Originally Published PMPN March 2005
Track & Trace
Sharing Secure Drug Data along the Supply Chain
Manufacturers, retailers, and others are coming together
to manage the data that make up electronic drug pedigrees.
Daphne Allen
Editor
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| The E-Pedigree software uses a database to track drugs through the supply chain. |
Efforts are under way to develop an electronic tracking system for building drug pedigrees that can work for manufacturers, distributors, retailers, and healthcare providers. Some pilot programs are progressing, especially those that involve multiple players.
One such collaboration is the Drug Security Network (DSN) Lab, organized by Capgemini. The DSN Lab is a pilot center that allows participants to test software, hardware, and certain other elements needed for the creation, tracking, sharing, securing, and archiving of electronic drug pedigree information.
The concept of the DSN Lab was started in June 2004 when a major drug manufacturer sought a new approach to its electronic product tracking. Tony Ross, Capgemini’s project director for the DSN Lab, says that he had heard that “other pilot programs just weren’t getting at the core of the problem. The real issue is to develop a system that works from manufacturing all the way to the pharmacy shelf. All players—manufacturers, wholesalers, repackagers, redistributors, pharmacists—must be involved.”
Capgemini decided to develop a lab environment and make it available to various supply-chain trading partners for electronic pedigree testing. In the DSN Lab, “multiple companies work together under one umbrella to determine how electronic-pedigree requirements affect data sharing and data security,” Ross says. In this environment, he says, “companies are breaking down walls and are working together in an unbiased manner to understand drug distribution.”
Once a team of trading partners is formed, they work together as partners throughout the entire program. For instance, the major drug manufacturer that started the first DSN Lab in November 2004, which Ross calls DSN Lab #1, was joined full-time by another major drug company and major drug wholesalers/distributors, and part-time by a major grocery chain and a healthcare provider from Florida. Newcomers will join new teams for separate pilots at the lab. Companies that wish to work independently can do so as well.
The lab itself—located in Cambridge, MA—is what Capgemini calls an Accelerated Solutions Environment (ASE), a process the firm has patented. The lab models an actual drug supply chain and is equipped to handle electronic pedigrees, mass serialization using Electronic Product Codes (EPC) according to EPCglobal standards, RFID, and 21 CFR Part 11 compliance. Stations that represent each function (in this case, stage of distribution) are set up to test events (product movement in the supply chain). Data on these functions and events are gathered, shared, and archived using E-Pedigree, which is electronic pedigree software from SupplyScape Corp. (Cambridge, MA).
E-Pedigree is a fundamental part of the DSN Lab. The software is built specifically to track pharmaceuticals in the supply chain. To develop it, SupplyScape executives worked closely with researchers at MIT, as well as with regulators at FDA and from Florida. The software tracks the distribution transactions of drugs at all packaging levels and transmits pedigree information for drug authentication. “The software uses a self-authenticating document approach for managing all pedigree data, such as EPC, serial numbers, and supply-chain events, and it maintains all documents of record,” explains Brenda Kelly, SupplyScape’s vice president of marketing. For instance, as soon as a drug shipment is received at a wholesaler, that wholesaler can match the shipment’s EPC serial numbers to those listed in the electronic pedigree already submitted by the previous drug custodian. “Each trading partner has their own pedigree management system, because each is required to maintain pedigree records for three years,” she says. And there are valuable data, she says, since “the pedigree archives more information with each step of the supply chain.”
Managing these documents and authenticating them is serious business, says Kelly. “The new pedigree laws put criminals on notice—there will be a paper trail on drug pedigrees.” Companies will be responsible for creating that trail if they create electronic pedigrees. For instance, she explains, “companies shipping drugs need to sign oaths that all the information in the pedigree is accurate. This includes documenting that previous owners have certified the pedigrees. Signatures are binding to the individual and to the company.”
After more than three months of study, DSN Lab #1 has completed its requirements studies. These involved looking at serialization and how and where pedigree data get transferred and archived throughout the supply chain. Other events studied included counterfeit discoveries, recalls, and missing or defective RFID tags.
The group has already reached some conclusions about handling data to build an electronic pedigree. “It makes sense for manufacturers to serialize unit-of-use packages, whereas wholesalers should serialize the unit-of-use packages they create from the bulk packages provided by manufacturers,” says Ross. The serialization number can be carried in a variety of ways, bar code or RFID. “In addition to addressing a fully-deployed E-pedigree system, members of the lab also pay attention to migration issues such as the evolving maturity of RFID tags,” he says. SupplyScape’s software should ease a transition to RFID, since “it provides migration paths from bar codes to RFID and handles case to unit-dose level coding,” adds Kelly.
DSN Lab #1 is now moving on to case studies involving field pilots at specific locations, such as a retailer’s warehouse. Questions the group hopes to answer include:
• When do you deactivate the data written to a tag so that no one can access it when the tag is discarded?
• Should pharmacists erase data on unit-of-use packages as it is being dispensed?
• Can you deactivate a tag too soon?
• What about keeping the data intact in the event of a recall?
DSN Lab #1 plans to give a list of recommendations to the various regulatory agencies at both state and federal levels that are developing pedigree laws. In the meantime, according to Ross, the lab is working to convince other manufacturers, retailers, and distributors to participate now in electronic pedigree development. “Avoid being in a silo and making decisions without consulting your distribution partners,” he says. “That may cost you a lot later on.”
Adds Robin Koh, SupplyScape’s chief strategy officer, who once led MIT’s Auto-ID Labs’ efforts to develop secure supply-chain practices: “Companies [can] deploy technology in the field that will have an immediate impact on patient safety.”
Copyright ©2005 Pharmaceutical & Medical Packaging News
