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Trigger tools for monitoring and reporting of adverse drug reactions in tuberculosis - A scientific tool for efficient reporting

. Deepalakshmi M Jerlin Anusha R, Anuvikashni R, Dinesh R, Jeyaram Bharathi J, Arun KP Department of Pharmacy Practice, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Ooty, The Nilgiris, Tamil Nadu, India.


The aim of the study was to use the trigger tools for efficiently detecting ADRs in Tuberculosis patients. The study was conducted in Nilgiris district, Tamil Nadu as a prospective open label study for a period of 8 months. While the patients of any age & gender under the DOTS therapy were included, the alcoholics, smokers and intensive care unit patents were excluded from the study. Prescriptions and or case sheets of the study patients were reviewed and the possible ADRs were detected by using a set of standardized trigger tools. 28 out of 180 patients experienced 34 ADRs. The incidence of ADRs was found high in male (n=21; 62%) than female (n=13; 38%). The organ systems mostly associated with the ADRs were gastrointestinal (32%), musculoskeletal (24%) and dermatological (18%). Respiratory, hematological, neurological and endocrine were the systems associated with less ADRs. Arthralgia (19.44%) was the highest number of ADR followed by diarrhea (11.11%) and vomiting (11.11%). WHO and, Hartwig and Seigel scales were used to find out the causality and severity of the ADRs. A total of 12 trigger tools found useful in detecting ADRs among which four were newly incorporated through this study. Thus, this study showed the efficiency of trigger tools, both existing and new ones towards detecting ADRs in tuberculosis patients.

Key words: Tuberculosis, Triggering tool, ADR, Severity, Prevalence

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