InBrief: Can ePedigree Be Deferred Until Mid-2016?

Unlabeled Time Line 9Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.It’s well known that the California pedigree law requires pharmaceutical manufacturers to serialize their drugs, 50% by January of 2015 and the remaining 50% by January of 2016.  But the law also requires those manufacturers to start drug pedigrees for those drugs by those same dates.  The only problem is, no one is required to be able to receive those pedigrees until July of 2016 when distributors and repackagers must have their systems ready, so why can’t we defer the selection of the ePedigree format and data exchange model until about that time at the latest?

Interestingly, Virginia Herold, the Executive Officer of the California State Board of Pharmacy gave some credibility to that idea during her Q&A with Shabbir Dahod on March 20, 2013 (hear the replay of that webinar on TraceLink’s website).  (See my previous essay, “Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy“.)  I won’t extract the quotes this time, but she pointed out that it is not the intent of the California Board of Pharmacy to inspect manufacturers to ensure that they have started a pedigree for their drugs prior to the need for wholesalers to receive them.  They really don’t have that kind of authority over manufacturers (unless the manufacturer also holds a California wholesaler’s permit).

Ms. Herold struggled to explain what should be done with the pedigrees that manufacturers would generate prior to the wholesale distributors being able to receive them.  She claimed that the Board will be able to tell if a manufacturer has started a pedigree for these drugs during that interim period because they will be able to have the wholesaler scan the unique identifier and look for the associated pedigree.  But that assumes that wholesalers will have their system deployed prior to their effective date (July 2016) and will receive the manufacturer’s pedigrees as a “pilot”.

Maybe that could happen for some drugs, but considering that even the standards necessary to do a network centric ePedigree based on the GS1 Electronic Product Code Information Services (EPCIS)–let alone the fully bug-free third-party solutions–probably won’t be done until sometime in 2014, it might make more sense to use that extra 18 months—from January 1, 2015 to July 1, 2016—to ensure that the target pedigree model is working properly rather than locking down the pedigree model on January 1, 2015.  If the model must be locked down on January 1, 2015, then more than likely the pedigree model will need to be based on the GS1 Drug Pedigree Messaging Standard (DPMS) because drug manufacturers would need to have their systems ready and tested well before January.

On the other hand, if manufacturers could simply hold the basic event data that would be necessary to produce either DPMS pedigrees or EPCIS event-based pedigrees in a model that has not yet been fully defined, the industry would have an additional 18 months to attempt to work out and test the new NCeP model.  If time runs out before the NCeP is working, manufacturers could then fallback and generate the DPMS pedigrees and finally pass them to wholesalers just prior to the July 1, 2016 deadline.

I think we’re going to need at least some of that extra time because it’s tough to accelerate the standards-making process without introducing unintended side-effects.  Let’s take the time to do it right.