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

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

3. Objective 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 systemTo 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

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

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

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

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

8. 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 formsThe 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 Coordination

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

10. Yes 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.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. This system is feasible in Nigeria.This system is feasible in Nigeria. However to ensure that reports begin to be generated as soon as possible a few modification may be necessaryHowever 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.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 CentersCurrently 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.Desktop mapping to identify these facilities for inclusion into the PVG programme, e.g State Governments, Missionary Hotels, NGO Support Facilities.

13. Why should drugs be monitored? To ascertain if drugs on the market fulfill their intended roles in the society.To ascertain if drugs on the market fulfill their intended roles in the society. 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.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.All drugs will be monitored for adverse reactions or events. This allows for comparison of reporting rates among different therapeutic classes of medicines.This allows for comparison of reporting rates among different therapeutic classes of medicines. Investigate all suspected ADRs.Investigate all suspected ADRs. Reports to investigate

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

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

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

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

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. How Should Monitoring Occur Spontaneous MonitoringSpontaneous Monitoring Cohort studiesCohort studies RegistriesRegistries

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