Monday, May 22, 2006

Pedigree: Making best into the enemy of good.

In case you missed the news, a last-minute addition to HB371, which dealt with cancer drug donations, creates a loophole that allows wholesalers to avoid Florida's paper pedigree requirements.

There is a less to this loophole than meets the eye. Some states -- Arizona, Indiana, Texas -- have already adopted the concept of a "normal distribution channel" to focus pedigree on where it is needed the most. Kevin Nicholson of NACDS summarized the logic of this argument in his presentation at the FDA's RFID meeting in February. The largest wholesalers and chain pharmacies within the normal channel have already moved away from secondary market sourcing.

Nevertheless, the curious timing of this provision is generating substantial editorial protest about Florida's Prescription for Peril, calls for Governor Jeb Bush to veto the revised bill, and commentary from Stephanie Feldman, who participated in the events described in the excellent book Dangerous Doses. Keep in mind that Florida enacted its strict paper pedigree requirements after a rash of blatantly egregious criminal behavior in the state.

The Healthcare Distribution Management Association (HDMA) makes the very compelling argument that "Paper pedigrees will provide a false sense of security" because paper can be easily forged. The Florida requirement also puts the cost and implementation burden onto the backs of an already profit-squeezed wholesale industry. Although the news articles above highlight HDMA's backroom maneuvering, HDMA has been attempting to make pedigree workable. (For example, see HDMA's August 2005 implementation suggestions.)

Nevertheless, the distribution industry should be careful not to portray an image of "electronic pedigree or nothing." Such a tactic will be perceived to be as reminiscent of Voltaire's statement that "The best is the enemy of the good."

On the other hand, everyone (including the FDA) needs to get real about pedigree, de facto or actual. RFID is not a magic bullet and will also lull us into a false sense of security. The complexity of today's drug channels should make all of us very skeptical about technological fairy tales spun by the vendors and consultants who will profit from further RFID mania. (I will comment further on RFID when the FDA issues their counterfeit drug update report later this month.)

Don't believe me? Read this story about a Texas pharmacy. I'm sure that they received paper pedigrees and may even have been willing to buy an RFID scanner.

Personally, I believe that existing technology linkages, combined with the adoption of secure business practices of the kind enabled by Edge Dynamics, can make the drug channel safer and more secure today. But that's a subject for another post...

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