1. WHO Programme for International Drug Monitoring
Shanthi Pal
Quality Assurance and Safety of Medicines
World Health Organization

2. In the sixties…
In1960s..

3. Forty+ years later……
Article published 1961 in The Lancet. Resulted in the birth of pharmacovigilance. Before this catastrophy the general opinion about drug use was only positive. No negative effects were expected. Phocomelia means ’limbs like a seal’.

4. 16th World Health Assembly 1963
Assembly Resolution Clinical and Pharmacological Evaluation of Drugs INVITES Member States to arrange for a systematic collection of information on serious adverse drug reactions observed during the development of a drug and, in particular, after its release for general use.

5. WHO Drug Monitoring Programme Founding Members 1968
10 countries in the beginning. Pilot project in USA. Move to Switzerland and then to Sweden.

6. 96 Full Members and 28 Associate Members
At the moment there are 94 full member countries and 28 associate member countries. 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. Less member countries in Africa but a major increase recently.

7. WHO Programme for International Drug Monitoring
Vaccines
HQ-WHO
+ 6 Regional
offices
WHO
Collaborating
Centre, Uppsala
HIV/AIDS
Malaria
Chagas
National
Centres
Others

8. Advisory Committee on Safety of Medicinal Products (ACSoMP)
The Advisory Committee on Safety of Medicinal Products shall provide advice on pharmacovigilance policy and issues related to the safety and effectiveness of medicinal products
to the relevant Assistant Director-General in WHO and through him / her
to the Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre), and
to the Member States of WHO.

9. Pharmacovigilance in WHO HQ
Exchange of Information
Policies, guidelines, normative activities
Country support
Collaborations
Resource mobilisation

10. 1. Exchange of Information
National Information Officers
Publications (WHO Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug Information)

11. 2. Policies, Guidelines and Normative Activities
The Importance of Pharmacovigilance (2002)
Safety Reporting - A guide to detecting and reporting adverse drug reactions (2002)
Policy perspectives on medicines (Pharmacovigilance) 2004
Safety monitoring of herbal medicines (2004)
Pharmacovigilance in Public Health

12. 3. Country support Training courses on pharmacovigilance
10 courses offered in 2008
Training courses on pharmacovigilance
Address specific / stated needs: kava, ARVs, antimlalarials….
Annual Meeting of Pharmacovigilance Centres

13. 4. Collaborations & Partnerships within WHO
Over a 100 million people targeted for either diethylcarbamazine citrate (DEC) plus albendazole or ivermectin plus albendazole.
Malaria
HIV/AIDS
Leprosy
Lymphatic Filariasis
Leishmaniasis
Chagas
Patient Safety
Poisons and Chemicals Safety
Traditional Medicines
Vaccines

14. 5. Resource Mobilisation
Gates foundation
European commission
Global Fund
Others
Human resources: PvSF

15. WHO Collaborating Centre the Uppsala Monitoring Centre
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 programme but WHO is responsible for policy issues.

16. Signal detection Primary UMC task
Identification of previously unknown drug reactions
Our primary goal is to find signals as early as possible.

17. What is a signal?
A WHO signal is a hypothesis together with data and arguments. A signal is not only uncertain but also preliminary in nature: the situation may change substantially over time one way or another.

18. Flow of ADR reports

19. Technical support Guidelines Reporting format etc. Terminologies
WHO Adverse Reaction Terminology
WHO Drug Dictionary
ATC Classification
Software development
VigiFlow
VigiSearch/VigiMine

20. Pharmacovigilance training
Uppsala
2 weeks
25-40 participants
12th course May 2009
Regional courses with WHO
National courses
The UMC has held an ADR course in Uppsala every other year since This course is an important basic education for new member countries. It should help and encourage the participants to establish an ADR centre in their own country. Many invitations to the course are sent out all over the world and unfortunately not all applicants can be accepted for the course.

21. Communication Internet website: http://www.who-umc.org
Vigimed mailing list
Publications
There is a lot of information and publications on the website. Vigimed is a global network which currently involves more than 300 people.

22. Part 1 is written and designed for the widest possible general audience. It centres on the obvious, but publicly little-known truth that no drug is 100% safe for all people in all circumstances. It looks at how hazards can be detected and prevented and the national and international efforts to improve therapy and its safety. Part 2 is an in-depth account of the WHO Programme and the work of the UMC for a more technical specialist audience. Every aspect of ADR reporting is described and illustrated in detail.

23. From the beginning of year 2000, drug safety information provided by the National Centres was incorporated in the WHO Pharmaceuticals Newsletter. 6 issues per year published by the WHO HQ. Uppsala Reports is the UMC’s regular news bulletin for everyone concerned with the issues of pharmacovigilance. It contains information about activities, projects and courses around the world, new member countries, new employers and so on. 4 issues per year distributed free of charge to everyone who is interested copies.

24. 3 tiers-approach for WHO
Maintain as the cheapest, easiest, most sustainable method
As before
(Spontaneous reporting)
Regional trainings
More than before
(Active surveillance)
Tools
Handbooks
Nigeria, Tanzania, Ghana
As never before
Indicators
Consumers
Medication errors
Cohort event monitoring; ECDD; EML; DTC
Measure, support, optmise

25. New development areas in UMC
Active surveillance support
Cohort Event Monitoring
Patient safety focus including medication errors
Improved reporting/analysis of vaccine reactions (AEFI)
Flu pandemic planning
Integrate Chinese ADR database
PandemicFlow