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Himangshu Mahato*, MBBS, st year MD PGT, Tanima Saha, MBBS, nd year MDPGT, Swati Bhattacharyya, MD, Assistant Professor, Jolly Seth, MD, RMO,Supreeti Biswas, MD, Professor and H.O.D


BACKGROUND: Patient safety has become a leading topic in the national level. An ADR can lead to significant morbidity, mortality and financial costs. People in every country of the world are affected by adverse drug reactions (ADRs) and it is estimated that at least 60% of ADRs are preventable (WHO fact sheet). Almost any medicine can induce skin reaction, certain drug classes such as NSAIDS, antibiotics and antiepileptics have drug eruption rates approaching 1-5%. Cutaneous adverse drug reactions are defined as noxious, unintended, morphologic skin changes with or without systemic involvement that develop after local or systemic administration of drugs in dosage commonly used for prevention, diagnosis or treatment of disease or modification of physiologic function. OBJECTIVES: To study clinical patterns, causality, preventability and severity of ACDRs(Adverse Cutaneous Drug Reactions) among patients attending Skin & Venereal Disease Department in a tertiary care hospital. METHODS: Cross-sectional descriptive observational study involving 1500 patients attending Skin OPD will be scrutinized for 2 months irrespective of age, sex and diagnosis. Only patients with suspected drug-related cutaneous reactions will be included. Relevant details including adverse events and medications will be recorded in a predesigned case report form. Causality Assessment carried out as per Naranjo’s algorithm whereas Preventability & Severity as per Schumock and Thornton Scale & WHO-guidelines, respectively. RESULT AND DATA ANALYSIS: Appropriate statistical methods will be used for analysis of result. DISCUSSION: Study will be discussed according to the result.

Keywords: ACDRs,NSAIDS,ADRs, Naranjo’s algorithm.

[Full Text Article]

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