Becky:
Hey everyone, thanks for tuning in to another partnership series with RJ Hedges and Associates. I'm Becky Templeton, the voice behind a lot of these productions that we put on, and I am glad that today I'm joined by two fabulous folks from RxScan. I've got Max Peoples and Rachel Reed joining. Can you guys say hi?
Max:
Hello, everyone.
Rachel:
Hi.
Becky:
Good to see you guys. Today we're going to be going over some of the items around DSCSA. It's been on everyone's radar for a number, number of years, and this November should be the very last implementation date. So Max is going to be sharing some information with us pertaining to what DSCSA is, what the main goals are, how it's going to implement you all in your pharmacies; most importantly, a really great solution to help you all comply with DSCSA. And we'll even spend a little bit of time going over how you can go about getting some easy steps today, working with RxScan to bring this to your pharmacies. So Max, can you give us a little bit of information on who you are, what your background is, your role at RxScan, pretty, pretty please?
Max:
Certainly. I am a pharmacist. I actually still [inaudible 00:01:15] a couple of community pharmacies. I get great staffs that run those pharmacies. My full-time position is the CEO here at RxScan, and my goal is really to help pharmacies meet, in this case, the DSCSA requirements, especially all the new ones that are going to kick up this November 27th.
Becky:
Awesome. And Ms. Rachel, how about you? Can you tell us a little bit about you and what you do within the company?
Rachel:
Certainly. As Becky said, my name is Rachel Reed, and I am the director of business development at RxScan. I have been in the medical field for 20 plus years, working in the pharmaceutical space as well as the software space. And basically what I do is I help RxScan partner with companies and pharmacies in order to bring our solution into the pharmacy to provide value and compliance solutions. So we're here to help our clients along from the very beginning, throughout using the product.
Becky:
Fabulous. All right, let's go ahead and dive into DSCSA or Track & Trace, I think, as most people have gotten to know this government regulation. So what's the overall goal or the impact that the government was hoping to implement out whenever they brought DSCSA to everyone's forefront of their mind several years ago?
Max:
This has been a 10-year progress, and the biggest primary goal of this is to eliminate counterfeits, as much as possible, from entering the pharmaceutical supply chain in the United States. So it affects manufacturers, distributors, wholesalers, 3PLs, and obviously pharmacies and some medical offices. So dispensers is a broad definition. The regulations talk about dispensers. Dispensers are basically anybody that's providing a medication to a patient.
There are some exceptions for doctor's offices. Sometimes they fall under it, sometimes they don't fall under it. Veterinarian products do not fall under it. There are certain types of prescription products that do not fall under it, but the majority of prescription products do fall under the DSCSA regulations. And of course, the newest, latest regulations to take effect this November 27th. There's no hints that the FDA is going to give any extensions, any waivers for all of the new regulations kicking in this November. In the past, they have been very gracious and given some extensions and stuff. This is the end of a 10-year process, and so we're not expecting to see the FDA letting people off the hook this November.
Becky:
10 years to do implementation. Can you wrap up in five minutes and give us the crash course or the 101 of DSCSA and what it is, what it entails, and maybe a little bit about those implementation milestones?
Max:
Yeah. Here's the four big things that are heading this year that really is where everything comes to head. One of course, as you've seen over the last few years, the products coming into your pharmacy have a new square two-dimensional barcode on it. Looks like a QR code. It's not a QR code, but it looks like one of those. And in that barcode is your NDC, number of the products, your lot number, your expiration date, and a serial number. All of these products that fall under DSCSA have to have a serial number now.
Secondly, your suppliers, come this November, have to make available to you a file of the serial numbers of the products they're sending to you. So either they have to make it viewable like on a portal, a web portal, or they're going to send you directly or through a solution provider, like us, that data. And you have to store that data for six years.
You have to have some process in place to make sure that that that data actually matches the physical products that you received. Because in the regulations, if you don't have the data for that product, you cannot give it to a patient. Key point there. If you do not have the data for that product, you are not to give it to a patient. You have to have ways to make sure that your trading partners, in other words your suppliers, or if you're a pharmacy and you're loaning or selling a product to a pharmacy down the street because they're out of it and it's an order that they need for a specific patient, 'cause under the regulations it really needs to be for a specific patient, you have to be able to transfer that data to the new owner.
So you're going to get data from the owner when it came to you because you're now the new owner. And if you trace it off to somebody else, you have to send them that information. You have to include a statement that says that you followed all the regulations. And you have to have some process in place to make sure that who you're doing business with is a legal licensed part of the pharmaceutical supply chain. So you have to communicate with them, with your supplier, with the pharmacist, "Hey, I need a copy of your pharmacy license. Need a copy of your distributor's license."
You have to make sure that they're still a valid part of the pharmaceutical supply chain 'cause again, the rule, the guide there is don't buy products when people aren't supposed to be part of the pharmaceutical supply chain because that's how you get counterfeit products. Think about ways to make sure that you're not getting a counterfeit product. If the price is too good from some source you've never heard of before, it came across in an email, came across in a fax, chances are it's not a good product.
Now, it doesn't mean that you couldn't buy the product, but you better do your due diligence. You better double check to make sure that they are a licensed part of the pharmaceutical supply chain. Do they have the ability to send to you, make available to you the serialized information that they are now required to send to you? Does your physical product actually match the data that they sent you?
These are all workflow, standard operating procedures that you need to have in place starting November 27th. If the board of pharmacy or the FDA would come in and ask you about a particular product, where's the information? Okay? It now needs to be readily available so that within 24 or 48 hours, depending on the question, you can tell them information about a particular product down to the serial number. Well, what might they ask? Well, they might ask, "Who did you get it from? Who did you send it to? Did you return it? Has it been recalled? How did you handle the recall?" Basic information that would help them identify why they maybe found the product on the side of the street; why when they raided somebody's house, they found this container in the house. 'Cause again, they need to track backwards to find out who was all involved in the ownership of this product.
So everything that you can do to help that inspector find out all of the ownership history of the product, you're required to do under the new regulations. Let's say that you got a container in, and it didn't look right, the label just looked off a little bit, or maybe when you took the lid off, it looked like the seal had been broken already. Okay, now that's a suspect product. At that point in time, under the DSCSA regulations, that should be considered a suspect product.
Well, what do you have to do with the suspect product? You have to investigate. You have to quarantine. It means you got to set it aside, and you got to check into it and make sure, hey, is this a good product? Is this a product that I would want to take myself, as a patient? Would I want to give this to a patient?
Well, one of those things is called product identifier verification. This is where you have to actually contact a manufacturer and ask them, "Hey manufacturer, did you make a product that had this NDC, lot number, expiration date, and serial number?" You have to verify those four pieces of information. And there's a couple of ways to do that. You can call them up, find out if they've got a web form, and go through that kind of a process. Or some solution providers like us, were building in an electronic method of being able to do that.
So you'd be able to scan that product, and the computers would talk to each other, and they would confirm that yes or no, that manufacturer made such a product. So these are really some of the key things that kick in this November: being able to trace the ownership history of a product, to be able to do a product identifier verification, to receive and store. All of this data needs to be stored for a minimum of six years, and there's some conditions will be longer than six years. All of that serialized information. Know exactly what you did physically receive; how well did that match up to the data that they sent you in a file? And that you have some method in place to know that the people you're doing business with are licensed and authorized part of the pharmaceutical supply chain. Hopefully that was a five-minute nutshell.
Becky:
Hey, it was so good 'cause it even included a couple things from future bullet points, so good job on going over things so well. Two things I want to pick out of there I'd like to expand on a little bit. And you mentioned a couple of things that they need to comply. And since, over at RJ Hedges and Associates, we're big nuts on SOPs and policies and procedures, can you expand a little bit on those policies and procedures that they need to have in place out outside of just the suspect and quarantine items?
Max:
Yes, absolutely. Absolutely. Obviously you need to have in place, as Becky mentioned there, something to deal with investigating suspect and illegitimate products in your quarantining process. So that's a key SOP. Your inspectors can come in, and they can ask for your SOPs, and you got to show them now. You don't have 24, 48 hours. "Show me your SOPs."
And you should be very cautious in thinking about how PBMs may abuse this new regulations down the road. I'll just stop there. I'm a pharmacist, so I have thoughts about PBMs. Anyways, you just your whole daily issues. Okay, how are you going to receive products? How are you going to make sure that your physical product matches the EPCS file? This is the serialized data that you're going to be receiving. How do you make sure the quantities match, the serial numbers match.
Everything about your daily workflow. How are you going to do a product identifier verification? If a board of pharmacy came in and said, "Hey, help me out here. Can you trace this item's information?" Well, what's your SOP for that? One, of course, you're going to make sure are they truly an inspector? How do you know that it's not somebody coming in trying to get data so that they can make counterfeit products?
So you prove that hey, yep, they are who they say they are. Then they're going to give you this information. So how are you going to do this? How do you do the product identifier verification, or how do you do a tracing? All of those in detail need to be inside your SOPs. Your staff needs to know where the SOPs are at, and they need to know those different procedures. They need to have been educated on them, be familiar with them. They don't want to be learning about it when? When they're in front of an inspector. That's not the time to be trying to learn what they're supposed to be doing.
So it's all of those daily routine features need to be in your SOPs: your verification, how are you going to make sure that you're do dealing with authorized trading partners? How are you going to trace an ownership? All of those features need to be in your SOPs.
Becky:
Great, thanks for sharing. And then the second question I have for you, and you hinted on a couple of those things that either the FDA, PBM, State Board of Pharmacy Inspectors might be asking for. Can you give us a few, maybe three other examples, of what they may ask for in regards to DSCSA when they come to do an onsite visit?
Max:
If an inspector were to come in, one thing they can ask you is, "Show me who you got this product from. Who did you get the serial number from?" Seems simple, but how are you going to do that, especially if you commonly buy that product from multiple vendors? Get it from particular wholesaler, but then you get it from a secondary wholesaler based on pricing and stuff. And they say, "Ah, this one right here." Just go to your shelf, take it off the shelf, say, "Who did you get this from?"
They're going to say, "How do you know that you received the data on this item before you gave it to a patient?"They're going to say, "Show me how you do a product identifier verification on this item item. Show me how to do it." These are some of the most common easy questions that they can ask that you want to be prepared for. It doesn't take a lot to show them how to do it. They're not really getting into all of the nitty gritty of the DSCSA regulations, but they're getting a sense if you have some understanding of DSCSA and some of the basic requirements.
Becky:
Good, thanks for sharing that. I know a lot of times with our clients, the things that they have to do are show the policy and procedures, show the support documentation, show the licensure. In this instance, it's really show me your process. So they're going to have to do it live with whatever process they have or software that they have integrated. So that's good information for our people to know about.
The next part, I would like to move into seeing a little bit of your platform. So if you guys could show us a little bit of your RxScan software and how it works, what a pharmacist might have if they have this implemented into their pharmacy.
Max:
Sure. The key thing is it is software as a service, so it's web-based. So you can do these procedures from anywhere. The basic receiving process, it's stuff, of course, obviously you're going to do in one of your pharmacy locations. It allows you to see across multiple locations. Everything is role-based, location-based, so you can really tie down who gets to see what features where.
And if you're at home at night and you want to run a report, you can run a report at home 'cause you've got the user rights to do that. Other people would only be able to see certain locations and certain features inside the system, again, based on how their settings are set up. Each organization gets their own username and password and company name. I'm going to log in here. So if you have multiple locations, you can choose the location that you're actually working from.
You can determine which locations a person can actually see, and so this dropdown would only show the locations that they're allowed to actually have access to. There is a Today's Message section, so if you wanted your staff to see a particular message when they log in, you can put it up there.
What we're going to focus on today is the DSCSA section. Our system is very modular, so an organization that would actually like to get into true inventory management. We have a perpetual inventory management system. We have the DSCSA features. We have features for medical offices. So it's kind of a la carte as far as what you want to use. Inside, under DSCSA, we have the EPCS reconciliation. That's where you actually match your physical product up against the data that you're going to be sent.
This is your transfer section. So this is where you're transferring a product from your pharmacy to another pharmacy. You don't have to do this if it's a pharmacy that's part of your organization. There may be reasons at times that you might want to transfer the data inside your own organization, but you don't have to. But if it's going to truly a new owner, you have to transfer all of this ownership history, updated with your information, over to the new owner. Even if you're loaning the product, that is a change in ownership; you need to send the data.
PI verifications. This is where you would go in to actually say to a manufacturer, "Hey, manufacturer, did you actually make this product?" Item tracing, this is where you find out your ownership, your particular ownership information on a particular product. We have a recall feature. This allows you to go in and actually scan a product and say, "Hey, is this one of those that's been recalled?"
Your recall documentation. So if you return it to a returns processor, you want to document that, so that if you get an investigation, somebody comes in and asks you about a product, you can tell them not only who did you get it from, but what did you do with it? In this case, I returned it to a reverse distributor on certain date and time, but by a particular shipping method.
The same way with returns. It's important to understand, come November 27th, you're no longer allowed to return a serial number to somebody that you did not buy it from. So if you bought it from wholesaler one, you can no longer return it to wholesaler two. Wholesaler two is not allowed to accept a return for a serial number that they did not sell you. So again, on our system, you can create the return documentation, and our system will know, okay, I returned it on this date and time to this particular supplier. And it will tell you who the supplier is obviously, 'cause behind the scenes we're storing all of this information for you.
We're trying to hide the complexity of DSCSA and all of this data so that you don't have to deal with it. We give you the information you need only when you need it. We also have a quarantine documentation process. The idea being if you have a product that's suspect, all of your documentations, all the steps that you do to comply with your SOPs is stored in our system, so that six months, a year, two years, somewhere down the road, somebody would come back and ask you about that product, you can pull up all the quarantine information.
Just because it went into quarantine doesn't mean that it's bad. It's the process of you determining whether it's bad or not. If you determine that it's not bad, then you can move it on to a patient. But you have to have documentation of, "Okay, here's why I decided it was okay that I could give it to a patient."
If you determine in working with the manufacturer, supplier that it is bad, that it is illegitimate, then your SOPs also kick in and say things like, "Okay, I have to fill out an FDA Form 3911. So we have a link to the Form 3911 in our system. We have to notify our supplier within 24 hours. You have things that you have to do that will be in your SOPs.
What we're trying to do is make it easy to document all of this stuff and have all the data in our system, so that the amount of time it takes to do a lot of this stuff is minimized.
So how does it start? Well, we built this from the perspective what really happens in most pharmacies? Doesn't matter whether you're a hospital, community pharmacy, chain pharmacy, whatever. At some point you're receiving products. And what most pharmacies do today is they got a packing slip. They open up their Totes, they pull out the packing slip, and they start counting in their Totes, and they start checking off on their packing slip.
And we said, "Okay, let's replace that. Let's just scan everything that's in your order. And we're going to get two benefits in that one scan. "The first benefit is just a financial benefit. I want to make sure that I'm paying for what I'm going to get billed for, the items that I'm going to get billed for and the quantities that I'm going to get billed for. I'm capturing all that by the scan process.
The second thing is I want to be compliant with DSCSA. I want to know that my physical product matches my serialized information that they sent me in that data file. So all I have to do is I can just scan on totes. A lot of times on Totes there is a barcode. It's called an SSCCID barcode. That's a barcode, it's off of a supplier tote. We just scan this barcode, so I'm going to do that right now. I scan that barcode. And that allows our system to find the item results. And it goes right into the scanning process.
So right now I just start scanning in my Tote. Doesn't matter whether it's a prescription product or an over-the-counter product; I just start scanning everything in my totes. I got 20 totes, just start scanning.
Now, I can stop in the middle of this if I need to. Let's say, okay, I got to take a bathroom break, or I got a patient, or it's lunchtime. And again, when I say I, I mean your support staff. This is your folks who are going to receive products. Usually it's going to be your technicians and so forth. This is not a quote "pharmacist only" type of work. So I can do some scanning, and then I could process my scans, and I could go do my thing, and I can go back and I can pick back up and finish off the rest of the order.
To give you a sense of what's going on behind the scenes, I'm going to close this window right now. I normally wouldn't do this, I would just start scanning. But I want to show you what's behind the scenes.
So behind the scenes is information already about the items that you're going to receive. So here's the lot number, expiration date, and serial number, this is another identifier called a G10, of the items that are coming in. Now, I've actually done some receiving on this, so this one says, "Okay, here's my purchase order quantity, here's my DSCSA quantity, and this is the actual quantity received." There's other items down here who the item has not been scanned yet. And so you see we're circling boxes with red, saying, "Hey, there's a problem here. My quantities don't match," or "My serialized information doesn't match." We will pull all of those out and warn you.
And then of course there's reports and so forth that you can run from a central offices, like if you wanted to report back to your supplier and say, "Hey, this data is not matching up; I want credits, or send me some items that I didn't receive," et cetera. But the idea is that really quickly your staff can just receive their items and get it on the shelf and get it to the patients.
So the scan process is very simple. You just start scanning all the products. And as it scans, you see that it's pulling out all that information. So it's identifying the product, we're documenting the time that the scanning is occurring, the NDC number, the item, lot number, expiration date, serial numbers, [inaudible 00:23:58]. Okay? And they just scan. And the system will give you messages as we get to the end of this process.
I'm going to do a few different ones here. One of these should be expired. We'll warn you if a product's expired. See if I ran across one here.
Here's a product that's expired. This would be a rare occurrence, but again, we're going to tell you. You would still want to receive this, right? Because it is now part of your ownership. It's been sold to you, it's part of your ownership history. And DSCSA is all about ownership history. So you're going to receive it, but I've told you, and you know, okay, I'm going to set that aside. I'm not going to put it on my shelf. I'm going to set it aside, and I'm going to deal with the fact that my supplier just sent me an expired product.
So here's all the items that I've received. I'm just going to hit Process, and it's going to do a bunch of comparisons. And so in this case, it says, "Hey, wait a second." This item that I just scanned, it's been recorded on a different purchase order number. And we got a couple of those in here. This item isn't on this purchase order. So we have a range of different kind of messages like this. And it will tell you if the serial number is actually found on a different purchase order, not this one.
When you're all done, you just close window. And then it opens it up. And it will still continue to tell you items that there's problems with. Just to kind of give you a sense of, okay, here's an item. Scanned, Humalog KwikPen. Here's the lot, expiration date, serial numbers. Now, if in this process I realized that, "Hey, you know what? There's a problem with this," I can hit this form, and I can start my quarantine process. And I can go in here, and I can say exactly which of these need to be quarantined. And I choose my reason. These are FDA-approved reasons why you would put something into quarantine. So I'm starting my documentation process here. Why? "Labels are smeared."
I put in notes. Every step that you do, you notify, you document. If you didn't document it, you didn't do it. That old maxim, right? So you go through this process. You fill out your Form 3911 when you're to that stage. Have I notified the FDA, yes or no? If I have, when? All of this is being documented inside the system. So if there's any question in the future, all the data's here. Somebody else can pick up, right? One person come in and start it. Another person could do some of the steps, different person. It doesn't all have to be the same person.
So right as part of your receiving process, if there's any troubles, you can document it right here and get started. So that's your basic receiving process. You can see it can work very fast. It doesn't make you change your current receiving process. You're just going from a manual paper process to a scanning process. Unless you're only receiving a couple of items, scanning is always going to be faster and it's always going to be more accurate. If you did a time study, you would see that receiving by scanning saves your staff a lot of time and improves your accuracy.
The other thing I'll point out here is we could get your invoices. Open that up again here. So here's the invoices that are attached to that particular purchase order. Because a lot of times your items come in and get billed across multiple invoices. But what does that mean? It means all this data is tied together.
And what the manufacturers or the suppliers are going to start requiring in November is that when you do a return, you tell them the purchase order number that you got it under, the invoice number that you paid it under, and possibly what was the price that you paid. They want that invoice number because they only want to give you the credit for the invoice that you actually paid for it under.
So in our system, we're serving as a repository for your invoices, for your purchase orders, it also goes by your advanced ship notices and for your E P C I S data, all of that is being stored in our system as an extra operational efficiency because it's one of the things that I wanted to go for. I wanted us not only to be compliant, but what can I do to increase our operational efficiency?
We sped up our receiving process. We made it more accuracy. We made it easy for you to find your invoices. It's all within one single system. And if you're going to do returns, all the data's in the system.
So let's say I got this product, it's suspect. Okay, what do I got to do? I got to do a PI verification. So I come into my system, and I scan that product. Identifies the product. I have to indicate that I've got it in my possession. Why am I doing it? These are all part of the process. So I'm just doing a status check on it. And who's that doing it? I'm doing it today as a dispenser.
You can imagine that the manufacturer of a product, they'd like to know who's asking this question, right? Because to them, if the FDA's asking the question, that's totally different than if Max at Uptown Pharmacy is asking the question. I send the verification request. Confirms that it went out, and it comes back and says, "Yes." Okay? The manufacturer said, "Yes, I made this product."
Now, in the future, the manufacturers will start sending more information than just yes or no. Right now, it's yes or no. But there's new standard coming out. I would expect sometime next year starting to get to be rolled out. They will provide more information such as, "Yes, we made it, but it's been recalled." "Yes, we made it, but we've been notified that this product has been stolen." "Yes, we made it. And oh, by the way, the expiration date has been extended or shorted." So if you think about COVID, what happened during COVID? They extended the expiration dates on a lot of the vaccines. If that happens in the future, you'd be able to scan the product, and you'd be able to get a message back from the manufacturer saying, "Yes, this particular lot number has had its expiration date extended."
Transfer: let's say I am going to loan a pharmacy down the street, across town, a product. I've got to do this documentation process. Well, you can go in and find who's the pharmacy you're going to transfer it to. You can scan the product. You'll identify it. I can do more than one product. And then here's just a preview of the information that I'm going to be sending to them. We send an EPCS file, we send a CSV file, we send an Excel file, we send a PDF for this information, over by email.
Now, if the person that you're sending it to, the pharmacy you're sending to, would also be a subscriber to our system, we will send all the data automatically into their database. So behind the scenes, everything's done automatically for both parties in this transfer documentation. But you can see here who's the sender? Who's it going to? NDC, the description, and the ownership. Got it from AmerisourceBergen. Who was the manufacturer? What was the lot, expiration date, serial number? All the information that needs to go to the new owner is in this document, including down at the bottom, the transaction statement.
You may be familiar, everybody who's changing ownership, they need to make a statement to the new owner that said, "I followed all the law." And that's what that statement says. That in this case, Uptown Pharmacy has followed the law as they transfer this item over to the new owner.
Real quick and simple, right? I just did a transfer. I pulled the stuff off the shelf, I identified who the pharmacy is it's going to. Boom. 30 seconds, the work is done. It's all about doing this stuff as fast and as efficient as possible, and then again, having all the information. I can go back and view former transfers.
Item tracing, they want to know who I got an item from. So I click on my item tracing, I can come in here, I scan the product. Now it'll show the full ownership history of the item. You can see I can do sorting different ways on products and so forth. But I scanned it, it filled in all the different sections. I do Preview Report. Return documentation. So let's say I'm creating a return. Hopefully my database is in here. It identifies the item by the scan. You notice it's already filled in the purchase order number, filled in the supplier's catalog number because returns are actually done by their catalog number, not typically by the NDC number. Here's the invoice number. Here's the price.
I put in a reason code. That's overage; I can put in a note. ""Patient discontinued. This is just internal for myself. Fix my spelling here today. And I kick update. I don't have a valid GTIN number in here somewhere.
So there's my information. I've done my return documentation. Now the system knows that this products have been returned. If I do a history on the product in the future, I'd be able to say, "Hey, I got it from this supplier in this date and time, and I sent it back to the supplier in this date and time." Again, the whole idea being quick, simple, and I'm prepared to answer any kind of questions an inspector may come after me for.
Reports. Going to go ahead and say, "Leave that." Go into reports here real quick. We got a real range of reports; more being added. But things like the Track & Trace reports, statistics, returns, recalls, recall inventory, quarantine, variances. If you're just using our solution for DSCSA, you can still get a list of items that you have received in the past that are due to expire.
So here. I want to see everything that I've received that are going to expire in the next 30 days. I review this report. So rather than having to look everything on my shelf, I can just go look at these products. This is liable to be a big database of stuff here; we'll see what comes up. But these are the products that I've received in the past. Here's their lot numbers, and here's when they're going to expire. So I could just go to the shelf.
And we've designed it and such that you could then mark all those products as having been checked. And when you run the report again in the future, those particular items won't show up. So you're only seeing items that you've never checked before to make sure that they're not in inventory. Again, what we're trying to do is operational efficiency. I'd rather just know the 10 products I need to look for on my shelves that could be going out of date. I don't want to have to look at every product on my shelf. That's really a quick overview of a lot of our DSCSA features.
Becky:
Fabulous. You guys certainly have an awful lot of information available within your program. I love all the different reports. I know you did spend a lot of time on them, but I was looking through your list when you scrolled through it real quick. I was like, "That's even great." So I think that'll help when someone wants to come in and say, "Hey, show me all your quarantine products that you've had in the past." You can just pull that quarantine report real quick. So great information. I love the earlier you said it's fast and efficient. And I couldn't help but think, a lot of these rules and regulations that pharmacies have to deal with are very complicated, very complex. They take a long time. This was 10 years to get all of the participants on par. But just because the regulation is complex, that doesn't mean that what you have to do is complex. So the speed and efficiency that you guys have taken into account for the pharmacist not to be overly burdened to comply with this is definitely an awesome job on your part, and I think that'll definitely help our pharmacists out.
Max:
Well, we appreciate that 'cause one of our primary goals is efficiency in the pharmacy, making sure the techs don't spend a lot of time in this type of stuff; they spending time on patients, preparing prescriptions so that the pharmacist can spend time with patients and providing support services and so forth. We have to be compliant, but we want to do it in the most efficient way possible.
Becky:
I think this will help them succeed. Next on my list to discuss, 'cause this all looks great. So if we've got folks that are watching this and they go, "Ooh, maybe this is what I want to roll into my system; how is it going to integrate with my software?" will the RxScan DSCSA program integrate with all pharmacy softwares?
Max:
Yes. Here's how it works. And what we advise is: you receive all of your items into our system. So we've gone out to your suppliers, we've gotten your purchase orders, we've gotten your EPCS, the serialized data. You go through this reconciliation process. You scan that barcode on your tote, identify the order. You do this whole scan process. Now we know exactly what you received. And so if you're using your prescription dispensing system as your inventory management system, we send to them a file of what you actually received. So we send them the NDC numbers and the quantities of the items that you actually received into your inventory system.
So if you currently have your pharmacy dispensing system going out to your suppliers to get what they're sending you, and of course then you would be scanning into their system and then you would be modifying quantities, you don't have to do that anymore. We work with your pharmacy dispensing system, so they pick up that information from us because we are now the point of truth of what you actually physically received. And again, you don't have to do anything. It's all done in the background.
Becky:
Fabulous. And what could a pharmacy expect to pay for a platform like this? Is it something that it's a one-time fee, monthly fees, annual fees?
Rachel:
Certainly. Right now, this is a subscription-based service, so you're going to subscribe to the solution. You are going to incur a one-time implementation fee. That fee covers allowing us to work with your suppliers, getting everything set up. That one-time implementation fee is $199, and that is a special price that's for the RJ Hedges clients and independent pharmacies.
And then for your DSCSA subscription, you are going to be looking at a dollar a day. So the cost you'll incur is $365 for the first year. And that's going to actually take them all the way to November 27th, 2024. So the sooner you come on, the more months you get packed into that first year.
We know that there will be a rush come those fall months moving towards November. So the sooner we can get people signed up, the better. So the sooner that people sign on, they're likely to get their system up and working rather than waiting until that deadline approaches when all of those wholesalers and manufacturers are going to be backlogged completely. That includes a license of our NDC Translator. That is the software that Max demonstrated using that allows you to scan the barcode that's on the medication container that then deposits the information into our solution. So that outlines the pricing structure. And then after the first year, the cost does go up just a little bit since this is a promotion. And that second year and moving forward, the price is $595. So we're still at a really competitive rate, and we really tried to keep things affordable for the independent pharmacy.
Becky:
Great. If someone has questions about the platform integration, ordering, maybe they have one pharmacy, maybe they have 15 pharmacies, who's the best person and what's the best way for them to reach out to you folks?
Rachel:
I would be happy to talk with that person and then get them scheduled for a full demonstration so they can see all of the features and functionality of our solution. Working alongside Max and I, we can address pharmacy-specific questions as well as understanding who your suppliers are and who and how you buy and purchase your inventory. Then after that, we would present you with a quote, and then we would move forward. If they decided to go with RxScan, we would start getting some of their information and move through the process. But I would be definitely the contact.
Becky:
Okay, so far we've gone over our DSCSA crash course on what it is, how it works, the different implementation items that are coming in November. We have talked about how your system works, how people can integrate it. The fact that it's fabulous and it works in with all the pharmacy softwares is fabulous. And thank you very much for sharing the pricing and the promo that's going on for all of our RJ Hedges & Associates clients. So I am going to go ahead whenever I have this all put together.
Anyone who's watching this video, you should also be able to link into our handout. Max was kind enough to provide us with a handout that'll be on our blog page that you'll be able to look at and get another crash course on what all these services are. And I love on the backside, he has probably about 20, 25 questions that you may encounter when you have someone from the FDA, your State Board of Pharmacy, et cetera, coming into your pharmacy and asking questions about DSCSA.
Max and Rachel, thanks so much for joining us today and sharing so much great information, not only with our RJ Hedges & Associate clients, but also all the folks that follow us out there in the great beyond on all things with regulations and compliance when it comes to independent pharmacy.
Max:
Well, thank you, Becky. And again, thanks to Jeff and RJ Hedges and so forth. And just a shout out to everybody that there's going to be some great SOPs coming from RJ Hedges, so look out for those.
Becky:
Thanks, Max.
