Tracking Pedigree Rules
June 30, 2009 – 12:20 pm
The Buyer-Matheson bill has generated a lot of interest, and with good reason. Pharma, the wholesalers, the retailers, and FDA have reported discussions or close collaboration with the bill’s sponsors on the pedigree legislation. Though its near-term prospects are uncertain given legislative focus on the economy, the bill is expected to be reintroduced into the 111th Congress this year.
Buyer would set new federal-level direction for serialization and traceability. Discussion drafts of the bill reference the requirement in the FDAAA ACT of 2007 for a serialized SNI, while setting implementation dates for an electronic solution in line with California’s law.
Buyer defines an interim pedigree process as a migration path to electronic pedigree. The pedigree requirements would circumvent problems with FDA’s partially-implemented PDMA-based pedigree rule that went into effect in 2006. Among other things, the bill revises the definition of an authorized distributor of record. (see the upcoming “Pulling For Auto ID” story in the July issue).
Not incidentally, the bill calls out that states’ pedigree rules can’t exceed the federal provision, thereby establishing a uniform pedigree requirement, for the run up to 2015.
As things stand today, wholesalers face a thicket of state regulations, and different pedigree practices by their supply chain partners. Novis Pharmaceuticals is providing electronic pedigrees on all shipments, regardless of prevailing regulations in each state. The specialty therapeutics distributor has adopted SupplyScape’s Nexus traceability and e-pedigree platform for sending pedigrees via GS1’s Drug Pedigree Messaging Standard.
The company often has to chase down information from manufacturers, and key in data from hard copy transactions, for initiating pedigrees following varying pedigree mandates, says Jorge Rodriguez, vice president of operations.
“We developed our own set of criteria. We classify each item based on the compliance level of the pedigree, then manage and control those items accordingly with the help of our business systems,” Rodriguez says.
The data from upstream partners “varies tremendously” in content and form. Virtually all of Novis’s downstream partners access the pedigrees from the SupplyScape software through a portal on Novis’s Web site.
“Most of our customers don’t have the gateways to receive the pedigrees electronically. After the shipment leaves our building, we communicate that the pedigree is available through the web site and provide an access code.
“Our responsibility is to make the pedigree available to the downstream customer prior to or simultaneously with its arrival at their dock. We haven’t really looked into (how it is being used). Some customers are very diligent about it. There are probably others that have never (visited the site),” he says.
Additionally, Novis is supplying serialized bar-coded medications to customers participating in its RxID solution. The distributor assigns serial numbers to all items received. Inventoried 2D bar-coded labels are applied to products shipped to customers of the RxID solution. Hospitals participating in recent pilots scanned the codes at established locations, and tracked inventory information and items’ pedigree history using the MedBoard web-based medication tracking system from MedKeeper.
“RxID is our patient safety initiative to help our customers track the products they purchase from us. We expect they will authenticate the information, so they can then know a product is safe prior to its use,’ Rodriguez says.
FDA played enforcer today, seizing drugs made by