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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

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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

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DRAFT
PDMA 1999 Final Rule
(if implemented as currently written)

No Pedigree
1. ADR to Pharmacy Pharmacy
Mfr. ADR

No Pedigree No Pedigree
2. ADR - ADR
Mfr. ADR ADR Pharmacy

No Pedigree
3. ADR Required
Pedigree
Pharmacy
To Mfr. ADR (Defacto Non-ADR Back to Mfr. or Another
Non-ADR Pedigree Dates, Lot #, etc. Distributor
Implied)

No No
Pedigree Pedigree
4. ADR Pedigree
Cleansing Mfr. ADR (Defacto
Non-ADR Back to
ADR Pharmacy
Pedigree Mfr. Dates,
Implied) Lot #, etc.
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,
8 Lot #,Pharmacy
Business name and Purchasing Outlook
address of all parties Networking
to each prior Conference
transaction (including manufacturer). August 9, 2006
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
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regulatoryPharmacy Purchasing
advice on pedigree legislation.Outlook Networking Conference
August 9, 2006
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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Pedigree Overview

TERM DEFINITION

A record of a drug's chain of custody, from


Pharmaceutical
the point of manufacture to the point of
Pedigree dispensing.

Electronic pedigree track and trace (chain of


E-pedigree custody) information on product information.

Radio Frequency Identification using


RFID electronic product code (EPC).
Technology

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Pedigree Overview

Strategic Benefits Long-term


Operational Benefits
• Faster, more accurate
shipping and receiving
• Counterfeit prevention
• Potential labor savings and
• Recall precision inventory costs
• Brand value • Expedited Returns
protection 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

TERM DEFINITION

A microchip attached to an antenna. The tag


Tag draws energy from an electromagnetic field
created by the reader.

Communicates with RFID tags and passes


Reader information in digital form to a computer system.

Electronic Product Code is the coding standard


EPC used to identify an item. Similar to UPC code with
the addition of serialization.

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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 Issues
• Regulatory Compliance
Safe & Secure • Product Security
Supply Chain • Consumer Safety
• Theft / Shrink Management

• Expiration Dating Management


• Lot & Batch Tracking
Reverse Logistics
• Returns Management
• Recall Expediting

• Shipping Accuracy
Operational
• Receiving Accuracy
Efficiencies • Operational Productivity

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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 Retailer Wholesale


Partners Partners Distributors
 GlaxoSmithKline  Rite Aid  Cardinal Health
 Novartis  Target  McKesson
 Pfizer  Walgreens
 Wal-Mart
 Purdue
 Roche

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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)
 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

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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
• Tag
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Purchasing Outlook Networking Conference 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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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)  Risperdal (risperidone)
 Celebrex (Celecoxib)  Rocephin (ceftriaxone)
 Combivir (lamivudine/zidovudine)  Serostim (somatropin, mannalian
 Crixivan (indinavir) derived)
 Diflucan (fluconazole)  Sustiva (efavirenz)
 Epivir (lamivudine)  Trizivir
 (abacavir/lamivudine/zidovudine)
Epogen (epoetin alfa)
 Gamimune (globulin, immune)
 Venoglobulin (globulin, immune)
 Gammagard (globulin, immune)
 Viagra (sildenafil)
 Immune globuin
 Videx (didanosine)
 Lamisil (terbinafine)
 Viracept (nelfinavir)
 Lipitor (atorvastatin)
 Viramune (nevirapine)
 Lupron (leuprolide)
 Zerit (stavudine)
 Neupogen (filgrastim)
 Ziagen (abacavir)
 Nutropin AQ (somatropin, E-coli
 Zocor (simvastatin)
derived)  Zofran (ondansetron)
 Panglobulin (globulin, immune)  Zoladex (goserelin)
 Procrit (epoetin alfa)  Zyprexa (olanzapine)
 Retrovir (zidovudine)

32 Pharmacy Purchasing
National Association of Boards Outlook
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2004 Conference August 9, 2006
Questions?