A Q&A with Matt Sample, senior vice president of manufacturer and replenishment operations at AmerisourceBergen.
After 10 years since initially becoming law, the Drug Supply Chain Security Act (DSCSA) will be fully implemented come November. Manufacturers, distributors, and pharmacies must be ready to comply with federal regulations by that time, forgoing the patchwork of state requirements that have long been the industry standards.
Drug Topics talked with Matt Sample, senior vice president of manufacturer and replenishment operations at AmerisourceBergen, about what dispensers should know before the deadline, and how they can be ready to comply with the new DSCSA regulations.
Drug Topics: To start off, can you give some background information on why the Drug Supply Chain Security Act was created?
Matt Sample: It started around about 2012. What was going on in the country then is you had varying states coming up with their own track and trace pedigree laws. So, Florida had a lot of based pedigree. California was the big one that was looking at serialization and barcoding. And then New York was looking at a couple of different laws. A lot of the industry got together—the manufacturers, the wholesalers and dispensers—and said, “Look, you know, if I'm a manufacturer, I don't package for California, I package for the United States.” If you're a dispenser, you might serve multiple states from a given distribution center. So, the industry basically lobbied together to work with Congress to create a federal drug supply chain security act, the federal standard, to basically prevent 50 different ways of tracking products.
If you look at the security of the supply chain, it's pretty safe from a global perspective. You look at Southeast Asia, it's got 20% counterfeits. This is just a tool that we add to our tool chest to help investigate in those rare instances of diversion or counterfeit. It all really drove from the fact we needed one way to do things and not 50.
Drug Topics: What impact will the DSCSA have on pharmacies and manufacturers’ businesses?
Matt Sample: At this point, with four months to go, all the requirements in November just build off of everything we've done for the past 9 years. The whole idea is that there is information sharing between the manufacturer and wholesaler, wholesaler and pharmacy, about what we sold them. And the simplest thing in the law says you can't take ownership of the product if you don't get this data. So, from a change perspective, now it's just we're putting new things into that data. It's just what you sold to the dispenser—the product, the quantity.
Tomorrow it's going to be the same, but then it's going to have a unique serial number about each bottle that you sold them. So, from a process perspective, it shouldn't change. It should just be more information.
What we're seeing is a lot of dispensers though, are now investing in third party systems to capture all this information. It's a lot of data. You've got to save it for 6 years in case there's an investigation. The biggest impact is really just as a dispenser, knowing where am I going to store my data? Am I going to use the wholesaler system? Do I need my own? Is everything I've put in place to date sufficient enough? Do I need to expand it? Many dispensers haven't done anything. So many of them are like “Oh, I need to do something now.” But in theory, it should just be building on what we've done already.
Drug Topics: Like you just said, in theory most of it is already being done, but you also said that there's still a lot of questions. What are the consequences if someone is non-compliant?
Matt Sample: That's a good question. That's a big “to be determined” because the FDA does not have staffing to audit pharmacies, wholesalers. I mean, there's 200,000 prescribers in the United States. We are seeing an ABP and the board of pharmacists start to get interested in understanding this because they'll be the ones auditing. I would imagine failure to comply could mean you get penalized from your board of pharmacy. If you're a manufacturer, this is just another requirement from the FDA. You could get a warning letter.
I think it's just one more requirement that the current licensure entities have to enforce. I think one of the big discussion points we've talked about is if somebody's not ready come November, say you're a manufacturer, what's that mean? You can't take products out of the supply chain. Right? You can't shut down an entire health system. So, I think that's a big question of “How are we going to enforce this?” Because at the end of the day, we don't want to punish the patient. We we're trying to secure the supply chain. We're not trying to punish the supply chain.
Drug Topics: Why is the act important for patients and drug safety?
Matt Sample: This is one that's kind of tough to unlock. Our supply chains are pretty safe. I think what we'll see, and we've had this happen a couple of times over the last couple of years with some counterfeit drugs, some diverted drugs. It helps when there is a safety issue, especially because we're going to have much better data that can either help us execute a recall quicker. Today, just the way the supply chain is structured, I don't necessarily know where're all the lots of a product went tomorrow. Hospitals may not be tracking it, it's not a requirement to, but they may choose to start tracking lot numbers to patients.
So, I think it's just going to give us more data to either, in the event of a counterfeit product, figure out who might have gotten it, or in the event of a product recall, identify quicker where those medicines are.
Drug Topics: Not all medications, like medical devices, are affected by the act. Why is that?
Matt Sample: Well, if you think about medical devices, and I spent 10 years there before pharma, they didn't even have an NDC code equivalent. So, they have regulations now called unique device identifier, which aimed to be able to uniquely identify a type of device with a number. So, they're about 10, 15 years behind where we are for pharma. They had their own challenges and that leaves us with human prescription drugs. Basically, anything that's got an RX on it for the most parts is in scope. There's a couple of things like sodium chloride, imaging agents, that are out of scope.
For the most part, it's every drug. They did take into account some certain emergency patient needs. If there is a pharmacist that gets a call from the pharmacy down street and says, “Hey, I have an urgent need. Can you loan me the drug?” There are some exempt transactions as well to make sure that doesn't put at risk emergency situations.
Drug Topics: How should pharmacies be working with their supply chain and distribution partners to prepare for the coming November deadline?
Matt Sample: If there's a pharmacy that doesn't know what to do, or has questions, reach out to your sales representative, they'll connect you with the right people. There are ample resources. If you Google “What do I do for DSCSA as a pharmacist?” you're going to get solution providers telling you what to do. The Healthcare Distribution Alliance worked with APHA and some other trade organizations to put out a more non-solution focused “Here's what you need to know.”
There is a ton of information out there, but reach out to your wholesaler. We're putting a lot of effort into the communication, and kind of dispelling some of those concerns and myths that people are hearing.
Drug Topics: Is there anything else you would like to say about DSCSA, or something important that you think we haven't discussed?
Matt Sample: I think the big thing with this, as a broad supply chain perspective, is it's changing the way the entire supply chain does business. We sell 4 billion units a year. Now there's a piece of data that has to go with it. And if that data is not with the drug, the drug doesn't move. And so, this is really not so much for the dispenser, it's more for the upstream trading partners. The data quality is just as important as the product quality. It's really challenging the supply chain to kind of evolve in our maturity.
I think that's also the message to the FDA, too. This is going to take time to stabilize. That's a big concern we've raised with new technology and a lot of data. We don't want to create more drug shortages. This is highly transformational. This is not a just a minor requirement that you implement and you move on.