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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.
By Claire Swedberg
May 19, 2010GS1 Healthcare US's Secure Supply Chain Task Force has developed a pharmaceutical supply chain model as part of a program known as 2015 Readiness. The model is intended to prepare members of the U.S. pharmaceutical supply chain to use a standard serialized track-and-trace system (known as an electronic pedigree, or e-pedigree) related to the movements of pharmaceutical items. Since January 2010, a group of 65 individuals representing 50 companies have been helping to craft a simulated supply chain that runs on software commonly used by businesses for Six Sigma processes, to improve efficiency. With the software, a user can map out a supply chain and send items with unique ID numbers, either on RFID tags or on 2-D bar codes. The program aims to develop a model for anyone in the pharmaceutical industry who is responsible for IT, logistics or packaging, as well as manufacturers, retail pharmacies and wholesalers. The model has been developed to simulate a typical forward-moving supply chain, and the group will now further refine it to allow for exceptions and scenarios involving product recalls and returns.

California's e-pedigree law, expected to go into effect in 2015, will require the collection of information related to every pharmaceutical item—including its description, place of origin and expiration date, as well as each sale or trade of the drug, along with the date of those transactions and the names and addresses of all involved parties.


Robert Celeste, the director of GS1 Healthcare US
The 50 companies represented on the task force include drug manufacturers, distributors, retailers and health-care groups, all of whom have become GS1 members. The simulated supply chain application the group is developing supports the intent of the e-pedigree law, says Robert Celeste, the director of GS1 Healthcare US, though the entire supply chain has not yet been simulated. The group may also need to incorporate additional steps into its model. For example, the model might be expanded to include staging areas, where products may wait temporarily as they change hands in the supply chain, in order to comply with some of the pedigree requirements. Such staging areas do not typically exist in the current pharmaceutical supply chain, but might become necessary in the future.

Those hoping to use the model to implement the e-pedigree system in 2015 can gain access to some results of the group's work at a two-hour mini-workshop that will explain the simulation and what it has found. The workshop will be held on June 8 at GS1's UConnect 2010 conference, in San Antonio, Texas.

By fall of this year, Celeste says, the model will be close to completion, and GS1 will offer two two-day workshops allowing members of the pharmaceutical supply chain to learn details of the model, including the work still ahead for the group—namely, how to handle recalls and supply chain exceptions. The workshop will enable users to see how the e-pedigree system would work, learn the potential challenges to using simulation software, and test their own ability to utilize and understand the system—finding a missing item in the supply chain, for example.

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