Pharmaceutical Industry Makes Steady Progress Toward Meeting 2023 DSCSA Interoperability Requirements

2020 Barcode Assessment Documents Year-Over-Year Improvements

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Feb 08, 2021, 09:15 ET

EWING, N.J., Feb. 8, 2021 /PRNewswire/ -- A new GS1 US Barcode Assessment study shows that the pharmaceutical industry is making continued, steady progress toward interoperability, with a growing majority of products now properly serialized according to 2013 Drug Supply Chain Security Act (DSCSA) requirements. Conducted in 2020 by AmerisourceBergen Corporation, McKesson Pharmaceutical and Cardinal Health, in collaboration with GS1 US, the study found that over 90 percent of packages and cases scanned at these three companies met all of the labeling requirements, with three years remaining until the final DSCSA deadline in 2023.

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

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

Angela Fernandez, vice president, community engagement, GS1 US, said, "It's encouraging to see continued improvement in recommended barcoding of pharmaceutical products – especially in 2020, as the healthcare industry had to focus on urgent supply chain issues related to pandemic response. The interoperability that will be enabled in 2023 by full DSCSA implementation is going to significantly enable better data sharing for improved supply chain efficiencies and patient safety. As the world moves toward post-pandemic operations, the foundational work that has been done with recommended barcoding will greatly improve pharmaceuticals distribution, patient safety and global health."

For four consecutive years, the pharmaceutical wholesalers have collaborated with GS1 US to conduct annual barcode assessments that provide a snapshot of industry progress in meeting DSCSA requirements. Each company examined a different slice of its wholesale operations to assess barcode readability: AmerisourceBergen assessed package (lowest saleable unit) barcoding of specialty pharmaceuticals; McKesson measured packages (lowest saleable units) of widely used prescription drugs sent to hospitals and retail pharmacies; and Cardinal evaluated progress with the labeling of homogeneous cases.

Both AmerisourceBergen and McKesson gauged the use of a two-dimensional (2D) barcode (e.g., GS1 DataMatrix barcode), while Cardinal examined use of either 2D or linear barcodes (e.g., GS1-128 barcode). Both 2D and linear barcodes containing required Application Identifiers (AIs) – Global Trade Item Number (GTIN) with the National Drug Code (NDC) embedded, serial number, batch/lot number and expiration date – are suitable for meeting DSCSA labeling requirements.

For more information about barcoding and serialization of pharmaceutical products, download the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability. To access the 2020 GS1 US Barcode Assessment report, please visit www.gs1us.org/barcode-readability.

For more information about GS1 US, visit www.gs1us.org.

About GS1 Healthcare US
GS1 Healthcare US^® is an industry group that focuses on driving the adoption and implementation of GS1 Standards in the healthcare industry in the United States to improve patient safety and supply chain efficiency. GS1 Healthcare US brings together members from all segments of the healthcare industry to address the supply chain issues that most impact healthcare in the United States. Facilitated by GS1 US^®, GS1 Healthcare US is one of more than 30 local GS1 Healthcare user groups around the world that support the adoption and implementation of global standards developed by GS1^®. For more information, visit www.gs1us.org/healthcare.

About GS1 US
GS1 US^®, a member of GS1 global, is a not-for-profit information standards organization that facilitates industry collaboration to help improve supply chain visibility and efficiency through the use of GS1 Standards, the most widely used supply chain standards system in the world. Nearly 300,000 businesses in 25 industries rely on GS1 US for trading partner collaboration that optimizes their supply chains, drives cost performance and revenue growth, while also enabling regulatory compliance. They achieve these benefits through solutions based on GS1 global unique numbering and identification systems, barcodes, Electronic Product Code (EPC^®)-based RFID, data synchronization, and electronic information exchange. GS1 US also manages the United Nations Standard Products and Services Code^® (UNSPSC^®).

For more information, please visit https://www.gs1us.org/.

SOURCE GS1 US