Information on WHO International Drug Monitoring Program

1. B Y
S N E H A K H A N D A L E
A S S I S T A N T P R O F E S S O R
S h r e e y a s h I n s t i t u t e o f P h a e m a c e u t i c a l
E d u c a t i o n a n d R e s e a r c h , A u r a n g a b a d
WHO International drug
monitoring program

2. Contents
 Introduction
 History
 Functions of International Drug Monitoring
 UMC’s role as WHO Collaborating centre
 Role of WHO in pharmacovigilance
 Reporting procedure
 Pharmacovigilance methods
 VigiBase

3. INTRODUCTION
 In 1963, during the 16th world assembly a resolution called for a
systemic collection of information on serious adverse drug reactions
during the development and particularly after medicines have been
made available for public use. This led to the formation of WHO
Program for International Drug Monitoring (PIDM).
 Initially the WHO PIDM members consisted of 10 countries.
 Currently, 143 countries are members of the WHO PIDM. Another
28 associate member countries are in the early stages of establishing
their pharmacovigilance systems in preparation for full membership.
 The ten founder members of the WHO Program in 1968 were
Australia, Canada, Czechoslovakia, Federal Republic of Germany,
Ireland, Netherlands, New Zealand, Sweden, United Kingdom, USA.
 WHO PIDM members submit reports of adverse reactions associated
with medicinal products, known as Individual Case Safety Reports
(ICSRs) to the global database VigiBase.

4. HISTORY
 The establishment of the WHO Program followed the thalidomide
disaster of 1961.
 In 1963, during the 16th World Health Assembly, formation of the
WHO Program for International Drug Monitoring.
 In 1971, an international database was established at WHO headquarter
in Geneva.
 In 1978, this database, now known as VigiBase, moved to Uppsala
(Pilot project in USA. Move to Switzerland and then to Sweden).

5. WHO HQ in Geneva
• To become an associate member country, the government of a country
needs to send an official application to the WHO HQ in Geneva. To
become a full member the country also needs to send at least 20 ADR
reports in a correct format.
WHO Collaborating Centers (+6)
•UMC Sweden
•Morocco
•The Netherlands
•Norway
•India

7. Functions Of Who PIDM Include
 Identification and analysis of new adverse reaction.
 Information exchange between WHO and National centers.
 Publication of periodical news letters, guidelines and books in the
Pharmacovigilance and risk management area.
 Supply of tools for management of clinical information including ADR case
reports
eg. WHO Drug Dictionary
WHO Adverse Reaction Terminology.
 Provision of training and consultancy support to National centers and
countries establishing Pharmacovigilance system.
 Computer software for case report management designed to suit the needs of
National centers.
 Annual meetings for representative of national centers at which scientific
and organizational matters are discussed.
 Methodological research for the development of pharmacovigilance as a
science

8. Functions of WHO HQ
 Exchange of Information
National Information Officers
Publications (WHO Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug
Information)
 Policies, guidelines, normative activities
The Importance of PV (2002)
Safety Reporting - A guide to detecting and reporting adverse drug reactions (2002)
Policy perspectives on medicines (PV) 2004
Safety monitoring of herbal medicines (2004)
PV in Public Health
 Country support Training courses on PV
Training courses on pharmacovigilance
Address specific / stated needs: antimlalarials….
Annual Meeting of PV Centre
 Collaborations or partnership
 Resource mobilization
Gates foundation
European commission
Global Fund

9. WHO Collaborating Centre the Uppsala Monitoring Centre
(UMC)
 Established as a foundation 1978
 Based on agreement Sweden – WHO
 International administrative board
 WHO Headquarters responsible for policy
 Self financing
 Six board members – three appointed by the government and three
appointed by WHO.
 UMC runs the program but WHO is responsible for policy issues.

10. UMC’s role as a WHO Collaborating Centre
 UMC is one of five officially designated collaborating centers.
 UMC is responsible for managing the technical and scientific aspects
of the WHO’s worldwide pharmacovigilance network.
It includes:- 1) Analyzing VigiBase data and identifying signals of
potential safety problems.
2)Pursue research.
3) Broadening the scope of pharmacovigilance through debate, research
and consultation.
4) To collect, assess and communicate information from member
countries about benefits, harms and risks of drugs to improve patient
therapy and public health worldwide.
5) To collaborate with member countries.
6) Developing and providing data-entry, management, retrieval and
analysis tools such as VigiFlow and VigiLyze.

11. Role of WHO in Pharmacovigilance
 To identify ADR that could not be found through clinical trial
program.
 Collecting case reports.
 Uppsala Monitoring Centre, Sweden.
 Jobs performed:
1) Signal detection
2) Signal review
3) Education and advisory
4) Research & Development

12. Signal detection Primary UMC task
 Identification of previously unknown drug reactions; Our primary goal is to
find signals as early as possible
(WHO definition)
Reported information on a possible causal association between an adverse event
and a drug, the relationship being unclear or incompletely documented
previously.
Information that arises from one or multiple sources (including observations and
experiments), which suggests a new potentially causal association, or a new
aspect of a known association, between an intervention and an event or set of
related events, either adverse or beneficial, that is judged to be of sufficient
likelihood to justify verificatory action.
The process of signal management in PV is a set of activities, which aim to
determine whether there are new risks associated with a particular drug, or
whether known risks associated with a particular drug have changed.

14. Advisory Committee on Safety of Medicinal Products (ACSoMP)
 ACSoMP was established in 2003 to provide advice to WHO, including
its Collaborating Centre for International Drug Monitoring (the UMC),
and through it to the Member States of WHO, on safety issues relating
to medicinal products.
 It guides WHO on general and specific issues related to
Pharmacovigilance (PV).
 The Committee is composed of 12 members drawn from the WHO
Expert Advisory Panels for Drug Evaluation and for Drug Policies and
Management and, where appropriate, in consultation with other
relevant WHO clusters and expert advisory panels.
 ACSoMP meets once a year to discuss ongoing and new PV topics, with
particular focus on issues related to public health programes.

17. VigiBase
 VigiBase is UMC’s starting-point for the journey from data to wisdom
about safer use of medicines and wise therapeutic decisions in clinical
practice.
 It is the driving-force at the heart of the work of UMC and the WHO
Programe.
 Since 1978 UMC has been responsible for the development and
maintenance of VigiBase.
 The purpose is to ensure that early signs of previously unknown
medicines-related safety problems are identified as rapidly as possible