Publication:

Dermatological adverse drug reactions in tertiary care hospital: an analysis of causality and severity

Background Dermatological adverse drug reactions (ADRs) are easily detected by patients and that precludes further usage of drugs. So, decided to study the pattern, causative drugs, severity of adverse drug reactions and their causality in tertiary care hospital.

Methods It was prospective non inventional cross sectional study. Patients attending OPD or admitted to IPD of all age group and both gender with suspected dermatological ADRs following drug intake were included and the ADRS were recorded on CDSCO’s Pharmacovigilance form. Collected data was analyzed for assessment of causality using WHO-UMC scale, for severity by using Modified Hartwig and Siegel. Morphological pattern, drug groups, gender and age distribution was analyzed.

Results 231 dermatological ADRs were recorded and analyzed. Maximum cases were found in 21-30 years age group (74 cases). Dermatological ADRs were found in 143 females and in 88 males. Three major classes of drugs found responsible for causing dermatological ADRs were -oral Antimicrobials-41 (17.75%) and Injectable Antimicrobials-40 (17.32%), NSAID's-40 (17.32%.) and Topical Betnovate-36 (15.58%.). Regarding the type, 95 cases were of maculopapular rashes (41.12%), steroid damaged face in 42 (18.18%) andacute urticaria in 20 (8.65%). In terms of Severity assessment, authors found 23 cases (9.95%) as Mild, 176 cases (76.19%) of moderate severity and 32 cases (13.85%) of Severe category. In terms of causality assessment: 3 cases as Certain, 68 cases as Probable and 160 cases as Possible.

Conclusions From this study, it was found maximum Dermatological ADRs of moderate severity and few cases of causality category as “Certain”.