Nigeria

1. Nigeria Discussions on Country Plans Dr Uzono Levi and Pharm Adegboyega Adewumi Presented at the WHO Training Course on Introduction of PVG in HIV/AIDS Programmes At Burgers Park Hotel, Pretoria - RSA 10th September 2004

2. Matthew 3:3 ‘the voice of one crying in the wilderness: Prepare the way of the lord, Make His paths straight –

3. To use the new knowledge that we have got, against the background of what we already know about our systems to suggest what we believe is an implementable Pharmacovigilance system Objective

4. Current systems in Nigeria The Primary Health Care Centers are under the Primary Health Care Development Agency – a parastatal under the Federal Ministry of Health The Secondary Health facilities are under the State Ministries of health in the various states

5. Current systems in Nigeria The Tertiary Health facilities are semi-autonomous but report to the department of Hospital Services of the Federal Ministry of Health The Research Centers (2) are Parastatals under the Federal Ministry of Health

6. Current systems in Nigeria The department of Food and Drugs in the Federal Ministry of Health The National AIDS/STI Control Programme is under the department of Public Health of the Federal Ministry of Health

7. Current systems in Nigeria The Drug Control and regulatory body – the national Agency for Food and Drugs Control and Administration is a parastatal under the Federal Ministry of Health Based on the current plans this will be our ADR Center

8. Coordination The National Agency for Food and Drugs Administration and Control (NAFDAC) - currently spear-heading the PVG System has been able to involve representatives of all these organizations in the planning and development of the guidelines and reporting forms

9. Organizational and Functional Pharmacovigilance Structure Hospital / Research Centers patient Pharmacy store Expert Safety Review panel PVC/DRA NASCP (NACA) Manufacturer UMC WHO Media

10. Yes This system is feasible in Nigeria. A senior staff of the drug regulatory agency has been trained at UPPSULA, workshops have been held and the PVG System is to be launched today. However to ensure that reports begin to be generated as soon as possible a few modification may be necessary

11. “Ready to Go” approach The approach is to identify the facilities already providing ARVs, carry out proper orientation and training for these facilities and commence reporting of ADRs. Currently 25 ARV Centers

12. Non-Government / Private facilities Providing ART Desktop mapping to identify these facilities for inclusion into the PVG programme, e.g State Governments, Missionary Hotels, NGO Support Facilities.

13. To ascertain if drugs on the market fulfill their intended roles in the society. Why should drugs be monitored? Drug monitoring is conducted to ensure that adverse reaction or event not discovered through clinical trials are detected with the aim to preventing such reactions/events.

14. What should be monitored? All drugs will be monitored for adverse reactions or events. This allows for comparison of reporting rates among different therapeutic classes of medicines. Reports to investigate Investigate all suspected ADRs.

15. The Pharmacovigilance Centers in collaboration with the reporting centers, manufacturing companies and other stakeholders. Who should monitor?

16. Pharmacovigilance Centers- Identify what to monitor Identify expert and stakeholders who will participate in evaluation Design protocol for the monitoring. Develop budget and Identify possible source of funding. Provide supervision. Roles and Responsibilities

17. Reporting Centers- Design the relevant studies. Carryout the study Present the report of study to the PV Center. Roles and Responsibilities Manufacturing Companies- • Collaborate with the PV Center and the reporting centers to design and carry out monitoring.

18. Experts and other stakeholders e.g. PLWHA - Provide necessary advice and support. Roles and Responsibilities

19. What to Report The basic issue for us will be the need to create a notification culture We recommend reporting of all suspected ADR known or not, serious or not.

20. Need for Special Investigation Teams The PGV Center should have a team that is capable of carrying out the initial confirmation of information's and reports These reports can then be sent to experts for review and the experts meet to discuss, arrive at a conclusion and make recommendations.

21. Reporting Flow Based on the current plans the current reporting approach is what is being adopted for Nigeria With more experience, we believe that the system will be adjusted to produce better results.

22. Printing of Forms • Duplicate -The reporter keeps a copy -The other copy to the PVG Center

23. Spontaneous Monitoring Cohort studies Registries How Should Monitoring Occur ?

24. When should you be encouraging reporting? ?

25. Reports • Timelines -Initial Report – Immediately (24hr) -Investigation report – Depends (1wk) -Aggregate Reports – 1 month All reports should be submitted to the National Coordinator. All reports should be investigated

26. How do you manage non-serious ADRs / Should you encourage reporting of serious events/reactions only or include non-serious as well ?

27. Resources Available Human Resources -A good number of trained health workers Infrastructures -Health Facilities in every state / Local Government areas -Centers of Excellence and research Centers Funding – Government/Global Funds –Donor funds

28. Critical Success Factors • Awareness of pharmacovigilance system within informal sector -Community & religious leaders, Shopkeepers, traditional healers, community health workers and school teachers • Quality control of laboratories

29. Critical Success Factors Literacy of reporters Clearly defined responsibilities Adequate training and education Open communication between public health care providers and policy makers Judicious and proactive use of the media, professional and general public Good Coordination

30. Thank You