Welcome and Overview. Learning Objectives

Transcription

1 Welcome and Overview Eleni Z. Anagnostiadis, RPh Associate Executive Director National Association of Boards of Pharmacy Mount Prospect, Illinois Learning Objectives Upon completion of this activity, participants 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 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

2 Counterfeit Drugs: A Global Epidemic Eleni Z. Anagnostiadis, RPh Associate Executive Director National Association of Boards of Pharmacy Mount Prospect, Illinois Road Map Scope of drug counterfeiting Internet pharmacy Wholesale drug distributors

3 Scope of the Problem Proliferation of Web sites offering prescriptions for lifestyle and popular drugs Counterfeit drugs in the US drug distribution system What Is a Counterfeit Drug? 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 such 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. Accessed March 3, 2008.

4 Counterfeit Categories Fake Packaging, Correct Quantity of Correct Ingredient (Clone) Fake Packaging, Wrong Ingredient Fake Packaging, No Active Ingredient Fake Packaging, Incorrect Quantity of Correct Ingredient Genuine Packaging, Wrong Ingredient Genuine Packaging, No Ingredient Genuine Packaging, Incorrect Quantity of Correct Ingredient Counterfeit medicines. Accessed March 5, Prevalence of Drug Counterfeiting According to the World Health Organization (WHO): Industrialized countries: approximately 1% Developing countries: over 10% WHO Fact Sheet N Accessed March 5, 2008.

5 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 above 20% Medicines purchased over the Internet from sites that conceal their physical address are counterfeit in over 50% of cases WHO Fact Sheet N Accessed March 5, A Growing Problem 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 Counterfeit medicines: the silent epidemic. Accessed March 5, 2007.

6 What Is Out There?

7 Authentic Ortho Evra Counterfeit Ortho Evra Counterfeit Drug Cases Opened By FDA Per Fiscal Year Number of cases Year US Food and Drug Administration. Counterfeit drug cases opened by FDA per fiscal year. Accessed March 10, 2008.

8 NABP Findings Selling prescription medications 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 buys December 2003 to January 2004 Purchased 8 drugs from 5 suspicious sites, including Xanax, codeine, Valium, injectable testosterone Site shipped isotretinoin to US, despite contrary claim All drugs labeled in foreign language Limited US Pharmacopeia (USP) testing: some testosterone was subpotent

9 NABP Findings Controlled substances and isotretinoin buys Testosterone 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 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 woman Drugs contaminated with extremely high quantities of metal Counterfeit drugs caused woman s death, coroner concludes -6 July Accessed March 5, 2008.

10 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. Accessed March 5, 2008.

11 The Diverters and the Gray Market: How Counterfeits Infiltrate the System and the Pharmacies at Risk Katherine Eban Investigative Reporter and Author New York, New York

12 How the Book Began The Phone Call

13 The Horsemen of the Apocalypse Horseman Fashion

14 The Sunshine Bureaucracy

15 Pharmaceuticals: the 21 st Century Gold Rush Michael Carlow

16 Getting Product

17 Jose Grillo Employment History Bodybuilder Staff member, Vegetarian Palace A Hot Chain

18 Playpen South Rap sheet: - Cocaine - Kidnapping - Aggravated battery

19 Tim Fagan, aged 16 years Received counterfeit Epogen from CVS pharmacy Corrupt Supply Chain Epogen Trail to Timothy Fagan

20 Reforms Big 3 pledged to stop buying from secondary market 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. Accessed March 6, 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. Accessed on March 6, 2008.

21 What Pharmacists Can Do Inspect all medicine for: Appearance Changes Misspellings Packaging Changes Sticky Traces on Boxes Resist deals that sound too good to be true Be wary of discounts Avoid suspicious wholesalers Stay on top of all manufacturer & FDA alerts and notices The Price Tells a Story -Cesar Arias, Former Florida State Drug Inspector Rep. Gil Gutknecht (R-MN) Congressional Testimony 11/01/2005 Rep. Gutknecht: There are 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. The reality counterfeiters do not provide a guarantee that the effect on the consumer will be the same. And so, it is a crapshoot.

22 The Zitomer Discount Swarovski crystal dog collar, $125 Counterfeit Drugs Reach Consumers Anyway Pharmacies Counterfeit Norvasc dispensed 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, China, found to contain diethylene glycol. Health Fairs Fake Flu Vaccine at Exxon-sponsored 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) You could clean shoes with it. -Sherri Painter, inmate at Atlanta s Metro St. Prison

23 Lola the Newfoundland and Family Now in paperback with updated chapter Dangerous Doses: A True Story of Cops, Counterfeiters, and the Contamination of America s Drug Supply Contact Katherine Eban: keban@dangerousdoses.com

24 Fixing the System: The Critical Role of Regulators, Pharmacists, and Patients Eleni Z. Anagnostiadis, RPh Associate Executive Director National Association of Boards of Pharmacy Mount Prospect, Illinois Road Map Fixing the system critical role of: Regulators Federal and state Stakeholders Pharmacists Patients

25 Federal Regulation of Wholesale Distributors Prescription Drug Marketing Act (PDMA) of 1987, Prescription Drug Amendments (PDAs) of 1992 Banned the Sale of Drug Samples and Drug Coupons Banned Reimportation (limited exceptions) Set Requirements for Sample Distribution and Storage Required State Licensing of Wholesale Distributors Required Identity Statements for Sales (pedigrees) by Unauthorized Distributors of Record Prescription Drug Marketing Act (PDMA). Accessed March 5, Federal Authorities Seize Prescription Drugs From Distributors April 28, 2005 FDA/US attorney, District of Utah Series of indictments against multiple prescription drug distributors ib t PDRX (Pharma Discount) Salt Lake City, UT Empire Pharmaceuticals Newberry Park, CA DRX Medical (Defonte Trading) Aberdeen, NJ PRNY Enterprises/AC Global/AC Healthcare/Afro Caribbean Healthcare Floral Park, NY Illegal 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. Accessed March 5, 2008.

26 2005 FDA Consumer Advisory Mexican Border Pharmacies Found Selling Counterfeit Pharmaceuticals State Board of Pharmacy Efforts Internet Pharmacy Brick and mortar prescriptions supplying Internet site(s) Florida-based Internet t prescriptions CO: pharmacy dispensed Tamiflu and tramadol based on online consultations State: Action Taken NC: shut down several pharmacies dispensing drugs on behalf of pharmacy Web site KY: seized 163 shipments of hydrocodone tablets from unlicensed online prescriptions CO: pharmacy fined and licensure surrendered; RPh manager disciplined

27 Verified Internet Pharmacy Practice Sites (VIPPS) Overview Launched in 1999 Multi-group task force drafted standards NOT industry regulated or maintained Investigate and report rogue sites Currently 15 VIPPS entities representing more than 12,000 pharmacies NABP Verifiable Internet Pharmacy Sites. Accessed March 5, 2008; Consumer Protection Features and Professional Practice Standards of VIPPS Program. Accessed March 5, How Are Counterfeit and Diverted Drugs Introduced Into the Drug Distribution System? Drug Distribution Models 1. Manufacturer Retailer Repackager 2. Manufacturer Wholesaler Retailer Repackager 3. Manufacturer Wholesaler Wholesaler Retailer Other Source of Drugs (eg, institutional pharmacies, closed door pharmacies, foreign markets) Counterfeit Drug Task Force Interim Report. http: // Accessed March 5, 2008.

28 Regulators: Greatest Challenges Lack of jurisdiction Little or no cooperation from some government officials Difficulty identifying location/owner Lack of resources Funding Staff Consumer education State Licensing of Wholesale Distributors State Boards of Pharmacy Out-of-State Wholesale Distributors NABP Model Rules for Licensure of Wholesale Distributors PhRMA Pedigree Model Stakeholder Meetings

29 2007 Wholesale Distributor Legislation State Activity Tracked 38 bills related to Wholesale Drug Distributors in 25 states NABP s involvement at state level Provides history and education to the boards Reviews legislation/regulations Testifies, upon board request Wholesale Distributor Enacted Legislation Arizona Nebraska California Nevada Colorado New Jersey Florida New Mexico a Georgia North Dakota Idaho Oklahoma Indiana South Dakota Illinois Iowa a Texas a Vermont Kansas Maryland Virginia a Mississippi Wisconsin Wyoming a Denotes clean-up bills. Note: Yellow text reflects 2007 activity.

30 Wholesale Distributor Regulations Arizona Arkansas Colorado Delaware Iowa Missouri Nebraska New Mexico Oregon Nevada Virginia Wyoming FDA Amendments Act 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

31 FDA Amendments Act 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 number No explicit requirement to implement serialization References promising technology but not prescriptive Radio-Frequency ID (RFID) Encryption technology Nanotechnology Other 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

32 Verified-Accredited Wholesale Distributors (VAWD) Overview Accreditation of wholesale distributors Launched in 2005 Multi-group task force drafted standards NOT industry regulated or maintained Currently 251 VAWD-accredited wholesalers VAWD Background Information. Accessed March 5, Adoption of VAWD/Accreditation Concept Since 2005 Recognize VAWD in Regulation or by Policy Require VAWD Recognize Recognize Accreditation Recognize VAWD in Legislation

33 Road Map Fixing i the system critical ii role of: Regulators Federal and state Stakeholders Pharmacists Patients What Can Stakeholders Do? Track and trace technology Educate yourself about other perspectives Work with other stakeholders to find common ground

34 World Health Organization May 2005 Launched Web-based Rapid Alert System Transmits reports on distribution of counterfeit medications to a country s relevant authorities Rapid Alert System Highlights. Accessed March 5, Road Map Fixing i the system critical ii role of: Regulators Federal and state Stakeholders Pharmacists Patients

35 What Can Pharmacists Do? Exercise due diligence Ask for wholesaler license number VAWD accredited? Pedigree, if unknown distributor Authenticate pedigree transactions Educate patients Dangers of Internet purchasing Road Map Fixing the system critical role of: Regulators Federal and state Stakeholders Pharmacists Patients

36 What Can Patients Do? Be their own advocate Shop in a safe manner Be aware Speak with their pharmacists Conclusion Patients Pharmacists Industry stakeholders Regulators

37 Eleni Z. Anagnostiadis, RPh Associate Executive Director National Association of Boards of Pharmacy Visit the NABP Web site at VIPPS Accreditation Program and Criteria VAWD Accreditation Program and Criteria

38 Question & Answer Session Closing Remarks