welcome and overview - cecitywelcome and overview eleni z. anagnostiadis, rph associate executive...

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Welcome and Overview

Eleni Z. Anagnostiadis, RPhAssociate Executive Director

National Association of Boards of Pharmacy

Mount Prospect, Illinois

Learning Objectives

Upon completion of this activity, participants

should be better able to:should be better able to:

Understand the global and domestic impact of counterfeit pharmaceuticals

Identify various ways that counterfeit drug products enter the drug distribution system in the US

Review regulatory and law enforcement actions that the FDA is addressing to ensure the safety of the drugFDA is addressing to ensure the safety of the drug supply chain in the US

Discuss the unique role of the pharmacist and the importance of “due diligence” strategies in preventing counterfeit medication in the US drug supply

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Counterfeit Drugs: A Global Epidemic

Eleni Z. Anagnostiadis, RPhAssociate Executive Director

N ti l A i ti fNational Association of Boards of Pharmacy


Road Map

Scope of drug counterfeitingScope of drug counterfeitingInternet pharmacyWholesale drug distributors

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Scope of the Problem

Proliferation of WebProliferation of Web sites offering prescriptions for lifestyle and popular drugsCounterfeit drugsCounterfeit drugs in the US drug distribution system

What Is a Counterfeit Drug?

US Food Drug and Cosmetic Act:US Food, Drug, and Cosmetic Act: “[A] drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark…of a drug manufacturer, processor…or distributor other than the person…who in fact manufactured, processed…or distributed , psuch drug and which thereby falsely purports or is represented to be the product of…such other drug manufacturer, processor…or distributor.”

Federal Food, Drug, and Cosmetic Act. http://www.fda.gov/opacom/laws/fdcact/fdcact1.htm. Accessed March 3, 2008.

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Counterfeit Categories

Fake Packaging, Correct Quantity of CorrectFake Packaging, Correct Quantity of Correct Ingredient (Clone)Fake Packaging, Wrong IngredientFake Packaging, No Active IngredientFake Packaging, Incorrect Quantity of Correct IngredientGenuine Packaging Wrong IngredientGenuine Packaging, Wrong IngredientGenuine Packaging, No IngredientGenuine Packaging, Incorrect Quantity of Correct Ingredient

Counterfeit medicines. http://www.wpro.who.int/health_topics/counterfeit_medicines/general_info.htm. Accessed March 5, 2008.

Prevalence of Drug Counterfeiting

According to the World Health Organization (WHO):

Industrialized countries: approximately 1%

Developing countries: over 10%

WHO Fact Sheet N. 275. http://www.who.int/mediacentre/factsheets/fs275/en/. Accessed March 5, 2008.

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Prevalence of Drug Counterfeiting

Industrialized countries with effective regulatory systems (eg, US, most of EU, Australia, Canada, Japan, New Zealand)–less than 1%Many countries in Africa and parts of Asia and Latin America–between 10% and 30% Many of the former Soviet republics–Many of the former Soviet republicsabove 20%Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases

WHO Fact Sheet N. 275. http://www.who.int/mediacentre/factsheets/fs275/en//. Accessed March 5, 2008.

A Growing Problem

“T d i t f it i t l“Trade in counterfeits is extremely lucrative, thus making it more attractive to criminal networks. A report released by the Centre for Medicines in the Public Interest, in the United States, projects counterfeit drug sales to reach US $75 billion in 2010, a 92% increase from 2005.”

Counterfeit medicines: the silent epidemic. http://www.who.int/mediacentre/news/releases/2006/pr09/en/. Accessed March 5, 2007.

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What Is Out There?

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Authentic Ortho Evra® Counterfeit “Ortho Evra”

5854

50

60

Counterfeit Drug Cases Opened By FDA Per Fiscal Year

11

21

2730

32

20

30

40

Numberof cases

95

116

0

10

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

YearUS Food and Drug Administration. Counterfeit drug cases opened by FDA per fiscal year. http://www.fda.gov/oc/initiatives/counterfeit/hdmanadcs1113_files/textmostly/slide3.html. Accessed March 10, 2008.

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NABP Findings

♦ Selling prescription medications without a valid prescription:without a valid prescription: ♦Without any prescription ♦Online consult; no physical exam♦Online consult + “physical

assessment” by non-physician

♦ Selling unapproved medications:♦Example: unapproved generic versions

of brand medications♦Counterfeit medications

NABP Findings

Controlled substances and isotretinoin buysControlled substances and isotretinoin buysDecember 2003 to January 2004Purchased 8 drugs from 5 suspicious sites, including Xanax®, codeine, Valium®, injectable testosteroneSite shipped isotretinoin to US, despite contrary claimAll drugs labeled in foreign languageLimited US Pharmacopeia (USP) testing: some testosterone was subpotent

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NABP Findings

Controlled substances and isotretinoin buysControlled substances and isotretinoin buysTestosterone purchase: ♦ Thai manufacturer♦ Supplier based in Republic of Seychelles♦ Web site registered in Slovenia♦ Payment processed in Quebec, Canada♦ Package arrived with Greek stamps

Internet Pharmacy

Canada’s first confirmed death fromCanada’s first confirmed death from counterfeit drugs purchased over the Internet (March 2007) British Columbia Coroner’s report–pills bought from a fake online pharmacy caused death of a Vancouver Island womanwoman Drugs contaminated with extremely high quantities of metal

Counterfeit drugs caused woman’s death, coroner concludes -6 July 2007. http://www.buysafedrugs.info/Reports/Counterfeit_Drugs_Caused_Womans_Death.htm. Accessed March 5, 2008.

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DEA—Operation Raw Deal

11.4 million steroid dosage units seized as part of Operation Raw Deal—September 27, 2007

“Raw Deal” Targets Illegal Steroids. http://www.fda.gov/bbs/topics/answers/2005/ANS01353lists.html. Accessed March 5, 2008.

The Diverters and the Gray Market: HowThe Diverters and the Gray Market: How Counterfeits Infiltrate the System and

the Pharmacies at Risk

Katherine Eban

By Katherine Eban • May 2005 • Harcourt, Inc.

Katherine EbanInvestigative Reporter and Author

New York, New York


How the Book Began

The Phone Call

How the Book Began



The Horsemen of the Apocalypse


Horseman Fashion



The Sunshine Bureaucracy


Pharmaceuticals: the 21st Century Gold Rush


Michael Carlow


Getting “Product”



Jose Grillo

Employment History

•Bodybuilder

•Staff member, Vegetarian Palace


A Hot Chain


Playpen South


Rap sheet:- Cocaine

- Kidnapping

- Aggravated battery


Tim FaganTim Fagan,aged 16 years

Received counterfeitEpogen®® fromCVS pharmacy


CVS pharmacy

Epogen®® Trail to

Timothy Fagan

Corrupt Supply Chain

Timothy Fagan


• Big 3 pledged to stop buying from secondary market

Reforms

• CVS announced a boycott of wholesalers who buy from secondary market

• Manufacturers threatened to cut off authorized distributors caught buying product from outside parties

• Food and Drug Administration (FDA) implemented long-postponed pedigree rule


• Individual states passed laws restricting wholesale licenses and requiring pedigrees

General information on counterfeit medicines. http://www.who.int/medcines/services/counterfeit/overview/en. Accessed March 6, 2008.

All Better Now, Right? Wrong!

• Big 3 still buy unknown amount from secondary market

• FDA pedigree rule tied up in court

• State reforms rolled back by wholesalers


Counterfeit medicines. http://www.wpro.who.int/health_topics/counterfeit_medicines/general_info.htm. Accessed on March 6, 2008.

What Pharmacists Can Do• Inspect all medicine for: • Resist deals that sound too p

• Appearance Changes• Misspellings• Packaging Changes• Sticky Traces on Boxes

• Be wary of discounts• Avoid suspiciouswholesalers

good to be true

• Stay on top of all manufacturer & FDA alerts


“The Price Tells a Story”-Cesar Arias, Former Florida State Drug Inspector

and notices

Rep. Gutknecht: “There are counterfeiters you may call them

Congressional Testimony 11/01/2005

counterfeiters—you may call them counterfeiters, I would call them entrepreneurs—that are bringing [knock-off Viagra] in and selling them for $5…the net result for the consumer is exactly the same.”

Rep Gil Gutknecht (R MN)


The reality—counterfeiters do not provide a guarantee that the effect on the consumer will be the same. And so, it is a crapshoot.

Rep. Gil Gutknecht (R-MN)

The Zitomer Discount


Swarovski crystal dog collar,$125

Counterfeit Drugs Reach Consumers Anyway…Pharmacies• Counterfeit Norvasc® dispensed

b H ilt ON Ph i t

Health Fairs• Fake Flu Vaccine at Exxon-sponsored

by Hamilton, ON Pharmacist (September, 2005)

• Counterfeit Lipitor® recalled by UK Health Officials (July, 2005)

• Poison Toothpaste stocked by Georgia Jails (August, 2007)Toothpaste imported from Suzhou

Health Fair (September, 2006)“Vaccine” containing water administered to at least 1,100.

Internet• FDA finds Xenical® purchased off the

internet to contain talc and starch (May, 2007)


Toothpaste imported from Suzhou, China, found to contain diethylene glycol.

“You could clean shoes with it.”-Sherri Painter, inmate at Atlanta’s Metro St. Prison


Lola the Newfoundland and Family

www.dangerousdoses.comNow in paperback with updated chapter

Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination ofAmerica’s Drug Supply


Contact Katherine Eban: [email protected]

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Fixing the System: The Critical Role of Regulators PharmacistsRole of Regulators, Pharmacists,

and Patients

Eleni Z. Anagnostiadis, RPhAssociate Executive DirectorAssociate Executive Director

National Association of Boards of Pharmacy


Road Map

Fixing the system—critical role of:Fixing the system—critical role of:Regulators

Federal and stateStakeholdersPharmacistsPatients

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Federal Regulation of Wholesale Distributors

Prescription Drug Marketing Act (PDMA) of 1987,Prescription Drug Marketing Act (PDMA) of 1987, Prescription Drug Amendments (PDAs) of 1992

Banned the Sale of Drug Samples and Drug CouponsBanned Reimportation (limited exceptions)Set Requirements for Sample Distribution and StorageRequired State Licensing of Wholesale DistributorsRequired Identity Statements for Sales (pedigrees) by Unauthorized Distributors of Record

Prescription Drug Marketing Act (PDMA). http://www.fda.gov/cder/regulatory/PDMA/default.htm. Accessed March 5, 2008.

Federal Authorities Seize Prescription Drugs From Distributors

April 28, 2005–FDA/US attorney, District of UtahSeries of indictments against multiple prescription d di t ib tdrug distributors

PDRX (Pharma Discount)–Salt Lake City, UTEmpire Pharmaceuticals–Newberry Park, CADRX Medical (Defonte Trading)–Aberdeen, NJPRNY Enterprises/AC Global/AC Healthcare/Afro Caribbean Healthcare–Floral Park, NY

Illegal distribution of the diverted drugs could affectIllegal distribution of the diverted drugs could affect the safety and efficacy of over 40 medications in over 80 pharmacies

Pharmacies and Drugs Affected by Drug Diversion Operation. http://www.fda.gov/bbs/topics/answers/2005/ANS01353lists.html. Accessed March 5, 2008.

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2005 FDA Consumer Advisory

Mexican Border PharmaciesMexican Border PharmaciesFound Selling Counterfeit Pharmaceuticals

State Board of Pharmacy Efforts

Internet Pharmacy“Brick and mortar” prescriptions supplying Internet site(s)

Florida-based I t t i ti

State: Action TakenNC: shut down several pharmacies dispensing drugs on behalf of pharmacy Web siteKY: seized 163 shipments ofInternet prescriptions

CO: pharmacy dispensed Tamiflu® and tramadol based on online consultations

KY: seized 163 shipments of hydrocodone tablets from unlicensed online prescriptionsCO: pharmacy fined and licensure surrendered; RPh manager disciplined

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Verified Internet Pharmacy Practice Sites (VIPPS) Overview

L h d i 1999Launched in 1999 Multi-group task force drafted standards NOT industry regulated or maintainedInvestigate and report rogue sitesCurrently 15 VIPPS entities representing more than 12,000 pharmacies

NABP Verifiable Internet Pharmacy Sites. http://vipps.nabp.net/intro.asp. Accessed March 5, 2008; Consumer Protection Featuresand Professional Practice Standards of VIPPS Program. http://www.netcaucus.org/events/2007/pharmacy/vipps.pdf. Accessed March 5, 2008.

How Are Counterfeit and Diverted Drugs Introduced Into the Drug Distribution System?

Drug Distribution Models1. Manufacturer Retailer

Repackager

2. Manufacturer Wholesaler Retailer

Repackager

3. Manufacturer Wholesaler Wholesaler Retailer

Counterfeit Drug Task Force Interim Report. http: //www.fda.gov/oc/initiatives/counterfeit/report/interim_report.html.Accessed March 5, 2008.

Other Source of Drugs(eg, institutional pharmacies, closed door

pharmacies, foreign markets)

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Regulators: Greatest Challenges

L k f j i di tiLack of jurisdiction Little or no cooperation from some government officialsDifficulty identifying location/owner Lack of resourcesLack of resources

FundingStaff

Consumer education

State Licensing of Wholesale Distributors

State Boards of PharmacyOut-of-State Wholesale DistributorsNABP Model Rules for Licensure of Wholesale DistributorsPhRMA Pedigree ModelStakeholder Meetings

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2007 Wholesale DistributorLegislation State Activity

Tracked 38 bills related to Wholesale Drug Distributors in 25 statesNABP’s involvement at state level

Provides history and education to the boardsboardsReviews legislation/regulations Testifies, upon board request

Wholesale Distributor Enacted Legislation

Arizona NebraskaCaliforniaColoradoFloridaGeorgiaIdahoIndiana

NevadaNew JerseyNew Mexicoa

North DakotaOklahomaSouth Dakota

IllinoisIowaa

KansasMarylandMississippi

Texasa

VermontVirginiaa

WisconsinWyoming

aDenotes clean-up bills. Note: Yellow text reflects 2007 activity.

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Wholesale Distributor Regulations

ArizonaArkansasColoradoDelaware Iowa

NebraskaNew MexicoOregonNevadaVirginiaIowa

MissouriVirginiaWyoming

FDA AmendmentsAct of 2007

Authorizes Health and Human Services (HHS) Secretary to develop standards and identify and validate effective technology to secure drug supply chain

Consult with manufacturers, distributors, , ,pharmacies, and other supply chain stakeholders

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FDA AmendmentsAct of 2007

Requires HHS to establish a “standardized numerical identifier” to be applied at point of manufacturing (within 30 months)

Unclear if requirement is for specific numberNo explicit requirement to implement serialization

References “promising technology” butReferences promising technology but not prescriptive

Radio-Frequency ID (RFID)Nanotechnology

Encryption technologyEncryption technologyOther technologiesOther technologies

NABP’s Model Rules:3 Tiers of Change

More stringent licensure requirements

Pedigrees and establishment of track and trace electronic pedigree system

Increased criminal penalties to dissuade criminals from counterfeiting drug

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Verified-Accredited Wholesale Distributors (VAWD) Overview

Accreditation of wholesale distributorsLaunched in 2005Multi-group task force drafted standards NOT industry regulated or maintainedCurrently 251 VAWD-accredited wholesalers

VAWD Background Information. http://www.nabp.net/vawd/VAWDbackground.pdf. Accessed March 5, 2008.

Adoption of VAWD/Accreditation Concept Since 2005

Recognize

Recognize VAWD in Regulation or by Policy

Require VAWD

Recognize Accreditation

Recognize VAWD in Legislation

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Road Map

Fi i h i i l l fFixing the system—critical role of:Regulators


What Can Stakeholders Do?

T k d h l♦ Track and trace technologyEducate yourself about other perspectives

♦ Work with other stakeholders to find common groundcommon ground

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World Health Organization

Ma 2005May 2005Launched Web-based “Rapid Alert System”Transmits reports on distribution of counterfeit medications to acounterfeit medications to a country’s relevant authorities

Rapid Alert System Highlights. http://218.111.249.28/ras/default2.asp. Accessed March 5, 2008.

Road Map

Fi i h i i l l fFixing the system—critical role of:Regulators


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What Can Pharmacists Do?

♦ Exercise due diligence♦ Exercise due diligenceAsk for wholesaler license numberVAWD accredited?Pedigree, if unknown distributorAuthenticate pedigree transactions

♦ Educate patients♦ Educate patientsDangers of Internet purchasing

Road Map

Fixing the system critical role of:Fixing the system—critical role of:Regulators

Federal and stateStakeholdersPharmacistsPharmacistsPatients

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What Can Patients Do?

Be their own advocate♦ Be their own advocate♦ Shop in a safe manner ♦ Be aware ♦ Speak with their pharmacistsp p

Conclusion

PatientsPharmacistsIndustry stakeholdersRegulatorsRegulators

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Eleni Z. Anagnostiadis, RPhAssociate Executive DirectorAssociate Executive DirectorNational Association of Boards of Pharmacy

[email protected]

Visit the NABP Web site at www.nabp.netVIPPS Accreditation Program and CriteriaVIPPS Accreditation Program and Criteria VAWD Accreditation Program and Criteria

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Question & Answer Session

Closing Remarks

welcome and overview - cecitywelcome and overview eleni z. anagnostiadis, rph associate executive...

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