Should Pharmacies Decommission EPCs Upon Dispense?

Santa Monica Pier
Santa Monica Pier

Important 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.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.


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.


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.


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?


4 thoughts on “Should Pharmacies Decommission EPCs Upon Dispense?”

  1. Dirk,
    You continue to put together clear and cogent discussions on the “state of the industry.”
    I couldn’t agree with you more on the need to decommission. But I would bet that, properly implemented, rather than a couple of seconds, there would be NO discernible transactional impact to the local pharmacists OR their corporate headquarters.
    If a database is going to be updated at each move through the distribution channel or dispense operation (and centralized is what it needs to be), that database should already “know” how many units of each product had already been received by the receiving party, so at the pharmacy, each dispense would be a simple decrement to that value. Upon attainment of a “zero” value, the EPC should be automatically decommissioned. The time required for such an action is almost certainly measureable in milliseconds, at most. Additionally, any negative value resulting from that final decrement could be used to flag potential discrepancies in the distribution channel and drive resolution activities. But then again, maybe that’s what some folks fear- the need to be responsible for what they’ve done with the product that they’ve received.

    1. JT,
      Thanks. I agree with you on the technology side. My “one or two seconds” assumed that the pharmacist would need to scan the new 2D barcode that would be on the drug package to identify which source package was being dispensed from. This is “pharmacist action time”. I hope that today, pharmacists routinely scan the existing linear barcode containing the FDA NDC but the time I have allocated for the 2D barcode is longer because 2D readers are not quite as aggressive as linear barcode readers and so there would be a small “hit” on pharmacist action time compared with today. My belief is that one to two seconds is well worth the investment in patient safety.

      However, I think there is also a concern by pharmacies about how often things will “go wrong” and what happens to pharmacist time in those cases. What happens when the local network/database/internet is down? What happens when the data is incorrect for non-criminal reasons? What happens when the barcode is severely smudged and is therefore unreadable? What happens when the dispense occurs based on a phoned-in order but the patient never shows up to pick up their drug and the pharmacy eventually puts it back into stock?

      All of these would compound the problems pharmacies face every day. The total industry solution will need to answer these questions too, not just the technology questions.


  2. Dirk,
    Thx for your response- There are some VERY interesting questions that must be considered when a set of user requirements are developed for these systems to be both efficient and effective when they are designed, developed and implemented. I’ve encountered many of these same kinds of questions/concerns with folks in both manufacturing and logistics environments and we proved them to be essentially non-concerns as we completed our development, testing and implementations. (I’m inclined to believe that there can be more “turf” concerns than truly insurmountable technical issues when it comes to traceability and authentication.)
    Also, I’m intrigued by your comment on the “aggressiveness” of 2D vs 1D barcode scanning. Depending on the definition of “aggressiveness,” I think that I would say the exact opposite. With the 2D readers that I’ve implemented having extremely high “reread” rates, e.g. <100 ms/read attempt; and, with the data capabilities inherent with ECC200 an immensely more robust read error rate than with 1D.
    I'd be very interested in your experiences, offline if you'd like, since we spent a huge amount of time working with both fixed and handheld readers over the years of development and implementation.
    Thx again, your insights to both the political and technical "goings-on" are ALWAYS thought provoking.

    1. JT,
      Thanks again for your comment. My 2D reader experience does not include all models/manufacturers and I must admit that it isn’t that recent. I’m glad to hear that 2D readers are now reading so fast. I hope that includes the lower cost models that companies are likely to invest in for this purpose.


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