Exploration and Evaluation of Adverse Drug Reactions Documented in a Tertiary-Care Hospital in Chennai: An In-Depth Retrospective Observational Study.

ABSTRACT

INTRODUCTION:  While drugs are intended to benefit patients, adverse drug reactions (ADRs) represent a significant negative outcome of drug consumption. They rank as the sixth leading cause of death among hospitalized patients. Many harmful effects are preventable and can reduce morbidity, mortality, and hospitalization duration. This study is a valuable resource for physicians, aiding in the safe and optimal use of medications. METHODOLOGY:  This retrospective observational study, conducted at the Pharmacovigilance Center of Saveetha Medical College and Hospital, Chennai, India, received approval from the Institutional Ethics Committee. All adverse drug interactions reported in our hospital from January 2019 to February 2024 were included after screening for inclusion and exclusion criteria. The collected reactions were analyzed, assessed, and evaluated between February 2024 and April 2024. Data on the drugs causing adverse reactions, the types of reactions, and the treatments administered were collected and documented. The reactions were categorized using the Rawlins and Thompson classification, while causality and severity were assessed using the standard Naranjo causality and modified Hartwig and Siegel severity assessment scales. RESULTS:  During the study, 252 ADRs were documented by the Central Drugs Standard Control Organization. The gender distribution showed 123 cases (48.8%) in males and 129 cases (51.2%) in females, with a higher prevalence in the 20-40 age group. The departmentwise distribution revealed the highest number of ADRs in Obstetrics and Gynecology (60 cases, 24%), followed by General Surgery (52 cases, 21%), General Medicine (44 cases, 17%), Pediatrics (22 cases, 9%), and Emergency Medicine (20 cases, 8%). Antimicrobial drugs constituted the majority of ADRs (149 cases, 59.1%), followed by vitamins and mineral supplements (21 cases, 13.8%), contrast dye (15 cases, 6%), antituberculosis drugs (15 cases, 6%), analgesics (13 cases, 5.2%), and gastrointestinal (GIT) drugs (8 cases, 3.2%). Cefotaxime was the most commonly reported antibiotic (42 cases, 28.2%), followed by Ciprofloxacin (41 cases, 27.5%). Among vitamins and mineral supplements, iron sucrose was implicated in the highest number of ADRs (15 cases, 71.4%). The parenteral route of drug administration showed the highest incidence of ADRs (229 cases, 91%), followed by oral (20 cases, 8%) and topical routes (3 cases, 1%). Dermatological manifestations were most frequently reported (196 cases, 77.8%), followed by GIT symptoms (27 cases, 10.7%), and other manifestations such as shivering, fever, seizures, and dyspnea (29 cases, 11.5%). Based on the Naranjo causality assessment scale, 179 ADRs (71%) were categorized as probable, 55 (22%) as possible, 10 (4%) as certain, and 8 (3%) as doubtful. Approximately 47.2% of ADRs were self-limiting, while 44.1% required symptomatic treatment and 8.7% necessitated aggressive treatment, leading to a prolonged hospital stay or admission to the intensive care unit. CONCLUSION:  The pattern of ADRs in our hospital aligns with findings from other studies. While many of these reactions are unpredictable and mild, they underscore the importance of raising awareness among clinicians and regulatory authorities to promote safe medication use and prevent potentially serious outcomes.