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The pharmaceutical supply chain e-Pedigree innovator SupplyScape has contributed its e-Pedigree intellectual property (IP) to the EPCglobal Drug Pedigree Standard, which was ratified last week.
The royalty-free IP contribution is the result of long-term investment in research and development (more than three years in total). Now ratified as an open standard, the EPCglobal Drug Pedigree Standard details the format for a pedigree document, including all the data fields and certification processes necessary to comply with all known drug pedigree laws in the US. These laws include the California electronic pedigree law and the Florida electronic pedigree rules, as well as all state pedigree laws and regulations and the federal Prescription Drug Marketing Act that allow paper or electronic approaches.
Action groups
The EPCglobal Healthcare Life Science and Software Action Groups asked Lucia Deus, Vice President of Product Development at SupplyScape, to be Editor for the technology specification of the new industry standard.
In this role, Deus collaborated with other experts in the working groups and participants from across the supply chain. The cross-industry initiative resulted in development and ratification of the new standard in just over one year - which is very fast for the development of any open industry standard.
Codification of business processes
Eli B. Perlman of TIBCO Software Health Sciences Industry Group, and co-chair of the EPCglobal Drug Pedigree Messaging Working Group, said: "While this is a technology specification, more importantly, it is the codification of the business processes and use cases that occur throughout the pharmaceutical supply chain."
In specifying the format that enables regulatory compliance, the EPCglobal pedigree standard accommodates a variety of approaches in use today across the drug distribution industry. Electronic pedigree documents are encouraged, but the standard also specifies how paper pedigrees can be scanned and embedded into the electronic document, ensuring a complete pedigree document record of the drug's chain of custody. Numerous product serialisation approaches can be used, including RFID, many types of barcode, or no product serialisation at all.
Widespread adoption
Over 200 million drug bottles have electronic pedigrees already, and e-Pedigree adoption is set to accelerate even faster now that this standard is completed, according to Jeff Durand, vice president of services for SupplyScape.
Source: SupplyScape Corporation
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