Expert: Industry needs ‘meticulous’ control over master data under DSCSA

Pharmaceutical manufacturers need to have control over their master data to ensure that pharmaceuticals move smoothly through the supply chain when the Drug Supply Chain Security Act (DSCSA) takes effect this November, according to experts who spoke a 27 June webinar sponsored by the Healthcare Distribution Alliance (HDA).

The webinar focused on preparing for the law’s implementation on November 27 and ensuring that trading partners have the correct processes in place to comply with the new law. At the online seminar, experts addressed two critical parts of the master data, the GS1 Global Trade Item Number (GTIN), which is the unique identifier for each drug at each packaging level and the GS-1 Global Location Number (GLN) which denotes the shipment destination.

Ameer Ali, senior director of manufacturing operations for Cencora, said it is essential that manufacturers work with their trading partners now to ensure they are passing along the correct master data, especially now during the stabilization period. Once the law takes effect in November it will be too late to fix problems.

“What happens today is not what happens in November … After the stabilization period is over the product will come to a hard stop,” he said.

April Sese, lead analyst, digital identification and traceability at Johnson & Johnson, said there are certain “requisites” that are critical for success in data exchange. One of these requisites is for manufacturers to have “meticulous” oversight over the GTINS and the GLNs to ensure these numbers on the product’s packaging are correct.

To stay on top of this, manufacturers need to “understand GS1 standards” and understand that these numbers are “moving targets” and always changing.

In the case of the GTIN, these numbers can change if the drug’s packaging changes or if the companies undergo an organizational change. She noted that there was a scenario where J&J acquired a company a few years ago but failed to file the necessary paperwork to ensure the acquired products had the proper J&J GTIN number.

Sese said it is also essential to have the correct GLN code; she noted that this code is not just an “arbitrary” set of digits. One company may have 1,100 to 1,200 GLNs or different shipping locations.

Ali concurred with Sese that having robust master data “is a critical component of this landscape.” He added that “when there is a problem with the master data it affects all of the operational processes.”

Ali noted that “we have tens of thousands of SKUs (stock keeping units) and if one of these units has multiple GTINs it becomes a problem.”

Scott Mooney, vice president of distribution operations at McKesson Corporation, said he is seeing problems with duplicate GLNs for the same shipment destination. For example, a company was using two sets of codes for the same hospital. The company was using the abbreviated name of the hospital as well as the full name, which he said can cause problems downstream. He said trading partners should be using the same GLP code on all product packaging to ensure they get to the right place.

Expert: Industry needs ‘meticulous’ control over master data under DSCSA

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