E-DRUG: Pharmacovigilance in public health: reviewers needed
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[E-drug has been asked to help source reviewers for this WHO publication.
Pharmacovigilance is nearly absent in developing countries, so it might be
useful if some e-druggers read the draft manual from their perspective and
comment on it. The table of contents is attached as well. Interested people
please approach mary Couper directly at couperm@who.int WB]
PHARMACOVIGILANCE IN PUBLIC HEALTH
A draft manuscript has been prepared which presents the case for integrating
pharmacovigilance into public health programmes. Ideally, every public
health programme should have a pharmacovigilance component and every
pharmacovigilance programme should have a risk/benefit component. It
highlights the critical strengths and weaknesses of both pharmacovigilance
systems and public health programmes and argues for the importance of using
a public health programme as an entry point for the establishment of a fully
functioning pharmacovigilance system. The document also highlights the
importance of collaboration and communication between pharmacovigilance
systems and public health programmes at both the national and international
level to ensure full integration.
It is intended primarily for policy makers and programme managers. More
detailed information for particular programmes should be formulated by the
specific public health programme.
The contributing authors are: Ms Niamh Arthur, Dr David Coulter, , Mr Murilo
Freitas Dias, Dr Li Dakui, Professor I.R Edwards, Professor Peter I. Folb,
Dr A. Feight, Dr Kenneth Hartigan-Go, Professor Nilima A. Kshirsagar, Mr S.
Olsson, Dr June Raine, Mr L. Bruce Rowsell, Dr Gunilla Sj�l�n-Forsberg, and
Dr Rachida Soulaymani-Bencheikh.
WHO is now soliciting comments on this manuscript. We need the input from
public health specialists. If you are interested in reviewing this, the
full text of 52 pages can be obtained from:
Dr Mary R. Couper
Quality Assurance and Safety: Medicines
Department of Essential Drugs and Medicines Policy
World Health Organization
20, Avenue Appia
1211 Geneva, Switzerland
Tel: +41 22 791 3643/2337
Fax: +41 22 791 4730
Email: couperm@who.ch
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PHARMACOVIGILANCE IN PUBLIC HEALTH
TABLE OF CONTENTS
1. Introduction
2. Public Health Programmes
2.1. The aim
2.2. The current scenario
2.3. Organization
2.4. Future needs of Public Health Programmes
3. Pharmacovigilance
3.1. Definition
3.2. Aims
3.3. The current scenario
3.4. Organization
3.5. Good pharmacovigilance practice
4. Effectiveness and risk assessment of therapies
4.1. Effectiveness and risk; benefit and hazard
4.2. Decision making
Good decision making practices
5. Pharmacovigilance/ public health programmes � current situation
5.1. Weaknesses
5.2. Strengths
5.3. Vaccines example
6. Integration of pharmacovigilance into Public Health Programmes
6.1. Introduction
6.2. Justification
6.3. Requirements for pharmacovigilance in public health
6.4. Cohort Event Monitoring
6.5. Roles and responsibilities
6.6. Training and capacity building
6.7. Evaluation of the system
7. Recommendations and conclusions
Examples Vaccines; malaria
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