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Free Content Substandard tuberculosis drugs on the global market and their simple detection

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SETTING: The prevalence of substandard anti-tuberculosis drugs is unknown. To maximize the effectiveness of tuberculosis (TB) control efforts, simple, inexpensive drug quality screening methods are needed.

DESIGN: Isoniazid (INH) and rifampin (RMP) single- and fixed-dose combination (FDC) formulations were collected from selected TB programs and pharmacies in Colombia, Estonia, India, Latvia, Russia and Vietnam. Samples were screened using a recently developed thin-layer chromatography (TLC) kit. All abnormal samples and a 40% random sample of normal formulations were further analyzed using confirmatory techniques. Samples outside of 85% to 115% of stated content, and/or containing compounds other than the stated drug, were defined as being substandard.

RESULTS: Overall, 10% (4/40) of all samples, including 13% (4/30) RMP samples, contained < 85% of stated content. More FDCs (5/24, 21%) than single-drug samples (2/16, 13%) were substandard. A comparison of TLC with the confirmatory analysis for RMP analysis showed a sensitivity of 100% (4/4), a specificity of 92% (24/26), a positive predictive value (PPV) of 67% (4/6), and a negative predictive value (NPV) of 100% (24/24). An analysis of INH showed a specificity of 90% (9/10). However, sensitivity, PPV, and NVP could not be determined.

CONCLUSION: A substantial number of anti-tuberculosis drugs from several countries, in particular FDCs, were found to be substandard. Such drugs may contribute to the creation of drug-resistant TB. TLC is an effective, convenient, and inexpensive method for the detection of substandard drugs.

Keywords: drug quality; drug-resistant TB; drugs; pharmaceutical management; thin-layer chromatography; treatment; tuberculosis

Document Type: Regular Paper

Affiliations: 1: Division of TB Elimination, National Centers for HIV/AIDS, STD and TB Prevention, and Epidemic Intelligence Service, Division of Applied Public Health Training, Epidemiology Program Office, Centers for Disease Control and Prevention, Atlanta, Geor 2: Division of Testing and Applied Analytical Development, US Food and Drug Administration, St. Louis, Missouri, USA 3: Division of TB Elimination, National Centers for HIV/AIDS, STD and TB Prevention, Atlanta, Georgia, USA, and The BOTUSA Project, Gaborone, Botswana 4: Division of TB Elimination, National Centers for HIV/AIDS, STD and TB Prevention, Atlanta, Georgia, USA

Publication date: May 1, 2001

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  • The International Journal of Tuberculosis and Lung Disease publishes articles on all aspects of lung health, including public health-related issues such as training programmes, cost-benefit analysis, legislation, epidemiology, intervention studies and health systems research. The IJTLD is dedicated to the continuing education of physicians and health personnel and the dissemination of information on tuberculosis and lung health world-wide.

    Certain IJTLD articles are selected for translation into French, Spanish, Chinese or Russian. They are available on the Union website

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