Marketplace Trends
• Trends of a growing problem
• Growth of state legislation
Pedigree Overview
• Industry collaboration
• RFID
Pharmacy Considerations
Drugstore Cowboys
The Dangerous Traffic in Fake
Prescription Medicines
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
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
9
regulatoryPharmacy Purchasing
advice on pedigree legislation.Outlook Networking Conference
August 9, 2006
Pedigree Overview
Objective:
TERM DEFINITION
• Compliance with
Prescription Drug Marketing
Act (PDMA) and State
requirements
RFID Tag
IC – “Chip”
TERM DEFINITION
RFID
Regulatory &
Trade
Validate Benefits
Category Issues
• Regulatory Compliance
Safe & Secure • Product Security
Supply Chain • Consumer Safety
• Theft / Shrink Management
• Shipping Accuracy
Operational
• Receiving Accuracy
Efficiencies • Operational Productivity
Mission Statement:
Drive towards a safe and secure supply chain
while increasing cost efficiency and the
quality of health care through pharmaceutical
serialization strategies.
Generation 2 Tags
• Became available in fall of 2005
• Superior reads
• Superior penetration into the case/pallet
• Encryption
• Tag
27 Pharmacy kill feature
Purchasing Outlook Networking Conference August 9, 2006
Considerations for Pharmacy
32 Pharmacy Purchasing
National Association of Boards Outlook
of Pharmacy,Networking
2004 Conference August 9, 2006
Questions?