Implementation of pharmaceutical serialization is important but really, really complicated.
That’s one of the things I learned while attending and presenting at the Pharmaceutical Traceability Forum held in Philadelphia November 30 to December 1.
I love Philly because of its rich history, great restaurants and wonderful people who will be happy to talk to you about the latest in politics, medicine and innovation. My favorite thing to do in Philly is to visit that Rocky statue because it continues to remind me of the power of an underdog to do great things.
I felt a little like that at the conference – an underdog of sorts, now representing an innovative technology company joining a crowd of conference-goers who came from the large pharmaceutical and wholesaler companies.
With over a hundred people who are knee-deep into getting ready for the November 27, 2017 serialization deadline for manufacturers, I learned three very interesting things:
1. Pharmaceutical serialization has become an industry on its own
There are so many companies, organizations and associations that are touched by the DSCSA (Drug Supply Chain Security Act), that the terminology has become a stand-alone industry. With specific conferences dedicated to companies who provide consulting services to data management companies to packaging and warehousing – the list of participants in the pharmaceutical serialization ecosystem has blossomed and will continue to do so.
What does this mean for the individuals in pharmaceutical companies charged with overseeing serialization? They face an often-overwhelming level of choices and support by experts who are ready to assist in implementation of pharmaceutical serialization.
2. Pharmaceutical serialization is not going to solve the pharmaceutical counterfeit problem
Yes, pharmaceutical serialization will certainly play an important role in allowing companies to track and trace products (assuming that there is data interoperability between manufacturers, wholesalers, distributors and retailers by 2023). Even if all the parties in the supply chain exchanged data on what a package’s bar code meant, bar codes are still vulnerable to copying and hacking.
In fact, wouldn’t serialization standards make it easier for the counterfeiters? Pharmaceutical counterfeiters try their best to print labels, copy blister packs and fake holograms that look authentic. But with serialization, they now have access to the same GS1 rules as the ethical pharmaceutical industry! Bar codes might make it easier for counterfeiters to print convincing-looking labels. And while a person in the warehouse may not be able to tell the difference between a real bar code and one put on by the counterfeiters, the system hopefully be able to catch it. This could be a big challenge.
3. Saleable returns might pile up with pharmaceutical serialization
I learned that about 57 million units are returned each year to the large wholesalers. That’s a lot! They come in from distributors and retailers for a host of reasons. Now, according to the DSCSA, each unit has to be VERIFIED of its authenticity before these units are repackaged, recommissioned and sent back out into the marketplace.
What’s interesting (and potentially a concern) is the following scenario: imagine the thousands of distributors and retailers who, upon seeing bar codes on these packs applied perhaps in an inconsistent manner, send the package back to the wholesaler because they’re not sure if it’s the real product. They don’t want to take legal responsibility of greenlighting a package when they can simply ship it back. So that 57 million number starts to climb.
Could return levels to the wholesalers increase? Could it double? Possibly. But here’s the real challenge: how are wholesalers going to deal with all those returns? How are they going to absolutely verify the authenticity of each package?
Pharmaceutical serialization is certainly not ideal, but the role it will play in advancing pharmaceutical supply chain security is an important one. I believe that we cannot rely on serialization alone to help prevent or deter counterfeit pharmaceuticals into the marketplace. We can do better. We should continue to explore innovative solutions that, when combined with pharmaceutical serialization, offer a compelling way of tracking, tracing and eventually strengthening trust in the medicines we take each day.
And while I’m no longer able (with weaker knees and all) to run up the stairs towards the statue of Rocky, I find comfort in that I was able to keep pace with the best of the conference-goers in advancing new ideas, a different perspective and showing them the possibilities of an underdog technology that, like Rocky’s statue can endure the test of time.