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Singer/songwriter Paul Simon may have found 50 ways to leave a lover, but drug manufacturers really don’t want to have to come up with 50 ways to comply with electronic pedigree laws, one for each state.
Truth be told, they probably don’t want to do this at all-except there are some compelling business benefits, such as improved inventory and better tracking of returns and chargebacks.
But providing a genealogy of every prescription pharmaceutical package made and distributed in the U.S. is quite a task. Especially since that number keeps growing as the population grows and ages.
As more states enact pedigree laws, just keeping track of (much less complying with) each state’s requirements can be as hard as the Saturday crossword in The New York Times. California’s recent requirements, for example, state that the pedigree “shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution.”
Although many are calling for it, national regulation seems unlikely. However, it looks like the industry is gravitating to its own electronic pedigree standards-ones that use robust technologies that allow for changes in the future.
One solution, from EPCglobal (www.epcglobalinc.org), builds on open standards for interoperable electronic systems, such as jpg, pdf and html.
Yes, electronic pedigree is a pain. But let’s keep in mind the worthy cause for doing all this: To prevent counterfeit products from harming patients.
With one year ending and another beginning, I’d like to wish you and yours a happy, healthy 2008. May you prosper in your endeavors, both personal and professional. As my father-in-law always reminds me, “You can have anything you want. You can’t have everything. But you can have anything.” Amen, father!
Egads! It's E-Pedigree!
Lisa McTigue Pierce is a member of the Int’l Packaging Press Organization.