Prevalence rate of spontaneously reported adverse events and determinants of serious adverse events among three outpatient care settings in Ghana: findings and implications

Israel Abebrese Sefah, Hope Edem Kordorwu, Darius Obeng Essah, Amanj Kurdi, Brian Godman

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Abstract

Introduction and objectives: Most evidence of adverse drug events (ADEs) comes from hospitals as the risks associated with hospital care are higher. However, under-reporting of ADEs is a critical problem in all health care settings. This is important in sub-Saharan African countries including Ghana with limited resources and high prevalence of both infectious and non-infectious diseases. Consequently, this study sought to determine the annual prevalence of spontaneously reported ADEs using six years reports and factors associated with the occurrence of serious ADEs among outpatient care settings in hospitals in Ghana to provide future guidance. Method: Cross-sectional study using duplicates of the Ghana Food and Drugs Authority adverse event forms retrieved from 3 outpatient care settings submitting their reports to the National Pharmacovigilance Centre in Ghana between 2013 and 2018. Descriptive and bivariate analysis were performed. Results: Overall, 93 spontaneously reported cases of ADEs were identified during the study period. The annual prevalence rate was 192 reports per 1,000,000 population among our study population and the rate of serious ADE was 35.48% (95% CI: 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
Original languageEnglish
Pages (from-to)97-105
Number of pages9
JournalAdvances in Human Biology
Volume11
Early online date6 Feb 2021
DOIs
Publication statusPublished - 1 Apr 2021

Keywords

  • adverse drug event
  • serious adverse drug event
  • spontaneous reporting
  • outpatient care setting

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