PhM: How do you see pharmaceutical companies reacting to e-pedigree requirements this time around?
TA: Although it’s not the first time the industry has discussed e-pedigrees, it is, in some ways, and we’re still dealing with those same issues. At the federal level, the PDMA law has been in effect now for almost 20 years, and, still, has yet to be enforced. There’s a legal injunction, and so it has never been put into effect. But the concepts are still being discussed and considered, and companies are keeping an eye on what that would mean for them.
So in the absence of the federal level action, the states have jumped in over the past several years – states like Florida and California primarily, but there are thirty-some states with active pedigree kinds of laws, either in place now or working their way through the legislative track. And so with California, which was the most stringent and one of the earliest to come on the scene, the industry has gone back and forth. The industry has taken it seriously in many cases, and a lot of manufacturers have at least started down the track of figuring out what it would take to be compliant. But the California law keeps on getting delayed itself, and so it has yet to be fully enacted and enforced.
Meanwhile, around the world, there are other similar laws taking shape, and across Europe and Asia, some of them similar to California, some of them more similar to a federal PDMA, and with different timelines for implementation as well.
PhM: Is there a lot of uncertainty out there?
TA: This environment has created a whole lot of uncertainty in the industry about what the requirements will ultimately be, what timeframe and when companies will need to act. To a large degree, companies are taking the requirement seriously, but they’re taking a measured approach to compliance, developing strategies, putting plans in place, and, in some cases, taking steps forward and running pilots . . . but there’s a general hesitation to go full-out to compliance at this point because the requirements seem to be changing all the time. A few companies, the exceptions, are moving forward in a more deliberate way. Some others are simply playing wait and see at this point, until the fog clears.
PhM: Some companies had already prepared for the Florida requirements. Are they more or less sufficient to meeting California standards? Where are the two most different?
TA: Well, the Florida requirements were the first real pedigree laws to hit on a state basis here in the United States. And what Florida did was focus on the track and trace – the ability to track drugs through the supply chain in a paper form – in a paper pedigree, really – and they focused on what they called “normal channels of distribution,” which means that as long as a drug goes through normal channels of distribution, it wouldn’t need a pedigree. However, anything traveling outside of the normal channels of distribution would need a pedigree. And also, the pedigree is required to be generated at the wholesaler stage of the supply chain, so it’s tracking a drug’s chain of custody from the wholesale distribution level down to the pharmacy or the doctor.
California is much more stringent, so just meeting Florida requirements is absolutely not acceptable for meeting California’s. California has said, first and foremost, that it is looking for an electronic pedigree. Then beyond that, it is looking for the pedigree to be initiated with the manufacturer, not the wholesaler. Also, they're looking for pedigrees for all drugs, whether they’re being distributed through normal authorized distribution channels or not.
By far the most significant aspect of California’s legislation is that they're requiring unique identification at the smallest saleable unit. What this means is mass serialization at the unit level for all drugs entering the state that are sold in the state.
PhM: What is the biggest technical challenge in meeting California requirements? Is it serialization, is it establishing the e-Pedigree, or is it the integration of the two?
TA: Well, there are certainly challenges in both of those areas. The pedigree, and particularly electronic pedigree, area is new and it’s evolving. I think the more significant issues, particularly on the technology side, lie in the serialization because serialization affects not only the information transfer that needs to happen between trading partners along the chain, but it also impacts, inherently, the packaging and the packaging process and, in some cases, the label of a drug, creating questions about how and where and what technology to use on the labels and what changes to make on a packaging line or in a warehouse.
PhM: How will this change supply chain partnerships?
TA: The greatest challenges to overcome have to do with the nature of the trading partner relationships up and down the supply chain. So, while the pedigree and serialization questions are inherently technology questions about IT, packaging and scanning, this issue is forcing new conversations and new models of relationships between the trading partners in terms of generating information, sharing information, and providing access to information up and down the supply chain.
PhM: How can one have serialization without creating manufacturing bottlenecks?
TA: It’s important to remember that serialization is not just a packaging or filling line issue. Aspects have to do with being able to label at the speed of production, and then being able to read and validate the information as it’s being packaged, but then also being able to process the information and get the information where it needs to go for the next trading partner, whether it be a warehouse or a distributor, to be able to receive the information . . . correctly, and then for a wholesaler distributor to be able to break down, say, cases and pallets and repackage and scan and read the information accurately.