I finally had time to listen to the recording of the original webcast of the interview with Virginia Herold, the Executive Officer of the California Board of Pharmacy that occurred on March 20, 2013. Shabbir Dahod of TraceLink, a supplier of ePedigree solutions and other supply chain products and services, asked a series of very detailed and very interesting questions of Ms. Herold. The information conveyed through the questions and answers are very compelling and anyone interested in meeting the requirements of the law should listen to the whole recording. You can get access to it here on the TraceLink website.
The questions asked by Mr. Dahod cover the following topics. The times given (HH:MM:SS) are from the recording to help you go directly to the point where the specific topic is covered. However, I recommend that you listen to the whole interchange. It is time well-spent.
|00:03:50||The staggered effective dates and their implications|
|00:14:13||Manufacturer timeline requirements|
|00:18:55||Wholesaler and Pharmacy timeline requirements|
|00:23:18||Serialization and Pedigree Management (ePedigree models)|
|00:29:00||Pedigree Creation & Update: Manufacturer definition in outsourced production
|00:34:50||Product serialization and labeling: complex scenarios|
|00:38:45||Inference and product-pedigree verification|
|0043:00||Pedigree Creation & Update:
|01:04:20||Non-compliance penalties at the deadlines|
Though the questions asked came from TraceLink’s customers, Mr. Dahod demonstrates a firm grasp of the issues they face in interpreting the law.
In the past, Ms. Herold and other Board representatives has replied to questions directed at them during public appearances and in emails by simply quoting directly from the text of the California law. That’s not very helpful for anything other than the simplest questions because the text of the law does not recognize the deep operational complexity of the legitimate drug supply chain.
There are many legitimate questions about the application of the law—that is, the enforcement of it—where the complex reality of the U.S. pharma supply chain extends well beyond the simple assumptions that are built into the text of the law. Legitimate companies need to understand its application within the context of their particular complexities before they know exactly how to acquire, develop and deploy solutions that ensure they are compliant.
And so I am encouraged by Ms. Herold’s new willingness to discuss implication beyond the simple text of the law. There is a danger, of course, that she will mis-speak and say something that differs from the law or how the Board will eventually enforce the law, but listeners should take that into consideration. Continue asking questions where comments seem to differ from the text of the law to confirm that the Board will allow certain deviations where reality doesn’t fit so neatly into the wording of the law.
INVOICE NUMBERS AND EXCEPTIONS
Just two of the areas in this Q&A where I heard Ms. Herold open up the possibility of significant deviations from the law are the handling of invoice numbers on pedigrees and the resolution of exceptions that occur through the use of inference.
One of the data elements that must be included on a pedigree is the seller’s invoice number for each sales transaction. The problem is, in many sales transactions, the invoice number is not known for a period of time that can extend from minutes, to hours, to days after the shipment leaves the seller’s dock. If a complete pedigree is necessary before the recipient can resell or dispense drugs, this delay would result in drugs sitting around, unusable, waiting for the invoice number to be generated so that pedigrees can finally be transmitted to the buyer.
You can hear the discussion of this issue starting at 00:43:00.
Ms. Herold pointed out that the invoice number is important for documenting the change of ownership of the drug, but she also acknowledged that having drugs sitting around waiting for the invoice number to be generated is “not in the best interest of patients“. And so she believes that some type of allowance, or absolute waiver perhaps, will be necessary to address this inconsistency. She believes this issue will be addressed through the resolution of the “drop shipment” scenario for which they are currently asking stakeholders to provide input. She is confident that the Board can address this problem through rules without requiring a change to the law but they need to hear ideas from those stakeholders.
The issue of exceptions due to the use of inference comes inside of a discussion of pharmacy pedigree updating at 00:51:50. That discussion lead to the topic of who is responsible for addressing exceptions that are uncovered when inferred drugs are scanned at the pharmacy distribution warehouse and found to be in error. That is, the package serial numbers found inside of a sealed homogeneous case do not match the serial numbers that were indicated by the manufacturer or repackager as being inside the case. (If you are new to the concept of “inference” related to drug pedigrees, see my recent essay “How Should Inference Work?“.)
Ms. Herold explains,
“The minute the case is opened then it has to be scanned and everything has to be rectified. But the issue we’ve got is who’s responsible for solving the problem, when it goes from a manufacturer through a wholesaler down to that [chain pharmacy] distribution warehouse who [finally] identifies the problem?”
“Now it seems to me…and this is just Virginia Herold chatting…it’s pretty easy to scan one of those products [and] go back to the manufacturer and determine whether or not that was a legitimate product that somehow ended up in the wrong [case]. That’s a pretty straight-forward thing to do and it seems that would be an easy way to authenticate […] and just note that it came in as part of an inferred [case] and it’s out of sequence.”
“But, that isn’t part of the reg[ulation]. Again, no one has discussed the issue publicly. We suspect that it is going to occur but no one is discussing how to deal with it. We need to hear from the supply chain members on how you intend to deal with this issue.”
“…I don’t think you want the Board of Pharmacy messing in the middle of exception management. I think a lot of you are going to have policies and procedures for that. We just want to get a feel for where it’s going to go and maybe we can find some way that you will handle it–one or two or three ways–and maybe that’s how we deal with it.”
“…But what we don’t want to have […] is […] a sizable number of products sitting in either a [chain pharmacy’s] distribution warehouse or sitting at a wholesaler that cannot be shipped because they don’t match the pedigree. And then what do you do? That’s going to ruin the distribution chain. We need real accurate distribution from the manufacturer to the wholesaler identifying what’s in the [case]. But then when there is a problem, we need to find […] relatively swift ways of resolving the issues from the ones where it’s clearly just a shipping issue from when it may have come in through the back door.”
What’s great about these comments is that they indicate that the Executive Officer of the Board of Pharmacy seems to acknowledge that:
- unintentional errors are going to happen;
- it is counter to the interests of California patients for large quantities of drugs to be tied up in administrative hold because of those unintended errors;
- the emphasis must be on the speed with which these unintended errors are recognized as such and addressed so that the drugs can continue moving;
- the resolution of these errors may be handled through some allowance given by the Board for deviation from the letter of the pedigree law;
- and, stakeholders are being asked to propose those deviation allowances.
Until this webinar, I was not aware that the Board might acknowledge these things. Now, at least we know that the Executive Officer does.
You will find the recording full of these kind of interesting statements. I highly recommend that you listen to it.