Background: Adverse drug reactions (ADRs) are regarded as one of the major causes of non-adherence to anti-tuberculosis (TB) treatment. Identify ADRs and Establish a causal relationship between Suspected drug and Adverse Event is very important step from Pharmacovigilance point of view.
Aim and Objective: This study aims to monitor the adverse effects of the drugs in the patients on treatment for TB and do the causality assessment.
Materials and Methods: A prospective, single-centric, observational, and open-labeled study was carried out in a tertiary care hospital of Mumbai. Patients presenting with ADRs were monitored, analyzed and causality assessment was carried out using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) and Naranjos assessment scale.
Results: A total of 459 patients presenting with ADRs were enrolled in the study, their mean age was 34.60±14.21 years while male patients outnumbered female patients. About 363 patients presented with at least any one type of ADR followed by 96 patients presented with combination of any two ADRs, so study population (n = 459) presented with total 555 ADRs. Gastrointestinal and hepatobiliary system were the most affected sites of body. Majority of ADRs showed possible relation to the suspected drug during causality assessment using both the WHO-UMC and Naranjos scale.
Conclusion: Majority of ADRs were mild to moderate in nature with no occurrence of severe ADR. It is important to establish information management systems to detect and report adverse drug events in chronic infective respiratory disease like TB. Focus should be given on assessment and prevention of medication errors resulting in ADRs.
Key words: Adverse Drug Reaction; Causality Assessment; Naranjos Algorithm; World Health Organization-Uppsala Monitoring Centre Scale
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