Many pharmaceutical suppliers may soon face penalties for failing to meet serialization requirements of the Drug Supply Chain Security Act (DSCSA). Last year, the U.S. FDA delayed enforcement of DSCSA serialization requirements until November 27, 2018. However, they recently announced that there would be no more extensions on serialization.
 
Despite the looming deadline, nearly 80 percent of pharmaceutical packages and 75 percent of homogeneous cases did not have a readable barcode with all four required data elements, according to a barcode assessment conducted in May 2018 by GS1 US^®, in collaboration with AmerisourceBergen, Cardinal Health, and McKesson Pharmaceutical (McKesson). The assessment was performed as a follow-up to a 2017 study, to gain an up-to-date view of suppliers’ progress.
 
Requirements
The DSCSA, enacted in 2013, defines requirements for an interoperable, electronic system to identify and trace pharmaceutical products throughout their distribution in the United States. It requires pharmaceutical products packaged after November 27, 2018 to be marked with a National Drug Code (NDC), serial number, lot number, and expiration date. (When using GS1 Standards, the NDC is represented by a GS1 Global Trade Item Number® or GTIN®.) The DSCSA also specifies that packages (“lowest saleable units”) must be marked with a two-dimensional (2D) barcode (e.g., GS1 DataMatrix barcode), and homogeneous cases with either a 2D barcode or linear barcode (e.g., GS1 DataMatrix barcode or GS1-128 barcode, respectively). 
 
Scanning for data
The three pharmaceutical wholesalers participating in the assessment represent approximately 90 percent of pharmaceutical distribution in the U.S. They examined package-level and homogeneous case-level barcodes in their distribution facilities to obtain an indicator of how many packages and homogeneous cases were marked with a readable barcode containing the four DSCSA-required data elements.
 
AmerisourceBergen and McKesson scanned 100 percent of on-hand package (lowest saleable unit) barcodes in their distribution centers. AmerisourceBergen assessed 5,009 packages of specialty medications and McKesson analyzed prescription pharmaceuticals, scanning 16,200 packages. Combined, they found that only 20.7 percent (compared with 6.6 percent in 2017) of packages carried a readable 2D barcode with all four required data elements. That’s an improvement from 2017 – but not much. 
 
Cardinal Health evaluated 15,708 barcodes on 6,481 homogeneous cases of pharmaceutical products. They found just 15.1 percent of those cases were marked with a readable barcode with all four data elements per the DSCSA.
 
Barcode issues
Additional issues identified in the assessment include poor barcode placement, a lack of alignment when UPC-A and 2D barcodes are used together on the same package, poor serialization adherence, improper coding, and inconsistent expiration date formats.
 
Readability problems were observed where barcodes were positioned too close to one another, or to a case’s edge. Case labels may become damaged in transit, and two labels are recommended on each case. A lack of alignment was observed in instances where two barcodes were needed: a UPC-A barcode to satisfy the U.S. FDA Barcode Rule, and a 2D barcode for DSCSA requirements. The key here is to make sure that the GTIN in both barcodes is the same.
 
The study also showed that the percentage of packages and cases with required serial numbers contained in the barcodes was lower than the other three data elements (i.e., NDC, lot number and expiration date).
 
Inconsistent expiration date formats were also found. The use of “zero-zero” as the day in the encoded expiration date, or failure to include the day in the human-readable representation of the date, creates confusion. For example, if a supplier uses December 3 as the expiration date in the barcode, yet the human-readable date beside it only shows the month and year (December 2018), the distributor could assume that the expiration date is December 30 rather than December 3.
 
Grandfathering provision
This year, the U.S. FDA provided guidance about “grandfathering” product that is packaged and in inventory prior to the November 2018 deadline. The guidance allows for un-serialized product without the 2D barcode to continue to be transacted in commerce until it expires. The grandfathering provision enables the industry to move forward without creating shortages to patients or financial loss.
 
Recommending action
With results from the May 2018 assessments, AmerisourceBergen, Cardinal Health, and McKesson are following up and sharing the data with individual manufacturers to help them make course corrections or accelerate implementation. All three wholesalers offer implementation assistance, including sample barcode testing, educational sessions, and individualized support.
 
Together with GS1 US, they’re recommending suppliers refer to GS1 Standards for guidance regarding barcode size, placement, encoding, and more. Suppliers should also pay particular attention to barcode placement on cases and packages to avoid readability issues, and use the DSCSA education and implementation resources available from GS1 US.
 
Common goal
The three companies urge pharmaceutical suppliers to take advantage of available resources that can help them implement DSCSA serialization requirements now, to avoid negative impacts on their companies’ reputations and bottom lines. By standardizing product identification for pharmaceuticals, the industry isworking toward a common goal of improvingtraceability, efficiency and accuracy – and most of all, patient safety.
 
Details of the barcode assessment methodology and findings, as well as recommendations and resources to support implementation, are published in a new GS1 US report,“2018 Update: Implementation of DSCSA Serialization Requirements.” For more information about GS1 US, visit www.gs1us.org.

---

Peter F. Sturtevant, Senior Director, Industry Engagement – Pharmaceuticals, GS1 US, has more than thirty years of global supply chain management experience. Currently, Mr. Sturtevant is responsible for engaging business partnerships with pharmaceutical manufacturers, wholesalers, distributors, retail pharmacies, hospital dispensaries, trade associations, and regulatory agencies in support of the implementation of the Drug Supply Chain Security Act.