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Patient advocate townhall: keeping patients safe from counterfeit drugs
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 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.
5.
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.
9. 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?
10. YouTube videos and
cartoons teach IUD
and implant
insertion and
removal,
despite the risk of
infection and death.
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.
14. Patient story: 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.
15. 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)
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 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. 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?
22. 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.
23. 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.
24. 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
25. 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.
26. 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)
27. 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.
28. 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.
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
Editor's Notes
It may seem obvious that certain medications are available illicitly on the internet, pain medications and lifestyle drugs, for example. And finding medications for recreational use can’t be so difficult because, as the NABP has determined from sampling for three years running, 97% of more than 10,000 websites analyzed were out of compliance with state and federal laws and or/NABP patient safety and pharmacy practice standards. Yet a December 2010 study by the Partnership at Drugfree.org found that 1 in 6 American obtain prescription drugs via the Internet without a valid prescription. This suggests that other medications are being purchased without doctor’s prescriptions to safeguard patient safety.
Add to this the direct-to-consumer marketing that can be done easily, and often for free, on social media sites like Facebook and Twitter, as well as through basic spambots, and we have an international syndicate of medicine counterfeiters out to gyp every American looking to save a dollar out of their health as well as their wallet.
The FDA warned patients that both counterfeit Adderall and counterfeit Vicodin had been found on the internet. But medications contained active ingredients, of other medicines, that could have seriously harmed patients. The Adderall contained Tramadol and acetaminophen instead, both pain relievers, instead of the psychostimulant medication expected. The fake Vicodin contained NSAIDs instead.These two FDA warnings are just a sample of the variety of fake medications sold online . This year alone, in the US there were 5 separate prosecutions of fake medications sold via fake online pharmacies, one alone which conspired “to commit $95 million worth of mail fraud” by selling unapproved medication to Americans
And it’s not just websites selling medications without prescriptions that promote harm. Social media sites such as Facebook, and instructional websites like YouTube are being used effectively to subvert the safety protocols of medicine. Every type of contraception is available online, including implants and IUDS complete with YouTube videos that demonstration self-implantation and insertion, despite the risk of infection and death. The health impact from a teenager purchasing and self-inserting a fake IUD is not just detrimental to the child’s health. It is symptomatic of a world-wide problem that causes the development of medicine-immune diseases and the death of many children.Fake medication given anywhere impacts health of everyone worldwide – It’s an issue that hurts everyone, especially women and children.
Cross-border jurisdiction problemsThe US case of the counterfeit cancer medications found in doctor’s clinics is a great example of how medication can move from country to country, with no authentication between sources. While the medication that ended up doctors’ offices from California to Illinois came from unauthorized distributors in the US, those people in turn purchased the medication from other unauthorized distributors from overseas where the medication wasn’t required to be inspected because it was “for export only.” Back from the UK, to Denmark, to Switzerland, to Egypt, the original signatory for the medication came froman illiterate supplier who signed his name with an “X” before traveling across three countries and through six countries.What jurisdiction did this crime occur in? Are the countries that passed the medication “for export only” through responsible? How do we protect patient safety when it’s so easy to pass the hot potato on to another party in another country?