Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital

Deepa Shanmugam; Sudha K Mukhyaprana; Gomathi Selvakumar; Siddiraju Devipriya; Ramachandra Bhat Chandramouliswaran

doi:10.5455/njppp.2023.13.0945202310102023

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Online Publishing Date:
19 / 10 / 2023

Natl J Physiol Pharm Pharmacol. 2024; 14(5):

doi: 10.5455/njppp.2023.13.0945202310102023

Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital

Deepa Shanmugam, Sudha K Mukhyaprana, Gomathi Selvakumar, Siddiraju Devipriya, Ramachandra Bhat Chandramouliswaran.

Abstract
Background: Standard anti-tuberculosis (TB) treatment is highly effective, but managing adverse drug responses is a major challenge that can negatively affect treatment compliance and outcomes of an anti-tubercular treatment (ATT) regimen. Hence, monitoring of these adverse drug reactions (ADRs) is very essential wherein the drug-causing ADR can be detected and an appropriate therapeutic regimen can be given to the patient.

Aims and Objectives: To assess the ATT-induced ADRs in Individual Case Safety Reports (ICSRs), to find the incidence and prevalence of ADRs due to ATT, and to analyze the causality assessment of the ADRs due to ATT.

Materials and Methods: A retrospective observational study was carried out using spontaneous ICSRs data from the ADR monitoring centre at Madras Medical College, Chennai. A suspected adverse drug reaction reporting form (sADR reporting form) provided by the Pharmacovigilance Programme of India was used to collect the data of an ICSR.

Results: A total of 93 ICSRs were assessed during the study period. The majority of the ADRs occurred in males (n = 55), and the maximum number of ADRs were found in the age group of 18–44 years (n = 46). The majority of the ICSRs were categorized as “serious” (n = 60), of which the maximum number of ADRs belonged to the “hospitalization/prolonged hospital stay” category (n = 45). Most of the suspected ATT drugs involved in implicating ADRs were found to be fixed-dose combination pills of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol (n = 71). Most of the ADRs were “skin and subcutaneous disorders” (n = 51) of the system organ class. The outcome of the ADRs was assessed and found that the majority of them were in the “recovering” (n = 54) category, and the majority of the ICSRs were found to be “probable” (n = 67).

Conclusion: An effective implementation of a Pharmacovigilance system with early detection and management of ADRs is needed to overcome the nonadherence to TB therapy.

Key words: Anti-tubercular Treatment; Tuberculosis; Adverse Drug Reaction; Pharmacovigilance

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How to Cite this Article

Pubmed Style

Shanmugam D, Mukhyaprana SK, Selvakumar G, Devipriya S, Chandramouliswaran RB. Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital. Natl J Physiol Pharm Pharmacol. Online First: 19 Oct, 2023. doi:10.5455/njppp.2023.13.0945202310102023

Web Style

Shanmugam D, Mukhyaprana SK, Selvakumar G, Devipriya S, Chandramouliswaran RB. Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital. https://www.njppp.com/?mno=167917 [Access: March 15, 2024]. doi:10.5455/njppp.2023.13.0945202310102023

AMA (American Medical Association) Style

Shanmugam D, Mukhyaprana SK, Selvakumar G, Devipriya S, Chandramouliswaran RB. Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital. Natl J Physiol Pharm Pharmacol. Online First: 19 Oct, 2023. doi:10.5455/njppp.2023.13.0945202310102023

Vancouver/ICMJE Style

Shanmugam D, Mukhyaprana SK, Selvakumar G, Devipriya S, Chandramouliswaran RB. Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital. Natl J Physiol Pharm Pharmacol, [cited March 15, 2024]; Online First: 19 Oct, 2023. doi:10.5455/njppp.2023.13.0945202310102023

Harvard Style

Shanmugam, D., Mukhyaprana, . S. K., Selvakumar, . G., Devipriya, . S. & Chandramouliswaran, . R. B. (2024) Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital. Natl J Physiol Pharm Pharmacol, Online First: 19 Oct, 2023. doi:10.5455/njppp.2023.13.0945202310102023

Turabian Style

Shanmugam, Deepa, Sudha K Mukhyaprana, Gomathi Selvakumar, Siddiraju Devipriya, and Ramachandra Bhat Chandramouliswaran. 2024. Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital. National Journal of Physiology, Pharmacy and Pharmacology, Online First: 19 Oct, 2023. doi:10.5455/njppp.2023.13.0945202310102023

Chicago Style

Shanmugam, Deepa, Sudha K Mukhyaprana, Gomathi Selvakumar, Siddiraju Devipriya, and Ramachandra Bhat Chandramouliswaran. "Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital." National Journal of Physiology, Pharmacy and Pharmacology Online First: 19 Oct, 2023. doi:10.5455/njppp.2023.13.0945202310102023

MLA (The Modern Language Association) Style

APA (American Psychological Association) Style

Shanmugam, D., Mukhyaprana, . S. K., Selvakumar, . G., Devipriya, . S. & Chandramouliswaran, . R. B. (2024) Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital. National Journal of Physiology, Pharmacy and Pharmacology, Online First: 19 Oct, 2023. doi:10.5455/njppp.2023.13.0945202310102023

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