Study of adverse cutaneous drug reactions as a part of pharmacovigilance from a tertiary care teaching hospital of Madhya Pradesh

Type of artical: Original Research Article

Background & objectives: Gaining a comprehensive understanding of the characteristics and mechanisms underlying Adverse Cutaneous Drug Reactions (ACDR) might facilitate the process of identifying the specific causative agent. The study aimed to evaluate incidence, assessment of causality, severity and preventability of Adverse Cutaneous Drug Reactions as a part of Pharmacovigilance from a central Indian medical college. Methods: The study employed several methods for data collection and analysis, including the CDSCO ADR Reporting Form, the WHO causality assessment scale, the Hartwig and Siegel’s Assessment scale, and the Modified Schomock and Thronton’s preventability assessment scale. Results: The findings of this study revealed that out of the total sample size of 23 patients, a small proportion of 0.3% were identified as having either one or both types of adverse cutaneous drug reactions (ACDRs). The most prevalent type of adverse cutaneous drug reactions (ACDRs) observed among the study patients was fixed drug eruption, accounting for 34.8% of cases. This was followed by acneform eruption, which accounted for 21.7% of cases, and urticaria, which accounted for 13% of cases. Conclusions: The implementation of pharmacovigilance activities has been found to have a considerable impact on the enhancement of adverse drug reaction (ADR) reporting.