Counterfeit drugs and the threat to Mississippi patients

COUNTERFEIT MEDICATION AND THE THREAT TO MISSISSIPPI PATIENTS

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

• Less common:– Physicians, pharmacists, and distributors buying

from unlicensed distributors• Uncommon:– 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.

How good are the fakes?

Authentic and Fake Lipitor

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.

UNIQUE THREATS TO THE MISSISSIPPI DISABILITY COMMUNITY AND THEIR FAMILIES

Unique challenges to our community• Medicaid & Medicaid Disable Child at Home

Program provide access to Medicaid coverage for children with disabilities, but limit prescription drug coverage to 2 name brand and 3 generic drugs per month.

• Individuals with disabilities and Seniors who are Medicaid beneficiaries and transitioning to the community out of care facilities have a limit of 5 prescription drugs where they had unlimited in the facility.

Children with seizure disorders• In most cases a generic is an easy swap with

no therapeutic difference, but we see problems in this area.

• Parents have reported generic antiseizure medications do not always work for the child and, in fact can make the condition and side affects worse.

• This can also be true of Psychotropic Medications.

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.

Our community needs information

• Patients and their caregivers don’t know the risks or that even safe options exist.

• Many seniors aren’t computer-savvy, and require assistance to take advantage of some of these programs.

THE PROBLEM BEYOND MISSISSIPPI

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.

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

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.

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.

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.

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.

Map graphic courtesy of the Wall Street Journal.

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.

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.

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.