Prevalence Rate of Spontaneously Reported Adverse Events and Determinants of Serious Adverse Events amongst Three Outpatient Care Settings in Ghana: Findings and Implications

Introduction: Most evidence of adverse drug events (ADEs) comes from hospitals as the risks associated with hospital care are higher. However, underreporting of ADEs is a critical problem in all healthcare settings. This is important in sub-Saharan African countries including Ghana with limited resources and a high prevalence of both infectious and non-infectious diseases. Consequently, this study sought to determine the annual prevalence of spontaneously reported ADEs using 6-year reports and factors associated with the occurrence of serious ADEs amongst outpatient care settings in hospitals in Ghana to provide future guidance. Methodology: This is a cross-sectional study using duplicates of the Ghana Food and Drugs Authority adverse event forms retrieved from three outpatient care settings submitting their reports to the National Pharmacovigilance Centre in Ghana between 2013 and 2018. Descriptive and bivariate analyses were performed. Results: Overall, 93 spontaneously reported cases of ADEs were identified during the study period. The annual prevalence rate was 192 reports/1000,000 population amongst our study population, and the rate of serious ADE was 35.48% (95% confidence interval: 25.83%-46.09%). Serious ADEs were associated with the type of indication for which the drug was prescribed (P = 0.048), the duration of the ADE (P = 0.047) and the need to administer treatment for the ADE at the reporting facility (P = 0.017). Conclusion: Early spontaneous reporting of ADEs at outpatient settings is essential. Patient and provider education and awareness of potential ADEs must be intensified for early identification and reporting.