June 19, 2013: This presentation to highlight the dangers of counterfeit drugs to Maine patients was given to the Bangor Dept. of Health Public Advisory committee

1. COUNTERFEIT MEDICATION: THE
IMMEDIATE DANGER TO MAINE PATIENTS
AND HOW TO PROTECT THEM
Felicity Homsted, PharmD, BCPS
Directory of Pharmacy at Penobscot Community Health Care
Shabbir Imber Safdar
Director, National Outreach at 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 and company 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. How patients are endangered from
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, pharmacists, and distributors buying
from unlicensed distributors
• Uncommon:
– Manufacturing supply chain producer

4. 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: 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

7. 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.

8. How good are the fakes?
Authentic and Fake Lipitor

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

10. Patient story: Fake IUDs in Kentucky
In March 2013, a Kentucky OB-GYN
was charged with buying
counterfeit non-FDA-approved
birth control devices from an
unregulated foreign supplier over
the Internet for a discount. The
indictment claims that for over a
year he then implanted them into
women and billed back insurance
for a normal (higher) cost.
If convicted, Canh Jeff Vo
faces fines of as much as
$3 million and a
maximum sentence of
233 years in prison.

11. 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.

12. 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.

13. Map graphic courtesy of the Wall Street Journal.

14. Patient story: Chicago, Illinois
Michael Markiewicz, a
pharmacist/pharmacy owner in Chicago,
Illinois was buying counterfeit medication
from China and filling prescriptions with it
for his customers.
He was charged in 2013 indictment he was
charged with eight counts of violating the
federal Food, Drug and Cosmetic Act, four
counts of trafficking in counterfeit drugs,
and three counts of smuggling.
His store remains open as a nutrition and
herb retailer.
The medications were ordered over the
Internet and then delivered in a package
identified on the customs declaration as
a “gift pen”.
Trafficking counterfeit drugs carries a maximum penalty of 20 years in prison and a $2
million fine.

15. UK pharmacies selling fakes to
Americans
• In June 2013 two men from the UK were
extradited to the US to face charges of selling
Americans drugs from their online pharmacy that
promised US citizens drugs from the UK.
• The real source of the medication was Pakistan
(steroids, Xanax, Valium, Ativan, and Klonapin).
• 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)

16. 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.

17. 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.

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

19. 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.

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. How do we protect patients?
• Teach patients
– how to address issues of cost without endangering
their safety.
– how to access affordable medications locally
– how to spot safe online options (proactive not
prohibitive message).
– the warning signs of non-FDA-approved medication so
they might spot them in a clinic setting.
• Teach healthcare professionals about the danger
and legal liability of breaking the secure supply
chain.

22. Affordable Care Programs
• Federal funding- ensures access to services
• Program Enrollment – at the health center
• Qualifying patients Receive
– Discounted health care services
– Discounted medication
– Access to other programs, including pharmacy run
prescription assistance programs

23. Patients Assistance Programs
• For qualifying patients, many drug
manufacturers offer discounted or free
medication through Bangor pharmacies.
• Types of Programs
– Pharmacy
– Health Center
– Other

24. PCHC Rx.AP Navigator Program
• Rx.AP Navigators for each site
• Coordinate prescription assistance application
– Meet with patient, gather needed application
components, submit applications,
• Coordinate medication delivery
• Troubleshoot issues
• Guide patients to other available services

25. 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.

26. How to save money at higher income
levels?
If you make too much money to qualify for any
of the programs mentioned previously, but you
still face income challenges affording your
medication, what options do you have?
• Comparison shopping (generics and branded
products)
• Discussing generics with your
doctor/pharmacist

27. GoodRX, WeRX, and LowestMed
Mobile apps and website comparison tools show local and mail-order US-licensed
pharmacies and their price differences. Also provide discount cards and coupons that
you can use to reduce your cost.

28. 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

29. 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.

30. 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.

31. What can my patient organization do
to educate our community?
• Have us conduct a webinar dedicated to your
community’s therapeutic or demographic
segment.
• Distribute our handouts to your patient
community.
• Adopt and echo our “patient safety tips”
series. Take 1 or more of our 26 tips and use
them in Facebook, Twitter, Email, or your print
newsletters.

32. 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.

33. Co-branded patient webinar
• We can hold a shorter,
customized joint co-branded
webinar for your patient
community.
• We can highlight the specific
dangers in your therapeutic or
demographic segment.
• The webinar can be recorded so
you can continue to promote it
to your community after it’s
conducted.

34. Infographics and postcards customized
for your community
Men’s Health Network is a very active member of PSM. Our deep commitment to working with each other resulted in this infographic
which is also being used as a large format postcard.

35. Live patient safety event
With active PSM members
we have also done live
events, where we bring
together patient
advocates and safety
experts to talk about
ensuring safety.
PSM Board member Bryan Liang led a
briefing on patient safety and
counterfeit drugs with the FDA and
PSM member the National Association
of Boards of Pharmacy in 2011 in
Washington DC.

36. How can my healthcare professional
association educate our community?
• Have us conduct a webinar dedicated to your
professionals role in medication handling.
• Distribute the LEADERS guide for physicians,
nurses, or pharmacists to your community.
• Adopt and echo our “patient safety tips”
series. Take 1 or more of our 26 tips and use
them in Facebook, Twitter, Email, or your print
newsletters.

37. Questions and Answers
Shabbir Imber Safdar
Director, National Outreach
Partnership for Safe
Medicines
shabbir@safemedicines.org
415-683-7526
Felicity Homstead
Director of Pharmacy
Penobscot Community Health
Care
fhomsted@pchcbangor.org
(207) 992-9200 x539