Evaluation of pharmacovigilance activities in the national HIV/AIDS, malaria, and tuberculosis control programs using the World Health Organization pharmacovigilance indicators

Introduction: Public health programs (PHPs) provide unique opportunities for addressing health issues in resource-limited settings. A major challenge to the implementation of existing PHPs in Nigeria is the absence of effective monitoring of the safety of medicines and vaccines. The introduction of the World Health Organization (WHO) pharmacovigilance (PV) indicators provides a useful tool to address this challenge. Objective: The objective is to assess the structures, processes, and outcomes of PV activities in three selected PHPs (the National Malaria, tuberculosis [TB], and HIV/AIDS) in Nigeria using the WHO PV indicators and identify possible challenges to achieving the outcomes. Materials and Methods: A cross-sectional mixed method study of the PV system in selected PHPs. Data sources were from the Federal Ministry of Health, the National PV Center (NPC), the National Malaria/TB, and HIV/AIDS Control Programs and official documents were reviewed. Data were collected quantitatively using the WHO PV and PHP indicator questionnaires and qualitatively using key informant interviews. Results: The basic structures and tools for carrying out PV activities in the PHPs were in existence but optimal implementation was lacking. Of the 790 adverse drug reaction (ADR) reports from the PHPs to the NPC ADR database, 77% were from the HIV/AIDS Control Programs, 14% from the malaria control program, and 9% from TB program. The interview with representatives of the different programs revealed a consensus of opinion around lack of adequate human resource for PV, poor funding, poor stakeholders' coordination to improve PV reporting across all three programs as well as in the NPC. Conclusion: This study highlighted the magnitude of suboptimal implementation of PV activities evident by the number of reports as against the expected.