RFID E-Pedigree’s Potential to Improve Pharma

This article recaps a recent webinar on how the electronic pedigree solutions based on EPCglobal's new Drug Pedigree Standard could help pharmaceutical companies improve patient safety, speed recalls, and improve inventory management.
Published: February 9, 2007

This article was originally published by RFID Update.

February 9, 2007—Businesses deploying pharmaceutical tracking systems based on the new Drug Pedigree Standard from EPCglobal can improve inventory management and speed product recalls, in addition to complying with new state and federal traceability requirements.

“Your ability to improve your business performance and increase revenues is enabled by leveraging the pedigree data both within your four walls and across the value network,” says Lucy Deus, vice president of product development at electronic pedigree solution provider SupplyScape, and technical editor of the EPCglobal Drug Pedigree Standard. Deus spoke at a SupplyScape webinar yesterday entitled “EPCglobal Drug Pedigree Standard – Peeking Behind the Curtain.”

The standard meets the U.S. federal pedigree requirements established in the Food and Drug Administration Prescription Drug Marketing Act (PDMA), as well as the requirements of more than a dozen states with similar laws on the books. A number of other states are also considering similar legislation. The first pedigree requirements took effect in Florida last year.

The national pedigree has not yet been instituted because of a lawsuit filed against the FDA’s Department of Health and Human Services by several pharmaceutical wholesalers to block the requirement (see Injunction May Slow Momentum for RFID E-Pedigrees). Small and mid-size wholesalers have objected to the PDMA pedigree exemption for “authorized distributors” (such as large companies like Cardinal Health and McKesson), which control the lion’s share of pharmaceutical distribution in the U.S.

The EPCglobal standard, which includes some SupplyScape intellectual property, supports the use of RFID and other technologies for creating electronic pedigrees and tracking the chain-of-custody of pharmaceuticals and other items (see E-Pedigree Standard Ratified, Supports RFID). Although it was ratified in January, a number of companies have been using an interim version of the standard since March 2006.

“That was done to help companies that needed to more forward because of the Florida law,” said Deus, who adds that more than 45 companies have implemented pedigree and authentication solutions from SupplyScape already.

According to Deus, the standard supports both serialized and non-serialized items, as well as kitted and repackaged products, and provides extensibility so that the standard can adapt to new technologies and requirements over time.

The standard also provides guidance on voiding and reissuance of pedigree data when an order is cancelled or modified, and guidance on how to maintain a history of these voids and alternations as specified by the various laws.

Companies that are using paper pedigree documentation can convert this data into electronic format, as defined by the standard. “The paper pedigree would be scanned and saved as an image or PDF document,” says Deus. “The pedigree standard allows you to take that raw data from the image and embed it directly into the XML standard.”

EPCglobal will provide interoperability and compliance testing for e-pedigree solutions vendors. According to Deus, a typical e-pedigree solution takes 60 to 90 days to implement.

Aside from compliance issues, Deus says that e-pedigrees can also help improve operations within companies and across the pharmaceutical supply chain.

Traceability can help improve patient safety by reducing fraud and drug diversion, and identifying counterfeit drugs before they reach the patient. These systems can also improve inventory management, which increases availability and lowers costs. The level of transaction detail available improves reconciliation and reduces chargebacks.

“With direct visibility to lot and expiration date information, companies can better manage shelf life and expiration,” Deus added.

Pedigree data can also help companies more narrowly target drug recalls and increase the speed at which a recall can be completed. As an example, SupplyScape customer US Oncology was able to complete a rapid recall of two lots of Methotrexate using pedigree data. The company identified the six practices where the drug was distributed, and provided lot details so that their customers could isolate and return the product. The entire process took only minutes.

“The pedigree data made it fast, efficient, and simple,” Deus said.