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Adverse drug reaction monitoring of antitubercular drugs during intensive phase at tertiary care medical college hospital: A prospective study

Manju Ramakrishnan, Nisha Maheshwari Y, Ezhil Ramya J, Krishnamoorthy K.

Abstract
Background: Tuberculosis (TB) an infectious disease can cause serious economic burden to the country and to the patients. About quarter of the world TB cases are reported in India. As many newer and newer drugs emerge it creates newer and rare side effects which may lead to the discontinuation of the drug and finally end up in multi-drug resistant TB. Hence, monitoring of these related adverse drug reactions (ADRs) is very essential wherein the drug causing ADR can be detected and appropriate therapeutic regimen can be tailored to the patient and thus reduce the economic burden.

Aim and Objective: The aim of the study was to assess the rate of prevalence of ADR with antitubercular drugs during intensive phase of treatment in Tirunelveli Medical College Hospital (TVMCH).

Materials and Methods: The sample size of 100 patients who were diagnosed with pulmonary TB and undergoing treatment in TVMCH was observed for any adverse effects. The observed adverse effects were recorded using “Adverse Drug Reactions reporting form.” The casualty and the severity assessment were done using WHO-Uppsala Monitoring Centre Criteria and Hartwig-Siegel Scale, respectively.

Results: Among 100 pulmonary TB patients receiving fixed-dose combination pills the most commonly observed adverse effects are Nausea (20 cases), hepatitis (19 cases), gastritis (15 cases), and other side effects such as pruritus, abdominal cramps, and diarrhea.

Conclusion: Early identification, reporting, and management of ADRs remain key factors in the treatment of a newly diagnosed TB patients. It can be revised even more to lower the severity levels and achieve elimination of TB.

Key words: Adverse Effects; Casualty Assessment; Severity Assessment; Hartwig-Siegel Scale; WHO- Uppsala Monitoring Centre criteria



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