A Q&A With ASD Healthcare on Planning for Serialization

US Drug Supply Chain Security Act (DSCSA) drug traceability requirements become mandatory beginning in 2015, and will be phased-in over the next ten years. Phase one, which started on Jan. 1, 2015 and will be in effect until December 2022, requires the exchange of "chain-of-ownership data." Beginning in November 2017, the second phase will require that "pharmaceutical products be marked with a national drug code, serial number, lot number, and expiration date in machine-readable and human-readable form." The final phase of the DSCSA requirements, starting in 2023, will require trading partners to share all data necessary to track serialized items to the product’s origin (1).

Pharmaceutical Technology spoke with Chris Flori, vice-president of business innovation at ASD Healthcare, a part of AmerisourceBergen, about the most important aspects of the 2015 and 2017 deadlines, what to consider when planning for the 2023 deadline, and what can be expected when using a cloud-based tracking system to facilitate serialization.

PharmTech: From your perspective, what are the most important aspects to consider when implementing equipment and systems for compliance with DSCSA 2015 and 2017 deadlines?   

Flori (AmerisourceBergen): When weighing the options available to meet the needs of manufacturers and providers, decisions should be based on what will be best for your patients and your business. From the distributor’s perspective, a key question for any equipment or system is: How can the granular data being collected be used efficiently to identify trends in treatment and adherence and to improve patient safety? The implementation of DSCSA can be seen as an opportunity to continue to focus on patient safety, both upstream with manufacturers and downstream with providers.

PharmTech: What do companies need to consider now, when installing equipment and systems, to plan ahead for future compliance with final DSCSA 2023 deadlines for item-level electronic tracking?

Flori (AmerisourceBergen): When making decisions today, companies need to plan for the best return on the investment in the future. Flexible, interoperable, and cloud-based systems are best positioned to remain impactful and relevant throughout the transition and into business as usual. While two-dimensional barcodes are the mandated format for product identifiers, radio-frequency identification technology can still be leveraged to obtain key benefits.  One would need to create a link between the data components, and then through the cloud, there would be ability to communicate with other systems and the option to view data as needed.

PharmTech: How does the use of cloud-based track and trace facilitate serialization? What are the concerns with the use of a cloud-based system and how can these be addressed? 

Flori (AmerisourceBergen): Today’s technology captures granular data in huge volumes that must be stored appropriately while still being accessible. The cloud is an excellent option for secure storage of the data, regardless of the amount. A common concern is understanding what happens if a system goes offline and more specifically, that while offline, the data won’t be captured. Before deciding on a system, ensure it is able to capture data while offline and self-heal when back online.

Reference
GS1 US, "Implementation Guideline: Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes, R1.1," (GS1 US, Sept. 14, 2014), pp. 8, 12-14.