Abstract

A PHARMACOVIGILANCE STUDY OF ADVERSE DRUG REACTIONS IN INDOOR PATIENTS OF TUBERCULOSIS TAKING ANTITUBERCULAR THERAPY (DOTS) IN A TERTIARY CARE HOSPITAL

Payal Naik* and Swati Patel

ABSTRACT

Background: Tuberculosis is a serious public health issue in India. The treatment regimen followed is Directly Observed Treatment Short-course (DOTS) approach. In a long period of treatment adverse drug reactions (ADRs) can be an important programmatic issue. Thus study was undertaken to assess the ADRs caused by DOTS therapy among hospitalized patients in a tertiary care hospital at Surat. Methods: The Observational, prospective study was carried out for one year period among indoor patients of tertiary care hospital. The causality was determined by WHO UMC scale and severity was determined by Modified Hartwig & Siegel scale. Z- test of proportion was applied for statistical analysis. Results: Among 231 tuberculosis patients, 72 (31.2%) patients developed ADRs. Occurrence of ADRs was more among females (42.9%). The commonly involved system is gastrointestinal system. The most common ADRs observed were nausea and vomiting (25.6%). High percentage of ADRs causing drugs were isoniazid (36.4%) followed by rifampicin (30.9%). Causality assessment showed 62.2% ADRs were possible, 35.6% ADRs were probable and 2.2% ADRs were certain. Severity assessment scale showed 82.2% of moderate, 11.1% of mild and 6.7% of severe grading. Conclusions: Anti tubercular treatment is safer but early detection, management and reporting of ADRs is required to prevent it at initial stage and helps to decrease default rate.

Keywords: Adverse drug reaction, DOTS, Tuberculosis, WHO-UMC.