Members of the pharmaceutical supply chain have two choices when it comes to complying with the long-deferred pedigree, or chain of custody, requirements taking effect on Dec. 1, 2006: manual or automated. Although manual data collection and maintenance of paper records for each container's travels from manufacturer to consumer may be feasible, an automated electronic method will provide more timely and accurate data in the long run with minimal expenditure of manpower.
E-pedigreeElectronic pedigree, or e-pedigree, systems rely on automatic identification technology to carry the serialized information that uniquely identifies each bottle or vial. The US Food and Drug Administration favors radio-frequency identification (RFID). The agency's Counterfeit Drug Task Force, however, noted in the June update to its report that bar-code technologies, particularly two-dimensional bar codes, are a viable alternative and that "a hybrid approach using both paper and electronic pedigrees will be needed during a transition period."
An e-pedigree system requires the integration of several technologies, item-level serialization, data capture at various points in the supply chain, and recordkeeping so recipients can trace the product's trip through the supply chain and confirm its authenticity.
Purdue Pharma, L.P. (Stamford, CT) quickly realized item-level tagging had track-and-trace benefits within its four walls when it started tagging containers of its "OxyContin" pain-killer to comply with requirements of Wal-Mart Stores (Bentonville, AR).
Purdue Pharma's system consists of ultrahigh-frequency (UHF) tags and readers, device management software, and data management software (Class 0 UHF tags and readers, Symbol Technologies, Holtsville, NY; device-management software, Northern Apex Software, Fort Wayne, IN; "Auto-ID" and "Event Manager" software from SAP AG, Walldorf, Germany). This system interacts with the company's enterprise resource-planning system ("R/3 ERP," SAP AG) and makes it possible to link each bottle of OxyContin to a specific case and pallet.
An e-pedigree trial undertaken with H.D. Smith (Springfield, IL) shipped tagged product and collected and transmitted chain-of-custody documentation using track-and-trace software and collaborative data management ("SupplyScape E-pedigree" software, SupplyScape, Woburn, MA; "ES7000" data management platform, Unisys Corp., Blue Bell, PA).