1. PUBLIC HEALTH PROGRAMMES & PHARMACOVIGILANCE Shanthi Pal Quality Assurance and Safety: Medicines Essential Medicines and Pharmaceutical Policies World Health Organization

2. Why the use of drugs in Public Health Programmes (PHP) could carry some risk of harm Proposals regarding synergy between PHP and Pharmacovigilance (PV) WHO GUIDELINE « PHARMACOVIGILANCE AND PUBLIC HEALTH PROGRAMMES »

3. Clinical Practice vs PHP Clinical practice PHYSICIAN Improve patient health Public Health Programmes HEALTH AUTHORITIES Improve population health (Prevent disease)

4. Public Health or community health Science and art of preventing disease, prolonging life and promoting health and efficiency through organized community efforts.

5. PHP Education Environmental modifications Nutrition intervention Lifestyle and behavioural changes Mass free distribution of drugs

6. PHP characteristics Vertical and intensive programmes Prophylaxis : vaccination, preventive treatment (ivermectine, albendazole, antibiotic and antiparasitic prophylaxis…) Treatment (artemisinine derivatives against malaria, ARVs, Tuberculosis, Schistosomiasis...) Eradication (lymphatic filariasis, Trachomatis, Leprosy, poliomyelitis elimination programmes…) Involve drugs and vaccines

7. PHP sponsors Government WHO Other non-governmental organizations : UNICEF - private associations Private sector : Onchocerciasis eradication /Merck, - Leprosis eradication/Novartis, Filariasis eradication/GSK, Trachoma eradication /Pfizer, ARV Access initiatives/ Merck, GSK, Roche, Boeringer Ingelheim, Abbot

8. PHP ORGANIZATION LEVE L I N T E R N A TI O N A L NATIONALNATIONAL LOCALLOCAL SPONSORS WHO OTHERS MALARIAMALARIA PROGRAMME MANAGERS HEALTH WORKERS PATIENTS V a c c i n e s Malaria, filariasis Tuberculosis H.I.V T r a c h o m a t i s PUBLIC HEALTH PROGRAMMES LOCAL COORDINATOR FOR HEALTH PROGRAMMES Others

9. PHP monitoring Incidence and prevalence of the disease Morbidity and mortality rates Number of patients treated Number of drug units delivered What about the risk / effectiveness of drugs used?

10. PHP guidelines (WHO, National) No mention of: ADRs Pharmacovigilance Reports

11. 1- DISEASES Tropical diseases Not well diagnosed (Exposed not always suffering from the disease) Comorbid conditions Insufficient follow-up

12. 2. POPULATION Low living standards (Malnutrition) Cultural specificities (Traditional medicines) Unlabelled and off-label indications (pregnant or breast feeding women, small children, elderly people) Food habits

13. 3. DRUGS Distribution of huge amounts of drugs Poor quality standards or counterfeits New drugs with little clinical experience Orphan drugs, donated drugs Improperly stored, delivered and used Lack of established manufacturers

14. 4. HEALTH CARE SYSTEM Under developed public health system Under developed drug regulatory system No pharmacovigilance programme Unqualified health workers Poor medical services Financial shortages

15. Need to monitor PHPs… To detect, evaluate and prevent ADRs related to: Harm Acceptance and tolerance Misuse Dependence Effect on pregnancy and children Therapeutic failures (resistance, quality defects, counterfeits)

16. PHP Crucial and critical Long standing Technically performed Good financial support PV Seen as a luxury discipline Not fully established No spontaneous reporting culture, no PV competence Poor support In most developing countries

17. In those countries PHPs could provide: Opportunity to implement PV activities Offer a cohort of patients under controlled conditions to be monitored for safety over a period of time PV will Detect, evaluate, and prevent adverse events Promote rational use of drugs in mass treatment programmes Evaluate the impact of the programmes Improve acceptability of the programme

18. EXISTING SYSTEMS WHO PROGRAMMES WHO PROGRAMMES V a c c i n e s Malaria Tuberculosis Filariasis HIV / AIDS WHO-PV (UMC) PV Coordinator National PV centre PATIENTS NATIONAL PUBLIC HEALTH PROGRAMMES Vaccines Malaria Tuberculosis Filariasis HIV/AIDS Health workers PATIENTS

19. Expert Safety Review Panel INTEGRATING PHP AND PV FUNCTIONAL AND STRUCTURAL RELATIONSHIP WHO PROGRAMMES WHO PROGRAMMES V a c c i n e s M a l a r i a T u b e r c u l o s i s F i l a r i a s i s HIV / AIDS WHO ADVISORY COMMITEE WHO-PV (UMC) PV Coordinator National PV centre Health workers NATIONAL PUBLIC HEALTH PROGRAMMES V a c c i n e s M a l a r i a T u b e r c u l o s i s F i l a r i a s i s HIV / AIDS DISTRICT INVESTIGATION TEAM DRUG REGULATORY AUTHORITY PATIENTS

20. RESPONSIBILITIES Promote National PV activity Develop a risk management plan Integrate PHP and PV Promote policies for best practice Health Authority

21. RESPONSIBILITIES Promote best practice; PV While starting the programme: Is the medicine well known? Is the company represented in the country? Is the safety profile of the drug established? Is the dosage in use authorised by marketing authorisation? In case of generic product: what about bioequivalence test? NATIONAL PHP MANAGER

22. RESPONSIBILITIES Health workers Diagnose ADRs Manage ADRs Take action Educate patients Attend meetings Promote rational use of drugs Report ADRs to the district Investigation team

23. RESPONSIBILITIES Assess causality Investigate and manage ADRs Take action Educate patients Train health workers Promote rational use of drugs Report ADRs to the national pharmacovigilance coordinator DISTRICT INVESTIGATION TEAM

24. RESPONSIBILITIES Coordinate the national PV programme for P.H.P Collect ADR reports Develop and adapt procedures Develop training modules Liaison with all the actors Submit recommendations Be the secretary for expert safety review panel PV Coordinator National PV centre

25. RESPONSIBILITIES Review ADRs Check and finalise causality assessment Generate possible signals Submit conclusions and recommendations to: 1.Public health programmes 2.National PV centre 3.Drug regulatory authority Expert Safety Review Panel

26. WHO PROGRAMMES WHO PROGRAMMES V a c c i n e s M a l a r i a T u b e r c u l o s i s F i l a r i a s i s HIV / AIDS WHO-PV (UMC) Initiating, organizing, carrying out, advising and guiding a number of clinical programmes Supporting member states in assuring the safe use of medicinal products Encouraging all clusters within WHO to advise member states on how to monitor the safe use of these products Encouraging initiatives to conduct operational research on PV RESPONSIBILITIES

27. Addressing the needs of public health programs Malaria HIV/AIDS Neutropenia with ACTs in malaria-HIV co-infected ? Result of repeated treatment with ACTs? Dystonia with As-Aq? SJS susceptibility Delete d4t? NVP in women? Can we use TDF without renal monitoring? Risk of severe anaemia in children with AZT? Use NVP & rifampicin concomitantly in HIV/TB patients?

28. CONCLUSION The success of PHP is largely dependent on the participation of society and the acceptance that drugs are safe PV should be an integral part of every PHP PV is essential to promote the rational and safe use of medicines and the acceptability of mass treatment programmes.

29. Complementary functions for a common goal PHP Reducing morbidity and mortality Pharmacovigilance Evaluating drug effectiveness, harm and cost IMPROVE PATIENT HEALTH