An observational study of adverse drug reactions in hospitalized patients of drug resistance tuberculosis taking PMDT therapy in a tertiary care hospital

Background: Drug resistant tuberculosis is an important public health issue in India. The treatment regimen followed is Programmatic Management of Drug resistant Tuberculosis (PMDT) approach. Adverse drug reactions (ADRs) are a serious issue which increases the risk of defaulter rate if poorly managed. Thus study was undertaken to assess the ADRs caused by PMDT therapy in indoor patients of Department of Respiratory Medicine in a tertiary care hospital at Surat.Methods: The prospective and observational study was carried out for one year period. The causality was determined by World Health Organization (WHO) Uppasala Monitoring Centre (UMC) scale and severity was determined by Modified Hartwig and Siegel scale. Fisher exact test was applied for statistical analysis.Results: Among 24 drug resistant tuberculosis patients, 12 (50%) patients developed ADRs due to second line antitubercular drugs. Occurrence of ADRs was more among Category V (100%) as compared to Category IV (36.8%). Occurrence of ADRs was more among females (60%). The commonly involved systems are auditory system (33.3%). Majority of ADRs developed within 61-90 days (66.7%) of initiation of drug therapy. Highest percentage of ADRs causing drugs was pyrazinamide (27.8%). On evaluation of the causality of ADRs, majority were found to be possible (53.3%). The severity assessment showed that most of the patients ADRs were of moderate level (73.3%).Conclusions: PMDT therapy is complicated but early management and reporting of ADRs decreases default rate.