During summer 2019, nearly 18,000 barcodes produced by 747 manufacturers were scanned at AmerisourceBergen and McKesson distribution facilities for this assessment. Additionally, another 19,000 linear and 2D barcodes applied to approximately 8,000 cases from 177 manufacturers were scanned at Cardinal Health facilities. These barcodes and the data they carry were evaluated to determine if they contained the four data elements required by the DSCSA to support an interoperable, electronic system to identify and trace pharmaceutical products. The four essential data points required by DSCSA include a National Drug Code (represented by a Global Trade Item Number®, GTIN®), serial number, lot number and expiration date. The DSCSA also specifies that packages (“lowest saleable units”) must be marked with a two-dimensional (2D) barcode (e.g., GS1 DataMatrix barcode), and that homogeneous cases must include a 2D barcode or linear barcode (e.g., GS1-128 barcode).
Specifically, the results showed:
- Of the specialty products at AmerisourceBergen, 71.9% of all packages had a readable 2D GS1 DataMatrix barcode with all four DSCSA-required data elements (compared to 20.4 percent in 2018).
- 71% of prescription products at McKesson’s facility met the same requirements (compared to 20.8% in 2018).
- At Cardinal Health, 78.7% of homogeneous cases with 2D (GS1 DataMatrix) barcodes and 73.3% with linear barcodes had all four data elements (compared to 15.1% in 2018).
Angela Fernandez, vice president, community engagement, GS1 US, noted, “The tremendous progress made in the past year underscores how pharmaceutical companies are prioritizing serialization to benefit the entire healthcare system and prepare for DSCSA electronic data exchange requirements by November 27, 2023. The industry has come a long way since 2017, when only 7% of packages carried all the necessary data elements. The number of serialized products found in this year’s assessment is particularly significant considering the supply chain still contains some products that were ‘grandfathered’ and placed into inventory before November 27, 2018.”
A grandfathering allowance from the U.S. FDA ensured supply chains remained stocked with inventory, and patients could obtain proper medications when needed. As the grandfathered inventory continues to be consumed, serialization percentages are expected to rise even higher. The average expiration date of products found in 2019 inventory was 1.6 years, compared to 2.3 years in 2018.
For more information about serializing pharmaceutical products, download the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability. To access the 2019 GS1 US Barcode Assessment report, please visit www.gs1us.org/barcode-readability.