As DSCSA enforcement looms, industry looks far from ready

A study of pharma industry readiness has found that almost 80% of medicine packs don’t meet the barcode requirements of the Drug Supply Chain Security Act (DSCSA) – with just over a month to go before the enforcement deadline.

The new report from the US’s big three pharma distributors – AmerisourceBergen, Cardinal Health, and McKesson Pharmaceutical – draws on some pretty reliable sources, namely the observations of all three companies from thousands of medicine packs that passed through  their facilities during the month of May 2018.

That’s just a snapshot – and of course there may have been a surge in compliance since – but their results reveal that just over 20 per cent of packs carried a readable 2D data matrix barcode with all four required data elements, namely a National Drug Code (NDC), serial number, lot number and expiration date.

That’s an improvement on an assessment a year earlier which found a readable 2D barcode rate of less than 7 per cent, but still suggests that there is a long way to go before the industry is ready to meet the serialization enforcement deadline – which remember has already been extended by one year.

At a recent Healthcare Distribution Alliance (HDA) traceability seminar, the deputy director of the FDA’s Office of Compliance – Ilisa Bernstein – said there would be no further extensions to the deadline, which means companies have until November 27 to make sure all products entered into the supply chain are DSCSA-compliant.

AmerisourceBergen assessed 5,009 packages of specialty medications, McKesson analysed prescription pharmaceuticals, scanning 16,200 packages, and Cardinal Health looked at case-level barcodes on products, scanning 15,708 barcodes on 6,481 cases. Among the latter, just 15 per cent of cases were properly marked.

The percentage of packages and cases with serial numbers in barcodes was lower than the other three data elements, painting an even bleaker picture of readiness, although the study suggests that companies maybe waiting to switch serialization functionality on until the last minute as it can impact packaging line productivity.

“The industry has made only marginal progress in the past year toward implementing DSCSA serialization, and US FDA enforcement is around the corner," said Siobhan O'Bara, senior vice president of industry engagement and services at GS1 US, which conducted the study on behalf of the distributors.

“Just over one month from now, failure to meet these critical requirements could begin to negatively impact companies' reputations and bottom lines, so time is of the essence,” she added.

The study also found problems with barcode placement, a lack of alignment when 2D and linear (UPC-A) barcodes were present on the same pack, and issues with serialization adherence, improper coding, and inconsistent expiration date formats.

“We noticed that many barcodes are too close to each other – something  that is happening more frequently on cases than on packages,” commented Ameer Ali, senior manager of secure supply chain and manufacturer operations at AmerisourceBergen. In some case they also wrapped around the edge of the pack, rendering them unreadable.

The top tips for industry from the report are as follows:

• Pay particular attention to barcode placement on cases and packages to avoid readability issues;
• Refer to and implement GS1 Standards for barcode size, placement, encoding, and more to improve barcode quality;
• Take advantage of assistance provided by all three wholesalers, including sample barcode testing, educational sessions, and individualized support;
• Use the DSCSA education and implementation resources available from GS1 Healthcare US;
• Accelerate the implementation of serialization and work out the any issues now before the deadline; and
• Keep your eye on the “prize” for all trading partners, as the promise of a standardized, highly efficient, global supply chain becomes a reality.