Transcript Electronic Pedigree

RF Pathways ™
RFID’s Role in Pharmaceutical
Pedigree
By: Stan A. Szlapetis
Director of Software Services
Pedigree in
Pharmaceutical Industry
 A pedigree is a certified chain of custody
detailing the movement of a drug from the
manufacturer through wholesaler/repackager, until final sale to a hospital or a
pharmacy.
 The goal of pedigree regulations is to
protect patients from counterfeit drugs.
 It should provide brand security to the
pharmaceutical companies.
By: Stan A. Szlapetis
Director of Software Services
Counterfeit Drugs
 Drug counterfeiters are becoming highly sophisticated with
knock offs that look identical to legitimate drugs.
 The majority of counterfeit drugs have little or no therapeutic
value and can lead to serious health issues.
 The counterfeits are often missing active ingredients, are
diluted, product's potency misrepresented or expiration date
extended.
 A large portion of these drugs reach pharmacies and
unsuspecting patients.
 Besides the economic incentives for counterfeiting, the
vulnerabilities can be exploited through bioterrorism.
 FDA criminal investigations of drug counterfeiting have
significantly increased in recent years.
By: Stan A. Szlapetis
Director of Software Services
Brand Security
 The US pharmaceutical industry loses
approximately $2 billion to counterfeiting annually.
 Counterfeiting tarnishes the reputation of a trusted
brands.
 Recall of counterfeit Lipitor® cost Pfizer $55 million
 World Health Organization estimates counterfeit
drugs compromise 5-8% of the world supply.
By: Stan A. Szlapetis
Director of Software Services
Electronic Pedigree
 Electronic Pedigree is an effective
method of protecting the patient and
the pharmaceutical company from
counterfeiting
By: Stan A. Szlapetis
Director of Software Services
How Electronic Pedigree
Works
 The electronic pedigree is an growing trail of the drug’s
custody through the supply chain.
 Each company handling the product adds to the pedigree
trial.
 The seller identifies the drugs and the full chain of custody.
Then certifies the pedigrees and transmits them in advance.
 The trading partner receiving the drugs authenticates the
pedigrees and verifies the authenticity of the product when it
is received.
 In case of an inspection, the company must be able to
produce the pedigree for that product. The specific audit trail
is retrieved from a compliant repository and presented to the
inspector.
 Electronic pedigrees authenticate automatically and workers
are alerted immediately to any discrepancies.
By: Stan A. Szlapetis
Director of Software Services
Maximum Security
 Electronic pedigrees are far more secure than
paper.
 They are much easier to record and manage
 Far quicker to retrieve and verify
 The PAPER pedigrees of counterfeits are easily
forged and thus hide the drug’s true origin.
By: Stan A. Szlapetis
Director of Software Services
EPC Standard to Serialize
Pharmaceutical Drugs
 By putting the EPC serial number on each drug,
it's possible to track every case, pallet and
individual unit as it moves through the supply
chain.
 The EPC and RFID tracking approach has already
been adopted by:
 Consumer packaged goods manufacturers such as
Gillette and Procter & Gamble
 Major retailers like Target, Wal-Mart and SAMS Club
 Department and Defense.
By: Stan A. Szlapetis
Director of Software Services
Pedigree Process
EPC Serial #
Manufacturer
Manufacturer
Distributor #1
Distributor
By: Stan A. Szlapetis
Director of Software Services
 Manufacturer records the
EPC serial numbers with
central agency and the
product is shipped to a
distributor
 Distributor verifies the
pedigree/origin of product on
receipt
Pedigree Process
EPC Serial #
Manufacturer
Distributor #1
Distributor #2
Distributor #1
Distributor #2
 Distributor 1 adds to the pedigree trail when they ship
the product to Distributor #2
 Distributor #2 verifies the COMPLETE trail from
manufacturer through Distributor #1 to them
By: Stan A. Szlapetis
Director of Software Services
Pedigree Process
EPC Serial #
Manufacturer
 Distributor #2 adds to the
pedigree trail when they
ship the product to the
pharmacy
 Pharmacy verifies the
COMPLETE trail from
manufacturer through
Distributor #1 and #2 to
them
Distributor #1
Distributor #2
Pharmacy
Distributor #2
Pharmacy
By: Stan A. Szlapetis
Director of Software Services
Benefit of RFID in Pharma
 RFID allow all of these businesses to
quickly read and record the serial
numbers from each individual bottle
of medication without opening the
cartons
 Manual process would be very
cumbersome and error prone
By: Stan A. Szlapetis
Director of Software Services
Paper Pedigree
 Inefficient, Labor intensive & Error Prone
 With volumes of documentation, retrieval can take
time
 Difficult to track which pedigree document
matches which product
 Physical documents can be forged, lost, or
damaged
 Manually verifying each transaction on each
pedigree can add hours to a receipt
 Manual signing is labor-intensive and timeconsuming, and prone to forgery
By: Stan A. Szlapetis
Director of Software Services
Electronic Pedigree
 Fast, Efficient, Verifiable and Secure
 Millions of documents can effectively be
stored and retrieved
 Electronic authentication occurs quickly
behind the scenes
 Precise pedigree to product match
 Secure documents and digital signatures
cannot be forged and tampering is easily
detected
By: Stan A. Szlapetis
Director of Software Services
Tasks for Client
 Label each product with an RFID tag as it is
produced
 The tags are read automatically when the product
is received in the warehouse
 Warehouse tracks the product wirelessly until it is
shipped
 As the product is shipped, the serial numbers
contained in the shipment are again read and
registered to form the pedigree trail
By: Stan A. Szlapetis
Director of Software Services
RF Pathways™
Automation Associates
 Founded in 1991, based in Toronto, Automation Associates
Inc. is a privately held corporation specializing in bar coding
and automated data collection solutions.
 Self-funded, profitable and growing, AAI has been delivering
unique warehouse management solutions that make
businesses better and more profitable.
 A sample of our client base includes
 Dare Foods, KN Logistics, IBM, Cadbury Adams, Trebor Allan, TRW
Automotive, Lucas Varity, Arvin Rides, Hewlett Packard, Glaxo Smith
Kline, Purolator, Taylor Steel, John Vince Foods, MacGregors Meats,
Map Art Publishing, York Uniforms/Unisync Group, Mitten Vinyl, Fenco
Automotive, Midland Courier and many others.
By: Stan A. Szlapetis
Director of Software Services
Roll of RF Pathways™
 Work with Client to derive specific
requirements for their operation
 Set up the RFID infrastructure
 Install Software System to manage
EPC serial numbers on receipt and
on shipment
 Connect RFID system to SAP
By: Stan A. Szlapetis
Director of Software Services
Questions?
By: Stan A. Szlapetis
Director of Software Services