We are now more than six weeks past the date that the DSCSA originally mandated drug manufacturers, repackagers and wholesale distributors to pass Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) to their customers in the U.S. and save a copy for six years (see “DSCSA: A Closer Look At The Six-Year Record-Keeping Requirement”). Of course, just before Christmas, the FDA pushed out that part of the requirement until May 1, 2015 to ensure that the requirement did not induce or exacerbate drug shortages (see “FDA Postpones Enforcement of DSCSA Transaction Data Exchange Until May 1”).
Despite the delay, many companies are already passing the required data to their trading partners through Electronic Data Interchange (EDI) Advance Shipment Notices (ASNs) (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again”). In fact, the vast majority of companies have decided to use ASNs to carry the mandated information rather than GS1’s Electronic Product Code Information Services (EPCIS) (see “Will GS1’s EPCIS Be Used Widely For DSCSA Data Exchange?”).
But are EDI ASNs the right approach to passing DSCSA transaction data? In that last essay listed above I theorized that once companies begin using ASNs to pass lot-based transaction data, they are not likely to switch from ASNs to EPCIS data exchange until sometime in 2021 or even 2022. Since posting that essay I have heard that some companies are finding it more difficult to use ASNs to carry this compliance data than they had originally thought, which leads me to wonder if the switch to EPCIS might happen sooner rather than later.
Many companies are relying on the new DSCSA-specific solutions that they purchased for the purpose of maintaining the required DSCSA transaction data to generate the ASNs that now carry that data. I have heard grumbling about DSCSA solution vendors who “don’t really understand EDI”, which has apparently led to difficulty solving DSCSA and non-DSCSA related problems in the ASNs that those solutions generate. Of course, not all of the vendors fall into this category, but maybe its really just an indication that perhaps EDI is not the best way to pass that kind of information. None of these people want to go on the record with their complaints and even if they would, my intent is not to point any fingers. My point is to wonder if this initial rocky experience with ASNs for some will lead to a quicker move to the use of EPCIS than I originally predicted.
Many pharma manufacturers and wholesale distributors have historically relied on ASNs for more traditional financial purposes, and prior to the use of ASNs for carrying the DSCSA TI, TH and TS, they had a single enterprise EDI solution that generated, received and processed all EDI message types—including ASNs. But now, in some cases, those enterprise EDI solutions are being used to generate all of the EDI message types except the ASNs, which might result in some complex data issues.
I don’t have enough information to be able to know for sure. Perhaps the problems will get ironed out and settle down soon into a smooth operation across the supply chain. But maybe not.
Drop me an email with your experience with your DSCSA transaction data exchange, whether ASNs, EPCIS, web portals or paper, and good or bad. If I get enough of them, I will strip all identifying information from them (including solution provider names) and post them in a future essay. If you have thoughts about the transition from EDI to EPCIS, leave a comment below.