The U.S. pharma supply chain will operate under two major phases as dictated by the Drug Supply Chain Security Act (DSCSA). We are now operating under the first major phase. Well, OK, it won’t be fully operational until July 1st when dispensers (see “Who Is A DSCSA Dispenser?”) are required to begin receiving, saving and retrieving Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) for each shipment they receive. Drug manufacturers, repackagers and wholesale distributors were supposed to begin exchanging those documents on January 1st but in late December the FDA issued a draft guidance that indicated they will not enforce that requirement until May 1st (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”). But be aware that according to the DSCSA, as of January 1st, all trading partners must be properly licensed and everyone may only buy and sell drugs legally from/to companies who hold a valid State or Federal license. Those and other requirements of the DSCSA were not delayed by the FDA.
The second major phase of the DSCSA will not occur until November 27, 2023 when the law transforms into something that is fairly nebulous right now. That is, between now and 2020 the DSCSA requires the FDA to work with the industry and other stakeholders to define exactly how that phase will work. But we do know that, whatever that effort determines, it will require every company to document exactly which unit-level and/or homogeneous case-level serial numbers were involved in each supply chain transaction. On that date, the operation of the supply chain will go through a huge change. All trading partners will need to have systems in place that allow them to accurately keep track of the serial numbers on every drug they ship and receive.
Manufacturers and repackagers often break the DSCSA into a total of three phases rather than two. The extra phase they like to include begins on November 27, 2017 for manufacturers and 2018 for repackagers. Those are the dates when those types of companies must begin applying a unique serial number encoded in a Datamatrix 2-dimensional barcode along with the NDC, lot number and expiration date on each individual drug package and homogeneous case. This is known as “the DSCSA product identifier”. This will require a lot of effort by every manufacturer and repackager selling into the U.S. market, but I don’t include this as a major phase of the DSCSA because it only affects that one segment. I certainly understand why they consider it a major phase, however.
Congress recognized the importance of the second phase and so they gave it a name. They called it the “Enhanced Drug Distribution Security” phase, or “EDDS”.
During the EDDS phase, companies will need to keep track of the various events that each drug package and homogeneous case goes through in the supply chain. Some of these correspond to supply chain events that are familiar today—like shipping and receiving—but some will be new as the result of the addition of serialization itself. These include “commissioning” and “decommissioning”. Commissioning describes the moment a manufacturer or repackager associates a unique serial number with a physical drug package or case (although for reasons we will not go into here, it may actually be created at some moment later in time). Without the commissioning event, there would be no way to know the details about a given serialized NDC (sNDC), also known as a “Standardized Numeric Identifier” (SNI) (the combination of an NDC and the specific package or case serial number) (see “FDA Aligns with GS1 SGTIN For SNDC”).
The serial number commissioning event can be thought of as the “birth certificate” of the physical drug package or case. Before the commissioning event exists within the EDDS, the package or case cannot legally exist in the supply chain. The commissioning event can only be created by the original DSCSA manufacturer or DSCSA repackager (see “Who Is A DSCSA Repackager?”), and for the EDDS to work properly, I believe that the commissioning event must be accessible to all trading partners that own the drug package or case that the event describes. We’ll eventually see what the FDA and the industry decide about that in the next six or seven years.
But what about serial number decommissioning?
WHAT IS “DECOMMISSIONING”
If the commissioning event can be viewed as the “birth certificate” of the serialized package or case, then the “decommissioning” event is the “death certificate” of the package or case. That is, the decommissioning event describes the end of association of the unique serial number with the specific physical package or case. The decommissioning event would be created at the moment that the homogeneous case is broken up into individual packages (if the serial number is associated with a homogeneous case) or when the package is fully emptied of its drug contents (if the serial number is associated with an individual package).
This might occur at the time a serialized bottle of pills is emptied into an automated dispensing hopper, or when a pharmacist dispenses the last dose (or maybe the first dose) from a serialized supply chain package. It might also happen if the drug package or the case and all its contents are destroyed intentionally or unintentionally, or perhaps if it is stolen. For a more complete explanation of what decommissioning is and other events GS1 US proposes for documenting destruction and dispensing, refer to the GS1 Healthcare US DSCSA Guidance vs. 1.1 document published last October (see “The GS1 Healthcare US Guidance For DSCSA, Vsn 1.1”).
Once a decommission event exists for a given sNDC/SNI, the associated package or case is considered non-existent (or more accurately “not traceable”…see the GS1 Healthcare US guidance) in the supply chain from that moment on. The serialized drug package or case must not be observed in the supply chain from that point forward. If it is observed, it would immediately be treated as “suspect product” (see “The FDA’s Draft Guidance on Suspect Product, and Farewell Columbus”). Like the commission event, for the decommission event to work, it must be accessible to all trading partners that could possibly be sold that product (or at least accessible to a “checking service” that would be used by companies in the supply chain, see “Should GS1 Continue Developing ePedigree Standards?”) and that event must be checked for before a patient is administered or dispensed each drug. The details of “how” are yet to be determined.
THE COMING BATTLE OVER DECOMMISSIONING AT THE PHARMACY
It was pretty clear at the FDA’s DSCSA Workshop last May (see “The 2014 FDA DSCSA Workshop”) that the FDA knows exactly what “decommissioning” is and they believe it is of critical importance. The topic came up briefly during the time when several roving members of the FDA had stopped by to listen to the discussion at the table I was assigned to. We were discussing the EDDS at the time. Someone commented that pharmacies were known to not want to bother creating decommissioning events. One of the roving FDA representatives spoke right up and challenged that comment. She indicated that the decommissioning event would be very important to the operation of the EDDS.
From my observation way back in the mid-2000s in GS1 US work groups, before the large chain pharmacies all at once stopped participating in such groups, representatives from those organizations always stopped the discussion of any solution that would require pharmacies to create and then share decommissioning events. At that time, they felt that it would require them to keep track of exactly which package serial number was used at the time of dispense and that would be unacceptable for several reasons.
As I recall (someone please correct me if I recall incorrectly), these reasons included:
- It would require the pharmacist to take one or more additional actions, which would decrease pharmacist efficiency and therefore negatively impact customer satisfaction and profitability;
- It would mean that one or more network database messages would need to be exchanged, probably with systems outside of their control, which would result in tying pharmacist efficiency to the performance of external systems which may be very slow and even inaccessible at certain times (see first bullet);
- It would increase the likelihood that a perfectly good drug might not be dispensable as the result of incorrect responses to validity checks (see first bullet);
- It would require the replacement of all linear barcode readers currently deployed at pharmacy counters nationwide with 2D barcode-capable readers; and,
- It would require the deployment of new software in every pharmacy to implement the necessary database updates and checks.
As I recall, the chain pharmacies were opposed to just about any new action that would be required of them, even if the action only occurred when their drugs arrived at their back door instead of at the moment of dispense. But decommissioning would probably need to be triggered by dispensing rather than at receiving, and to maximize patient safety, the check for legitimate/suspect product should occur as close to the point of dispense as possible. In my view, the greatest gain in patient safety does not require these actions to occur at the moment of dispense as long as they occur at some point during the possession by the pharmacy. Will the FDA and the chain pharmacies agree with me?
At least one chain pharmacy was a member of the Prescription Drug Security Alliance (PDSA) which played a major role in the development of parts of the DSCSA as it moved through Congress (see “Federal Pedigree: Caught In A Web Of Politics”). To get the legislation through Congress and eliminate the various State pedigree laws, every segment of the supply chain had to make some concessions. It is unclear what concessions the pharmacy segment believes they made to accomplish the goals of the PDSA and it is particularly unclear how likely they are to accept the creation/checking of decommissioning events at any point in their ownership of a drug.
We will get a clearer picture of the pharmacy segment’s communal opinion when the FDA begins holding the mandated public meetings to collect input on the design and operation of the EDDS in the coming years. But I’m predicting the pharmacy segment will be ready to battle against any form of decommissioning. (For more on my thoughts about this issue back in the days of the California pedigree regulation, see “Should Pharmacies Decommission EPCs Upon Dispense?”.)
What do you think about decommissioning? Is it necessary in the EDDS phase? Is there an alternative that would be more palatable to the pharmacy segment and meet the goals of the EDDS mandate? Or do you think it is too early to discuss issues related to the EDDS? Leave a comment below.