Safety evaluation of antitubercular therapy under revisednational tuberculosis control programme in India

Abstract

Introduction: The World Health Organization declared tuberculosis (TB) as a global emergency in 1993. To intensify the efforts to control TB, the Government of India gradually replaced the National Tuberculosis Programme by the Directly Observed Short Course Therapy (DOTS) programme which is now known as the Revised National Tuberculosis Programme (RNTCP). Objectives: The present study was carried out to evaluate the safety of the DOTS therapy by monitoring adverse drug reactions (ADRs). Methodology: All the TB patients admitted at the DOTS centre Kasturba Hospital, Manipal, and at the DOTS Centre, Udupi, were enrolled as per the study criteria and were monitored for ADRs. The data were evaluated for patient demography, types of TB, types of DOTS treatment, incidence of ADRs, predisposing factors for developing ADRs and the types, onset, management and outcome of the ADRs. ADRs were also assessed for their causality and severity as per the standard algorithms. Results: Out of 94 TB patients, a majority of them were males (70%) and belonged to the age group of 18-40 years (52%). The incidence of ADRs was 17.02%. Gastritis was the most common ADR and multiple drug therapy was the major predisposing factor. We found that 28.51% of the total ADRs belonged to Type-A ADRs. In 87.1% of the cases, the suspected drug was continued in spite of the ADR, without any complications. On evaluation of the causality of ADRs, a majority of them were found to be ‘possible’ by both WHO and Naranjo’s scales. The severity assessment of ADRs showed that 31(51%) reactions were moderate and 30 (49%) were of the ‘mild’ nature. Conclusion: We found DOTS therapy to be safer. But regular monitoring is required for ADRs, so that certain percentage of ADRs can be prevented.