In March 2008, when the California Board of Pharmacy postponed the deadline for compliance with the state's electronic pedigree
(ePedigree) law from Jan. 1, 2009 to Jan. 1, 2011, members of the pharmaceutical supply chain breathed a huge sigh of relief.
Few firms were prepared to comply.
One company that could have met the 2009 deadline, privately held wholesale distributor H.D. Smith (Springfield, IL), began
exploring pedigree options in 2005. Since then, it has conducted a series of pilot projects with select suppliers, customers,
and vendors. "We are fully prepared to handle 100% serialization in Carson, California," reports Rob Kashmer, vice-president
of information services at H.D. Smith, referring to the location of one of the company's distribution centers (DC).
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At the moment, however, pedigree requirements involve extra handling and expense. For example, Florida ePedigree regulations
require lot tracking. "This is not a normal process in our DCs, so it adds additional labor and complexity," says Kashmer.
To meet Florida's requirements, H.D. Smith confirms each lot as it's received and assigns each lot number a specific location
in the DC. This way, order fulfillment can be done by lot number. "There's also additional labor at order-verification stations,"
he notes, adding, "We do 100% outbound verification at all of our facilities to make sure the invoice and order match perfectly.
In Florida, that means packers must look for the lot number on the product. [Currently,] very few are scannable."
SupplyScape software provides ePedigree records that list each stop a drug makes as it moves through the supply chain.
To achieve the item-level serialization that would be necessary to meet California's ePedigree requirements, H.D. Smith has
studied radio-frequency identification (RFID) and two-dimensional (2D) barcodes. Unfortunately, a "high percentage of product
in the pharmaceutical supply chain has neither," says Kashmer.
In addition, H.D. Smith pilot projects have shown that both technologies currently involve additional labor and expense but
don't contribute enough efficiency to the process for full-scale deployment. In fact, Kashmer believes that RFID, which doesn't
require the line-of-sight scanning that barcodes do, has an advantage because it can automate receiving and order verification.
However, only a small percentage of product currently needs a serialized code. For this reason, tagged and nontagged products
must be handled separately; thus RFID also involves extra complexity, handling, and cost.
Nevertheless, technology that has no line-of-sight requirements offers many advantages. For retailers and hospitals, tagged
product can not only automate receiving, but also confirm the correctness of prescriptions and locate misplaced product. At
the consumer level, a smart medicine cabinet in the home could serve as a compliance aid by tracking when medication is removed
from the shelf. The technology could potentially provide an alert when it's time to take a dose or a reminder if a dose is
Of course, the prime reason for pedigree laws is product authentication to ensure that counterfeit product is not introduced
to the supply chain. Pedigree information also can help identify cases of diversion.
The new product-authentication process did hit an early snag, though. H.D. Smith could not immediately authenticate the first
order of "Viagra" it received with high-frequency 13.56-MHz tags. The order arrived in days, but Pfizer (New York) initially
updated pedigree files once a week. Daily pedigree file updates now keep up with the fastest order-to-delivery cycle.
The RFID system at H.D. Smith required participation from numerous suppliers, including providers of hardware (e.g., conveyor
portals, antennas, and readers) and software as well as a systems integrator (ePedigree software, SupplyScape, Woburn, MA),
and systems-integration services (Franwell, Lakeland, FL). Not only must the components work together, they also must be easy
to change. "We've probably changed hardware such as antennas and readers four or five times now as the system [and equipment]
continues to evolve," reports Kashmer.
The wholesaler also wanted the system to integrate seamlessly with its warehouse-management system, which works in real time
to accept orders and generate advance ship notices, order confirmations, and electronic invoices. As a result, H.D. Smith
can send pedigree data to shipment recipients or allow customers to retrieve the data by interrogating its system.