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

In the sixties… In1960s..

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’.

16th World Health Assembly 1963 Assembly Resolution 16.36 - 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.

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

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.

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

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.

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

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

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

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

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

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

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.

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

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.

Flow of ADR reports

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

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 1993. 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.

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.

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.

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. 2500 copies.

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

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