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



Counterfeit (or falsified) and substandard medicines pose a major public health risk. We describe the findings of Operation Storm I and II conducted in 2008–2009 to combat counterfeit medicines through partnership between national customs, Drug Regulatory Agencies (DRAs), and police in Cambodia, Indonesia, Laos, Myanmar, Singapore, Thailand, and Vietnam. Samples were obtained from seizures and market surveillance by national DRAs. Laboratory analysis using spectroscopic and chromatographic techniques and examination of packaging were performed. Ninety-three suspect antibiotics and 95 antimalarial samples were collected. Of the 93 antibiotics, 29 (31%) had % active pharmaceutical ingredient content (%API) < 85% or > 115% (including one counterfeit). Of the 95 antimalarials, 30 (32%) had %API < 85 > 115% API (including one counterfeit). A significant minority of samples, antimalarials (13%) and antibiotics (15%), were collected in plastic bags with minimal or no labeling. Of 20 ampicillin samples, 13 (65%) contained < 85% API (with one counterfeit containing additional amoxicillin). Of 34 oral artesunate samples, 7 (21%) contained %API out of the 85–115% range. Coordinated and synergistic partnership adopted by the participating countries, International Criminal Police Organization (INTERPOL), World Health Organization (WHO), and laboratories facilitated a platform for discussions and intelligence sharing, helping to improve each participating country's capacity to combat poor-quality medicines.

[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. 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] [Google Scholar]
  2. 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] [Google Scholar]
  3. Caudron JM, Ford N, Henkens M, Macé C, Kiddle-Monroe R, Pinel J, , 2008. Substandard medicines in resource-poor settings: a problem that can no longer be ignored. Trop Med Int Health 13: 10621072.[Crossref] [Google Scholar]
  4. Bate R, Coticelli P, Tren R, Attaran A, , 2008. Antimalarial drug quality in the most severely malarious parts of Africa: a six country study. PLoS ONE 3: e2132.[Crossref] [Google Scholar]
  5. 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] [Google Scholar]
  6. Newton PN, Green MD, Fernández FM, Day NJP, White NJ, , 2006. Counterfeit anti-infective medicines. Lancet Infect Dis 6: 602613.[Crossref] [Google Scholar]
  7. 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] [Google Scholar]
  8. 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 southeast Asia. PLoS Med 5: e32.[Crossref] [Google Scholar]
  9. Newton PN, Fernández FM, Green MD, Primo-Carpenter J, White NJ, Sosa AJ, Byarugaba DK, Amábile-Cuevas CF, Hsueh P-R, Kariuki S, Okeke IN, , 2009. Counterfeit and substandard anti-has in developing countries. In: Antimicrobial Resistance in Developing Countries. , eds. Springer, New York. [Google Scholar]
  10. Kaur H, Goodman C, Thompson E, Thompson KA, Masanja MI, Kachur SP, Abdulla S, , 2008. A nationwide survey of the quality of antimalarials in retail outlets in Tanzania. PLoS ONE 3: 10.[Crossref] [Google Scholar]
  11. Leslie T, Kaur H, Mohammed N, Kolaczinski K, Ord RL, Rowland M, , 2009. Epidemic of Plasmodium falciparum malaria involving substandard antimalarial drugs, Pakistan, 2003. Emerg Infect Dis 15: 17531759.[Crossref] [Google Scholar]
  12. Wellcome Trust, 2009. Opinion Formers' Conference on Counterfeit Medicines: Perspectives and Action. Available at: http://apg.uk.com/assets/Counterfeit_Medicines_Report_finalsmall.pdf. Accessed September 11, 2014. [Google Scholar]
  13. Onwujekwe O, Kaur H, Dike N, Shu E, Uzochukwu B, Hanson K, Okoye V, Okonkwo P, , 2009. Quality of anti-malarial drugs provided by public and private healthcare providers in southeast Nigeria. Malar J 8: 22.[Crossref] [Google Scholar]
  14. 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] [Google Scholar]
  15. Fondation Chirac, 2009. The Cotonou Declaration. Available at: http://www.fondationchirac.eu/en/the-cotonou-declaration-october-12-2009-benin/. Accessed September 11, 2014. [Google Scholar]
  16. World Health Organization, 2011. Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa. Geneva, Switzerland: World Health Organization, WHO/EMP/QSM/2011.1. Available at: http://www.who.int/medicines/publications/WHO_QAMSA_report.pdf. Accessed September 11, 2014. [Google Scholar]
  17. World Health Organization, 2008. Executive Board 124th Session Provisional Agenda Item 4.11. Counterfeit Medical Products. EB124. Available at: http://www.who.int/gb/ebwha/pdf_files/EB124/B124_14-en.pdf. With corrigendum—see http://apps.who.int/gb/ebwha/pdf_files/EB124/B124_14Corr1-en.pdf. Accessed September 11, 2014. [Google Scholar]
  18. World Health Organization, 2011. Working Group of Member States on Substandard/Spurious/Falsely-labeled/Falsified/Counterfeit Medical Products, Provisional Agenda Item 5, A/SSFFC/WG/3 Rev.1, February 17, 2011. Available at: http://apps.who.int/gb/ssffc/pdf_files/A_SSFFC_WG3Rev1-en.pdf. Accessed September 11, 2014. [Google Scholar]
  19. 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] [Google Scholar]
  20. Attaran A, Barry D, Basheer S, Benton D, Byrne D, Chauvin J, Garrett L, Kickbusch I, Midha K, Newton PN, Nishtar S, Orhii P, McKee M, , 2012. How to achieve international action on falsified and substandard medicines: a consensus statement. BMJ 345: e7381.[Crossref] [Google Scholar]
  21. Khan MH, Okumura J, Sovannarith T, Nivanna N, Akazawa M, Kimura K, , 2010. Prevalence of counterfeit anthelminthic medicines: a cross-sectional survey in Cambodia. Trop Med Int Health 15: 639644.[Crossref] [Google Scholar]
  22. Newton PN, Lee SJ, Goodman C, Fernández FM, Yeung S, Phanouvong S, Kaur H, Amin AA, Whitty CJM, Kokwaro GO, Lindegårdh N, Lukulay P, White LJ, Day NPJ, Green MD, White NJ, , 2009. Guidelines for field surveys of the quality of medicines: a proposal. PLoS Med 6: e1000052.[Crossref] [Google Scholar]
  23. United Nations Office on Drugs and Crime (UNODC) with ENFSI Drugs Working Group, 2009. Available at: http://www.unodc.org/documents/scientific/Drug_Sampling.pdf. Accessed September 11, 2014.
  24. Green MD, Nettey H, Villalva Rojas O, Pamanivong C, Khounsaknalath L, Grande Ortiz M, Newton PN, Fernández FM, Vongsack L, Manolin O, , 2007. Use of refractometry and colorimetry as field methods to rapidly assess antimalarial drug quality. J Pharm Biomed Anal 43: 105110.[Crossref] [Google Scholar]
  25. Fernández F, Cody RB, Green MD, Hampton CY, McGready R, Sengaloundeth S, White NJ, Newton PN, , 2006. Characterization of solid counterfeit drug samples by desorption electrospray ionization and direct-analysis-in-real-time coupled to time-of-flight mass spectrometry. Chem Med Chem 1: 702705.[Crossref] [Google Scholar]
  26. Nyadong L, Green MD, De Jesus VR, Newton PN, Fernández FM, , 2007. Reactive desorption electrospray ionization linear ion trap mass spectrometry of latest-generation counterfeit antimalarials via noncovalent complex formation. Anal Chem 79: 21502157.[Crossref] [Google Scholar]
  27. Keoluangkhot V, Green M, Nyadong L, Fernández F, Mayxay M, Newton PN, , 2008. Impaired clinical response in a patient with uncomplicated falciparum malaria who received poor quality and underdosed intramuscular artemether. Am J Trop Med Hyg 78: 552555. [Google Scholar]
  28. Newton PN, Green MD, Mildenhall DC, Plancon 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] [Google Scholar]
  29. Okeke IN, Laxminarayan R, Bhutta ZA, Duse AG, Jenkins P, O'Brien TF, Pablos-Mendez A, Klugman KP, , 2005. Antimicrobial resistance in developing countries. Part I: recent trends and current status. Lancet Infect Dis 5: 481493.[Crossref] [Google Scholar]
  30. Anon, 2010. Regulatory action needed to stop the sale of oral artemisinin-based monotherapy. WHO Drug Inform 24: 98104. [Google Scholar]
  31. World Health Organization, 2006. WHO Calls for an Immediate Halt to Provision of Single-Drug Artemisinin Malaria Pills. Available at: http://www.who.int/mediacentre/news/releases/2006/pr02/en/. Accessed September 11, 2014. [Google Scholar]
  32. Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ, , 2009. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 361: 455467.[Crossref] [Google Scholar]
  33. World Health Organization, 2010. WHO Guidelines for the Treatment of Malaria. Geneva. Available at: http://whqlibdoc.who.int/publications/2010/9789241547925_eng.pdf. Accessed September 11, 2014. [Google Scholar]
  34. Newton PN, Hampton C, Alter-Hall K, Teerwarakulpana T, Prakongpan S, Ruangveerayuth R, White NJ, Day NPJ, Tudino M, Mancuso N, Fernández F, , 2008. Characterization of Yaa Chud Medicine on the Thailand–Myanmar border: selecting for drug-resistant malaria and threatening public health. Am J Trop Med Hyg 79: 662669. [Google Scholar]
  35. Plasai V, Spielman A, , 1996. Mefloquine insusceptibility of malaria in Thailand not promoted by nonregulated drug-use. Acta Trop 60: 281289.[Crossref] [Google Scholar]
  36. Ballereau F, Prazuck T, Schrive I, Lafleuriel MT, Rozec D, Fisch A, Lafaix C, , 1997. Stability of essential drugs in the field: results of a study conducted over a two-year period in Burkina Faso. Am J Trop Med Hyg 57: 3136. [Google Scholar]
  37. United States Pharmacopeia, 2011. Uniformity of Dosage Units (USP NF Chapter 905). Available at: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/2011-02-25905UNIFORMITYOFDOSAGEUNITS.pdf. Accessed September 11, 2014. [Google Scholar]
  38. Toscano P, , 2011. CNBC.com. The Dangerous World of Counterfeit Prescription Drugs. USA Today/Money, 10/7/2011. Available at: http://usatoday30.usatoday.com/money/industries/health/drugs/story/2011-10-09/cnbc-drugs/50690880/1. Accessed September 11, 2014. [Google Scholar]
  39. Davison M, , 2011. Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs. Hoboken, NJ: Wiley.[Crossref] [Google Scholar]
  40. World Health Organization, 2013. WHO project for the surveillance and monitoring of SSFFC medical products. WHO Drug Info 27: 97100. [Google Scholar]

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Supplementary PDF

  • Received : 12 Sep 2014
  • Accepted : 05 Jan 2015
  • Published online : 03 Jun 2015

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