Adverse Drug Reaction Monitoring and Reporting in a Tertiary Care Teaching Hospital in Goa

Abstract

Introduction: The objective of a hospital-based adverse drug reaction (ADR) monitoring program is to enhance patient safety through proper identification and quantification of the risks associated with the use of drugs. Materials and Methods: This study was carried out in a tertiary care hospital in Goa, primarily designed to strengthen ADR monitoring for over 12 months through prospective and observational studies. Results: Data collated from various parameters, such as patient demographic characteristics, drug profile, drug reaction outcomes, reaction severity, preventability, and causality, revealed that the overall incidence rate of ADRs was 0.65% and incidence in the female patient population was higher than in males; there was no significant difference in the distribution of ADRs in various age groups. The most common ADR observed was skin rashes with the use of antibiotics. The majority of ADRs observed (type A reactions) showed moderate severity. Most cases required intervention, of which 48.07% of the patients received symptomatic treatment. Upon causality assessment, most reports were rated as probable (75.1%). Mild and moderate reactions accounted for 15.7% and 77.8%, respectively. Conclusion: These findings shall ensure the safer use of drugs in the hospital and, thereby, better patient care, especially for preventable ADRs.