Presentation to the FDA AntiCounterfeiting Drug Initiative Public Workshop

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Presentation to the FDA Anti-Counterfeiting Drug
Initiative Public Workshop Vendor Display

• What is Needed for Widespread RFID
  Implementation
  
• Stephen Perlowski
• Vice President, Industry Affairs
• NACDS

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Agenda

• RFID vs. 2-D Bar Code
• NDC in the EPC
• Data Management
• Initiating a Pedigree

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RFID vs. 2-D Bar Code

• Operational Efficiency
• One improves
• One detracts
• Reduced Errors
• Eliminate Line of Sight
• Better Manage Inventory

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Need for the NDC within the EPC
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Need for NDC within EPC

• Patient Safety
• Patient Profiles
• DUR
• Drug Recalls
• Drug Interactions

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Need for NDC within EPC

• Supply Chain Benefits
• Receiving Verification
• Pedigree Authentication
• Processing Returns Damages
• Item Set-up
• PO Transmission
• Invoice Processing and Remittance
• Physical Inventory Cycle Counting

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Need for NDC within EPC

• In-Store Uses
• Verification of receipt
• Pedigree Authentication
• Storage Item Set-up
• Dispensing
• Inventory Control
• Process Returns
• PO Transmission
• Invoice Processing and Remittance
• Payment from 3rd Parties

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Need for NDC within EPC

• NDCs reside in multiple databases within the same
  store one for inventory, one for operations
  
• Many current processes rely on NDCs including
  Third Party Pre and Post adjudication processes
  
• Accounting systems Utilize NDC to reconcile
  payment

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Impact on Pharmacy if NDC is not Included

• Additional investments would have to be made
• Internet access for all stores
• Time to access databases for each manufacturer
• Cost to develop Interface system to various web
  sites
  
• Add at least 3 seconds to every transaction
• What happens if system goes down?
• Cost to develop systems to receive and validate
  the cross reference and to maintain integrity of
  cross reference tables

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Data Management

• Three Potential Paths
• Central Database
• Multiple Databases
• Peer to Peer

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Data Management

• Three Potential Paths
• Central Database
• Multiple Databases
• Peer to Peer

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Electronic Pedigree

• Universally Recognized Fields
• Pedigree Fields Initiated by Manufacturer