A Pharmacovigilance study on anti-tubercular medications in the department of chest and tuberculosis of Tertiary care hospital

Abstract

Introduction: Tuberculosis has been one of the common diseases in human communities during the past 40 years. It has been reported by World Health Organization (WHO) that one third of the world’s population is infected with Mycobacterium tuberculosis resulting in 8.4 million new tuberculosis cases in 1999.1 this high incidence of infection has caused a large number of morbidity and mortality which is partly due to serious adverse reactions induced by Anti-TB drugs. Aim: The study aimed to assess Pharmacovigilance study on Anti Tubercular Medications in the Department of Chest & Tuberculosis of a Tertiary Care Hospital. Methodology: A regular ward round participation was carried out in the department of Chest & TB. All the information’s of patients was recorded. During data collection patients were informed about the study using patient information format and obtained their written consent either from the patients or their caregivers. Results: The results of the study showed that the incidence of all major adverse effects was 1.48 per 100 person’s month of exposure. The occurrence of any major side effect in the study was associated with female sex. It does appear that with Anti-TB drugs used in this study the rate of ADRs increases with increased age.  In our study the major cause of admission was adverse drug reactions in 15.9% of patients.  In our study Hepatitis was observed in 25 (25.77%) patients, leading to the death of 2 patients. Conclusion: Anti-TB drugs could cause significant adverse effects both in quantity and severity. These reactions may lead to hospitalization, prolonged hospital stay and even death.