title: Substandard and falsified anti-tuberculosis drugs: a preliminary field analysis.
abstract: METHODS
  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.
  
  
  METHODS
  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.
authors: American Enterprise Institute, Washington, DC, USA.
authors: R
authors: R
authors: Bate
authors: P
authors: P
authors: Jensen
authors: K
authors: K
authors: Hess
authors: L
authors: L
authors: Mooney
authors: J
authors: J
authors: Milligan
mesh_terms: D000349:Africa; D000995:Antitubercular Agents / Q000032:analysis* / Q000592:standards; D001208:Asia; D002626:Chemistry, Pharmaceutical; D002855:Chromatography, Thin Layer; D003157:Community Pharmacy Services; D058110:Counterfeit Drugs / Q000032:analysis*; D003415:Crime; D003906:Developing Countries; D024881:Drug Resistance, Bacterial; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D007538:Isoniazid / Q000032:analysis* / Q000592:standards; D017149:Private Sector; D011786:Quality Control; D012293:Rifampin / Q000032:analysis* / Q000592:standards; D012426:Russia; D012995:Solubility
chemical_list: D000995:Antitubercular Agents; D058110:Counterfeit Drugs; D007538:Isoniazid; D012293:Rifampin