1. An Overview of
Fake Online Pharmacy Issues
A Panel Discussion
Amelia Arnold, PharmD, Maine Pharmacist
Daniel Burke, MCJ, Special Agent, Senior Operations
Manager in Charge of Cybercrime Investigations for
FDA-OCI
Gg Levine, MS, Policy and Communications Project
Manager, National Association of Boards of Pharmacy
Bryan A. Liang, MD, PhD, JD, Professor of
Anesthesiology and Director of San Diego Center for
Patient Safety at the University of California, San Diego
School of Medicine. PSM Board Member

2. Illicit Online Pharmacies –
A Contextual Review
Bryan A. Liang, MD, PhD, JD
Vice President, Partnership for Safe Medicines
Director, San Diego Center for Patient Safety,
UC San Diego School of Medicine
Interchange 2013
October 24, 2013

3. State:
The Role of Pharmacy Boards
•
In the US, pharmacy regulation is primarily
through state-level boards of pharmacy that:
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Write pharmacy rules and regulations;
License pharmacists and pharmacies;
Inspect pharmacies;
Investigate complaints; and
Discipline noncompliant pharmacists and
pharmacies.

4. Feds: The Role of FDA
• FDA protects the public health by:
Drugs—Safety and Efficacy: ―Ensuring that human and
veterinary drugs, and vaccines and other biological
products and medical devices intended for human use
are safe and effective‖
✦ Drugs, Cosmetics and Supplements—Safety and
Correct Labeling: ―Assuring [products] are safe and
properly labeled.‖
✦
• Important Distinction:
The FDA does not regulate pharmacies,
only the products they sell.

5. Difficult Oversight:
Regulation of Internet Pharmacies
Big Problem:
• 2006: FDA warns consumers about the dangers of ―Canadian‖
online drug sellers.
• FDA Warns Consumers Not to Buy or Use Prescription Drugs from Various
Canadian Websites that Apparently Sell Counterfeit Products,
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01441.html
• 2007: FDA warns consumers about misrepresented drugs
online.
• FDA Alerts Consumers to Unsafe, Misrepresented Drugs
Purchased Over the Internet
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01564.html
• 2008: Federal Ryan Haight Online Consumer Protection Act
passed; MN State Justin’ Law passed.

6. Difficult Oversight:
Regulation of Internet Pharmacies
Problem still not solved—expansion:
•2009: Search engine marketing allows for illicit online sales,
including sponsored links.
•2011: Social media use first reported for illicit online pharmacy
marketing.
•2012: Illicit online marketing extends to virtually all medicines in
shortage globally.
•2013: Combination of search engine and social media first
reported to fuel illicit online sales.
•2013: Illegal online sales now extend to unreleased products
(Belviq).
•2014?

7. Third Party Programs: Active Verification
of Legitimate Pharmacies
NABP - The VIPPS Program
• VIPPS: Verified Internet Pharmacy Practice Sites
(VIPPS) program.
• High Standards: Industry’s toughest accreditation
program
• Public-Private Coalition: Developed by broad array of
stakeholders: state and federal regulatory
associations, professional associations, and consumer
advocacy groups.

8. Third Party Programs: Active Verification
of Legitimate Pharmacies
Legitscript
• Founded in 2007 by John Horton (former Associate
Deputy Director of the White House’s Office of National
Drug Control Policy)
• Classifies online pharmacies as ―legitimate‖,
―unapproved‖, ―unverified‖ and ―rogue‖
• Rigorous certification standards

9. Consumer Knowledge Base: FDA
Consumers buy from online storefronts with no
understanding that:
● drugs
are unregulated by any source
● drugs
claiming to be from Canada and other ―Tier
One‖ countries may come from anywhere in the
world
● drug
importation online or otherwise is illegal
● Legitimate
generic drugs and prescription assistance
programs offer safer and potentially cheaper options
for medicines.
FDA Says Consumers Continue to Buy Risky Drugs Online: Self-medication a concern;
FDA-approved generics may be cheaper alternative, http://
www.fda.gov/bbs/topics/NEWS/2007/NEW01735.html

10. Consumer Behavior: Research
Patients cannot distinguish safe pharmacy
websites from fake ones.
• 2010 Study: One quarter of 1,914 college students
unable to spot danger signs on fake pharmacy
websites.
• This was true even for those who were studying in
healthcare fields.
Ilana Vanitskaya, et al, ―Dirt Cheap and Without Prescription:
How Susceptible Are Young Us Consumers To
Purchasing Drugs From Rogue Internet Pharmacies?‖
J Med Internet Res. 2010;12(2): E11.

11. Consumer Behavior: Research
Patients are drawn to no-prescription sites,
despite risks.
•Social media is very effective for illicit sales and
unmonitored, expanding past search engines.
• Costless Entry and Sustained Marketing: dummy noprescription online pharmacy marketing on social media sites
(Facebook; Twitter; MySpace) over a 10-month period
garnered nearly 3,000 unique users from US, EU, emerging
markets, and low and middle income countries.
• No Oversight: At present, one year later fake online
pharmacy sites still up and obtaining hits.
Mackey TK, Liang BA. Global Reach Of Direct-To-Consumer Advertising Using Social Media
For Illicit Online Drug Sales. J.Med Internet Res. 2013 Sept 12; 15(5):e105.

12. Consumer Behavior: Research
Consumers can buy dangerous medicines w/o
prescriptions that require close provider
oversight.
• NTI Drugs: Narrow therapeutic index drugs (NTIs)
must be closely monitored because their therapeutic
doses are close to toxic doses.
• Unfettered Availability: NTI drugs are readily
available through online pharmacies without a
prescription.
Liang BA, Mackey TK, Lovett KM. Illegal "no prescription" internet access
to narrow therapeutic index drugs. Clin Ther. 2013;35(5):694-700.

13. Discussion: Panelists
Amelia Arnold, PharmD, Maine Pharmacist
Daniel Burke, MCJ, Special Agent, Senior Operations
Manager in Charge of Cybercrime Investigations for
FDA-OCI
Gg Levine, MS, Policy and Communications Project
Manager, National Association of Boards of
Pharmacy
Bryan A. Liang, MD, PhD, JD, Professor of
Anesthesiology and Director of San Diego Center for
Patient Safety at the University of California, San
Diego School of Medicine, PSM Board Member