In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.

1. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Counterfeit Drugs in America:
2017 Overview
Shabbir Imber Safdar
Director of National Outreach
Partnership for Safe Medicines
shabbir@safemedicines.org

2. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
PSM Members
Academy of Managed Care Pharmacy
Alaska Pharmacists Association
The ALS Association
American Association for Homecare
American College Health Association
American Pharmacists Association
American Society of Health System Pharmacists
Arizona Pharmacy Alliance (AzPA)
Association of Nurses in AIDS Care
BioForward
Biotechnology Industry Organization
California Healthcare Institute
California Pharmacists Association
California Society of Health-System Pharmacists
(CSHP)
Colorado Bioscience Association
Community Access National Network
The Council for Affordable Health Insurance
European Federation of Pharmaceutical Industries
and Associations (EFPIA)
Generic Pharmaceutical Association
Global Medicines Program
Healthcare Distribution Management Association
HealthCare Institute of New Jersey
Healthcare Leadership Council
The Hispanic Institute
Illinois Pharmacists Association
Institute of Health Law Studies
Institute for Safe Medication Practices
International Anti-Counterfeiting Coalition
International Federation of Pharmaceutical
Manufacturers and Associations
Kidney Cancer Association
The Latino Coalition
The Life Raft Group
Maine Pharmacists Association
Maine Society of Health-System Pharmacists
(MSHP)
Maryland Pharmacists Association
Men’s Health Network
Minnesota Pharmacists Association
Missouri Pharmacy Association
National Alliance for Hispanic Health
National Alliance On Mental Illness
Maryland Pharmacists Association
National Association of Boards of Pharmacy
National Association of Chain Drug Stores
National Association of Drug Diversion
Investigators
National Association of Manufacturers
National Alliance of State Pharmacy Associations
National Biopharmaceutical Security Council
National Community Pharmacists Association
National Grange of the Patrons of Husbandry
National Latina Health Network
NeedyMeds
New York State Council of Health-system
Pharmacists (NYSCHP)
North Carolina Association of Pharmacists
Oklahoma Pharmacists Association
Parenteral Drug Association
PDMA Alliance
Pennsylvania Pharmacists Association
Pennsylvania Society of Health-system
Pharmacists
Pharmaceutical Industry Labor Management
Association (PILMA)
Pharmaceutical Security Institute.
PhRMA
RetireSafe
San Diego Center for Patient Safety
Spina Bifida Association of America
Texas Pharmacy Association
Texas Society of Health-System Pharmacists
United States Chamber of Commerce
University of New England College of Pharmacy
University of Texas Pharmacy School
Vietnam Veterans of America
Virginia Pharmacists Association
Vermont Pharmacists Association
West Virginia Rx
WomenHeart
To have your nonprofit join
PSM, contact
shabbir@safemedicines.org

3. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Agenda
• Counterfeit drugs in America today
• Myths and facts about drug importation
proposals
• Recommended techniques for saving money
safely on prescriptions
• Q&A

4. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
 Wholesalers forge documentation of legitimacy for
counterfeit drugs and pass off as authentic.
 Doctors and pharmacists purchase from counterfeit
drug distributors.
 Stolen and partially used medications are re-sold as
unused, untampered drugs through clearinghouses
back to into the legitimate supply chain.
Counterfeit medicine raid - Heilongjiang Province, China – May 22, 2014

5. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter

6. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
What could be in the confiscated
drugs?

7. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Counterfeits made with fentanyl
• Americans in 30 states across
the US have died from
counterfeit prescription drugs
made with lethal doses of
fentanyl in the last 24
months.
• This includes musician Prince,
who was found with
counterfeit hydrocodone pills
made with fentanyl.
Fatal doses of heroin and fentanyl
Photo: New Hampshire State Police Crime Lab
Counterfeits with fentanyl are
tracked by our team at:
http://safedr.ug/fentanylpills

8. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Counterfeit cosmetic injectables
Since 2012, the FDA has warned 2,234 medical
practices in 49 states that they have done business
with unlicensed distributors.
This is a radiograph of a 30 year old
female who died after an illegal
cosmetic injectable containing silicon
leaked through her bloodstream into
her lungs. The silicon particulate shut
down her lungs.

9. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Black market IUDs
Patients typically do not see the IUD before it’s surgically inserted. Nor do
they have the ability to check it or remove it should they become
concerned.
Doctors and clinics in 45 states (in
red) received warnings from the
FDA about purchasing fake IUDs.
Doctors and clinics in 8 states (in
orange) were convicted trafficking
in fake IUDs.

10. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Black market oncology medication
The unlicensed wholesalers that
trafficked in Betty Hunter’s fake oncology
medication were finally sentenced in
2014, three years after her death in 2011.
The problem is far from solved. Since
2012, the FDA has warned 1,205 medical
practices in 47 states and the District of
Columbia that they had done business
with unlicensed distributors who had
been found selling counterfeit oncology
medication.
Betty Hunter before her death in 2011 (top)
Betty Hunter’s son describes his mother’s
gruesome reaction to her untreated cancer for
the TV Special “Lethal Fake Medicine” by
Bullitt Film (bottom)

11. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
MYTHS AND FACTS ABOUT DRUG
IMPORTATION

12. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Myth: “Canadian websites sell Canadian drugs.”
• It’s not legal for a Canadian pharmacist to
dispense medication to an American without a
Canadian doctor’s prescription.
• What you may get is a drug that was bought on
the black market from a third world factory, not
one from the Canadian drug supply.
• Canadian bricks and mortar pharmacy regulators
do not permit any Canadian online pharmacy to
sell/ship to Americans. If you’re ordering from
one, it’s likely not a Canadian pharmacy.

13. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Myth: “Canadian websites sell Canadian drugs.”
• It’s not legal for a Canadian pharmacist to
dispense medication to an American without a
Canadian doctor’s prescription.
• What you may get is a drug that was bought on
the black market from a third world factory, not
one from the Canadian drug supply.
• Canadian bricks and mortar pharmacy regulators
do not permit any Canadian online pharmacy to
sell/ship to Americans. If you’re ordering from
one, it’s likely not a Canadian pharmacy.

14. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Myth: “This is a partisan political issue.”

15. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Myth: “I got a package from Canada, it must be
safe.”
• We have found that orders places from so-
called “Canadian websites” are often sourced
from Turkey, India, or somewhere else.
• But when you do get a package from Canada,
it probably has been trans-shipped through
Canada without passing Canadian Customs.
• Health Canada (their FDA) does not inspect
trans-shipped packages.

16. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Myth: “Criminal penalties will deter foreign
criminals from selling counterfeits to
Americans.”
• In 2015 executives from CanadaDrugs.com were
indicted for a $78 million conspiracy to sell
medications not approved by the FDA to
Americans, including oncology drugs.
• The FDA intercepted some of their medications
and lab-tested them. They were fake.
• These executives remain at large in Canada today,
operating their fake internet pharmacy site selling
to Americans.

17. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Myth: “Canadians are happy to have Americans
participate in their healthcare system.”
“We urge Americans not to raid Canada's
pharmacies to try and buy cheaper medicines.
Our mothers, fathers, siblings, and kids will all be
further harmed by this.
Furthermore many generic drugs are cheaper in
America than they are in Canada.”
-Linda Wilhelm, Canadian Arthritis Patient Alliance (2016)
Similar statements are available from Canadian patient
advocates in the asthma, cancer, epilepsy, hemophilia,
kidney, lymphoma, and Parkinson’s community.

18. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Myth: “I can tell that my medication is
working.”
• Not even trained pharmacists
can determine whether a real
medication is fake without lab
tests.
• Criminals have access to
blister packs, litho printing,
and even security holograms.
• Sometimes a small amount of
active ingredient is used to
fool chemical screens. It’s not
enough to treat your disease.
Professor Kenneth ‘Mac’
McCall, University of New
England Pharmacy School

19. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
• In November 2013, then-
Maine Pharmacy Association
President Kenneth "Mac"
McCall saw an ad from
Canada Drug Center in the
newspaper.
• The pharmacy's website bore
"certifications" from that
make it look legitimate to
consumers.
What if you really bought it?

20. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
“A deal too good to be true.”
• McCall wanted to know what Canada Drug
Center was selling. He ordered three widely
used generic maintenance medications for
heart disease, inflammation and acid reflux.
• The pharmacy assigned him a Canadian doctor,
asked him to waive any liability for bad
outcomes, and mailed him the drugs.

21. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
“A deal too good to be true.”
• What he got was not what the patient needed.
•Esomeprazole (the generic of Nexium,
which treats acid reflux disease)
• INSUFFICIENT ACTIVE INGREDIENT.
ONLY 58% OF THE PRESCRIPTION DOSAGE.

22. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
“A deal too good to be true.”
• What he got was not what the patient needed.
•Celecoxib (the generic of Celebrex,
an anti-inflammatory)
• INSUFFICIENT ACTIVE INGREDIENT.
23% LESS THAN THAN PRESCRIPTION DOSAGE

23. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
“A deal too good to be true.”
What he got was not what the patient needed.
•Clopidogrel (the generic of Plavix,
a blood thinner)
CONTAMINATED!
The Clopivas product contained an unknown
contaminant. (Possibly methyl chloride, known to
exhibit genotoxic properties.)

24. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
SAVING MONEY SAFELY

25. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Saving Money Safely – Consumer Reports Advice
Shop around, but then
talk to your local
pharmacist about price
matching and keep all
your medications there
for safety.
“[Local] pharmacists [...]
have more flexibility to
match or beat
competitor’s prices.”
One CR survey in Raleigh, NC found
a price range of $43 to $220 for the
same dose of a generic.

26. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Use medication assistance programs
www.needymeds.org
www.pparx.org
NeedyMeds provides a free prescription discount
card that can be used in all 50 states in the US.
The Partnership for Prescription Assistance® may
help patients who are uninsured or underinsured
access the medicines they need through the
program that is right for them – free of charge. Many
patients will get their medications for free or nearly
free.

27. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
Use US web pharmacies
• Some US web pharmacies can
have discounts that you can then
price match with your local
pharmacist.
• Look for a pharmacy website
that ends in .pharmacy or has
the VIPPS logo
• See
https://nabp.pharmacy/program
s/vipps/ for more info

28. Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter
What you can do to protect yourself
and your patient community
• Sign our letter to Congress to
protect the US drug supply:
http://safedr.ug/feb2017-letter
• Join the Partnership for Safe
Medicines and let us provide you
with free educational materials for
your community by emailing me at
shabbir@safemedicines.org.
• Q&A