Original Articles
Pharmacovigilance Analysis of Adverse Cutaneous Drug Reactions in a Tertiary Care Dermatology OPD | |
Dr. Rashmi Roy, Dr. Mamta Yadav | |
Background: Adverse cutaneous drug reactions (ACDRs) represent a significant proportion of drug-related complications observed in dermatology outpatient settings. Monitoring these reactions through pharmacovigilance activities is essential for early detection, causality assessment, and preventive strategies to improve patient safety. Materials and Methods: This prospective observational study was conducted over a period of six months in the dermatology outpatient department (OPD) of a tertiary care hospital. Patients presenting with suspected ACDRs were evaluated through detailed history, clinical examination, and relevant investigations. Each case was analyzed for demographic profile, suspected drug(s), latency period, morphological pattern, and severity. Causality assessment was performed using the WHO-UMC scale and severity was categorized according to the Hart wig and Siegel scale. Results: A total of 112 ACDR cases were documented from 3,840 dermatology OPD visits (2.9%). The mean age of affected individuals was 38.7±14.2 years with a male to female ratio of 1.1:1. The most common drug groups implicated were antibiotics (35.7%), non-steroidal anti-inflammatory drugs (NSAIDs) (26.8%), and anticonvulsants (18.7%). The predominant clinical patterns included maculopapular rash (41%), fixed drug eruption (25%), and urticaria (17%). According to WHO-UMC causality scale, 52% of the reactions were classified as “probable,” 36% as “possible,” and 12% as “certain.” Most cases were mild (58%) to moderate (36%) in severity, with 6% requiring hospitalization. Conclusion: Antibiotics and NSAIDs remain the leading contributors to ACDRs in dermatology OPDs. Early recognition, appropriate documentation, and causality assessment play a crucial role in patient safety and drug regulation. Strengthening pharmacovigilance systems at the outpatient level is recommended. |
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