I finally had a chance to listen to the recording of the rfXcel webinar with Virginia Herold, Executive Officer of the California Board of Pharmacy, and Joshua Room, Deputy Attorney General, California Department of Justice assigned to the Board of Pharmacy. The webinar was recorded on May 29, 2013. Ms. Herold and Mr. Room have done these kind of webinars before (see “Q&A With Virginia Herold, Executive Officer, California Board Of Pharmacy”). But don’t worry, while there is a fair amount of repetition as you might expect, the Q&A is different enough that I always learn something new. I found this one to be entertaining as well as informative.
One of the questions they addressed was regarding the need for pharmacies to “deactivate” the pedigree or decommission the Electronic Product Code (EPC) for a given unit when the drug package is fully dispensed. According to Ms. Herold and Mr. Room, there should be something
“…in the database that reflects this product ought not to be sold and should not re-appear [in the supply chain]…”.
Mr. Room followed up saying that
“Pharmacists [won’t] need to do anything [special] but the data has to reflect where that product has gone and that it ought not to come back [into the supply chain].”
They indicated that this would be the subject of regulation development at some point in the future.
We have heard comments like this before, most recently during the Board of Pharmacy Enforcement Committee meeting in March.
THE ONLY PROBLEM IS…
I have not found anything like this in the California law. In fact, a California pedigree is intended to show all changes in ownership of a given drug. But these comments by Ms. Herold and Mr. Room anticipate the existence of a database that would routinely be used by supply chain members and regulators to check whether or not a given package of drugs has already been dispensed. The law does not anticipate that at all. The law requires trading partners to pass pedigrees from seller to buyer so that, supposedly, a Board of Pharmacy inspector will be able to pick up a drug package on a wholesaler or pharmacy shelf and ask to be shown the pedigree of that unit. We have heard this simple scenario time and again as an example of the goal of the California pedigree law.
In this scenario, the wholesaler or pharmacy would need to show the inspector “the pedigree” that was received from the latest upstream trading partner. When the drug is in a pharmacy, the pedigree would show all of the changes of ownership up to the receipt by the pharmacy. Only the pharmacy would be in possession of that complete pedigree so no one else in the supply chain would have visibility to it. No one else could check to see where that drug package currently resides.
Not only that, but there is no requirement to append the pedigree with the dispense status—no “deactivation” or decommission update. Even if there were, this update would be visible only to the pharmacy that dispensed the drug and for an inspector to see that pedigree they would have to know which serial number to ask for because presumably the drug’s packaging and serial number would be gone. An inspector would never be able to pick a drug package from a legitimate wholesaler or pharmacy shelf and ask, “show me the pedigree” if the drug has already been dispensed because the package would no longer be on the shelf.
But what if the wholesaler or pharmacy is not legitimate and they are selling drugs in packages whose original contents have previously been dispensed? The drug package on the shelf might have been refilled, perhaps with drugs obtained illegally over the internet. In that case the criminal is not likely to append the pedigree to indicate that the drug had been fully dispensed, and then refill the bottle or vial. Instead, they are most likely to repeatedly refill the bottle without updating the pedigree so that the pedigree would always look valid whenever they are inspected.
WHAT ABOUT THAT DATABASE?
My ears perked up when I heard Ms. Herold refer to “the database”. What she was describing does not make much sense in a pure document-based pedigree system because only the company in possession of the drug right now would have visibility to the current state of the drug—and that current state would be updated by that same company. But in a network centric ePedigree system (NCeP, also known as an Event Based Traceability system) a central or semi-central checking service could have visibility to the current state of the drug. If a legitimate pharmacy updated the NCeP database to indicate that the drug package was fully dispensed, and then a wholesaler later tried to ship that same serial number, or a pharmacy later tried to dispense it, the system could immediately recognize that these were invalid transactions. I think this is what Ms. Herold and Mr. Room were thinking when they answered this question in this way.
But so far, the Board of Pharmacy has not sanctioned the use of an NCeP approach. To recap, Mr. Room does not see any reason why an NCeP like the one used in the Abbott, McKesson, VA, GHX pilot last year (see “The Significance of the Abbott, McKesson and VA Pilot“) cannot be used to meet the California law as long as everything specified by their law is included (see “California Board of Pharmacy Clarifies Use Of GS1 EPCIS”). But there is currently no agreement on how to include the certifications that are a required piece of information that must be included for each change of ownership and passed on in the pedigree (see “‘The Shadows Of Things That MAY BE, Only’ : EPCIS and California Compliance”).
A central or semi-central e-pedigree checking service-based system has clear advantages over a document-based pedigree system, as Ms. Herold and Mr. Room seem to see. Will they compromise to get an NCeP that has those benefits but does not include certifications? I don’t think so but some may wish to try.
CHAIN PHARMACIES FEAR PEDIGREE DEACTIVATION AND DECOMMISIONING
Not many pharmacies have been involved in the search for a viable, interoperable electronic pedigree solution for the industry, even though they will fill an important role in that solution. However, if there is one message I have observed from the intermittent participation of that segment since 2003, it is that chain pharmacies are scared to death of having to update any new database after dispensing a drug.
As I recall, chain pharmacy representatives fear that updating a database would slow the pharmacist down and interfere with the important pharmacist-patient interaction. Frankly, the chain pharmacy representatives I have observed on this issue have sometimes gotten kind of militant about it, not wanting to discuss it at all. It is as if the potential patient safety benefits of decommissioning could not possibly exceed the cost so let’s not talk about it. Hospital pharmacies, on the other hand, seem to be a little more open to the possibilities.
Considering that the law adopted by the California legislature does not mandate a pharmacy update on dispense that is accessible to all supply chain members, and considering that chain pharmacies have been strongly opposed to doing such a thing, I don’t think it is likely to be a part of the system that the industry adopts to meet the California law.
The same is true of the current federal bills that are working their way through Congress right now (see “The Federal Lot-Based Pedigree Before Congress“). They require the FDA to study the impact of any and all new actions that pharmacists might be expected to perform and justify them. Personally, I don’t think it will be too hard to justify decommissioning serial numbers after dispense if you design it so the process is automated and part of the existing pharmacy management systems that are already in use. The pharmacist should not need to take any new actions other than scanning the package barcode on dispense and that would only add a second or two to each dispense event.
But that’s just me. What do you think?