WHO Programme for International Drug Monitoring

1. WHO Programme for International Drug Monitoring Mary Couper and Shanthi Pal Quality Assurance and Safety of Medicines Medicines Policy and Standards

2. WHO Programme for International Drug Monitoring WHO Collaborating Centre, Uppsala WHO HQ + 6 Regional offices National Centres

3. Secretariat of WHO • The Director-General (Office Term 5 years; Nominated by the Executive Board; Elected by Member States) • Staff (Health professionals, other experts and support staff working at HQ in Geneva, 6 Regional Offices and representatives throughout the world)

4. Regional Offices of WHO • AFRO (Brazzaville) • AMRO/PAHO (Washington DC) • EMRO (Cairo) • EURO (Copenhagen) • SEARO (New Delhi) • WPRO (Manila)

5. WHO structure at headquarters Health Systems and Services MEDICINES Director-General Dr Margaret Chan - Representatives of the Link to Director-General a.i. Regional Offices Health Action in Crises Polio Eradication Noncommunicable HIV/AIDS, TB and Diseases and Malaria and neglected Tropical diseases Mental Health Family and Community Health Health Security and Environment Information, Evidence and Research General Management

6. Drug safety activities in WHO HQ • Publications • Reviews of Specific Medicines • Advisory Committee Meetings on Medicines and Vaccines • Training Courses • Collaborative activities • Annual meeting of National PV centres, October 2008

7. Publications • 6 issues of Pharmaceutical Newsletter also available on-line • Promoting Safety of Medicines in children, 2007 • Pharmacovigilance for antimalarials, 2008 • WHO Restricted List 2008 in press • Web page: http://www.who.int/medicines/

13. Specific publications • Assessment of hepatotoxicity of kava • Pharmacovigilance for antiretrovirals • Amodiaquine + artemisinine • Articles in journals

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

15. Sharing information • Annual meeting of national pharmacovigilance centres: An important forum for national PV centres to meet and discuss matters of common interest • Problems of Current Interest • Turkey, Tunisia, New Zealand, Amsterdam, New Delhi, Dublin Geneva, Belgium, Argentina, Sweden • Vigimed discussion group • ICDRA

16. Collaboration with ICH • ICH MedDRA Management Board • ICH EWG M5 Data Elements and Standards for Drug Dictionaries • ICH E2B M Harmonization of electronic transfer of International Case Safety Reports • Maintenance of Controlled Vocabularies • EWG on Developmental Safety Update Reports

17. Collaboration with Vaccines • Advisory Committee on Vaccine Safety June 2008 • Joint reviews of specific vaccines • Project for improving vaccine signal detection • Global Network for Post-marketing Surveillance of Newly Pre-qualified Vaccines • New position at UMC for vaccine safety

18. Collaboration with Visceral Leishmaniasis • New medicines for visceral leishmaniasis are being developed • Not enough data on safety is known • A new programme for monitoring ADRs is being set up in India, Nepal and Bangladesh

19. Collaboration with HIV/AIDS • Joint training programmes • Joint terminology meetings • Joint fund raising proposal • Joint cohort event monitoring studies proposed

20. Collaboration with Malaria • Investigation of specific antimalarials • Amodiaquine-artesunate • Joint training courses • Joint reviews of specific antimalarials • Artemisinine derivatives in pregnancy • Chlorproguanil-dapsone • Collaboration on development of pregnancy register

21. Collaboration with Traditional Medicines Programme • Participation in meetings • Publication on Safety of Herbal medicines • Joint training courses on safety of herbal medicines

22. Collaboration with Parasitic Disease Programme • Advice to Lymphatic filariasis programme on mass drug administration • Advice on labelling for specific medicines in intestinal parasitic diseases • Advice on safe use in pregnancy for medicines used in intestinal parasitic diseases • Advice on safety of medicines for children

23. Lymphatic filariasis Almost 110 millionpeople targeted for MDA under the WHO-recommended strategies of administering either diethylcarbamazine citrate (DEC) plus albendazole or ivermectin plus albendazole. Need for WHO to have a mechanism for accepting ADR reports from Public Health Programmes

24. Collaboration with Essential Medicines List and WHO Model Formulary • Safety reviews for new medicines to be included on the 15th EML in 2009 • Advice on toxicity for medicines to be deleted • Advice to the editors of the WHO Model Formulary on pharmacovigilance section

25. WHO HQ training courses • Two PV training courses 1) CEM 2) Advanced PV, Ghana, June 2007 • PV training course December, UAE, 2007 • ARV follow-up course, Suriname March 2008 • ARV toxicity management course April 2008 • Advanced French-speaking course May 2008 • Advanced Antimalarial PV Ghana June 2008 • Training course for public health programmes in Sierra Leone, August, 2008 • Introductory PV course in Philippines September 2008 • Technical Briefing Seminar ,Switzerland, September 2008

26. Identifying reports of medication errors: the 'patient safety' pilot project • Project to define an extended role for national PV centres • Partners: WHO, UMC, Moroccan PV Centre • Prospective and retrospective analysis of database to track reports of medications errors • Project concluded March 2008; plans to expand to other centres

27. WHO Programme for International Drug Monitoring WHO Collaborating Centre, Uppsala WHO HQ + 6 Regional offices National Centres

28. WHO Collaborating Centrethe Uppsala Monitoring Centre • established as a foundation 1978 • based on agreement Sweden – WHO (1978 and revised 2002) • international administrative board • WHO Headquarters responsible for policy • Staff of about 50

29. WHO Collaborating Centre (Uppsala Monitoring Centre) • Collection & processing of data: maintaining & developing the international adverse drug reaction database > 4 million reports • Regular screening of data to issue signals • Research • new ADR findings, new methodology, technology, methods of communication • Information centre • Training centre

30. WHO Programme for International Drug Monitoring WHO Collaborating Centre, Uppsala WHO HQ + 6 Regional offices National Centres

31. WHO International Drug Monitoring Programme August 2008

32. 86 countries participate in the WHO Programme on International Drug Monitoring Include Argentina, Ghana, Kenya, Nepal, Netherlands, Nigeria, Russia, Sri Lanka, Tunisia, Uganda, USA 31 Associate Members Include Ethiopia, Sierra Leoneq and Sudan Countries not yet participating include Namibia and Slovenia National Centres participating in the Programme August 2008

33. Top ten contributors to WHO database

34. National Centres - flow of information

35. Requirements for joining the WHO Programme • programme for collection of spontaneous ADR reports established • a National Centre designated by Ministry of Health • technical competence to fulfil WHO reporting requirements

36. Process for joining WHO Programme 1 2 5 3 4 • Ministry of Health (or equivalent) designates National Centre Ministry of Health National Centre • Ministry of Health sends formal application to WHO-HQ, Geneva • National Centre sends sample reports to the UMC the UMC • UMC notifies WHO-HQ that reports are compatible WHO-HQ Geneva • WHO-HQ advises Ministry of Health of admittance to the Programme

37. Drug safety is a global responsibility. WHO cannot work alone. With increasing global awareness and much under-reptorting much work remains.

38. Website addresses • http://www.who.int/medicines • http://www.who.int/medicines/areas/quality_safety/safety_efficacy/en/index.html • http://www.who-umc.org

39. Thank You Merci beaucoup !