This presentation is designed to train patient advocates in the safety issues around counterfeit drugs: how counterfeits enter our supply chain and how patients can protect themselves.

1. BUYING MEDICATIONS ONLINE: HOW
TO DO IT SAFELY AND AFFORDABLY
Shabbir Imber Safdar, Director, National Outreach
Partnership for Safe Medicines

2. How American Patients Are Protected
• Regulated, closed, secure supply chain, covering:
– Pharmacists and pharmacies
– Nurses, Physicians
– Wholesalers & Manufacturers
• FDA testing of medications
• FDA pharmacovigilance programs
• Physician/Pharmacist supervision of medication choices and
protocol
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. Where and how the supply chain breaks
• Common: patients break it
– Buying online from a non-VIPPS pharmacy
– Buying from an offline non-pharmacy (in the US or
outside)
• Less common:
– Physicians buying from unlicensed distributors
– Pharmacists buying from unlicensed distributors
• Uncommon:
– Manufacturing supply chain producer

4. 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

5. 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.

6. 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.

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

8. 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.

9. Fax advertisements offer unrealistic discounts
on expensive and popular medications.
The doctors aren’t passing those savings on to
their patients, nor are they letting them know
where they got the medication from.
States with doctors warned about unapproved
medications by the FDA.
Botox
Avastin
Altuzan
Aclasta
Prolia

10. Map graphic courtesy of the Wall Street Journal.

11. Pharmacist with fakes
A Chicago pharmacist was substituting Chinese
counterfeits for authentic drugs through his pharmacy.
(April 2013)
A pharmacy chain purchased over $1 million in stolen HIV
medication and sold to Medicare patients (May 2012)
11 heart disease patients died, 4 attributed, from
counterfeit heart medication. Canadian pharmacist was
purchasing and distributing talcum powder pills instead of
life-saving medication (September 2005)

12. UK pharmacy with fakes
• In Wales, four people were sentenced for
distributing counterfeit drugs, manufactured in
Pakistan, all over Europe. (April 2013)
• 70,000 packs of counterfeit life-saving drugs in UK
pharmacies – cancer, stroke, schizophrenia
(June 2007)
• The fifth most likely country in which you will find
counterfeit drugs is the UK. (April 2013 United
Nations Office on Drugs and Crime report)

13. 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.

14. Many “Canadian” Websites, Few Actual
Vendors, None Canadian Pharmacies

16. 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.

17. Myths: You are protected when buying from a
Canadian online pharmacy by the Canadian FDA
Additionally medicines that are shipped between countries
aren't required to be inspected for authenticity.
Health Canada isn't going to check to make sure the
medicines you receive are authentic, neither are the
governments of any other country and that is most likely
where your packages are coming from anyway.

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

19. Myth: Canadian pharmacists cannot
legally fill American prescriptions
• 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.

20. 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.”

21. 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.

23. 5 separate
prosecutions of fake
medications sold via
fake online pharmacies
in 2012
Fake Adderall contained
Tramadol and acetominophen
Fake Vicodin contained NSAIDs
One case alone
estimated $95 million
in fraud selling
unapproved
drugs to Americans
What ELSE are we getting?

24. Ok, I’m scared.
• How do I stay safe if I’m not in control where
the medication comes from?
• How do I stay safe but still save money?

25. 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.

26. 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
This is one of the 26 images
from our upcoming
“consumer safety tips”
campaign that you can be a
part of.

27. 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

28. 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.

29. Handout resources at PSM
• 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)
• A Risky Proposition: Opening The US To Foreign Medicines
Will Put American Children At Heightened Risk (brochure)
• Other?

30. 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