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.