Objective: Drug is beneficial for the treatment, prevention or diagnosis of disease. However, adverse drug reactions (ADRs) associated with the use of drugs are also very common. Due to the lack of knowledge and awareness, many adverse incidents due to a drug remain unnoticed. Present study was conducted to evaluate the prevalence of adverse drug reactions in a tertiary care hospital in Kolkata, West Bengal, India. Method: Present study was an observational study based on the reports collected during July 2014 to June 2015 from different departments of a tertiary care hospital, with prior consent. The reports comprised of patients of age group ranging from 1 month to 85 years, of either sex. The causality assessment was done on the basis of “Naranjo’s Assessment Scale” and severity assessment was done in accordance with “Hartwig and Siegel scale”. Result: During the study period, among 529 prescriptions, adverse drug reactions was suspected in 287 patients. This comprised of 144 (50.17%) females and 143 (49.83%) males. According to Anatomical Therapeutic Chemical (ATC) Classification System, the drug mostly associated with adverse drug reactions was anti-infective agents (63.07%). The causality assessment according to Naranjo Scale showed 5% ADRs have definite, 40% probable and 55% possible correlation. Conclusion: In order to ensure a better treatment regimen and improve patients’ compliance, it is essential to reduce and prevent adverse drug reaction. Implementation of pharmacovigilance programs in the hospitals is thus essential to enhance the awareness regarding early detection, reporting, management and further prevention of Adverse Drug Reactions.
Key words: Adverse Drug Reaction (ADR), Pharmacovigilance, Tertiary care hospital, Anti-infective agents, Causality assessment.