PROFILE OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL: A CROSS-SECTIONAL STUDY

Abstract

Objective: The objective of this study was to analyze incidence, presentation, severity of adverse drug reaction, and identification of offending drug in a tertiary care hospital setting. Methods: This was a cross-sectional study conducted in the department of pharmacology of a tertiary care medical institute for assessing the clinical spectrum and pattern of adverse drug reactions (ADRs). Total 50 patients with ADRs were included in this study on the basis of a predefined inclusion and exclusion criteria. Demographic details and history were noted in all cases. The Naranjo scale was used to determine the causality and categorize it into definite, probable, possible, or doubtful causation. Severity of the ADR was assessed using the modified Hartwig scale. The Statistical Package for the Social Sciences 23.0 version was used for statistical analysis. For statistical purposes, p<0.05 was considered as significant. Results: In this study, out of 50 patients, there were 36 (72%) males and 14 females (28%). There was a male preponderance with M: F ratio being 1:0.388. The most common ADR symptoms were itching (76%) and skin rashes (26%). Antimicrobials were the leading cause of ADRs (14%), followed by antiretroviral agents (10%) and non-steroidal anti-inflammatory drugs (6%). The Naranjo scale classified 14% of ADRs as definite, 44% as probable, and 42% as possible. Severity assessment revealed 54% mild, 40% moderate, and 6% severe ADRs. The most affected age group among males was 41–50 years (20%), while among females, it was 31–40 years (10%). Conclusion: Prompt recognition and management of ADRs are crucial for minimizing their adverse effects on patient health and for guiding safer prescribing practices in clinical settings.