DSCSA and exception handling — We need a plan

For pharmaceutical industry veterans, November 2023 marks the end of a decade-long journey to “achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.”  This milestone will come with little fanfare, but with gigantic impact to the pharmaceutical supply chain.

Each of the major three players in getting drugs to market, manufacturers, wholesalers and dispensers, will now have a mandatory data infrastructure to deliver the interoperability and product tracing required as part of the regulation. A cross-industry coalition, the Partnership for DSCSA Governance (PDG), has worked diligently to create a “Foundational Blueprint for 2023 Interoperability.” 

This blueprint does a remarkable job of defining how the serialized product data infrastructure and flows should work as product moves through the supply chain. Systech is proud to be a PDG member and an active participant in the reviews and workshops that helped put the blueprint together. I’d like to thank Systech’s Octavio Rodriguez  for his contributions to PDG and ensuring Systech is perfectly positioned to meet our customers’ requirements to comply with DSCSA.

At the end of the day, the objective of DSCSA is to protect the pharmaceutical supply chain by mirroring the physical product flow with a digital record of product movement and verifying that the two match at each ownership change. Essentially when product is physically shipped, its digital record is “shipped” to the recipient.

Despite all this great planning and design, there will be issues.

Because there will be exceptions to all data matching, dealing with them efficiently will be critical to keep the pharmaceutical supply chain moving. There is a myriad of reasons why the physical product received will not match the digital record of what was sent. There are scenarios of product received, but no data for the product is present. Scenarios of data received, but no corresponding product has arrived will occur. Dealing with damaged product and possible suspect product will be part of the exception handling equation as well.

The HDA did publish an Exceptions Handling Guidelines report last year; but, this covered the transactions between manufacturers and distributors, not dispensers.

Remember, the reconciliation of this data goes down to the serialized unit. Given the volume of covered medicines under the DSCSA, even 1% of products having “misalignment exceptions”—when there is a misalignment between the physical supply chain and virtual supply chain—could be crippling to distribution if not effectively handled.

Recently, I represented Systech at a PDG/HDA/GS1 Workshop on Exception Handling in Washington, DC. This was an exciting two-day event bringing together all the key stakeholders of the pharmaceutical supply chain, including manufacturers, wholesalers and dispensers. Nine different exception scenarios were to be reviewed and discussed, but only six were ultimately able to be completed due to the sheer volume of discussion.

Because the final PDG Blueprint was issued mere months before the November 2023 deadline, the industry has largely been focused on getting the architecture right and getting solution providers equipped to service this virtual supply chain properly. In other words, the focus has been on the “perfect state”, and not the reality that our supply chains are not perfect. This is why the workshop couldn’t finish all nine scenarios.

It's clear that all parties responsible for DSCSA compliance need to do a lot more planning for exception handling. I believe there are two important attributes of what will be an effective exception handling program: clear procedures and regular audits of them.

First, define clear procedures and processes for exception handling. Establishing a clear set of guidelines for handling exceptions can help ensure that everyone involved in the DSCSA data management process is on the same page. This can include defining what constitutes an exception, who is responsible for handling exceptions, and what steps should be taken to resolve them.

Second, conduct regular audits and reviews of exception handling processes. Regular audits can help identify areas where the exception handling process could be improved. This can include reviewing the effectiveness of automated tools, assessing the accuracy of exception identification and evaluating the timeliness of exception resolution.

I am not sure how many stakeholders have established their exception handling procedures let alone planning for reviewing them regularly. The next six months will be critical to do just that, lest we encounter major disruption from exceptions that are discovered.

My next post will focus primarily on manufacturers. The best way to deal with exceptions is to eliminate them in the first place. Ensuring the pallets that leave manufacturing facilities arrive at their destination where the physical products perfectly match the transaction data shared will be critical.