Counterfeit Drugs in America: 2017 Overview

Tell Congress protect our medicine supply: http://safedr.ug/feb2017-letter

Counterfeit Drugs in America: 2017 Overview

Shabbir Imber SafdarDirector of National OutreachPartnership for Safe Medicines

[email protected]


PSM MembersAcademy of Managed Care PharmacyAlaska Pharmacists AssociationThe ALS AssociationAmerican Association for HomecareAmerican College Health AssociationAmerican Pharmacists AssociationAmerican Society of Health System PharmacistsArizona Pharmacy Alliance (AzPA)Association of Nurses in AIDS CareBioForwardBiotechnology Industry OrganizationCalifornia Healthcare InstituteCalifornia Pharmacists AssociationCalifornia Society of Health-System Pharmacists

(CSHP)Colorado Bioscience AssociationCommunity Access National NetworkThe Council for Affordable Health InsuranceEuropean Federation of Pharmaceutical Industries

and Associations (EFPIA)Generic Pharmaceutical AssociationGlobal Medicines ProgramHealthcare Distribution Management AssociationHealthCare Institute of New JerseyHealthcare Leadership CouncilThe Hispanic InstituteIllinois Pharmacists AssociationInstitute of Health Law StudiesInstitute for Safe Medication PracticesInternational Anti-Counterfeiting Coalition

International Federation of Pharmaceutical Manufacturers and Associations

Kidney Cancer AssociationThe Latino CoalitionThe Life Raft GroupMaine Pharmacists AssociationMaine Society of Health-System Pharmacists

(MSHP)Maryland Pharmacists AssociationMen’s Health NetworkMinnesota Pharmacists AssociationMissouri Pharmacy AssociationNational Alliance for Hispanic HealthNational Alliance On Mental Illness Maryland Pharmacists AssociationNational Association of Boards of PharmacyNational Association of Chain Drug StoresNational Association of Drug Diversion

InvestigatorsNational Association of ManufacturersNational Alliance of State Pharmacy AssociationsNational Biopharmaceutical Security CouncilNational Community Pharmacists Association National Grange of the Patrons of HusbandryNational Latina Health NetworkNeedyMedsNew York State Council of Health-system

Pharmacists (NYSCHP)North Carolina Association of PharmacistsOklahoma Pharmacists Association

Parenteral Drug AssociationPDMA AlliancePennsylvania Pharmacists AssociationPennsylvania Society of Health-system

PharmacistsPharmaceutical Industry Labor Management

Association (PILMA)Pharmaceutical Security Institute.PhRMARetireSafeSan Diego Center for Patient SafetySpina Bifida Association of AmericaTexas Pharmacy AssociationTexas Society of Health-System PharmacistsUnited States Chamber of CommerceUniversity of New England College of PharmacyUniversity of Texas Pharmacy SchoolVietnam Veterans of AmericaVirginia Pharmacists AssociationVermont Pharmacists AssociationWest Virginia RxWomenHeart

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Agenda

• Counterfeit drugs in America today• Myths and facts about drug importation

proposals• Recommended techniques for saving money

safely on prescriptions• Q&A


Wholesalers forge documentation of legitimacy for counterfeit drugs and pass off as authentic.

Doctors and pharmacists purchase from counterfeit drug distributors.

Stolen and partially used medications are re-sold as unused, untampered drugs through clearinghouses back to into the legitimate supply chain.

Counterfeit medicine raid - Heilongjiang Province, China – May 22, 2014



What could be in the confiscated drugs?


Counterfeits made with fentanyl

• Americans in 30 states across the US have died from counterfeit prescription drugs made with lethal doses of fentanyl in the last 24 months.

• This includes musician Prince, who was found with counterfeit hydrocodone pills made with fentanyl.

Fatal doses of heroin and fentanylPhoto: New Hampshire State Police Crime Lab

Counterfeits with fentanyl are tracked by our team at: http://safedr.ug/fentanylpills


Counterfeit cosmetic injectablesSince 2012, the FDA has warned 2,234 medical practices in 49 states that they have done business with unlicensed distributors.

This is a radiograph of a 30 year old female who died after an illegal cosmetic injectable containing silicon leaked through her bloodstream into her lungs. The silicon particulate shut down her lungs.


Black market IUDs

Patients typically do not see the IUD before it’s surgically inserted. Nor do they have the ability to check it or remove it should they become concerned.

Doctors and clinics in 45 states (in red) received warnings from the FDA about purchasing fake IUDs.

Doctors and clinics in 8 states (in orange) were convicted trafficking in fake IUDs.


Black market oncology medicationThe unlicensed wholesalers that trafficked in Betty Hunter’s fake oncology medication were finally sentenced in 2014, three years after her death in 2011.

The problem is far from solved. Since 2012, the FDA has warned 1,205 medical practices in 47 states and the District of Columbia that they had done business with unlicensed distributors who had been found selling counterfeit oncology medication.

Betty Hunter before her death in 2011 (top)Betty Hunter’s son describes his mother’s gruesome reaction to her untreated cancer for the TV Special “Lethal Fake Medicine” by Bullitt Film (bottom)


MYTHS AND FACTS ABOUT DRUG IMPORTATION


Myth: “Canadian websites sell Canadian drugs.”

• It’s not legal for a Canadian pharmacist to dispense medication to an American without a Canadian doctor’s prescription.

• What you may get is a drug that was bought on the black market from a third world factory, not one from the Canadian drug supply.

• Canadian bricks and mortar pharmacy regulators do not permit any Canadian online pharmacy to sell/ship to Americans. If you’re ordering from one, it’s likely not a Canadian pharmacy.


Myth: “Canadian websites sell Canadian drugs.”

• It’s not legal for a Canadian pharmacist to dispense medication to an American without a Canadian doctor’s prescription.

• What you may get is a drug that was bought on the black market from a third world factory, not one from the Canadian drug supply.

• Canadian bricks and mortar pharmacy regulators do not permit any Canadian online pharmacy to sell/ship to Americans. If you’re ordering from one, it’s likely not a Canadian pharmacy.


Myth: “This is a partisan political issue.”


Myth: “I got a package from Canada, it must be safe.”

• We have found that orders places from so-called “Canadian websites” are often sourced from Turkey, India, or somewhere else.

• But when you do get a package from Canada, it probably has been trans-shipped through Canada without passing Canadian Customs.

• Health Canada (their FDA) does not inspect trans-shipped packages.


Myth: “Criminal penalties will deter foreign criminals from selling counterfeits to

Americans.”• In 2015 executives from CanadaDrugs.com were

indicted for a $78 million conspiracy to sell medications not approved by the FDA to Americans, including oncology drugs.

• The FDA intercepted some of their medications and lab-tested them. They were fake.

• These executives remain at large in Canada today, operating their fake internet pharmacy site selling to Americans.


Myth: “Canadians are happy to have Americans participate in their healthcare system.”

“We urge Americans not to raid Canada's pharmacies to try and buy cheaper medicines.Our mothers, fathers, siblings, and kids will all be further harmed by this. Furthermore many generic drugs are cheaper in America than they are in Canada.”

-Linda Wilhelm, Canadian Arthritis Patient Alliance (2016)Similar statements are available from Canadian patient advocates in the asthma, cancer, epilepsy, hemophilia, kidney, lymphoma, and Parkinson’s community.


Myth: “I can tell that my medication is working.”

• Not even trained pharmacists can determine whether a real medication is fake without lab tests.

• Criminals have access to blister packs, litho printing, and even security holograms.

• Sometimes a small amount of active ingredient is used to fool chemical screens. It’s not enough to treat your disease.

Professor Kenneth ‘Mac’ McCall, University of New England Pharmacy School


• In November 2013, then-Maine Pharmacy Association President Kenneth "Mac" McCall saw an ad from Canada Drug Center in the newspaper.

• The pharmacy's website bore "certifications" from that make it look legitimate to consumers.

What if you really bought it?


“A deal too good to be true.”• McCall wanted to know what Canada Drug

Center was selling. He ordered three widely used generic maintenance medications for heart disease, inflammation and acid reflux.

• The pharmacy assigned him a Canadian doctor, asked him to waive any liability for bad outcomes, and mailed him the drugs.


“A deal too good to be true.”• What he got was not what the patient needed.

•Esomeprazole (the generic of Nexium, which treats acid reflux disease)

• INSUFFICIENT ACTIVE INGREDIENT. ONLY 58% OF THE PRESCRIPTION DOSAGE.


“A deal too good to be true.”• What he got was not what the patient needed.

•Celecoxib (the generic of Celebrex, an anti-inflammatory)

• INSUFFICIENT ACTIVE INGREDIENT. 23% LESS THAN THAN PRESCRIPTION DOSAGE


“A deal too good to be true.”What he got was not what the patient needed.

•Clopidogrel (the generic of Plavix, a blood thinner)

CONTAMINATED!

The Clopivas product contained an unknown contaminant. (Possibly methyl chloride, known to exhibit genotoxic properties.)


SAVING MONEY SAFELY


Saving Money Safely – Consumer Reports AdviceShop around, but then talk to your local pharmacist about price matching and keep all your medications there for safety.

“[Local] pharmacists [...] have more flexibility to match or beat competitor’s prices.”

One CR survey in Raleigh, NC found a price range of $43 to $220 for the same dose of a generic.


Use medication assistance programs

www.needymeds.org

www.pparx.org

NeedyMeds provides a free prescription discount card that can be used in all 50 states in the US.

The Partnership for Prescription Assistance® may help patients who are uninsured or underinsured access the medicines they need through the program that is right for them – free of charge. Many patients will get their medications for free or nearly free.


Use US web pharmacies

• Some US web pharmacies can have discounts that you can then price match with your local pharmacist.

• Look for a pharmacy website that ends in .pharmacy or has the VIPPS logo

• See https://nabp.pharmacy/programs/vipps/ for more info

https://nabp.pharmacy/programs/vipps/

https://nabp.pharmacy/programs/vipps/


What you can do to protect yourself and your patient community

• Sign our letter to Congress to protect the US drug supply: http://safedr.ug/feb2017-letter

• Join the Partnership for Safe Medicines and let us provide you with free educational materials for your community by emailing me at [email protected].

• Q&A

http://safedr.ug/feb2017-letter

http://safedr.ug/feb2017-letter