జర్నల్ ఆఫ్ ఫార్మకోవిజిలెన్స్

నైరూప్య

Monitoring of Cutaneous Adverse Drug Reactions in a Tertiary Care Hospital

Raja Amrinder, Inderpal Kaur, Jatinder Singh and Tejinder Kaur

Introduction: Cutaneous adverse drug reactions (ADRs) are the most frequently occurring ADRs to drugs. These reactions have a varied morphology and are responsible for significant mortality and morbidity. The aim of this study is to characterize the morphological patterns of cutaneous ADRs and to determine the incriminating agents.

Method: The study was carried out in the Dermatology, Venereology and Leprosy department, Guru Nanak Dev Hospital, Government Medical College, Amritsar from 1st March 2014 to 31st May 2015. World Health Organization– Uppsala monitoring centre (WHO-UMC) causality scale was used to determine the causality of cutaneous ADRs and severity was assessed using Hartwigs severity scale.

Results: In the present study, the highest incidence of cutaneous ADRs was in the age group of 31-40 years (25.0%), and more frequently in female patients (54.2%). Antimicrobials were the most commonly implicated drugs (37.5%) followed by Non-Steroidal Anti-inflammatory drugs (NSAIDs) (25.0%), various combination drugs (10.0%), corticosteroids and antiepileptics (6.6%). The most commonly observed morphological pattern was of Fixed drug eruptions (33.3%) followed by maculopapular rash (30.8%) and Steven Johnson Syndrome (5.8%). Causality assessment was certain, probable and possible for 1.6%, 93.3% and 41.5% of the reactions, respectively. 109 cases were of level 3 severities, 10 cases to level 4 severities and one case of level 7 where ADR was responsible for death in one patient.

Discussion: Most of the adverse drug reactions are preventable, provided the drugs are used rationally. Antimicrobials were the most common causative group and fixed drug eruption was the most frequently encountered morphological pattern. Therefore it is imperative that in each patient the risk of drug administration should be weighed against the expected therapeutic benefit.