A Pharmacovigilance Study of Medicines Used in Tuberculosis and Associated Complications in Indian Scenario

Abstract

The foundation of Pharmacovigilance (PV) is rooted in the Hippocratic principle of quotdo no harmquot. Pharmacovigilance programs by the World Health Organization initiated in response to the Thalidomide tragedy of the 1960s. Adverse Drug Reactions (ADRs) associated with antitubercular drugs pose significant challenges, leading to treatment dropouts and drug-resistant tuberculosis (TB) worldwide, including in India. To address these issues, comprehensive national PV programs are essential, as highlighted by the example of the Morocco TB Control Program (PV-MTCP), which saw a substantial increase in ADR reporting post-implementation. Despite advancements, ADR surveillance and reporting remain critical, as evidenced by the rise of tuberculosis cases post-COVID-19 outbreak. The management of ADRs in TB treatment is crucial to prevent treatment dropouts and ensure successful therapy completion. Various WHO programs, such as the End TB Strategy and DOTS, along with national initiatives like the National Tuberculosis Elimination Program in India, aim to combat TB through comprehensive strategies involving prevention, diagnosis, treatment, and patient support. Effective implementation of Pharmacovigilance initiatives, alongside collaborative efforts among healthcare stakeholders, is imperative to mitigate the multifaceted challenges posed by ADRs and achieving the goal of ending TB as a public health threat by 2030. newlineAim and Objectives: newlineThe aim of this study was to conduct pharmacovigilance research on medications utilized in tuberculosis treatment and associated complexities in the Indian context. Objectives include determining incidence and prevalence rates of adverse drug reactions, assessing ADR predictability, preventability, severity, and seriousness, examining demographic associations, and calculating ratios of fixed drug combinations, polytherapy, and treatment dropouts due to ADRs. newline