Product Pedigree

Product Pedigree

Ron Bone, MBA Sr. Vice President, Distribution Support McKesson Pharmaceutical

Session Agenda

 Marketplace Trends

• Trends of a growing problem • Growth of state legislation

 Pedigree Overview

• Industry collaboration • RFID

 Pharmacy Considerations 2

Pharmacy Purchasing Outlook Networking Conference

August 9, 2006

Marketplace Trends

The FDA has been Opening Cases Since 1997

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There has been Recent Negative Press Coverage

Drugstore Cowboys The Dangerous Traffic in Fake Prescription Medicines

Vanity Fair May 05

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Counterfeit Labeling Of Epogen

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FDA Combating Counterfeit Drugs February 2004 • Called for the use of RFID December 2004 • Called for Pedigree Database May 2005 • Called for Electronic Track and Trace May 2006 • PDMA Final Rule effective 12/2/06. Reaffirms RFID Dropped the central Database 7

Pharmacy Purchasing Outlook Networking Conference

August 9, 2006

DRAFT

PDMA 1999 Final Rule (if implemented as currently written) 1. ADR to Pharmacy

2. ADR - ADR

3. ADR To Non-ADR

4. ADR Cleansing

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Mfr.

ADR

Mfr.

ADR

No Pedigree

No Pedigree

ADR

No Pedigree Required

Mfr.

Mfr.

ADR

ADR

(Defacto Pedigree Implied) No Pedigree

(Defacto Pedigree Implied)

Non-ADR

Non-ADR

Pedigree Back to Mfr. Dates, Lot #, etc.

Pharmacy

No Pedigree

Pedigree Back to Mfr. Dates, Lot #, etc.

ADR

No Pedigree

Pharmacy

Pharmacy or Another Distributor

Pharmacy

Explanation • By “defacto” pedigree, we mean that even though the rule doesn’t require a pedigree for an ADR to sell to another ADR, the first ADR must supply the pedigree information for the second one so that the second one may meet the rule’s requirements. • Pedigrees must contain the following information for all transactions going back to the manufacturer: Drug names, Dosage, Container size, Number of containers, Lot #,Pharmacy Business name and address of all parties to each prior transaction (including manufacturer). August 9, 2006 Purchasing Outlook Networking Conference

28 States - Pending or Passed Pedigree Legislation

Disclaimer: This map summarizes the states who have passed or introduced pedigree legislation. This map is not intended to be legal or August 9, 2006 Purchasing regulatoryPharmacy advice on pedigree legislation.Outlook Networking Conference

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Pedigree Overview Objective:

To ensure a safe and secure supply chain.

Electronic pedigree provides efficient and paperless technology to achieve this.

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Pharmacy Purchasing Outlook Networking Conference

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Pedigree Overview

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TERM

DEFINITION

Pharmaceutical Pedigree

A record of a drug's chain of custody, from the point of manufacture to the point of dispensing.

E-pedigree

Electronic pedigree track and trace (chain of custody) information on product information.

RFID Technology

Radio Frequency Identification using electronic product code (EPC).

Pharmacy Purchasing Outlook Networking Conference

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Pedigree Overview Strategic Benefits

• Counterfeit prevention • Recall precision • Brand value protection

Long-term Operational Benefits • Faster, more accurate

shipping and receiving

• Potential labor savings and inventory costs

• Expedited Returns processing

• Compliance with

Prescription Drug Marketing Act (PDMA) and State requirements

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Radio Frequency Identification (RFID)

RFID Gen2 Chip – Available Fall 2005

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Gen2 Chip has 48,000 Transistors

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RFID Tag and Terminology

RFID Tag

IC – “Chip”

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RFID Tag and Terminology

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TERM

DEFINITION

Tag

A microchip attached to an antenna. The tag draws energy from an electromagnetic field created by the reader.

Reader

Communicates with RFID tags and passes information in digital form to a computer system.

EPC

Electronic Product Code is the coding standard used to identify an item. Similar to UPC code with the addition of serialization.

Pharmacy Purchasing Outlook Networking Conference

August 9, 2006

RFID vs. Bar code Barcode

Data Matrix 2D

RFID

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Pilot Projects 2002-2006

RFID Evaluation - Jumpstart Project Program Management

Manufacturers

Wholesalers

Retailers

Regulatory & Trade

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Business Scenarios Approach Validate Benefits Category Safe & Secure Supply Chain

• • • •

Regulatory Compliance Product Security Consumer Safety Theft / Shrink Management

Reverse Logistics

• • • •

Expiration Dating Management Lot & Batch Tracking Returns Management Recall Expediting

Operational Efficiencies

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Issues

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• Shipping Accuracy • Receiving Accuracy • Operational Productivity

August 9, 2006

On Track Mission Statement:

 Drive towards a safe and secure supply chain while increasing cost efficiency and the quality of health care through pharmaceutical serialization strategies.

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On Track Participants Manufacturer Partners

 GlaxoSmithKline  Novartis  Pfizer  Purdue  Roche

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Retailer Partners

 Rite Aid  Target  Walgreens  Wal-Mart

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Wholesale Distributors  Cardinal Health  McKesson

August 9, 2006

On Track is an Opportunity to… • Bring together trading partners and create a living laboratory across the supply chain to advance product safety, item serialization, and the quality of healthcare

• Leverage the learnings and momentum of industry leading companies to reduce costs and development time

• Gain real-world experience with product serialization in a technology-agnostic environment

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On Track is an Opportunity to… • Leverage learnings into practical commercial serialization installations

• Provide fact-based information to the membership, the industry, the technology community and policy makers

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Challenges for Potential Solutions  Competing electronic technologies

• Various primary electronic tags i.e. 2D bar codes (line-of-sight) • Non-Standard tags • Bar code vs. RFID (backwards track)

     26

Manufacturers Serializing all Rx products States requiring different data elements Data Sharing (Peer to Peer vs. Shared Network) Technology and standards continue to evolve Adoption time across industry

Pharmacy Purchasing Outlook Networking Conference

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RFID Activity and Future Considerations  EPCglobal is the standards setting body for RFID/EPC

 Industry segments work with EPCglobal Business Action Groups • Healthcare & Life Sciences is the business action group for pharmaceuticals and medical devices

 Generation 2 Tags

• Became available in fall of 2005 • Superior reads • Superior penetration into the case/pallet • Encryption kill feature • Tag Purchasing Outlook Networking Conference 27 Pharmacy

August 9, 2006

Considerations for Pharmacy What is happening in your state on pedigree?

• Is there a way for you to influence the

legislation or regulations to achieve the goal of improved patient safety?

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Considerations for Pharmacy

How will you store and provide pedigree information, upon request?

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Considerations for Pharmacy

Does the PDMA final rule impact your pharmacy operation?

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Pharmacy Purchasing Outlook Networking Conference

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Considerations for Pharmacy Are you aware of the most commonly counterfeited items? • National Association of Boards of Pharmacy

(NABP®) lists of 34 specified list of susceptible products.

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National Specified List of Susceptible Products               

Bextra (Valdecoxib) Celebrex (Celecoxib) Combivir (lamivudine/zidovudine) Crixivan (indinavir) Diflucan (fluconazole) Epivir (lamivudine) Epogen (epoetin alfa) Gamimune (globulin, immune) Gammagard (globulin, immune) Immune globuin Lamisil (terbinafine) Lipitor (atorvastatin) Lupron (leuprolide) Neupogen (filgrastim) Nutropin AQ (somatropin, E-coli derived)  Panglobulin (globulin, immune)  Procrit (epoetin alfa)  Retrovir (zidovudine)

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 Risperdal (risperidone)  Rocephin (ceftriaxone)  Serostim (somatropin, mannalian             

derived) Sustiva (efavirenz) Trizivir (abacavir/lamivudine/zidovudine) Venoglobulin (globulin, immune) Viagra (sildenafil) Videx (didanosine) Viracept (nelfinavir) Viramune (nevirapine) Zerit (stavudine) Ziagen (abacavir) Zocor (simvastatin) Zofran (ondansetron) Zoladex (goserelin) Zyprexa (olanzapine)

National Association of Boards Outlook of Pharmacy,Networking 2004 Pharmacy Purchasing Conference

August 9, 2006

Questions?