Indian Journal of Pharmacy Practice Association of Pharmaceutical Teachers of India Causality Assessment of Adverse Drug Reactions in Tuberculosis Patients who are on Directly Observed Treatment Short Course Strategy in Mysore District

Tuberculosis (TB) is one of the foremost public health problems, curable disease if diagnosed and treated properly with antituberculosis drugs. In addition to disease related complications there are serious adverse drug reactions due to Anti-tuberculosis therapy. The present study was carried out to monitor, document and reporting of Adverse Drug Reactions (ADRs) in Tuberculosis patients who are on Directly Observed Treatment Short course (DOTS) strategy and to assess their causality by using Naranjo and WHO algorithms. This was a prospective observational and active surveillance study conducted over a period of 9 months. Each reported Adverse Drug Reaction was documented and assessed for its causality as per standard algorithms. A total of 128 Adverse Drug Reactions were identified out of which the prevalence of Adverse Drug Reactions 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 Adverse Drug Reactions, 128 (100%) Adverse Drug Reactions were probable and based on WHO probability assessment scale 119 (92.97%) were possible where as 9 (7.03%) were probable. The study concluded that Directly Observed Treatment Short course therapy is safer but regular monitoring of Adverse Drug Reactions should be adopted.