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Introduction: Adverse drug reactions (ADRs), including cutaneous adverse drug reactions (CADRs), are significant global health concerns with India among the top affected countries. CADRs represent a significant concern in healthcare, impacting the skin, its appendages and mucous membranes ranging from mild rashes to severe, life-threatening conditions like Stevens-Johnson syndrome and toxic epidermal necrolysis. Self-medication with over-the-counter drugs is a notable public health issue linked to CADRs. Clinical trials often miss long-term and rare CADRs making early detection and monitoring crucial. This study aims to evaluate CADRs by assessing their causality, severity and preventability; determining onset lag time; identifying morphological patterns; and investigating associations with different drug classes. It also explores the links between self-medication and CADRs and analyses related outcomes. This research addresses gaps in understanding CADRs' epidemiology, impact and management providing valuable insights for healthcare practitioners. Material and methods: A 12-month prospective observational study conducted at a tertiary care hospital involved dermatology patients from both outpatient and inpatient units. Inclusion criteria comprised patients diagnosed with CADRs by physicians in the outpatient department (OPD) (active surveillance) and reported cases to pharmacovigilance unit (passive surveillance) while those unwilling to provide written consent were excluded. Result: The majority (44.25%) of the patients were aged 18-39 years. Maculopapular rash (53.98%) and urticarial rash (9.73%) were the most common CADR types. Anti-bacterials (42.63%) were the primary suspected drug class. Serious CADRs were predominant (74.34%) with 1.77% resulting in fatalities. Severity was moderate in 79.65% and mild in 17.7% of the cases. Preventability was low (5.31%) with three CADRs attributed to self-medication. Recovery was seen in 46.9% of the patients with 42.48% still in recovery at discharge and a mortality rate of 1.77% due to Stevens-Johnson syndrome. Conclusion: A comprehensive pharmacovigilance system for continuous monitoring of patients' health status can lead to opportunities to reduce the CADRs, lower drug-related morbidity and rationalize drug therapy.
Dhage et al. (Wed,) studied this question.