Abstract

SAFETY REPORTING STUDY OF ANTISCABIETIC DRUGS IN A TERTIARY CARE TEACHING HOSPITAL

Dey S*, Sayedda K** and Ahmed QS***

Abstract

Objective: This prospective observational study was carried out to identify the incidence and severity of ADRs of antiscabietic drugs in a tertiary care teaching hospital. Material & Methods: A total of 120 patients were enrolled in a study. They were randomly divided into 4 groups. Group A received 5% permethrin & oral placebo, group B was given topical placebo cream & oral ivermectin. Group C received topical 1% gamma benzene hexachloride & oral placebo & group D was given 5% permethrin & oral ivermectin. ADRs were monitored & their severity were assessed by using ‘Common Terminology Criteria for Adverse Events’(CTCAE version 4). Naranjo’s probability scale was used to know causality relationship. Results: Total 4 ADRs were identified in 16 patients. The percentage of ADRs in groups A, B, C & D were 10%, 20%, 6.67% & 16.67% respectively. 75% of ADRs were of mild & 25% of moderate type. There were no severe ADR reported in the study. Skin irritation was the most common (n=7, 43.75%) side effect reported. Two ADRs were definite, one was probable & one was possible. There was no doubtful ADR. Conclusion: Incidence of ADRs with antiscabietic drugs was 13.33%. More clinical studies are needed to further explore the statistics of ADRs due to oral & topical antiscabietic drugs.

Keywords: antiscabietic drugs, Adverse drug reaction, CTCAE, naranjo’s probability scale.