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Int J Tuberc Lung Dis. 2013 Mar;17(3):308-11. doi: 10.5588/ijtld.12.0355. Epub 2013 Jan 14.

Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis.

Author information

1
American Enterprise Institute, Washington, DC, USA.

Abstract

SETTING:

Pharmacies in 19 cities in Angola, Brazil, China, Democratic Republic of Congo, Egypt, Ethiopia, Ghana, India (n = 3), Kenya, Nigeria, Russia, Rwanda, Thailand, Turkey, Uganda, United Republic of Tanzania and Zambia.

OBJECTIVE:

To assess the quality of the two main first-line anti-tuberculosis medicines, isoniazid and rifampicin, procured from private-sector pharmacies, to determine if substandard and falsified medicines are available and if they potentially contribute to drug resistance in cities in low- and middle-income countries.

DESIGN:

Local nationals procured 713 treatment packs from a selection of pharmacies in 19 cities. These samples were tested for quality using 1) thin-layer chromatography to analyze levels of active pharmaceutical ingredient (API), and 2) disintegration testing.

RESULTS:

Of 713 samples tested, 9.1% failed basic quality testing for requisite levels of API or disintegration. The failure rate was 16.6% in Africa, 10.1% in India, and 3.9% in other middle-income countries.

CONCLUSIONS:

Substandard and falsified drugs are readily available in the private marketplace and probably contribute to anti-tuberculosis drug resistance in low- and middle-income countries. This issue warrants further investigation through large-scale studies of drug quality in all markets.

PMID:
23321423
DOI:
10.5588/ijtld.12.0355
[Indexed for MEDLINE]

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