Study Suggests that More Pharma Companies are Ready for DSCSA

Results of the 2019 Update on Barcode Readability for Drug Supply Chain Security Act (DSCSA) 2023 Interoperability showed that 74.3% of the pharma barcodes scanned in wholesaler facilities meet serialization requirements. This research is conducted annually by the “Big Three” pharmaceutical distributors AmerisourceBergen Corporation, McKesson Pharmaceutical, and Cardinal Health, together with the standard setting organization GS1 US. Results showed a 54% improvement when compared with last year’s update.

Data was gathered during the summer of 2019, when 18,000 barcodes produced by 747 pharmaceutical manufacturers were scanned at AmerisourceBergen and McKesson distribution facilities. Another 19,000 linear and 2D barcodes applied to approximately 8,000 cases from 177 pharmaceutical manufacturers were scanned at Cardinal Health facilities.  Distributers evaluated codes to determine whether they contained all four data elements required by DSCSA, to support an interoperable traceability system:

• A National Drug Code, represented by a Global Trade Item Number (GTIN)

• Serial number

• Lot number

• Expiration date.

Because the DSCSA also specifies that packages at the lowest saleable level be marked with a two-dimensional (2D) barcode (e.g., GS1 DataMatrix), and that homogeneous cases include a 2D or linear barcode (e.g., GS1-128 type), assessment also covered readiness in those areas. 

Following are some of the results of the study:

• Of the specialty products that were scanned at AmerisourceBergen, 71.9% of all packages had a readable 2D GS1 DataMatrix barcode with all four DSCSA-required data elements (compared with 20.4% 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).

“Results suggest that pharmaceutical companies are prioritizing serialization to prepare for DSCSA electronic data exchange requirements by November 27, 2023,” said Angela Fernandez, vice president, community engagement, GS1 US, in a press release issued by the organization on October 23, 2019.  “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.”

FDA’s grandfathering allowance was designed to ensure that pharmaceutical supply chains would remain stocked with inventory, so that patients could obtain medications when needed. As grandfathered inventory continues to be consumed, the serialized percentages of pharma inventory is expected to reflect the move toward more agile inventory management, the average expiration date of inventory in the 2019 assessment was 1.6 years, compared to 2.3 years in 2018.

Source: GS1 US