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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
Pharmacy Purchasing Outlook Networking Conference August 9, 20064
The FDA has been Opening Cases Since 1997The FDA has been Opening Cases Since 1997
Pharmacy Purchasing Outlook Networking Conference August 9, 20065
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
Pharmacy Purchasing Outlook Networking Conference August 9, 20066
Counterfeit Labeling Of EpogenCounterfeit Labeling Of Epogen
Pharmacy Purchasing Outlook Networking Conference August 9, 20067
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
Pharmacy Purchasing Outlook Networking Conference August 9, 20068
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).
Pharmacy Purchasing Outlook Networking Conference August 9, 20069
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.
Pharmacy Purchasing Outlook Networking Conference August 9, 200610
Pedigree OverviewPedigree Overview
Objective:
To ensure a safe and secure supply chain.
Electronic pedigree provides efficient and paperless technology to achieve this.
Pharmacy Purchasing Outlook Networking Conference August 9, 200611
Pedigree OverviewPedigree Overview
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 August 9, 200612
Pedigree OverviewPedigree 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
Radio Frequency Identification (RFID)Radio Frequency Identification (RFID)
Pharmacy Purchasing Outlook Networking Conference August 9, 200614
RFID Gen2 Chip – Available Fall 2005RFID Gen2 Chip – Available Fall 2005
Pharmacy Purchasing Outlook Networking Conference August 9, 200615
Gen2 Chip has 48,000 TransistorsGen2 Chip has 48,000 Transistors
Pharmacy Purchasing Outlook Networking Conference August 9, 200616
RFID Tag and TerminologyRFID Tag and Terminology
RFID Tag
IC – “Chip”
Pharmacy Purchasing Outlook Networking Conference August 9, 200617
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.
Pharmacy Purchasing Outlook Networking Conference August 9, 200618
RFID vs. Bar codeRFID vs. Bar code
Barcode
RFID
Data Matrix 2D
Pilot Projects2002-2006Pilot Projects2002-2006
Pharmacy Purchasing Outlook Networking Conference August 9, 200620
Manufacturers Wholesalers Retailers
Regulatory & Trade
Program Management
RFID Evaluation - Jumpstart Project
Pharmacy Purchasing Outlook Networking Conference August 9, 200621
• 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
Pharmacy Purchasing Outlook Networking Conference August 9, 200622
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.
Pharmacy Purchasing Outlook Networking Conference August 9, 200623
On Track ParticipantsOn Track Participants
Manufacturer Partners
GlaxoSmithKline
Novartis
Pfizer
Purdue
Roche
Retailer Partners
Rite AidTargetWalgreensWal-Mart
Wholesale Distributors
Cardinal Health McKesson
Pharmacy Purchasing Outlook Networking Conference August 9, 200624
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
Pharmacy Purchasing Outlook Networking Conference August 9, 200625
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
Pharmacy Purchasing Outlook Networking Conference August 9, 200626
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
Pharmacy Purchasing Outlook Networking Conference August 9, 200627
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
Pharmacy Purchasing Outlook Networking Conference August 9, 200628
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?
Pharmacy Purchasing Outlook Networking Conference August 9, 200629
Considerations for PharmacyConsiderations for Pharmacy
How will you store and provide pedigree information, upon request?
Pharmacy Purchasing Outlook Networking Conference August 9, 200630
Considerations for PharmacyConsiderations for Pharmacy
Does the PDMA final rule impact your pharmacy operation?
Pharmacy Purchasing Outlook Networking Conference August 9, 200631
Considerations for PharmacyConsiderations 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.
Pharmacy Purchasing Outlook Networking Conference August 9, 200632
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?