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The Impact of Fake 
Online Pharmacies on 
Patient Safety 
Libby Baney, J.D., Executive Director, ASOP 
Partnership for Safe Medicines Interchange 
September 18, 2014
What We Know: Data 
• 40,000-50,000 active online drug sellers 
operating globally (LegitScript) 
• 97% of online drug seller sites are operating 
in violation of applicable laws (NABP) 
• 50% of the prescription medicines sold online 
by websites that hide their physical address 
are counterfeit (WHO)
What We Know: Data 
Illegal online drug sellers are the most frequent 
conduit of counterfeit drugs (NABP) 
23% of adult Internet consumers surveyed 
have bought prescription medicine online (US 
FDA) 
Illegal online drug sellers can make $1 million 
and $2.5 million in sales each month (MIT)
Risks to Patient Safety: 
Illegal online drug sellers: 
1. Sell prescription-only medicines 
without a valid prescription. 
2. Sell unapproved, adulterated, 
misbranded or counterfeit drugs 
3. Do not have the required 
pharmacy license in 
the jurisdictions it ships drugs to.
Headlines from August and September 2014
Examples of Patients Harmed 
Lorna Lambden 
No medical exam; bought unapproved sleeping pills 
Died from drug interaction 
Marcia Bergeron 
Fake drugs bought from illicit online pharmacy 
Heavy metal poisoning (lead, titanium, arsenic) 
Steven Kovacs 
Bought prescription drugs online without a prescription 
Overdosed and died / no medical supervision
So, where is the bright side?
Five Signs We Are Making An Impact
Five Signs We Are Making An Impact 
1. Internet commerce companies agree to take voluntary 
action against illegal online drug sellers 
• Visa issues Internet Pharmacy Guide for Acquirers 
• CSIP issues Principles of Participation 
• Realtime Register B.V. (Netherlands) changes practices 
Top 10 Registrars Harboring Rogue Pharmacies 
1. TodayNIC (China) 
2. BizCN (China) 
3. Gransy (Czech Republic) 
4. Joker.com (Germany) 
5. Momentous Group/Rebel.com (Canada) 
6. Paknic (Pakistan) 
7. WebNIC.cc (Malaysia) 
8. Dattatec (Argentina) 
9. IPMirror (Singapore) 
10. Domain.com (US)
Five Signs We Are Making An Impact 
2. Transatlantic IPR Working Group prioritizes Internet 
pharmacies 
3. APEC creates an Internet Sales Working Group 
• ASOP helps lead engagement with 21 economies
Five Signs We Are Making an Impact 
4. DotPharmacy launches (Fall 2014) 
5. ASOP raises public awareness 
• ASOP issuing a CME/CPE program with the Federation of State 
Medical Boards 
• ASOP and CSIP run a search advertising campaign: 
5.5+ million hits to date 
• ASOP speaks at 20+ events annually
ASOP is a nonprofit organization with the mission to protect patient safety globally 
Federation of State Medical 
Boards 
National Health Council 
National Association of 
Boards of Pharmacy 
PhRMA 
Partnership for Safe 
Medicines 
Rx-360 
APhA 
LegitScript 
Amgen 
Merck 
Boehringer Ingelheim 
Men’s Health Network 
Consumer Healthcare 
Information Corp 
NACDS 
Eli Lilly & Company 
NeedyMeds 
ASOP Observers 
MEMBERS 
EAASM 
NOVA ScriptCentral 
GPhA 
Takeda 
International Pharmaceutical 
Federation 
Italian Medicines Agency 
Partnership for Drug-Free 
Kids 
U.S. Pharmacopeia 
Convention

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PSM Interchange 2014 Panel 3, Libby Baney, The Impact of Fake Online Pharmacies on Patient Safety

  • 1. The Impact of Fake Online Pharmacies on Patient Safety Libby Baney, J.D., Executive Director, ASOP Partnership for Safe Medicines Interchange September 18, 2014
  • 2.
  • 3. What We Know: Data • 40,000-50,000 active online drug sellers operating globally (LegitScript) • 97% of online drug seller sites are operating in violation of applicable laws (NABP) • 50% of the prescription medicines sold online by websites that hide their physical address are counterfeit (WHO)
  • 4. What We Know: Data Illegal online drug sellers are the most frequent conduit of counterfeit drugs (NABP) 23% of adult Internet consumers surveyed have bought prescription medicine online (US FDA) Illegal online drug sellers can make $1 million and $2.5 million in sales each month (MIT)
  • 5. Risks to Patient Safety: Illegal online drug sellers: 1. Sell prescription-only medicines without a valid prescription. 2. Sell unapproved, adulterated, misbranded or counterfeit drugs 3. Do not have the required pharmacy license in the jurisdictions it ships drugs to.
  • 6. Headlines from August and September 2014
  • 7. Examples of Patients Harmed Lorna Lambden No medical exam; bought unapproved sleeping pills Died from drug interaction Marcia Bergeron Fake drugs bought from illicit online pharmacy Heavy metal poisoning (lead, titanium, arsenic) Steven Kovacs Bought prescription drugs online without a prescription Overdosed and died / no medical supervision
  • 8. So, where is the bright side?
  • 9. Five Signs We Are Making An Impact
  • 10. Five Signs We Are Making An Impact 1. Internet commerce companies agree to take voluntary action against illegal online drug sellers • Visa issues Internet Pharmacy Guide for Acquirers • CSIP issues Principles of Participation • Realtime Register B.V. (Netherlands) changes practices Top 10 Registrars Harboring Rogue Pharmacies 1. TodayNIC (China) 2. BizCN (China) 3. Gransy (Czech Republic) 4. Joker.com (Germany) 5. Momentous Group/Rebel.com (Canada) 6. Paknic (Pakistan) 7. WebNIC.cc (Malaysia) 8. Dattatec (Argentina) 9. IPMirror (Singapore) 10. Domain.com (US)
  • 11. Five Signs We Are Making An Impact 2. Transatlantic IPR Working Group prioritizes Internet pharmacies 3. APEC creates an Internet Sales Working Group • ASOP helps lead engagement with 21 economies
  • 12. Five Signs We Are Making an Impact 4. DotPharmacy launches (Fall 2014) 5. ASOP raises public awareness • ASOP issuing a CME/CPE program with the Federation of State Medical Boards • ASOP and CSIP run a search advertising campaign: 5.5+ million hits to date • ASOP speaks at 20+ events annually
  • 13. ASOP is a nonprofit organization with the mission to protect patient safety globally Federation of State Medical Boards National Health Council National Association of Boards of Pharmacy PhRMA Partnership for Safe Medicines Rx-360 APhA LegitScript Amgen Merck Boehringer Ingelheim Men’s Health Network Consumer Healthcare Information Corp NACDS Eli Lilly & Company NeedyMeds ASOP Observers MEMBERS EAASM NOVA ScriptCentral GPhA Takeda International Pharmaceutical Federation Italian Medicines Agency Partnership for Drug-Free Kids U.S. Pharmacopeia Convention