The march to DSCSA interoperability

The ability to track pharmaceutical product inventory and movement through the healthcare supply chain is an increasingly obvious priority to help support the highest possible quality of care and patient safety. The pharmaceutical industry has been implementing major improvements since 2013 that—when fully implemented across the entire industry—will go a long way to facilitate better supply chain visibility and inventory management through more consistent and standards-based product identification. This visibility will help the industry plan and prepare for changing circumstances as efficiently as possible and enable providers to obtain the products they need, when they need them, and to anticipate those needs as accurately as possible.

Serialization, barcodes and crucial data

Pharmaceutical companies have been working to implement globally unique product identification in accordance with the 2013 Drug Supply Chain Security Act (DSCSA). Trading partners are getting closer to item-level traceability and have already made significant investments in implementing serialized item traceability systems.

Serialization and unique product identification enable trading partners—from manufacturers to wholesalers and distributors, all the way to healthcare providers—to positively identify every pharmaceutical product as it moves through the supply chain and hospital inventories. As products are scanned along the journey, real-time data becomes available to stakeholders, including the product’s location on its way, so healthcare providers can accurately predict when their orders will be delivered.

Getting there?

Item-level serialization of all regulated pharmaceutical products will enable vast improvements to the supply chain’s efficiency and performance. It is a tall order for manufacturers—requiring intensive collaboration between trading partners, installment of internal data systems and production adjustments to allow for the necessary labeling and tracking. But the good news is, the industry is well on its way.

GS1 US recently conducted its fourth annual barcode assessment in collaboration with AmerisourceBergen Corporation, McKesson Pharmaceutical and Cardinal Health to quantify the industry’s progress in serializing their products. Barcodes were scanned in three different facilities and evaluated for correct application of the required data standards.

Each year, improvements have been documented as the major pharma companies increase their implementation and more products enter the supply chain with the proper identification. At the same time, inventories of “grandfathered” products that entered the supply chain before new labeling requirements kicked in (Nov. 27, 2018) are being used as allowed before they expire; as these inventories are whittled down, newer products with the proper labeling will take their place. The average expiration date of products found in inventory during the 2020 assessment was 1.6 years for the second consecutive year, down significantly from 2.3 years during the 2018 assessment.

As those products are consumed or expire, the percentage of fully serialized products in the supply chain will continue to go up, heading towards the goal of 100%.

Scanning barcodes

The three participating companies in the assessment each evaluated labels on a specified slice of the market. AmerisourceBergen assessed package (lowest saleable unit) barcoding of specialty pharmaceuticals; McKesson measured lowest saleable units of widely used prescription drugs sent to hospitals and retail pharmacies; and Cardinal evaluated progress with the labeling of homogeneous cases.

Over 90% of packages and cases scanned at these three companies’ facilities met all of the labeling requirements, with three years remaining until the final DSCSA deadline in 2023.

Specifically, the 2020 barcode assessment showed that a vast majority of products were correctly marked with all of the necessary data elements, including 90.1% of specialty packages tracked by AmerisourceBergen; 86.6% of packaged drugs tracked by McKesson; and 93.1% of homogeneous cases tracked by Cardinal. Taken together in aggregate, 90.1% of all the scanned barcodes met the standard.

DSCSA barcoding requirements

The DSCSA requires pharmaceutical products to be serialized and labeled to support an interoperable, electronic system for identifying and tracing throughout their distribution in the US. Four standardized data elements are required to be encoded in a barcode, including 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 2-dimensional (2D) barcode (e.g., GS1 DataMatrix barcode), and homogeneous cases must include a 2D or linear (e.g., GS1-128) barcode. The application of standardized data facilitates product traceability throughout the healthcare supply chain and will be used to associate the physical product markings with serialized electronic data exchange that will be required in 2023.

Wholesaler distributors will also become accountable for verifying the unique identifier of returned products before they can be placed into inventory for resale. The enforcement deadline has been extended to 2023 for all remaining DSCSA milestones for all trading partners, including for dispensers, who will be expected to receive only product with 2D Data Matrix barcode and product identifiers in accordance with the regulation. To meet this requirement, pharmacies will need 2D barcode scanners connected to supply-chain data systems containing product information that can be exchanged between trading partners.

Immeasurable dividends

End-to-end implementation of the DSCSA will result in improved inventory visibility and better detection of product counterfeits. Ultimately it helps protect patients’ “five rights” of medication use: assuring that the right patient can receive the right drug, at the right time, in the right dose and via the right route—all of which are generally regarded as a standard for safe medication practices.

The interoperability that will be enabled in 2023 by full DSCSA implementation will significantly enable better data sharing for improved supply chain efficiencies and patient safety. As the world moves toward post-pandemic operations, the work that has been done will greatly improve pharmaceutical distribution, patient safety and global health.

Details of the Barcode Assessment study are published in a new GS1 US report, “Progress on 2023 DSCSA Interoperability.”

About the Author

Peter Sturtevant, Sr. Director – Community Engagement, GS1 US