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

Abstract

Abstract.

Over the past decade, the number of countries reporting falsified (fake, spurious/falsely labeled/counterfeit) medicines and the types and quantities of fraudulent drugs being distributed have increased greatly. The obstacles in combating falsified pharmaceuticals include 1) lack of consensus on definitions, 2) paucity of reliable and scalable technology to detect fakes before they reach patients, 3) poor global and national leadership and accountability systems for combating this scourge, and 4) deficient manufacturing and regulatory challenges, especially in China and India where fake products often originate. The major needs to improve the quality of the world's medicines fall into three main areas: 1) research to develop and compare accurate and affordable tools to identify high-quality drugs at all levels of distribution; 2) an international convention and national legislation to facilitate production and utilization of high-quality drugs and protect all countries from the criminal and the negligent who make, distribute, and sell life-threatening products; and 3) a highly qualified, well-supported international science and public health organization that will establish standards, drug-quality surveillance, and training programs like the U.S. Food and Drug Administration. Such leadership would give authoritative guidance for countries in cooperation with national medical regulatory agencies, pharmaceutical companies, and international agencies, all of which have an urgent interest and investment in ensuring that patients throughout the world have access to good quality medicines. The organization would also advocate strongly for including targets for achieving good quality medicines in the United Nations Millennium Development Goals and Sustainable Development Goals.

[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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References

  1. Nayyar GML, Breman JG, Newton PN, Herrington J, , 2012. Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488496.[Crossref] [Google Scholar]
  2. Almuzaini T, Choonara I, Sammons H, , 2013. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open 3: e002923.[Crossref] [Google Scholar]
  3. Mackey TK, Liang BA, , 2011. The global counterfeit drug trade: patient safety and public health risks. J Pharm Sci 100: 45714579.[Crossref] [Google Scholar]
  4. World Health Organization, 2011. Substandard/Spurious/Falsely-labeled/Falsified/Counterfeit Medical Products. Geneva, Switzerland: World Health Organization. Available at: http://www.who.int/medicines/services/counterfeit/WHO-ACM-Report.pdf. Accessed January 2014. [Google Scholar]
  5. Kwok K, Taylor LS, , 2012. Analysis of counterfeit Cialis® tablets using Raman microscopy and multivariate curve resolution. J Pharm Biomed Anal 66: 126135.[Crossref] [Google Scholar]
  6. Lung DD, Gerona RR, Wu AH, Smollin CG, , 2012. Confirmed glyburide poisoning from ingestion of “street Valium.” J Emerg Med 43: 276278.[Crossref] [Google Scholar]
  7. Dorlo TPC, Eggelte TA, de Vries PJ, Beijnen JH, , 2012. Characterization and identification of suspected counterfeit miltefosine capsules. Analyst (Lond) 137: 12651274.[Crossref] [Google Scholar]
  8. Mackey TK, Liang BA, Kubic T, Herrington JE, Nayyar GML, Breman JG, , 2015. Empirical analysis of counterfeit drug penetration in global legitimate medicine supply chains: a descriptive assessment. , eds. The global pandemic of falsified medicines: laboratory and field innovations policies and perspectives. Am J Trop Med Hyg 92 (Suppl 6): 5967.[Crossref] [Google Scholar]
  9. Campbell N, Clark JP, Stecher VJ, Goldstein I, , 2012. Internet-ordered Viagra (slidenafil citrate) is rarely genuine. J Sex Med 9: 29432951.[Crossref] [Google Scholar]
  10. Porta M, (ed.), 2014. A Dictionary of Epidemiology, 6th edition. New York, NY: International Epidemiology Association, 209. [Google Scholar]
  11. World Health Organization, 2010. New Definition for “Substandard Medicines.” Working document QAS/10.344/Rev.1. Available at: http://www.who.int/medicines/services/expertcommittees/pharmprep/14052010NewDefinitionSubstandardMeds-QAS10-344Rev1.pdf. Accessed January 2014. [Google Scholar]
  12. Attaran A, Barry D, Basheer S, Bate R, Benton D, Chauvin J, Garrett L, Kickbusch I, Kohler JC, Midha K, Newton PN, Nishtar S, Orhii P, McKee M, , 2012. How to achieve international action on falsified and substandard medicines. BMJ 345: 2325.[Crossref] [Google Scholar]
  13. Newton PN, Green MD, Fernández FM, , 2010. Impact of poor-quality medicines in the ‘developing’ world. Trends Pharmacol 31: 99101.[Crossref] [Google Scholar]
  14. United States Pharmacopeia, 2013. Media Reports on Medicine Quality: Focusing on USAID-Assisted Countries. Rockville, MD: United States Pharmacopeia. Available at: http://www.usp.org/sites/default/files/usp_pdf/EN/PQM/pqm-media-reports.pdf. Accessed January 2014. [Google Scholar]
  15. PR Newswire, 2013. Ten Global Health Organizations United in a Worldwide Campaign to Protect Patients from Fakes. Available at: http://www.prnewswire.com/news-releases/ten-global-health-organizations-united-in-a-worldwide-campaign-to-protect-patients-from-fake-medicines-233414271.html. Accessed January 2014. [Google Scholar]
  16. Institute of Medicine, 2013. Countering the Problem of Falsified and Substandard Drugs. Washington, DC: The National Academies Press. Available at: http://www.iom.edu/Reports/2013/Countering-the-Problem-of-Falsified-and-Substandard-Drugs.aspx. Accessed January 2014. [Google Scholar]
  17. Mackey TK, Liang BA, , 2013. Improving global health governance to combat counterfeit drugs: a proposal for a UNODC-WHO-Interpol trilateral mechanism. BMC Med 11: 233.[Crossref] [Google Scholar]
  18. 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: e100052.[Crossref] [Google Scholar]
  19. World Health Organization, 2014. Recommendations on the Content of a Survey Protocol for Surveys of the Quality of Medicines (July 2014). Working document QAS/14.590. Geneva, Switzerland: World Health Organization. [Google Scholar]
  20. Green MD, Hostetler DM, Nettey H, Swamidoss I, Ranieri N, Fernandez F, Newton PN, Herrington JE, Nayyar GML, Breman JG, , 2015. Integration of novel low-cost colorometric and visual fluorescent techniques for rapid identification of falsified artemether-lumefantrine and other drugs in resource poor areas. , eds. The global pandemic of falsified medicines: laboratory and field innovations policies and perspectives. Am J Trop Med Hyg 92 (Suppl 6): 816.[Crossref] [Google Scholar]
  21. United States Pharmacopeia, 2009. Survey of the Quality of Selected Antimalarial Medicines Circulating in Madagascar, Senegal, and Uganda. United States Pharmacopeia. [Google Scholar]
  22. U.S. Pharmacopeial Convention, 2013. PQM in Africa. Available at: http://www.usp.org/around-world/pqm-uspusaid/global-impact/africa. Accessed January 2014. [Google Scholar]
  23. Hajjou M, Krech L, Roth L, Pribluda V, El Hadri L, Evans L, Chibwe K, Phanouvong S, Lukulay P, Herrington JE, Nayyar GML, Breman JG, , 2015. Monitoring the quality of medicines: results from Africa, southeast Asia, and Latin America. , eds. The global pandemic of falsified medicines: laboratory and field innovations policies and perspectives. Am J Trop Med Hyg 92 (Suppl 6): 6874.[Crossref] [Google Scholar]
  24. Ranieri N, Tabernero P, Green MD, Verbois L, Herrington J, Sampson E, Satzger RD, Phonlavong C, Thao K, Newton PN, Witkowski MR, , 2014. Evaluation of a new handheld instrument for the detection of counterfeit artesunate by visual florescence comparison. Am J Trop Med Hyg 91: 920924.[Crossref] [Google Scholar]
  25. Food and Drug Administration, 2013. FDA Facts: FDA's Counterfeit Detection Device CD-3. Available at: http://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM349286.pdf. Accessed January 2014. [Google Scholar]
  26. The Indian Express online, 2013. India Aims to Clock USD 15.5 Bn Pharma Exports FY13. Available at: http://www.indianexpress.com/news/india-aims-to-clock-usd-15.5-bn-pharma-exports-in-fy13/1060896/. Accessed May 2014. [Google Scholar]
  27. Nychis B, , 2011. Import of Human Drugs and Human Drug Components. Washington, DC: Food and Drug Administration. [Google Scholar]
  28. Gostin LO, Sridhar D, , 2014. Global health and the law. N Engl J Med 370: 17321740.[Crossref] [Google Scholar]
  29. Callard C, , 2010. Follow the money: how the billions of dollars that flow from smokers in poor nations to companies in rich nations greatly exceed funding for global tobacco control and what might be done about it. Tob Control 19: 285290.[Crossref] [Google Scholar]
  30. UNICRI, 2007. Counterfeiting, A Global Spread, a Global Threat. Available at: http://www.unicri.it/news/2007/0712-3counterfeitingcrtfoundation/. Accessed January 2014. [Google Scholar]
  31. Sun X, Xu X, Zhang X, , 2011. Counterfeit bevacizumab and endophthalmitis. N Engl J Med 365: 378379. [Google Scholar]
  32. NABP, 2013. Internet Drug Outlet Identification Program. Progress Report for State and Federal Regulators. Mount Prospect, IL: National Association of Boards of Pharmacy. Available at: https://awarerx.s3.amazonaws.com/system/redactor_assets/documents/179/NABP_Internet_Drug_Outlet_Report_Apr2013.pdf. Accessed January 2014. [Google Scholar]
  33. Tremblay M, , 2013. Medicines counterfeiting is a complex problem: a review of key challenges across the supply chain. Curr Drug Saf 8: 4355.[Crossref] [Google Scholar]
  34. Food and Drug Administration, 2012. FDA Takes Action Against Thousands of Illegal Internet Pharmacies. Food and Drug Administration News Release, October 4, 2012. Available at: http://fda.gov/newsevents/newsroom/pressannouncements/UCM322492.htm. [Google Scholar]
  35. World Health Organization, 2003. Effective Medicines Regulation: Ensuring Safety, Efficacy and Quality. Geneva, Switzerland: World Health Organization. Available at: http://whqlibdoc.who.int/hq/2003/WHO_EDM_2003.2.pdf. Accessed January 2014. [Google Scholar]
  36. World Health Organization, 2004. Availability of Drug Regulatory and Quality Assurance Elements in Member States of the WHO African Region. Brazzaville, Congo. Available at: http://apps.who.int/medicinedocs/documents/s20138en/s20138en.pdf. Accessed January 2014. [Google Scholar]
  37. Ndomondo Sigonda M, Ambali A, , 2011. The African medicines regulatory harmonization initiative: rationale and benefits. Clin Pharmacol Ther 89: 176178.[Crossref] [Google Scholar]
  38. World Health Organization, 2014. International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Available at: http://www.who.int/impact/en/. Accessed January 2014. [Google Scholar]
  39. Binagwaho A, Bate R, Gasana NM, Karema C, Mucyo Y, Mwesigye JP, Biziyaremye F, Nutt CT, Wagner CM, Jensen P, Attaran A, , 2013. Combating substandard and falsified medicines: a view from Rwanda. PLoS Med 10: e1001476.[Crossref] [Google Scholar]
  40. Yeung S, Lawford HLS, Tabernero P, Nguon C, van Wyk A, Malik N, DeSousa M, Rada O, Boravann M, Dwivedi P, Hostetler DM, Swamidoss I, Green MD, Fernandez FM, Kaur H, Herrington JE, Nayyar GML, Breman JG, , 2015. Quality of antimalarials at the epicenter of antimalarial drug resistance: results from an overt and mystery client survey in Cambodia. , eds. The global pandemic of falsified medicines: laboratory and field innovations policies and perspectives. Am J Trop Med Hyg 92 (Suppl 6): 3950.[Crossref] [Google Scholar]
  41. Kohler JC, Mackey TK, Ovtcharenko N, , 2014. Why the MDGs need good governance in pharmaceutical systems to promote global health. BMC Public Health 14: 63.[Crossref] [Google Scholar]
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  • Received : 25 Jun 2014
  • Accepted : 25 Mar 2015

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