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Ready or not, electonic pedigree is coming. But bumps in the road area already rocking the pharmaceutical world. The biggest bump: vague definitions and conflicting exptectations.
"When people speak of e-pedigree, they are usually speaking of the kind of document that was set up for Florida with lot numbers, NDC numbers, and all the other attributes of a product," said Shay Reid, VP, integrated solutions, AmerisourceBergen.
"But if you want to ensure that a product is genuine-which is the real goal-you need to be able to trace the entire life cycle of a product from manufacture to dispensing or destruction." Not only trace the entire life cycle, he added, but trace the entire life cycle of individual units.
Bumps in the road
None of those practicalities was included in the federal Prescription Drug Marketing Act (PDMA), which has required prescription drug pedigrees since the mid-1980s. The Food & Drug Administration has repeatedly said that e-pedigree should become the standard. But federal pedigree enforcement is on hold during a court battle between New York-based wholesaler RxUSA and the FDA.
RxUSA is challenging PDMA provisions that exempt authorized distributors from pedigree requirements. Security experts told Drug Topics that product pedigree starting at any point after manufacture is wasted effort.
Industry sources say pedigree has forced wholesalers to segregate product by lot numbers in Florida distribution centers. Product segregation has quadrupled distribution center (DC) storage space needs. The Florida Pharmacy Association reported that pedigree requirements have disrupted drug supplies and pushed some generic acquisition costs above reimbursement levels.
California will require e-pedigree that begins with the manufacturer for all prescription products sold in the state starting Jan. 1, 2009. Provisions require that all Rx products be serialized, or uniquely identified, at the unit level.
National wholesalers AmerisourceBergen, Cardinal Health, and McKesson are each testing e-pedigree systems in at least one California distribution center. No manufacturer has yet rolled out e-pedigree.
"The idea of not having dangerous counterfeits out there is important, but I would hope we look at the trade-offs involved," said Lynn Rolston, CEO of the California Pharmacists Association. Rolston said there are more questions than answers about how e-pedigree might work, how it might affect drug distribution in different healthcare settings, and how it might affect costs. "For those products that are being counterfeited, e-pedigree makes total sense," she said. "But for other products, pedigree and tracking just add costs all along the line. The costs are mind-boggling."