Toward a Safe and More Secure Supply Chain

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Toward a Safe and More Secure Supply Chain
A case study in the real-world application of
RFID technology in the pharmaceutical supply chain
January, 2007 John Cunningham, Director RFID,
Asia Pacific Motorola (formerly
Symbol) John.cunningham_at_symbol.com 65 9616 9961
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Market Landscape

• Definitions
• RFID Radio Frequency Identification. Uses
  radio waves instead of bar code.
• E-pedigree Electronic certificate that tracks
  an individual products as they move through the
  supply chain.
• EPC Electronic Product Code, Unique item level
  identification. Standards established by GS1
  which is same organization that establishes
  barcode standards.

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Market Landscape

• Main factors motivating Pharma companies to adopt
  RFID
• Comply with mandates by retailers (Wal-Mart)
• Meet regulations (Federal and State Pedigree
  laws)
• Prescription Drugs Marketing Act (stay expires
  1/07)
• E- Pedigree legislation in Florida, California
  and other states
• Reducing Fraudulent and Imitation Drugs Act
  (Burton)
• Drive business benefits by addressing significant
  industry problems (Counterfeiting, diversion and
  safety)

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FDA Recommendations

• FDA Recommends RFID technology for combating
  counterfeiting of pharmaceuticals
• Not a mandate for RFID, but did reinforce its
  belief in the technology as a key element in the
  fight against counterfeiting.
• FDA wants to see the Pharma supply chain
  stakeholders "continue to work expeditiously"
  toward the realization of electronic pedigrees. 
   
• All of the pedigree regulations outlined in the
  Prescription Drug Marketing Act of 1987 will be
  implemented. (Note these regulations refer to
  paper pedigree, not RFID-enabled electronic
  pedigree.) Enforcement of the regulations will
  initially apply to those drugs most susceptible
  to counterfeiting.
• Four aspects of RFID adoption are cited as
  needing further development
• Technical complexities of mass serialization
• Realization of a national pedigree regulation
  instead of a fractured group of regulations
  coming from individual states
• Privacy protections
• Consumer education about RFID including full
  disclosure when purchased drugs contain RFID tags.

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Pharmaceutical Item Tracking
ISSUE

• Expected FDA Mandate to track prescription drugs
• Better supply chain visibility

SOLUTION

• RFID item level tagging
• Reader for tracking product?packaging?shipping

RESULTS

• Compliance with future mandates
• Prevention of theft counterfeiting
• Improved control of expired meds and stock levels

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Purdue Pharma
Worlds first system for tagging large numbers of
unique items with EPC tags
Track Trace
Problem
No history or origin tracability
Compliance
Wal-Mart requires Schedule II narcotics suppliers
to RFID tag individual bottles
Pharmacy robberies are growingand OxyContin has
become a target"
Counterfeiting
Benefits
Solution

• Creation of an Electronic Pedigree
• A secure file that stores data about each move a
  product makes through the supply chain
• Each bottle will be able to be traced back
  through the supply chain
• Tagging cases will enable Purdue to locate a
  specific bottle more precisely (48/carton)
• RFID augments existing RSS bar code solutions

• Symbol tags and handheld readers integrated into
  Purdues OxyContin production line.
• Capture data as the product moved from its
  packaging area and then to the shipping area

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Wal-Mart Class II Initiative at Purdue
Two things
1.) RFID-label C2 product at the unit-level
Custom Symbol Inlay
463426786058705434 347651657658054535 734857873434
854566 545414545474546356 454135465463466366 61361
6665645645645 677357567567567567 56878679699789758
9 653436236326665334
2.) Verify 100 read rate in shipper carton
All 48 EPCs read
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EPC Numbering provides a Unique Electronic
Pedigree

• Electronic Product Code

Product Code Number
Serial Number
00359011100101
000000001
Product event data
Electronic Pedigree
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The Purdue Manufacturing Process
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Packaging Line - Item Level

• Reader Station with Symbol reader and antenna
  that interfaces with line PLC
• Verifies EPC manager and item number
• Assures that there is a EPC tag
• Diverts bottle if tag doesnt read

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Packaging Line Case Pack

• Reads case pack of 48 bottles at end of packaging
  line
• Interfaces with SAPs AII EPC system or stores
  data locally
• Verifies uniqueness of EPC serial numbers and
  Reads all 48 bottles in case in 5 seconds
• Used at vault receiving and shipping, also

Reader Station with Symbol reader and antennas
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HD Smith
First Drug Wholesaler in U.S. to Adopt RFID
Problem
Inefficient Product handling and logistics
Poor Product supply chain security integrity
Solution

• HD Smith is using Symbol readers to scan Purdue
  Pharmas tagged products and labeling non-RFID
  tagged products with Symbols 1 x 1 item tags
• HD Smith then ships the product to four
  participating pharmacies, creating the first
  RFID-based pharmaceutical supply chain

Benefits

• Increased Product Integrity with an Electronic
  Pedigree at the bottle serial number level

HD Smith is the seventh largest pharmaceutical
wholesaler in the U.S.,
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Pedigree
Pedigree
Pedigree
Manufacturer
Wholesaler A
Wholesaler A
Wholesaler A
Chain Warehouse
Purdue
HD Smith
Shipping
Receiving
Shipping
Receiving
Shipping
Receiving
Reader
Reader
Reader
Reader
Reader
Reader
Nodes
Electronic Pedigree Processing
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Conclusions

• RFID is a proven technology for counterfeit
  prevention for pharmaceuticals
• Demonstrated improvement in supply chain
  management for manufacturers and suppliers -
  proven ROI
• Full potential benefits will not be realized
  unless end to end supply chain integration exists
  -manufacturer to pharmacy
• Government involvement is needed to provide
  guidance and mandates.

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THANK YOU!

• Questions?
• Email John.cunningham_at_symbol.com
• Phone [phone]

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Symbol R/W Tag can Deliver both Product
Authentication and Pedigree
First Page EPC Global SGTIN-96 Data Structure
stores manufacturer and item information
CRC 16 bits
Reserved 8 bits
Serial Number 38 bits
Note The contents of the Partition field
defines the field lengths of the Manager And
Class fields.
Filter 3 bits
Partition 3 bits
Second Page User memory
Header 8 bits
User Data 104 bits,
CRC 16 bits
where the User data could be formatted as
Mfg Location 8 bits
Carrier ID 8 bits
Distr. ID 8 bits
Carrier ID 8 bits
Store ID 8 bits
Password/Signature 64 bits
E Pedigree
Authentication
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Landscape

• Legislative Update
• Congressman Dan Burton from Indiana introduced
  The Reducing Fraudulent and Imitation Drugs
  (RFID) Act of 2006 in response to the growing
  problem of fraudulent, imitation and counterfeit
  prescription drugs.
• The Act requires that the packaging of any
  prescription drug incorporate,
• RFID, or similar track-and-trace technology
• Tamper-indicating technologies and
• Blister security packaging when possible.
• Beginning no later than 180 days after the
  legislations enactment, publish National
  Specified List of Susceptible Prescription Drugs,
  and will contain no fewer than 30 prescription
  drugs.
• Within one year (or no later than December 31,
  2007) of the initial publication of the
  above-mentioned List, the act will be in forced.

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Landscape

• Legislative Update
• The Prescription Drugs Marketing Act (PDMA)
  Pedigree stay expires Jan 07, requiring all
  prescription drugs to have a Pedigree.
• The FDA assembled a task force with the charter
• organize a workshop with the key industry
  stakeholders on Feb 8-9th
• release a report in May with their findings.
• The consensus is that there are 3 potential
  courses of action for the FDA
• Allow the stay to expire
• Extend the stay with new provisions
• Propose Federal legislation for ePedigree.
• The most likely outcome is for a provisional
  stay. If a provisional stay is introduced it
  would be for 1 year, because individual states
  are now developing Pedigree Laws and requesting a
  nationwide standard.