The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Implications
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645



Carrying out chemical analysis of antimalarials to detect low-quality medications before they reach a patient is a costly venture. Here, we show that a library of chemical color tests embedded on a paper card can presumptively identify formulations corresponding to very low quality antimalarial drugs. The presence or absence of chloroquine (CQ), doxycycline (DOX), quinine, sulfadoxine, pyrimethamine, and primaquine antimalarial medications, in addition to fillers used in low-quality pharmaceuticals, are indicated by patterns of colors that are generated on the test cards. Test card sensitivity for detection of these pure components ranges from 90% to 100% with no false positives in the absence of pharmaceutical. The color intensities from reactions characteristic of CQ or DOX allowed visual detection of formulations of these medications cut with 60% or 100% filler, although samples cut with 30% filler could not be reliably detected colorimetrically. However, the addition of unexpected fillers, even in 30% quantities, or substitute pharmaceuticals, could sometimes be detected by other color reactions on the test cards. Tests are simple and inexpensive enough to be carried out in clinics, pharmacies, and ports of entry and could provide a screening method to presumptively indicate very low quality medicines throughout the supply chain.

[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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  1. World Health Organization, 2005. Constitution of the World Health Organization. Geneva, Switzerland: World Health Organization. [Google Scholar]
  2. Tabernero P, Fernandez FM, Green M, Guerin PJ, Newton PN, , 2014. Minds the gaps—the epidemiology of poor-quality anti-malarials in the malarious world-analysis of the WorldWide Antimalarial Resistance Network database. Malar J 13: 139.[Crossref] [Google Scholar]
  3. Nayyar GML, Breman JG, Newton PN, Herrington J, , 2012. Poor-quality drugs in the southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488496.[Crossref] [Google Scholar]
  4. Newton PN, Green MD, Mildenhall DC, Placon A, Nettey H, Nyagong L, Hostetler DM, Swamidoss I, Harris G, Powell K, Timmermans AE, Amin A, 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 public health priority. Malar J 10: 352.[Crossref] [Google Scholar]
  5. Newton PN, Green MD, Fernandez FM, Day NPJ, White NJ, , 2006. Counterfeit anti-infective drugs. Lancet Infect Dis 6: 602613.[Crossref] [Google Scholar]
  6. Hall KA, Newton PN, Green MD, De Veiij M, Vandenabeele P, Pizzanelli D, Mayxay M, Dondrop A, Fernandez FM, , 2006. Characterization of counterfeit artesunate antimalarial tablets from southeast Asia. Am J Trop Med Hyg 75: 804811. [Google Scholar]
  7. Purdue Pharma, 2002. Thousands of Counterfeit OxyContin® Tablets Seized by U.S. Customs Service. Available at: http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=34754. Accessed April 29, 2014. [Google Scholar]
  8. Kelesidis T, Kelesidis I, Rafailidis PI, Falagas ME, , 2007. Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother 60: 214236.[Crossref] [Google Scholar]
  9. Newton PN, Fernandez FM, Placon A, Mildenhall DC, Green MD, Ziyong L, Chrostophel EM, Phanouvong S, Howells S, McIntosh E, Laurin P, Blum N, Hampton CY, Faure K, Nyadong L, Soong CWR, Santoso B, Zhiguang W, Newton J, Palmer K, , 2008. A collaborative epidemiological investigation into the criminal fake artesunate trade in southeast Asia. PLoS Med 5: e32.[Crossref] [Google Scholar]
  10. Aldhous P, , 2005. Murder by medicine. Nature 434: 132136.[Crossref] [Google Scholar]
  11. Desingh AK, , 2005. Pharmaceutical counterfeiting. Analyst (Lond) 130: 271279.[Crossref] [Google Scholar]
  12. Brien KLO, Selanikio JD, Hecdivert C, Placide M, Louis M, Barr JR, Hospedales CJ, Lewis MJ, Schwartz B, Philen RM, Victor SS, Espindola J, Needham LL, Denerville K, , 1998. Epidemic of pediatric deaths from acute renal failure caused by diethylene glycol poisoning. JAMA 279: 11751180.[Crossref] [Google Scholar]
  13. Singh J, Dutta A, Khare S, , 1998. Diethylene glycol poisoning in Gurgaon, India. Bull World Health Organ 72: 8895. [Google Scholar]
  14. Chaccour C, Kaur H, Mabey D, Del Pozo J, , 2012. Travel and fake artesunate: a risky business. Lancet 380: 1120.[Crossref] [Google Scholar]
  15. 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] [Google Scholar]
  16. Ioset J-R, Kaur H, , 2009. Simple field assays to check quality of current artemisinin-based combination formulations. PLoS ONE 4: e7270.[Crossref] [Google Scholar]
  17. Green MD, Nettey H, Villalva Rojas O, Pamanivong C, Khounsaknalath L, Grande Ortiz M, Newton PN, Fernandez FM, Vongsack L, Manolin O, , 2007. Use of refractory and colorimetry as field methods to rapidly assess antimalarial drug quality. J Pharm Biomed Anal 43: 105110.[Crossref] [Google Scholar]
  18. Green M, Mount D, Wirtz R, White N, , 2000. A colorimetric field method to assess the authenticity of drugs sold as the antimalarial artesunate. J Pharm Biomed Anal 24: 6570.[Crossref] [Google Scholar]
  19. Feigl F, , 1947. Quantitative Analysis by Spot Tests, 3rd edition. New York, NY: Elsevier Publishing. [Google Scholar]
  20. Jahnke R, Kusters G, Fleischer K, , 2001. Low-cost quality assurance of medicines using the GPHF-Minilab® . Drug Inf J 35: 941945. [Google Scholar]
  21. World Health Organization, 1991. Basic Tests for Pharmaceutical Dosage Forms. Geneva, Switzerland: World Health Organization. [Google Scholar]
  22. Weaver AA, Reiser H, Barstis T, Benvenuti M, Ghosh D, Hunkler M, Joy B, Koenig L, Raddell K, Lieberman M, , 2013. Paper analytical devices for fast field friendly screening of beta-lactam antibiotics and antituberculosis pharmaceuticals. Anal Chem 85: 64536460.[Crossref] [Google Scholar]
  23. Sesay M, , 1988. Fake drugs—a new threat to healthcare delivery. Afr Health 1315. [Google Scholar]
  24. Lutter R, , 2013. Testimony on Counterfeit Drugs. U.S. Department of Health and Human Services News Events. Available at: http://www.fda.gov/newsevents/testimony/ucm112670.htm. Accessed June 18, 2013. [Google Scholar]
  25. Weaver A, Lieberman M, Gray BL, Becker, 2014. Paper analytical devices for detection of low quality pharmaceuticals. , eds. Microfluidics, BioMEMs, and Medical Microsystems XII. Vol. 8976. Bellingham, WA: International Society for Optics and Photonis, 89760H189760H6.[Crossref] [Google Scholar]
  26. Yagoda H, , 1938. Test Paper Patent. Patent number 2129754. [Google Scholar]
  27. Martinez AW, Phillips ST, Whitesides GM, Carhillo E, , 2010. Diagnostics for the developing world: microfluidic paper-based analytical devices. Anal Chem 82: 310.[Crossref] [Google Scholar]
  28. Schneider C, Rasband K, Eliceiri K, , 2012. NIH Image to ImageJ: 25 years of image analysis. Nat Methods 9: 671675.[Crossref] [Google Scholar]
  29. World Health Organization, 1998. Basic Tests for Drugs: Pharmaceutical Substances, Medicinal Plant Materials and Dosage Forms. Geneva, Switzerland: World Health Organization. [Google Scholar]

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  • Received : 20 Jun 2014
  • Accepted : 11 Dec 2014
  • Published online : 03 Jun 2015

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