The California Board of Pharmacy has begun to hold ePedigree-specific meetings with staff and a subset of the Board present. The first of these occurred on Monday of this week. The agenda was fairly long and promised action on a number of important topics, including the possibility that the Board would consider the use of EPCIS as a pedigree platform, inference, pedigree certifications and drop shipments. I came away disappointed that the only thing that happened was a brief discussion of each topic but seemingly no real action. It was almost as if the Board members and staff had made no progress on any of these topics since the March Enforcement Committee meeting. All that seemed to happen since that meeting was the collection of more written comments from the public and industry (see the meeting materials including those written comments here).
Considering how close we are to the first deadline for manufacturers to comply with the California law I was expecting a lot more aggressiveness by the Board to resolve these remaining regulatory questions. Even the regulations that the Board has already adopted are still under administrative review with no new progress to report since March. These include the use of the FDA’s Standardized Numeric Identifier (SNI), grandfathering and manufacturer reporting of their 50% calculation. All of these regulations were drafted last year and all are less complex and less controversial than the three new regulations that the Board has proposed this year: inference, certifications and inspections (see “California’s Draft Inference Regulation”, “Draft Regulations On Certifications Within California ePedigrees” and “California’s Draft Regulation on Inspections”).
Judging from the comments received by the Board related to these three current draft regulations I would say that the Board has a lot of work ahead of it if they want to maintain the level of detail and complexity currently found in those drafts. And also judging by the rate of progress since March on questions vital to the industry’s preparations I would say that the Board might have an energy problem. Is it due budget cuts, furloughs or maybe the potential that the whole effort might disappear if Congress passes a national track & trace bill and the President signs it? All of the above?
(For more on the potential for the enactment of a Federal law that would preempt the California law see:
- The House Hearing on ‘Securing Our Nation’s Prescription Drug Supply Chain’
- California Responds To The Senate Pharma Track & Trace Discussion Draft
- An Industry Protection Bill Concealed Under The Veil Of Patient Protection
- InBrief: A Track & Trace bill Has Made It To The Senate Floor
- The Politics Of Federal Track & Trace Legislation
- The Federal Lot-Based Pedigree Before Congress
- InBrief: The Pharma Track & Trace Bill Has Passed the U.S. House Of Representatives
- The Preemption Provisions Built Into The California Pedigree Law)
Maybe I’m being too hard on the Board and their staff (whom I have great respect for, by the way). Perhaps little could have been done while waiting for members of the industry and the public to comment on their draft language. In that case, now that that opportunity has been given and the key industry associations have all had a chance to propose changes to these drafts, now we should see swift action on adjusting the drafts based on those comments and republishing them for additional comments or action by the Board. Do we have to wait until the September meeting of the ePedigree Committee to republish? I hope not. Do we have to wait until the December meeting for the Committee to recommend adoption by the Board in their January or February meeting? Is there a plan to get these done?
USE OF EPCIS-BASED SYSTEMS FOR COMPLIANCE WITH THE CALIFORNIA LAW
Bob Celeste Senior Director of GS1 Healthcare US made two back-to-back presentations to the Committee during the meeting. The first was a quick overview of that organization’s implementation guideline document “Applying GS1 Standards to US Pharmaceutical Supply Chain Business Processes, Release 1.0” (see “The New GS1 Healthcare US Track & Trace Guidance”). This was a shorter repeat of the presentation he gave to the Enforcement Committee in March.
The second presentation was intended to setup the question for the Committee and the Board “could an EPCIS-based ePedigree system be used to meet the California pedigree law?”. We know from statements made over the last six months that the Board and/or staff members seem to want to allow its use, but, as Mr. Celeste pointed out, until the Board makes a supportive statement like the one it made regarding the GS1 Drug Pedigree Messaging Standard back in 2007, solution providers and members of the supply chain will not be willing to invest in that technology and thus doom it (see “California Board of Pharmacy Clarifies Use Of GS1 EPCIS”, “’The Shadows Of Things That MAY BE, Only’ : EPCIS and California Compliance”, “Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy” and “The Board of Pharmacy Must Respond To Ideas For Making EPCIS Work”).
What did the Committee say? Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy and Committee Chair, Randy Kajioka, asked a few clarifying questions but the Committee took no official action. Here is my transcript of the conclusion of the agenda item.
Mr. Room: “Is there a certain outcome you were hoping for from this presentation to the Committee?”
Mr. Celeste: “I think today we just wanted to start the conversation around what it is, because it is different. And then come back again, and again just like with DPMS, say ‘here is something that was created using this’. There are some pilots that we’d like to have take place around the chain of ownership that could provide some really good data back, and then [we’d] be able to say, ‘should someone present you with a pedigree based on this architecture, would it be acceptable?’. That essentially needs to be answered, otherwise folks will just not invest and move forward on it.”
Mr. Room: “Maybe…I’ll take the Board member’s direction on this…it may be premature to do this, but one of the things that Giny [Virginia Herold, Executive Office of the Board of Pharmacy] and I talked with Bob and the other members of the call on Friday about was, the ways in which our law, written originally in 2003, was written in essentially a pre-EPCIS environment, or, EPCIS existed but it wasn’t utilized for this purpose, and so it is written in a way that more grammatically, or programmatically meshes with the DPMS type of world, where you are actually sending and receiving essentially complete electronic documents. EPCIS is different than that. Unless you use the chain of ownership…’pointers’, as I call them, to pull forward the entire chain of ownership data, you would not, in every single transaction, be receiving a complete chain of ownership document. You would be receiving only the document from your immediate trading partner showing their transaction with you, and then if you wanted anything more you would have to go out to these EPCIS identifiers that are housed at individual sites or maybe housed centrally, or wherever they are, to pull in that information.
“The Board is going to have to consider and decide whether that constitutes receipt of a pedigree, or transmission or provision of a pedigree within the meaning of the law, and/or the specific certification piece…are you able to see the certifications provided by trading partners that are not your immediate trading partners as part of what you are able to see in order to have confidence in the data that you are receiving.
“Those are the two main […] questions that will need to be asked about what is provided under EPCIS and whether it complies with the law.”
Chairman Kajioka: “I have two points. I think it makes sense that you know exactly who you bought it from and they know exactly who they sold it to but that you may not be…necessarily be able to validate that they got it from ‘C’, ‘D’…on down the line. And, it makes sense…it’s ten years old? The first draft…we don’t want to try to already propose something that’s over a decade old, so I would think it would be the Committee’s recommendation to order the Board staff to use current language as a descriptor and then we can vet it out and then make a recommendation to the full Board on its acceptance.”
Mr. Room: “OK, I gotchya.”
Mr. Celeste: “One last thing, we’ve done this in a number of industries…used EPCIS, and typically what happens on day one, everybody doesn’t trust anything so they pull everything forward. We did this in the apparel industry, they pulled everything forward until their system were filled with data, and then they started to trust that it was there and then they said, ‘OK, we’ll pull every hundredth one, and then finally they got to the point where […] they had good guidance through their SOP’s for when you pull something forward, if you had a question, or when you believed that the information was still there and you could do that, but…”
Chairman Kajioka: “That’s exactly why we have this thing going for so long is we want…public safety for California is paramount, but we just want to make sure we do the right thing and not just put up technological barriers for the industry to get the meds out, which is counterproductive to the public safety of California. It’s a long drawn out process and I applaud the patience of the industry and their willingness to share sometimes sensitive information, but it’s necessary information, so we applaud the industry for taking part in public safety. That’s our charter.”
I’m not an expert on the workings of lower committees within the California bureaucracy, but I guess this exchange means that Mr. Room has been instructed to compare the language in the California law with the operation of an EPCIS-based pedigree system and report back to the Committee so they can decide if they want to recommend to the full Board of Pharmacy that it should be accepted. There are so many assumptions built into that guess that we’ll just have to see what happens in the next Committee meeting in September to see if my guess is right.
With the little action that occurred at this meeting I absolutely agree with something that Virginia Herold said during the meeting:
“Now, time wise, time is starting to play a little role. If we are not preempted, we’re to the stage where we need to aggressively move with respect to inference. I frankly personally think we are in better shape with the drop shipments [regulation], but with respect to inference and certification, which are the two main issues right now […], I think the Board’s got to do some work, and I’m not sure this is the best forum to do it in.”
It’s pretty obvious, time is going to run out. So here is my suggestion to the Board. You need to remove all complexity from these three pending regulations and just get something adopted for each. For example, don’t place any limit on the number of units in homogeneous case when using inference. Don’t require wholesalers to be included on a pedigree in a drop shipment if they did not touch the product. Don’t specify the use of digital signatures in the certification regulation. Strip these down to their bare essentials so that you are able to finalize them quickly and the industry will still have time to implement them. Then, since you have the authority to create them in the first place, you should still have the authority to tighten them if you find it to be necessary down the road, after the law is operational. Today you no longer have the time to develop and impose a complex, detailed regulations that companies will have difficulty implementing.
…Or, I suppose you could push the dates out again so that you have enough time to work it out. 😉