A Breadcrumb of Serialized Data

PC: What is the current state of affairs of DSCSA?

Rowe: In order to set the context for where things are today, you have to look back over the past couple years of where we've been. The DSCSA has these series of milestones. In 2015, the industry went to lot level tracing, where we were tracking quantities and lots, and how those products were being moved through the supply chain. In 2017 and 2018 is when products started to become serialized by the manufacturer. A lot of packaging changes were happening, and the manufacturers were storing a lot of data, but that data really wasn't leaving or moving with the product.

Since 2018/2019, the industry has been working toward getting through fully interoperable data exchange. The enhanced distribution requirements—as laid out in the law—were set to kick in in Nov. 27, 2023. Up until this time, almost last year, the industry really was sharing that the amount of data that was supposed to be flowing with the product was not where it needed to be. The FDA introduced this “stabilization period,” this one additional year for companies to continue to improve the ability to transmit the serialized data with the product. I like to say that there's a breadcrumb of serialized data that moves with the product as it moves, as it changes hands, and as a way for companies to have their own database to use in a suspect drug investigation to help identify counterfeits. That’s the background of where we are and where we got to.

The current state of affairs is the amount of data that's being moved and the amount of connections that are happening has really improved significantly over this time last year, where the industry at whole was reporting that maybe they were getting 20% of all of the products coming with good data. Right now, wholesalers are generally reporting that it's in that 70% range of where we've moved the needle about another 50%, so that's really where we are today in terms of data exchange, and that's been improving.

PC: Where do you see opportunities for improvement?

Rowe: Where I see the opportunities for improvement and where things are still needing to improve is around what I call exception handling. This is a big buzzword in the industry right now.

What happens if product arrives but there's no data? What happens when the file is late and the product shows up before the file? While there's been a lot of good work theorizing on how to solve those exceptions, there are types of exception scenarios—including the ability to test and pilot in order figure out how to fix those issues and build those standard operating procedures— that aren’t really where they need to be in the industry.

I'll give you an example with a client of ours. There was a file that was inadvertently transmitted, so wrong serial numbers were sent to their customer. We spent months trying to figure out, how do you correct a file that's already been sent out? It's those types of interoperable data challenges that the industry really is still not prepared to handle.