Another week has gone by with no official movement in the Senate on the compromise pharmaceutical compounding and track & trace bill, H.R. 3204, the Drug Quality and Security Act (DQSA) (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”). With the focus of the Congress rightly on reopening the government I think we should expect to wait a little longer. You can bet that the supporters and the opposition are both developing their strategy as time goes by.
I attended the GS1 Global Healthcare Conference in San Francisco last week and it was a great opportunity to reconnect with a lot of people I have worked with over the years on defining workable standards for healthcare supply chain data exchange. Some of us are still at it. It was great seeing you all.
CALIFORNIA DRAFT REGULATION ON INFERENCE
The California Board of Pharmacy has been working on a draft regulation for the practice of inference for a long time (see “California’s Draft Inference Regulation”). Because the process they are required to follow to transform a draft into actual regulation takes about one year, they are going to freeze that draft sometime in the next two months or they risk not having a working regulation by the time their law goes into effect on January 1, 2015 (assuming they are not preempted by the recent bills in Congress). The same goes for regulations on inspections and certifications (see “California’s Draft Regulation on Inspections” and “Draft Regulations On Certifications Within California ePedigrees“).
At last week’s GS1 Healthcare conference, Virginia Herold, the Executive Officer of the California Board of Pharmacy, explained that if the process takes too long the Board can invoke an emergency clause to ensure that companies know the regulation before the effective date.
The latest draft of the proposed inference regulation can be found within the meeting materials for the Board’s ePedigree Committee meeting on September 26, 2013. It is a weighty regulation that would require trading partners to jointly develop standard operating procedures (SOPs) that define the circumstances under which inference would be deployed, the limitations of that deployment, a sampling plan for sampling sealed homogenous cases for continued compliance and the means and time limits for remediation of any data and product discrepancies discovered. And it would require you to notify the Board of Pharmacy of those discrepancies within 3 business days.
But probably the most onerous and, in my opinion, unnecessary provision is the following:
“Where, once a sealed case is opened, the entire contents of the case are immediately scanned and confirmed to the pedigree data received, and any discrepancies are reported”
The problem is with the term “immediately”. This is unrealistic and adds nothing to public safety. Instead of “immediately”, the Board should require that the entire contents of the case are scanned prior to further distribution or dispensing. That would address the same public safety concern without subjecting supply chain participants to undue and unnatural process changes. In fact, when a case is opened today, most members of the supply chain already scan the barcodes on all of the units inside, just not immediately. These scans occur over a period of time as less-than-full-case orders are fulfilled. Forcing this to occur immediately would really mess up the natural sequence of events in a distribution center without adding any additional benefit. Companies are going to find the discrepancies either way. Isn’t that the important thing?
It’s tough for everyone to think about and continue working on the California regulations in light of the pending action in Congress, but if you take your eyes off of California right now you elevate your risk of not meeting that law should the compounding pharmacy lobby successfully block the bill currently in the Senate. Every company’s situation is different and so there is no one-size-fits-all strategy (see “California ePedigree Uncertainty”). However, here are a few things to consider.
The serialization part of the bill in Congress makes use of the same technologies and standards that the California law does, so investments in those technologies—including line management, number management and local EPCIS repositories—are safe. I recommend that you proceed with that part of your projects regardless what happens.
Be aware that the California law does not require serialization of shipping containers, like cases, but supply chain efficiencies dictate that you do so. The federal bill would require it anyway. California does not require the inclusion of the lot and expiration date in your barcodes but many companies are planning to include them anyway. The federal bill would require that too.
When it comes to pedigree software, it may be unlikely (though certainly still possible) that the FDA will mandate the use of any of the technology and standards that are currently being applied by solution providers for meeting the ePedigree part of the California law. The federal bill would give the FDA one year to specify how transaction information, history or statements must be exchanged by parties in the supply chain. Remember, these data elements could be exchanged by trading partners in either paper or electronic form for 10 years after enactment. If you have already made an investment in an ePedigree solution, proceed with the deployment unless and until the federal bill passes.
But if you have not yet made an investment but are on the verge of doing so, you might consider holding off a couple more weeks to see what happens with H.R. 3204 in the Senate. If the bill passes without amendment, reset your decision-making process. If the bill is blocked, or if nothing happens in the next few weeks, you have to decide if the risk of waiting is worth the possibility that you might not be ready for California should the federal bill fail. It is a tough call.
AGGREGATION AND THE BILL IN CONGRESS
There appears to be a lot of uncertainty and debate going on around the industry about whether or not the enactment of H.R. 3204 would require pharmaceutical companies to generate aggregation data. I’ve heard both sides and I have been asked what my opinion is on the subject several times, including in a comment left on last week’s essay.
My read of the bill leads me to believe that aggregation would not be required, at least for the 10 year period starting with enactment. During that period, the system would operate as a lot-based pedigree system, not a unit-level serialization-based pedigree system. So during that time (starting after 4 years), the unit-level serial number would have to appear on each drug package and each case, but no one would need to make use of it. That is, the unique serial numbers would not need to appear in anyone’s transaction statement, information or history—the pedigrees—because they would be lot-based. In that case there would be no need for serial number-based aggregation data.
It is possible that aggregation data might be a necessity, either by FDA rule or for supply chain efficiencies, once the enhanced supply chain track and trace rules would take effect 10 years after enactment, but that’s so far out and there will be so many public meetings and time to re-think the whole solution that I cannot even guess at this time.
That’s my observation. Leave a comment below if you disagree.