The WHO International Drug Monitoring Program was established in 1963 in response to the thalidomide disaster. It aims to collect reports of adverse drug reactions from member countries. The program has grown from 10 founding members to 143 member countries currently. Countries submit individual case safety reports to the global Vigibase database managed by the Uppsala Monitoring Centre in Sweden, a WHO collaborating center. The program identifies new safety issues, facilitates information exchange between countries, and provides tools and training to support pharmacovigilance systems globally.

1. Class :- Final Year
Roll no:- 11 , 12 , 13.
Topic Name:- WHO International Drug
Monitoring Program

2. WHO INTERNATIONAL DRUG
MONITORING PROGRAM

3. WHO INTERNATIONAL DRUG MONITORING
PROGRAM
 In 1963, during the 16th world assembly a resolution called for systemic collection of
Information on serious adverse reactions during development and particularly after
medicine have been made available for public use. This leds to the formation of WHO
program for International Drug monitoring (IDMP )
 Initially the WHO IDMP members consisted of 10 countries.
 Currently 143 countries are members of WHO IDMP. Another 28 associate member countries
are in early stages of establishing their pharmacovigilance Systems In preparation for full
membership
 The ten founder members of the WHO program in 1968 there Australia, Canada,
Czechoslovakia, Federal Republic of Germany, Ireland. Netherlands New Zealand, Sweden,
UK, USA.

4.  WHO PIDM Members submit reports of Adverse reactions associated with the medicinal
product Known as individual case safety report ( ICSR ) to the global database vigibase
.
 The establishment office WHO program followed the thalidomide disaster on 1961 .
 In 1963 during the 16th World Health Assembly Formation of the WHO program for
International drug monitoring.
 In 1971 on International database was established at WHO headquarter in Geneva.
 In 1978, this data base, now known as vigibase, moved to Uppsala.
WHO INTERNATIONAL DRUG MONITORING
PROGRAM

5. WHO Headquarters In Geneva :-
To become an associate member country the government of country needs to send an
official application to WHO Headquarter In Geneva To become a fall member the country
also needs to send at least 20 ADR Reports to correct format.
WHO collaborating centers (+6)
1) Uppsala monitoring center .
2) Morocco .
3) Netherlands .
4) Norway
5) India

6. Functions of IDMP :-
 Identification and analysis of new adverse drug reaction .
 Information exchangbetween 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. For
example :- WHO Drug dictionary . & WHO Adverse drug reaction Terminologies .
 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.

7. Functions of IDMP :-
 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.
 Exchange of Information National information officer’s. Publications ( WHO Pharm
newsletter , restricted pharm list Drug center’s.
 Policies, guidelines, normative activities . policy perspective on medicines
Pharmacovigilance in public health.
 Country support training courses on pharmacovigilance. Annual meetings of PV center.

8. WHO Collaborating center the
Uppsala monitoring center ( UMC )
 Established as Foundation .
 Based on agreement between Sweden- WHO .
 International Administrative board.
 Self Financing.
 Six board members :- 3 appointed by government and 3 appointed by WHO .
 UMC runs the program but WHO IS responsible for policy issues .

9. UMC’s Role as WHO Collaborating center :-
 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 :- Analyzing vigibase data and identifying. Signals of potential safety problems.
 Pursue research
 Broadening scope of pharmacovigilance through database Research & constitution .
 To collect, assess and communicate information from member countries about benefits, harms
and risks of drugs to improve patient therapy. and public health worldwide.
 To collaborate with member Countries .
 Developing and providing data-entry, management, retrieval and analysis tools such as Vigiflow
and vigilyse .

10. Role of WHO in PV:-
 To identify ADR that could not be found through clinical program.
 Collecting case reports .
 UMC, Sweden.
 Job performed :-
 1) Signal detection.
2) Signal review.
3) Education and advisory .
4) Research & Development.