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Panel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy Issues

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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
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
State:
The Role of Pharmacy Boards
•

In the US, pharmacy regulation is primarily
through state-level boards of pharmacy that:
●
●
●
●
●

Write pharmacy rules and regulations;
License pharmacists and pharmacies;
Inspect pharmacies;
Investigate complaints; and
Discipline noncompliant pharmacists and
pharmacies.
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.
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.
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?
Ad

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Panel 2 Moderated by Dr. Bryan Liang Overview of Fake Online Pharmacy Issues

  • 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: ● ● ● ● ● 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