product pedigree

Product Pedigree Product Pedigree

Ron Bone, MBASr. Vice President, Distribution SupportMcKesson Pharmaceutical

Ron Bone, MBASr. Vice President, Distribution SupportMcKesson Pharmaceutical

Pharmacy Purchasing Outlook Networking Conference August 9, 20062

Session AgendaSession Agenda

Marketplace Trends•Trends of a growing problem•Growth of state legislation

Pedigree Overview• Industry collaboration•RFID

Pharmacy Considerations

Marketplace TrendsMarketplace Trends


The FDA has been Opening Cases Since 1997The FDA has been Opening Cases Since 1997


Drugstore CowboysThe Dangerous Traffic in Fake

Prescription Medicines

Vanity Fair May 05

There has been Recent Negative Press CoverageThere has been Recent Negative Press Coverage


Counterfeit Labeling Of EpogenCounterfeit Labeling Of Epogen


FDA Combating Counterfeit DrugsFDA Combating Counterfeit Drugs

February 2004• Called for the use of RFID

May 2005• Called for Electronic Track

and Trace

December 2004• Called for Pedigree Database

May 2006• PDMA Final Rule effective

12/2/06. Reaffirms RFID Dropped the central Database


DRAFT

PDMA 1999 Final Rule(if implemented as currently written)

Mfr. ADR

Mfr. ADR Non-ADRPharmacyor AnotherDistributor

Mfr. ADR ADR Pharmacy

Mfr. ADR Non-ADR ADR Pharmacy

Pharmacy1. ADR to Pharmacy No Pedigree

2. ADR - ADR No Pedigree No Pedigree

3. ADRTo

Non-ADR

No PedigreeRequired

(DefactoPedigreeImplied)

Pedigree

Back to Mfr. Dates, Lot #, etc.

4. ADRCleansing

NoPedigree

(DefactoPedigreeImplied)

Pedigree

Back toMfr. Dates,Lot #, etc.

NoPedigree

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 #, Business name and address of all parties to each prior transaction (including manufacturer).


28 States - Pending or Passed Pedigree Legislation 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 regulatory advice on pedigree legislation.


Pedigree OverviewPedigree Overview

Objective:

To ensure a safe and secure supply chain.

Electronic pedigree provides efficient and paperless technology to achieve this.



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).



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

Radio Frequency Identification (RFID)Radio Frequency Identification (RFID)


RFID Gen2 Chip – Available Fall 2005RFID Gen2 Chip – Available Fall 2005


Gen2 Chip has 48,000 TransistorsGen2 Chip has 48,000 Transistors


RFID Tag and TerminologyRFID Tag and Terminology

RFID Tag

IC – “Chip”


RFID Tag and TerminologyRFID Tag and Terminology

TERM DEFINITION

TagA 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.

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


RFID vs. Bar codeRFID vs. Bar code

Barcode

RFID

Data Matrix 2D

Pilot Projects2002-2006Pilot Projects2002-2006


Manufacturers Wholesalers Retailers

Regulatory & Trade

Program Management

RFID Evaluation - Jumpstart Project


• Regulatory Compliance • Product Security• Consumer Safety• Theft / Shrink Management

Safe & Secure Supply Chain

Reverse Logistics

Operational Efficiencies

• Expiration Dating Management• Lot & Batch Tracking• Returns Management• Recall Expediting

• Shipping Accuracy• Receiving Accuracy• Operational Productivity

Category Issues

Business Scenarios Approach

Validate Benefits


On TrackOn 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.


On Track ParticipantsOn Track Participants

Manufacturer Partners

GlaxoSmithKline

Novartis

Pfizer

Purdue

Roche

Retailer Partners

Rite AidTargetWalgreensWal-Mart

Wholesale Distributors

Cardinal Health McKesson


On Track is an Opportunity to…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


On Track is an Opportunity to…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


Challenges for Potential SolutionsChallenges 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


RFID Activity and Future ConsiderationsRFID 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 kill feature


Considerations for PharmacyConsiderations 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?



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



Does the PDMA final rule impact your pharmacy operation?



Are you aware of the most commonly counterfeited items?

• National Association of Boards of Pharmacy (NABP®) lists of 34 specified list of susceptible products.


National Specified List of Susceptible Products 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)

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 of Pharmacy, 2004

Questions?Questions?

product pedigree

Documents

pedigree adr

pedigree pharmacy

adr adr

pedigree information

pedigree database

pedigree overviewobjective

electronic pedigree

adr cleansing