DOI: 10.21276/ajptr
Tue, 21 May 2019

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


K.V. Ramanath1*, Ramesh.S1


1. Department of Clinical Pharmacy, Sri Adichunchanagiri College of Pharmacy, B G Nagara, Nagamangala Taluk, Mandya District, Karnataka ,Pin-571448, India.



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.

Keywords: Adverse drug reactions, Tuberculosis, World health organisation, Directly Observed Treatment-Short course (DOTS), Revised National Tuberculosis Control Programme (RNTCP).


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