Dr. Timothy Mackey: Clear and Present Danger: Availability of Dangerous, Unapproved and Recalled Drugs Online
Clear and Present Danger:
Availability of Dangerous, Unapproved and Recalled
Tim K. Mackey, MAS, PhD
UC San Diego
NTI, Unapproved, and Recalled
The Internet Pharmacy Ecosystem
Dangerous Drugs Online: Avoiding the Controversy
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Increasing use of the Internet for
health, equitable access to
medicines, drug and patient
safety, intellectual property
engagement, law enforcement.
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WHAT HAS BEEN FOUND
Online availability and safety of drugs in
shortage: a descriptive study of internet
vendor characteristics. JMIR (2012).
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Suspect online sellers and contraceptive
access. Contraception (2012).
Digital social media, youth, and
nonmedical use of prescription drugs: The
need for reform. JMIR (2013).
Vaccine shortages and suspect online
pharmacy sellers. Vaccine (2012).
Searching for Dangerous Drugs Online:
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Drugs subject to
NARROW THERAPEUTIC INDEX
• Danger: Narrow proximity between therapeutic
and toxic amounts requires close professional
oversight and precise manufacturing.
• Challenges: Switching can entail risks arising
from variable active ingredient bioavailability.
Acceptable list of NTI drugs not well defined.
• Availability: Actively marketed for sale. Core list
13/14 (92%, digitoxin available on Alibaba.com);
Including Expanded list 24/26 (92%).
• Implications: Higher risk of adverse event
associated with NTI patients; no physician
monitoring; manufacturing processes need to be
precise and rely on originator information for BE.
Liang BA, Mackey TK, Lovett KM. Illegal “no prescription”
internet access to narrow therapeutic index drugs. Clin Ther.
35(5): 694-700 (2013)
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• Danger: Obesity is global health crisis. Belviq
(lorcaserin HCI, S-IV CS) approved by FDA but
was not legally marketed by manufacturer.
Weight loss drugs previously identified as being
• Opportunity: Research was conducted after
FDA approval but prior to DEA scheduling.
• Availability: Actively marketed for sale by “no
prescription” online vendors
(e.g., buybelviqonline.com) and Alibaba.com.
• Implications: Drug is not approved, consumers
have no idea what they are getting. Could be
other weight loss products or counterfeit.
Liang BA, Mackey TK, N Archer-Hayes A, Shinn LM. Illicit
online marketing of lorcaserin before DEA scheduling. Obesity.
21(5): 861-864 (2013)
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DRUGS SUBJECT TO
• Danger: Drugs subject to equivalent of FDA
class I recall may cause serious adverse health
consequence or even death. There may be no
“authorized” manufacturing of drug.
• Challenges: There is no central list of globally
recalled drugs (2002-2012). We had to construct
such a list for this research from multiple sources.
• Availability: Total of 16 (12 oral/4 injectable)
identified. 50% marketed for sale “no rx” online.
• Additional Findings: Internet ecosystem for
recalled drugs is diverse, including heavy
presence of affiliates, use of social media, B2B
(Alibaba.com) and sites NABP/LegitScript “not
recommended”, “rogue”, or “unapproved”
Part of larger grant through Canadian Social Sciences and
Humanities Research Council on counterfeit drugs. Authors:
Mackey TK, Liang BA, Aung PS. Work in progress.
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DANGEROUS DRUG ONLINE
Future use of emerging tech
of “Deep Web” such as Tor
Increasing importance of
affiliates when dealing with
Legal entity facilitators that
wholesale API or finished
product to online sellers
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Identify High-Risk Dangerous Drugs
Identification of drug and health products that can cause
serious harm to patients
Develop Global Lists
Harmonize lists of NTI drugs and recalled drugs for
consumer education and safety
Identification of Ecosystem
Identification and surveillance of entire illicit online
Special and Unique Enforcement
Enforcement against ALL facilitators in the trade of
Prioritize Dangerous Online Drugs
The domestic and international community needs to prioritize identification,
surveillance, and enforcement against the online marketing and sale of these clearly
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UC San Diego
Thank you for listening and we welcome any questions/comments
Special thanks to the Partnership for Safe Medicines for advocating for fights against counterfeit medicines
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