Abstract

A Study of Adverse Drug Reactions in Tuberculosis Patients in a Tertiary Care Hospital

Background: Adverse drug reactions to anti-tubercular drugs cause significant morbidity, mortality, incurring substantial additional costs because of added outpatient visits, tests, and hospitalizations. Objectives: The study was carried out with the objectives of assessing the rate & type of Adverse Drug Reactions (ADRs) & detecting serious and preventable ADRs with a collection of demographic details of patients taking anti-tubercular drugs & developing ADRs. Methods: A Cross-sectional, prospective, observational study was conducted in the department of Chest & TB of tertiary Health care and teaching hospital in both Outpatient Department and Inpatient Department patients for 18 months. 480 patients monitored Results: Among 480 patients 120 i.e. 25% developed ADR. Frequency is significantly higher in males (58%) & adult age group (>18 years) amongst hospitalized compared to outdoor patients with 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% of ADRs were moderate in severity followed by 36% mild & 9% severe. 30% of ADRs were preventable followed by 20% of probably prevented according to the schumock thronstone preventability scale. Conclusions: The study highlights the importance of routine monitoring and a robust pharmacovigilance system for the success of National Tuberculosis Programmes in India as well as worldwide.

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