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

The Impact of Fake Online Pharmacies on

Patient SafetyLibby Baney, J.D., Executive Director, ASOP

Partnership for Safe Medicines InterchangeSeptember 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

Lorna LambdenNo medical exam; bought unapproved sleeping pillsDied from drug interaction

Marcia BergeronFake drugs bought from illicit online pharmacyHeavy metal poisoning (lead, titanium, arsenic)

Steven KovacsBought prescription drugs online without a prescriptionOverdosed and died / no medical supervision

Examples of Patients Harmed

So, where is the bright side?

Five Signs We Are Making An Impact

Five Signs We Are Making An Impact

1. TodayNIC (China)2. BizCN (China)3. Gransy (Czech Republic)4. Joker.com (Germany)5. Momentous Group/Rebel.com (Canada)

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

6. Paknic (Pakistan)7. WebNIC.cc (Malaysia)8. Dattatec (Argentina) 9. IPMirror (Singapore)10. Domain.com (US)

Top 10 Registrars Harboring Rogue Pharmacies

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

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

Federation of State Medical Boards National Health Council

National Association of Boards of Pharmacy PhRMA

Partnership for Safe Medicines

Rx-360

ASOP is a nonprofit organization with the mission to protect patient safety globally

APhALegitScript

Amgen

Merck

Boehringer Ingelheim

Men’s Health Network

Consumer Healthcare Information Corp

NACDS

Eli Lilly & Company

NeedyMeds

ASOP Observers

EAASM

NOVA ScriptCentral

GPhA

Takeda

International Pharmaceutical Federation

Italian Medicines Agency

Partnership for Drug-Free KidsU.S. Pharmacopeia Convention

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