Improving Patient Safety through Pharmacovigilance – A Review of Spontaneous ADR Reporting Trends in Clinical Practice

Open Access

Abstract

Introduction: Adverse drug reactions (ADRs) are a leading cause of hospitalization and morbidity worldwide and pose a significant challenge to patient safety. Early detection is important through effective pharmacovigilance by spontaneous reporting of ADRs by clinicians. The current study will assess trends, determinants, and impact of spontaneous adverse drug reaction (ADR) reporting in clinical practice to achieve optimal patient safety through effective pharmacovigilance. Methods & Materials: This cross-sectional, observational study was conducted in 56 patients who had experienced adverse drug reactions (ADRs) during their course of treatment in Dhaka Medical College from January 2024 to December 2024. Data were analyzed according to the Statistical Package for Social Sciences (SPSS) version 26. Descriptive statistics such as mean, frequency, and percentage were used for categorical variables. Result: Fifty of the 56 participants (89.3%) had heard about pharmacovigilance, but only 24 (42.9%) had ever submitted an ADR report, and 16 (28.6%) reported to a national authority. Antibiotics (18; 34.6%) and NSAIDs (10; 19.2%) were the most common drug classes involved. While 32 (57.1%) were aware of the WHO-UMC reporting form and 28 (50.0%) of the causality assessment criteria, barriers like time constraints (22; 39.3%) and fear of legal consequences (18; 32.1%) were interfering with reporting. Conclusion: It is concluded by this study that most ADRs occurred with antibiotics and analgesics, were of mild to moderate intensity, and were largely avoidable. Despite the importance of spontaneous reporting for improving patient safety, underreporting is a critical problem due to low training and awareness.