An exploration of counterfeit medicine surveillance strategies guided by geospatial analysis: Lessons learned from counterfeit avastin detection in the us drug supply chain

BMJ Open

Volumn 4, Issue 12, 2014, Pages

  Cuomo, Raphael E ^a,b   Mackey, Tim K ^a,b,c  

^a Global Health Policy Institute   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c University of California   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BEVACIZUMAB; COUNTERFEIT DRUG; ANGIOGENESIS INHIBITOR; MONOCLONAL ANTIBODY;

AGED; ARTICLE; DEMOGRAPHY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; GEOGRAPHIC DISTRIBUTION; GEOGRAPHIC MAPPING; GEOSPATIAL ANALYSIS; GROUPS BY AGE; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; HUMAN; UNITED STATES; ZIP CODE; DRUG CONTROL; HEALTH EDUCATION; ORGANIZATION AND MANAGEMENT; PHARMACIST; PROFESSIONAL STANDARD; STANDARDS; SUPPLY AND DISTRIBUTION;

ANGIOGENESIS INHIBITORS; ANTIBODIES, MONOCLONAL, HUMANIZED; BEVACIZUMAB; COUNTERFEIT DRUGS; DRUG AND NARCOTIC CONTROL; HEALTH EDUCATION; HEALTH POLICY; HUMANS; PHARMACISTS; PROFESSIONAL ROLE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84920719277     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2014-006657     Document Type: Article

References (36)

1. Siegel R, Ma J, Zou Z, et al. Cancer statistics, 2014. CA Cancer J Clin 2014;64:9-29.
2. Mackey TK, Liang BA. Oncology and the internet: regulatory failure and reform. J Oncol Pract 2012;8:341-3.
3. Kuehn BM. FDA warning: new batch of fake bevacizumab found. J Am Med Assoc 2013;309:864.
4. Kelesidis T, Kelesidis I, Rafailidis PI, et al. Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother 2007;60:214-36.
5. Food and Drug Administration. Counterfeit Version of Avastin in the U.S. Distribution. 2012.
6. Eskens F, Sleifer S. The use of bevacizumab in colorectal, lung, breast, renal and ovarian cancer: where does it fit? Eur J Cancer 2008;44:2350-6.
7. Welch S, Spithoff K, Rumble RB, et al. Bevacizumab combined with chemotherapy for patients with advanced colorectal cancer: a systematic review. Ann Oncol 2010;21:1152-62.
8. Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 2012;30:2039-45.
9. Berenson A. A cancer drug shows promise, at a price that many can't pay. N Y Times 2006;15:2618-22.
10. FDA Center for Drug Evaluation and Research. Counterfeit version of Avastin in U.S. distribution. Silver Spring, Maryland. 2012.
11. Garcia-Aguirre G, Vanzinni-Zago V, Quiroz-Mercado H. Growth of Scytalidium sp. in a counterfeit bevacizumab bottle. Indian J Ophthalmol 2013;61:523-5.
12. Weaver CM, Whalen J. How fake cancer drugs entered U.S. doctors ' offices . Journal WS, 2012.
13. Nsimba SE. Problems associated with substandard and counterfeit drugs in developing countries: a review article on global implications of counterfeit drugs in the era of antiretroviral (ARVs) drugs in a free market economy. East Afr J Public Health 2008;5:205-10.
14. Liang BA. Parallel trade in pharmaceuticals: injecting the counterfeit element into the public health. N C J Int Law Commercial Regul 2005;31:847-900.
15. Newton PN, Green MD, Fernández FM. Impact of poor-quality medicines in the "developing" world. Trends Pharmacol Sci 2010;31:99-101.
16. Fackler M. China 's fake drugs kill thousands. San Francisco Examiner. 2002.
17. Chakravarty S, Unnithan S, Ram A. Deadly doses. India Today. 2001.
18. Crampton T. Fatalities grow as people use cheap but worthless 'drugs ': fake malaria pills haunt Asians . Times NY, 2003.
19. Mackey TK, Liang BA. The global counterfeit drug trade: patient safety and public health risks. J Pharm Sci 2011;100:4571-9.
20. Newton PN, Green MD, Fernández FM, et al. Counterfeit anti-infective drugs. Lancet Infect Dis 2006;6:602-13.
21. Food and Drug Administration. Health care provider alert: another counterfeit cancer medicine found in the United States. 2013.
22. Cockburn R, Newton PN, Agyarko Ek, et al. The global threat of counterfeit drugs: why industry and government must communicate the dangers. PLoS Med 2005;4:e289.
23. Nelson M, Vizurraga M, Chang D. Counterfeit pharmaceuticals: A worldwide problem. The Trademark Reporter 1068. 2006.
24. Food and Drug Administration. Letters to doctors about risks of purchasing medications from foreign or unlicensed suppliers. Silver Spring, Maryland. 2012.
25. U.S. Census Bureau. Maps and Data. Suitland, Maryland. 2014.
26. National Cancer Institute. Median Age of Cancer Patients at Diagnosisa, 2005-2009. Surveillance, Epidemiology and End-Results. Program. Rockville, Maryland. 2009.
27. U.S. Department of Labor. Labor force statistics from the current population survey. Washington DC: Statistics BoL, 2014.
28. Mukherji SK. Bevacizumab (Avastin). AJNR Am J Neuroradiol 2010;31:235-6.
29. Curran K. Cape Cod counterfeit drug ring focus of federal investigation . WCBV, 2013.
30. Partnership for Safe Medicines. Counterfeit cancer drugs are a big money maker for fake drug criminals. 2012.
31. Imber S. Update On Fake Avastin-FDAWarnings In 28 States, Six Prosecutions. Partnership for Safe Medicines. 2013.
32. Attaran A, Barry D, Basheer S, et al. How to achieve international action on falsified and substandard medicines. BMJ 2012;345:e7381.
33. Gostin LO, Buckley GJ, Kelley PW. Stemming the global trade in falsified and substandard medicines. JAMA 2013;309:1693-4.
34. Mackey TK, Liang BA. Improving global health governance to combat counterfeit medicines: a proposal for a UNODC-WHOInterpol trilateral mechanism. BMC Med 2013;11:233.
35. Institute of Medicine. Countering the problem of falsified and substandard drugs. 2013.
36. WHO pilots surveillance system targeting fake meds. Reactions Weekly 1418:2. 2012.