Saved by the Delay

Postponement of California's deadline gives the supply chain time to refine ePedigree solutions.
Aug 02, 2008
Volume 32, Issue 8

Hallie Forcinio
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).

SupplyScape software provides ePedigree records that list each stop a drug makes as it moves through the supply chain.
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."

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 missed.

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.

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