Assessment of the quality of anti-tuberculosis medicines in Almaty, Kazakhstan, 2014

Details

• Alternative Title:
  Int J Tuberc Lung Dis
• Personal Author:
  Nabirova, D. ; Schmid, G. ; Yusupova, R. ; Kantarbayeva, M. ; Ismailov, S. I. ; Moffett, D. ; Jähnke, R. W. O. ; Nuorti, J. P.
• Description:
  SETTING
  
  In 2009, the World Health Organization (WHO) conducted a survey of the quality of four anti-tuberculosis drugs in the former Soviet Union countries. Kazakhstan had the highest proportion of substandard drugs.
  
  OBJECTIVE
  
  To assess the quality of anti-tuberculosis drugs used in Kazakhstan in 2014.
  
  DESIGN
  
  Fourteen anti-tuberculosis drugs from the Almaty Interdistrict TB Dispensary were randomly selected and screened for quality using Global Pharma Health Fund Minilab™ testing. First, the product and packaging were physically inspected to determine whether tablets/capsules were intact (i.e., whether they contained the full amount of the drug, and whether the packaging was genuine). Second, the tablets/capsules were dissolved in water to test whether they could be adequately absorbed by the body. Finally, semi-quantitive analyses were undertaken using thin-layer chromatography to verify the presence and concentration of the active pharmaceutical ingredient and to detect impurities.
  
  RESULTS
  
  We discovered no counterfeit medicines. However, 163 (19%) of the 854 anti-tuberculosis drugs sampled failed at least one of the three tests. These samples were found among 24/50 (48%) batches of 14 anti-tuberculosis drugs.
  
  CONCLUSION
  
  Our study identified a high proportion of poor-quality first- and second-line anti-tuberculosis drugs. Use of these medicines may lead to treatment failure and the development of drug resistance. Confirmatory testing should be performed to determine if they should be removed from the market.
  
  
• Subjects:
  Antitubercular Agents Article Capsules Chromatography, Thin Layer Drug Liberation Humans Quality Control Tablets
• Source:
  Int J Tuberc Lung Dis. 21(10):1161-1168
• Pubmed ID:
  28911362
• Pubmed Central ID:
  PMC5696143
• Document Type:
  Journal Article
• Funding:
  CC999999/Intramural CDC HHS/United States
• Place as Subject:
  Kazakhstan
• Volume:
  21
• Issue:
  10
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:86dbff6b2f944163da274be6c0f84c827470ec44123e3733b88698c98d9b103f
• Download URL:
  https://stacks.cdc.gov/view/cdc/49940/cdc_49940_DS1.pdf
• File Type:
  [PDF - 677.88 KB ]