by: stan a. szlapetis director of software services rf pathways ™ rfid’s role in pharmaceutical...

By: Stan A. SzlapetisBy: Stan A. SzlapetisDirector of Software ServicesDirector of Software Services

RF Pathways ™RF Pathways ™

RFID’s Role in Pharmaceutical RFID’s Role in Pharmaceutical Pedigree Pedigree


Pedigree in Pedigree in Pharmaceutical IndustryPharmaceutical Industry

A pedigree is a certified chain of custody A pedigree is a certified chain of custody detailing the movement of a drug from the detailing the movement of a drug from the manufacturer through wholesaler/re-manufacturer through wholesaler/re-packager, until final sale to a hospital or a packager, until final sale to a hospital or a pharmacy. pharmacy.

The goal of pedigree regulations is to The goal of pedigree regulations is to protect patients from counterfeit drugs. protect patients from counterfeit drugs.

It should provide brand security to the It should provide brand security to the pharmaceutical companies.pharmaceutical companies.


Counterfeit DrugsCounterfeit Drugs

Drug counterfeiters are becoming highly sophisticated with Drug counterfeiters are becoming highly sophisticated with knock offs that look identical to legitimate drugs. knock offs that look identical to legitimate drugs.

The majority of counterfeit drugs have little or no therapeutic The majority of counterfeit drugs have little or no therapeutic value and can lead to serious health issues. value and can lead to serious health issues.

The counterfeits are often missing active ingredients, are The counterfeits are often missing active ingredients, are diluted, product's potency misrepresented or expiration date diluted, product's potency misrepresented or expiration date extended. extended.

A large portion of these drugs reach pharmacies and A large portion of these drugs reach pharmacies and unsuspecting patients. unsuspecting patients.

Besides the economic incentives for counterfeiting, the Besides the economic incentives for counterfeiting, the vulnerabilities can be exploited through bioterrorism. vulnerabilities can be exploited through bioterrorism.

FDA criminal investigations of drug counterfeiting have FDA criminal investigations of drug counterfeiting have significantly increased in recent years. significantly increased in recent years.


Brand SecurityBrand Security

The US pharmaceutical industry loses The US pharmaceutical industry loses approximately $2 billion to counterfeiting annually. approximately $2 billion to counterfeiting annually.

Counterfeiting tarnishes the reputation of a trusted Counterfeiting tarnishes the reputation of a trusted brands. brands. Recall of counterfeit Lipitor® cost Pfizer $55 millionRecall of counterfeit Lipitor® cost Pfizer $55 million

World Health Organization estimates counterfeit World Health Organization estimates counterfeit drugs compromise 5-8% of the world supply. drugs compromise 5-8% of the world supply.


Electronic PedigreeElectronic Pedigree

Electronic Pedigree is an effective Electronic Pedigree is an effective method of protecting the patient and method of protecting the patient and the pharmaceutical company from the pharmaceutical company from counterfeitingcounterfeiting


How Electronic Pedigree WorksHow Electronic Pedigree Works

The electronic pedigree is an growing trail of the drug’s The electronic pedigree is an growing trail of the drug’s custody through the supply chain. custody through the supply chain.

Each company handling the product adds to the pedigree Each company handling the product adds to the pedigree trial. trial.

The seller identifies the drugs and the full chain of custody. The seller identifies the drugs and the full chain of custody. Then certifies the pedigrees and transmits them in advance. Then certifies the pedigrees and transmits them in advance.

The trading partner receiving the drugs authenticates the The trading partner receiving the drugs authenticates the pedigrees and verifies the authenticity of the product when it pedigrees and verifies the authenticity of the product when it is received.is received.

In case of an inspection, the company must be able to In case of an inspection, the company must be able to produce the pedigree for that product. The specific audit trail produce the pedigree for that product. The specific audit trail is retrieved from a compliant repository and presented to the is retrieved from a compliant repository and presented to the inspector.inspector.

Electronic pedigrees authenticate automatically and workers Electronic pedigrees authenticate automatically and workers are alerted immediately to any discrepancies. are alerted immediately to any discrepancies.


Maximum SecurityMaximum Security

Electronic pedigrees are far more secure than Electronic pedigrees are far more secure than paper.paper.

They are much easier to record and manageThey are much easier to record and manage Far quicker to retrieve and verifyFar quicker to retrieve and verify The PAPER pedigrees of counterfeits are easily The PAPER pedigrees of counterfeits are easily

forged and thus hide the drug’s true origin. forged and thus hide the drug’s true origin.


EPC Standard to Serialize EPC Standard to Serialize Pharmaceutical DrugsPharmaceutical Drugs

By putting the EPC serial number on each drug, By putting the EPC serial number on each drug, it's possible to track every case, pallet and it's possible to track every case, pallet and individual unit as it moves through the supply individual unit as it moves through the supply chain. chain.

The EPC and RFID tracking approach has already The EPC and RFID tracking approach has already been adopted by:been adopted by: Consumer packaged goods manufacturers such as Consumer packaged goods manufacturers such as

Gillette and Procter & GambleGillette and Procter & Gamble Major retailers like Target, Wal-Mart and SAMS ClubMajor retailers like Target, Wal-Mart and SAMS Club Department and Defense.Department and Defense.


Pedigree ProcessPedigree Process

Manufacturer records the Manufacturer records the EPC serial numbers with EPC serial numbers with central agency and the central agency and the product is shipped to a product is shipped to a distributordistributor

Distributor verifies the Distributor verifies the pedigree/origin of product on pedigree/origin of product on receiptreceipt

Manufacturer

Distributor

EPC Serial #Manufacturer

Distributor #1



Distributor 1 adds to the pedigree trail when they ship Distributor 1 adds to the pedigree trail when they ship the product to Distributor #2the product to Distributor #2

Distributor #2 verifies the COMPLETE trail from Distributor #2 verifies the COMPLETE trail from manufacturer through Distributor #1 to themmanufacturer through Distributor #1 to them

Distributor #1Distributor #2


Distributor #1

Distributor #2



Distributor #2 adds to the Distributor #2 adds to the pedigree trail when they pedigree trail when they ship the product to the ship the product to the pharmacypharmacy

Pharmacy verifies the Pharmacy verifies the COMPLETE trail from COMPLETE trail from manufacturer through manufacturer through Distributor #1 and #2 to Distributor #1 and #2 to themthem

Distributor #2

Pharmacy


Distributor #1

Distributor #2

Pharmacy


Benefit of RFID in PharmaBenefit of RFID in Pharma

RFID allow all of these businesses to RFID allow all of these businesses to quickly read and record the serial quickly read and record the serial numbers from each individual bottle numbers from each individual bottle of medication without opening the of medication without opening the cartonscartons

Manual process would be very Manual process would be very cumbersome and error pronecumbersome and error prone


Paper PedigreePaper Pedigree

Inefficient, Labor intensive & Error ProneInefficient, Labor intensive & Error Prone With volumes of documentation, retrieval can take With volumes of documentation, retrieval can take

timetime Difficult to track which pedigree document Difficult to track which pedigree document

matches which productmatches which product Physical documents can be forged, lost, or Physical documents can be forged, lost, or

damageddamaged Manually verifying each transaction on each Manually verifying each transaction on each

pedigree can add hours to a receiptpedigree can add hours to a receipt Manual signing is labor-intensive and time-Manual signing is labor-intensive and time-

consuming, and prone to forgeryconsuming, and prone to forgery


Electronic PedigreeElectronic Pedigree

Fast, Efficient, Verifiable and SecureFast, Efficient, Verifiable and Secure Millions of documents can effectively be Millions of documents can effectively be

stored and retrievedstored and retrieved Electronic authentication occurs quickly Electronic authentication occurs quickly

behind the scenes behind the scenes Precise pedigree to product matchPrecise pedigree to product match Secure documents and digital signatures Secure documents and digital signatures

cannot be forged and tampering is easily cannot be forged and tampering is easily detecteddetected


Tasks for ClientTasks for Client

Label each product with an RFID tag as it is Label each product with an RFID tag as it is producedproduced

The tags are read automatically when the product The tags are read automatically when the product is received in the warehouseis received in the warehouse

Warehouse tracks the product wirelessly until it is Warehouse tracks the product wirelessly until it is shippedshipped

As the product is shipped, the serial numbers As the product is shipped, the serial numbers contained in the shipment are again read and contained in the shipment are again read and registered to form the pedigree trailregistered to form the pedigree trail


RF Pathways™RF Pathways™Automation AssociatesAutomation 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.


Roll of RF Pathways™Roll of RF Pathways™

Work with Client to derive specific Work with Client to derive specific requirements for their operationrequirements for their operation

Set up the RFID infrastructureSet up the RFID infrastructure Install Software System to manage Install Software System to manage

EPC serial numbers on receipt and EPC serial numbers on receipt and on shipmenton shipment

Connect RFID system to SAPConnect RFID system to SAP


Questions?Questions?

by: stan a. szlapetis director of software services rf pathways ™ rfid’s role in pharmaceutical...

Documents

pharmaceutical drugs

pharmaceutical pedigree

drugs custody

counterfeiting slide

legitimate drugs

majority of counterfeit

pedigree trial

pharmaceutical company