Study to Find Out Predisposing Factors, Causality, Severity and Avoidability of Adverse Drug Reactions among Patients Treated under DOTS Centre of Northern India.

Introduction: Tuberculosis (TB) is among the top 10 leading causes of death globally. Association of Adverse Drug Reactions (ADRs) with Anti Tubercular Therapy (ATT) drugs has been encountered more commonly which causes significant morbidity and even mortality. Aim: To find out the predisposing factors and to assess the causality, severity and avoidability of the ADRs in proven TB patients treated under Directly Observed Treatment Shortcourse (DOTS) regimen. Materials and Methods: This study was conducted at the Department of Respiratory Medicine, King George's Medical University, Lucknow. TB patients who were kept on DOTS regimen under Revised National Tuberculosis Control Programme (RNTCP), satisfying the inclusion and exclusion criteria with written informed consent, were recruited and monitored from May 2016 to April 2017. A total of 115 patients were enrolled for the study. TB diagnosis was confirmed by sputum smear. The treatment was initiated as per Category I-newly diagnosed patients of TB and Category II-previously treated patients pending drug sensitivity testing result (According to Treatment of TB: Guidelines, 4th edition, 2010, WHO, Geneva). The patients were followed up and monitored for suspected ADRs. For causality assessment Naranjo's algorithm and WHO-UMC classification scales, for severity assessment Modified Hartwig and Siegel Scale according to severity levels, for avoidability assessment Halla's scale were used. Categorical variables were presented in number and percentage (%). Chi-Square test/Fisher's-exact test was used for the comparison of qualitative variables. The p-value of <0.05 was considered statistically significant. Results: Out of 115 patients enrolled, 87 ADRs were observed in 67 cases. Incidence of ADRs were more in patients of TB with Diabetes Mellitus (DM) (79.16%) and with HIV (70.59%) than in patients of TB without diabetes (52.75%) and without HIV (56.12%). Naranjo's causality assessment accounted 47.12% of the ADRs as "probable", 51.72% as "possible", 1.15% as "doubtful". WHO-UMC causality assessment scale accounted 43.68% as "probable", 44.82% as "possible", 8.05% as "unlikely", and 3.44% as "unclassified". Modified Hartwig and Siegel Scale for assessment of severity of ADRs showed 70.11% as mild, 27.58% as moderate and 2.29% as severe. Halla's avoidability assessment scale showed 44.83% ADRs as 'not avoidable', 48.28% as 'possibly avoidable', 4.59% as 'not evaluable', and 2.29% as 'definitely avoidable'. Conclusion: Regular and vigilant drug monitoring of various ADRs can improve the clinical outcome, quality of life as well as patient adherence towards treatment. Results of this study can help to promote safer drug use and increase awareness regarding these ADRs. Data obtained can be used as a guide to make future decisions regarding therapy and risk benefit assessment of drugs in therapy. [ABSTRACT FROM AUTHOR]