Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers. Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.

1. COUNTERFEIT DRUGS 101 FOR
HEALTHCARE PROFESSIONALS
Tom Kubic, President and CEO of the Pharmaceutical Security Institute
and Treasurer of the Partnership for Safe Medicines
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 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 (but getting more common):
– Physicians, pharmacists, and distributors buying
from unlicensed distributors
• Uncommon:
– Manufacturing supply chain producer

4. How often are medicines counterfeited?
Where do they come from?
What’s counterfeited?

5. 2012 Situation Report
Industry’s assessment of worldwide pharmaceutical crime

6. How Often?
• 7,844 incidents – 2012
• 5,242 incidents – 2011
• 49.6% increase in reported incidents
• 2,504 reports, studies, summaries reviewed

7. Incident Trends
• 2,018 unique incidents* – 1.6% increase
• 1,664 counterfeiting incidents – 2.2% increase
• 327 illegal diversion incidents – virtually even
• 27 major theft incidents – v. 33 in 2011
*Unique incidents are less than reported incidents as PSI staff
link related incidents as part of their analytical reviews.

8. Where do fake medicines come from?
123 Countries with identified incidents:
218 Illegal manufacturing operations since 2009
These products are not made in a sterile environment.
Sold to American patients from “Canadian pharmacies”

9. Incidents by Region

10. Incidents by Country

11. What’s being counterfeited?
523 different drugs
53 different drugs in one case
Genito-urinary, anti-infectives, CNS
Tablets/Cap. 86%; Injectables 10%
Increase TC - Hormones

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

13. Patient story: Fake IUDs in Kentucky
3/2013, a Kentucky OB-GYN was charged
with buying counterfeit non-FDA-approved
birth control devices from an unregulated
foreign supplier over the Internet.
• The indictment claims that for over a
year he billed insurance for the cost of
genuine devices.
• If convicted, Canh Jeff Vo faces fines of
as much as $3 million and a maximum
sentence of 233 years in prison.

14. Physicians and their staff are the new
weak link in the supply chain
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.

15. Myths: Canadian online pharmacies sell
price-controlled medication from Canada
1/9/2013 Canadian Andrew Strempler,
sentenced to 4 years after pleading guilty
to conspiracy to commit mail fraud.
•He used ten different online pharmacies to
fill orders.
•FDA discovered that 90% of the drugs they
seized from a Mediplan shipment were
counterfeit
•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.

16. Map graphic courtesy of the Wall Street Journal.

17. Oncologists paying steep prices for
their mistakes
• Dr. Wm Kincaid (TN): 2 years prison, $2.55M civil
claims. His fellow oncologists fined $850k each.
Office manager Mr. Combs plead guilty.
• Dr. Abid Nisar (MO): Forfeited $1m for false
Medicare/Medicaid claims - two years probation.
Seven year ban from gov’t programs for 7 years.
• FDA warned over 100 physicians that they may
have done business with unlicensed suppliers and
broken the law.

18. 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, Kansas City Regional OI, DHHS 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.”

19. And even pharmacists…
Michael Markiewicz, a Chicago pharmacist
bought counterfeit medication from China
and filled prescriptions with them.
2013 - 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.
Medications ordered online and declared as
“gift pens”
Trafficking c/f drugs carries a maximum
penalty of 20 years and a $2 M fine.

20. Nurses play a role in patient safety
• In Dr. Kincaid’s case, the first
introduction of illegally acquired
medication was spotted by the leader
of the nursing team who ensured the
practice was stopped.
• After she left the cancer center 18
months later for another job, the
practice of illegally acquiring and
administering non-FDA appoved
medication resumed.
Dr. William Kincaid
at the courthouse in
December 2012

21. Doctors giving dangerous advice
Ali Baney a Colorado resident in 2009 whose doctor told
her to go online to buy medication to save money. She
received a counterfeit and suffered life-threatening side
effects.
Rachael Jablo, a San Francisco resident, provided PSM an
affidavit that her doctor at the University of California –
San Francisco suggested she go to an online “Canadian
pharmacy” to save money on an antibiotic that costs
$1,000 for a two week cycle.
The online pharmacy is a Canadian business, but not a
pharmacy, and ships it medications from countries such
as Turkey and Singapore. Of course, they could come
from anywhere.
Libby Baney telling her
sister’s story at the PSM
annual conference in 2011.

22. Addressing the problem
• Educating all healthcare professionals (nurses,
doctors, pharmacists, support staff) on two
issues:
– Legal and best practices for medication sourcing;
– Legal and financial consequences for receiving,
administering, or claiming reimbursements for
misbranded medication
• Additionally, providing some basic patient-level
education to healthcare professionals on how to
safely save money

23. How PSM can partner with you to
educate healthcare professionals
With co-branded handouts, articles for your
newsletter, infographics, and videos, PSM can
help educate your audience and protect their
patients.
Slides from a recent PSM patient
safety training webinar

24. 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.

25. A safety tips campaign in a box
• PSM has created 26 safety tips
for healthcare professionals that
can be adapted for Twitter,
Facebook, Email, Websites, or
Print.
• All illustrations are in black and
white.
• Entire collection of tips is licensed
through Creative Commons
Tip #12: Tell your patients that while
we think of Canada as a safe, modern
country, an online pharmacy that has
a Canadian flag on its home page
does not mean it is located in
Canada. Find out where that online
pharmacy is really located before
buying anything from them.

26. Custom educational materials
This is part of a custom handout
for a non-profit in Virginia that
works with volunteer
pharmacists to connect patient
with low-cost medication.
It was designed specifically with
Virginia residents in mind, and
discusses specific programs
available to them.

27. Resources for 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)

28. Articles written for your newsletter
• We’ve helped to get the word out…
– Malpractice insurance carrier The Doctor Company
– Parenteral Drug Association
• We’d be happy to write one for you!
– PSM has written articles about drug safety that
specifically speak to that audience and their needs.

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