The use of Electronic Data Interchange (EDI) Advance Ship Notices (ASNs) in the U.S. pharmaceutical supply chain has expanded over the last year, due entirely to its recognition by the FDA as a valid method for passing the Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) as required by the Drug Supply Chain Security Act (DSCSA). The Healthcare Distribution Management Association (HDMA) has encouraged that expansion by publishing a “how-to” guide for meeting the requirements of the DSCSA using an ASN (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”).
Although not everything has worked out perfectly (see “Is An ASN Really The Best Way to Pass Lot-Based DSCSA Transaction Data?”), it appears that the industry has entered a new steady state using ASNs to meet the electronic exchange of transaction data under the new law—at least for the big volume flows and therefore covering the great majority of drugs.
But how long will that new steady state last? And when it ends, will ASNs be replaced by EPCIS event data exchange? These were just some of the deeper questions behind the 2015 RxTrace U.S. Pharma Traceability Survey that was sponsored by Frequentz (free results and analysis available here).
One of the questions asked of all respondents was
“Do you think there will be a movement in the industry toward using GS1’s EPCIS standard to pass serialized transaction data before it is required in 2023?”
The responses looked like this:
The “Other” response was “Hard to say. The ease of adding serial numbers to an ASN may be the most attractive alternative.”
First of all, adding serial numbers to ASNs, as this last respondent mentions, is probably the least likely to occur at any time, in my opinion. That’s because the number of serial numbers added, and the sheer volume of data they would represent, would blow up the size of a typical ASN by a huge factor, and would likely overwhelm the recipient’s ASN processor.
Yes, all of that infrastructure could be beefed up to handle serial numbers, but that would only be used until November of 2023 anyway, when most people acknowledge that EDI will be incapable of meeting the requirements of the Enhanced Drug Distribution Security (EDDS) system. It doesn’t make sense for every company to spend money on beefing up their EDI solutions for a need that will change in less than 8 ½ years now.
Clearly most people agree that the industry will shift to the use of EPCIS event-based data exchange, even before it is necessary to meet the EDDS in 2023. But how long before? It makes sense for manufacturers, repackagers, CMO/CPOs and 3PLs to invest in EPCIS-based serial number management and application solutions for in-house use or between themselves as part of their deadline to apply serial numbers to every package by November of 2017, but that may not mean they will be ready to switch to EPCIS events for serialized TI/TH/TS exchange at that time. That would be a lot of change in a short time and since the serial numbers are not needed in the data exchanged between parties in the supply chain until 2023, I suspect EPCIS will not have a great impact on it until much closer to that date.
So I personally disagree with most of the respondents to the survey on this question. In fact, I think the new steady state that has just been achieved with ASNs fulfilling the electronic DSCSA data exchange will be very difficult to budge until the EDDS deadline in the law necessitate it. Pilots excepted, of course. It will be very interesting to see what actually happens.
Remember, if you have an interest in adding serial number randomization to your global compliance solution, make sure you sign up for the third webinar in the series that Riya Cao ofLSPediA and I are conducting. Our next webinar in the series will cover that topic in some detail. Register here for the event occurring next Tuesday. You can also register to listen to the recordings of our earlier webinars.