Wholesalers report progress with meds track-and-trace compliance

Top pharmaceutical wholesalers in the US say that there has been significant progress towards the universal adoption of serialized codes on medicine packs over the last two years.

AmerisourceBergen, McKesson Pharma and Cardinal Health, working with barcode standards body GS1, assessed ‘lowest saleable unit’ medicine packs or cases coming through their facilities to see if they were bearing the standardised codes required by the 2013 Drug Supply Chain Security Act (DSCSA).

It’s the third time the companies have carried out the study, and they say that the results show a marked increase in effective coding rates compared to 2017 and 2018. The earlier studies identified issues with lack of adherence to industry barcode standards and improper placement that could leads to codes being mis-identified and delays.

Since November 2018 (after a one-year enforcement holiday), manufacturers of medicines in the US have had to ensure that all their medicines packs carry serialized unique product identifiers.

The same commitment applied for medicine re-packagers from November 2018, with the deadline for wholesale distributors accepting only serialized packs due in November 2019 and for dispensers a year later.

From November 27, 2023, full unit level traceability including aggregation will be mandatory, and for the first time this year the analysis was expanded to give a sense of readiness for that upcoming deadline.

In the 2019 assessment AmerisourceBergen and McKesson concentrated on lowest saleable unit codes, while Cardinal Health focused on cases, in all cases seeing if the codes comprised the four mandatory code components – National Drug Code, serial number, lot number and expiry date.

AmerisourceBergen scanned 1,545 packages from 270 manufacturers, making up all the specialty pharma products coming through the facility during the test. It found that 71.9 per cent had readable DSCSA-compliant codes, up from just over 7 per cent in 2017 and 20 per cent last year.

McKesson study looked at 16,314 prescription pharma products from 477 manufacturers, and found that 71 per cent had readable, compliant codes, up from 21 per cent last year and 6.5 per cent in 2017.

Finally, Cardinal Health and GS1 scanned 19,444 barcodes on 7,996 cases from 177 manufacturers , and found almost 79 per cent of cases with 2D barcodes and 73 per cent with linear barcodes had all four data elements, up from 15 per cent in 2018.

The results exceeded the expectations of the wholesalers, who had predicted that they would get a 50 to 60 per cent compliance rate in this year’s survey.

“The results just blew me away,” says Scott Mooney, vice president of distribution operations, supply chain assurance at McKesson.

“It was fantastic to see the percentage increase so high. Now, we just have to fill the gap to get to 100 per cent.”

Ameer Ali, senior manager of secure supply chain & manufacturer operations at AmerisourceBergen, said it was clear that the November 2018 deadline “really drove suppliers’ actions toward serialization”, with grandfathered inventory – unserialized product that can still be distributed under the regulations for the time bring – expected to continue to decrease over the next several months.

Quentin Dittman, director of operations technology at Cardinal Health, said that “We’re getting to a point where all the products will soon be serialized as we’re seeing the expiration dates slide,” with average expiry falling to 1.6 years in 2019 from 2.3 years in 2018.