Assessment of the quality of anti-tuberculosis medicines in Almaty, Kazakhstan, 2014
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.
Document Type: Research Article
Affiliations: 1: Centers for Disease Control and Prevention (CDC), Central Asia Regional Office, Almaty, Kazakhstan, School of Health Sciences, University of Tampere, Tampere, Finland 2: Tajik-Afghan Field Epidemiology Training Program, CDC, Dushanbe, Tajikistan 3: Central Asia Field Epidemiology Training Program, AIDS Prevention and Control Center, Almaty 4: State Enterprise Scientific and Practical Centre for Epidemiological Inspection and Monitoring, Ministry of Health, Almaty 5: National Center of Tuberculosis Problems, Ministry of Health, Almaty, Kazakhstan, The Global Fund, Geneva, Switzerland 6: Centers for Disease Control and Prevention (CDC), Central Asia Regional Office, Almaty, Kazakhstan 7: Global Pharma Health Fund, Merck, Darmstadt, Germany 8: School of Health Sciences, University of Tampere, Tampere, Finland
Publication date: October 1, 2017
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