Understanding U.S Pharmaceutical Information Exchange

00:00:00 My name is Danielle, and I will be your host for today’s conversation. The topic of discussion is understanding US pharmaceutical information exchange specifically in regard to the DSCSA so, you should be a little familiar with the term but we’ll get into the details in a short bit. This conversation is specifically designed for Wholesale Distributors, so we’ll talk a little bit more about what Distributors specifically need to be doing to remain compliant with the DSCSA. So, I won’t take up too much time now let’s get into the introductions.

00:00:39 We have Darren Myher from Blue Link ERP speaking with us today and we have Gary Lerner from Gateway Checker, President of Gateway Checker. Blue Link and Gateway Checker do work very closely together as partners to ensure Wholesale Distributors in the pharmaceutical space can remain compliant while you know still running their distribution businesses effectively so keep in mind both speakers are very familiar with the requirements and this interview is going to be compiled of frequently asked

00:01:11 questions if there are any questions that we don’t answer please put them in the chat and we’ll try to get to them before the end.

00:1:19 So, let’s get into it. The pharmaceutical industry right now they’re trying to understand why serialized inventory or serialized files my mistake there are important. So, Darren maybe you can speak to this a little bit and Blue Link ERPs role in it.

00:01:35 (Darren) Yeah so Blue Link ERP is first and foremost an ERP system it’s the software that you use to run your company as a distributor keeping track of everything from orders, purchasing, inventory management, and the actual day-to-day running of the business is actually done through that software.

00:01:51 When it comes to your requirements under DSCSA however it’s not good enough to just have your own Silo of information, you now need to be able to receive files that tell you from you know your suppliers about what’s in the shipment that they’re sending to you you’re going to have to you know verify that the products you received against those files match up

00:02:13 And as a distributor you’re now going to be responsible for creating those files outbound to your customers whether they’re in a position to consume those files or not so that’s kind of your high-level overview.

00:02:25 (Danielle) Awesome thank you. Specifically it sounds like you know, there needs to be some kind of specific solution for the DSCSA so when Distributors are looking for Solutions what would you say are the minimum requirements that they need to be looking for to remain compliant with the DSCSA?

00:02:42 (Darren) Yeah so at minimum there’s some requirements imposed on you as a distributor that I just mentioned, as well, you do have a requirement under DSCSA to verify that the products that you receive from your suppliers matches up with the electronic files that they’ve sent to you about what they’ve shipped to you,  you do have requirements to produce/scan you know the serial numbers that you’re shipping outbound to your customers and be able to produce a file that those customers can consume on their side

00:03:12 There are some other requirements around serialized returns as well if you do accept returns in your business you’re going to have to verify that the information on those products that have been returned matches up with what the manufacturer has on file and there’s some technologies that we’ll mention during this webinar to talk about that as well.

00:03:33 (Danielle) awesome um so you mentioned that the requirements to receive and send serialized data is you know necessary for Distributors so Gary maybe I can pass off to you  this process of receiving and shipping of serialized data can it be performed manually and still comply with the DSCSA?

00:03:51 (Gary) It can’t be received manually because the law requires electronic interoperable exchange of information so that is sort of written into the law and it’s expected and in fact FDA has said they’re not going to come look for physical pieces of paper they’re going to be looking for your electronic records so it’s really important that you receive the digital representation of the information electronically in an interoperable fashion those are the key aspects of it.

00:04:22 (Danielle) Perfect thanks so obviously like you said the electronic aspect is mandatory so in some cases some businesses already have solutions in place. Darren maybe you can talk about the integration aspect of it how will these, you know, solutions integrate with what they’ve already got?

00:04:39 (Darren) So we have seen some Distributors who you know can’t afford to switch ERP systems try to implement kind of a bolt-on solution for compliance reasons so in that case maybe they’re purchasing a siloed system that is able to receive those files electronically, lets them do their verification and lets them produce a file outbound but you may find yourself in a situation where you have to duplicate all of that information.

00:05:05 About your purchase orders to your suppliers might have to entered in your main ERP system but also be entered into some other system you might have to duplicate every order outbound to a customer in your main ERP system to run your business plus in those other systems as well

00:05:21 So there is an opportunity you know if you’re able to find a system that can be your ERP and also allow you to comply then there’s efficiencies to be gained there

00:05:31 (Danielle) Yeah so they could use Standalone Solutions if they wanted to but that’s not really the most efficient or effective way to do things

00:05:41 (Darren) Yeah but those Standalone Solutions themselves must still be able to meet the you know what Gary mentioned in terms of the electronic interchange

00:05:53 (Danielle) Yeah gotcha, so maybe just to kind of piggyback on other processes like Warehouse procedures just standard operating procedures what kind of changes can people expect there in terms of their warehouses?

00:06:09 (Darren) That’s a really important question because one of the things that some business owners don’t realize is, while maybe you’re checking the boxes in terms of what the software needs to do have you thought about the operations team and what your people in the warehouse actually have to do differently.

00:06:23 So again if you think about it in terms of the inbound operations maybe today a product shipment would show up from a supplier you’re just checking for damage and checking the quantities overall and then putting that product away in the warehouse shelving right away that’s not good enough under DSCSA, you actually have to do the scan verification or comparison to the serial numbers against the inbound file that’s going to maybe

00:06:45 alter your workflow in the warehouse and take additional time maybe you need to stage it differently or have computer equipment in the back that wasn’t previously in your staging area or your receiving area that now needs to be there.

00:06:56 Likewise on the way out in terms of shipments outbound, you have to make sure that you’ve got a moment in time in your picking workflow where you’re scanning these items to gather the serial data that then needs to be included in those files so if your current workflow doesn’t include

00:07:13 scanning verification on the way out then or your current system only is grabbing lot information and not grabbing serial data then maybe you need to if you’re using a separate system you need to duplicate a second scan in the second system or if you’re using an integrated system like Blue Link now that one scan is  achieving both of those objectives giving your serial data and your lot data up to date.

00:07:34 (Danielle) yeah perfect and everybody before we get into the next questions about EPCIS files I just wanted to reiterate that with your current workflows if you are a little bit confused about your current workflows you know are they managing lots and serial numbers the whole point of the system evaluation questionnaire is for you to ask those questions for yourself and for you to realize are my current systems and processes compliant or what needs to be changed so I just wanted to throw that out there

00:08:00 (Darren) Yeah the questionnaire you get at the end is a great starting point especially as a business owner to just assess your current capabilities and also you know your plan forward

00:08:10 Yeah absolutely so Gary I’m going to head over to you again and talk about the actual EPCIS files. That’s what’s going to be holding the serialized data, So, what requirements the Distributors have to receive an EPCIS file from a supplier?

00:08:27 Well from a receiving standpoint the best way to do it is through some secure uh protocol we use the AS2 protocol but there are different ways files can be exchanged there can be some direct connections there can be manual uploads and things like that but in terms of handshaking

00:08:36 pretty much GS1 identifiers are required on both ends that that you need to establish uh GS1 company prefixes or GS1 sGLN identifiers to uniquely identify each entity and that’s really important from our application standpoint because we automatically route inbound files directly into subscribers accounts based on that information so we do spend in the setup and staging process a little bit of time trying to capture and verify and

00:09:18 validate that those pieces of information so if you have a GS1 identifier that uh identifies your site you’re in good shape if you don’t know what it is or haven’t established one you better go ahead and get that in in place at this point in time.

00:09:33 (Danielle) Yeah there’s not a whole lot of time so now’s the time if you haven’t already for sure um Gary you talked about your application and how it you know captures the information so Darren what I want you to talk about or answer is why can’t Blue Link just accep this stuff automatically on its own why do we need to have a third party solution?

00:09:55 (Darren) Yeah I mean this is a good example of you know companies doing what they do best so Blue Link is primarily an ERP software developer we’re focused on the inventory management and order management – the you know the tools that your employees would actually interact with in the warehouse.

00:10:12 What we don’t do is we’re not an expert on AS2 data transmission and secure file transfers and doing all of the things that Gary’s team and you know the Gateway Checker team are experts in so we let them be the experts in moving data around parsing the data validating that the format of the data that they’ve received is actually valid and is well constructed so that when Blue link connects and we ask the Gateway Checker system hey give us the latest information that’s come in we’ve got a nice already clean file that is in a format that we can understand and present to the users  through the software and then likewise on the way

00:10:51 Out we’re presenting  the Gateway Checker system with the contents of what your team did the scans that you’ve performed and then they’re Translating that into a compliant file format that’s been validated and is the right structure that other systems are going to be able to consume so we’re being we’re able to take advantage of the years of experience that his team has in terms of both how the files are structured but also how to interact and uh you know communicate between systems.

00:11:21 (Gary) If I may add one thing to that Darren one of the things that we’re doing uniquely  first of all we’re very focused on the EPCIS standard having been involved in the initial drafting of the standard going back to 2016 and being a GS1 certified conformance testing service we the only practicing GS1 conformance testing service in the United States and that means that GS1 has examined our application and make sure that that we are following the standards and can assess a good file from a bad file we took that experience and expertise and

00:11:54 integrated it in with our application and hence Blue Link as well so collectively we represent I think one of the only companies that’s doing a 100% Trace Ready Assessment every file that comes in we’re automatically assessing it for its compliance and conformance to GS1 application standards as well as the HDA (DSACA) requirements we do that on inbound and outbound to assure that we’ve got good data Integrity but also compliance and that we’re not missing critical pieces of information

00:12:27 (Danielle) yeah and I think that’s important for the audience to realize is that having a kind of an all-in-one solution or you know a solution that can kind of do everything is necessary at this point. So we’re going to move on a little bit

00:12:43 So this one is for Darren, Why is the process being used between Blue Link and Gateway Checker different than other processes?

00:12:50 (Darren) Yeah so, I guess that would we can just reemphasize that the handoff of information right so the Gateway Checker systems receiving those files they’re pulling them apart, they’re handing off uh nice clean data about what the serial numbers are that were transmitted including the aggregate information so

00:13:09 One of the keys there is that uh for example imagine a pallet of product shows up that pallet the entire pallet is going to be identified with a serialized shipping container label and SSCC label it’s possible in the Blue Link system to scan that label and then we can look up in the file that we’ve received from the Gateway system all of the serial numbers

00:13:30 and cases and information that’s on that pallet so you could end up with a much more efficient process in terms of you know receiving those files inbound um there’s also uh you know other functionality related to the inventory management and ERP side of things that if you happen to be using an ERP system and not just a separate system then that data about the products that have uh shown up now can flow into your purchase order receiving process and then that can make for a more efficient PO receiving process, there no

00:14:03 chance of duplicate data being mis-keyed by an end user for example yeah when you’re using everything in one system

00:14:10 (Danielle) Perfect and Gary just a follow-up question for you. From your end can you put multiple purchase orders on one transaction?

00:14:19 (Gary) Yes you can and I think um you need to do that and people increasingly are doing that it doesn’t happen that often but it is uh definitely starting happen um the key there is to make sure the serial numbers are associated with a particular PO.

00:14:36 (Darren) That’s definitely one of the areas we spent development time on as well is to ensure that if a mixed pallet were to show up for example that actually represents multiple purchase orders, your team in the warehouse can just scan what they have in front of them and then we’re worrying about matching it up with what the data uh coming in is behind the scenes for the user so that’s purchase order one and that’s purchase order two..

00:14:57 (Gary) You know I think the beauty of what we put together collectively is that you often don’t see the integration because it is so seamless because you can work pretty much entirely within the Blue Link application and someone actually asked me today well how will we know that the data is there or what is it that we have to do well once we’re connected uh to your trading partners or your customers um the information’s instantly available to Blue Link so there isn’t another layer of testing and certification and that kind of stuff that you have to do once we’ve made the connection once the information’s flowing it’s readily

00:15:37 accessible within Blue Link and then anything that happens to that data anything throughout the life cycle of that serial number that Blue Link may update like opening up a shipper case or whatnot that’s automatically known to our application as well so that when you come to ship to your customers we already have the accurate up-to-date information and there’s no extra steps that you need to take to communicate from one application to the next.

00:16:06 And what about accuracy Gary? How do we ensure that the EPCIS data file structure is correct and the contents are correct?

00:16:14 (Gary) Yeah so we run literally hundreds of uh checks, I mean that is our core capability this conformance testing that we put together and in fact that’s one of the ways that Darren and I got to know each other because he sat in on some of the Committees and things uh that that we’re doing so we’re actually reading every file that comes in and we’re reading every file that comes out and we actually assess its readiness.

00:16:40 So when information is missing or perhaps not exactly correct, we’ll flag it as either being a failure or an alert or a warning so that people can take corrective action on the various spot.

00:16:53 (Darren) it’s been interesting while we’ve been implementing this as well where Gary’s actually his team has received a from a distributor in some cases from relatively large distributors and noticed that the aggregate data is missing for some items like or they’ll send the data for a case but not what’s inside the case so we don’t know what

00:17:10 the bundles are inside or the serial numbers of the eaches and you know that can get that’s going to get caught automatically by the trace ready system and get flagged and not result in bad data ending up in the ERP system and then you know Gary’s team’s been successful in going back to those files and you know waving a by the way know that file that you sent us was had the following errors and it’s made it a lot better in terms of you know during the stabilization period that

00:17:38 we’re in right now to identify those issues and get them corrected before you know the FDA brings down the hammer and actually expects everything to work.

00:17:47 (Gary) we even look for sequence of events you know things are supposed to happen in sequence and we’ve had some to your point Daren we’ve had some files that have been packed after they’ve been shipped right which physically can’t happen um but we know that people obviously aren’t reading and checking their files because we shouldn’t be able to find these things

00:18:08 as often as we do so it’s good for our customers I think we’re helping to ensure Integrity both inbound but also outbound so we think um that’s really important and we will be Gateway certifying those customers that we work with that fully comply on sort of a good house keeping seal of approval that we’ll be adding as part of our joint application to the Blue Link data environment.

00:18:37 (Danielle) Perfect um so audience we are kind of approaching our last final question so I just want to reiterate if you do have other questions please put them in the chat and we can try and get to them um but I do want to jump to one question that I think is worth us talking about and this one could be for either Darren or Gary but some Distributors have received product you know before EPCIS came into law so those distributors who have cases which don’t have inbound data how do they ship them in compliance with the DSCSA?

00:19:24 (Gary) Well um our system would know right whether we have a record for that information or not based on our life cycle approach so if we’ve received the serial numbers in we know and we can approve and send it out but by contrast we also know when we don’t have that information so when we don’t have that information we present that to the user and we give them the opportunity to substantiate that indeed it is a good product we can verify the product because we have product verification capabilities built in so we can go back to the manufacturer and verify its product identifier uh but we also can provide the ability to

00:19:54 commission the product on behalf of the supplier the distributor I should say and keep records of the fact that they have bought other products on the same lot right they may not have been able to substantiate this particular order but they can do that the one downside in Darren reminds me of this often is that you if it’s a factory sealed case there’s no way to know what the contents are so unfortunately for any of the Legacy product you need to open up the cases and scan at the each level which is one of the reasons why

00:20:28 we’re trying to get people to be proactive and get onboarded now to get their inventory captured even before uh Blue Link comes online because as long as we’re receiving the data in as soon as the Blue Link connection is established we can make all of those serial numbers available to the Blue Link user.

00:20:47 (Darren) Yeah that’s a really important real world risk to your business operations is if you find yourself come November of this year with a warehouse full of product that you don’t know what the aggregate data is for what’s inside those boxes.

00:21:02 If you want to comply with letter of the law you have to provide the serial information at the lowest saleable unit of measure which means exactly what Gary mentioned you have to open those cases. Imagine you have a case of a hundred units you have to open that case of 100 units and you can’t just scan the case now because it goes and looks up in the system and says oh sorry we don’t have inbound data we don’t know what’s in that case so now you have to open that out take 100 products line up the

00:21:30 the barcodes and then do 100 individual barcode scans just so you can ship that case of 100 units. So, you know we don’t want you to end up in that situation so getting the data flowing inbound as soon as possible um is really important even if you weren’t live on the Blue Link system uh yet if you’ve got your inbound connections configured with the Gateway team and they’re receiving that data when you do go live on the Blue Link system later, all of that back flows into the system and we’ve we can make use of anything you’ve

00:21:59 gathered over the last several months uh for example so a it’s an important operational thing to realize and you may if you find yourself in a with a system that doesn’t do that you may need to start staffing up now like think about how many employees am I going to need come November to be able to handle this potentially massive increase in the amount of work that has to be done to just comply with the law

00:22:25 (Danielle) Yeah and I just want to reiterate that there’s not a lot of time. People got to get running right now! Get started now with that stuff if you haven’t already. So, let’s just get over to you know our final questions and just some parting thoughts um so Darren can you just talk kind of more generally about what are the risks for distributors simply if they don’t comply?

00:22:26 (Darren) Yeah so I mean ultimately, we’re in the I guess the transition period right now, the law is actually technically already in effect fact and the FDA is using their discretion to um you know they they’re

00:23:02 calling the period between now and November of 2024 as a stabilization period they’re expecting um you know if they went and visited any distributor they would be able to see your team actively engaged in the process of making these systems communicate making it work modifying your business procedures to actually um you know engage and you know come November if you don’t have those systems in place you’re not actually transmitting the data now you actually are in violation of the of the rules of

00:23:3 the law so you know I’m not an FDA person so I can’t speak exactly to how they’re going to penalize you just realize that you don’t want to put yourself in that position as a business owner.

00:23:43 (Gary) If I can add one thing that’s emerged literally within the last one to two months has been two different phenomena’s that both are probably another aspect of risk, one is the major wholesalers have set April 1st as a deadline for all manufacturers to be on boarded but that actually impacts

00:24:02 some of our distributors who might be um a authorized a single entity or an authorized distributor that may be selling product to the big three. So to avoid big penalties you really need to be on board ASAP or at least talk to or get registered with the big three wholesalers.

00:24:22 The other phenomena that we’ve seen is that a number of large chains of pharmacies,  they’ve started to threaten to cut off um buying from certain entities if they can’t demonstrate that they’re compliant

00:24:38 so whereas there’s a lot of regulatory pressure and the FDA is some real penalties that they could apply, I think the larger issue for a lot of us as business people is we’re going to lose revenue or uh or it could really be at risk and the flip side is also true which is if you were compliant and you were ready to go today you might actually win incremental business because there are definitely both pharmacies and large chains that are looking to only buy from those that can provide them with serialized transactions.

00:25:13 (Darren) I mean it ties nicely into kind of one of the other questions around you know costs and connections like we talked about electronic transfer of information as a requirement but there’s more than one way to accomplish electronic transfer of information so for example if you’re selling into mom and pop pharmacies who don’t have electronic systems that can receive these files through AS2 connections you would be able to have that Pharmacy log into a website for example and then look at their sales

00:25:43 history and then download the file that you make available so the files are you know in the Blue Link example, the file is still being generated by the Blue Link Gateway Checker system but now it’s being made available through a web portal to your end customers so, even if your customers aren’t all in a position where they can receive those files now you’re at least still complying with the law and you can show an FDA auditor this customer just needs to log into this website and he link and

00:26:07 now they’ve received their file in a secure interoperable manner

00:26:23 (Danielle) Yeah that’s a great point Darren so for example if anybody just doesn’t have the electronic capability to send or receive anything AS2 connection wise they can do it through a web portal for example as another option. Yes okay so we’re going to stop it off there thank you everybody and I hope you have a great rest of your day.