COUNTERFEIT MEDICATION: THE IMMEDIATE DANGER TO MAINE PATIENTS AND HOW TO PROTECT THEM

Felicity Homsted, PharmD, BCPSDirectory of Pharmacy at Penobscot Community Health Care

Shabbir Imber SafdarDirector, National Outreach at Partnership for Safe Medicines

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.

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

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.

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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.

How good are the fakes?

Authentic and Fake Lipitor

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

Patient story: Fake IUDs in Kentucky

In March 2013, a Kentucky OB-GYN was charged with buying counterfeit non-FDA-approved birth control devices from an unregulated foreign supplier over the Internet for a discount. The indictment claims that for over a year he then implanted them into women and billed back insurance for a normal (higher) cost.

If convicted, Canh Jeff Vo faces fines of as much as $3 million and a maximum sentence of 233 years in prison.

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 story: Chicago, IllinoisMichael Markiewicz, a pharmacist/pharmacy owner in Chicago, Illinois was buying counterfeit medication from China and filling prescriptions with it for his customers.

He was charged in 2013 indictment 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.

His store remains open as a nutrition and herb retailer.

The medications were ordered over the Internet and then delivered in a package identified on the customs declaration as a “gift pen”.

Trafficking counterfeit drugs carries a maximum penalty of 20 years in prison and a $2 million fine.

UK pharmacies selling fakes to Americans

• In June 2013 two men from the UK were extradited to the US to face charges of selling Americans drugs from their online pharmacy that promised US citizens drugs from the UK.

• The real source of the medication was Pakistan (steroids, Xanax, Valium, Ativan, and Klonapin).

• 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)

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.

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.

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

controlled

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.

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.”

How do we protect patients?

• Teach patients– how to address issues of cost without endangering their

safety.– how to access affordable medications locally– how to spot safe online options (proactive not prohibitive

message).– the warning signs of non-FDA-approved medication so

they might spot them in a clinic setting.• Teach healthcare professionals about the danger and

legal liability of breaking the secure supply chain.

Affordable Care Programs

• Federal funding- ensures access to services• Program Enrollment – at the health center• Qualifying patients Receive– Discounted health care services– Discounted medication – Access to other programs, including pharmacy run

prescription assistance programs

Patients Assistance Programs

• For qualifying patients, many drug manufacturers offer discounted or free medication through Bangor pharmacies.

• Types of Programs– Pharmacy– Health Center– Other

PCHC Rx.AP Navigator Program

• Rx.AP Navigators for each site• Coordinate prescription assistance application– Meet with patient, gather needed application

components, submit applications, • Coordinate medication delivery• Troubleshoot issues • Guide patients to other available services

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.

How to save money at higher income levels?

If you make too much money to qualify for any of the programs mentioned previously, but you still face income challenges affording your medication, what options do you have?• Comparison shopping (generics and branded

products)• Discussing generics with your

doctor/pharmacist

GoodRX, WeRX, and LowestMed

Mobile apps and website comparison tools show local and mail-order US-licensed pharmacies and their price differences. Also provide discount cards and coupons that you can use to reduce your cost.

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

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: 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.

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.

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.

Co-branded patient webinar

• We can hold a shorter, customized joint co-branded webinar for your patient community.

• We can highlight the specific dangers in your therapeutic or demographic segment.

• The webinar can be recorded so you can continue to promote it to your community after it’s conducted.

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.

Live patient safety eventWith active PSM members we have also done live events, where we bring together patient advocates and safety experts to talk about ensuring safety.

PSM Board member Bryan Liang led a briefing on patient safety and counterfeit drugs with the FDA and PSM member the National Association of Boards of Pharmacy in 2011 in Washington DC.

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.

Questions and Answers

Shabbir Imber SafdarDirector, National Outreach

Partnership for Safe Medicines

shabbir@safemedicines.org415-683-7526

Felicity HomsteadDirector of Pharmacy

Penobscot Community Health Care

fhomsted@pchcbangor.org(207) 992-9200 x539