ANALYSIS OF CUTANEOUS ADVERSE DRUG REACTIONS PRESENTING TO THE DERMATOLOGY DEPARTMENT OF A TERTIARY CARE TEACHING HOSPITAL: A PROSPECTIVE, OBSERVATIONAL STUDYAbstract
Background: Cutaneous adverse drug reactions (CADRs), having a wide range in terms of its spectrum, are an important cause of morbidity and mortality. They comprise 2-3% of all ADRs. This study was conducted to analyze various parameters of CADRs at our setup. Methodology: This prospective, observational study was carried out for 1 year at our setup after ethical approval. Those diagnosed as CADRs by the Dermatologist were included. Data was collected in suspected ADR reporting form and analyzed for various parameters like suspected drug and drug class for CADRs, spectrum as well as its type, severity, preventability, causality assessment, seriousness, and outcome. The lag period for the development of CADRs was also analyzed. This data collection was also uploaded via Vigiflow under Pharmacovigilance Programme of India (PvPI). Results: Total of 125 cases were recorded with 134 CADRs. These 134 cases included a wide range comprising of 27.61% rashes to 5.97% Stevens-Johnson syndrome (SJS). For these CADRs, most common suspected drug classes were anti-infectives (34.32%) followed by NSAIDs (29.10%) whereas most common suspected drugs were Diclofenac (17), Paracetamol (12), Amoxicillin (10), etc. 83.58% CADRs were type B hyper-sensitivity reactions. Causality assessment according to WHO-UMC criteria showed 61.94% CADRs had probable causality. The lag period for the majority of CADRs was 1 day. Conclusion: CADRs were frequent with drugs commonly prescribed in day to day clinical practice. Thus, the meticulous use of drugs is inevitable. Strict rules and regulations for judicious drug use, workshops on pharmacovigilance for health care professionals, adequate reporting of ADRs, etc. can all lead to increased general vigilance.
H. J. Sheth, R. P. Patel, R. G. Chaudhary and S. D. Malhotra *
Department of Pharmacology, Smt. NHL MMC, Ellisbridge, Ahmedabad, Gujarat, India.
23 June 2018
29 August 2018
31 August 2018
01 March 2019