Adverse drug reactions monitoring among TB patients on anti-tubercular drugs under RNTCP in Pondicherry.

A recent WHO definition of an Adverse Drug Reaction(ADR) ‘An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.’ For effective control of TB and to prevent patient withdrawal due to non-compliance it is essential to know various ADRs and their management. There is an increased risk of having multi-drug resistant disease among the WHO category II patients who have received anti-tuberculosis treatment for more than one month in the past. The added problem in the treatment of TB is that a combination of drugs is used for prolonged periods of time and therefore there is likelihood of potentiating the adverse reactions of one drug by the other co-prescribed drugs. Worldwide, many countries have started ADR monitoring programmes with varying degree of success. In India, ADR monitoring is still in its infancy. Till date, there are various studies on daily regimen verses DOTS, but very few studies have been done to evaluate the safety of DOTS regimen. Therefore, there is a need to study the safety aspect through monitoring of ADRs in patients on DOTS with focus on reasons for drop-outs and non-compliance for non-completion of the course of treatment. Hence, the present study was undertaken with following objectives: Aims & Objectives: 1. To describe the socio-demographic pattern of TB patients experiencing ADRs in Pondicherry receiving DOTS. 2. To describe the pattern of ADRs caused by ATT in DOTS patients. 3. To assess the causality and severity of reported ADRs. Methods: This Prospective Cohort study was started after obtaining the approval of Institutional Ethics Committee for a period of 12 months. Fifty patients receiving DOTS under RNTCP in five DOTS centres were subjected to the study after explaining and obtaining their written informed consent. All the patients were registered into the study during the first month of their Intensive Phase, and all the patients were followed-up for 6 months. Patients’ profile: Sex, location, literacy, socio-economic status, pregnancy status and concomitant diseases like HIV and Diabetes Mellitus etc., were recorded using a pre-tested questionnaire.