OR WAIT null SECS
Nearly all regulated pharmaceutical products now entering the supply chain are fully serialized and labeled with barcodes according to requirements of the 2013 US FDA Drug Supply Chain Security Act (DSCSA)—containing data that improves traceability, and thus, patient safety.
The next challenge is a big one—and it is the ultimate culmination of all the work that has been done to date. Beginning November 27, 2023, DSCSA requires healthcare manufacturers, distributors, providers, and dispensers to exchange the serialized item-level product information that has been collected, standardized and digitized—that’s when the benefits of full supply-chain visibility will be realized by safely delivering the right medications to the patients who need them.
All along, phased DSCSA implementation deadlines have been building to this final date when industry stakeholders can effectively share complete, accurate, and timely information about pharmaceutical products and their status at any point in the supply chain. Product details, movement and chain-of-ownership events will be automatically recorded with barcode scans at key points in distribution.
However, this achievement hinges on intensive collaboration that must begin now, if it hasn’t already, between manufacturers and their supply chain partners. Even if all products are properly labeled with all the required data, in the right standardized format, and required barcodes that scan reliably and accurately, it will be meaningless unless trading partners’ respective systems are compatible to enable interoperability. Furthermore, information exchange is pointless if the data itself is flawed.
These two caveats are intricately intertwined. Everything must begin with fully vetted, high-quality, accurate data. Then, trading partners’ IT systems must be capable of successfully importing and reading it. Any glitches in this transfer of information, minor errors in the existing data, and any inconsistencies or incompatibilities between systems will prevent effective information sharing and nullify all the benefits. Data quality is essential, and interoperability is complex.
DSCSA specifies four standardized data elements that must be embedded in barcodes on regulated pharmaceutical products: a National Drug Code (embedded in the Global Trade Item Number®, GTIN®), serial number, lot number and expiration date. Packages (“lowest saleable units”) must be marked with a 2D (e.g., GS1 DataMatrix) barcode, and homogeneous cases must include either a 2D or linear (e.g., GS1-128) barcode. These pieces of information are building blocks for product traceability, now standardized and digitized so they can be shared and understood between organizations.
Historically, companies have tended to use their own proprietary product identification schemes for internal use with little or no cross-pollination to make that information usable and available externally. Products were entered into these systems over many years, mostly via manual data entry which can lead to data quality concerns. Proprietary product identification can cause issues due to the lack of standardization and create duplication in the supply chain due to the lack of uniqueness. These issues will prevent receiving partners from importing the data into their systems, thus breaking the chain of communication and destroying the opportunity for traceability that is intended. Also, inaccurate data may be transferred, creating confusion and increasing the potential for additional mistakes.
Trading partners need to know they are exchanging reliable, trustworthy data about the products they handle. To that end, each organization must commit to comprehensive data management and allocate necessary resources to analyze, update and maintain their product information. The crucial process of creating and maintaining trusted data must be recognized and supported as an ongoing fundamental priority.
Even with impeccable data, each organization must be able to import, understand, update and share it forward and backward through the supply chain.In addition to standardized product identification and barcodes, a complete record of supply chain events such as shipping and receiving is an essential part of full product traceability. This record of transaction data detailing the movement of products through the supply chain can be created and shared with the use of GS1’s Electronic Product Code Information Services (EPCIS), as recommended in the FDA draft guidance. Industry stakeholders are urging FDA to clarify this recommendation in the final guidance since EPCIS meets DSCSA’s standards requirements and many believe that without it, full DSCSA implementation will be further delayed as stakeholders wait for clarification.
Is the Industry ready for the 2023 interoperability deadline? In a new Healthcare Distribution Alliance (HDA) survey, most (68%) of manufacturers reported they are not yet sending data to distributors even though 88% have transitioned to EPCIS 1.2, the minimum version of the standard required for secure electronic, interoperable exchange of data.They cited numerous challenges that are complicating the establishment of data connections between organizations. Among them is a lack of clarity on requirements vs. “good to haves,” and technical ambiguities (e.g., exception management, enabling of aggregation) in the U.S. FDA guidance, which has yet to be finalized. A lack of dedicated IT resources (26%) and of trading partner understanding or commitment (24%) were also mentioned as impediments to progress.
Still, the clock is ticking. In preparation for 2023, suppliers and wholesalers/ distributors need to prioritize the establishment of system compatibility and conduct rigorous testing to ensure viable data exchange. Then similar testing will be needed with supply chain partners all the way to the final point of sale—including many thousands of dispensers whose IT capabilities, infrastructure and preparedness for receiving and leveraging the data are inconsistent.
The HDA survey found zero distributors having established the necessary data connection with dispensers. Yet In November 2023, dispensers will only be allowed to receive products that are uniquely identified and marked with 2D barcodes meeting DSCSA specifications. Since many smaller organizations are not yet equipped with the necessary systems infrastructure, pharmacies will need 2D barcode scanners that are connected to supply chain data systems for product information exchange. FDA’s June 2021 draft guidance further sets fast turnaround expectations for dispensers to respond to FDA data requests (within one day) and to resolve clerical errors such as missing data (three business days). While discrepancies are being resolved, the product cannot be sold. Wholesalers will also be required to verify the unique identifiers of returned products before they can be placed into inventory for resale.
Establishing interoperability is a major undertaking that can only be accomplished through industry-wide collaboration and with the larger, more advanced organizations taking a leadership role to bring their smaller counterparts into the fold.
To help supply chain partners establish interoperability, GS1 US offers the following resources:
This is the time for companies to fast-track a thorough review of their product and location data, update and improve it and begin testing their ability to exchange it with supply chain partners. Many companies already immersed in the process stress the importance of collaboration to be sure organizations’ systems work together, understanding there will be a period of trial and error while data systems are being harmonized. Expect this to be a lengthy process.
Full supply chain transparency that enables reliable track-and-traceability will generate broad improvements in the industry’s ability to provide medicines where and when they are needed, and to identify and remedy problems as they occur. Providers and dispensers will know when they can expect delivery. Inventories will be clarified. Orders and shipments will be consistently recorded and tied to unit-level product identifiers for improved accuracy and efficiency.
The resulting visibility will benefit all stakeholders in the healthcare system—delivering operational efficiencies, cost savings, inventory control and more. And of course, the ultimate gain: beyond providing patients with timely access to needed medications, full traceability will increase patient safety by enabling faster, accurate, efficient removal of products when they expire or if they are recalled.
Tracy Nasarenko is Senior Director, Community Engagement at GS1 US.