A study of adverse drug reactions in tuberculosis patients in a tertiary care hospital

Background: Tuberculosis is the most rambling communicable infectious disease on earth. It is the single most common cause of death in individuals aged 15-49 years. Adverse drug reactions to antitubercular drugs causing significant morbidity, mortality, incurring substantial additional costs because of added outpatient visits, tests, and hospitalizations. Study was carried out with objectives of assessing the rate and type of adverse drug reactions (ADRs) and detecting serious and preventable ADRs with collection of demographic details of patients taking antitubercular drugs and developing ADRS.Methods: A cross sectional, prospective, observational study conducted in department of chest and TB of a tertiary Health care and teaching hospital in both IPD and OPD patients for a period of 18 months. 480 patients monitored.Results: Among 480 patients 120 i.e., 25% developed ADR. frequency being significantly higher in males (58%) and adult age group (>18 years) amongst hospitalized comparing to outdoor patients the gastrointestinal tract [GIT] (39%) followed by, generalized body disorders (19%) hepatobiliary system (17%) were organ systems most affected Majority (56%) ADRs reported in 0-2 month of starting therapy (63%) of cases were in “probable according to Naranjo causality assessment (37%) being possible. 55% ADRs were moderate in severity followed by 36% mild and 9% severe. 30% of ADRs were definitely preventable followed by 20% of probably prevented according to schumock thronstone preventability scaleConclusions: Study highlights the importance of routine monitoring and robust pharmacovigilance system for success of national tuberculosis programmes in India as well as worldwide