Podcast: Is The Pharmacy World Prepared For DSCSA?

Todd Eury: You're listening to the Pharmacy Podcast Network. Hey, what are the DSCSA updates for 2023? If you have been in the profession--I know you have been otherwise you're not listening to the Pharmacy Podcast Network or,
and if you are, you might be just curious of what's happening in the pharmacy profession. Well, this is the podcast network for you today. We're excited about this update information because I'm curious myself, we have studied and have accessed professionals in our pharmacy profession about DSCSA in the past. I think of RJ Hedges and associates who does a lot of work for compliancy and policies for community pharmacies. But we really strive to bring in people who really understand the structure,the meaning. So I get excited to be able to feature our professionals in the pharmacy industry. Josh Bolin is the Associate Executive Director of Government Affairs and Innovation for the National Association of Boards of Pharmacy, known to us all as the NABP. More alphabet soup for us to digest, and the DSCSA 2023 requirement. It's added a new level of complexity for dispensers.

The final phase of the 10 year rollout of the Srug Supply Chain Security Act, DSCSA. It charges the pharmaceutical industry with the implementation of an enhanced system for interoperability, electronic tracing of drugs and really trying to get this launched and going, I believe by end of the year. So I wanna welcome Josh to our program today and also shout out Drug Topics for helping us to put this content together as we're featuring a story on uh the drug topics magazine. Josh, welcome to the show.

Josh Bolin: Thanks Todd, I appreciate the opportunity. Thanks for having me.

TE: So let's kick this off with you. Why are you part of the NABP? What attracted you to that organization? You had to have had a pharmacy background. I can't imagine that you'd want to have joined that team without one. So give us a little background on yourself too.

JB: Sure. So I'm, I'm actually not a pharmacist by education or training. My background is in public policy, political science major in school. And actually my first job out of college was working for the State Board of Pharmacy in the State of Indiana. So I was the director for the Border Pharmacy uh for a number of years and then got to know NABP as an organization really liked the concept of being able to work to work on problems at a national level as opposed to just the state level. And so I joined NAV P in 2005 and have been working in various capacities for the organization ever since. But I think for me it's, you know, being a public servant working for the state, you know, and being able to transfer that and still still do some of that public good on a national level is really what attracted me to a VP.

TE: So I've been following the NABP for this topic and the DS CS A initially was kind of confusing to me until I started reading some of the updates that your organization was putting out. There was one that you actually authored back in 2022 that was titled How Pharmacies Can prep now for the 2023 DSCSA Requirements. So let's take listeners through that. Let's start off with the changes that are taking place and how this impacts our pharmacists.

JB: Sure. And so, you know, as you mentioned, the DSCSA has actually been a 10 year staged implementation. There have been various requirements that have gone into effect, some that went into effect in 2013 when the law was enacted and others that have been staged out over the course of the past, you know, 9.5 years. One of the things that occurred immediately was that any state or federal serialization or pedigree system for tracking and tracing medications that were in effect at the state level, those were immediately preempted and the DSCSA set, what those requirements were would be for how products would be traced throughout the supply chain.

Then there have been other requirements where manufacturers have had to actually serialize products with two D bar codes. So if you're, you know, in a pharmacy, you can see that two D barcode there along with different identifiers for that product, that is part of, you know, this process of moving towards serializing products down to the unit level. And so as we're moving toward that, you have, you know, information that is supposed to be flowing in an electronic manner, you have the products that are also moving through the supply chain. But in November, the concept is that there will be this enhanced tracing or that tracing down to the package level. And at that time, information is supposed to flow in an electronic and interoperable manner. And so that's really one of the big shifts from present day to what is supposed to be implemented in November of this year.

TE: I really liked how you spelled out and laid out what was necessary responsibility requirements being prepared. Let's take listeners uh through those responsibilities. What are the responsibilities of pharmacies today? We'll start there and then we're gonna jump to what's necessary for November of 2023.

JB: Sure. So there are sort of three major areas or three major buckets of responsibility for dispensers today. So, first making sure that you're only doing business with authorized trading partners and what that means, you know, authorized trading partners are defined in the DSCSA. So your pharmacy and you're doing business with a wholesale drug distributor. What that means is that, that wholesale drug distributor has to be licensed by the state. It also means that they have to report their licenses into the FDA database on at least an annual basis. And so as a dispenser, then you have an obligation to make sure that your upstream trading partner that that distributor that is selling you medication is actually licensed and in good standing.

So that's where one of the first requirements and that also seems like an obvious one second is making sure that you have a process in place to ensure that you're accepting prescription drugs that are accompanied by transaction information. So making sure that when you receive a product in the inventory, that it has the relevant information about um you know, the who owned that product prior to, you know, prior to sending it to you. As well is a statement that indicates that, you know, seller is selling that product to you in accordance with the DSCSA.

So it's this concept called the, the three Ts, the transaction information transaction history and transaction statement. So there's that visual examination and comparing that you that the product you have matches up with what's on the invoice that you've received. And then the third area is having a process in place to ensure that you have, you know what to do if you identify a product that's suspect or potentially illegitimate. And so a suspect product is something that maybe the packaging looks discolored or the medication inside of the bottle, isn't how it normally appears or, you know, if you know, you're just otherwise unsure that this product is unfit for distribution. You know, if you have reason to believe any of those things exist, that's a suspect product.

If you have credible evidence that those things are true, then that becomes an illegitimate product and that triggers other requirements under the DS CS A where you as a dispenser would have to conduct an investigation into that product. So you would have to, you know, trace the ownership history, you would have to verify that product with the manufacturer. And most importantly, you have to quarantine the product to make sure it doesn't make its way to the patient until you know, whether it's a legitimate product or not. So those are sort of the three major buckets that are that exist today.

TE: Ok. So we're, we're ensuring that we're doing business with authorized trading partners. We're receiving storing and providing product tracing information which I sounds electronic to me, but it could be electronic and manual too and then you're establishing procedures to investigate and properly handle suspect or ill illegitimate drugs out there. So this is all based on safety.
So let's talk about what's in place today from a technological perspective.
We know that the pharmacy management system is ready. We know that the wholesaler systems are set up and ready. We know that the NACP that has a lot of the, the structure that's built out is uh is ready. What technology is kind of the the one ring to rule them all? What, where does that all pull together to make sure that we're reporting properly?

JB: So that's what's a little bit, not a little bit quite a bit different about the supply chain here in the United States. First is the supply chain in Europe and,
and other countries, you know, there is no one big database of data under the DSCSA. It is very much a decentralized system, meaning that each of the individual trading partners are responsible for storing their own information.
Now, some of them may use a solution provider to do that. There are a lot of EPCIS, which is another one of that alphabet soup that's out there.

That will help with the, you know, creation of those of those files and then storage of those files and then helping you move those files through the supply chain. But ultimately, there needs to be a way to connect all of these disparate uh data sources together. And that's something that, you know, we've been working on over the course of the past, over the course of the past several years.

TE: All right, Josh, let's move to what's happening. So,can you share with us the four points that we need to be aware of to be prepared for November 27th,
2023.

JB: Again, one of the big shifts from what is happening um today, you know,
the product moves and then also that that transaction information, transaction history and transaction statement that also moves with the product in a physical manner. So as as the product moves through the supply chain,
that transaction history who owned that product previously built and in the DSCSA today, there is a requirement to pass and store that transaction information with the physical movement of product. And then ultimately, that resides with the pharmacy at the end of the line. What is shifting in November is that the requirement to pass and store that transaction history with the physical movement or product that actually sunsets in the law. And what's problematic about that is that that transaction history is how a state regulator or even how a pharmacy knows who owned that product previously and so what's happening in November is that, that information is just supposed to flow in an electronic and interoperable manner. Meaning that, you know, either these individual uh trading partners have to connect their systems together or their solution providers that are storing their EPCIS information for them will have to connect.

And then ultimately, that's how information would be traced back because there has to be a mechanism to go back and rebuild that bread crumb trail as you're trying to identify prior ownership. Um you know, for that product in terms of the other November requirements now, from a dispenser perspective, one of the keys is knowing how you are actually going to store that transaction information. Now dispensers can use a solution provider, they can, you know, work with someone to actually help them store that information. Uh but they can also rely on their wholesale distributor to store information and in particular, they can store information for the pharmacy, but only for the products that that wholesaler has sold them.

So, wholesaler A can store the transaction information for products that wholesaler A sold to pharmacy A. But wholesaler B can't store transaction information for wholesaler A. So it all has to be with, you know, those individuals that you are doing business with can, can account for what um what they've sold you. Why that becomes important is that if in the event that a pharmacy identifies a suspect or an illegitimate product or a regulator identifies a suspect or illegitimate product. There will be an obligation to actually respond to that request from a regulator within two business days. And so what that means is if a regulator identifies a suspect product and they ask the pharmacy, who did you purchase this product from? The pharmacy has an obligation to have, be able to go back and retrieve that information and provide that in and provide the train transaction information to the regulator. So that's the other major obligation here. Yes, the information has to flow electronically and interoperable. But then there's also an obligation to respond uh to regulator requests for information. And then also if the pharmacy finds something that pharmacy has to do their own investigation,
as I mentioned earlier.

TE: I think of the evolution of the QR code and I remember when they first came out, it was pretty annoying to me because I didn't know what they were.
I didn't know what it was. I didn't know how to read them, you know, the complexity. Now it's pretty common even in conference registration. So one of the things I'm thinking of if I take a picture of our conference right now, our screen and I text that picture of you and I on screen for our listeners,
you can't see us but Josh, a handsome man and myself with my US Pharmy shirt on um you're missing out if you don't see us but if I take that picture,
Josh and I text it to someone and then they text it to someone and someone texts it and all of a sudden maybe it becomes viral. Someone that wanted to investigate that picture could look at metadata on it, they could take the transaction of this, sending this picture and they could say, when was the picture taken? What location was it taken from? And I think that's pretty much the basic information that they could, you know, be able to say and possibly even trace, maybe there might be an IP address or something related with it.

I think through QR codes, you could probably show all of the data of what you have described is that kind of what's happening today in moving forward with the implementation of the changes for November.

JB: Yeah. So again, you reference the QR code in this case on the,
you know, on the individual visual package. It's that two D barcode. And so what that will tell you at the time of scanning, it is certain information about that product. So you would understand, you know who the manufacturer of the product is by nature of, you know, those numbers that are on the on the packaging. But then what that allows the pharmacy to do is to make additional requests.

So you, you identify the serialized unit and then you can ask the manufacturer, did you actually affix these data elements, the serial number,
lot number, expiration date and, and G 10 or NDC to this product?
That is, it's what's known as a product verification. It's one of the tools that's provided under the DSCSA. The other thing that scan would allow the,
the pharmacy or even the regulator to do is to initiate what's called a product tracing. And that's going back and gathering that prior ownership history of the product. And so, yes, there's absolutely some of that information embedded into the two D barcode. And that's also how you can have confidence that you're getting legitimate information back. And so that's been one of the major advancements that's gone into place over the course of the past several years.
And it's using that 2D barcode. Now, in the context of these other tools that the DCSA provides for the, the supply chain, as well as the regulatory community.

TE: One of the, there's always these buzzwords that float around in our industry. Josh, sometimes it'll stick around forever. Other times they are reinvented and reclassified. One of the buzzwords that came out in 2018, definitely in 2020 now, it's not really talked about as much is Blockchain and how the technology is going to verify financial transactions almost instantaneously based on um assuring that it is what it is and they can kind of squeeze out any of the um uh you know, the the wrong doings of people that might be talented with algorithms. And so there's a system there and I think is the is that infrastructure is the system of Blockchain going to assure the DCSA's processes are in fact um compliant.

JB: So Blockchain is a technology that is being used by different solution providers within the DS CS A space. It is not to to go back to your earlier statement. It is not the end all be all of solutions. Every solution provider sort of has set up their own technology stack and what they think is best to help facilitate and not to get into too many of the details of the Blockchain. But using Blockchain as an exclusive way to solve for DSCSA, a kind of runs a little bit counter to folks wanting, wanting to store and protect their own information,
which is, you know, again how the supply chain here in the United States has evolved. Um NAV-P actually has acquired a tool that will help with product verification that utilizes Blockchain technology.

What allows for saleable returns to occur within the DSCSA and essentially the Blockchain portion of that is a look up directory of the different drug products throughout the supply chain. And so the manufacturers will come in and will populate that information and then you remember that products I was referring to for product verification. Once that product scan occurs, then it will hit the look up directory. So it knows where to send uh the request and where to send the message. And so that's some technology that NABP actually acquired to help move forward our um initiative that we're working on to help facilitate interoperability.

TE: Josh, your writings really helped me to stay up to date on what's happening. And I've been curious, you put out an article in June of 2023 just recently, how trading partners can prepare for DSCSA? And you mentioned something called Pulse by NAPP. Can you describe what pulse is?

JB: So Pulse is a digital directory for the prescription drug supply chain. And so a good way to think about it. I referenced that look up directory before. So it's kind of the next iteration of that where what it will allow is to establish these,
you know, trusted and verified relationships between trading partners.
So that way if you have to conduct a product verification, you can do so in a secure and interoperable manner.

If you have to go back and track prior ownership history you're able to do that in a secure electronic and interoperable manner. And initially why we started down this pathway to developing pulse by NAV P was really to try to help serve our member boards of pharmacy, you know, you'll recall, I mentioned that um that transaction history, which is an investigative document that they rely on today when they're investigating suspect or illegitimate products that sunset. So that's not a tool that's going to be available for them after November of this year. And so what we initially set out to do was to try to build a mechanism that would allow regulators to go and rebuild that Breadcrumb Trail and trace the prior ownership of a product when they're conducting a suspect or illegitimate product investigation.

And so as we were going through that exercise, we also recognized that the dispenser community, which is again, who we're talking to here today, they, many of them are, you know, not ready because they've been worried about things, you know, such as getting us out of the pandemic and working conditions and all of the other things that you, you know, you will talk about here on this podcast. So there are those obligations that dispensers have to meet.

So we also viewed Pulse as being a way that we can provide those, you know, those communication tools and product tracing and product verification. And because it's the small pharmacy community in particular, that is most often targeted by counterfeiters and criminals, that's the community that really needs the uh tools within DSCSA the most. So that way they can have assurance and confidence that when they're dispensing a medication to a patient that it is the actual medication and that um they've obtained it from you know, from a legitimate source. And so with pulse, we're actually using that as a means to try to simplify compliance for DSCSA and providing this set of tools that dispensers would be able to um utilize to meet their compliance obligations. And then in doing so, we're actually providing those at no cost uh to the dispenser community. We believe that the more entities that participate in this electronic and interoperable system, the safer the supply chain is gonna be for all of us. And so, you know, with pulse, we view it as being a this digital platform that can help facilitate that secure communication, but also simplify compliance.

TE: The organizations and people that I think of first are the independent community pharmacy owners out there, 19,000 plus of them out there throughout the country and there are many businesses in of themselves. So they have to think of how does you know this affect us? How do, how do we stay um compliant? Um Alan Mcgill, who's a special agent with the Pennsylvania State government and he keeps people safe from investigating for diversion of drugs. He has so many interesting stories. We interviewed him last week uh for our Fourth of July special. If you want to go listen to that. Uh Alan mcgill thank you. So much for your service to our state.

But he was saying the number one thing that independent community pharmacies can do almost in any case is just be fluid with communications, with their boards of pharmacy just in case if they, if he even said if you think it's a mistake or you think that there's an issue if they report it and then they say, oh, that's, you know, it's not a big deal or this is an easy correction at least three months, two years, five years later, if there's ever an audit, you're not gonna put yourself in a bad situation. So kind of in wrapping up today's interview. Josh, what is your statement to our pharmacy owners out there? Of course, but also pharmacists in general with the coming changes to DSCSA?

JB: Absolutely correct that you should view your Board of Pharmacy as being a resource for, you know, information. And I would encourage everyone to not just view your inspector as being someone who's there assessing compliance,
but as someone who can, you know, help educate and can help you understand what the requirements are. Uh, three main things that I would tell pharmacies today as they look ahead to the DSCSA requirements. Many of these things that we've mentioned in terms of authorized trading partners, you know,
the examination of products before you pull them into inventory suspect and illegitimate product investigations. It is critical to have an established,
detailed policies and procedures for, you know, how you will document your training of staff on those procedures.

But then also how you'll prove that you're actually following them. So for example, like if you've checked your authorized trading partners, you know, um, one time, but then you've never checked them again. How do you know that they're still authorized?

So it's creating that sort of ongoing compliance for these areas for DSCSA.
The other key thing is to understand um how you're going to store your product tracing information. That's the major requirement that's coming. So are you going to use your wholesale distributor for that or do you need to look for a solution provider to help you store that information? And what I would say is the more upstream trading partners you have. So the more suppliers you purchase from, the more complex complying with that aspect may become.
So it may make more sense to utilize a solution provider. And then finally,
you know, there are those product verification and product tracing requirements if you um you know, if you identify a suspect or illegitimate product, so obviously you could pick up the phone and meet those requirements.

You can use a solution provider and then I'll uh obviously with what we've been working on with pulse, that's another option that won't cost pharmacy in order to be able to utilize those tools. Then just a final point and a couple of resources, I'd encourage everyone to visit Pulse dot Pharmacy for more information on the platform uh that platform is launching this summer. And so we'll be going through a process of getting folks on board and beginning training and education around those tools. And also as part of that,
we're doing free webinars uh throughout the course of the summer, that can dig into more of the detail that that relates to um relates to the DSCSA compliance. And then a final resource I would point to is DSCSA dot Pharmacy.
And that's a collaborative effort between NAVPA lot of the National pharmacy organizations and some other supply chain organizations to create a trusted and consolidated resource uh for DSCSA education. So I'd encourage everyone to, to visit both those websites for more, more details.

TE: Josh, we wanna thank you uh on behalf of the Pharmacy Podcast Network but also Drug Topics for doing this interview with us today, updating us. This is important. We want to stay ahead of this. We want pharmacists to thrive. Obviously, we also want our uh business supporters to thrive just like you and I, you are, we're not pharmacists, but we love pharmacy and we love what we do and supporting pharmacists to keep our nation safe. And that's the number one, the number one reason for pharmacists and the NABP is definitely safety. So, thank you, I can't wait to have you back Josh giving us uh your next update from NABP. I hope you have a terrific day and weekend.

JB: Great. Thank you so much.