Adverse Reactions Due to Directly Observed Treatment Short Course Therapy: An Indian Prospective Study

Introduction: Tuberculosis (TB) causes enormous social and economic disruption and hampers nation’s development. DOTS strategy under RNTCP is one of the largest public health programs found to be beneficial against TB. Adverse drug reactions lead to decrease in patient compliance and adherence. Good patient adherence to the treatment regimen is the foundation stone to effective anti-tubercular therapy. Noncompliance is cited as the major problem to the control of the tuberculosis at the level of public health which finally leads to drug resistance in case of TB. Aim and Objectives: To identify the occurrence and pattern of Adverse Drug Reactions (ADRs) associated with anti-tubercular drugs in TB patients under DOTS therapy during Intensive phase of treatment. Materials and methods: A prospective observational study was conducted in 2 randomly selected DOTS centers of Jalandhar. A total of 102 patients of categories I and II who were registered in third quarter of 2014 were selected for study. The follow up period was during the intensive phase of DOTS regimen. All patients on ATT were followed up at the end of 1 week, 1 month and after the completion of intensive phase or if/ when self reporting was done due to adverse drug reactions. Detection and monitoring of adverse drug reaction was done by interviewing patients, consulting with physicians about the patient’s clinical problems, reviewing laboratory test and medical records. The data so collected was entered and analyzed using SPSS 21 software. Results: The Incidence of adverse drug reaction was observed in 20.4% i.e. 21 out of 102 patients. Total number of adverse reactions developed in 21 patients were 31, with most common being GIT system (38.7%), followed by skin problems (29%). History of alcoholism, associated co-morbidities, pulmonary TB and DOTS treatment Category II were found to be significantly associated with occurrence of ADRs. Conclusion: The present study highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely. In addition, a proper educational counseling may promote more ADR reporting by patients. These strategies may improve the patient adherence to treatment and therapeutic outcome.