NigeriaNigeria

Dr Uzono Levi andDr Uzono Levi and

Pharm Adegboyega Pharm Adegboyega AdewumiAdewumi

1010thth September 2004 September 2004

Discussions on Country Discussions on Country PlansPlans

Presented at the WHO Training Course on Presented at the WHO Training Course on Introduction of PVG in HIV/AIDS Introduction of PVG in HIV/AIDS

ProgrammesProgrammes

At Burgers Park Hotel, Pretoria - RSAAt Burgers Park Hotel, Pretoria - RSA

Matthew 3:3Matthew 3:3

• ‘‘the voice of the voice of one crying in one crying in the the wilderness: wilderness: Prepare the Prepare the way of the way of the lord, Make His lord, Make His paths straight paths straight – –

ObjectiveObjective

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

Current systems in Current systems in NigeriaNigeria

• The Secondary Health facilities are The Secondary Health facilities are under the State Ministries of health under the State Ministries of health in the various statesin the various states

• The Primary Health Care Centers The Primary Health Care Centers are under the Primary Health Care are under the Primary Health Care Development Agency – a parastatal Development Agency – a parastatal under the Federal Ministry of under the Federal Ministry of HealthHealth

• The Tertiary Health facilities are The Tertiary Health facilities are semi-autonomous but report to the semi-autonomous but report to the department of Hospital Services of department of Hospital Services of the Federal Ministry of Healththe Federal Ministry of Health

• The Research Centers (2) are The Research Centers (2) are Parastatals under the Federal Parastatals under the Federal Ministry of HealthMinistry of Health

Current systems in Current systems in NigeriaNigeria

• The National AIDS/STI Control The National AIDS/STI Control Programme is under the Programme is under the department of Public Health of the department of Public Health of the Federal Ministry of HealthFederal Ministry of Health

• The department of Food and Drugs The department of Food and Drugs in the Federal Ministry of Healthin the Federal Ministry of Health

Current systems in Current systems in NigeriaNigeria

• The Drug Control and regulatory The Drug Control and regulatory body – the national Agency for body – the national Agency for Food and Drugs Control and Food and Drugs Control and Administration is a parastatal Administration is a parastatal under the Federal Ministry of under the Federal Ministry of HealthHealth

• Based on the current plans this will Based on the current plans this will be our ADR Centerbe our ADR Center

Current systems in Current systems in NigeriaNigeria

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

CoordinationCoordination

Organizational and Functional Organizational and Functional Pharmacovigilance StructurePharmacovigilance Structure

Hospital / Hospital / Research CentersResearch Centers patientpatient Pharmacy storePharmacy store

ManufacturerManufacturer WHOWHO UMCUMC

NASCPNASCP(NACA)(NACA)

Expert Safety Expert Safety Review panelReview panelPVC/DRAPVC/DRA

MediaMedia

YesYes

• A senior staff of the drug A senior staff of the drug regulatory agency has been regulatory agency has been trained at UPPSULA, workshops trained at UPPSULA, workshops have been held and the PVG have been held and the PVG System is to be launched today.System is to be launched today.

• This system is feasible in Nigeria. This system is feasible in Nigeria.

• However to ensure that reports However to ensure that reports begin to be generated as soon as begin to be generated as soon as possible a few modification may be possible a few modification may be necessarynecessary

““Ready to Go” approachReady to Go” approach

• The approach is to identify the The approach is to identify the facilities already providing ARVs, facilities already providing ARVs, carry out proper orientation and carry out proper orientation and training for these facilities and training for these facilities and commence reporting of ADRs.commence reporting of ADRs.

• Currently 25 ARV CentersCurrently 25 ARV Centers

Non-Government / Private Non-Government / Private facilities Providing ARTfacilities Providing ART

• Desktop mapping to identify these Desktop mapping to identify these facilities for inclusion into the PVG facilities for inclusion into the PVG programme, e.g State Governments, programme, e.g State Governments, Missionary Hotels, NGO Support Missionary Hotels, NGO Support Facilities.Facilities.

Why should drugs be Why should drugs be monitored?monitored?

• To ascertain if drugs on the market To ascertain if drugs on the market fulfill their intended roles in the fulfill their intended roles in the society.society.

• Drug monitoring is conducted to Drug monitoring is conducted to ensure that adverse reaction or ensure that adverse reaction or event not discovered through event not discovered through clinical trials are detected with the clinical trials are detected with the aim to preventing such aim to preventing such reactions/events.reactions/events.

What should be What should be monitored?monitored?

• All drugs will be monitored for All drugs will be monitored for adverse reactions or events. adverse reactions or events.

• This allows for comparison of This allows for comparison of reporting rates among different reporting rates among different therapeutic classes of medicines.therapeutic classes of medicines.

•Investigate all suspected ADRs.Investigate all suspected ADRs.

Reports to investigateReports to investigate

Who should monitor?Who should monitor?

• The Pharmacovigilance Centers in The Pharmacovigilance Centers in collaboration with the reporting collaboration with the reporting centers, manufacturing companies centers, manufacturing companies and other stakeholders.and other stakeholders.

Roles and ResponsibilitiesRoles and Responsibilities

Pharmacovigilance Centers-Pharmacovigilance Centers-

• Identify what to monitorIdentify what to monitor• Identify expert and stakeholders who Identify expert and stakeholders who

will participate in evaluationwill participate in evaluation• Design protocol for the monitoring.Design protocol for the monitoring.• Develop budget and Identify possible Develop budget and Identify possible

source of funding.source of funding.• Provide supervision.Provide supervision.

Roles and ResponsibilitiesRoles and ResponsibilitiesReporting Centers-Reporting Centers-

• Design the relevant studies.Design the relevant studies.• Carryout the studyCarryout the study• Present the report of study to the PV Present the report of study to the PV

Center. Center.

Manufacturing Companies-Manufacturing Companies-

• Collaborate with the PV Center and Collaborate with the PV Center and the reporting centers to design and the reporting centers to design and carry out monitoring. carry out monitoring.

Roles and ResponsibilitiesRoles and Responsibilities

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

What to ReportWhat 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.

Need for Special Need for Special Investigation TeamsInvestigation 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.

Reporting FlowReporting 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.

Printing of FormsPrinting of Forms

• Duplicate

-The reporter keeps a copy

-The other copy to the PVG Center

How Should Monitoring How Should Monitoring OccurOccur

• Spontaneous Spontaneous MonitoringMonitoring

• Cohort studiesCohort studies

• RegistriesRegistries

When should you be When should you be encouraging reporting?encouraging reporting?

ReportsReports• 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

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

Resources AvailableResources AvailableHuman ResourcesHuman Resources

-A good number of trained health -A good number of trained health workersworkers

InfrastructuresInfrastructures-Health Facilities in every state / -Health Facilities in every state /

Local Government areasLocal Government areas-Centers of Excellence and research -Centers of Excellence and research

CentersCenters

Funding Funding – – Government/Global Government/Global

Funds Funds ––Donor fundsDonor funds

Critical Success FactorsCritical 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

Critical Success FactorsCritical 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