Pharmacovigilance: Awareness and Practice of Nurses and Midwives in Monitoring and Reporting Adverse Drug Reactions in a Selected University Teaching Hospital, Rwanda

Abstract

Background Adverse drug reactions result in thousands of deaths, disabilities, and other serious outcomes. Nurses and midwives administer drugs, monitor both therapeutic and adverse drug reactions, and are on the front line of safety reporting. This study aimed to assess awareness of nurses and midwives about pharmacovigilance and their practice in monitoring and reporting adverse drug reactions at the University Teaching Hospital of Kigali. Methods We conducted a cross-sectional study on 147 randomly selected nurses and midwives. Self-administered questionnaires were used to collect data. We analyzed data using SPSS version 22 computer software for descriptive and inferential statistics. Results Concerning the awareness of nurses and midwives, 88% had heard about pharmacovigilance, and 22.3% were aware of Rwanda Food and Drug Authority. Nearly two-thirds (62.3%) reported inadequate practice in monitoring adverse drug reactions. Their practice was associated with having heard about pharmacovigilance (p=0.004) and knowing the hospital’s adverse drug reactions reporting system (p=0.005). Concerning practice in reporting adverse drug reactions, 66.2% had observed adverse drug reactions, and 18.2% filled out adverse event notification forms. Conclusion Few nurses and midwives were aware of the pharmacovigilance system in Rwanda, and many of them reported inadequate practices toward monitoring and reporting adverse drug reactions.