Even the coding pioneers have asked for more time to fully implement saleable item-level serialization, so the work must be daunting. Back in December 2007 at a meeting of the California State Board of Pharmacy’s electronic pedigree enforcement committee, for instance, Pfizer’s Peggy Staver told the board that it could take “five to seven years to serialize all our products.”
What could the hold up possibly be? Perhaps it is what Stewart McCutcheon, CEO of Acsis Inc., describes as a major “paradigm shift in packaging” that is occurring, he noted during RFID World 2008’s conference track in Las Vegas in September. Traditionally, “large numbers of identical products were packaged and coded to an exacting standard,” he explained. Soon, companies will have to “produce large numbers of identical units to a standard and be able to uniquely identify each unit and associate that data with specific handling events.”
I asked Scott Gray of GS1 whether manufacturers in the United States are moving toward serializing large bottles on packaging lines in quantities that would then be broken down and repackaged for distribution, or does he see manufacturers interested in packaging and serializing items in unit-of-use quantities?
“Most of the companies we work with are advising a walk-before-you-run approach,” Gray explains. “To illustrate, anyone can go into distribution centers of regulated healthcare products around the world and find as many solutions as there are manufacturer-care provider partnerships. No one can achieve critical mass for automatic identification technology, even at the pallet, much less case, secondary pack, or primary pack, so focusing on the dispensing unit seems premature today.”
The reasons are simple, Gray says. “Proper identification and marking of dispensing units depends on identification solutions at higher levels of packaging, and it also depends on the product packaging integrity—once it is broken down, then the manufacturer cannot control the integrity of the product. While ultimately this level makes sense, it is at the higher levels of packaging we can begin to gain a foothold in supply-chain accuracy, efficiency, and visibility (i.e., traceability). It is a big world, and again, we must walk before we run.”
So, is the uniquely serialized healthcare item on its way? It seems as though it may take a while for the entire healthcare supply chain—from manufacturer to distributor to pharmacy—to shift in that direction. Perhaps the new deadline for California’s e-pedigree rule isn’t so far away.
Daphne Allen