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/re-
             packager, 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




                                                Manufacturer records the
                                                 EPC serial numbers with
                                                 central agency and the
                                 Distributor
                                                 product is shipped to a
                                                 distributor
                                                Distributor verifies the
                                                 pedigree/origin of product on
 By: Stan A. Szlapetis
 Director of Software Services                   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   Distributor #1


                 pedigree trail when they     Distributor #2


                 ship the product to the       Pharmacy

                 pharmacy
                Pharmacy verifies the
                 COMPLETE trail from
                 manufacturer through            Distributor #2

                 Distributor #1 and #2 to
                 them



                                                                  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 time-
               consuming, 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

				
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