 2011
100% of STGs accessible
Healthcare providers in public & private sectors
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Part 6: PRESCRIBING AND DISPENSING PRACTICE Strategy 1: Enforce the use of generic names in prescriptions
No. 1. Activities Incorporate regulation on use of generic names in prescriptions in New Pharmacy Bill Implementation Timeline Indicators Yes Targets Stakeholders PSD; MOH & AG Chambers
When new Bill Is regulation is enacted incorporated in New Pharmacy Bill?
Strategy 2: Separate prescribing and dispensing functions

No. 1. Activities Consultation on situational analysis and implementation of dispensing separation Comments/Suggestion: Should a poll be conducted? Distance between clinics and pharmacies to be taken into consideration? Implementation Timeline 2010 Indicators Has the consultation been held? Has a consensus been reached between all stakeholders? Has the ideal ratio of pharmacists-topopulation been determined? Has the ideal distribution of pharmacies been determined? Has the ideal ratio of pharmacists-topopulation been attained? Has the ideal distribution of pharmacies been attained? 2. Amendment/enactment of legislation for separation of dispensing and prescribing functions [if necessary] To be determined at consultation Yes Targets Stakeholders PSD, Healthcare providers in public & private sectors, Health Promotional Board; Medical Development Division of MOH
Yes
Yes
Yes
Yes
Is legislation in Yes place to implement separation of dispensing and prescribing functions? No. of activities held to promote dispensing separation To be collected
PSD; AG Chambers
3.
Carry out promotional activities targeting the public and healthcare providers
To be determined postconsultation
Professional associations; consumer associations & government agencies
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No. 4.
Activities Benchmarking and accreditation of community pharmacies Comments/Suggestion: Continuous review of benchmarks under Quality Use of Medicines Subcommittee Discussion with MSQH is ongoing
Indicators
Targets 100% compliance
Stakeholders MOH; MPS; MSQH & Pharmacy Enforcement Division of MOH
Benchmarking Proportion of New premises: pharmacies Jan 2010 complying with benchmarks. Existing premises: Dec 2011 Frequency of review of benchmarks Is there an accreditation body? Proportion of premises accredited
Annually
Yes
10% of community pharmacies accredited by Dec 2010 MPS in co-operation with the Pharmacy Enforcement Division of MOH
5.
Mapping of community pharmacies by zones/states to identify areas feasible to commence dispensing separation
2009
Have all the Yes community pharmacies been mapped out? Frequency of updates to map Quarterly
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
To be determined postconsultation
No. of private clinics still dispensing medicines in areas where ideal distribution of pharmacies and ideal ratio of pharmacistto-population for dispensing separation has been attained
Pharmacy Enforcement Division of MOH
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Part 7: ROLE OF PHARMACISTS Strategy 1: To establish the central role of the pharmacist
No. 1. Activities Strengthen and expand pharmacists roles in clinical pharmacy at public/private facilities Implementation Timeline October 2010 Indicators Is there at least one clinical pharmacist per specialized eld? Targets 1 clinical pharmacist per specialized eld Stakeholders PSD; Pharmacy Enforcement Division of MOH
Sufcient for at No. of clinical pharmacist posts least one clinical in public hospitals. pharmacist per specialized eld Is there at least one pharmacist in each private hospital? No. of clinical pharmacists in private hospitals Yes
No. of pharmacists 1 pharmacist trained in following per specialized specialized area per state areas pharmacoepidemiology, pharmacoeconomics and pharmacosociology 2. Strengthen and expand pharmacists role in the primary care setting Comments/Suggestion: Training for Medication Reviews to be conducted by Academy of Pharmacy. Payment for service to be determined also 2010 2015 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 Academy of Pharmacy; MPS; PSD; NPCB & State Health Departments (JKN)
50
30
To be collected
2 activities per pharmacist per year
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No. 3.
Activities Set up committee to establish counselling guidelines on common diseases for community pharmacists Comments/Suggestion:
Indicators Has a committee been set-up to produce counselling guidelines? No. of guidelines published Yes
Targets
Stakeholders PSD; MOH; MPS; Academy of Pharmacy
2010 Cough / cold, hypertension, Diabetes Mellitus, minor ailments, self-medication 4. Establish and coordinate referrals with General Practitioners Comments/Suggestion: Discuss accessibility of medical records and sharing of information among health professionals. 2010
Guidelines for 5 common diseases published
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
MOH, MPS, MMA; Private Medical Practitioners Association
Yes
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
No. 1. Activities Develop guidelines on GGM Promote and disseminate guidelines on GGM Implementation Timeline 2010 Indicators Are guidelines on GGM ready? Awareness about GGM guidelines? 2012 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 Yes Targets Stakeholders Government agencies, professional bodies & pharmaceutical industry Government agencies, professional bodies & pharmaceutical industry
100% awareness
2.
Adherence to Code of Conduct on Prescription Products Promotion by: Manufacturers and distributors Health Professionals
100% adherence
100% adherence
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COMPONENT 5: HUMAN RESOURCES DEVELOPMENT Policy: The human resource needs of the pharmaceutical sector shall be planned and developed. Aim: To ensure sufcient 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 resources i) Undergraduate Training
No. 1. Activities Enhance knowledge of graduates by reinforcing existing educational m od u les or intr oducing new modules in the form of; a) electives b) postgraduate diplomas Implementation Timeline a) 2014 b) 2010 Indicators Targets Stakeholders Academia; MOPI; PSD
No. of graduates a) LT: 50% of of modules (i.e. graduates GMP, GLP, GCP, validation, process b) ST: 10% of management) graduates LT: 50% of graduates No. of graduates of modules (i.e. communication, entrepreneurship, management) ST: 50% of graduates LT: 100% of graduates
2.
Enhance the soft skills of graduates with regards to communication (spoken & written), leadership & managerial, interpersonal relationships & entrepreneurial skills, professionalism & ethics.
2010
PSD; Academia
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ii)
No. 1.
Compulsory Service Period

Activities Compulsory service: Propose to be reduced to 2 years Implementation Timeline Indicators Targets Stakeholders PSD; Academia
Initiate proposal Approval given for 2011 in 2009 the service year of 2011 2010 No. of pharmacists /other related critical health personnel involved in the collaborative effort ST: 2 pharmacists per year LT: 4 pharmacists per year.
2.
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
Industries; Academia; Research Institutes; JPA (Public Services Department )
iii)
No. 1.
Postgraduate Training
Activities Ministry of Health to identify needs for postgraduate training and to ensure equitable distribution of post graduate training opportunities Industry to identify needs in industry, retail, commerce and research (collaborative effort between industry & govt./ universities/research institutes Implementation Timeline Indicators Targets ST: growth 1.3% (100) LT : growth 2% (460) Stakeholders PSD ; Training Division, MOH; Academia
current : 6.7% No. of PhD and ST: 8% MSc holders and LT: 10% their areas of specialization.
2.
current : (e.g.2 No. of PhD holders from 1 industry) produced via this collaborative effort ST: 10 LT: 100
Current : (e.g. 2 from 1 industry) ST: 10 LT: 100 Disciplines to be dened Current total: 4000 ST : additional 2000 (total 6000) LT: Additional 10,000 (total 14000)
Industries; Academia ; Research Institutes
3.
Communicate and justify with human resource division for allocation of more posts
2009
No. of posts made available
Public Services Department (JPA); PSD
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Part 2: EDUCATION AND TRAINING Strategy 1: Strengthen the quality assurance mechanism of training institutions / Accreditation of Programmes
No. 1.
Activities Recognition/accreditation of pharmacy programmes and pharmacy-related programmes
Implementation Timeline ongoing
Indicators No. of recognized /accredited programmes
Targets
Stakeholders
All Bachelor of Pharmacy Board; Pharmacy MQA programmes to be accredited by the Pharmacy Board All Diploma Pharmacy programmes or pharmacy-related programmes (diploma level) to be accredited by MQA MQA, PSD
Strategy 2: Training of healthcare providers in line with the principles of the National Medicines Policy
No. 1. Activities Include principles of the National Medicines Policy in curricula of all Pharmacy Programmes Implementation Timeline 2010 Indicators Targets Stakeholders Academia ; PSD
No. of pharmacy 100% by 2014 programmes that include the NMP in their curricula No. of CPD activities that includes the NMP At least twice a year for both sectors (public & private)
2.
Include principles of the National Medicines Policy in CPD activities for all health care providers
2010
PSD; MPS; MOPI; PhAMA; Other Health Providers; Associations PSD; Training Division, MOH; Academia; Public Services Department(JPA)
3.
Create pharmacist specialists in centres of excellence in hospitals (or other government sites) who are joint appointees of MOH and universities
2012
No. of pharmacists Current: Not in specialists who are practice joint appointees ST: 1 per category A, tertiary hospital (Clinical Pharmacy) LT: 1 pharmacist specialist per specialization/ sub-specialization per tertiary hospital.
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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
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Part 1: DRUG UTILIZATION AND MANAGEMENT Strategy: Conduct research in the following priority areas:
No. 1.
Impact of NMP Pharmacoeconomics Issues related to prescribing and dispensing Behavioural and cultural aspects of drug use
Activities Implementation Timeline 2012 Indicators No. of research completed Targets No. of priority areas - 6 for 9th Malaysia National Health Plan Stakeholders Research centres/agencies; academia; NIH; MOSTI; MOPI; PhAMA and other industries
Conduct research based on topics in priority areas and submit proposals to NMRR and any relevant agencies to acquire funding
2.
Conduct social research in collaboration with the universities, policy makers, health care providers, research institution, industry, professional bodies NGOs, and consumer association Provide training in drug utilization and pharmacoeconomic research
2012
No. of collaborative No. of research research completed conducted
3.
Ongoing activity
No. of personnel trained No. of research done
No. of personnel trained No. of research done 1-2 research (estimated) completed DOE; academia with environmental department / faculty
4.
Conduct study on the implementation of schemes for the disposal of harmful medicines. Promote the use of research ndings for continual improvement in drug utilization and management Data source: 1. NMRR 2. PSD
2012
No. of research conducted
5.
Ongoing
No. of policy/ management reviews based on research ndings/ recommendation
10% of researches done result in policy change
6.
Establish pharmacy services research centre
2010
To establish data 1 research centre and resource center: Establishment of a focal point for reference and data
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Part 2: DRUG RESEARCH AND DEVELOPMENT Strategy: Encourage research of drugs for common diseases, new and emerging conditions and traditional medicines
No. 1. Activities Provide new incentives to encourage clinical trials Comply with government policy on Intellectual Property Rights (IPR) pertaining to governmentfunded R&D 2. Provide technical assistance to GLP standard Encourage basic research i.e. New Chemical Entity, New Biological entity and New Molecular Entity. Cluster research by clinical and non clinical 2012 Implementation Timeline 2012 Indicators Targets Stakeholders Research centres/ agencies; academia; NIH and industries
No. of clinical trial No. of clinical conducted & result trials utilized- depends on the new type of incentives
No. of test facility complied No. of research conducted
10% of test facilities Number of research completed Research centres / agencies ; Academia ; NIH; MOSTI; MOPI; PhAMA and Other Industries
3.
2012
4.
To encourage/ focus on research with outcomes/ output which contribute directly to NMP. Data source: 1. NMRR 2. MIDA 3. MITI 4. PhAMA 5. MOPI 6. Academia 7. FRIM, SIRIM, etc 8. PSD
2012
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
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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: Strategy 2: Strategy 3: Training for enhancement of skills in technical expertise Sharing and exchange of informationexpertise, ADR, Post marketing Surveillance (PMS), notication of adulteration of products Sharing and exchange of information on precursors (PEN)
Strategy 1: Training for enhancement of skills in technical expertise

No. 1. Activities Collaborate with established centres for skills training in policy management Implementation Timeline Indicators No. of training (government regulators in terms of policy management) 2012 No. of collaboration Targets Depending on the number of graduates produced by the local universities 2 experts per year NPCB; Industries Stakeholders
2.
Collaborate and exchange technical expertise with institutions abroad who are expert in specic elds
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Strategy 2: Sharing and exchange of information expertise, ADR, Post marketing Surveillance (PMS), notication of adulteration of products
No. 1. Activities ASEAN Post Market Alert System PIC/S rapid alert 2. Regional and international harmonization of regulatory requirements (ACCSQ) Sharing and exchange of pre-marketing assessment of medicine Ongoing activity No. of harmonized 100% (according area achieved to target date) NPCB; Industries Implementation Timeline Ongoing activity Indicators No. of alerts issued / received Targets Stakeholders
No. of registered NPCB products removed from the market
3.
Ongoing activity
No. of products No. of collaborating centres
100% of all exchange shared
NPCB
Strategy 3: Sharing and exchange of information on precursors (PEN)

No. 1. Activities Communicate with other competent authorities for activities involving the importation and exportation of precursors Implementation Timeline Ongoing Indicators Targets Stakeholders PSD
No. of PEN issued 100% of all PEN shared No. of PEN received
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PANEL DISCUSSION Repertoire : 1. Dr. Asrul Akmal bin Shae (USM) 2. Pn. Azura binti Abdullah (NPCB) 3. Pn. Saimah binti Mat Noor (PSD)
No. Panel Members Issues Opinions
1.
MPS
Quality, safety and efcacy 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.
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No.
Panel Members
Issues
Opinions
MPS run programme awareness in hospital & clinics. Eg : Clean Your Cabinet Campaign.
Drug Affordability
Advocate the balance on pro-business measure and at the same time keeping cost affordable. Should be looking Insurance Policy. into National
Human Resources Development
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.
General
2.
MMA
General
3.
Pharmacy Board
Human Resources Development
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.
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No.
Panel Members
Issues
Opinions
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.
Pharmacist registration
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 classied 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.
Research
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 efcient research. Universitys 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.
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No.
Panel Members
Issues
Opinions
4.
FOMCA
Quality, Safety & Efcacy of Drugs
Lots of complaints of unsafe product especially beauty, counterfeit, dubious medicines sold in night market (pasar malam), misleading promotion (yers, banners, leaet, poster, billboard etc.) FOMCA can play a part in channeling complaints for post marketing surveillance. Structured complaints can be set up.
Drug Availability
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.
Drug Affordability
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 doctors practice and no generic name for medicines in doctors practice. Health subsidy in Malaysia might not be sustainable. Hope discussion on medicines also includes health nancing.
Quality Used of Drugs
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.
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No.
Panel Members
Issues
Opinions
Dispensing separation is supported by FOMCA provided the infrastructure is ready and cost is affordable. Human Resources Development More qualied 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.
5.
MOPI
General
MOPI is ready to deliver quality medicines. Half billion has been invested to implement GMP/PICS standards etc. There should implementation. be commitment to
Challenges to adding value. Can be done by exporting locally manufactured products to penetrate international market. Need support and more funding (MOF/ MIDA).
6. PhAMA
General
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. information Disseminate trainings, CPD, CME. through
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LIST OF COMMITTEES
Advisor Mdm Eisah binti A.Rahman

Senior 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 Ms. Siti Aida binti Abdullah Deputy Director of Prevention and Protection Pharmacy Enforcement Division Ministry of Health Ms. Zawiyah binti Mat Johor Deputy Director of Pharmacy Development Pharmacy Practice and Development Division Ministry of Health Dr. Salmah binti Bahri State Health Deputy Director (Pharmacy) WP Kuala Lumpur & Putrajaya Health Department Ministry of Health Ms. Yogeswary a/p V. Markandoo State Health Deputy Director (Pharmacy) Selangor Health Department Ministry of Health Dr. Nour Hanah binti Othman Senior Principal Assistant Director Pharmacy Management Division Ministry of Health Ms. Anis binti Talib Senior Principal Assistant Director National Pharmaceutical Control Bureau Ministry of Health 28-30 July 2009 S heraton S ubang Hotel & Towers, S ubang Jaya 8. Ms. Bariah binti Abd Rani Senior Principal Assistant Director National Pharmaceutical Control Bureau Ministry of Health Ms. Saimah binti Mat Noor Senior Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health
2.
9.
3.
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
4.
5.
6.
7.
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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 Sona 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
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TECHNICAL WORKING COMMITEE
1.
Dr. Salmah binti Bahri State Health Deputy Director (Pharmacy) WP Kuala Lumpur & Putrajaya Health Department Ministry of Health Dr. Nour Hanah binti Othman Senior Principal Assistant Director Pharmacy Management Division Ministry of Health Ms. Saimah binti Mat Noor Senior Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health Mr. Mazlan bin Ismail Senior Principal Assistant Director Pharmacy Enforcement Division Ministry of Health Ms. Wan Mohaina binti Wan Mohammad Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health Ms. Salwati binti A. Kadir Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health Ms. Norhayati binti Musa Senior Assistant Director Pharmacy Management Division Ministry of Health Ms. Normawati binti Mohamed Noor Assistant Director Pharmacy Enforcement Division Ministry of Health Ms. Azlina binti Ismail Senior Assistant Director National Pharmaceutical Control Bureau Ministry of Health
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
2.
3.
4.
5.
6.
7.
8.
9.
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)
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PUBLICATION WORKING COMMITTEE
1.
Ms. Yogeswary a/p V. Markandoo State Health Deputy Director (Pharmacy) Selangor Health Department Ministry of Health Mr. Chow Ching Yei Assistant Director Pharmacy Management Division Ministry of Health Ms. Hafsah binti Md. Yusof Assistant Director Pharmaceutical Services Division, Selangor Mr. Lam Kai Kun General Manager Malaysian Pharmaceutical Society (MPS) Mr. Tong Yew Sum Executive Director Malaysian Organisation of Pharmaceutical Industries (MOPI) Ms. Tan Booi Charn Representative Pharmaceutical Association of Malaysia (PhAMA) Prof. Dr Mohamed Mansor bin Manan Lecturer Faculty of Pharmacy University of MARA Technology (UiTM)
8.
Dr. Ng Shiow Fern Senior Lecturer Faculty of Pharmacy National University of Malaysia Dr. Mohd Makmor Bakry Senior Lecturer Faculty of Pharmacy National University of Malaysia
2.
9.
3.
10. Ms. Junaidah binti Amir Lecturer Pharmacy Department, Faculty of Medicine University of Malaya
4.
5.
6.
7.
LOGISTIC WORKING COMMITTEE
1.
Ms. Anis binti Talib Senior Principal Assistant Director National Pharmaceutical Control Bureau Ministry of Health Ms. Bariah binti Abd Rani Senior Principal Assistant Director National Pharmaceutical Control Bureau Ministry of Health Ms. Syazwani binti Shaharuddin Lecturer Faculty of Pharmacy University of MARA Technology (UiTM)
4.
Ms. Akalily Sona binti Mohamed Arif Representative Pharmaceutical Association of Malaysia (PhAMA) Mr. Yuhaidy bin Yusof Administrative Assistant Pharmacy Management Division Ministry of Health
5. 2.
3.
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GROUP LEADER
GROUP 1 (QUALITY, SAFETY & EFFICACY OF DRUGS) Ms. Abida Haq binti Syed M. Haq Deputy Director Centre of Product Registration National Pharmaceutical Bureau Ministry of Health
GROUP 2 (DRUG AVAILABILITY) Mr. Mohd Hatta bin Ahmad Director of Pharmacy Enforcement Ministry of Health
GROUP 3 (DRUG AFFORDABILITY) Ms. Zawiyah binti Mat Johor Deputy Director of Pharmacy Development Pharmacy Practice and Development Division Ministry of Health
GROUP 4 (QUALITY USE OF DRUGS) Dr. Salmah binti Bahri State 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. Yusof Principal Assistant Director Pharmacy Practice and Development Division Ministry of Health
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LIST OF PARTICIPANTS
GROUP 1: QUALITY, SAFETY & EFFICACY OF DRUGS Attendance

No Name Abida Haq Syed M. Haq Mazuwin Zainal Abidin Hasniza Zaidan Nor Hayati Abdul Rahim Ahmad Ayob Nor Aza Hassan Latifah Haji Idris Normawati Mohamed Noor Dato' Dr. Dorai Raja Designation Deputy Director (U54) Principal Assistant Director (U48) Principal Assistant Director (U48) Senior Assistant Director (U44) Senior Principal Assistant Director (U52) Principal Assistant Director (U48) Principal Assistant Director (U48) Assistant Director (U41) President, PEPTIM Manager, Pharmaniaga Senior Manager, CCM Pharmaceuticals CEO, Pharmaniaga Senior Technical & Regulatory Executive, Amway Medical Officer (UD41) Lecturer Head of Pharmacy Department General Honorary Secretary Stakeholder / Agency/ Organisation Representative National Pharmaceutical Control Bureau (NPCB) National Pharmaceutical Control Bureau (NPCB) National Pharmaceutical Control Bureau (NPCB) National Pharmaceutical Control Bureau (NPCB) Pharmacy Enforcement Division, MOH Pharmacy Enforcement Division, MOH Pharmacy Enforcement Division, MOH Pharmacy Enforcement Division, MOH Pertubuhan Perubatan Tradisional India Malaysia (PEPTIM) Malaysian Organisation of Pharmaceutical Industries (MOPI) Malaysian Organisation of Pharmaceutical Industries (MOPI) Malaysian Organisation of Pharmaceutical Industries (MOPI) Direct Selling Association of Malaysia (DSAM) Clinical Research Center (CRC) Universiti Sains Malaysia (USM) Universiti Malaya (UM) Federation Of Chinese Physicians & Medicines Dealers Associations of Malaysia (FCPMDAM)
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17.
Noor Azlina Abdul Rahman Yeo Lee Choo Stephen Sze Kwong Yew Norsiah Hamid Dr. Ariza Zakaria Dr. Asrul Akmal Shafie Prof. Madya Dr. Mohamed Ibrahim Noordin Ting Ka Hua
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No
Name Prof. Dr. Yeoh Peng Nam Lum Wai Hoong Ewe Kheng Huat Sumitha Ganasegaram J S Sunitha Devi Shanmugam Dr. Low Bee Yean Sam Wong
Designation Lecturer, International Medical University (IMU) Pharmacist Managing Director Regulatory Affairs Director Regulatory Affairs & Quality Director Lecturer
Stakeholder / Agency/ Organisation Representative Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS) Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA) International Medical University (IMU) The Federation of Malaysian Consumers Associations (FOMCA) Malaysian Direct Distribution Association (MDDA) National Poison Center
18. 19. 20. 21. 22. 23. 24. 25. 26.
Amy Ding Prof. Madya Razak Hj. Lajis Lecturer
Absent (With Apologies)

No Name Lawrence Cheah Dr. Syid Ayob Syid Mustafa Al -Qudsi Designation Director Stakeholder / Agency/ Organisation Representative Direct Selling Association of Malaysia (DSAM) Malaysian Direct Distribution Association (MDDA) Persatuan Pengeluar-Pengeluar Ubat Tradisional Melayu Malaysia (PURBATAMA) Ministry of International Trade and Industry (MITI)
1. 2. 3. 4.
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GROUP 2 : DRUG AVAILABILITY Attendance

No Name Mohd Hatta Ahmad Rosminah Mohd Din Norhaliza A. Halim Zainab Md Yusuf Noor 'Ain Shamsuddin Dr. Hussain Imam Hj. Mohammad Ismail Ruhaiyem Yahaya Wee Suat Bee Abd. Aziz Dan Aileen Chong Jimmy Piong Ch'ng Kien Peng Abdul Aziz Fazal Mohamad Mohamed Rosli Abdul Rashid Prof. Madya Dr. Habibah A Wahab Dr. Nik Musa'adah Mustapa Prof. Saringat Hj Baie Dr. Tey Kim Kuan Hisyam Yong Abdullah Nik Iryani Nik Ahmad Damian Suraiya Abdul Rahman Billy Yau Designation Director of Pharmacy Enforcement Senior Principal Assistant Director (U52) Principal Assistant Director (U48) Senior Principal Assistant Director (U52) Assistant Director (U41) Head of Department & Senior Consultant of Pediatric, HKL TPKN(F) Perak TPKN(F) Pahang Manager, Duopharma General Manager, Vitacare Pharmacy Managing Director General Manager Senior Manager, Pharmaniaga Senior Principal Assistant Secretary Director of Division Senior Research Officer Lecturer Lecturer Principle Assistant Secretary Pharmacy Officer (U41) Head of Drug Regulatory Affairs Senior Country Manager Stakeholder / Agency/ Organisation Representative Pharmacy Enforcement Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Practice & Development Division, MOH National Pharmaceutical Control Bureau (NPCB) Medical Development Division, MOH Pharmaceutical Services Division, Perak Pharmaceutical Services Division, Pahang Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS) Malaysian Organisation of Pharmaceutical Industries (MOPI) Malaysian Organisation of Pharmaceutical Industries (MOPI) Malaysian Organisation of Pharmaceutical Industries (MOPI) Policy and International Relations Division, MOH Malaysian Institute of Pharmaceutical and Nutraceutical, USM Forest Research Institute Malaysia (FRIM) Universiti Sains Malaysia (USM) International Medical University (IMU) Procurement and Privatisation Division, MOH Procurement and Privatisation Division, MOH Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA)
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22.
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No
Name Tan Booi Charn Dr. Wan Nurdiana Zaireen Zainal Abidin Hamzah Mahadi
Designation Regulatory Affairs and Policy Manager Head, Medical Coordinator, Relief Operation Department Senior Assistant Director Deputy Director Manager Pharmacy Officer U48
23. 24. 25. 26. 27. 28.
Stakeholder / Agency/ Organisation Representative Pharmaceutical Association of Malaysia (PhAMA) Malaysian Medical Relief Society (MERCY) Ministry of Domestic Trade, CoOperation and Consumerisms (MDTCC) Malaysian Industrial Development Authority (MIDA) Kualiti Alam Sdn Bhd Melaka Hospital
Zarina Saad Malini Sailin Halisah Kasdi

No Name Dr. Ng Shiow Fern Mohan a/l K.P Gangadharan Dr. Neelam Shahab Designation Lecturer Sciences Officer (C54) Researcher Stakeholder / Agency/ Organisation Representative Universiti Kebangsaan Malaysia (UKM) Ministry of Science, Technology and Innovation (MOSTI) SIRIM Berhad Malaysian Medical Association (MMA) Association of Private Hospitals of Malaysia (APHM) Ministry of International Trade and Industry (MITI) Economic Planning Unit (EPU) Department of Environmental, Malaysia (DOE) Finance Division,MOH Engineering Division, MOH Traditional and Complementary Traditional and Complementary Medicine Division, MOH Medicine Division, MOH
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 11.
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GROUP 3 : DRUG AFFORDABILITY Attendance

No Name Zawiyah Mat Johor Designation Deputy Director, Pharmacy Development (U54) Senior Principal Assistant Director (U52) Principal Assistant Director (U48) Principal Assistant Director (U48) Senior Principal Assistant Director (U52) Principal Assistant Director (U48) Pharmacist GM, Pharmacy Practice, Guardian Pharmacy Stakeholder / Agency/ Organisation Representative Pharmacy Practice & Development Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Management Division, MOH National Pharmaceutical control Bureau (DCA Secretariat) Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS) Federation of Private Medical Practitioners Associations of Malaysia (FPMPAM) Malaysian Organisation of Pharmaceutical Industries (MOPI) Malaysian Organisation of Pharmaceutical Industries (MOPI) Malaysian Organisation of Pharmaceutical Industries (MOPI) Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA) General Insurance Association of Malaysia (PIAM)
1. 2. 3. 4. 5. 6. 7. 8. 9.
Dr. Ng Swee Choon
Saimah Mat Noor Fatimah Abd. Rahim Helina Abdul Halim Dr. Nour Hanah Othman Rosilawati Ahmad Mariani Ahmad Nizaruddin Wan Hwei Yen
10. 11.
Y. S. Tong Ng Su Yee
Executive Director General Manager, Technical Support & Development Senior General Manager, Pharmaniaga Director of Government Affairs and Medical Affairs Commercial Excellence Manager General Manager
12. 13. 14. 15. 16. 17. 18. 19.
Jamaludin Elis Nathan, Kothandaraman Christopher Dion Henry Francis Del-Val Keh Song Hock Rohan Talalla Narinder Kaur Lee Swee Hua
Head, Corporate & Government Affairs Director, Public Affairs Vice President, Health Services, American International Assurance Bhd
88
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No
Name Y. Bhg. Datin Dr. Hjh. Aziah Datin Dr. Y. Bhg.Ahmad Hjh. Mahayiddin Aziah Ahmad Mahayiddin Prof. Mohamed Izham Mohamed Ibrahim Prof. Mohamed Izham Mohamed Ibrahim Abdul Aziz Mansor Abdul Aziz Mansor
Designation Pakar Perunding Kanan Perubatan / Pakar Pakar Perunding Kanan Perubatan Pakar Perubatan /Respiratori, HKL Perubatan Respiratori, HKL Deputy Dean Deputy Dean Pharmacist Officer (U48) Pharmacist Officer (U48)
Stakeholder / Agency/ Organisation Representative Medical Development Division, MOH Medical Development Division, MOH Universiti Sains Malaysia (USM) Universiti Sains Malaysia (USM) Selayang Hospital Selayang Hospital
20. 20. 21. 21. 22. 22.
Absent (With Apologies) Absent (With Apologies)

No No
1. 1. 2. 2. 3. 3. 4. 4. 5. 5. 6. 6. 7. 7. 8. 8. 9. 9. 10. 10.
Name Name Fatkhiah Abd. Khalil Fatkhiah Abd. Khalil Dr. Ahmad Razid Salleh Dr. Ahmad Razid Salleh Shantini a/p Thevendran Shantini a/p Sudha Sivadas Thevendran Sudha Sivadas Chua Kee Long Chua Kee Long Julia Mohamad Saber Julia Mohamad Saber
Designation Designation Principal Assistant Director Assistant Principal (U48) Deputy (U48) Director Director Deputy Director Pharmacist Officer U48 Pharmacist Officer U48 Principle Assistant Director Principle Assistant Senior DirectorPrincipal Assistant Director Senior Principal Senior Assistant Assistant Director Director Senior Assistant Director
Stakeholder / Agency/ Organisation Representative Stakeholder / Agency/ Organisation Representative Pharmacy Practice & Development Division, MOH Pharmacy Practice & Medical Practice Division, MOH Development Division, MOH Medical Hospital Division, MOH Kajang Practice Kajang Hospital Economic Planning Unit (EPU) Economic Planning Unit (EPU) Planning and Development Division, MOH Planning and Development Planning and Division, MOHDevelopment Division, MOH Planning and Development Malaysian Medical Association Division, MOH (MMA) Malaysian Medical Association Association of Private Hospitals of (MMA) Malaysia (APHM) Association of Private Hospitals of Finance (APHM) Malaysia Division, MOH FinanceHealth Planning Division, Family Division, MOH MOH Family Health Planning Division, MOH
89
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GROUP 4 : QUALITY USE OF DRUGS Attendance

No Name Designation TPKN(F), Wilayah Persekutuan Kuala Lumpur dan Putrajaya TPKN(F) Selangor Senior Principal Assistant Director (U52) Assistant Director (U41) Principal Assistant Director (U48) Principal Assistant Director (U48) Principal Assistant Director (U48) Principal Assistant Director (U48) Assistant Director(U41) Senior Assistant Director (U44) Senior Principal Assistant Director (U52) Assistant Director (U41) Assistant Director (U41) Lecturer, UKM Stakeholder / Agency/ Organisation Representative Pharmaceutical Services Division, Wilayah Persekutuan Kuala Lumpur dan Putrajaya Pharmaceutical Services Division, Selangor Pharmacy Enforcement Division, MOH Pharmacy Enforcement Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Practice & Development Division, MOH Pharmacy Management Division, MOH National Pharmaceutical Control Bureau (NPCB) National Pharmaceutical Control Bureau (NPCB) Pharmaceutical Services Division, WP Kuala Lumpur dan Putrajaya Pharmaceutical Services Division, Selangor Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS) Malaysian Pharmaceutical Society (MPS)
1.
Dr. Salmah Bahri
2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.
Yogeswary a/p Markandoo Mazlan Ismail Mohammad Rizalmazli Salim Noraini Sa'ari Siti Aisah Bahri Wan Mohaina Wan Mohammad Salwati Abd. Kadir Chow Ching Yei Suhailah Abu Bakar Bariah Abd Rani Carolyn Marie Peter Hafsah Md Yusof Prof Dr. P T Thomas Lam Kai Kun Alex Tan C.J Yip Sook Ying Usha Rajasingham Jeff Kong Wong Hooi Fen
Pharmacist Pharmacist Pharmacist Pharmacist Chief Pharmacist, Caring Pharmacy
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No
Name Dr. Steven Chow
Designation
21. 22.
Dr. Chang Keng Wee
Stakeholder / Agency/ Organisation Representative Federation of Private Medical Practitioners Associations of Malaysia (FPMPAM) Federation of Private Medical Practitioners Associations of Malaysia (FPMPAM) Oral Health Division, MOH Ministry of Education Ministry of Information Communication and Culture Medical Development Division, MOH UKM Medical Centre UKM Medical Centre UM Medical Centre Pusat Pengajian Sains Farmasi, USM, Pulau Pinang Pusat Pengajian Sains Perubatan, USM, Kelantan Malaysian Organisation of Pharmaceutical Industries (MOPI) Malaysian Organisation of Pharmaceutical Industries (MOPI) Universiti Malaya Universiti Malaya Universiti Malaya Health Technology Assessment, MOH Bahagian Perkhidmatan Kesihatan, Kementerian Pertahanan Malaysian Medical Association (MMA) Pharmaceutical Association of Malaysia (PhAMA) Pharmaceutical Association of Malaysia (PhAMA) College of Allied Health Sciences
23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38.
Dr. Norlida Abdullah Dr. Samsuddeen Abd. Aziz Tan Hee Looi Dr. Chuah Siew Kee Faridah Md. Yusof Dexter Francis Vandort Amrahi Buang Dr. Mohamed Azmi Ahmad Hassali Dr. Mohd Suhaimi Ab Wahab Khoo Joo Lee Zarina Noordin Assoc. Prof. Dr. Chua Siew Siang Prof. Dr. Hjh Samsinah Hj. Hussain Dr. Fariz Ab. Rani Noormah Mohd Darus Anwar Abdullah
Senior Principal Assistant Director (U52) Assistant Director Principal Assistant Secretary Pakar Perunding Head of Department Assistant Manager Pharmacist (U52) Lecturer Lecturer R&D Manager Senior Manager, Pharmaniaga Lecturer Lecturer Pensyarah Senior Principle Assistant Director (U52) Pengarah Farmasi Committee Member Associate Regulatory Manager Head Of Marketing Pharmacist Officer (U41)
39. 40. 41. 42.
Dr. Mohd Gowdh Akalily Sofina Mohamed Arif Vong Yuit Meng Nurzita Ahmad Nasir
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No Name George Wong Lai Khai Norddin Daud Lt. Kol. Dr. A Halim Hj. Basari Jaarah Mat Designation TPKN(F) Sarawak Principal Assistant Director PS 1 Farmasi Lecturer Stakeholder / Agency/ Organisation Representative Pharmaceutical Services Division, Sarawak Health Education Division, MOH Bahagian Perkhidmatan Kesihatan, Kementerian Pertahanan College of Allied Health Sciences Association of Private Hospitals of Malaysia (APHM) Malaysian Dental Association (MDA) National Union of Journalist Malaysia Kulliyyah of Pharmacy, International Islamic University Malaysia The School of Pharmacy University of Nottingham Malaysia Campus Faculty of Pharmacy International Medical University Academy of Medicine Economic Planning Unit (EPU) Malaysian Administrative Modernisation and Management Planning Unit (MAMPU) Family Health Planning Division, MOH
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.
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GROUP 5 : HUMAN RESOURCES DEVELOPMENT, RESEARCH & DEVELOPMENT AND TECHNICAL CO-OPERATION Attendance
No Name Dr. Faridah Aryani Md. Yusuf Siti Aida Abdullah Designation Principal Assistant Director (U48) Deputy Director , Prevention & Protection (U54) Senior Principal Assistant Director (U52) Principal Assistant Director (U48) Senior Assistant Director (U44) Senior Principal Assistant Director (U52) Senior Principal Assistant Director (U48) Senior Assistant Director (U44) Pharmacist Officer (U48) Pharmacist Officer (U52) Chief Sceintific Officer Senior Manager, Pharmaniaga Dean, Faculty of Pharmacy Lecturer Lecturer Lecturer Lecturer Principal Assistant Secretary Senior Director, Bhg. Tumbuhan Ubatan Assistant Secretary Stakeholder / Agency/ Organisation Representative Pharmacy Practice and Development Division, MOH Pharmacy Enforcement Division, MOH Pharmacy Management Division, MOH Pharmacy Management Division, MOH Pharmacy Management Division, MOH National Pharmaceutical Control Bureau (NPCB) National Pharmaceutical Control Bureau (NPCB) National Pharmaceutical Control Bureau (NPCB) Hospital Sultanah Bahiyah, Alor Setar Clinical Research Centre (CRC) Malaysian Organisation of Pharmaceutical Industries (MOPI) Malaysian Organisation of Pharmaceutical Industries (MOPI) Universiti Teknologi MARA Universiti Teknologi MARA Universiti Sains Malaysia Universiti Teknologi MARA Universiti Malaya Policy and International Relation Divison, MOH Forest Research Institute Malaysia (FRIM) Training Management Division, MOH
1. 2. 3. 4. 5. 6. 7.
Faridah Hanin Ismail Hasnizan Hasan Norhayati Musa Anis Talib Dr. Hasenah Ali
8. 9. 10. 11. 12.
Azura Abdullah Baharudin Baba Dr. Lian Lu Ming Dr. Azizi Ayob Mohd Danil Daud
13. 14. 15. 16. 17. 18. 19. 20.
Prof. Dr. Aishah Adam Shazwani Shaharuddin Prof. Madya Mohd Baidi Bahri Prof. Dr. Mohamed Mansor Manan Junaidah Amir Unny Sankar a/l Ravi Sankar Dr. Rasadah Mat Ali Mohamad Raya bin Mohd Ali
93
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No
Name Maimun Yusoff Ramli Zainal Mohd Isa Wasiman Terence Tan Yew Chin Dr. H Krishna Kumar Norsaedah Mohd Ibrahim Merican Noor Yang Azwar Kamarudin Adrian Abdul Ghani
Designation Deputy Director Pharmacist Research Officer Pharmacist Officer (U41) Chairman Senior Assistant Director Senior Manager Vice Presiden Legal & Regulatory, Strategic & Planning Division
21. 22. 23. 24. 25. 26. 27. 28.
Stakeholder / Agency/ Organisation Representative Human Resource Division, MOH Institute for Health Systems Research (IHSR) Institute of Medical Research (IMR) Institute of Medical Research (IMR) Malaysian Medical Association (MMA) Malaysian Industrial Development Authority (MIDA) Pharmaceutical Association of Malaysia (PhAMA) Malaysian Biotechnology Corporation Sdn Bhd

No Name Dr. Kamaruzaman Salleh Dr. Azizi Ayob Prof. Dato' Dr. Mohamed Isa Abdul Majid Dr. S Asmaliza Ismail Designation Senior Principal Assistant Director (U52) Chief Sceintific Officer Chief Director Stakeholder / Agency/ Organisation Representative National Pharmaceutical Control Bureau (NPCB) Malaysian Organisation of Pharmaceutical Industries (MOPI) Institut Farmaseutikal/Neutraseutikal Negara ,USM NIH Secretariat (IHM) Malaysian Medical Association (MMA) Malaysian Qualifications Accreditation (MQA- Pharmacy) Malaysian Industries Government Group for High Technology (MIGHT) Faculty of Medical Sciences (Pharmacy), UCSI University
1. 2. 3. 4. 5. 6. 7. 8.
Chief Secretary
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LIST OF PANEL MEMBERS

No Name Eisah A. Rahman Designation Senior Director of Pharmaceutical Services Lecturer, Universiti Kebangsaan Malaysia President President President Honorory General Secretary Policy and Research Manager Stakeholder / Agency/ Organisation Representative Pharmaceutical Services Division, MOH Pharmacy Board Malaysian Pharmaceutical Society (MPS) Malaysian Organisation of Pharmaceutical Industries (MOPI) Pharmaceutical Association of Malaysia (PhAMA) Malaysian Medical Association (MMA) The Federation of Malaysian Consumers Associations (FOMCA)
1. 2. 3. 4. 5. 6. 7.
Prof. Dr. P.T Thomas Datuk Nancy Ho Jimmy Piong Ewe Kheng Huat Dato' Dr. NKS Tharmaseelan Cheah Chee Ho
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PANEL DISCUSSION
During this 2 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) Mr. Jimmy Piong Malaysian Organisation of Pharmaceutical Industries (MOPI) En. Ewe Kheng Huat Pharmaceutical Association of Malaysia (PhAMA) Dato Dr. NKS Tharmaseelan Malaysian Medical Association Mr. Cheah Chee Ho Federation of Malaysian Consumer Associations (FOMCA) Prof. Dr. P.T. Thomas Pharmacy Board
b)
c)
d)
e)
f)
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CURRICULUM VITAE OF PANEL MEMBERS 1. DATUK NANCY HO (MPS) Name : Datuk Nancy Ho Bachelor of Pharmacy, Unversity of Otago, New Zealand (1982) 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) 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
Academic Qualications :
Post held in MPS
: : : : : : : :
Professional Commitment : : : :
Work Experience 1. 2. 3. Queen Elizabeth Hospital (1973) Sabah Central Medical Store (1979-1981) 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 Award 1995 - Malaysian Woman Manager of the year by Women at work Magazine 2001 - Anugerah Tokoh Wanita Cemerlang by Jabatan Ketua Menteri Sabah - Tokoh Sukarelawan Kebajikan/Sumbangan Ikhlas Negeri Sabah by Majlis Perkhidmatan Masyarakat Sabah 2003 - State Award PGDK [DATUK] 2004 - Outstanding Jaycee Senator of Junior Chamber Malaysia
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2. JIMMY PIONG TECK ONN (MOPI) Name : Jimmy Piong Teck Onn Bachelor of Science in Pharmacy (Honors), University of Wales, Cardiff, UK (1982) Vice President (2001) President (2007 - 2009) Co-Chairman Malaysias Industry Master Plan 3 for Pharmaceutical Products (2008)
Post held in MOPI
: : :
Work Experience 1. Managing Director - Kotra Pharma (1984 - present 25 years)
3. EWE KHENG HUAT (PhAMA) Name : Ewe Kheng Huat Bachelor of Science (Honors), UM 1982
Work Experience 1. 2. 3. 4. 5. Pharmacist Syalin Enterprise Sdn.Bhd. (1983-1984) National Sales Manager Wellcome (M) Sdn.Bhd (1984-1994) Country Manager Summit Company (M) Sdn.Bhd. (1994) Country Manager MSD Malaysia (1997) Managing Director MSD, Malaysia (2002- present)
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4. DATO DR. NKS THARMASEELAN (MMC) Name : Dato Dr.Nks Tharmaseelan 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) Hon. Gen. Secretary (2009-2010) Chairman PPSMMA (2005-2007) 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
Academic Qualications : : : :
Post held in MMA
Posts held other medical NGOs :
: :
Work Experience 1. 2. 3. 4. 5. General Hospital Klang (1976) Medical Ofcer Hospital Tanjung Karang Registrar in O&G GH Klang and University Hospital Consultant O&G ( GH Kuala Lumpur, Melaka and Seremban) Private practice (since 1990)
5. CHEAH CHEE HO (FOMCA) Name : Cheah Chee Ho Bachelor Sains (Pengajian Makanan) Universiti Putra Malaysia (2004)
Work Experience 1. 2. 3. Manager of policy and research (FOMCA) Active in civil society represented FOMCA in Coalition against the privatization of healthcare Active in other NGO Coalitions on drug patents and access to medicines
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6. PROF. DR. P. T. THOMAS (PHARMACY BOARD MALAYSIA (PBM) Name : Prof. Dr. P.T. Thomas Bachelor of Pharmacy, Nagpur University, India Master of Science, University of Texas, Austin, USA PhD in Pharmacology/Toxicology, University of Texas, Austin, USA 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
Academic Qualications : : :
Post held in PBM
Work Experience 1. 2. 1977 Present - Hospital Kuala Lumpur / National Pharmaceutical Control Bureau - Professor of Pharmacy Practice, Faculty of Pharmacy, Universiti Kebangsaan Malaysia.
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ABBREVIATIONS ADR AG APC APPL APHM BE CME CPD CTIL CTX CVD DCA DIC DOE DTC EBM ED FOMCA FPMPAM FRIM GCP GGM GLP GMP GP HCPs HS ICT IP JPA LIAM LT MDG MDTCC MERCY MIDA MINDEF MITI MMA MOE - Adverse Drug Reactions - Attorney General - Annual Practicing Certicate - Approved Products Purchase Lists - Association of Private Hospitals of Malaysia - Bioequivalence - Continuous Medical Education - Continuing Professional Development - Clinical Trial Import License - Clinical Trial Exemption - Cardiovascular Disease - Drug Control Authority - Drug Information Centre - Department of Environment - Drug Therapeutic Committee - Evidence Based Medicines - Essential Drugs - Federation of Malaysian Consumers Association - Federation of Private Medical Practitioners Associations Malaysia - Forest Research Institute of Malaysia - Good Clinical Practice - Good Governance in Medicines - Good Laboratory Practice - Good Manufacturing Practice - General Practitioners - Healthcare Providers - Health Supplements - Information and Communication Technology - Intellectual Property - Public Services Department - Life Insurance Association of Malaysia - Long Term - Millennium Development Goals - Ministry of Domestic Trade, Co-Operatives and Consumerism - Malaysian Medical Relief Society - Malaysian Industrial Development Authority - Ministry of Defence - Ministry of International Trade and Industry - Malaysian Medical Associations - Ministry of Education
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MOF MOH MOHE MOPI MOSTI MPS MQA MSQH MTAC MyIPO NEDL NGOs NHFM NHFS NIH NMRR NMP NMUS NPCB OECD OTC PBS PhAMA PIAM PEN PIL PMS PSD QC Q1 Q3 R&D RRP SIRIM ST STG TBD TCM TOR TRIPS UMMC USM WHO
- Ministry of Finance - Ministry of Health - Ministry of Higher Education - Malaysian Organization Pharmaceutical Industry - Ministry of Science, Technology & Innovation, Malaysia - Malaysian Pharmaceutical Society - Malaysian Qualications Agency - Malaysian Society For Quality in Health - Medication Therapy Adherence Clinic - Intellectual Property Corporation of Malaysia - National Essential Drug List - Non-Government Organizations - National Healthcare Financing Mechanism - National Health Financing Scheme - National Institute of Health - National Medical Research Register - National Medicines Policy - National Medicines Use Survey - National Pharmaceutical Control Bureau - Organisation for Economic Co-operation and Development - Over The Counter - Pharmaceutical Benets System - Pharmaceutical Association of Malaysia - General Insurance Association of Malaysia - Pre- Export Notication - Patient Information Leaet - Post Marketing Surveillance - Pharmaceutical Services Division - Quality Control - Quarter 1 - Quarter 3 - Research & Development - Recommended Retail Price - Standard and Industrial Research Institute of Malaysia - Short term - Standard Treatment Guidelines - To Be Determined - Traditional Complementary Medicines - Terms of Reference - Trade Related Intellectual Property Rights - University Malaya Medical Center - Universiti Sains Malaysia - World Health Organisation
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Photo Gallery
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Pa r t i c i p a n t s
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R eg is t r a t i o n
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O p e n i n g
C e r e m o ny
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G r o u p
D i s c u s s i o n
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Panel Discussion & Group Presentation
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O t h e r s
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National Medicines Polic y Mid-Term Review Workshop

National Medicines Policy Mid-Term Review Workshop

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National Medicines Polic y Mid-Term Review Workshop

First Printing: December 2009

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National Medicines Polic y Mid-Term Review Workshop

WELCOMING ADDRESS BY SENIOR DIRECTOR OF PHARMACEUTICAL SERVICES, MINISTRY OF HEALTH MALAYSIA

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Slide 27 Routine reports such as QA and KPIs. 26

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Plans of Action of DUNAS

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