A CROSS-SECTIONAL OBSERVATIONAL STUDY ON ADVERSE DRUG REACTIONS OF ANTITUBERCULAR DRUGS AT TERTIARY CARE CENTER.
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Keywords
Anti-tubercular therapy, Fixed dose combination, Adverse Drug Reaction.
Abstract
The National Tuberculosis Elimination Programme (NTEP) in India implemented the daily weight-based Fixed Dose Combination (FDC) Anti-tuberculosis Treatment (ATT) regime to enhance compliance, and ultimately lead to better treatment outcomes. Adverse drug reactions (ADRs) are a significant element that can affect an ATT regime's treatment compliance and results. As a result, vigilant monitoring for adverse reactions in patients receiving anti-tubercular therapy (ATT) is necessary
Objectives: i) To assess the pattern and frequency of adverse drug reactions with a fixed-dose combination of anti-tubercular drugs ii) To determine the causality, severity, and factors that predispose to the development of adverse drug reactions.
Methodology: A 6-month cross-sectional observational study was undertaken at the tertiary care hospital Chandramma Dayananda Sagar Institute of Medical Education and Research (CDSIMER). 120 patients with tuberculosis were included in the study after obtaining informed consent. Data was collected and analysed on demographics, treatment regimes, and any adverse drug reactions (ADRs) experienced. The statistical analysis test chi-square aimed to identify significant factors linked to adverse drug reactions. Additionally, the WHO causality assessment scale and the modified Hartwig and Siegel scale were used to analyse the causality and severity of any reported ADRs.
Results- 43 out of 120 patients had an adverse reaction. Gastrointestinal adverse effects were most common followed by dermatological issues. According to the WHO causality scale, the majority of ADRs were probable and mild on the modified Hartwig-Siegel scale. The study found that urban, female, and employed individuals had higher rates of ADRs.
Conclusion- ATT-induced ADRs are frequent. As a result, monitoring and counselling patients about their lifestyle, as well as early diagnosis and care, will reduce the incidence of ADRs and enhance treatment adherence.
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Dr Anusha SJ
Assistant Professor, Department Of Pharmacology, Dr Chandramma Dayananda Sagar Institute Of Medical Education and Research, A Unit Of Dayananda Sagar University
Dr. Puneet K Nagendra
Associate Professor, Department Of Respiratory Medicine, Dr Chandramma Dayananda Sagar Institute Of Medical Education and Research, A Unit Of Dayananda Sagar University.
Dr Pratibha D Nadig
Professor & HOD, Department of Pharmacology, Dr Chandramma Dayananda Sagar Institute Of Medical Education and Research, A Unit Of Dayananda Sagar University
Uppada Vibha.
Phase IV MBBS Student, Dr Chandramma Dayananda Sagar Institute Of Medical Education and Research, A Unit Of Dayananda Sagar University