TRACK AND TRACE
Editor
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A flowchart from DDN Pharmaceutical Logistics shows potential product paths and pedigree processing.
(Click image to enlarge) |
The drug industry is gearing up to secure the supply chain against counterfeiting and diversion with electronic pedigrees. Michael Bartholomew supports that effort. His company, outsource service provider DDN Pharmaceutical Logistics (Germantown, WI), has invested in technology to help drug companies build such pedigrees.
But Bartholomew also believes that electronic pedigrees can be used to turn the supply chain into a “value chain.” He shared his perspectives on best practices in supply-chain management at LogiPharma Europe 2008 on April 24.
“In the United States, a shrinkage rate of one-half to one percent has been acceptable,” says Bartholomew, who serves as vice president, sales and marketing, for DDN. “But in Europe, it is zero percent.”
The difference between the two regions, he points out, is that Europe requires serialization. Such rules are just beginning to take shape here in the United States. FDA, individual states, and legislators are still working out the details of developing electronic pedigree standards, some of which could be finalized in 2010.
Manufacturer duties for serializing salable units seem likely, but that could be too costly for some companies. “It will be too burdensome for some companies to handle all aspects needed to support serialization,” Bartholomew says.
DDN has grown its business in recent years by helping life sciences companies commercialize their products without being purchased by other companies, Bartholomew reports. “We’ve provided a bridge from development to market for virtual companies. We have also provided infrastructure for growing generics companies.”
DDN is now extending its services to support pedigree compliance initiatives. “For some companies that could otherwise not afford serialization, DDN will invest more than a million dollars in its pedigree solution. It employs a software platform using Electronic Data Interchange (EDI)–type messaging that is compliant with EPCglobal’s Pedigree Messaging Standard,” Bartholomew says.
Bartholomew reports that DDN can provide the following support:
Authenticating the pedigree of inbound inventory. DDN can confirm that serialized units match electronic-pedigree records sent by manufacturers through an advanced shipment notice (ASN). “One hundred percent unit-level authentication is an impossible task given the tens of millions of units DDN receives annually. DDN will use an inference approach through a statistically validated protocol to confirm serial numbers match the electronic ASNs,” says Bartholomew. “All cases received at DDN must be labeled with a bar coded case ID that ties back to the serial numbers of the salable units within each case. If shipping less-than-case quantities is required, each inner pack is required to have a bar coded inner-pack ID to link the unit serial numbers within the inner pack to the inner-pack ID. Each pallet must also contain a bar code pallet ID that would link each case to the pallet and units in each case.”
Outbound recording. DDN will capture the serial numbers of all salable units shipped and build pedigree records that can be electronically forwarded.
Returns processing. DDN can receive product and either destroy it or send it elsewhere and update pedigree records.
For proposed process flow from DDN, see the figure on page 22.
Bartholomew believes pedigree rules will make long-term economic sense for the pharmaceutical industry. “As an economist by education, I don’t always find government regulations positive,” he says. “However, pedigree requirements offer cost savings by enabling supply-chain partners to know exactly what is in each case and easing returns and charge-backs.”
