Tuesday, March 25, 2008
CA e-pedigree: Going to '11!!
As predicted, the California Board of Pharmacy today announced its decision to extend the deadline for implementation of e-pedigree laws to 2011.
The timing was unexpected but not the outcome. Apparently, my sarcastic mocking on the Drug Channels blog was just too much for them to bear. Plus, the Board now avoids the embarrassment of having a legislative or legal solution imposed on them.
Let's hope that the Board members can put aside their pharma-bashing and get on with the hard work needed over the next 33 months.
Here is the official announcement: DECISION OF THE CALIFORNIA STATE BOARD OF PHARMACY PURSUANT TO BUSINESS & PROFESSIONS CODE SECTION 4163.5Best sentence: “For the moment, the Board concludes that its primary duty to protect the public is better served by a delay permitting a less disruptive implementation, than by a rush to secure industry compliance.”
Nonetheless, I remain surprised at “leading edge” role that California has assigned to itself. As a point of historical fact, Florida’s pedigree laws were prompted in part by a 2003 Grand Jury report that documented widespread problems with the wholesale distribution of pharmaceuticals in the state. Most of these secondary market excesses have been corrected by national, industry-wide efforts such as new data sharing practices and the major wholesalers’ renunciation of secondary trading. I am not aware of a similar grand jury report for the state of California nor have I seen any California-specific research on counterfeiting.
BTW, the Heparin example is completely misleading because the contamination allegedly occurred overseas. Pedigree would have had no value or role in preventing this tragic situation.
The New York Times covered the Board's decision in California Delays Plan to Track Prescription Drugs.ReplyDelete
However, I don't see how comments such as this one help the industry to move forward in a constructive manner:
“All I’m getting is ‘We can’t do it, we can’t do it, it’s too expensive,’ ” said a board member, D. Timothy Dazé. “And I ask, ‘What value do you folks put on a life?’ ”
Still, Mr. Dazé, who is a deputy city attorney in Los Angeles, voted reluctantly for the delay, saying later that he feared depriving Californians of drugs they needed. No board member voted against the delay."
I appreciate your work in following this matter. Do you know if the Pharmacy board will be issuing more specific gudielines regarding compliance for the new 2011 date?
I must be outdated in my language. I noted the quote, "electronic pedigree system, to track and trace" in the decision. This matches recent legislation. Are the differences between the concepts of "pedigree" and "track and trace" lost to history? Is track and trace just fading away?ReplyDelete
Unfortunately, the terms are often used interchangeably although they are fundamentally different concepts. Some people see epedigree as a building block (or perhaps an intermediate step) for track-and-trace, while others advocate moving directly to a track-and-trace system. Right now, it's a compliance issue that favors e-pedigree.
Love the Spinal Tap reference. Well done!ReplyDelete