A PROSPECTIVE OBSERVATIONAL STUDY ON THE EVALUATION OF ANTI-TUBERCULAR THERAPY INDUCED ADVERSE DRUG REACTIONS IN PATIENTS WITH TUBERCULOSIS

BACKGROUND: Tuberculosis is a disease of great antiquity and ranks the second highest contagious disease globally which is caused by Mycobacterium Tuberculosis. According to WHO, an adverse drug reaction is defined as “a response to a drug which is noxious, unintended and which occurs at normal doses used for prophylaxis diagnosis or therapy of disease or for the modification of physiological functions”. METHODOLOGY: This study was conducted with the objective to evaluate the anti- tubercular therapy induced adverse drug reactions in patients who were diagnosed with sputum positive tuberculosis in Govt. General and Chest Hospital, Erragadda, Hyderabad. This study is observational in nature and the subjects enrolled under this study were about 150. Informed consent was obtained from all the subjects. Subjects recruited in the study were admitted as in-patients in the hospital. The causality assessment of suspected ADR’S was done by using WHO-UMC SCALE and severity assessment by using modified Hartwig and Siegel scale. RESULTS: This study identifies the incidence and patterns of adverse drug reactions in patients who were prescribed with DOTS Therapy (category I and category II drug regimens). Out of 150 patients, 44 patients were suspected with 53 ADR’S, in which female patients(60.3%) were more prone to the occurrence of ADR’S when compared with male patients(39.7%).Based upon the categories of the drug regimens more number of ADR’S were associated with category II (63%) than ADR’S associated with category I (37%).More number of probable reactions (51%) and moderate reactions (55%) were identified by using WHO-UMC scale and Hartwig and Siegel scale respectively. CONCLUSION: Major adverse reactions in anti-tubercular drugs can cause significant morbidity and compromise treatment regimens for tuberculosis. These events may result in substantial additional costs because of added outpatient visits, investigations and in more serious instances hospitalization. As a result, the risk of treatment failure and relapse are higher.Regular ADR monitoring is required to reduce morbidity and to improve patient compliance after initiation of anti-tubercular therapy. Further study is required for preventing the occurrence of ADR’S.