A Study on Assessment of Adverse Drug Reactions in Tuberculosis Patients.

The present study was carried out to monitor, estimate the prevalence and consequences of ADRs on treatment of TB and to assess causality, predictability, preventability and severity of the ADRs. A prospective observational and active surveillance study was conducted over a period of 9 months. Each reported ADR was assessed for its causality, severity, predictability and preventability as per standard algorithms. The management and outcome of ADRs were determined. A total of 128 ADRs (in 53 patients) were identified out of which the prevalence of ADRs in female was found to be 31.58% and 29.66% in male patients. The causality assessment by Naranjo’s scale showed that out of 128 ADR’s, 128 (100%) ADR’s were probable and based on WHO probability assessment scale 119(92.97%) were possible where as 9(7.03%) were probable. Preventability assessment showed that 125 (97.66%) were not preventable and 03 (2.34%) were definitely preventable. Severity Assessment by Modified Hartwig and Siegel Scale showed that 82 (64.06%) ADRs were mild and 46(35.94%) ADRs were moderate. 128(100%) were found to be predictable. Majority of the ADRs were recovered without giving symptomatic treatment. The study concluded that there is a need of a system for proper monitoring of ADRs caused by anti-TB drugs in RNTCP centre.  The counselling of patients for timely prevention, detection and management of ADRs will helps in further ADR occurrence minimisation.