Event Monitoring in Patients Prescribed with Anti-tubercular Therapy

Abstract

Tuberculosis is a chronic, granulomatous infectious disease caused by Mycobacterium tuberculosis. Multidrug resistance is a chronic problem associated with treatment of tuberculosis where a substantial proportion of tuberculosis cases reported in India are multi-drug resistant. Poor patient compliance plays a major role in development of resistance. The main objective of the study was to monitor the events associated with ATT in pulmonary and extrapulmonary tuberculosis patients and to achieve better patient outcomes by regular monitoring. This was a prospective observational study which analysed patients diagnosed with pulmonary and extra-pulmonary kochs', attending inpatient and out-patient departments as well as registered under the RNTCP at Dr. B.R Ambedkar Medical College and Hospital for a period of 1 year for any events associated with ATT. Routine investigations which are carried out by the patient at the treatment initiation and whenever required were monitored. A total of 175 patients were monitored in the study out of which majority were males. Most patients were category 1 patients. More than one-third of the patient population reported an adverse event. Most ADRs were related to the GI system, followed by Skin Allergy. Most of the events (72%) were patient reported during physician visit while 26% were reported on investigation. The study found that ADRs has led to medication incompliance which leads them to discontinue the medication for a short duration. Close monitoring of these events from the treatment initiation should be emphasized to prevent medication in adherence. It is suggested that the establishment of pharmacovigilance programs in DOTS centres is essential.