A Prospective, Observational Study of the Spontaneous Reporting Patterns of Adverse Drug Reactions in a Tertiary Care Teaching Hospital

Objectives: To analyse the adverse drug reactions (ADRs) reported from clinical departments of a tertiary care hospital.

Materials and Methods: A prospective, observational study to analyse the reported ADRs to the pharmacovigilance unit, Department of Pharmacology, East Point College of Medical Sciences and Research Centre, between 2019 and 2021. Institutional Ethics Committee approval was taken before doing the study. The data pertaining to various parameters were recorded in the Central Drugs Standard Control Organization (CDSCO) approved ADR reporting form and were analysed with respect to each reported data using descriptive statistics and expressed as numbers and percentages using Microsoft Excel.

Results: Overall, 114 ADRs were reported during the study duration, and ADRs were most commonly reported amongst females (69) and 31–45 years (27.2%) age group. Causality assessment was done using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, which showed 75 (66%) probable and 39 (34%) possible ADRs. The highest number of ADRs were reported by Medicine department (48.2%), emergency and intensive care unit (ICU) (16.6%) followed by Dermatology department (9.6%). The majority of them were due to antimicrobial agents (53.5%). The most commonly affected organ system was found to be dermatological (68.4%) followed by the body as a whole (15.7%) and gastrointestinal system (8.7%). The presentations of ADRs were diverse; itching and rashes (34 cases) were most commonly reported.

Conclusion: This study gives an overall understanding of the current situation and trends in ADRs and their reporting status by health professionals in a tertiary care hospital, which would help to strengthen the pharmacovigilance activities at all levels of health care.