Adverse Medication Response Recorded in a Referral Health Facility: An Observational Study

Abstract

Introduction: The incidence of adverse drug reactions (ADRs) has significant implications for patient safety and public health. In 1937, the introduction of sulphanilamide for streptococcal infections marked a pivotal moment in drug safety. Present study assessed the pattern, causality and severity of the ADRs reported from a tertiary referral centre.  Materials and Methods: Study conducted at the Mahatma Gandhi Mission Medical College and Hospital Kamothe Navi Mumbai recorded the pattern of ADRs between January 2021 and December 2022. The data was collected from the ADR Monitoring Center using the suspected ADR reporting form, version 1.4 of IPC, Ghaziabad, India. The suspected ADR forms were assessed to understand the pattern of ADRs regarding the completeness score of the ADR form.  Findings and Discussion: A total of 111 ADRs were recorded, with 43.24% of cases falling within the age range of 21 to 40. Antimicrobial medications were the main culprits behind the majority of ADRs reported by the departments of dermatology and general medicine. Rashes, edema, and urticaria are among the skin-related symptoms among the most frequently reported adverse drug reactions (ADRs). 72.9% of instances were classified as mild, according to severity assessment, whereas 57.65% of ADRs were found to be likely.  Conclusions: Because ADRs represent a serious threat to public health, our study highlights the significance of pharmacovigilance in tracking and preventing them. Databases on a national and international level are enhanced by systematic, regular reporting and monitoring of ADRs. In order to raise awareness of ADRs among patients and healthcare professionals, spontaneous reporting is still essential.