Exceptions, the errors that can occur with DSCSA transactions, are an increasingly common issue as the industry transitions to EPCIS data ahead of the November 27, 2023 deadline. This isn't because EPCIS is a less reliable standard; on the contrary, it's due to the combination of two important layers of security: First, EPCIS is a highly detailed standard that records an item's entire event history, and second, DSCSA requires a precise match between the transaction data and the shipment delivered, preventing diverted, illegitimate, or otherwise dangerous drugs from entering the supply chain.
These might seem like common annoyances rather than an important business consideration, but after this coming November, they'll have the potential to stop product movement, a factor that can incur high costs and require large amounts of time and labor to fix.
Even if your organization is already making progress on DSCSA, it's important to make sure that the plan includes a playbook for exceptions management. Ideally, this would include a robust solution that can minimize the (often meticulous and difficult) manual work of investigating and resolving them, and standard operating procedures (SOPs) for working through exception scenarios with your trading partners.
While exceptions often have to do with data errors, sometimes they can be caused by variances with the product or the shipment. Some standard shipping practices and eventualities can result in DSCSA exceptions that can stall or prevent product from being received.
For example, it's common for trading partners who ship out pharmaceuticals to require multiple deliveries to fulfill a single purchase order. Even if everything is correctly documented in the EPCIS data — the packages are serialized, have the correct product identifier, and are properly aggregated — the shipments may not arrive at the same time. The receiving party already has the EPCIS file and knows to expect the rest of the purchase, but for that moment, they have an EPCIS order that technically doesn't match the product they have in hand.
Simply put, there is a mismatch between the product as delivered and the EPCIS data for the order. The recipient can't proceed with the assumption that the rest will arrive; doing so defeats the purpose of DSCSA's requirements, as it would create a false tracking history that would only worsen the situation if, in fact, the missing delivery was lost or diverted. The product can't be received immediately, and yet, completion of the order may be imminent. It may arrive the following day; it may arrive after a week or more; it may not arrive.
Pre-DSCSA, in such a situation, the shipper might file a claim for missing goods, request a credit for the products, and then issue a new PO for them. Under DSCSA serialization, the recipient may need to decide whether to wait, to seek another EPCIS file, or to take some other course of action. The manufacturer would also need to be informed, such that any lost product can be flagged if it turns up elsewhere. All the while, the shipment is not received, and the dispenser cannot provide even the portion in hand to the patient.
Damaged labels also present new difficulties. Usually, in such situations, the outermost box can be discarded, and the items inside can be taken into inventory using the information on each individual package. But what if the package labels are damaged as well? They may even still have human-readable elements, but if the transaction data can't be recorded in EPCIS, then they can't be accepted. Recording them in an inventory system but not in EPCIS means there are competing records to sync down the line, which could be a problem if the status of the packages changes yet again.
Disruptions to a company's supply chain continuity force tough decisions. If a shipment must be quarantined and can't be immediately accepted, or if product isn't available as ordered in a timely fashion, the next move may be to re-order, order a generic or find another brand, which can add great difficulty (and potentially require the pharmacy to spend additional time working with patients). And if a business is losing vital inventory, they may pursue higher production to compensate.
Further, the need to quarantine product while issues are resolved imposes an additional logistical issue for pharmacies, as space is limited and expensive. Most dispenser locations are set up to receive product in time for it to be provided to a customer, and don't have storage space for product that can't be legally moved through the supply chain while its status is decided. The cost and disruption of these situations will be felt sharply by businesses that don't proactively plan ahead for exceptions.
Beyond the matter of exceptions, receiving DSCSA data will be mandatory simply to continue receiving pharmaceutical products after November 27, 2023. In short, it's not a matter of when you adopt DSCSA data, it's a matter of how well you do it. Without a robust system in place, any daily receiving effort could require additional hours or even days to resolve transaction errors, rather than minutes. Resolving EPCIS exceptions by hand is a daunting prospect. Trading partners who expect personnel to find errors by scrolling through long code documents, which potentially amount to hundreds of pages, should expect staff hours to go up (many of them wasted on time-consuming manual tasks) and productivity to go down.
LSPedia's Investigator is the industry's leading exceptions management solution, automating numerous aspects of the EPCIS receiving process. The solution, part of the OneScan Suite, uses hundreds of factors — including DSCSA requirements, GS1 standards, and configurable business rules — to alert receiving staff to exception situations, report the error, and guide its resolution, saving valuable time and effort.
In addition to automation and easy-to-use functionality, working with LSPedia gives you access to some of the industry's top experts in exceptions management, ensuring that your solution evolves as new types of errors emerge, amid the industry's broad adoption of EPCIS this year.
Learn more about OneScan Investigator or contact us to learn more about how LSPedia protects customers across the pharmaceutical supply chain from the high costs, lost productivity, and stress of exceptions management.