A study on adverse drug reactions in a tertiary care hospital of Northeast India

Abstract

Objective: Purpose of this study was to monitor adverse drug reactions reported from various departments of a tertiary care hospital in Northeast India. Reported adverse drug reactions were analysed for causality and severity assessment.

Methods: This cross sectional study was conducted in a tertiary care hospital at Guwahati, Northeast India, for 7 months. Patients of all age and either sex were included. Adverse drug reactions were reported by the physicians of this hospital and their causality and severity assessments were performed as per Naranjo’s and Hartwig’s assessment criteria respectively. Descriptive statistics were used for data analysis.

Results: Total 255 adverse drug reactions were reported from various departments of this tertiary care hospital. Most of the adverse drug reactions were observed in the age group of 21–30 year. Acne (46) was commonly reported reaction. Topical steroids, betamethasone sodium phosphate and clobetasol were reported to induce maximum number of reactions (59). Skin (227, 66.9%) was commonly affected organ system. Most of the adverse drug reactions were possible (240, 94.1%) and mild (222, 87%) in nature.

Conclusions: The topical steroid (betamethasone sodium phosphate) was reported to induce adverse drug reactions in majority of the patients. The commonly reported reaction was acne.

Keywords: ADRs; Northeast; Naranjo; Hartwig; Pharmacovigilance