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GENERAL SECRETARIAT
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MEDICINES REGULATORY AUTHORITY OF MADAGASCAR
NATIONAL
PHARMACOVIGILANCE
POLICY
OF MADAGASCAR
PREFACE
The development of the political and socio-economic policies which marked the development of Madagascar over the past few years, led the Ministry of Public Health to start a process of reform of the health sector. This is based on decentralisation, improvement in the quality of service as well as on the promotion of partnership and community participation in health development.
These reforms are certainly very timely in the context of our National Pharmaceutical Policy which aims to render accessible and available medicines, as well as the WHO recommendations, in particular those concerning the improvement in patient's safety by the continuous monitoring of the impact on healthcare products. This National Pharmacovigilance Policy, presenting the main strategic guidelines, constitutes a reference which any stakeholder involved in health development should consult and put into practise for the harmonisation of activities.
The implementation of the content of this document will undoubtedly contribute to an improvement in the prescribing of drugs and encourage greater use by the population of health centres, thus facilitating the detection and management of adverse effects of medicines, as well as their reporting.
Therefore, I invite all health professionals to adhere thereto and to make their effective contribution in the application of this policy for better patient health safety.
Done in Antananarivo on
Ministry of Public Health
[Signature]
LIST OF CONTENTS
INTRODUCTION ………………………………………………………………………………………………………………………………………6
I- CURRENT SITUATION OF PHARMACOVIGILANCE IN MADAGASCAR 7
I-1 National Pharmaceutical Policy 7
I-1 Principles of the National Pharmaceutical Policy 7
I-1-2 Vision 7
I-1-3 Aim 7
I-1-4 Specific objectives 7
I-1-5 Strategic priorities and main activities 7
I-2- National Pharmacovigilance System 9
I-2-1- Background 9
I-2- Organisation of the National Pharmacovigilance System ……………………………………………….9
I-3 Legislative and regulatory framework 12
I-4 Resources 12
I-4-1 Human Resources 12
I-4-2 Material Resources 12
I-4-3 Financial Resources 13
I-5 Activities carried out 13
I-5-1 Training 13
I-5-2 Reporting of adverse effects of medicines 14
I-5-3 Communications 15
I-5-4 Raising awareness 15
I-5-5 Formative follow-up and monitoring 16
I-5-6 Activities of the Unit providing Information on Medicines and Poisons (UNIMINTOX) 16
I-5-7 International Relations 17
II- OBJECTIVES OF THE NATIONAL PHARMACOVIGILANCE POLICY 18
II-1- General objective 18
II-2- Specific objectives 18
III- STRATEGIC LINES 18
III-1- Setting up of a legislative and regulatory framework governing pharmacovigilance 18
III-2- Progressive decentralisation of the system 18
III-3-Participation in the international Drug Surveillance Network 20
CONCLUSION 22
APPENDICES 23
ACRONYMS
ACT: Artemisinin based Combination Therapy
Afssaps: Agence française de sécurité sanitaire des produits de santé (French Health Products Safety Agency)
AMFm: Affordable Medicines Facilities for malaria (Facilité de Médicaments Antipaludiques à des
prix Abordables)
CAPM: Anti-poison and Pharmacovigilance Centre of Morocco
CAPQ: Centre Anti Poison du Québec (Quebec Anti-Poison Centre)
CDC: Central Disease Control
CHD: Centre Hospitalier du District (District Hospital)
CHU: Centre Hospitalier Universitaire (University Hospital)
CHU A.: Centre Hospitalier Universitaire d’Antananarivo (Antananarivo University Hospital)
CNPV: National Pharmacovigilance Centre
CPPV: Provincial Pharmacovigilance Centre
CSB: Basic Health Centre
DRSP: Regional Public Health Directorate
EIM: Undesirable Side Effects
FDF: Training of Trainers
FN: Package Insert
GF 7: Global Fund Round 7
HJRA: Hôpital Joseph Ravoahangy Andrianavalona
IEC: Information Education Communication
MSANP: Public Health Ministry
NSA: National Strategy Application
OMD: Millennium Health Development Goal
WHO: World Health Organisation
SO: Specific Objective
ACRONYMS (cont.)
Pact: Private Agency Collaborating Together
PEC: Taking responsibility
EPI: Expanded Programme of Immunisation
PhV: Pharmacovigilance
PMI: Presidential Malaria Initiative
PNLP: National Anti-Malaria Programme
PPN: National Pharmaceutical Policy
RBM: Roll Back Malaria
SDSP: District Public Health Department
UGP: Project Management Unit
UMC: Uppsala Monitoring Centre
UNICEF: United Nations Children’s Fund
UNIMINTOX: Drug and Poisons Information Centre
USAID: United States Agency for International Development
USP: United States Pharmacopeia
LIST OF APPENDICES
Appendix I : Notification Sheet listing the adverse effects of medicines/vaccines
Appendix II : List of participants at the National Pharmacovigilance
Validation Workshop
Appendix III : List of members of the Committee involved in compiling the National Pharmacovigilance Policy (draft 0)
Appendix IV : List of participants at the National Pharmacovigilance Policy validation Workshop
Appendix V : Recommendations of the National Pharmacovigilance Policy
Validation Workshop
INTRODUCTION
Within the framework of the health sector reforms, the Ministry of Public Health defined a "National Health Policy" which aims to guarantee each individual of a standard of health enabling him/her to lead a socially and economically productive life.
To this end, where it appears that one of the basic objectives of the "Poverty Reduction Strategy Paper" is "human and material security and social protection", and, following the adoption of the National Pharmaceutical Policy, which aims at ensuring the entire population of efficient and effective pharmaceutical services which are sustainable, equitable and affordable with essential safe, efficient, quality and correctly used medicines, the definition of a "National Pharmacovigilance Policy" is absolutely essential.
In fact, the main aim of pharmacovigilance is the improvement in the safety of patients by the continuous monitoring of the health impact of the use of health products and by the evaluation of the risk/benefit ratio of these products. The WHO defines it as a "science and activities related to the detection, evaluation, understanding and prevention of adverse effects or any other problem linked to health products put on the market against payment or free of charge, irrespective of whether this is a proven or potential risk". This definition shows that pharmacovigilance does not only study the adverse effects of medicines but also all problems linked to the use of the medicines. The implementation of the National Pharmaceutical and Pharmacovigilance Policies will thus contribute to the reaching of the Millennium Development Goals (MDGs) for health.
This document, which serves as a reference framework in the same manner as that of the National Pharmaceutical Policy, defines the objectives and main strategic lines set for its implementation.
I- CURRENT SITUATION OF PHARMACOVIGILANCE IN MADAGASCAR7
I-1 National Pharmaceutical Policy 7
The National Pharmaceutical Policy (NPP) of Madagascar, drafted in November 2005 and revised at the end of 2011, takes into account the basic elements for the revitalisation of the pharmaceutical sector in Madagascar. It highlights in particular the directions to be taken and the strategies to be developed concerning the pharmaceutical products, processes required to ensure access to medicines by the entire population and the system for the supply of pharmaceutical products.
I-1-1 Principles of the National Pharmaceutical Policy
The National Pharmaceutical Policy of Madagascar is based on four principles:
o Human Rights: the right to health constitutes a fundamental human right;
o Essential Medicines: medicines which satisfy the priority health needs of the population;
o The pharmaceutical care approach which is aimed at improving or maintaining the patients' quality of life;
o The effective partnership to ensure pharmaceutical services.
I-1-2 Vision
To have coherent pharmaceutical services which are managed in an efficient manner so as to make essential medicines accessible to the entire Madagascan population.
I-1-3 Aim
Provide the entire Madagascan population with efficient and effective pharmaceutical services, which are sustainable, equitable and affordable with safe, efficient, quality and correctly used essential medicines.
I-1-4 Specific objectives
o Make medicines available and accessible, including products of specific programmes;
o Restructure the logistical and pharmaceutical framework;
o Ensure the quality of inputs for human consumption;
o Improve the cooperation and partnership between countries.
I-1-5 Strategic lines and main activities
To reach these objectives the PPN (National Pharmaceutical Policy) has established 4 strategic lines
I-1-5-1 Quality assurance
To have quality, safe and efficient medicines according to legal and professional standards, it is necessary to:
o Develop and introduce a coherent national pharmaceutical quality assurance system;
o Encourage collaboration within the framework of pharmaceutical quality control;
o Develop and promote the application of quality management principles respecting the pharmaceutical quality assurance of public and private sectors;
o Favour the involvement of the pharmaceutical industry, private sector, health professionals and consumers in the field of pharmacovigilance and monitoring of medicines after being launched on the market;
o Support the pharmaceutical inspection department with human, material and financial resources.
I-1-5-2 Pharmaceutical care
For a pharmaceutical service focussed on the patient for better therapeutic results, it is recommended to:
o Develop and implement a strategy to institutionalise pharmaceutical care, taking into account the recommendations, tools and skills;
o Promote the application of pharmaceutical care principles at all levels of the health system.
I-1-5-3 Therapeutic and medical information
To access unbiased, accurate and practical information on medicines and therapies, it is advisable to:
o Develop, re-examine and communicate information on medicines and therapies, in particular by initially concentrating on recommendations at the time of administering first aid;
o Support the institutions responsible for medicines, in particular the pharmacovigilance department of the Medical Drug Agency, to improve treatment practises and the use of medicines;
o Establish and support an effective national medicines and poisons information service.
I-1-5-4 Use of medicines by consumers
For the rational use of medicines by consumers, it is necessary to:
o Formulate and initiate an effective IEC strategy amongst consumers;
o Strengthen current regulations on advertising and the promotion of medicines by including products originating from traditional medicine and therapeutic nutritional supplements;
o Establish an efficient mechanism to monitor consumers' reactions and claims regarding problems encountered with medicines;
o Involve and make accountable consumers and all competent stakeholders in the appropriate use of medicines and information related thereto;
o Collaborate with the Ministry of Information in order to draw up a public education programme in order to prevent self medication.
As the main objective of the NPP (National Pharmaceutical Policy) is to ensure the availability of safe and effective medicines, the implementation of pharmacovigilance is therefore necessary for better care of patients and above all to improve their safety.
I-2- National Pharmacovigilance System
I-2-1- Background
Up until 2005, the activities of the Pharmacovigilance Department were very limited and consisted of collecting information on medicines and above all the distribution of warnings from the WHO, AFSSAPS and pharmaceutical laboratories.
At the end of 2005, the change in the National Anti-Malaria Policy, by the introduction of ACTs to care for simple malaria cases, required the implementation of pharmacovigilance for their safe use.
Thus, in February 2006, a workshop was organised to define a pharmacovigilance system applicable to Madagascar. Then the Pharmacovigilance Department of the Medical Drug Agency of Madagascar was appointed as the "National Pharmacovigilance Centre" (CNPV).
To support the CNPV, the Drug and Poisons Information Centre (UNIMINTOX) was set up in December 2008 through collaboration between the Medical Drug Agency of Madagascar and the Antananarivo Hospital "Hôpital Joseph Ravoahangy Andrianavalona (CHUA/HJRA) and with financing from the US Pharmacopeia/USAID.
I-2- Organisation of the National Pharmacovigilance System
The 2006 workshop defined the following organisation to be applied in Madagascar:
I-2- Organisation of the National Pharmacovigilance System
MSANP (Ministry of Public Health):
NATIONAL PHARMACOVIGILANCE
Centre
NOTICES
Health Professionals
The powers of the entities making up the system are described below:
I-2-2-1 Role of the National Pharmacovigilance Centre
o Collect and distribute information on adverse drug reactions (ADR);
o Centralise the EIM declarations;
o Evaluate the causal link between the medicine(s) and the adverse effect through accountability mechanisms;
o Create a data bank;
o Respond to the requests for information on ADRs and other health products;
o Ensure contact between the International Pharmacovigilance Centre (UPPSALA MONITORING CENTRE);
o Schedule Pharmacovigilance enquiries and investigations;
o Organise prevention campaigns for the public;
o Participate in the teaching and training of health professionals with regard to pharmacovigilance;
o Generate warnings in the field of Pharmacovigilance. I-2-2-2 Role of the Pharmacovigilance Technical Committee
This committee constitutes a permanent unit of pharmacology and public health experts, as well as clinical experts.
It is entrusted with:
o Evaluating the causal link between the drug(s) and the adverse effect through accountability mechanisms;
o Evaluating the risks incurred by man and proposing measures to be adopted in the event of a serious ADR;
o Preparing the works of the National Pharmacovigilance Committee;
o Providing technical advice on all matters of a scientific nature
brought before the National Pharmacovigilance Centre;
o Deciding on the opportunity for pharmacovigilance enquiries.
I-2-2-3 Role of the National Pharmacovigilance Committee
o Validating the National Pharmacovigilance Policy;
o Defining a legislative and regulatory framework for Pharmacovigilance;
o Analysing the warnings and advising the Ministry of Public Health on measures to be adopted.
I-2-2-4 Role of Health Professionals
Doctors, dental surgeons, pharmacists, nurses and midwives must collaborate on the safety of use of medicines and must therefore:
o Notify the National Pharmacovigilance Centre as soon as possible:
Ø of any alleged adverse reactions in relation to the use of one or several medicines;
Ø any observation of abuse or misuse;
Ø any other effect that they deem pertinent to declare (withdrawal symptoms, incorrect treatment, therapeutic ineffectiveness etc.).
o Respond to the requests of the National Pharmacovigilance Centre to document the initial observation.
o Keep the documents concerning the alleged adverse effects in order, if need be, to supplement previous information made available.
o Keep themselves informed and take into account in their professional practise data on the tolerance of medicines that they prescribe, dispense or administer.
I-3 Legislative and regulatory framework
To date, no law governs pharmacovigilance, apart from the following measures:
· Appointment of the Pharmacovigilance Department as the "National Pharmacovigilance Centre" by letter no 029-SANPF of 14 February 2006 confirmed by order No 2010-0960 of 30 November 2010 on the creation, organisation and operating of the Medical Drug Agency of Madagascar;