Preparing for DSCSA – All About GLNs: Webinar Series

Hello and welcome. This video is part of a series by McKesson Corporation to explain the Drug Supply Chain Security Act or the DSCSA to our trading partners. This video series will cover a variety of different topics focusing on what is the DSCSA and what changes come in November of 2023 is a global location number or a GLN. And why is it used for Drug Supply Chain Security Act and traceability? Where will I find my transaction information and transaction data that I need in order to be able to perform the required traceability steps of the November 27th, 2020 3d SA requirements. What changes will come for saleable returns as a result of the November 27th, 2023 requirements. And finally the last one, which things must I as a pharmacy or a dispenser or practitioner do on my own that I need to be prepared for, for the drug Supply Chain Security Act. Each of these videos is intended to be a short crisp summary of what's going on in the Drug Supply Chain Security Act segmented into about 15 minute segments so that you can consume them at your own pace and at your own time as you have available and you can pick and choose from the topics that may interest you. So let's begin with the Drug Supply Chain Security Act and Global location numbers and why the global location numbers are important for the Drug Supply Chain Security Act. So in the DSCSA, there's a requirement to be able to in an interoperable electronic system, exchange, transaction information and transaction statements. Every time there's a change of ownership of a prescription drug in the United States. The DSCSA definition of what qualifies as a DSCSA drug is a finished human arts drug intended for further distribution or consumption. So it covers most pharmaceutical products that are in the commercial supply chain. There are a few exceptions that are outside the scope of the DSCSA. In order to create an interoperable electronic system. International standards are used to format the data and exchange the data between the various different trading partners in the United States. The use of the GS one electronic product code information services or EP CS file has been selected by industry and ratified by the FDA as an appropriate tool to be able to share DSCSA transaction data between trading partners. This file system is used to exchange data between contract manufacturers and manufacturers, between manufacturers and distributors and distributors to dispensers. So it's used all the way through the supply chain in this file, we will be exchanging serialized level information that identifies the individual products or the individual bottles that are being transacted in any particular sale. If a person is buying three bottles of one particular NBC number, as an example, they will receive three records inside their D DS A data one describing bottle number one and the serial number of the lot. And the expiration date of bottle number 11 describing number two again with the serial number lot and expiration date of bottle number two. And finally, a third record explaining bottle number three again with the serial number of the lock. And the expiration also included in this information though is information about who is the seller, who is the purchaser. These are required fields that are mandatory in the DSCSA because the DSCSA is all about changing or tracking and the changes of ownership that occur in the supply chain. So I reflect information that may say sold from McKesson to Jim's Health Mart or Genesis Drugstore as an example. And in order to make sure that this is an interoperable system in electronic fashion, it works across a variety of supply chain partners. It's necessary to be able to use keys or indexes to identify who the trading partners are. As one could imagine. There's a a lot of opportunity for abbreviations at certain names Saint Mary's Hospital might be spelled out Saint Mary's Hospital, but it may also be spelled out as ST period Mary's Hospital and these abbreviations, even the word hospital might be spelled out with the full alphabet numeric Hospital versus just an abbreviation for a OS P. So for this reason, it's not suitable to be able to match DSCSA data by the name alone or by the address alone as addresses also have the same abbreviation challenges in the E PC is standard. This is done using what's called a global location number. Each trading partner is identified with a global location number that identifies the sold to party in a particular transaction, the sold from party in a particular transaction. These are mandatory requirements of the DSCSA to have these parties identified and then optionally for business purposes. Many EP CS files also contain the ship from identifier to indicate where the product may have originated from physically and the ship to identifier to identify where that product is being delivered to these four sold pros sold to ship from ship to are presented in the DSCSA data using global location numbers which represent the details about those particular entities and the locations those entities are at. Now. The industry looked at a lot of different uh identifiers that were already in use across the supply chain to see if there is one that was suitable to be able to carry this message in the EP CS file and create that interoperable system. Keep in mind that an interoperable system not only reflects the transaction in the current state, the one perhaps between McKesson and you as a purchaser from McKesson, but it also has to be able to for that particular product reference, the transaction of where McKesson may have sourced that inventory from the manufacturer and the manufacturer needs a record that also keeps track of where the manufacturer may have sold that inventory. So we have bits and pieces almost like a breadcrumb trail all the way through the supply chain. And it's these unique identifiers that are in the ep message to help assemble those bread crumbs. Anytime a regulator or the FDA is asking you to trace a particular product or even you as part of the supply chain are looking to trace a product to figure out where its origin was. It will be the GNS that assemble the records from the different systems to line them up to say this went from party A to party B on a given date I mentioned earlier, we looked at alternate identifiers that could be used instead of a global location number. And we looked at DEA numbers and unfortunately not everybody who's subject to the DF CS A deals with controlled substances. So they may not always have a DEA number. We looked at State Pharmacy license numbers which helps to illuminate or illustrate who the pharmacies may be in the supply chain. But the drug supply chain. Security Act also applies to wholesale distributors who don't have pharmacy license numbers applies to medical practitioners who don't have pharmacy license numbers applies to manufacturers who don't have pharmacy license numbers. So existing DEA numbers of state pharmacy licenses were not appropriate. We looked at hin numbers and again, not everybody in the supply chain uses a hin. We looked at N CPD P numbers and those who are filing claims tend to have an N CPD P number. But again, other participants in the supply chain did not have one. So at the end of the day, uh the consensus through the GS one workgroups and through the partnership for DS CS A governance was that the best identifier to use in the interoperable electronic system was a global location number. It could be created for almost every entity up and down the supply chain at minimal to no expense in many cases and it can be created in a variety of different methods. Historically, many customers were enumerated several years ago uh by their group purchasing organization. So in the health uh supply chain uh where hospitals and clinics are typically active. Uh We saw many of the GPO s enumerate their members four or five years ago with the GLNS uh that they use as part of their membership roster. These GLNs can be used for the DSCSA many chain stores or stores that have their own private label are also barcoding that product with a U PC barcode that U PC barcode means that they have access to GS one data sources. They have a global company prefix that they use to create the barcode. But that global company prefix can also be used for them to self create their own GLN enumeration for their stores if it happens to be a chain in the independent and small business space McKesson along with several other wholesalers has been able to acquire a license from GS one to be able to assist customers in securing a GS one global location number. Now, the license allows us for independent small businesses which includes individual practitioners to be able to submit to GS one, the relative information about a particular customer. GS one looks in their data hub tool to see if that customer already has a global location number. And if so based on matching the name and the address that's submitted, they inform us as to what that GLN is for that particular customer. If the customer that we're submitting to GS One's data hub tool does not happen to have a GS one GLN already. The data hub tool informs us that this customer does not have a GLN and then it informs us as to what GLN data hub has created for that particular customer. These GLNS are issued by GS one transmitted back to the wholesale distributor that submitted the information to the data hub tool and it's up to us wholesale distributors to be able to share that information with you. So for the most part, we've talked about what happens with the health system where they may have been enumerated by their, their group purchasing organization. We've talked about typically the chains of the larger entities that have a global company prefix where they can assign their own GLNs using that global company prefix. We've talked about the path for the small businesses and the independent pharmacies and individual practitioners where the wholesaler has the ability to assign a GLN and it kind of leaves like the mid size businesses as to what do they do or where do they go? Uh Unfortunately, they're not covered by the license that GS one is issued to the wholesalers, we cannot assign global location numbers to entities that have more than nine locations. If someone does have more than nine locations and they don't presently have a GCP, they are able to get a hold of GS one for small fee. GS one will assign you global location numbers and register you in the data hub tool. Now, the data hub tool is important for the management of global location numbers because the GPO GLNs are there, the wholesalers uh manage or wholesaler uh assisted GLNS are also in the data hub tool. And as individual companies come to GS one and ask them to help create a GLN for their mid-sized operations. GS one also logs those in the data hub tool. This makes that GLN visible not only to the party to help you assist in getting the GLN in the first place, but it also makes that GLN visible to other trading partners. You may have a relationship with these GLNS would be used for any transaction that you're purchasing product under the TS CS A. So if you're buying direct from McKesson, we use the GLN to designate the sold to relationship on your particular account. We will have a GLN designating the ship to location on your particular account. And those same two GLNS will be used. If you're buying something direct from a manufacturer and they're shipping it to you, you'll want to use the cmglns because they're your identifiers, they identify your business as the sold to and your delivery point as the ship to these GLNS are also used. If you have business with other wholesalers. This wholesaler program, the wholesaler assisted program for getting GLNS is a coordinator program between many of the distributors and it is relatively easy for any of them to help you locate your GLN and use that GLN. But you'll use the same GLN with any one of the distributors that you may be dealing with. So, GLNS are an important role in aligning of what's going on with the DSCSA and creating that identity that's used across the interoperable electronic uh system. It creates a unique key for any member industry system to be able to identify dispensers, distributors, manufacturers, contract manufacturers, repacks uh practitioners, you name it. They, they could all be identified with a GLM at this point in time McKesson as uh we're moving towards the November 27th, 2023 requirements is in the process of gathering the GLNS that we can find whether they were created through the wholesale or assisted program, whether they were created originally by the group purchasing organizations. If you haven't been in health system space, uh if you're a chain store, we're probably reaching out uh through our contacts with you asking for what cha Ns you may have assigned. And if you're doing your own GLN request at GS one, we're looking in data hub for those GLNs, we're loading those presently to our master data system. And within the next week, we will make those GLNs available to you so that you can see what GLNs we believe are appropriate for you and you can review those. And if you see something that does not look right for your account, please feel free to reach out to our customer support organization or reach out to your sales contact to have an adjustment page of the GLNs. We have loaded for you. The GLNs that we believe are the ones for your particular account are going to be printed at the top of your invoice. Uh In about the center of the page, there will be sold to GLN represented there and there will be a ship to GLN represented there. So uh you don't have to reach out specifically to call and find out what your GLN is. It will be showing up relatively quickly on your documents, on your invoice, documents on a regular basis. We thought we would put it on a, a document that you receive frequently. So if you ever had a request in the future for somebody wanting to know what your GLN is, hopefully you've got a recent invoice laying around that you could pull out and say, oh, here's the GLNs that I'm using with McKesson. Let's use those with somebody else as well. If that's the case, if you do have a question about what GLN has been assigned to, you are listed for you, I should say, or if you wish to change the GLN, it have been listed for you. You can always call the customer support team, you can call our, our customer experience group. Uh And at the 800 numbers and ask a question about it there. And as I mentioned, you could talk to your sales representative as well. So this primer here is on how GNS are used, how GNS are important to the exchange of serialized DSA data, which is a requirement that begins this November. We hope you found this video useful. There will be other videos released over the next week to two weeks and more information on the other subjects and uh we look forward to uh hearing anything from you that you may have in terms of questions or comments. Again, you can reach out through the CXO organization, through the customer experience side, customer support, or you can reach out through your sales team for comment. Thank you and have a good day.