Spotlight: EPCglobal Drug Pedigree Standard
Business Benefits Result from the Pedigree Standard
More than 45 companies across the pharmaceutical supply chain are already gaining business benefits from the GS1 EPCglobal Drug Pedigree Standard
"This [EPCglobal Drug Pedigree Standard] technology specification...is the codification of the business processes and use cases that occur throughout the pharmaceutical supply chain."Eli B. Perlman, TIBCO Software Health Sciences Industry Group, and co-chair of the EPCglobal Drug Pedigree Messaging Working Group
Examples of business benefits from standard-based pedigrees include improved product availability and inventory management for all trading partners in the drug supply chain; faster and more targeted recalls; and rapid, more precise reconciliation for chargebacks and returns.
Companies also benefit from more efficient receiving, more accurate order fulfillment and fewer stock-outs. Each of these improvements can occur immediately.
Customers using SupplyScape E-Pedigree realize these benefits and more, as a result of the SupplyScape pedigree data management system which is a core component of the pedigree solution. A recall that occurred within a month of the standard ratification provides an excellent example.
A specialty distributor of oncology drugs realized significant savings in time, labor and cost when a drug recall occurred. The distributor was able to assess within minutes whether they had ever received and/or distributed the recalled product. Using their SupplyScape E-Pedigree solution, they identified how much of the recalled product was received, and to which customers it had been distributed. Knowing the exact volume and customers enabled this distributor to rapidly recall all of the product. Patients were protected, customers were pleased with the efficiency, and the distributor was confident the recall was complete. The cost savings was significant for the distributor as well as all the downstream trading partners who had received the product, since the exact quantities and locations were quickly assessed using the standard pedigree details captured in the distributor's pedigree data management system provided by SupplyScape.
"The board believes the standard meets California's electronic pedigree requirements."California Board of Pharmacy, March 14, 2007
Compliance with All Pedigree Laws and Regulations
Ratified as an open standard by companies across the pharmaceutical supply chain in January, 2007, the GS1 EPCglobal Drug Pedigree Standard details the pedigree format, including all the data fields and certification processes necessary to comply with all drug pedigree laws in the US. These 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.
"At SupplyScape we believe standards are essential to ensure pedigree interoperability across the value network of trading partners. I was particularly pleased to work closely with the pedigree initiative leaders at Cardinal Health, McKesson and HDMA, in addition to pharmaceutical manufacturers, pharmacies and technology providers."Lucy Deus, SupplyScape Vice President of Product Development, and technical editor of the EPCglobal Drug Pedigree Standard
The EPCglobal standard accommodates a variety of approaches in use today for drug distribution.
- Electronic pedigrees are encouraged, but the standard also specifies how paper pedigrees can be scanned and embedded into the electronic record, ensuring a complete pedigree of the drug's chain of custody
- Numerous product serialization approaches can be used, including RFID, many types of barcode, or no product serialization at all
- The diverse operational demands of the pharmaceutical industry are addressed, including processes, scenarios and use cases for manufacturers, wholesalers, distributors, pharmacies and third party logistics providers.
SupplyScape Customers Gain Rapid Compliance, Interoperability and Value
"Over 200 million drug bottles have electronic pedigrees already, and ePedigree adoption will accelerate even faster now that this standard is completed."Jeff Durand, Vice President of Services at SupplyScape
SupplyScape customers are leading the industry in the adoption of the GS1 EPCglobal Drug Pedigree Standard to ensure electronic pedigree interoperability. Over 45 companies are using the standard-based SupplyScape E-Pedigree solution.
Because all elements of the software adhere to the GS1 EPCglobal standards, pharmaceutical manufacturers, wholesale distributors, and pharmacies can quickly and cost-effectively add E-Pedigree to their current supply chain infrastructure and processes, helping streamline operations and secure the prescription drug delivery chain from counterfeits. The SupplyScape E-Pedigree format, business rules and integration capabilities support the standard and ensure interoperability with trading partners across the supply chain.
SupplyScape leaders actively participate in all phases of standards development and in standards compliance forums to insure that the E-Pedigree software complies with the GS1 EPCglobal standards. SupplyScape experts contributed essential concepts including the universal e-pedigree format, the pedigree envelope, the self-authenticating pedigree, and the serialization approach now being adopted by the Pharma industry.
