STUDY OF THERAPEUTIC OUTCOME AND MONITORING OF ADVERSE DRUG REACTIONS (ADRS) IN PATIENTS COMING TO OUTDOOR PATIENT DEPARTMENT (OPD) OF DERMATOLOGY, VENEREOLOGY AND LEPROSY IN TERTIARY CARE HOSPITAL OF NORTHERN INDIA

Introduction: Cutaneous adverse drug reactions (CADRs) associated with significant morbidity and mortality are probably the most frequent of all manifestations of drug sensitivity. Material and Methods: It was a prospective observational study where newly diagnosed patients with ADRs reporting to OPD of Dermatology, K.G.M.U, Lucknow and satisfying inclusion criteria were enrolled. The various study tools used were the suspected ADR reporting form (CDSCO), Naranjo’s causality scale, Modified Hartwig and Siegel severity scale and Dermatology Life Quality Index. Results: In a total of 124 patients recorded with CADRs, males (60.5%) were found more affected than females (39.5%). The most common age group found was 21-30 yrs (36.3%) followed by 31-40 yrs (25.8%) with a mean age ± SD 35.88 ± 13.87 range (18-78) years. The most common clinical pattern observed was Fixed Drug Eruption (FDE) (49.2%) followed by maculopapular rash (MPR) (36.3%). The incidence of Severe CADRs (SCADR) was 8.06%. Antimicrobial (50.8%) followed by unknown (17.7%), combinations (14.5%) and anti-epileptics (8.9%) were the most common drug groups suspected. On the severity scale, the majority of CADRs were moderately severe (70.9%). Causality assessment categorized most of the CADRs as probable (83.1%). The majority of FDE (39.3%) showed a small effect, MPR (33.3%) and SCADR (60%) showed an extremely large effect, other drug rashes (50%) showed a very large effect on the quality of life (QoL). The association of type of CADR with causality, severity and QoL was found statistically significant. (p-value <0.05). Conclusion: Prompt reporting and monitoring of ADRs is needed to timely manage and prevent them which may even progress to fatal scenarios.