Evaluation of Adverse Drug Reactions in a Tertiary Care Hospital in Kolkata, West Bengal: An Observational, Cross-sectional Study

Abstract

Background:In the present world, drugs are inevitable to cure diseases. However, these drugs are reported to cause unwanted complications to the patients.Adverse drug reactions (ADRs) are considered as one of the leading causes of morbidity and mortality, identified globally. Thus, vigilance of these adverse effects is essential in order to reduce patient suffering. Present study thus aimed to collect reports and to evaluate on adverse drug events from patients attending a tertiary care hospital in Kolkata.Materials &Method: This is a cross-sectional, observational study conducted for a period of six months at R.G. Kar Medical College and Hospital, West Bengal, India providing tertiary level of healthcare to the community. Data were collected from both outpatient and inpatient departments. Collected datawere evaluated on the basis of different parameters like demographic features of patients, drugs responsible for the adverse effects, symptoms of the adverse effects and causality assessment based on WHO-UMC and Naranjo assessment scale.Results: Out of the 100 reports collected on adverse drug reactions, 55% of the patients were female and 45% male. The mean age of the patients was 47 years. Anti-neoplastic and immunomodulating agents was responsible for maximum number (41.78%) of ADR cases. Using the WHO-causality assessment scale, 67% of ADRs were found to be probably drug-related and 33% of the ADRs were possible.Based on the Naranjo-causality assessment scale, 43% ADRs were found to be definite,45% probable and 12% possible.Conclusion:Monitoring of ADRs is thus essential to create awareness in the society and to optimize therapy by increasing patient compliance.