Incidence of adverse drug reaction and its outcome among patients in tertiary care hospital, Uttar Pradesh

Abstract

Introduction: World Health Organization defines adverse drug reactions (ADRs) as any noxious, unintended, and undesired effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or therapy. For evaluating the incidence and outcome of adverse drug reactions (ADRs) to assist in minimizing the deleterious effects, the present study was planned to find the incidence of ADR, its severity, and outcomes among patients. Material and Methods: The spontaneous ADR reporting technique and the Suspected Adverse Drug Reaction Reporting Form were used for the data collection and reporting. All patients who developed an ADR during the study period has included. By using Expanded Rawlins and Thompson’s classification, all patients were categorized into types A to F and classified according to the severity levels (mild, moderate, severe) by applying the Modified Hartwig severity scale. The classification of outcomes of the ADRs was done as per WHO criteria as fatal, continuing, recovering, recovered, unknown, or any other. Results: Type B (Bizarre) ADRs were found to be the most frequently occurring ADRs (51%) followed by type A (Augmented) 29%. Maximum ADR cases were found in the 12-45 years age group (58%).

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“…There was an another study reported a lower incidence of 3.7% ADRs among hospitalized patients in India, highlighting the need to investigate the reasons for this discrepancy, including under-reporting and inadequate pharmacovigilance systems 22 . In our study, the majority of adverse drug reactions (ADRs) were classified as Type A according to Rawlins and Thompson's classification, consistent with the established observation that approximately 80% of ADRs fall into this category, while the remaining 20% are categorized as Type B 23 . This finding is further substantiated by two additional studies 24,25 .…”