PUBLIC HEALTH PROGRAMMES & PHARMACOVIGILANCE

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 PHYSICIAN Clinical Practice vs PHP Public Health Programmes HEALTH AUTHORITIES Improve population health Improve patient 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 I NTERNATIONAL Others SPONSORS WHO OTHERS T r a c h o m a t i s H.I.V LEVEL Tuberculosis Malaria, filariasis V a c c i n e s MALARIA PUBLIC HEALTH PROGRAMMES NATIONAL PROGRAMME MANAGERS LOCAL COORDINATOR FOR HEALTH PROGRAMMES HEALTH WORKERS LOCAL PATIENTS

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

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

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

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 DISTRICT INVESTIGATION TEAM • 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

24. RESPONSIBILITIES PV Coordinator National PV centre • 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

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

26. RESPONSIBILITIES HIV / AIDS F i l a r i a s i s T u b e r c u l o s i s M a l a r i a V a c c i n e s WHO-PV (UMC) WHO PROGRAMMES • 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

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