As with any new initiative there is going to be a learning curve. The Drug Supply Chain Security Act is no exception.
"This is all new," said Matt Sample, Senior Director, Secure Supply Chain for Amerisource Bergen, during the Pharmaceutical Traceability Form in Philadelphia. "No industry is using it [traceability] the way we will be."
While the newness of such a complex law can be intimidating, and has generated plenty of grief across the industry, it's not all bad.
"We have done a ton of work as an industry to get to this point," said Sample. "We are feeling relatively compliant, but there are still some challenges."
There have been many lessons learned as more portions of the law get implemented, and tested out through pilot programs.
Sample explained they have learned that not all labeling is equal. Operational impacts can vary significantly, exceptions to the rules can become challenging and that data is a big variable on many levels.
For example, he said in one test they found the physical product showed up before the data. That created a host of questions, and issues.
Does it mean the data was compromised somewhere? Was the product compromised because it showed up early? What do we do with the product until the data arrives?
Looking ahead, these are some of the questions that will have to be answered.
Specifically, a number of issues have come up around labeling.
"Can the pharmacies scan the barcodes and get the information into their system," Sample asked?
And, that question has multiple layers that can impact the answer, including the actual placement of the label and the type of scanner being used. Sometimes it can even be an issue of having too many similar codes on the same package and someone physically scanning the wrong one out of confusion.
The problem is that if a product cannot be read, it cannot be sold, or used.
"We need to accept there are going to be issues," he said. "So, how do we deal with them? When is it OK to override a situation? I have a cancer patient waiting. When do we make an exception?"