OVERVIEW OF PHARMACOVIGILANCE (PV) DIRECTORATE

The Pharmacovigilance (PV) Directorate is one of the technical Directorates of the Agency. It operates from the NAFDAC Corporate Headquarters in Abuja and the PV office in Lagos. The Directorate implements the National Policy on Pharmacovigilance and coordinates PV activities nationwide by creating awareness of PV to health professionals, healthcare providers, marketing authorization holders (MAHs), and the general public.

We maintain a functional national database on ADRs/AEFIs and other medicine-related problems and provide science-based advice and information on the rational use of drugs. We collect and analyze safety data about drugs, vaccines/biologicals, and cosmetics received through electronic reporting platforms such as the Med Safety App and E-Reporting Platform through the NAFDAC Website that are already in the market.

In a bid to ensure an integrated Pharmacovigilance system, we collaborate with both National and International organizations on safety issues including public health programs. The Directorate conducts scientific detailing of our activities to different healthcare facilities and professionals and also conducts outreach to stakeholders in conjunction with relevant departments.

The PV Directorate coordinates the activities of the National Drug Safety Advisory Committee (NDSAC) and activities of the Zonal PV Centres (ZPCs). We support the establishment of active PV Centres in healthcare institutions in Nigeria and coordinate special aspects of PV which include:

• Herbal medicines
• Pediatric PV
• Biosimilar products

We source, collate, preserve, store, retrieve, and disseminate information on food, drugs, cosmetics, chemicals, and other NAFDAC-regulated products. We collate scientific materials generated from within and outside the directorate and disseminate such information to health professionals and the public, as appropriate through the quarterly newsletter. We draft and issue alert notices on NAFDAC-regulated products and coordinate the activities of NCSC in schools nationwide.

The PV Directorate establishes and maintains effective working relationships with other National Pharmacovigilance Centres and with the Uppsala Monitoring Centre as a participating member of the WHO Collaborating Centre for International Drug Monitoring

We train and retrain MAHs towards coordination of PV inspection activities and monitor and review Post Authorization Safety Studies, Risk Management Plans (RMPs) and periodic safety update reports (PSURs/PBRERs).

Structure

The Directorate is headed by a Director and it is structured into the following Divisions:

• Pharmacovigilance Division
• Food, Drug Information Centre
• Advocacy & Public Health Collaborations Division
• PV Lagos Division
• PV has its presence in the six (6) Zonal Offices including the State Offices.

In addition, the PV Directorate coordinates the activities of the Zonal Pharmacovigilance Centers situated in various Tertiary Institutions to complement the work of the Directorate by creating awareness on Pharmacovigilance among Healthcare Providers as well as collation of completed Adverse Drug Reaction (ADR) reporting forms. The Host Institutions include;

• Ahmadu Bello University Teaching Hospital (ABUTH) Zaria
• University of Ilorin Teaching Hospital (UITH)
• University of Maiduguri Teaching Hospital (UMTH)
• Lagos University Teaching Hospital (LUTH)
• University of Benin Teaching Hospital (UBTH)
• Federal University Teaching Hospital Owerri (FUTHO).

1. Function

• Implementation of the Nigerian National Pharmacovigilance Policy.
• Provision of science-based advice and information on safe use of medicines.
• Coordination of Pharmacovigilance activities Nationwide.
• Implementation of Risk Management Plans (RMP) in collaboration with the Pharmaceutical Industry and MAHs as appropriate.
• Pharmacovigilance Inspections.
• Support the establishment of active Pharmacovigilance Centers in Healthcare Institutions in the Country.
• Creation of awareness on Pharmacovigilance among health professionals, healthcare providers, Marketing Authorization Holders, and the general public.
• Promote rational and safe use of medicines in Nigeria.
• Medicine safety communication.
• Coordinate the activities of the National Drug Safety Advisory Committee (NDSAC).
• Source, collate, preserve, store, retrieve, and disseminate information on food, drugs, cosmetics, Chemicals, and other NAFDAC-regulated products.
• Establish and maintain a functional national database on ADRs and other medicine-related problems.
• Coordinate the activities of NAFDAC Consumer Safety Club NCSC in Secondary Schools and NAFDAC Consumer Safety Publications NCSP.

2. Service offerings

• Handling Adverse Drug Reactions (ADR) and Adverse Event Following Immunisation (AEFI)
• Med Safety App
• E-Reporting
• Notifications on Recalls and Safety Alerts
• Green book
• Policy

3. Policy
   Nigerian National Pharmacovigilance Policy
   
   
4. Events/Seminar/Workshops that you have done and on-going

• Advocacy visit to the state Ministry and Zonal Pharmacovigilance Centers
• Meeting with the Zonal Pharmacovigilance Centre
• CEM Report Dissemination Launch
• Training of Stakeholders on the use of the Med Safety app and E-reporting platform
• Pharmacovigilance inspection engagement meeting with Marketing Authorization Holders.