This presentation covered the current threats of counterfeit drugs to Americans.

1. BROKEN PROMISES:
COUNTERFEIT MEDICATION AND
AMERICAN PATIENTS
Shabbir J. Imber Safdar, Director of National Outreach

2. How Patients Are Protected
• Regulated, closed, licensed, secure supply chain, covering:
– Pharmacists and pharmacies
– Nurses, Physicians
– Wholesalers & Manufacturers
• FDA testing of medications
• FDA and company pharmacovigilance programs
• Pharmacist and physician supervision of medication choices and
interactions
Any break in the hand to hand regulatory chain
endangers patients. America is one of the few
countries with a closed, secure, drug supply chain.

3. How patients are endangered from
supply chain breaks
• Common: patients break it
– Buying online from unlicensed pharmacies
• Uncommon:
– Physicians, pharmacists, and distributors buying
from unlicensed distributors
– Manufacturing supply chain producer

4. Myths: Canadian online pharmacies are
pharmacies in Canada with a website
Unless you drive over the border into Canada to
a bricks and mortar pharmacy, when you order
from an online pharmacy you're getting a
company that pretends to sell non-Canadians
price-controlled medications for citizens.
These companies are not regulated by Health
Canada or the Provincial Pharmacy Boards.

5. Myth: Canadian pharmacists can legally
fill prescriptions from US physicians
• Pharmacists in Canada are not allowed to
legally fill a prescription written by an
American physician.
• Therefore if a “Canadian pharmacy” tells an
American to fax their prescription in, they’re
either breaking laws in their own country, or
there’s no pharmacist involved at all.

6. Myths: Canadian online pharmacies sell
price-controlled medication from Canada
Canadian citizen Andrew Strempler,
38, sentenced January 9th, 2013 to
4 years after pleading guilty to
conspiracy to commit mail fraud.
Strempler’s company, Mediplan,
fulfilled online medicine orders for
ten different online pharmacies.
FDA discovered that 90% of the drugs they seized from a Mediplan shipment were
counterfeit: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the
US), Crestor, Celebrex, Arimidex, and Propecia.
These were not Canadian medicines, they were fakes from all over the world,
mailed from the Bahamas, with labels saying they were filled from Canada.

8. So, where do the fake pharmacies get
their medications?
These products are not made in a sterile environment. And then these fakes are sold
to American patients from “Canadian pharmacies” who ingest them.

9. Patient story: Buying meds online isn’t
like buying socks
(where’s the cheapest price?)
• Even if it’s an over-the-
counter medicine, it’s still
medicine.
• Victims purchased over-
the-counter weight loss
medication from a website,
"www.2daydietshopping.co
m."
• Purchasers reported many
life-threatening side effects
including stroke.
• 2 people were convicted in
2011.
Containing sibutramine, a
prescription-only ingredient,
the pills could lead to
• elevated blood pressure
• stroke
• heart attack
• anxiety
• nausea
• heart palpitations
• a racing heart
• insomnia
• increases in blood pressure

10. Patient story: Lorna Lambden
Even getting real medication can be deadly
She bought medication online without a
prescription and without a pharmacist to
inform her.
Said her family: “Lorna died after taking a
small amount of medication which she had
purchased on the internet to help with
tiredness and sleeping. This medication
turned out to be exceptionally dangerous.
The Coroner thought Lorna’s death was a
tragic accident. Please can this be a warning
to anyone purchasing prescription drugs on
the internet!”
Lorna Lambden, 27, ordered from
an online pharmacy ended up
receiving a very powerful sleeping
aid without any safety instructions.

11. 97% of more
than 10,000
websites
sampled were
out of
compliance
with laws and
pharmacy
practice
standards.
1 in 6
Americans buy
drugs on the
Internet
without a
prescription.

12. Map graphic courtesy of the Wall Street Journal.

13. Doctors have been found with
misbranded drugs
In the past year alone…
• Cancer drugs – 134 doctors in
28 states
• Osteoporosis – 20 doctors in 10
states
• Botox – 350 doctors in 38 states
Fragile biologics that require
in-clinic use and careful storage are
becoming new targets for
counterfeiters.
The clear liquid could be
medication, or it could be saline.

14. YouTube videos and
cartoons teach IUD
and implant
insertion and
removal,
despite the risk of
infection and death.

15. First occurrence: fake devices
Two physicians in
Kentucky were
recently indicted
for purchasing IUDs
bought from an
unlicensed Chinese
manufacturer and
implanting them in
patients.

16. Myth: You or your doctor can bill
insurance back for imported drugs
The government prosecutes people and physicians who commit fraud
by billing government health programs for misbranded drugs. One
doctor paid $1 million in fines.
As Gerald T. Roy, of the Kansas City Regional Office of Investigations for
the Department of Health and Human Services stated last year, “These
investigations and their outcomes not only protect the taxpayer from
waste, fraud and abuse but, more importantly, insure our Beneficiaries
are not provided misbranded or adulterated drugs that may adversely
impact their health.
We will continue to aggressively pursue those who seek to defraud
the Medicare and Medicaid programs by administering non- FDA
approved products and services.”

17. Physician: Johnson City, TN
An oncologist and his office manager
conspired to buy oncology injectables from
an unlicensed wholesaler and deliver them
to patients.
When caught by the head nurse spotting
foreign writing on the vials, they ceased
their activity for 18 months until she left the
practice.
When they restarted they rented a storage
unit as a temporary holding facility and
smuggled the fake medication into the office
at night.
A second physician in Tennessee is under
indictment. Other physicians have plead
guilty in Maryland and Missouri.
The three main doctors with the McLeod
Cancer and Blood Center have since
worked out a restitution settlement with
the U.S. government and State of
Tennessee for a combined $4.4 million.
Dr. Kincaid will also serve two years in
prison.

18. Pharmacist: Ontario, Canada
A pharmacist in Hamilton, Ontario was
arrested in 2005 after 11 people died after
being prescribed Norvasc, a heart
medication. The pharmacist filled their
prescription with pills made only of talcum
powder.
The coroner cited “unauthorized medication
substitution” in four of the deaths.
At trial it was discovered that he bought
medications from a distributor who walked
in off the street and drove a white van.
Several customers pointed out differences
between the medication from this
wholesaler and previous doses acquired
from reputable wholesalers.
The pharmacist was acquitted by a court
in 2007 because prosecutors failed to
prove criminal intent. He sued to get his
pharmacy license back.
According to LinkedIn, he is the
owner/operator of a pharmacy today in
Toronto.

19. Save Money by Using FDA Approved
Generics
Not only can a generic be cheaper than a name brand, but a generic in the US
is usually cheaper than a name brand from a fake “Canadian pharmacy”. And
safer too.

20. Patient Safety: Comparison shop the
VIPPS pharmacies online
VIPPS = Internet
pharmacy that
complies with
state licensing.
Look for the
seal, and find
the list at
http://vipps.info

21. Myths: Canadian medicines are cheaper
• Generics are often cheaper in the US
• Not all Canadian medication is price-
controlled

22. Patient Safety: How to find discounts
The NeedyMeds Drug Discount Card
saves you up to 80% or more off
the cost of:
Prescription Medicines
Over-the-Counter Drugs
Pet Prescription Drugs
The Partnership for Prescription Assistance
will help you find the program that’s right for
you, free of charge.

23. Patient Safety: How to stay safe in the
doctor’s office
• Signs of suspicious medication in
the doctor’s office.
– Look for foreign writing
– Ask to see bottle/bag/unit with lot
number and write it down or take a
photo
• Pay attention to new or unusual
side effects or lack of therapeutic
benefit and notify your
physician/pharmacist.

24. Healthcare provider education

25. Clinic poster for patients

26. Partnering locally – co-branded
handouts

27. Digital outreach to patients
Over a 30 day period, this
advertising ran and was
exposed to 140,000 people
in communities in Virginia
where our partner has free
health clinics.

28. Distribute our resources to your
community
• Save Money Safely on Your Prescriptions from Online
Pharmacies (brochure)
• Learn 5 Kinds of Poisons Found in Counterfeit
Medicines (interactive)
• The 5 Secrets Canadian Web Pharmacies Don’t Want
You to Know (webpage)
• SAFEDDRUG: An 8 Step Checklist for Medicine Safety
(brochure)
• Safe Savings: Tips for Saving Money on Medicine Safely
(brochure)
• We can also design a custom patient safety handout
for your community.

29. Questions and Answers
Our members conduct joint education projects with us to
improve patient safety in their communities. Our
members include groups that represent patients,
pharmacists, physicians, nurses, distributors and
manufacturers.
To start educating your community, contact:
Shabbir Imber Safdar
Director, National Outreach
shabbir@safemedicines.org
415-683-7526