Assessing Current DSCSA Implementation

A barcode assessment study conducted in the summer of 2019 indicates that the pharmaceutical industry is making steady progress toward serializing its products in accordance with the US FDA’s 2013 Drug Supply Chain Security Act (DSCSA) requirements, leading to improvedpatient safetyby enabling accurate identification and tracking of pharmaceutical products throughout the healthcare supply chain. Between 2018 and 2019, the percentage of products that were properly serialized increased dramatically from 20% to over 70%, marking a tremendous surge in momentum. 

To obtain a view of industry’s progress, GS1 US collaborated with AmerisourceBergen Corporation and McKesson Pharmaceutical to assess the barcodes on packages of “lowest saleable units” in their distribution facilities. Cardinal Health and GS1 US also conducted barcode assessment for homogeneous cases from pharmaceutical manufacturers for the second year. The results are good news for the industry – and for patients.

DSCSA 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 United States. 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 two-dimensional (2D) barcode (e.g., GS1 DataMatrix barcode), and homogeneous cases must include a 2D barcode or a linear barcode (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 the serialized electronic data exchange required by November 27, 2023.

Assessing Industry Readiness
Three consecutive barcode assessments were conducted in 2017, 2018 and 2019 to obtain a yearly snapshot of the industry’s progress in meeting the requirements. The assessment was conducted by scanning over 50,000 barcodes on thousands of products within each of the Big 3 wholesalers’ distribution facilities to see if they scanned properly and contained all four required data elements. Each assessment showed a year-over-year improvement – from 2017 to 2018 the percentage of properly barcoded and serialized packages went from 7 to 20 percent. The dramatic change, however, occurred between the 2018 and 2019 assessments: all the way to 74 percent of products in inventory successfully meeting the standard.

In the latest assessment, nearly 18,000 barcodes produced by 747 manufacturers were scanned at AmerisourceBergen and McKesson distribution centers, and another 19,000 linear and 2D barcodes on approximately 8,000 cases from 177 manufacturers were scanned at Cardinal Health facilities. Results showed that 74.3% of pharmaceutical barcodes scanned in the wholesalers’ facilities met the requirements—a 54% year-over-year improvement when compared to the same study conducted in 2018.

Grandfathered products dwindling
The FDA allowed products that were placed into commerce before November 27, 2018 to be “grandfathered,” exempting them from serialization enforcement under DSCSA. This allowed the industry to prevent shortages and ensure that patients could obtain proper medications when needed. The average expiration date of products found in inventory during the 2018 assessment was 2.3 years; in 2019, it went down to 1.6 years. As those products are used up or expire, the percentage of fully serialized products in the supply chain will continue to go up, heading towards the goal of 100 percent.   

Learning curve
The first two assessments revealed problems with the application of barcode standards, such as expiration date discrepancies and barcode legibility issues. By 2019 these anomalies had been almost entirely resolved. As a result, nearly all barcodes scanned properly, which saves time and improves accuracy by eliminating the need to resort to manual data entry.

The wholesalers found that talking with their suppliers was crucial to work through any quality issues. By testing the barcode consistency in three consecutive years and collaborating with each other, they were able to adjust and improve. Periodic check-ups enable them to follow up and share results with their individual supplier manufacturers and repackagers so that they can continue to make any course corrections, as needed.

Using the encoded information to benefit patients
One of the benefits of standardized data capture is interoperability for information exchange between trading partners. The industry began using the barcode data for saleable returns verification in November 2019, enabling confirmation of returned pharmaceutical products’ eligibility for resale. That is just the beginning.

The full impact of serialization will begin to be realized in 2023, when DSCSA requires implementation of an electronic, interoperable system for product traceability. At that point, transaction information for each sale of certain prescription drugs will be exchanged electronically to verify product identifiers at the package level. Such unprecedented levels of specific information sharing will enable cost savings, transactional accuracy improvements and more efficient recalls when needed, ultimately making the drug supply safer for patients.
 
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.