International Journal of Clinical Pharmacy

, Volume 37, Issue 6, pp 1076–1085 | Cite as

Illicit Internet availability of drugs subject to recall and patient safety consequences

  • Tim K. MackeyEmail author
  • Phyo Aung
  • Bryan A. Liang
Research Article


Background Permanently recalled drugs are a public health concern if they remain accessible in violation of applicable regulation. Illicit online pharmacies act as an alternative form of access and have been associated with the sale to patients of counterfeit/falsified/fraudulent/substandard drugs. We wished to determine if permanently recalled and significantly restricted drugs were illegally marketed for sale online. Objective The study was conducted in two phases with two objectives. The first phase attempted to identify drugs subject to permanent recall in certain major pharmaceutical markets as well as those listed as recalled or significantly restricted by the United Nations. We also examined the market authorization status of identified drugs in China and India. The second phase used structured searches on the Internet to determine if identified drugs were marketed for sale online. Setting The World Wide Web. Method After identification of permanently recalled and restricted drugs we conducted Internet searches for illegal “no prescription” marketing events. We assessed the form of marketing, whether a site offered direct-to-patient sale, use of social media marketing, and the site’s compliance status with external monitoring bodies. Main Outcome Number of recalled drugs marketed as available for purchase on the Internet. Results We identified 16 class I equivalent permanently recalled or restricted drugs, 56.3 % (n = 9) of which maintained market authorization in either China or India. Half (n = 8) were marketed for sale online without a prescription direct-to-patient. Use of social media marketing was mixed, with only 18.8 % (n = 3) of recalled drugs having a presence on Facebook, though 50.0 % (n = 8) had content on Twitter. We also found the majority (68.8 %, n = 11) were available and marketed for sale by vendors on the wholesale/business-to-business website primarily as active pharmaceutical ingredient. Conclusion Despite efforts in several countries to restrict access to these drugs or permanently remove them from the market, our study indicates that various sources actively market recalled drugs for sale online. Drug regulators, public health agencies, and law enforcement officials should act with urgency to appropriately restrict and regulate these sales to protect global patients and consumers.


Drug recalls Drug withdrawals Internet pharmacies Market removal Online pharmacies Public health Social media marketing 



PA received support from an NIH Summer Research Training Grant Fellowship and greatly acknowledges this support. The authors would like to thank the Canadian Social Sciences and Humanities Research council for their support.


TM received funding from the Canadian Social Sciences and Humanities Research Council in support of this research.

Conflicts of interest

The authors have report no conflicts of interest pertaining to this study.

Supplementary material

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Supplementary material 1 (DOC 42 kb)
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Supplementary material 2 (PNG 39263 kb)


  1. 1.
    U.S. Food and Drug Administration [Internet]. FDA Website. [cited 2015 Jun 1]. Drug recalls.
  2. 2.
    Waxman HA. The lessons of Vioxx—drug safety and sales. N Engl J Med. 2005;352(25):2576–8.CrossRefPubMedGoogle Scholar
  3. 3.
    Moore TJ, Psaty BM, Furberg CD. Time to act on drug safety. JAMA. 1998;279(19):1571–3.CrossRefPubMedGoogle Scholar
  4. 4.
    Dieppe PA. Lessons from the withdrawal of rofecoxib. BMJ. 2004;329(7471):867–8.PubMedCentralCrossRefPubMedGoogle Scholar
  5. 5.
    Maxwell SRJ, Webb DJ. Internet pharmacy: A web of mistrust? Br J Clin Pharmacol. 2008;66(2):196–8.Google Scholar
  6. 6.
    Pharma&MedTech [Internet]. Drug recalls soared again in 2013, driven by contamination. [cited 2015 Jun 1].
  7. 7.
    Mitka M. Improving drug safety. JAMA. 2010;304(10):1060.Google Scholar
  8. 8.
    Lexchin J. How safer are new drugs? Market withdrawal of drugs approved in Canada between 1990 and 2009. Open Med. 2014;8(1):e14–9.PubMedCentralPubMedGoogle Scholar
  9. 9.
    Almuzaini T, Choonara I, Sammons H. Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open. 2013;3(8):e002923–3.CrossRefGoogle Scholar
  10. 10.
    Williams G. Withdrawal of sibutramine in Europe. BMJ. 2010;340:c824.CrossRefPubMedGoogle Scholar
  11. 11.
    Balakrishnan K, Tordoff J, Norris P, Reith D. Establishing a baseline for the monitoring of medicines availability for children in the UK: 1998–2002. Br J Clin Pharmacol. 2007;63(1):85–91.PubMedCentralCrossRefPubMedGoogle Scholar
  12. 12.
    Mackey TK, Liang BA. The global counterfeit drug trade: patient safety and public health risks. J Pharm Sci. 2011;100(11):4571–9.CrossRefPubMedGoogle Scholar
  13. 13.
    Liang BA, Mackey T. Searching for safety: addressing search engine, website, and provider accountability for illicit online drug sales. Am J Law Med. 2009;35(1):125–84.PubMedGoogle Scholar
  14. 14.
    Liang BA, Mackey TK. Online availability and safety of drugs in shortage: a descriptive study of Internet vendor characteristics. J Med Internet Res. 2012;14(1):e27.PubMedCentralCrossRefPubMedGoogle Scholar
  15. 15.
    Siva N. Tackling the booming trade in counterfeit drugs. Lancet. 2010;376(9754):1725–6.CrossRefPubMedGoogle Scholar
  16. 16.
    Growing threat from counterfeit medicines. Bull World Health Organ. 2010;88(24):247–8.Google Scholar
  17. 17.
    Fittler A, Bősze G, Botz L. Evaluating aspects of online medication safety in long-term follow-up of 136 Internet pharmacies: illegal rogue online pharmacies flourish and are long-lived. J Med Internet Res. 2013;15(9):e199.PubMedCentralCrossRefPubMedGoogle Scholar
  18. 18.
    Liang BA, Mackey TK. Prevalence and global health implications of social media in direct-to-consumer drug advertising. J Med Internet Res. 2011;13(3):e64.PubMedCentralCrossRefPubMedGoogle Scholar
  19. 19.
    Liang BA, Mackey T. Direct-to-consumer advertising with interactive Internet media: global regulation and public health issues. JAMA. 2011;305(8):824–5.CrossRefPubMedGoogle Scholar
  20. 20.
    Mackey TK, Liang BA. Pharmaceutical digital marketing and governance: illicit actors and challenges to global patient safety and public health. Global Health. 2013;9(1):45.PubMedCentralCrossRefPubMedGoogle Scholar
  21. 21.
    Alwon BM, Solomon G, Hussain F, Wright DJ. A detailed analysis of online pharmacy characteristics to inform safe usage by patients. Int J Clin Pharm. 2015;37:148–58.CrossRefPubMedGoogle Scholar
  22. 22.
    Liang BA, Mackey TK, Lovett KM. Suspect online sellers and contraceptive access. Contraception. 2012;86(5):551–6.CrossRefPubMedGoogle Scholar
  23. 23.
    Liang BA, Mackey TK. Vaccine shortages and suspect online pharmacy sellers. Vaccine. 2012;30(2):105–8.CrossRefPubMedGoogle Scholar
  24. 24.
    Khan MH, Tanimoto T, Nakanishi Y, Yoshida N, Tsuboi H, Kimura K. Public health concerns for anti-obesity medicines imported for personal use through the Internet: a cross-sectional study. BMJ Open. 2012;2(3):e000854–4.CrossRefGoogle Scholar
  25. 25.
    Liang BA, Mackey TK. Sexual medicine: online risks to health—the problem of counterfeit drugs. Nat Rev Urol. 2012;9(9):480–2.CrossRefPubMedGoogle Scholar
  26. 26.
    Lovett KM, Liang BA, Mackey TK. Online, direct-to-consumer access to insulin: patient safety considerations and reform. J Diabetes Sci Technol. 2012;6(6):1503–6.PubMedCentralCrossRefPubMedGoogle Scholar
  27. 27.
    Liang BA, Mackey TK, Lovett K. Emerging dangers from direct botulinum access and use. J Homel Secur Emerg Manag. 2012;. doi: 10.1515/1547-7355.1973.Google Scholar
  28. 28.
    Forman RF. Availability of opioids on the Internet. JAMA. 2003;290(7):889.CrossRefPubMedGoogle Scholar
  29. 29.
    Forman RF, Block LG. The marketing of opioid medications without prescription over the Internet. J Pub Policy Mark. 2006;25:133–46.CrossRefGoogle Scholar
  30. 30.
    Jena AB, Goldman DP, Foster SE, Califano JA. Prescription medication abuse and illegitimate Internet-based pharmacies. Ann Intern Med. 2011;155(12):848–50.CrossRefPubMedGoogle Scholar
  31. 31.
    Lagan BM, Dolk H, White B, Uges DRA, Sinclair M. Assessing the availability of the teratogenic drug isotretinoin outside the pregnancy prevention programme: a survey of e-pharmacies. Pharmacoepidemiol Drug Saf. 2014;4:411–8.CrossRefGoogle Scholar
  32. 32.
    Tatsioni A, Gerasi E, Charitidou E, Simou N, Mavreas V, Ioannidis JPA. Important drug safety information on the Internet: assessing its accuracy and reliability. Drug Saf. 2003;26(7):519.CrossRefPubMedGoogle Scholar
  33. 33.
    Liang BA, Mackey TK, Lovett KM. Illegal “no prescription” Internet access to narrow therapeutic index drugs. Clin Ther. 2013;35(5):694–700.CrossRefPubMedGoogle Scholar
  34. 34.
    Liang BA, Mackey TK, Archer-Hayes AN, Shinn LM. Illicit online marketing of locaserin before DEA scheduling. Obesity. 2013;21(5):861–4.CrossRefPubMedGoogle Scholar
  35. 35.
    National Association of Boards of Pharmacy [Internet]. Not recommended sites. [cited 2015 Jun 1].
  36. 36.
    LegitScript. [Internet]. Frequently asked questions. [cited 2015 Jun 1].
  37. 37.
    Ninan B, Wertheimer AI. Withdrawing drugs in the us versus other countries. Innov Pharm. 2012;3(3):1–12.Google Scholar
  38. 38.
    Wolfe SM. When EMA and FDA decisions conflict: Differences in patients or in regulation? BMJ. 2013;347:f5140.CrossRefPubMedGoogle Scholar
  39. 39.
    Tafuri G, Stolk P, Trotta F, Putzeist M, Leufkens HG, Laing RO, et al. How do the EMA and FDA decide which anticancer drugs make it to the market? A comparative qualitative study on decision makers’ views. Ann Oncol. 2014;25(1):265–9.CrossRefPubMedGoogle Scholar
  40. 40.
    Wang B, Gagne JJ, Choudhry NK. The epidemiology of drug recalls in the United States. Arch Intern Med. 2012;172(14):1110–1.CrossRefGoogle Scholar

Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2015

Authors and Affiliations

  1. 1.Department of AnesthesiologyUniversity of California, San Diego School of MedicineSan DiegoUSA
  2. 2.Division of Global Public Health, Department of MedicineUniversity of California, San Diego School of MedicineSan DiegoUSA
  3. 3.Global Health Policy InstituteLa JollaUSA
  4. 4.Skaggs School of Pharmacy and Pharmaceutical SciencesUniversity of California, San DiegoSan DiegoUSA

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