1921
Volume 91, Issue 5
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract.

There is an urgent need for accurate and inexpensive handheld instruments for the evaluation of medicine quality in the field. A blinded evaluation of the diagnostic accuracy of the Counterfeit Detection Device 3 (CD-3), developed by the US Food and Drug Administration Forensic Chemistry Center, was conducted in the Lao People's Democratic Republic. Two hundred three samples of the oral antimalarial artesunate were compared with authentic products using the CD-3 by a trainer and two trainees. The specificity (95% confidence interval [95% CI]), sensitivity (95% CI), positive predictive value (95% CI), and negative predictive value (95% CI) of the CD-3 for detecting counterfeit (falsified) artesunate were 100% (93.8–100%), 98.4% (93.8–99.7%), 100% (96.2–100%), and 97.4% (90.2–99.6%), respectively. Interobserver agreement for 203 samples of artesunate was 100%. The CD-3 holds promise as a relatively inexpensive and easy to use instrument for field evaluation of medicines, potentially empowering drug inspectors, customs agents, and pharmacists.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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2014-11-05
2017-09-21
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References

  1. World Health Organization, 2011. World Health Organization Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit Medical Products. Sixty-Fourth World Health Assembly A64/16. Provisional Agenda Item 13.7. 2011. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA64/A64_16-en.pdf. Accessed September 16, 2014.
  2. Nayyar GN, Breman JG, Newton PN, Herrington JE, , 2012. Poor quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488496.[Crossref]
  3. Reddy D, Banerji J, , 2012. Commentary: counterfeit antimalarial drugs. Lancet Infect Dis 12: 829.[Crossref]
  4. Newton PN, Proux S, Green M, Green M, Smithuis F, Rozendaal J, Prakongpan S, Chotivanich K, Mayxay M, Looareesuwan S, Farrar J, Nosten F, White NJ, , 2001. Fake artesunate in southeast Asia. Lancet 357: 19481950.[Crossref]
  5. Newton PN, McGready R, Fernández F, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJ, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NPJ, Greenwood BM, Nosten F, White NJ, , 2006. Manslaughter by fake artesunate in Asia—will Africa be next? PLoS Med 3: e197.[Crossref]
  6. Newton PN, Fernández FM, Plançon A, Plançon A, Mildenhall DC, Green MD, Ziyong L, Christophel EM, Phanouvong S, Howells S, McIntosh E, Laurin P, Blum N, Hampton CY, Faure K, Nyadong L, Soong SWR, Santoso B, Zhiguang W, Newton J, Palmer K, , 2008. A collaborative epidemiological investigation into the criminal fake artesunate trade in south east Asia. PLoS Med 5: e32.[Crossref]
  7. Sengaloundeth S, Green MD, Fernández FM, Manolin O, Phommavong K, Insixiengmay V, Hampton CY, Nyadong L, Mildenhall DC, Hostetler D, Khounsaknalath L, Vongsack L, Phompida S, Vanisaveth V, Syhakhang L, Newton PN, , 2009. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR—implications for therapeutic failure and drug resistance. Malar J 8: 172.[Crossref]
  8. Lon CT, Tsuyuoka R, Phanouvong S, Nivanna N, Socheat D, Sokhan C, Blum N, Christophel EM, Smine A, , 2006. Counterfeit and substandard antimalarial drugs in Cambodia. Trans R Soc Trop Med Hyg 100: 10191024.[Crossref]
  9. Newton PN, Green MD, Mildenhall DC, Plançon A, Nettey H, Nyadong L, Hostetler DM, Swamidoss I, Harris GA, Powell K, Timmermans AE, Amin AA, Opuni SK, Barbereau S, Faurant C, Soong RCW, Faure K, Thevanayagam J, Fernandes P, Kaur H, Angus B, Stepniewska K, Guerin PJ, Fernandez FM, , 2011. Poor quality vital anti-malarials in Africa—an urgent neglected public health priority. Malar J 10: 352.[Crossref]
  10. WHO, 2011. Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa, 2011. Available at: http://www.who.int/medicines/publications/WHO_QAMSA_report.pdf. September 16, 2014.
  11. WWARN. Antimalarial Quality Surveyor. Available at: http://www.wwarn.org/aqsurveyor/. Accessed September 16, 2014.
  12. Khan MH, Okumura J, Sovannarith T, Nivanna N, Nagai H, Taga M, Yoshida N, Akazawa M, Tanimoto T, Kimura K, , 2011. Counterfeit medicines in Cambodia—possible causes. Pharm Res 28: 484489.[Crossref]
  13. Laing R, Vrakking H, Fourie B, , 2004. Quality and stability of TB medicines: let the buyer beware! Int J Tuberc Lung Dis 8: 10431044.
  14. Taylor RB, Shakoor O, Behrens A, Everard M, Low AS, Wangboonskul J, Reid RG, Kolawole JA, , 2001. Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet 357: 19331936.[Crossref]
  15. Amon JJ, , 2008. Dangerous medicines: unproven AIDS cures and counterfeit antiretroviral drugs. Global Health 4: 5.[Crossref]
  16. World Health Organization, 2014. WHO List of Prequalified Quality Control Laboratories. Available at: www.who.int/prequal/lists/PQ_QCLabsList.pdf. Accessed September 16, 2014.
  17. World Health Organization, 2005. Counterfeit and Substandard Drugs. Frequently Asked Questions. Available at: http://www.who.int/medicines/services/counterfeit/faqs/15/en/index.html. Accessed September 16, 2014.
  18. Green MD, Mount DL, Wirtz RA, , 2001. Authentication of artemether, artesunate and dihydroartemisinin antimalarial tablets using a simple colorimetric method. Trop Med Int Health 6: 980982.[Crossref]
  19. Jähnke RWO, Pachaly P, Gobina NP, Schuster A, Nigge OJ, Dwornik K, Rubeau V, Davydova N, Bradby S, Hajjou M, Smine A, Phanouvong S, , 1998. Concise Quality Control Guide on Essential Drugs, Vol. II, Thin Layer Chromatography, Frankfurt: German Pharma Health Fund, 1998. Supplement 1999, 2002, 2003, and 2004. Available at: http://www.gphf.org/images/downloads/Demo2GPHFTLCTestProtocol.pdf. September 16, 2014.
  20. Dowell FE, Maghirang EB, Fernández FM, Newton PN, Green MD, , 2008. Detecting counterfeit antimalarial tablets by near-infrared spectroscopy. J Pharm Biomed Anal 48: 10111014.[Crossref]
  21. Fernández FM, Hostetler D, Powell K, Kaur H, Green MD, Mildenhall DC, Newton PN, , 2011. Poor quality drugs: grand challenges in high throughput detection, countrywide sampling, and forensics in developing countries. Analyst (Lond) 136: 30733082.[Crossref]
  22. Ricci C, Eliasson C, Macleod NA, Newton PN, Matousek P, Kazarian SG, , 2007. Characterization of genuine and fake artesunate anti-malarial tablets using Fourier transform infrared imaging and spatially offset Raman spectroscopy through blister packs. Anal Bioanal Chem 389: 15251532.[Crossref]
  23. Ricci C, Nyadong L, Yang F, Fernandez FM, Brown CD, Newton PN, Kazarian SG, , 2008. Assessment of hand-held Raman instrumentation for in situ screening for potentially counterfeit artesunate antimalarial tablets by FT-Raman spectroscopy and direct ionization mass spectrometry. Anal Chim Acta 623: 178186.[Crossref]
  24. Eliasson C, Matousek P, , 2007. Noninvasive authentication of pharmaceutical products through packaging using spatially offset raman spectroscopy. Anal Chem 79: 16961701.[Crossref]
  25. Newton PN, Amin A, Bird C, Passmore P, Dukes G, Tomson G, Simons B, Bate R, Guerin PJ, White NJ, , 2011. The primacy of public health considerations in defining poor quality medicines. PLoS Med 8: e1001139.[Crossref]
  26. Hall KA, Newton PN, Green MD, De Veij M, Vandenaabele P, Pizzanelli D, Mayfong M, Dondorp A, Fernández F, , 2006. Characterization of counterfeit artesunate antimalarial tablets from southeast Asia. Am J Trop Med Hyg 75: 804811.
  27. US Government. 21 USC 301, section 201(g)(2); 21 USC 311, section 301 (i)(1-3). Available at: http://www.gpo.gov/fdsys/pkg/USCODE-2013-title21/html/USCODE-2013-title21-chap9-subchapIII.htm. Accessed September 17, 2014.
  28. US Food and Drug Administration, 2010. US Patent Application No. 13/262,371 (filed March 31, 2010) and EP Patent Application No. 107284765.5 (filed March 31, 2010).
  29. US Food and Drug Administration, 2013. CD-3: A New Tool in FDA's Fight Against Counterfeit Products. Available at: http://www.youtube.com/watch?v=mfYUkiKAJvA. Accessed September 16, 2014.
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  • Received : 05 Nov 2013
  • Accepted : 26 Aug 2014

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