1. Clear and Present Danger:
Availability of Dangerous, Unapproved and Recalled
Drugs Online
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Tim K. Mackey, MAS, PhD
UC San Diego
PSM Interchange
October 2013

2. PRESENTATION AGENDA
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NTI, Unapproved, and Recalled
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The Internet Pharmacy Ecosystem
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Dangerous Drugs Online: Avoiding the Controversy
Solutions?
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3. INTERNATIONAL DEBATE
Increasing use of the Internet for
health, equitable access to
medicines, drug and patient
safety, intellectual property
rights, physician/patient
engagement, law enforcement.
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4. WHAT HAS BEEN FOUND
ONLINE
Published Research
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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).
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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).

5. Searching for Dangerous Drugs Online:
Narrow Therapeutic
Index Drugs
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Drugs not
approved
Drugs subject to
Global Recall

6. NARROW THERAPEUTIC INDEX
DRUGS
Primary Findings
• 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.
Citation
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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7. DRUGS NOT
APPROVED
Primary Findings
• 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
counterfeited.
• 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.
Citation
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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8. DRUGS SUBJECT TO
GLOBAL RECALL
Preliminary Findings
• 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”
Funding Source
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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9. DANGEROUS DRUG ONLINE
ECOSYSTEM
Future Challenges
Future use of emerging tech
of “Deep Web” such as Tor
and Bitcoin
Affiliate Networks
Increasing importance of
affiliates when dealing with
dangerous drugs
Business-to-Business
Vendors
Legal entity facilitators that
wholesale API or finished
product to online sellers
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10. MOVING FORWARD
Goals
Description
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
pharmacy ecosystem
Special and Unique Enforcement
Status
Enforcement against ALL facilitators in the trade of
dangerous medicines
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
dangerous medicines.
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Done
In progress
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Not started

11. Questions
UC San Diego
tmackey@ucsd.edu
www.linkedin.com/in/tkmacke
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@tkmackey
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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