1. Pharmacovigilance in public health programmes Author: Oscar O Simooya, Copperbelt University, Kitwe, Zambia Presented at the training course for introducing pharmacovigilance in public health programmes 1 –10 September 2004, Pretoria, South Africa 1

2. Topics Topics Introduction Definitions Challenges of pharmacotherapy SWOT analysis of PHPs and PV Update on the malaria PV project Conclusion Acknowledgements 2

3. 3 Introduction Introduction no drug is completely safe drugs may contribute to 5 –10% of all hospital admissions 10 –20% of all inpatients may suffer a serious ADR in hospital ADRs 4 th to 6 th leading cause of deaths in USA ADRs may contribute 5 –10% of hopsitalcosts

4. 4 Therefore ……… the monitoring of the adverse effects of drugs is an important component of good medical practice

5. 5 Hippocrates (460 –377 B.C.) Hippocrates (460 –377 B.C.) ‘ Above all, do no harm ’

6. 6 Definitions ….. Public health The science or art of preventing disease, prolonging life and promoting health and efficiency through organised community effort

7. 7 Definitions….. Pharmacovigilance The science for the detection,assessment and prevention of adverse reactions to drugs

8. 8 Components of public health programmes (PHPs) education environmental modification nutrition intervention lifestyle and behaviour change pharmacotherapy

9. 9 Goals and objectives of pharmacovigilance the rationale and safe use of drugs the assessment and communication of benefits/risks of drugs educating and informing patients

10. 10 Goals and objectives of pharmacovigilance ……. Specific objectives early detection of hitherto unknown ADRs detection of increases in frequency of known ADRs identification of risk factors and possible mechanisms underlying ADRs estimation of benefit/risk dissemination of information

11. 11 Challenges of pharmacotherapy in PHPs …. may use agencies and staff with a wide variety of skills and patients may not be seen by a physician insufficient diagnosis and follow up large numbers exposed, may include special populations i.e. pregnant &breast feeding mothers

12. 12 Challenges of pharmacotherapy in PHPs …. use of new drugs with limited experience, i.e. ARVs, ACTs; use of substandard drugs;incorrect use of drugs;counterfeit drugs weak health care systems, often poor drug control/legislation

13. 13 SWOT analysis of PHPs and PV Strengths of PHPs well established roles usually well funded technical guidelines monitoring and evaluation procedures good databases

14. 14 SWOT analysis of PHPs and PV …… Strengths of PV new drugs, high interest in drug safety exists in a few African countries expertise in assessment of drug safety training in benefit/risk assessment good international support, WHO, UMC

15. 15 SWOT analysis of PHPs and PV …… Weaknesses of PHPs lack experience in drug safety monitoring drugs used in PHPs considered safe lack of coordination between PHPs, duplication may cover special populations

16. 16 SWOT analysis of PHPs and PV …… Weaknesses of PV relatively new concept role not well recognised poorly funded, considered a luxury not seen as a component of PHPs

17. 17 SWOT analysis of PHPs and PV …… Opportunities together, PV and PHPs may greatly benefit each other. PV will assist in the early identification and prevention of ADRs and product quality problem ……..

18. 18 SWOT analysis of PHPs and PV …… Opportunities PHPs may provide resources, reliable databases,M&E tools leading to …….

19. 19 SWOT analysis of PHPs and PV …… Opportunities 1. rationale drug use 2. better patient adherence 3. improved drug procurement All this will lead to …….

20. 20 SWOT analysis of PHPs and PV …… BETTER HEALTH OUTCOMES AND RESOURCE SAVINGS

21. 21 SWOT analysis of PHPs and PV ….. Threats lack of political/public support funding shortfalls misunderstanding of each other’s roles

22. 22 The malaria PV project – an update

23. 23 Background artemisinins highly effective for malaria recommended in combination for use in malaria endemic regions efficacy and safety well documented in SEA new to malaria area of Africa

24. 24 Therefore …….. Need to monitor efficacy and safety in new populations and in areas with co morbid conditions such as HIV/AIDS, TB and malnutrition

25. 25 Launched …….. March/April 2003 following training workshop on phamarcovigilance held in Lusaka, Zambia to introduce drug safety monitoring in Burundi, DRC, Mozambique, Zambia and Zanzibar

26. 26 Lusaka workshop organised by WHO and UMC attended by national malaria managers & drug regulatory authorities course based on international PV course run by UMC basic skills in ADR monitoring covered

27. 27 …. Lusaka workshop Resolutions draft action plans from each country action plans to be presented to health authorities monitoring to cover antimalarials but to extend to HIV/AIDS, TB and immunisation programmes

28. 28 Project Description Goals to introduce PV in Burundi, DRC, Mozambique, Zambia and Zanzibar initially planned to monitor ACTs but to roll out to other PHPs

29. 29 Project description Specific objectives/activities training in PV for key personnel introduce concept of PV to health authorities prepare proposals and protocols for ADR monitoring creation of centres for PV, staff, equipment

30. 30 Project description Specific objectives /activities prepare case report forms create databases training of health personnel stimulation of reporting linkage to international networks

31. 31 Achievements Training of PV resource persons took place March/April 2003 attended by 18 malaria managers and drug regulators basic skills of ADR monitoring and operations of PV centres

32. 32 Achievements Government approval written commitment to PV obtained in all countries, in DRC Minister of Health wrote to WHO supporting PV and in Burundi, met with Minister of Health to discuss PV

33. 33 Achievements Preparation of proposals and protocols prepared and submitted in all countries. Includes detailed budgets for operation of PV centres

34. 34 Achievements Creation of PV centres, design of case forms and data base Location of centres agreed: Burundi – directorate of pharmacy, DRC – drug regulatory offices, Mozambique – CIMed, Zambia – pharmacy board, Zanzibar – malaria programme

35. 35 Achievements Training of health workers On going in all countries, latest in DRC for nursing staff, from 13 th August 2004

36. 36 Achievements Preparation of case report forms AVAILABLE IN ALL COUNTRIES

37. 37 Challenges Creation of data base compatible with the WHO programme AWAITS DEVELOPMENT IN ALL COUNTRIES

38. 38 Needs assessment source funding for activities continued training stimulation of reporting creation of databases networking with other PHPs

39. 39 Lessons learnt good progress in all countries need for PV recognised training of key personnel vital government and international support needed linkages with international network need strengthening

40. 40 Recommendations culture of reporting ADRs must be stimulated development of data bases training of health workers vital integration with other PHPs networking with international groups must continue

41. 41 Conclusion Good progress made in early implementation with key personnel in place and active. Need to scale up activities with stimulation of reporting and data collection

42. 42 Acknowledgements Participating countries World Health Organisation Uppsala Monitoring Centre University of Cape Town Colleagues

43. 43 Thank you for your attention and patience