Original Articles
A Retrospective Analysis of Spontaneously Reported Cutaneous Adverse Drug Reactions At ADR Monitoring Centre of A Tertiary Health Care Teaching Hospital of India | |
Dr. Jhanvi Vaghela | |
Introduction: Cutaneous adverse drug reactions (ADRs) present a substantial challenge in healthcare, ranging from mild rashes to life-threatening conditions, impacting patient safety and clinical management. Understanding the prevalence, patterns, and causative drugs of cutaneous ADRs in India is critical for optimizing patient care. The Adverse Drug Reaction Monitoring Centre (AMC) plays a pivotal role in assessing drug-related adverse events, utilizing spontaneously reported data to explore real-world drug impact. The objective of this retrospective observational study was to describe clinical patterns, identify associated drugs, and conduct causality assessments for cutaneous ADRs using the WHO causality assessment scale. Methods: Data from spontaneously reported cutaneous ADRs between August 2015 to September 2020 at the ADR Monitoring Centre were analyzed. Demographics, clinical characteristics, implicated drugs, and causality were assessed using WHO-UMC criteria. Results: Among 164 reported CADRs, 56.7% occurred in males, with a higher prevalence in the 16-30 age group. Maculopapular rash (28.7%) and erythema multiforme (19.5%) were predominant. Antimicrobial drugs (62 cases) and anti-epileptic drugs (30 cases) were frequently implicated. 80% of cases were classified as "serious," with 45.7% experiencing complete resolution. Conclusion: The study provides insights into CADR demographics, manifestations, causative drugs, outcomes, and causality assessments. Regional consistency in patterns emphasizes the importance of understanding local variations. The findings underscore the significance of antimicrobial, anti-epileptic, and NSAID drugs, informing vigilant prescribing and monitoring practices. This information is invaluable for healthcare practitioners, aiding in risk identification, intervention planning, and contributing to enhanced drug safety measures. These insights may inform clinical guidelines and contribute to safer drug formulations, addressing the complex landscape of cutaneous ADRs in diverse populations. |
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