Impact of Pharmacovigilance in Monitoring Adverse Drug Reactions: A Retrospective Study

Adverse drug reactions (ADRs) are a major problem for healthcare systems around the world. Effective pharmacovigilance is therefore necessary to ensure patient safety. The purpose of this retrospective observational study, which ran from March to August 2023 in a tertiary care hospital for six months, was to evaluate the frequency, trends, and features of adverse drug reactions. There were 115 ADRs in all, with an average of 11 cases reported per month and an incidence of 0.95 cases per 1,000 patients. Skin/subcutaneous tissues (24.34%) and the gastrointestinal system (38.26%) were the most frequently affected organs, with adult patients aged 18-65 accounting for the majority of cases (64.34%). The most common mode of administration (72.17%) was oral. The severity assessment classified the ADRs as follows: 16.52% as severe, 36.53% as moderate, and 46.95% as mild. The causality analysis yielded 10.43% certain, 39.1% probable, and 30.43% plausible ADRs. Antihypertensives (25.2%), antimicrobials (39.13%), and antidiabetics (16.52%) were the most implicated drug classes. These results highlight the need for enhanced ADR reporting protocols and ongoing surveillance to improve patient safety, especially with regard to focused interventions for high-risk populations such as women and adults.