Analysis of spontaneously reported suspected adverse drug reactions reported at a tertiary care teaching hospital

Introduction: Adverse drug reactions (ADRs) are a significant cause of morbidity, mortality, and economic burden in healthcare. In India, the ADR reporting rate remains low despite the Pharmacovigilance Programme of India (PvPI). Aim: To analyze spontaneously reported suspected ADRs in a tertiary care teaching hospital with respect to demographic characteristics, drug classes, organ systems affected, severity, seriousness, causality, and outcome. Material and Methods: A retrospective, academic, observational, record-based study was conducted at the ADR Monitoring Centre, GMERS Medical College and General Hospital, Gandhinagar. All spontaneously reported ADR forms received between April 2022 and March 2023 were analyzed. Data were evaluated for completeness and categorized by patient demographics, organ system classification (MedDRA SOC), suspected drugs, severity (Hartwig-Siegel scale), seriousness (PvPI criteria), and causality (WHO-UMC scale). Descriptive statistics were applied. Results: A total of 1,004 drug encounters were analyzed. ADR occurrences were similar in males (51.09%) and females (48.91%), with most reports from adults aged 18-35 years (47.41%). Antibiotics (33.27%), analgesics (12.15%), and antidepressants (7.67%) were the leading drug classes. The skin (33.33%), gastrointestinal (28.77%), and nervous systems (8.31%) were most frequently affected. Most ADRs were mild (85.25%), non-serious (86.45%), and classified as probable in causality assessment (64.64%). Recovery occurred in 66.43% of cases, while outcomes were unknown in 29.98%. Conclusion: Cutaneous ADRs were most common, primarily due to antimicrobials and NSAIDs. Strengthening ADR documentation and fostering a reporting culture are essential for enhancing patient safety and optimizing pharmacotherapy.