The study of adverse drug reactions in indoor patients of tuberculosis taking standardized antitubercular therapy (directly observed treatment short-course and programmatic management of drug resistant tuberculosis) in a tertiary care hospital at Surat

Authors

  • Payal P. Naik Department of Pharmacology, Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India
  • Arvindsingh Panwar Department of Pharmacology, Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India
  • Swati Patel Department of Community Medicine, Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20211644

Keywords:

Adverse drug reaction, DOTS, PMDT, Antitubercular drugs

Abstract

Background: Tuberculosis is a serious public health issue in India. The treatment regimen followed is Directly observed treatment short-course (DOTS) and Programmatic Management of Drug resistant Tuberculosis (PMDT) approach. In a long period of treatment adverse drug reactions (ADRs) can be an important programmatic issue. Thus, study was undertaken to assess the ADRs caused by antitubercular therapy in indoor patients in a tertiary care hospital at Surat.

Methods: The Observational, prospective study was carried out for one year period. The causality was determined by WHO UMC scale and severity was determined by Modified Hartwig and Siegel scale. Chi square test was applied for statistical analysis.

Results: Among 255 tuberculosis patients, 85 (33.3%) patients developed ADRs. Occurrence of ADRs was more among females (46.6%). The commonly involved systems are gastrointestinal (40.6%) followed by haematological (17.9%). The most common ADRs observed were nausea and vomiting (21.7%). High percentage of ADRs causing drugs were isoniazid (30.6%) followed by rifampicin (26.1%). Causality assessment showed 60.4% ADRs were possible, 37.7% ADRs were probable and 1.9% ADRs was certain. Severity assessment scale showed 81.1% of moderate, 12.3% of mild and 6.6% of severe grading. Occurrence of ADRs was more among PMDT (60%) in comparison to DOTS therapy (31.06%) [p value = 0.0084 (significant p value < 0.05)].

Conclusions: Antitubercular treatment is safer but early detection, management and reporting of ADRs is required to prevent it at initial stage and helps to decrease default rate.

Author Biographies

Payal P. Naik, Department of Pharmacology, Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India

DEPARTMENT OF PHARMACOLOGY, Surat Municipal Institute of Medical Education and Research (SMIMER), SURAT

Arvindsingh Panwar, Department of Pharmacology, Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India

DEPARTMENT OF PHARMACOLOGY, Surat Municipal Institute of Medical Education and Research (SMIMER), SURAT

Swati Patel, Department of Community Medicine, Surat Municipal Institute of Medical Education and Research (SMIMER), Surat, Gujarat, India

Department of Community Medicine, Surat Municipal Institute of Medical Education and Research (SMIMER), SURAT

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Published

2021-04-26

How to Cite

Naik, P. P., Panwar, A., & Patel, S. (2021). The study of adverse drug reactions in indoor patients of tuberculosis taking standardized antitubercular therapy (directly observed treatment short-course and programmatic management of drug resistant tuberculosis) in a tertiary care hospital at Surat. International Journal of Basic & Clinical Pharmacology, 10(5), 507–511. https://doi.org/10.18203/2319-2003.ijbcp20211644

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Original Research Articles