Awareness and Reporting of Adverse Drug Reactions: Bridging the Gap Between Patient Knowledge and Pharmacovigilance Practice

Abstract

This study investigates the gap between patient knowledge of adverse drug reactions (ADRs) and their actual reporting practices, aiming to identify critical weaknesses in pharmacovigilance systems. We employed a descriptive cross-sectional design with a structured questionnaire administered to 300 respondents recruited through convenience sampling. Our analysis focused on three key dimensions: awareness of ADRs, personal experience of such reactions, and the frequency of formal reporting. The results revealed that 64.7% of participants (n = 194) were aware of ADRs, yet only 39.0% (n = 117) had ever formally reported an ADR. Among the 46.0% (n = 138) who reported experiencing an ADR, moderate severity reactions were the most common (42.3%, n = 127), followed by mild (29.3%, n = 88) and severe reactions (28.3%, n = 85). Despite moderate awareness and a substantial prevalence of ADR experiences, reporting rates remained disproportionately low; this discrepancy was especially pronounced for moderate reactions, which constituted the majority of cases. The primary contribution of this research lies in quantifying the disparity between patient-level awareness and pharmacovigilance engagement—a gap that compromises the detection and prevention of medicine-related harms. These findings underscore an urgent need for targeted educational interventions and simplified reporting mechanisms to empower patients. Furthermore, healthcare providers must be trained to systematically counsel patients on reporting obligations, thereby strengthening the pharmacovigilance pipeline from patient experience to systematic data collection