Safety evaluation of directly observed treatment short course (DOTS) regimen in a tertiary care hospital, Pune.
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Date
2014-03
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Abstract
Background: Directly observed treatment short course (DOTS) is a cornerstone of
Revised National Tuberculosis Control Program of India. Adverse drug reactions
(ADRs) induced by this therapy is common and it causes signifi cant morbidity and
mortality. Hence, the present study was undertaken to determine the incidence and
pattern of ADRs and to assess causality and severity.
Methods: We conducted prospective, observational study at DOTS center of tertiary
care hospital, Pune. 150 pulmonary tuberculosis patients undergoing DOTS therapy
were enrolled. They were monitored weekly in an intensive phase and monthly in the
continuation phase. The suspected ADRs were recorded and assessed for causality
and severity by standard algorithms.
Results: Incidence of ADRs due to DOTS was 19.33% & total 35 ADRs had occurred
in our study. Gastrointestinal intolerance, arthralgia & itching with or without rashes
were most common ADRs (incidence rates: 12.67%, 2.67% and 2.67%, respectively).
On evaluation of causality by Naranjo algorithm, majority of ADRs 91.43% were
“possible.” As per WHO- Uppsala Monitoring Center scale, majority of ADRs
91.43% were “possible.” As per Modifi ed Hartwig and Siegel scale, majority of
ADRs were “moderate” (48.57%) but 8.57% were “severe.” Female gender was
found to be a signifi cant risk factor for developing ADRs (odds ratio: 3.08, 95%
confi dence interval: 1.33-7.12. 3.33%). ADRs & hepatotoxicity was major reason
for defaulting from DOTS (60%).
Conclusion: ADRs induced by DOTS are common and there is need of incorporating
pharmacovigilance system for this vital public health program. Counseling of patients
for timely prevention, detection, and management of ADRs will help in minimizing
the further occurrence of ADRs.
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Keywords
DOTS, Adverse drug reactions, Tuberculosis, Pharmacovigilance
Citation
Dalal Nishant P, Karandikar Yogita S, Pandit Vijaya A. Safety evaluation of directly observed treatment short course (DOTS) regimen in a tertiary care hospital, Pune. International Journal of Basic & Clinical Pharmacology. 2014 Mar-Apr; 3(2): 369-376.