A Comparative Study of Pharmacovigilance System in Nigeria and Ghana using Indicator Based Pharmacovigilance Assessment Tools ( IPAT).

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Abstract Introduction: Nigeria and Ghana are both members of the World Health Organization (WHO) Program for International Drug Monitoring (PIDM) operated by the Uppsala Monitoring Centre (UMC) in Sweden. The requirements to join the WHO PIDM include submission of 20 reports in the internationally accepted E2B format to UMC and a formal letter from the ministry of health requesting to join the program. Even though the two countries are members of the WHO PIDM, they have different capacities. Aim: To assess and determine the functionality, scope of operation, strengths and limitations of the national pharmacovigilance systems in Nigeria and Ghana using IPAT indicators as standard. Method: National PV documents backed by law and other statutory documents governing the PV systems of both Nigeria and Ghana were examined using the WHO indicators. Indicator–based Pharmacovigilance Assessment (IPAT) was developed by WHO to assess PV systems, PV in the two countries were compared by reviewing the government policies on PV. The staff of the pharmacovigilance unit of the National Medicines Regulatory Authorities (NMRAs) were interviewed using WHO Pharmacovigilance Indicators tool. The responses were recorded, and data collected were analyzed. Results: The PV systems in Nigeria and Ghana were supported by law and regulations in line with international standards. The Standard operating procedures for reporting, processing, and communicating suspected adverse event reports from stakeholders of PV were in place in both countries, but reporting of suspected medicine-related harm from stakeholders was not reported countries. The number of Physician density per 1000 population in Nigeria and Ghana is 0.38 and 0.10. The two countries did not meet the 200 number of reports of suspected ADRs report by 1 million of the population in 2020. The national pharmacovigilance systems in the two countries did not have access to data on drug utilization. The national PV unit in NAFDAC and Ghana FDA scored 69% and 72% respectively using IPAT indicators measuring standard and both met the standard requirements of PV by scoring greater than 60%. The lack of relevant PV regulations and legislation coupled with absence of implementation could be accounted for low scores under some sub headings in IPAT indicators Conclusion: The national pharmacovigilance systems in the two countries have policy and legal frameworks defined by law and regulation to conduct pharmacovigilance activities. However, the two national PV systems are at different levels of dimension and performance with respect to conducting PV activities. In other to have an effective PV system in both countries, there is a need to formulate and implement strategic PV interventions that will involve all relevant stakeholders, including public health programs, healthcare facilities and professionals, academic institutions, and patients, to build a standard national PV systems.

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