DESCRIPTIVE AND ANALYTICAL STUDY OF CUTANOUS ADVERSE DRUG REACTIONS (CADRs): A HOSPITAL BASED OBSERVATIONAL STUDY IN SOUTHERN ODISHA.

Background - Skin being largest organ in body is frequently affected by drug reactions accounting for 2% in OPD, 10% in IPD admissions and 2-7% have serious, fatal consequences. Thus spontaneous reporting is very essential . objectives - 1.To analyze the clinical characteristics and to identify the Culprit drugs,responsible for CADRs, 2.Assess the severity, know the outcome of CADRs 3. Associate the degree of severity with different risk factors.. Methods - It was a prospective observational study was done both in the OPD and IPD of Skin and VD department of MKCG hospital, Berhampur, Odisha from September 2022 to March 2023. 82 cases of CADR of either sex of any age were included in this study. Data were collected in suspected ADRs reporting form version 1.3, PvPI .The Causality,severity assessment was done by valid scale and data were analyzed by descriptive statistics in numbers and percentages . The severe form of CADRs associated with risk factors were analyzed by Chi--square test. P value < 0.05 was considered as statistically significant. Results - CADRs had female preponderance 58.5%) and the most commonly affected age group was the elderly population ( 42.6 %) in this study. Fixed drug eruption (FDE) was most common (29.2%) type and the commonly involved culprit drugs suspected were anti-microbials (52.4%). Major CADRs belonged to probable (54%) category in Causality assessment and were of Mild (40.2 %) variety in Severity assessment. The risk factors found to be significantly associated were extreme age (> 60 years), H/O previous skin allergy, multi-medications (>2 drugs) with p=0.019*, p=0.001+, p= 0.02* respectively. Conclusions - FDE are identified as major type of cutaneous adverse drug reactions. Major Group of drugs responsible for this were found to be Antimicrobials. The severe CADRs were mostly associated with extreme age, previous allergic history and multi -medications which should be taken with caution to avoid CADRs. [ABSTRACT FROM AUTHOR]