Substandard tuberculosis drugs on the global market and their simple detection
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.
Document Type: Regular Paper
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
Division of Testing and Applied Analytical Development, US Food and Drug Administration, St. Louis, Missouri, USA
Division of TB Elimination, National Centers for HIV/AIDS, STD and TB Prevention, Atlanta, Georgia, USA, and The BOTUSA Project, Gaborone, Botswana
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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