BROKEN PROMISES:COUNTERFEIT MEDICATION AND AMERICAN PATIENTS

Shabbir J. Imber Safdar, Director of National Outreach

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.

How patients are endangered from supply chain breaks

• Common: patients break it– Buying online from unlicensed pharmacies

• Uncommon:– Physicians, pharmacists, and distributors buying

from unlicensed distributors– Manufacturing supply chain producer

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.

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.

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.

How good are the fakes?

Authentic and Fake Lipitor

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.

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.com."

• 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

Patient story: Lorna LambdenEven getting real medication can be deadlyShe 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.

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.

Map graphic courtesy of the Wall Street Journal.

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 statesFragile 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.

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

First occurrence: fake devices

Two physicians in Kentucky were recently indicted for purchasing IUDs bought from an unlicensed Chinese manufacturer and implanting them in patients.

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.”

Physician: Johnson City, TNAn oncologist and his office manager conspired to buy oncology injectables from an unlicensed wholesaler and deliver them to patients.

When caught by the head nurse spotting foreign writing on the vials, they ceased their activity for 18 months until she left the practice.

When they restarted they rented a storage unit as a temporary holding facility and smuggled the fake medication into the office at night.

A second physician in Tennessee is under indictment. Other physicians have plead guilty in Maryland and Missouri.

The three main doctors with the McLeod Cancer and Blood Center have since worked out a restitution settlement with the U.S. government and State of Tennessee for a combined $4.4 million. Dr. Kincaid will also serve two years in prison.

Pharmacist: Ontario, CanadaA 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.

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.

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

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

controlled

Patient Safety: How to find discounts

The NeedyMeds Drug Discount Cardsaves you up to 80% or more offthe 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.

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.

Healthcare provider education

Clinic poster for patients

Partnering locally – co-branded handouts

Digital outreach to patients

Over a 30 day period, this advertising ran and was exposed to 140,000 people in communities in Virginia where our partner has free health clinics.

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.

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 Outreachshabbir@safemedicines.org

415-683-7526