Challenges for the WHO Programme for International Drug Monitoring

1. Challengesfor the WHOProgramme for International Drug Monitoring Shanthi PalQuality Assurance and Safety of Medicines Cecilia Biriell Reports, Analysis and Country Support

3. Risk No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty.

4. What is Pharmacovigilance? WHO definition: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. This applies throughout the life-cycle of a medicine equally to the pre-approval stage as to the post-approval. ADR monitoring – Medicines safety – Drug Monitoring

5. What is the scope of pharmacovigilance? improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions, improve public health and safety in relation to the use of medicines, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public

6. Why pharmacovigilance? Humanitarian concerns Hippocrates admonition at least do not harm Economical concerns

7. Examples of product recalls due to toxicity

8. Studies of ADR related deaths UK: It has been suggested that ADRs may cause 5700 deaths per year in UK Pirmohamed et al, 2004 US: ADRs were 4th-6th commonest cause of death in the US in 1994 Lazarou et al, 1998 Sweden: ADRs were 7th commonest cause of death in Sweden in 2001 Jönsson et al, 2010

9. 125 Patients • 24 Patients experienced ADRs (19%) 59% were avoidable

10. Cost of ADRs in the US? Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000 Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc ADR related cost to the country exceeds the cost of the medications themselves

11. Pharmacovigilance in WHO HQ • Exchange of Information • Policies, guidelines, normative activities • Country support • Collaborations • Fund raising

12. WHO HQ Pharmacovigilance staff Dr Shanthi Pal, Acting Manager Medicines Saftey, QSM + 3 support staff

13. 1. Exchange of Information • National Information Officers • Publications (WHO Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug Information) • International Conference of Drug Regulatory Authorities (ICDRA)

14. 2. Policies, Guidelines and Normative Activities Guidelines 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 Advisory Committee for the Safe Use of Medicinal Products (ACSoMP)

15. 3. Country support • Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ) • Address specific / stated needs: kava, ARVs, antimalarials…. • Annual Meeting of Pharmacovigilance Centres

16. 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

17. 5. Resource Mobilisation • Gates foundation • European Commission • Global Fund • Others • Human resources: WHO Consultants Network for Pharmacovigilance (PV) in Africa (PvSF – Pharmacovigilance Sans Frontières)

18. WHO International Pharmcovigilance ProgrammeFull and Associate Members November 2010, 102 member countries

19. Uppsala Monitoring Centre (UMC)WHO Collaborating Centre for International Drug Monitoring • the operational centre of the WHO PV Programme • established as a foundation 1978 • based on agreement Sweden - WHO • international administrative board • WHO Headquarters responsible for policy • self financed

20. UMC main tasks - summary • Collect and analyse ICSRs worldwide • Communicate potential drug safety issues • Actively support and provide training • Develop the science of pharmacovigilance

21. WHOProgramme for International Drug Monitoring UMC-A WHO-CC Accra UMC WHO-CC Uppsala WHO-HQ Geneva National Centres Medical practices Pharma companies

22. Number of members of the WHO International Drug Monitoring Programme

25. Challenges to Pharmacovigilance An analysis of pharmacovigilance activities in 55 low- and middle-income countries Sten Olssona, Shanthi Palb, Andy Stergachisc, Mary Coupera Drug Safety 2009/2010 (a: WHO CC, Uppsala; b: WHO QSM; c: UWa)

26. Challenges to Pharmacovigilanc

27. Type of assistance needed

28. WHO - UMC relationships HIV/AIDS WHO Classifi- cations Vaccine safety Other Tropical Diseases Malaria Patient Safety Alliance Medicines Policy and Standards UMC

29. 3 tiers-approach for WHO As before Spontaneous reporting Regional trainings – WHO and UMC Country support – WHO, UMC and UMC-A More than before - Active surveillance Tools - CEMFlow for Cohort Event Monitoring Handbooks Nigeria, Tanzania, Ghana – Cohort Event Monitoring in Public Health Programmes Maintain as the cheapest, easiest, most sustainable method

30. Expecting the Worst - Crisis Management Support, guidelines & technical resources

31. 3 tiers-approach for WHO As never before Indicators Minimum requirements for a Functional National PV System Fundraising EuropeAid; UNITAID, GFATM, PEPFAR; FP7 etc Centres of excellence Ghana – WHO Collaborating Centre for Advocacy and training in PV Morocco – training for francophone countries Developing networks PV Consultants Network for Africa Global Network for ADR reporting in prequalified vaccines National Centres meeting in Ghana

32. Activities the last few months • Ghana, May • PV conference arranged by West African Health Organization • Morocco, June • Training course for francophone countries • Togo, October • PV Consultants Network for Africa • Ghana, November • Stakeholders meeting, Donors and WHO • Activities in other parts of the world: • Training course in Singapore for Asian countries • UMC country visits in eastern European countries • Restart of PV in India • Coming – training course in Mexico

33. Members of PV Consultants Network for Africa

34. Challenges for the future To make PV systems sustainable through: • stable financing • trained and dedicated staff Create a culture of reporting • from health professionals • the public

35. Thank you for your attention www.who.int info@who-umc.org www.who-umc.org