Fighting black market and counterfeit drugs in America

Shabbir Imber Safdar

Director of National OutreachPartnership for Safe

Medicines

www.safemedicines.org

415-683-7526

shabbir@safemedicines.org

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PSM MembersAcademy of Managed Care PharmacyAIDS Drug Assistance ProgramAlaska 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 Biotechnology 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 Practices

Interamerican College of Physicians and SurgeonsInternational Anti-Counterfeiting CoalitionInternational Federation of Pharmaceutical

Manufacturers and AssociationsKidney Cancer AssociationThe Latino CoalitionThe Life Raft GroupMaryland Pharmacists AssociationMaine Pharmacists AssociationMaine Society of Health-System Pharmacists

(MSHP)Men’s Health NetworkMissouri Pharmacy AssociationNational Alliance for Hispanic HealthNational Alliance On Mental Illness National Association of Chain Drug StoresNational Association for Uniformed ServicesNational Association of Boards of PharmacyNational 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 NetworkNeedyMedsNevada Board of PharmacyNew York State Council of Health-system

Pharmacists (NYSCHP)

North Carolina Association of PharmacistsOklahoma Pharmacists AssociationParenteral Drug AssociationPDMA AlliancePennsylvania Pharmacists AssociationPennsylvania Society of Health-system

PharmacistsPharmaceutical Industry Labor Management

Association (PILMA)Pharmaceutical Security InstitutePharmacists Planning Services, Inc.PhRMARetireSafeSpina Bifida Association of AmericaTexas Pharmacists 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

International and Governmental Organizations

World Health OrganizationOrange County Healthcare Agency

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

• Patients, too, break the supply chain by buying from fake online pharmacies (often claiming to be Canadian) or other unapproved avenues.

• Recent examples:● Weight loss pills ● Flu Treatments● Adderall

Patients Buy Counterfeits in Pursuit of Savings or

Magical Solutions

#fakedrugs #PSM2013#fakedrugs #PSM2013

Patients Buy Counterfeits in Pursuit of Savings or Magical Solutions

• These consumers don't realize that:

● Drugs they buy from Canadian online pharmacies are not from Canada's legitimate drug supply.

● Despite the assurances of drug exporters about "Tier One" countries the FDA has never designated any country from which it is universally safe to import medicine.

● If it’s not FDA-approved, you can’t be assured that the contents are safe, or what they’re supposed to be.

#fakedrugs #PSM2013

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

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

The Problem of Misbranded Treatments

● The United States has seen a rash of cases in which medical professionals have purchased non-FDA approved medicines and other medical devices.

● Illegal distributors make a profit selling drugs from sources that aren’t trustworthy -- illegally imported, expired, stolen, damaged by bad handling.

● Doctors and pharmacist generate profit by billing insurance, Medicare and patients the full price for legitimate treatments.

#fakedrugs #PSM2013#fakedrugs #PSM2013

The Problem of Misbranded Treatments

●This problem threatens a broad range of patients who must rely on their healthcare providers for safe treatments.

●Infused, injected and inhaled drugs are particularly easy to counterfeit; the main challenge is packaging.

Misbranded Treatments Botox

• Botox (onabotulinumtoxinA) -- injected anti-wrinkle treatment, also for repetitive neck spasms and chronic migraines

● Multiple cases. One false distributor sold almost 6,000 doses of unapproved, imported Botox and Juviderm.

● FDA warnings to over 350 medical offices, including a Dallas area hospital, since 2012.

#fakedrugs #PSM2013#fakedrugs #PSM2013

Misbranded Treatments Botox

• What’s the Impact?• 2.95 million Americans use Botox for a variety of reasons, both

cosmetic and medical.

• Since 2005, fake Botox has been found in investigations in Los Angeles, Miami, and Kentucky.

• Patients have been disfigured and suffered respiratory paralysis from counterfeit Botox.

Counterfeit Medicines and Chronic Illness

● Patients are easily exploited while they are seeking better or less expensive treatments.

● Patients taking ongoing medications are at high risk because they have longer exposure to more medicines.

● Poor response to counterfeit or substandard medicines may be misdiagnosed as treatment failure.

#fakedrugs #PSM2013

Misbranded Treatments Osteoporosis Drugs

• Aclasta (zoledronate) and Prolia (denosumab) -- injected medicines to treat osteoporosis.

● Since September 2012, the FDA has warned 23 US medical practices that they may have purchased unapproved versions of these treatments.

• What’s the Impact?● 40 million Americans suffer from osteoporosis or

are at high risk.

#fakedrugs #PSM2013

Diverted TreatmentsHIV Drugs• MOMS Pharmacy, New York, 2012

● 4 individuals allegedly resold black market HIV and AIDS medications that included drugs previously dispensed to individuals, as well as stolen and expired medications.

● MOMS Pharmacy and its parent company, Allion Healthcare sought reimbursement from Medicaid.

● The alleged scheme was a multi-state operation that netted millions of dollars.

#fakedrugs #PSM2013

Diverted TreatmentsHIV Drugs

• What’s the Impact?

● 1.1 million people are living with AIDS in the United States.

‣ (130,000 in New York State)

● Expired or poorly handled treatments are less effective (or ineffective). HIV/AIDS patients rely on these medicines to control their illness. Ineffective treatments lead to decline and death.

#fakedrugs #PSM2013

Misbranded Drugs - Dialysis• American Inhalation Medication Specialists,

Inc., Tennessee, May 2013

● Tennessee pharmacist Robert Harshbarger, Jr. substituted a cheap Chinese import for the iron sucrose used to treat anemia kidney dialysis patients.

● Benefit programs paid more than $848,000 for the misbranded iron sucrose between 2004 and 2008.

● Several patients of Kansas Dialysis Services, L.C were treated with the misbranded dialysis drugs.

#fakedrugs #PSM2013

Misbranded Drugs - Dialysis

• What’s the Impact?

● At the end of 2009, more than 871,000 Americans were being treated for End Stage Renal Disease.

● Untreated (or ineffectively treated) iron deficiency anemia causes fatigue, shortness of breath, chest pain. Severe cases can cause heart problems, infections and other complications.

● Adulterated iron sucrose could cause severe illness and death.

#fakedrugs #PSM2013

Fake Drugs - Diabetes

● 2013: FDA warned diabetics to beware of illegal “natural” remedies for the treatment of diabetes.

● Other cases around the world:○ 2011 - Fake test strips in India○ 2009 - Counterfeit insulin needles in the UK○ 2006 - Counterfeit test strips in the US

#fakedrugs #PSM2013

Fake Drugs - Diabetes• What’s the Impact?

● As of 2011, 18.8 million Americans had been diagnosed with diabetes.

● Diabetes contributes to 231,404 deaths each year.● Ineffective treatment and poor blood sugar control

cause heart disease, stroke, blindness, kidney disease, amputations, and poor immunity to other diseases.

#fakedrugs #PSM2013

Emerging trend: black market IUDs

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

Map graphic courtesy of the Wall Street Journal.

Misbranded TreatmentsAvastin

● McCleod Blood and Cancer Center○ Kincaid, and his business manager

purchased misbranded drugs, and administered them to patients.

○ Kincaid made at least $500,000 by seeking reimbursement through the Medicare and Medicaid/ TennCare programs as well as other health benefits programs.

#fakedrugs #PSM2013

Misbranded TreatmentsAvastin

• What’s the Impact?

• It’s difficult to know because the drugs were administered to gravely ill patients who might have died anyway.

• "People who receive a fake medication instead of Avastin could have lost several months of their lives.” – Dr. Nimesh Nagarsheth, oncologist

#fakedrugs #PSM2013

Battleground: Maine

• Prescription drug broker in Canada facilitates orders but not fulfillment.

• New state law passed in 2013 allows importation of medication and prohibits board of pharmacy from any oversight.

• Program has been going for over 8 eight years by the Portland Employees Union and several private Maine corporations.

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.

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 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.

Buy from a VIPPS-certified online pharmacy. Find a list at http://www.vipps.info

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.

Solving the problem

• Distribute these materials to educate the public

• Get informed by joining our email list for counterfeit warnings at www.safemedicines.org

• Get our packet of handouts• Join the Partnership for Safe Medicines

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Efforts of the Partnership This Year

This year we have worked with partners to reach over 300,000 vulnerable American patients, nurses, doctors, and pharmacists, and nearly 1,000 at-risk clinics and doctor’s offices in six key states.

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Save the Date for the 2014 Interchange

September 18, 2014Newseum

Freedom ForumKnight Conference Center

Washington, DC

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Thank you!

Please leave me your business card if you want to receive a complete packet of our printed materials after our next printing run in January 2014.We can provide large print runs of any printed product for distribution for free to any organization that joins PSM.

Customized for Tennessee Nurses Association

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.

Misbranded TreatmentsAvastin

• Kincaid and the

manager

conspired to hide

the illegal

purchases from

nursing staff who

recognized that

the treatments

were counterfeit. #fakedrugs #PSM2013