By: Stan A. Szlapetis Director of Software Services 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  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

By: Stan A. Szlapetis Director of Software Services Pedigree Process  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  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

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 Paper vs. Electronic 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 Paper vs. 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?