The next 10 years of pharma serialization?

For people concerned with the integrity of the US pharma supply chain, 2009 was a dark year. It was the first year after California postponed its “e-pedigree” legislation from implementation in that year to 2015, with the proviso that if a federal law came into place before then, the federal law would supersede the state’s effort. (Which happened, in 2013, with the passage of the Drug Supply Chain Security Act [DSCSA].) While other states had their own pieces of legislation (and while the European Union worked fitfully toward what ultimately became the 2013 Falsified Medicines Directive), California was the bellwether.

So, in retrospect, it was a bold step to start a conference dedicated to advancing the theme of securing the pharmaceutical supply chain. But that is what Excellis Health Solutions, a then-new consulting organization, opted to do. “We knew that serialization would be required for patient safety in some fashion going forward,” says Greg Cathcart, CEO of Excellis, “and we wanted to be involved in that. That first GTT meeting had eight attendees, and this year, we had nearly 200.” In addition, Excellis has sponsored seven other meetings this year, in Europe, Russia and the US; total attendance was over 2,000.

At that 10th annual GTT meeting (Lambertville, NJ, Nov. 13-14), participants assessed where the industry is, and where it is going. While there has been substantial progress to a full implementation of the Drug Supply Chain Security Act in 2023—and comparable efforts in 40-50 other countries around the world, there is a long march ahead. The GTT meeting featured a “Serialization 2.0” session, in which Cathcart and various panelists sketched out next steps. These include addressing:

• Resolution of the “saleable returns” component of DSCSA, by which wholesalers need to verify the authenticity of product returns, before those products can be put back into commercial distribution. Several billion dollars’ worth of product rides on resolving this by November 2020.
• Line aggregation—the need to create parent-child digital relationships between the codes of individual products and the cases in which they are packed. While not a requirement of DSCSA, it is an essential step for downstream supply chain participants to manage their own requirements. According to Cathcart, only half of the existing DSCSA packaging-line implementations include this step.
• Warehouse and distribution-center operations, which will call for extensive training and automation in functions, such as pick, place and ship, that are mostly manual today.
• Onboarding downstream partners, specifically, retail pharmacies and hospital pharmacies. While the big chain drug stores, and some of the larger health systems, have been preparing for their 2020 (?) deadline, large swaths of the US pharma supply chain have not. Panelists noted that some wholesalers have more than 60,000 downstream trading partners; some manufacturers that do direct distribution have more than 1 million.
• Interoperability of data systems: As written, the DSCSA is supposed to enable FDA inspectors to trace a pharma package from the pharmacy shelf back to the manufacturer quickly and easily. But to do that, multiple IT systems and databases need to pass messages and data nearly effortlessly, and the technical capability to do that is, currently, only a vision and not a reality. Panelists noted the effort to develop an industry-wide governance organization to address this and other questions, but the effort is only just getting underway.

“DSCSA compliance is costly, but there’s a ton of value to be had when it’s done right,” concludes Cathcart. “We’re encouraged that the conversations at our meetings are including the rest of the supply chain—pharmacies and hospital systems, even insurance companies. DSCSA is proving to be broader than the original intention of securing the supply chain.”