A STUDY OF ADR AMONG PULMONARY TUBERCULOSIS PATIENTS TREATED UNDER DOTS

Dr. J. Femi Retna*

ABSTRACT

Introduction: Directly observed treatment strategy (DOTS) under RNTCP is the current treatment available for Pulmonary Tuberculosis. This mode of treatment shows a higher range of efficacy with minimal toxicity. The present study aims to determine prevalence and characteristics of patients with pulmonary tuberculosis and to study the ADRs caused by ATT and to assess the causality and severity of the reported ADRs. Methods: We studied cases of Pulmonary Tuberculosis diagnosed and treated under DOTS at Our hospital for the period of Six months (July 2014 to January 2015). Adverse effects observed during treatment course were recorded in standard ‘Adverse Drug Event Reporting Form’. ADRs were also assessed for their causality and severity by using WHO-UMC criteria. Results: Pulmonary cases accounted for 61.2% of total TB cases. Among 217 cases of pulmonary tuberculosis 17 (7.8%) patients were defaulters; among them 5 cases were defaulters due to ADRs. In our study 47 patients developed 95 ADRs of various types and most of the ADRs noted within first 14 days after starting treatment. Gastritis was the most common ADRs (n=22)followed by anorexia (n=18). Conclusions: In our study 21.6% of patients developed ADRs. ADRs recorded in our study were categorised under ‘probable’ and ‘possible’ causes and severity assessment showed 39% are moderate and 61% are ‘mild’ in nature. Hence carrying out of good patient care programs are needed for early diagnosis and to reduce default rate and drug resistance.

Keywords: Naranjo’s causality assessment scale, Pulmonary Tuberculosis, DOTS.