Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis
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.
Keywords: MDR-TB; XDR-TB; drug resistance; malaria; substandard drugs
Document Type: Research Article
Affiliations: 1: American Enterprise Institute, Washington, DC, USA 2: Pivit LLC, Washington, DC, USA 3: Africa Fighting Malaria, Washington, DC, USA 4: Africa Fighting Malaria, Cambridge, UK
Publication date: 01 March 2013
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