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GS1 Group Completes Early Phase of E-Pedigree Model
The organization's 2015 Readiness Program includes 50 companies in the pharmaceutical supply chain simulating the movement of products from a manufacturer to a drug store, as well as the electronic data that is captured, stored and shared along the way.
The work is being prompted by California's passage of an e-pedigree requirement for 2015 that will require all members of the supply chain to share data via a single ID number for each bottle of pharmaceutical product. The mandate is intended to reduce incidences of product counterfeiting, theft and other problems, such as the expiration of items delayed in the supply chain, as well as invoice disputes between manufacturers and customers (such as pharmacies) regarding what was shipped and received. The establishment of an e-pedigree system is also intended to make return and recall processes more efficient, the organization reports, by making it easier for members of the supply chain to trace back a recalled item's transit route.
By 2015, the California Board of Pharmacy is requiring pharmaceutical manufactures to track, at the item level, 50 percent of the products they ship that are destined for California, applying a 2-D bar-code label or an RFID tag on each saleable container, and encoding that label or tag with a serial number linked to the product, its expiration date and the manufacturer's name. In 2016, the remaining 50 percent of products must sport such bar-code labels or RFID tags as well, and wholesalers will also need to be using the system, inputting data regarding their receipt and shipment of the products on a shared system, such as software based on EPCglobal's EPC Information Services (EPCIS) standard. (The task force's simulated supply chain model is based on EPCIS-based software, to allow the sharing of data within and across enterprises.)
In 2017, California's drug retailers will need to be using the e-pedigree system as well, in order to identify when they are in receipt of product. Although the regulation is only being implemented in that state, "manufacturers don't just create product destined for California," Celeste notes, so if one state mandates e-pedigree compliance, drugmakers are likely to make all of their products compliant, whether destined for California or elsewhere. "Most conversions [into e-pedigree compliance] are already underway," Celeste says. "All large manufacturers are aware of this and making plans," with generic drug manufacturers and smaller pharmaceutical firms following closely behind.
In some cases, companies are testing the attachment of an RFID tag on each item, while more commonly, they are applying tags only to cases of items and the pallets on which those cases are loaded. The case and pallet tags could then be linked to the unique identifier on every bottle contained in each case or on each pallet, whether that identifier is in the form of a bar code or an RFID tag.
The GS1 Healthcare US Secure Supply Chain Task Force was organized to develop a software application that simulates the supply chain, and that would allow companies to test product movements using e-pedigrees, as well as testing any exceptions that might occur. With this information, they could then begin working on the challenges facing supply chain members to implement this system. "What we're trying to do now," Celeste explains, "is create a simulation of the supply chain with software representing behavior of supply chain partners," using EPCIS software for sharing data, as well as Discovery Services (a data exchange standard under development by GS1) and a map of the supply chain to determine which existing supply chain processes will meet the e-pedigree standard and which will require adjustment. The process, he says, enables wholesalers to see a manufacturer's mapping of logic, and vice versa, in a simulated environment, and to determine how their actions will affect the entire supply chain.
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