Preparing for DSCSA – Accessing Transaction Data

Hello and welcome. My name is Scott Mooney from McKesson Corporation and I'm working on our Drug Supply Chain Security Act readiness program. This video is about the topic of how do I access my transaction information from mckesson. How do I find it in either the portal or in the third party solution provider? And how can I make use of that particular information? This video is part of a series on the Drug Supply Chain Security Act and the changes coming in November of 2023. The other videos in this series include what changes should I expect for the DSCSA in November of 2023. What is a global location number? And why do I need one for DSCSA purposes? What do I need to do as a practitioner or a pharmacy on my own to be able to be compliant with the DSCSA that I cannot rely on my wholesale distributor perform for me. This video of course, and how do I access my DSCSA data? And finally, the last one in the series is what changes can I expect to sell over returns as the DSCSA changes the requirements for wholesale distributors to take product back in November of 2023. So as I mentioned, this particular video um is intended to talk about how do I find my transaction information? Where can I look at it? Where can I see it? What will it tell me and is intended to give you in a short 10 to 15 minute primer the the information necessary for you to be able to find that data and understand its use. Feel free to listen through this one but also be sure to check out the other videos in the particular series. So in the earlier video on what changes in November of 2023 I talked extensively about how the DSCSA tracing information is going to change from the rudimentary loba traceability that we began in 2015 to a fairly precise detailed version. Now where we're going to be documenting as part of every transaction, the N DC number in a global trade identification number format, the lot number in the transaction, the expiration date of that particular product and the individual serial numbers of each of the packages and the cases involved in that particular transaction, those four data elements along with some additional data such as um description of the product form strength unit and measure, et cetera. Make up what's in the DSCSA terminology, the transaction information in addition to transaction information in your DSCSA data records for November 2023 you'll also find what's called the transaction statement. This is an assertion by the seller that they've completed or complied with various components of the DS CS A that are required and is usually expressed in a statement, essentially something to the effect of seller asserts or a test that they've complied with section 582 A through G of the Drug Supply Chain Security Act. These stations are that the information is true and correct to the best of our knowledge or ability that there's no known fraud in this particular example, that the seller only purchases from authorized trading partners and that the information contained within is truthful. So a variety of different legal statements involved in that particular process. But you are required to receive in every Ds CS A transaction after November 2023 the transaction information and the transaction statement. Now, this differs from what you've received prior to this point in time. Because since 2015, you've been receiving transaction information, which is basically just the N DC number, maybe the lot number, but generally not because it was not required under almost all circumstances except a few rare exceptions. And then you receive the quantity, the buyer and the seller were there before they'll still be there in the new transaction information. But there was something called transaction history that was there before and transaction history sunsets on November 27th, the preve 27th 2023 model assumed that paper was used in the process especially in the early days. And because it allowed for the use of paper, it required that the history ride with every single transaction document that was passed through the supply chain in November of 2023. The DSCSA requires that all the DSCSA transaction information and transaction statements only be passed in an interoperable electronic format. So to do that, portals are used for holding DSCSA data where the data is passed to the portal, it's stored there. It can be retrieved there, it can be viewed there, printed, exported, whatever. But the portal will serve at least a wholesaler portal like McKesson's will serve as a DSCSA, a repository and hang on to that data for the entire six year required record retention period. In addition, the DSCSA data may be transmitted to you. If you happen to have an internal or a third party DSCSA, a solution provider who's able to store your DSCSA transaction data for you. Why you would use the portal And why you would use a third party solution provider is based primarily on two different things. If you're primarily purchasing from one source or mostly from one source and you only occasionally buy product elsewhere. The portal provides you a cheap and fairly easy and efficient manner to be able to store most of your DSCSA data without making an investment or without having to purchase any additional software from someone. The portal can store that data. You can retrieve it on a daily basis if you wish of everything you purchased today, so you can match it to your incoming freight that may be coming from McKesson. You can also use it to go back into to say I need to search for a particular serial number to see if I purchased this ever in my history or if I've ever purchased a particular lot number over a range of period of time so that you can look back and see what may have happened before. A portal of McKesson is provided in a variety of different forms. It doesn't matter which business unit at mckesson that you do business with and it doesn't matter which one of the portals you use to access our DSCSA system, all of the portals will connect you to same data and we'll show you all of your purchases from mckesson. When you go in to make an inquiry. The advantage of the portal is you don't have to have anything more than your user ID and your password and log in just as you do today for other purposes such as placing orders, looking at catalogs, things like that. The disadvantage of the portal is it only contains information for your purchases from mckesson. It differs from a third party system in that it does not allow you to store information in the portal from other purchasers such as if you're buying something direct from the manufacturer or if you're buying something from another wholesaler as well, switching over to what's going on with the third party solution providers or the in-house solutions. If you're choosing to go down that path, there's an obvious opportunity where you have the ability to merge multiple suppliers into a single platform. You can request mckesson to send your DSCSA data in an industry standard EP CS file to your chosen solution. And we will do that for you every day at no charge, you can also make a similar request. Therefore of any manufacturers you're buying from direct to send E PC is data to your third party solution or if you're buying from another wholesaler to send their DSCSA data to that third party solution. Both of them using the EP CS file format. EP CS has been adopted across the industry for manufacturers and distributors. So you can use that methodology to aggregate all of your purchases into one single system. The downside of that though, however, is these systems do come at a cost. They do have a fee for subscription. They do have a fee for operation if you're doing an in-house and maintenance of the system, but you kind of have to balance in your own mind. How often will you be retrieving the data? What is the cost of that portal or that system that you're looking to do and decide whether the portal will meet your needs or whether you need to go with a third party system. The portals in many cases can facilitate reconciliation of your daily receiving. So you can match the data in the DSCSA system to the product that you receive. This could be done manually. This could be done with scanners. That's that's an open topic depending upon how you're configured and how you're accessing the portals. Similarly, you can do the same kind of features oftentimes with the third party solution providers. So your DSCSA transaction data is going to be in one of those two places. It is up to you to decide which one you wish to use by default. We will put everybody's data at mckesson into the portals. So every customer who's purchasing from any one of the mckesson business units is automatically going to have their data available to them in the portal provided, they have their user credentials and logins to see it. The data is there in any case, whether you have user credentials or logins or not. But in order to access it, you need to be able to get into the system. If you're choosing to have your data put to a third party there will be an enrollment process where we're going to need to ask you who is the third party you want your DSCSA data transmitted to and then we will set up your account. So that as soon as DS CS A data is generated for your location, it is transmitted over to your solution provider. In all likelihood, you may be doing external connections from your solution provider to your own platforms For a variety of reasons, you may be including that solution provider as part of your receiving process. As an example, if you are doing that, that activity is between you and the solution provider, we will support it to the point where we're testing with that solution provider and we can make sure they can read our files and they can receive our files and our files are complete and accurate when they get them. But you may have a step where you have to on board with the solution provider and connect their platform in order to make it interact with your receiving system. If you're choosing to go down that particular path, you're going to want to know how to get into whatever chosen system you've used, whether you're choosing to use the portal or whether you're choosing to use the third party solution provider. You're going to want to be educated in how to access the data and how to look at the data so that you understand how to get at it. Should an inspector come into your facility? We'll cover this topic a little bit more detail when we talk about what things do you have to do as a dispenser or practitioner on your own? Should an inspector come in that you can't rely on your wholesaler to do for you. But just be aware that you're gonna wanna need to know how to exercise these systems and how to make practical use of the information that's inside there as you may need it. So as I mentioned, this is part of a video series, a little bit longer topics or a little larger topics on a variety of different things. Feel free to share the link to this particular video on where is my transaction information and how do I access it with others in your organization who may have an interest. If you happen to want to have them do some kind of targeted review, they may want to pick the topics out of the list of videos that may pertain to their particular role, but these are all designed to be digestible over a short break over a lunch. Recognizing that almost all of you are so busy in your day to day practices that taking time out for regulatory topic is tough. So we try to put this into a format that is manageable for you. Thank you for joining me for today. If you have any other questions that may come up, feel free to reach out to your customer support representative or team to ask them those questions. McKesson is prepared to take those intakes through the customer support team and answer your questions as quickly and rapidly as possible. Take care.