A Prospective-Observational Study to Assess the Prevalence of Adverse Drug Reactions in MDR-TB Patients at Tertiary Care Hospital in India

Background: Adverse Drug Reactions (ADRs) constitute an enormous burden for the society. The aim of the present study was to detect, document, assess and report the suspected ADRs. Methods: A prospective-observational study was conducted in the Department of Pulmonary Medicine of a tertiary care hospital for 12 months from April 2014 to March 2015. Patients on RNTCP (Revised National Tuberculosis Control Programme, India) MDR-TB (Multidrug resistant tuberculosis) regimen were enrolled. Detected and suspected ADRs were analysed for causality, severity and preventability using appropriate validated scales and were reported. Results: A total of 121 ADRs were detected, documented, assessed and reported during the study period. Assessment of severity of the suspected ADRs revealed that 23.14% of suspected ADRs were severe and 28.29% of ADRs were moderate in severity. Causality assessment was done which revealed 61.1% of ADRs were certainly drug-related. The majority of patients who had suffered from ADRs were above 20 years. Ototoxicity was most common (37%) and the drug mostly associated with ADRs was kanamycin (27%). Preventability of ADRs was assessed; and the results revealed that 15.7 % of ADRs were definitely preventable. Conclusions: Measures to improve detection and reporting of adverse drug reactions by all health care professionals is recommended to be undertaken, to ensure, and improve patient's safety and adherence to MDR-TB regimen