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- Title
A REVIEW ON ADVERSE EVENT STUDY ON ANTI-TUBERCULAR DRUGS.
- Authors
Sharma, Pragya; Arora, Rashmi; Dubey, Raghvendra
- Abstract
Tuberculosis (TB) is a major global health problem. TB is an infectious disease caused by the bacillus Mycobacterium tuberculosis. It typically affects the lungs (pulmonary TB) but can affect other sites as well (extra pulmonary TB). Tuberculosis can be cured with combinations of first line anti-tuberculosis drugs like Isoniazid, Rifampin, Pyrazinamide, Ethambutol & Streptomycin and in multi drug resistant with second line anti TB drugs. The TB patient on treatment is taking more than one anti-TB medicine simultaneously and regimens last from many months to 2 years or more. Pharmacovigilance (PV) needs to be an integral accompaniment to treatment programmes. This increases the likelihood of ADRs, some of which are severe. Most patients on treatment for drug-resistant TB experience at least one side-effect and two thirds of such patients have had at least one medicine stopped temporarily or permanently as a result of ADRs. These events may damage public confidence and affect patient adherence. Appropriate measures need to be put in place to ensure that harm is reduced and symptoms relieved. Several PV methods can be used to collect safety information in Pharmacovigilance. Statistical analysis and study designs are two methods to collect safety information. Naranjo's and Hartwig's Scale can be used to estimate potential risk of anti-TB drugs. Comparative Observational Studies like Cohort event monitoring and cross sectional studies are also used to design the protocol of adverse event study.
- Subjects
TUBERCULOSIS treatment; ANTITUBERCULAR agents; ADVERSE health care events; MYCOBACTERIUM tuberculosis; ISONIAZID; PYRAZINAMIDE; PUBLIC health; THERAPEUTICS
- Publication
International Journal of Pharmacy & Life Sciences, 2016, Vol 7, Issue 9, p38
- ISSN
0976-7126
- Publication type
Article