This was a presentation to the NADDI annual conference: St. Louis MO (Nov 20, 2013)

1. Fighting black market and counterfeit
drugs in America
Shabbir Imber Safdar
Director of National Outreach
Partnership for Safe Medicines
www.safemedicines.org
415-683-7526
shabbir@safemedicines.org

2. PSM Members
Academy of Managed Care Pharmacy
AIDS Drug Assistance Program
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 Biotechnology 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
Interamerican College of Physicians and Surgeons North Carolina Association of Pharmacists
International Anti-Counterfeiting Coalition
Oklahoma Pharmacists Association
International Federation of Pharmaceutical
Parenteral Drug Association
Manufacturers and Associations
PDMA Alliance
Kidney Cancer Association
Pennsylvania Pharmacists Association
The Latino Coalition
Pennsylvania Society of Health-system
The Life Raft Group
Pharmacists
Maryland Pharmacists Association
Pharmaceutical Industry Labor Management
Maine Pharmacists Association
Association (PILMA)
Maine Society of Health-System Pharmacists
Pharmaceutical Security Institute
(MSHP)
Pharmacists Planning Services, Inc.
Men’s Health Network
PhRMA
Missouri Pharmacy Association
RetireSafe
National Alliance for Hispanic Health
Spina Bifida Association of America
National Alliance On Mental Illness
Texas Pharmacists Association
National Association of Chain Drug Stores
Texas Society of Health-System Pharmacists
National Association for Uniformed Services
United States Chamber of Commerce
National Association of Boards of Pharmacy
University of New England College of Pharmacy
National Association of Drug Diversion
University of Texas Pharmacy School
Investigators
Vietnam Veterans of America
National Association of Manufacturers
Virginia Pharmacists Association
National Alliance of State Pharmacy Associations Vermont Pharmacists Association
National Biopharmaceutical Security Council
West Virginia Rx
National Community Pharmacists Association
WomenHeart
National Grange of the Patrons of Husbandry
International and Governmental Organizations
National Latina Health Network
World Health Organization
NeedyMeds
Nevada Board of Pharmacy
Orange County Healthcare Agency
New York State Council of Health-system
Pharmacists (NYSCHP)
2

3. 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.

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

5. Patients Buy Counterfeits
in Pursuit of Savings or
Magical Solutions
• Patients, too, break the supply
chain by buying from fake online
pharmacies (often claiming to be
Canadian) or other unapproved
avenues.
• Recent examples:
●
Weight loss pills
●
Flu Treatments
#fakedrugs
#PSM2013

6. Patients Buy Counterfeits in Pursuit of
Savings or Magical Solutions
• These consumers don't realize that:
●
Drugs they buy from Canadian online pharmacies are not
from Canada's legitimate drug supply.
●
Despite the assurances of drug exporters about "Tier One"
countries the FDA has never designated any country from
which it is universally safe to import medicine.
●
If it’s not FDA-approved, you can’t be assured that the
contents are safe, or what they’re supposed to be.
#fakedrugs
#PSM2013

7. 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.

8. Patient story: Buying meds online isn’t
like buying socks
(where’s the cheapest price?)
• Even if it’s an over-thecounter medicine, it’s still
medicine.
• Victims purchased overthe-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

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

10. The Problem of
Misbranded Treatments
●
The United States has seen a rash of cases in which
medical professionals have purchased non-FDA
approved medicines and other medical devices.
●
Illegal distributors make a profit selling drugs from
sources that aren’t trustworthy -- illegally
imported, expired, stolen, damaged by bad
handling.
●
Doctors and pharmacist generate profit by billing
insurance, Medicare and patients the full price for
legitimate treatments.
#fakedrugs
#PSM2013

11. The Problem of
Misbranded Treatments
● This problem threatens a broad range of
patients who must rely on their healthcare
providers for safe treatments.
● Infused, injected and inhaled drugs are
particularly easy to counterfeit; the main
challenge is packaging.

12. Misbranded Treatments Botox
• Botox (onabotulinumtoxinA) -injected anti-wrinkle treatment, also
for repetitive neck spasms and
chronic migraines
●
Multiple cases. One false distributor sold almost
6,000 doses of unapproved, imported Botox
and Juviderm.
●
FDA warnings to over 350 medical offices,
including a Dallas area hospital, since 2012.
#fakedrugs
#PSM2013

13. Misbranded Treatments Botox
• What’s the Impact?
• 2.95 million Americans use Botox for a variety of reasons, both
cosmetic and medical.
• Since 2005, fake Botox has been found in investigations in Los
Angeles, Miami, and Kentucky.
• Patients have been disfigured and suffered
respiratory paralysis from counterfeit Botox.

14. Counterfeit Medicines
and Chronic Illness
#fakedrugs
#PSM2013
●
Patients are easily exploited while they are seeking better or
less expensive treatments.
●
Patients taking ongoing medications are at high risk because
they have longer exposure to more medicines.
●
Poor response to counterfeit or substandard medicines may be
misdiagnosed as treatment failure.

15. Misbranded Treatments
Osteoporosis Drugs
• Aclasta (zoledronate) and Prolia (denosumab) -injected medicines to treat osteoporosis.
●
Since September 2012, the FDA has warned 23 US
medical practices that they may have purchased
unapproved versions of these treatments.
• What’s the Impact?
●
40 million Americans suffer from osteoporosis or
are at high risk.
#fakedrugs
#PSM2013

16. Diverted Treatments
HIV Drugs
• MOMS Pharmacy, New York, 2012
●
4 individuals allegedly resold black market
HIV and AIDS medications that included
drugs previously dispensed to individuals,
as well as stolen and expired medications.
●
MOMS Pharmacy and its parent company,
Allion Healthcare sought reimbursement
from Medicaid.
●
The alleged scheme was a multi-state
operation that netted millions of dollars.
#fakedrugs
#PSM2013

17. Diverted Treatments
HIV Drugs
• What’s the Impact?
●
1.1 million people are living with AIDS in
the United States.
‣ (130,000 in New York State)
●
Expired or poorly handled treatments
are less effective (or ineffective).
HIV/AIDS patients rely on these
medicines to control their illness.
Ineffective treatments lead to decline
and death.
#fakedrugs
#PSM2013

18. Misbranded Drugs - Dialysis
• American Inhalation Medication Specialists, Inc.,
Tennessee, May 2013
●
Tennessee pharmacist Robert Harshbarger, Jr. substituted a
cheap Chinese import for the iron sucrose used to treat
anemia kidney dialysis patients.
●
Benefit programs paid more than $848,000 for the
misbranded iron sucrose between 2004 and 2008.
●
Several patients of Kansas Dialysis Services, L.C were
treated with the misbranded dialysis drugs.
#fakedrugs
#PSM2013

19. Misbranded Drugs - Dialysis
• What’s the Impact?
●
At the end of 2009, more than 871,000 Americans were being
treated for End Stage Renal Disease.
●
Untreated (or ineffectively treated) iron deficiency anemia
causes fatigue, shortness of breath, chest pain. Severe cases
can cause heart problems, infections and other complications.
●
Adulterated iron sucrose could cause
severe illness and death.
#fakedrugs
#PSM2013

20. Fake Drugs - Diabetes
● 2013: FDA warned diabetics to beware of illegal
“natural” remedies for the treatment of diabetes.
● Other cases around the world:
○
2011 - Fake test strips in India
○
2009 - Counterfeit insulin needles in the UK
○
2006 - Counterfeit test strips in the US
#fakedrugs
#PSM2013

21. Fake Drugs - Diabetes
• What’s the Impact?
●
As of 2011, 18.8 million Americans had been diagnosed with
diabetes.
●
Diabetes contributes to 231,404 deaths each year.
●
Ineffective treatment and poor blood sugar control
cause heart disease, stroke, blindness, kidney disease,
amputations, and poor immunity to other diseases.
#fakedrugs
#PSM2013

22. Emerging trend: black market IUDs
Two physicians in
Kentucky were
recently indicted
for purchasing IUDs
bought from an
unlicensed Chinese
manufacturer and
implanting them in
patients.

24. Map graphic courtesy of the Wall Street Journal.

25. Misbranded Treatments
Avastin
●
McCleod Blood and Cancer Center
○
Kincaid, and his business manager
purchased misbranded drugs, and
administered them to patients.
○
Kincaid made at least $500,000 by
seeking reimbursement through the
Medicare and Medicaid/ TennCare
programs as well as other health
benefits programs.
#fakedrugs
#PSM2013

26. Misbranded Treatments
Avastin
• What’s the Impact?
• It’s difficult to know because the drugs were administered
to gravely ill patients who might have died anyway.
• "People who receive a fake medication instead of Avastin
could have lost several months of their lives.” – Dr. Nimesh
Nagarsheth, oncologist
#fakedrugs
#PSM2013

28. Battleground: Maine
• Prescription drug broker in Canada facilitates
orders but not fulfillment.
• New state law passed in 2013 allows
importation of medication and prohibits board
of pharmacy from any oversight.
• Program has been going for over 8 eight years
by the Portland Employees Union and several
private Maine corporations.

29. 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.

30. 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.

31. 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.

32. 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.

33. Patient Safety: How to find discounts
The NeedyMeds Drug Discount Card
saves you up to 80% or more off
the cost of: Prescription Medicines, Overthe-Counter Drugs, Pet Prescription Drugs
The Partnership for Prescription
Assistance will help you find the program
that’s right for you, free of charge.
Buy from a VIPPS-certified online
pharmacy. Find a list at
http://www.vipps.info

34. 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.

35. Solving the problem
• Distribute these materials to educate the
public
• Get informed by joining our email list for
counterfeit warnings at
www.safemedicines.org
• Get our packet of handouts
• Join the Partnership for Safe Medicines

36. Efforts of the Partnership
This Year
This year we have worked with partners to reach
over 300,000 vulnerable American
patients, nurses, doctors, and pharmacists, and
nearly 1,000 at-risk clinics and doctor’s offices in six
key states.
Facebook ads
Fact pack
Patient handout
8

54. Save the Date for the
2014 Interchange
September 18, 2014
Newseum
Freedom Forum
Knight Conference Center
Washington, DC
17

55. Thank you!
Please leave me your business card if you
want to receive a complete packet of our
printed materials after our next printing run in
January 2014.
We can provide large print runs of any
printed product for distribution for free to any
organization that joins PSM.
55

56. Customized for Tennessee Nurses Association

59. ‹#›

60. 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.

62. Misbranded Treatments
Avastin
• Kincaid and the
manager conspired
to hide the illegal
purchases from
nursing staff who
recognized that the
treatments were
counterfeit.
#fakedrugs
#PSM2013