Preparing for DSCSA Interoperability
DSCSA Phase II
Q: What changes are coming in 2023 under Phase II of DSCSA?
Matt Sample: The big change is that when you exchange transaction information with your downstream trading partners, you'll be required to include the serial number, lot number and expiration date of the product you're selling. AmerisourceBergen sells about 800 million products a year, and to provide that information in the file means that we'll have to scan each product. We're tying the physical unit to the requirement of exchanging data with our trading partners. Today, we track the physical movement of drugs through the supply chain at the National Drug Code (NDC) and quantity level. In 2023, an electronic movement, down to the individual unit, will have to mirror that. And the systems that exchange data and track these electronic movements must be interoperable.
Q: What are some of the complexities associated with achieving interoperability?
MS: The first component of interoperability is the exchange of transaction information. By 2023, we'll have to tell our downstream trading partners what item we're selling, the quantity, the national drug code, and now the serial number. When we implemented Phase I, we used an electronic transmission called an advanced shipping notice (ASN) to exchange information. ASNs have been around for over 20 years, and we more or less hijacked the technology in order to meet regulatory compliance in the supply chain. But when we look at exchanging transaction information that includes serial numbers, ASNs are not built for that. So, we're looking at another technology standard, EPCIS (electronic product code information services), which is a GS1 standard developed for tracking and tracing. It's new in that we haven't ever used it on the scale the pharmaceutical supply chain will be using it on, and as with any new standard or technology, there are going to be bumps in the road.
Q: The second interoperability requirement involves tracing products. What will that mean for manufacturers and sites of care?
MS: Currently, when you sell a pharmaceutical product from trading partner to trading partner, you keep track of which partner you bought it from and pass along the Transaction History. So, if a manufacturer sells a product to AmerisourceBergen and AmerisourceBergen sells it to a secondary wholesaler, and then that secondary wholesaler sells it to one of their hospital clients, the document that ultimately shows up at the hospital will show the full history of who had that product. In Phase II, DSCSA actually eliminates the requirement for the Transaction History to be collected and passed down the supply chain.
So, the industry needs to build technology that makes it possible to piece together the Transaction History of a product so you can produce it for the FDA if requested. We'd have to pull data from AmerisourceBergen, from the manufacturer, and from the secondary wholesaler to put together that Transaction History and produce a product tracking document. To do this in "near real time," we need an interoperable system in order to collect that information from multiple trading partners' databases. No standards or technology exists yet to do that. There are also a lot of security concerns when you start connecting trading partners that don't normally interact.
Q: Can you explain the requirement for product verification, the third component of interoperability?
MS: Basically, you need to confirm you have good product. In Phase I, that just meant looking at the lot number. In Phase II, it goes down to the serial number. This requires some level of interoperability because requests for information about the product can come from anywhere and we're trying to do this all electronically. A request can come from AmerisourceBergen back to the manufacturer or it can come from a pharmacy to the manufacturer. So, you need to have messaging standards and rules around who's allowed to ask the question, how they ask the question and how it gets answered.
Q: Why is it important for the industry to start preparing now for 2023?
MS: It takes time to move an entire industry toward one technical solution or a connected set of technical solutions that don't exist yet. We are trying to get 500 manufacturers, 200 wholesalers, 200,000 dispensers and 10 to 20 solutions providers aligned on the use of the right standards and interoperable. Without a federal mandate that says, 'You shall do it this way,' you have to try to get the industry to work together and get aligned. Trying to build consensus across the pharmaceutical supply chain is not an easy task.
Q: The Pharmaceutical Distribution Security Alliance (PDSA) recently proposed a governing body. Why is this needed?
MS: The first benefit of a governing body is that it creates a totally independent forum to discuss difficult questions. Historically, the Healthcare Distribution Alliance (HDA) has facilitated a lot of the discussions. The problem is, that's a drug wholesaler association and, even though it was open to manufacturers, it still gives the impression that the wholesalers are leading the discussion. We're also hoping governance can create a mechanism that allows us to have an open conversation with the FDA about what they want and what's achievable.
Q: Has PDSA already proposed technical structures for interoperability?
MS: There are groups that have started looking at blockchain to do some of this. The Center for Supply Chain Studies is looking at different use cases for how blockchain can augment electronic product code information services.
AmerisourceBergen is also part of the MediLedger Project, where we looked at a blockchain network and piloted ideas around how you can use it to accomplish some of this interoperability. The challenge is that there are no standards as yet, and you could end up having three or four different companies with three or four different blockchains that don't talk to each other. So, I'd say there are good technical discussions taking place.
Q: What steps can manufacturers take now to start preparing for 2023?
MS: Many manufacturers forget there's still more work to do after you put the barcode on the product. They need to make sure they're producing data that matches the data in the physical barcode, and they need to store it in a database for at least six years. They have to make sure that, when they distribute the product, they're scanning the serial number and can produce a list of serial numbers they've sent out. Manufacturers also need to think about verification now. Once you start putting a serial number on the product, any downstream trading partner can call a manufacturer and ask, 'Is this a good serial number?' Manufacturers should make sure they have manual processes in place to respond to those questions today.
Q: And what are you doing to help sites of care get ready for Phase II?
MS: It's mostly about education. Right now, pharmacies are starting to see 2D barcodes, which contain the lot, expiration and serial number, show up on products. We've started having discussions with some of our larger health system customers about how they can scan and use that information in the barcode. People are seeing the barcodes potentially being useful. For instance, recalls today are very manual. Tracking the batch number to the prescribed patient isn't easily done because you have to type it in. We're also looking at how AmerisourceBergen can modify the tools we provide on an order so that we're taking advantage of this new barcode.
Q: What other ways is AmerisourceBergen preparing–and helping pharma stakeholders prepare–for Phase II?
MS: AmerisourceBergen has been conducting serialized data exchange pilots with large manufacturers since 2015 to ensure we're able to anticipate challenges and create the right solution. In addition, we are running an end-to-end pilot with eight manufacturers and two customers where we execute as if we're in a 2023 scenario and ship serialized products, scan the receipt and get complementary data behind the scenes. I think it's the first time anyone's ever piloted serialization and data exchange on this scale.
Mr. Sample recently contributed to a PDSA governance proposal and white paper. Learn more and request the white paper.