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A New Approach to Pharmaceutical E-Pedigrees
EPCIS can support chain-of-custody verification—without a cumbersome data burden.
Jan 16, 2012—Many countries have been seeking ways to stem the flow of counterfeit drugs into the pharmaceutical supply chain. RFID and 2-D bar codes enable serial-level traceability of individual packages of medicines, giving each package its own history—or electronic pedigree. This provides robust proof of the chain of custody, from manufacture through distribution to pharmacies. An e-pedigree is an effective anticounterfeiting technique, because it is difficult to falsify the information trail.
California, Florida and other states passed e-pedigree laws, but there were significant variations in their requirements. The Drug Pedigree Messaging Standard (DPMS), developed by GS1 EPCglobal to satisfy all the requirements, was ratified in January 2007, providing a way to format and digitally sign e-pedigree data as it moved through the supply chain. But DPMS involved collection of large quantities of data that had to be exchanged and stored, placing an operational and financial burden on small, independent retail pharmacies, which lacked the IT infrastructure to handle large data files containing nested layers of digitally signed information.
To develop the event-based approach, we have been gathering requirements for robustness and considering the data content and architectural options for message-flow choreography. A new key concept is a "shared checking service": As soon as pedigree data is captured, the service could automatically check to ensure the information is complete and consistent with the previous pedigree history for that item package. It also would be able to perform a number of configurable checks, according to regulations in different regions, as well as any additional tests users might specify.
This approach would let us move from a paradigm of passing a cumbersome, multilayered pedigree document downstream to a service that can provide a prechecked list of EPC numbers for which the pedigree information has been verified before the physical goods arrive, so the receiver knows the items are correct. Detailed pedigree reports could be generated on request.
End users within the health-care sector are considering the service and other architectural approaches to event-based pedigrees.
Mark Harrison is director of the Cambridge Auto-ID Lab.
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