A Study of Cutaneous Adverse Drug Reactions; Clinical/ Morphological Pattern & Causative Agents Reported in an ADR Monitoring Centre in a Tertiary Care Hospital of North Karnataka

Abstract

Cutaneous adverse drug reactions (CADRs) are common, comprise approximately 2-3% of all the ADRs. Most of them are mild, self-limiting. Severe and potentially life-threatening eruptions occur in approximately 1 in 1000 hospitalised patients. Which carry a high degree of morbidity & mortality. Hence early detection, evaluation and monitoring of ADRs in particular CADRs are essential. As the pattern of CADRs is changing every year with the introduction of new medications & evolving prescription practices. To determine the pattern of various types of CADRs & to identify causative drug implicated in our setup, this study was carried out. A retrospective analysis of the CADRs retrieved from the Pharmacovigilance centre database, reported spontaneously between 25thAug 2015 to 31stOct 2019. The CADRs obtained were categorized according to their morphology & the suspected drugs were grouped according to ATC classification. Causality, severity & preventability assessment was done by using pretested scales. 70 patients had CADRs with male to female ratio of 1:2. Urticaria (37.14%) was the most common CADR & 5.7% of the CADRs were severe. Anti-infectives for systemic use (48.6%) was predominantly involved in the causation of CADRs. Most of the CADRs belong to a possible category, 75% of them were either recovered or recovering at the time of reporting & only 25% of the CADRs are preventable. Pattern of ACDRs & the drugs causing them are slightly different in our population as compared to other previous studies. Which emphasizes the need for robust ADR monitoring system in our setup.