Journal of Pharmacovigilance

Cutaneous drug reactions reported in a dermatology outpatient clinic of a tertiary care hospital

3^rd International Conference and Exhibition on Pharmacovigilance & Clinical Trials

October 27-29, 2014 Hyderabad International Convention Centre, India

Swathi Ratnam R, Prabhakar I, Usha Kiran P and B Balachandrudu

Scientific Tracks Abstracts: J Pharmacovigilance

Abstract:

Background: Cutaneous Adverse Drug Reactions (CADR) are the most frequent serious adverse reactions reported in outpatient department of dermatology. Aims: The aim of the study to assess the prevalence and clinical spectrum of CADR among patients and to assess causality and identify the offending drugs. Materials and methods: An observational study was undertaken over 6 months period (Dec 2013-May 2014) in Dermatology OPD of tertiary care teaching hospital in Govt. General Hospital, Kakinada, Andhra Pradesh by ADR card reporting. Drug history was recorded in a format specified in Indian National Pharmacovigilance Programme and causality assessment carried out as per WHO-UMC criteria. Results: Study showed that, ADR reported among 522 total, 217 (41.5%) were CADRs. These CADR are mostly seen in gender female & age group between 18-45 years. Group of drugs leading to above manifestations are Antimicrobials-30. 4%, NSAIDS-26.2%, Steroids-23.9%, Others-19.3%. CADR manifestations are: Maculopapular rash-26.3%, Photosensitivity-22%, Urticaria-18.1%, Bullous eruptions-12.4%, Severe Mucositis-10.5%, Pruritis-5.2%, Fixed drug eruption-2.8%, Stevens- Johnson Syndrome (SJS)-0.9%, Toxic Epidermal Necrolysis (TEN)- 0.9%, Erythema multiformae-0.4%. Causality assessment was certain 35% and Probable 15.2% of the reactions. Conclusions: CADRs are utmost necessary for a physician to have understanding, as well as knowledge of the drugs essential for diagnosis and prevention.

Biography :

Swathi Ratnam Regidi is pursuing postgraduate in MD Pharmacology (final year) at Rangaraya Medical College, Kakinada, AP. She has attended many workshops like therapeutic drug monitoring at CMC Vellore 2012, Pharmacovigilance conducted by IPSCON 2013 at NIMHANS Bangalore etc, and attended various national and international conferences. Area of interest is awareness of pharmacovigilance at Teritary Care Hospital and adverse drug monitoring and drug safety.