Adverse drug reactions: a prospective observational study at a tertiary care hospital

Rithunandana Sreeja; Balakeshwa Ramaiah; Banjara Raju Prabhudev; Pratik Bangi

doi:10.18203/2319-2003.ijbcp20254160

Authors

Rithunandana Sreeja Department of Pharmacy Practice, Karnataka College of Pharmacy, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
Balakeshwa Ramaiah Department of Pharmacy Practice, Karnataka College of Pharmacy, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
Banjara Raju Prabhudev Department of Pharmacy Practice, Karnataka College of Pharmacy, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India
Pratik Bangi Department of Pharmacy Practice, Karnataka College of Pharmacy, Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20254160

Keywords:

Adverse drug reaction, Incidence, Pharmacovigilance programme of India, Patient safety, Spontaneous reporting

Abstract

Background: Reporting and assessing adverse drug reactions is essential for regulators to monitor, research and maintain patient safety. The main purpose of this study was to report, assess the adverse drug reactions and its incidence at a tertiary care hospital.

Methods: This was a prospective observational study conducted in a tertiary care hospital in Bengaluru. A total of 184 suspected adverse drug reactions were recognized and documented during the study period of six months. After data collection, each suspected adverse drug reactions were assessed.

Results: The suspected adverse drug reactions were reported and evaluated from 178 patients. Among them, 60.11% were adults and 35.39% were elderly patients. The majority of patients were females (55.98%) followed by males (44.02%). A higher number of adverse drug reactions was reported from the general medicine department (48.37%). The majority of the route of administration of suspected drugs was through the oral route (54.31%). Most of the Adverse drug reactions outcome were recovered/resolved (57.60%). The severity of the majority of ADRs was moderate (77.17%). According to causality assessment, most of the ADRs were probable (75%) and were classified as type A (54.34%) reactions. The incidence rate of ADRs during the study period was 0.93%.

Conclusions: The study results indicate a significant decrease in the occurrence of adverse drug reactions compared to previous year. This reduction highlights the need for enhanced monitoring, improved drug safety measures and more effective ADR reporting. This investigation draws attention to ADR reporting practices and highlights the need for a more organized approach to ADR detection and management in hospitals.

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