E-Pedigree Model for Pharmaceuticals in the Works

The GS1 Healthcare group has put into place a supply chain model for the pharmaceutical industry as part of its 2015 Readiness program. The model uses a standard serialized track-and-trace system, known as an electronic pedigree (e-pedigree). The e-pedigree tracks movements of pharmaceutical products throughout the supply chain.

In 2006, the U.S. Food and Drug Administration (FDA) stated in its Compliance Policy Guide for the Prescription Drug Marketing Act that “A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties to them.”  As of 2008, most states have enacted some sort of pedigree requirement, but they amount to little more than requiring that pharmaceutical supply chain companies be able to provide reports in various formats, such a PDF file.

The existing e-pedigree requirements are a good first step, but a more standardized and automated system would provide important benefits. As a result, GS1 Healthcare US™, an industry group that focuses on driving the adoption and implementation of GS1 standards in the healthcare industry, created a task force to develop the supply chain model. The model simulates the supply chain to 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 addressing the challenges facing supply chain members to implement this system.

The Readiness program, prompted by California’s e-pedigree requirement for 2015, requires that each pharmaceutical product be identified by a single number so that product data is shared as it moves from the manufacturer to the drug store. Each product will have a unique ID number on an RFID tag, or on a 2-D bar code and be encoded with a serial number linked to the product, its expiration date, and the name of the manufacturer. The benefit of this program is to reduce incidences of product counterfeiting, theft, and expiration of items delayed in the supply chain. The system would also make return and recall processes more efficient, because members of the supply chain would be better able to trace back a recalled item.

Another consideration for the task force is how to handle exceptions that can occur, such as a missing bottle in a case, or a bar code that can’t be read by a member of the supply chain. The group will attempt to suggest ways to mange such problems efficiently so as not to delay product movement through the supply chain.

Are you involved in labeling products for the pharmaceutical industry? How do you handle the e-pedigree requirements? We’d be interested in hearing your thoughts, so please, leave a comment.