Implementation of Self Reporting Pharmacovigilance in Anti Tubercular Therapy Using Knowledge Based Approach

K, Sainul Abideen P Chandrasekaran

doi:10.4172/2329-6887.1000101

Cited by 4 publications

(1 citation statement)

References 16 publications

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“…ATT exhibits greater level of efficacy but with a significant degree of toxicity, especially during 1 st and 2 nd month of the start of therapy. 6,7 The need of the hour is pharmacovigilance study of anti-tubercular therapy so that early diagnosis and management of ADR's can be done actively, which will further improve patient adherence and treatment outcomes.…”

Section: Introductionmentioning

confidence: 99%

Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis

Agarwal¹,

Goel²,

Rai³

et al. 2017

Int J Basic Clin Pharmacol

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Background: Study was done to determine incidence of ADR’s in sputum positive, pulmonary TB patients, on DOTS category I and to determine the effect of ADR’s on sputum conversion.Methods: Open, prospective, observational, non-comparative study conducted in the Department of Pharmacology in collaboration with Department of Tuberculosis and Chest Diseases, Government Medical College, Amritsar for the duration of 18 months (March 2015 to September 2016). One hundred sputum positive patients of pulmonary tuberculosis on DOTS category I, of either sex, in age group of 14 years to 65 years, were recruited and followed up during intensive phase of therapy at end of 1st and 2nd month. Causality and Severity assessment were done by using WHO-UMC causality scale and Hartwig’s severity scale respectively.Results: Out of 100 patients 84 (84%) developed one or more ADR’s and a total of 118 ADR’s occurred in our study. The most common ADR was GI upset 45(38.13%), followed by hepatitis 42 (35.59%), rash 12 (10.16%), CNS 8 (6.77%), arthritic symptoms 5 (4.23%), visual disturbance 2 (1.69%), bleeding problems 2 (1.69%), hyperuricemia 1 (0.84%) and peripheral neuropathy 1 (0.84%). Causality assessment revealed that most of ADR’s(60) were in probable category and severity assessment revealed that most of ADR’s(55) belonged to level 4 (Moderate severity). Most of the ADR’s occurred within 30 days of the start of treatment (84.74%).Conclusions: With such a high incidence of ADR’s there is a need of incorporating pharmacovigilance programme into this vital health programme for more comprehensive monitoring of tuberculosis patients on DOTS for timely prevention, detection, and management of ADR’s. This will decrease non-adherence and dropouts, and thus result in better treatment outcomes.

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Section: Introductionmentioning

confidence: 99%

Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis

Agarwal¹,

Goel²,

Rai³

et al. 2017

Int J Basic Clin Pharmacol

View full text Add to dashboard Cite

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Isolation and Quantitative Determination of New Tuberculostatic 1,2,4-Triazole Derivative in Urine and Plasma Samples

Tatarczak-Michalewska¹

2014

J Anal Bioanal Tech

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A Review on Adverse Drug Events to Create Awareness

Jaiswal¹

2016

J Pharmacovigilance

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Adverse Drug Events (ADE) reporting is the foundation of any Pharmacovigilance system. There is always a risk in the proactive management of newly marketed drugs. Most drugs are used in a larger population after their commercialization than in clinical trials. It is important to detect the full safety profile of the drug before its marketing and throughout its marketing period. The post marketing pharmacovigilance provides the assurance of rational and safe use of medications. The medical practitioners and the pharmacovigilance body under the guidance of World Health Organization are responsible for the risk management system of a drug in different countries. The level of education and training on ADE reporting has improved the Pharmacovigilance of many drugs. Education and training is the most recognized means of improving ADE reporting.

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Implementation of Self Reporting Pharmacovigilance in Anti Tubercular Therapy Using Knowledge Based Approach

Cited by 4 publications

References 16 publications

Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis

Pharmacovigilance of first line anti-tubercular therapy in category I patients of pulmonary tuberculosis

Isolation and Quantitative Determination of New Tuberculostatic 1,2,4-Triazole Derivative in Urine and Plasma Samples

A Review on Adverse Drug Events to Create Awareness

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