Nov 15, 2005Two RFID-enabled, integrated solutions for pharmaceuticals track and trace applications were announced Monday at the RFID Healthcare Industry Adoption Summit in Arlington, Va. Both use electronic pedigrees, or e-pedigrees, to prove a drug's chain of custody and protect against the introduction of counterfeit and/or diverted (fraudulently obtained and resold) drugs into the supply chain.
In 2004, the U.S. Food and Drug Administration (FDA)'s Office of Criminal Investigations (OCI) initiated investigations into 58 instances of drug counterfeiting. This represented a significant increase from the 30 cases opened in 2003, an indicator that counterfeiting is becoming more prevalent. Because of this, the FDA is interested in implementing new technologies to protect the U.S. drug supply more effectively. Counterfeit medicines pose significant health risks to consumers and greatly impact the pharmaceutical industry through lost revenue.
Sun Microsystems released its Sun RFID Drug Authentication Solution, a combination of Sun and third-party hardware and software designed to help companies in the pharmaceutical supply chain authenticate drugs and create an e-pedigree using unique electronic product codes (EPCs) encoded to RFID tags. SupplyScape also announced an integrated solution at the health-care summit, in partnership with RFID tag and reader manufacturer Tagsys and Systech, a provider of automated packaging and data collection systems.
Sun is partnering with two different software vendors to provide e-pedigree applications as part of the RFID Drug Authentication Solution. Users can chose between SupplyScape's E-Pedigree Application or Raining Data's ePharma Application Suite. Either application allows users to create, manage and certify pedigree data across the supply chain.
Vivek Khandelwal, principal RFID solutions manager for Sun's RFID Business Unit, says the solution is scalable because pharmaceutical makers, distributors and retailers can start using it now to authenticate the EPC data encoded to a product's tag between two points in the supply chain. Once all trading partners begin reading tags, they can perform chain-of-custody tracking. Khandelwal says users can write their own applications to perform point-to-point authentication, or they can purchase the Raining Data or SupplyScape pedigree application. For end-to-end pedigrees, however, which create a complete chain of custody from the point of manufacture through to the point of sale, they would need a pedigree application.
To deploy the solution, companies use Sun's RFID middleware to commission the EPCs, then collect and filter the EPC data from RFID tags and readers, not included in the offering. The middleware supports both high frequency (13.56 MHz) and ultra-high frequency (915 MHz) RFID tags. In field trials for RFID for track and trace applications, end users in the pharmaceutical industry are testing both types of tags to track drugs. (See Six U.K. Drugmakers Pilot RFID and Purdue Pharma Tags OxyContin.)
Sun is demonstrating its RFID Drug Authentication Solution at the RFID Healthcare Industry Adoption Summit through Nov 16.
Unlike the Sun solution, the SupplyScape-Systech-Tagsys package includes RFID hardware: Tagsys ARIO 40-SDM 13.56 MHz tags and readers. It also includes Systech's serialized product tracking solution, which manages all packaging line devices, including RFID interrogators (readers) used to encode EPCs to RFID tags attached to individual containers of drugs. (This system also reads and records bar code data printed on the drug labels.) Systech software verifies all data on the RFID tag and bar code of each container. Once the containers are cased and placed on pallets, it also maintains a parent-child correlation to track the containers and pallets.
Systech then exports the EPC data to SupplyScape's e-pedigree application, which the supply chain partners would use to manage the authentication and pedigree for each drug bottle as it moves through the pharmaceutical supply chain.
"Once the SupplyScape software receives each specific serial number [from an RFID tag or bar code], it performs a query of the number against those provided by the drug manufacturer," says Brenda Kelly, SupplyScape's vice president of marketing. The e-pedigree software also checks for any alerts from the drug manufacturer to see if the serial number belongs to a drug that cannot be sold due to a recall or an expired sell-by date."We wanted to work with Tagsys and Systech on this integrated solution because both of those companies have been working with end users who wanted a reliable pedigree solution," says Kelly.
Last month, EPCglobal US introduced its EPC Value Model software and documentation, geared toward helping pharmaceutical manufacturers find the business case for using EPC RFID (see EPCglobal US Offers Tool for Pharma). The FDA has recommended the use of RFID as a means of securing drugs in the supply chain, and a number of states are rolling out initiatives requiring supply chain partners to maintain pedigrees, so as to prove drugs' chains of custody in the supply chain. Both integrated solutions announced on Monday comply with these FDA requirements. The Sun RFID Drug Authentication Solution is available now from Sun, while the SupplyScape-Systech-Tagsys solution is available now from any of the three partnering companies. Pricing information has not yet been released, and none of the companies have so far announced any pilot trials of their solutions.
