I am confident that GS1’s Electronic Product Code Information Services (EPCIS) standard will take center stage in 2023 when the U.S. Drug Supply Chain Security Act (DSCSA) transitions into what that law calls the “Enhanced Drug Distribution System”, or EDDS. That’s when the DSCSA mandates that supply chain changes of ownership of prescription drugs must be documented in an interoperable electronic system based on their unique serial numbers.
Each of the steps that must be implemented by the industry between now and that year are preparing for that ultimate, if nebulous, system. I don’t know anyone who questions whether that system will be based on EPCIS, even though we really won’t know how that system is supposed to work for a few more years. We all just assume it will be. There is little doubt.
But what about before 2023? The DSCSA requires manufacturers to put unique serial numbers on their drug packages and cases by late 2017 (repackagers by late 2018) and it requires the various types of trading partners in the supply chain to only deal in drugs that have those unique serial numbers on them in 2019 (wholesale distributors) and 2020 (dispensers), but is that enough to cause companies in large numbers to invest in EPCIS-based systems? Even if a large number of companies make those investments, will they then chose to use the EPCIS data format to exchange transaction data–Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS)?
Maybe. Maybe not. Investments in new technology in the pharma supply chain is pretty tough unless there is a clear requirement. New regulations like those contained in the DSCSA can compel large investments. But it appears that the first widely deployed electronic data exchange technology to meet the DSCSA will be Electronic Data Exchange (EDI) Advance Ship Notices (ASNs) instead of the EPCIS data format. That is because EDI systems are already widely deployed throughout the supply chain, except for independent and small chain pharmacies (see “HDMA Has Updated Their EDI ASN Guidance For DSCSA, Again“).
Companies have realized that they can capitalize on solutions they already own to pass the new TI, TH and TS data for now. And that can continue for as long as the data required is only lot-based. That is, as long as unique package-level serial numbers are not required in the data. And that lasts until 2023, so why would anyone switch from EDI ASNs to EPCIS for data exchange before they need to? In my view, they won’t. At least not in large numbers. (See my thoughts on this topic from last year, “DQSA: Getting To Electronic Transaction Data Exchange“.)
ON THE OTHER HAND…
On the other hand, quite a few companies are investing in DSCSA solutions that include the ability to exchange the transaction data in either EDI ASN format or EPCIS format–offered by multiple vendors. Users may chose either format for their data exchange on a customer by customer basis and the messy details are taken care of by the solution provider behind the scenes. Overall, these solutions may cost a little more, but because the data exchange chore is taken over by the solution provider, in many cases, this may be worth it.
If a large number of pharma manufacturers invest in this type of service, then it will be up to the large wholesale distributors to determine when the switch in data format occurs. If the “big 3” (AmerisourceBergen, Cardinal Health and McKesson) decide at some point they want to switch as many of their suppliers as they can from ASNs to EPCIS data exchange, then those manufacturers who invested in this type of service could all be switched very quickly by the solution vendors without the involvement of their clients. So it is at least possible for GS1’s EPCIS to be used widely for data exchange prior to 2023.
But I don’t think this is likely to happen before maybe 2021 or even 2022 because the extra costs to the wholesale distributors to make that switch cannot be justified until it is necessary. Once these wholesale distributors are receiving large amounts of transaction data through EDI in just the next few months, why would they switch to EPCIS format until either the law requires them to, or the date the law requires them to include serial numbers is approaching and they want to get a head-start?
That is my prediction. How do you see it shaking out? Leave a comment below.
Later this week I am speaking at the Healthcare Supply Chain Association (HSCA) Expo event in Washington DC later. If you see me there, introduce yourself.