Part 2 of this podcast series discusses the background for current barcode formats used on medication packages. Our speakers provide insight into regulations currently affecting barcoding practices, as well as changes that are needed for the future.
The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.
(upbeat music) - Welcome to the ASHP official podcast, your guide to issues related to medication use, public health, and the profession of pharmacy. - Thanks for joining us on this episode of informatics bites. Podcasts where we talk with our members about innovation in pharmacy, hot topics and informatics, and new technology. Brought to you by ASHP section of pharmacy informatics and technology. These podcast cover topics on innovation and pharmacy, hot topics and informatics, and new technology. My name is Madeline Kamehoe, and I am the Vice President and Chief Pharmacy Officer at Baptist Health South Florida, and a member of the section of pharmacy informatics and technology section advisory group on operations and automation. And today, we once again are joined by Kevin Marvin and Mark Newinschlonder for part two of our discussion on medication barcodes. Kevin, who is a pharmacy informaticist, leader with a specific experience working for and consulting with multiple large academic medical centers, pharmaceutical companies, and healthcare technology vendors. Kevin is an ASHP and hems fellows and has received a distinguished award from ASHP informatics section. Mark Newinschlonder is a founding director of Thrive Coalition for IV Accuracy. Mark is a recipient of ISMP's 10th lifetime achievement award for champion barcode medication administration and advocating for FDA regulations related to medication barcodes. Now today, we're gonna be discussing the concerns with barcode medication requirements and what is needed from vendors and pharmacies to facilitate change. So thanks for joining us. And Mark, let's start with you this time. - Thank you. Our previous podcast offered a historical overview of barcodes on hospital medications. We talked about how in the early 2000s we appeal to the FDA that they require manufacturers to include barcodes on all immediate drug packages used in hospitals so that we could in fact use the technologies for patient safety purposes. Immediate package is an FDA term. It refers to any container that touches the drug, whether it's a pill and a blister, a pill and a bottle or any liquids in any size, ample vials, syringes, bags. Any of those that touch the drug are immediate containers. Though we had asked the FDA that these barcodes contain NDC numbers and lot number and expiration dates, the FDA's final 2004 rule required that manufacturers use linear barcodes embedded only with NDC numbers as they could not handle all three data components. Nevertheless, the rule tipped the dominoes for today's ubiquitous adoption of BCMA and the continued expansion with BCMP or barcode medication preparation, often called IV workflow systems. The FDA did indicate at the time that they would revisit the rule of adding lot and expiration date as barcode symbologies evolved to the point that they could incorporate the data. However, 20 years have passed and we still do not have lot number and expiration date in immediate drug packages. In the previous and in this podcast, we seek to sustain the appeal that the FDA finished the rule to include lot and expiration in all drug packages. Now, at the 35,000 foot level, there are two powerful rationales behind our request for a completed barcode. The first is if we have lot and expiration in a barcode, then we can automatically identify and intercept any expired or recalled drug any time, anywhere it is scanned in a hospital, whether we are filling storage bins, loading automated dispensing cabinets, preparing IVs or administering medications. This results in safety and quality of care and legal compliance. The second big compelling reason is that lot numbers and expiration dates in barcodes enable simultaneous documentation of lot numbers and expiration dates of all ingredients used during IV preparations. Such documentation is required by the USP in chapter 797, 795 and 800. And so a complete rule we say would result in consistent documentation, accurate documentation, efficient documentation practices, and it would promote sterility. So Kevin, we've been up in the clouds and now it's time to take us down into the weeds to get granular to help us see what hospitals are missing by not having lot and expiration date in barcodes and what may be gained when they are present in scanable codes. - Thank you, Mark. So Seattle, where you live, has many clouds, and my year in Vermont where I live has lots of weeds that seems quite appropriate. First, I'd like to give a shout out to Mark and ASHP for the significant effort and accomplishment they had as they gathered support and evidence to convince the FDA to require linear barcodes with NDC in 2004. That was a gigantic effort. The linear barcode technology and NDCs enabled the significant use of barcodes that we currently see throughout the medication processes at health systems. Over the last 18 years, I have been working as an independent consultant supporting EHR implementations at large health systems. In 2021, I was supporting such an implementation at Marin Health in California. To gain an understanding of this facility's pharmacy operations, I have observed the dispensing and preparation processes for IVs. They used a sophisticated IV preparation software system that verified IV components through the barcode scans. In previous experience, I was expecting the IV workflows to be, to concentrate really on simple verification scans combined with proper sterile technique, including pictures, taken to support a pharmacist check. I was surprised to see a significant amount of activity during the IV preparation, where technicians were keying in expiration dates and lot numbers for all the IV components used. I questioned this activity as it added confusion to the preparation process and compromised sterility. I was told that this logging was a requirement of the California State Board of Pharmacy. The users also complained that there was no validation of the functional or the functional use of the expiration dates or the lot numbers that they entered. They could enter garbage data into the lot number field because there's no real validation of that information. The system did validate that the expiration date was a correct date and a current date, meaning the item wasn't expired, but the end-rate was not used when the system calculated and printed a beyond use date on the compounded product. This beyond use date was generally set to 24 to 48 hours out of sterility concerns without regard for the expiration dates and the compounded vials. In summary, the users found little value from the entry of this additional data, but it definitely complicated their processes. Upon further investigation, I also found that both California and Texas have such requirements, which extend beyond the recommendations of USP 797. USP 797 only asks for such logging of bulk non-patient specific IV preparations, but not patient-specific individual preparations. - So, Kevin, I'm not clear, I don't think I'm clear, on where USP standards and state boards requirements overlap or intersect or contradict or. - That's a good question. USP actually creates recommendations and standards of practice. They do not have direct enforcement ability, but instead make recommendations and create model rules to be adopted by state boards of pharmacy. Most state boards directly reference and adopt the USP rules, but some determined to adopt modified versions of the USP rules. This modification has occurred in California and Texas. - Okay, so both California and Texas require the logging of lot and expiration of all components, right, on patient-specific compounded products. This appears to impact the efficiency of IV preparation. How does that impact patients? - Well, it's generally known that IV preparation is one of the most error prone functions in pharmacy. The work involves proper product selection, volume and concentration calculations, which in many cases are quite complex, and proper technique to maintain sterility. Imagine taking such a process and then requiring the worker to insert into this process the entry of random numbers, consisting of expiration dates and lot numbers, while they are still working these calculations. Also consider how moving hands in and out of a sterile field during this preparation to enter these numbers impacts the maintenance of that sterile field and sterile technique. Most of the devices used in sterile preparation are notepad computers with touchscreen keyboards that are very difficult to accurately use. The end result in this activity increases the risk of calculation errors and sterile contamination. What we see are the unintended consequences of the requirement to log lot in expiration dates. - Well, it seems like IV workflow system vendors ought to have a solution to make this more efficient and reduce activity and data entry. - Yes, I agree and I had some further discussions with the Automation NEHR vendors. I found that the requirements to log lot in expiration dates change IV workflows from a two barcode scan process to 20 or more keystrokes, mouse clicks and scans. Furthermore, this data entry forces the technicians reaching out of that sterile field, as I mentioned earlier, because some products are currently available containing barcodes with lot in expiration dates and some manufacturer, one manufacturer has started doing that. The vendors acknowledge that such barcodes result in simple two scan workflows, but the vast majority of products require manual entry. - So it appears that the rules in California and Texas are different, were you able to identify why? - I wasn't able to directly identify why, but upon discussion with other experts in the barcode field, many were of the understanding that all medication barcodes meet the 2014 distribution supply chain security act formats. And those include lot in expiration. I even found published articles that stated that the disk of barcodes support tracking of medications all the way to the patients. This tracking is not possible with the current requirement for linear barcodes on immediate products. So therefore, the assumption that these new rules went all the way to patients was not correct. It was clear there was a misunderstanding of the current state of medication barcodes. I believe that California and Texas created the requirement with the goal to better track medications within health systems to support drug recalls and to assure no use of expired medications. But they were not aware of the secondary impacts of those changes. And many of the members of state boards of pharmacy have primarily a retail background and don't understand hospital workflows. - So are there products that already though require the needed data in the barcodes? - Yes, but such barcodes are not required and therefore not universal on all products. For example, most immunizations, I believe it was about four or five years, I think it was probably more than that. Five years ago have barcodes with lot in expiration because the FDA created an official exemption to allow such barcodes on immunizations. Also, one pharmaceutical company is printing 2D barcodes on their immediate products with a lot in expiration. But because of the FDA rule, they are also required to print 1D barcodes with only the NDC on these 1D barcodes. And these both barcodes appear on the same packages. Therefore, additional label space is used and the user may still read the wrong barcode and not capture the lot in expiration. - So that sounds like you've uncovered some unintended consequences created from the Californians and Texas boards. - Yeah, that's correct. There's certainly some value in tracking these lot in expiration during IV preparation. Expiration dating is required on all prepared medications. Therefore, expiration or beyond use dating is also applied to these products. But it's normally kept to 24 to 48 hours for sterility concerns, which is much shorter than the explorations on the component vials. Beyond use dating standards are also defined by USB 797. Lot numbers can be helpful for drug recalls, which is why USB requires that logging for batch preparation. But patient-specific IVs are used so close to when they are prepared that is unlikely that patient-specific PrEP lot number logging will be very useful for these recalls. As it is unlikely that patient-specific PrEP with the 24 to 48 hour beyond use date will be involved in a recall and intercepted at the time by pharmacy. Recalls generally take days to develop. Overall, I personally see little value with the manual entry of Latin expiration dates into patient-specific sterile compounding, regardless of whether the entry is on paper or computer. The reason for this is that I would not trust the data as the data is not used in the workflows. It is not validated well and has minimal value. Automating the capture of Latin expiration dates, on the other hand, has significant value because the data can be trusted and used in real time to enhance the medication preparation process and create no unintended results. So, Kevin, does this just apply to injectables or how about other compound and drugs? What factors in there? - Yeah, I think there are a lot of other uses for this information. There's significant workflow in pharmacy to assist to assure that patients do not receive expired or recalled medications. This is currently a manual process with rare exception. Pharmacy staff are consistently scanning shelves, return bans, ADS cabinets to identify and pull expired medications. In some cases, discovery of expired medications creates inventory shortages within the facility because they have to pull all their stock of that medication. So imagine how better these processes would be if every time a barcode is read, the expiration date and recall status are checked and logged. Not only would this catch issues at the time of stocking, the dispensing cabinets and filling medication carts, but it will also check at the patient's bedside when the nurse is administering the medications. ADS inventory systems could potentially keep track of the expiration dates on all medications stocked in the cabinets, which would significantly improve the processes that remove these expired meds from the ADS devices. Inventory management systems could consider expiration dating and order replacement stock before the expiration occurs. Advances such as these are what pharmacy needs to create efficiencies that enable them to reallocate efforts and people to functions that provide enhanced patient care. In the retail sector, pharmacies are also required to log the lot and expiration date on all prescriptions. Many of the packages they handle are saleable units and have expanded barcodes. At an ASHP meeting, I had a pharmacist approach me from a large retail operation who said this rule change would help them significantly as they have to manually log lot and expiration on many products, including prepackaged birth control meds and inhalers. - So I'm hoping right about now the average listener is saying if all these advantages exist and they must, and they are certainly attractive, and why don't we have the barcodes on all products now? - That's a good question Mark, I feel the same way. So I believe this all boils down to priority setting and understanding. First, the change is hard, especially when the value of the change differs between stakeholders and we have many stakeholders involved in this. Most pharmaceutical companies fight this change to immediate products because it requires labeling changes and provides little value to them. They don't use these barcodes. Many in the healthcare system, pharmacy world, see this as too difficult of a change to take on as it requires an FDA rule change and agree by the pharmaceutical industry. I look at the need as one label change by manufacturer can save many thousands of manual data entry efforts by pharmacy personnel, not just creating efficiency, but significantly improving safety. I feel also most importantly that many stakeholders believe that the problem is being addressed or has already been resolved and they just need to wait for the implementation. This is due to the misinformation out there. Let's face it, bar coding is not the latest new technology. It's not RFID, artificial intelligence or robotics. You don't hear meeting presentations on barcodes because it's not deemed to be an interesting topic. And kudos to everybody on this listening to this podcast that you understand the importance. This furthers the misinformation as stakeholders are unaware of the issues. Barcodes are actually the foundation of our pharmacy house. We depend on them to safely and efficiently get the correct medications to patients. Many processes and systems are dependent on these barcodes, but it's time to update this foundation to better support our patients. Bar coding may not be exciting, but it is certainly foundational and necessary. - Hey, Kevin, when I go back to the original barcode, we're one of the arguments for sticking with the linear code is that even if we did ask for a 2D code, which we wasn't quite ready yet, but when it did come, we didn't have scanners that could read the 2D codes. We had lasers that could read linear codes. So the question some ask is, are healthcare systems and vendors ready and able to support reading 2D barcodes? Or do we not have the scanners and technology in place to do that? - Yeah, so Mark, that's a very significant and important part of this. It was a very significant argument back in 2013. - Yeah. - When the 2D GS1 standard did not exist. And most hospitals were in the middle of implementing bedside barcode scanning. They didn't want to take on it, changing a process that they're still implementing. Since then the image scanners that support 2D barcode scanning have become significantly less expensive than the linear laser barcode scanners. Many facilities have the ability to read these barcodes, but don't even know it as their IT departments have disabled the 2D reading functionality in their scanners. In many cases, it's a simple update of their software to enable it. Though some health systems will need to update their barcode scanners for 2D barcodes, the vast majority of health system barcode readers can read these 2D barcodes today. I discussed this whole issue with several IV workflow software vendors as well as several large EHR vendors. And they all have the ability to read and use lot and expiration dates already in their systems, or they will have that ability shortly. One EHR vendor specifically stated that lot and expiration validation would be available everywhere a medication barcode is read on their system. Their software is structured in such a way that they share the same code whenever a barcode is read. - So Kevin, what would a new FDA rule look like or an amended FDA rule look like? And how can they get the pharmaceutical industry to change the barcode to add these two important pieces of data? - Yeah, I think first the FDA will need to specify a universal standard for the format of these barcodes. That standard already exists within other FDA standards. And that's the GS1 standards that support this. Next there needs to be a target date for the implementation, especially understanding that it could take years for older packages to work their way through its buy chain. And I think we need to be aware of that potential delay. Lastly, there needs to be some incentives for the pharmaceutical industry to make the change. This could be done by setting a final implementation date and penalties for not complying. Another approach would be for the FDA and the supply chain to identify or flag products that carry the new barcode. So facilities at their time of purchasing can select those medications to carry these barcodes. This will eventually drive the industry into compliance. - Kevin, I hope some people listening are saying, okay, I'm a pharmacist, I'm a technician, I'm a manager. What can I do to support the changes you're asking for? - Good question, I initially struggled with that myself. What could I do? But I think there are several things you can do. The first is to be aware of the issue. Recognize how this barcode change can increase the efficiency and quality and pharmacy operations. And as a result, better support clinical pharmacy practice. A policy in support of this initiative was unanimously approved at the 2023 ASHP summer meeting. This policy actually has three components to it, which I think are important to be aware of. The first component is that we need to educate pharmacists and others on this issue and the need. Secondarily, we need to advocate a rule change by the FDA. Third, we need to advocate that rulemaking bodies such as California and Texas, relax some of the enforcement of the expiration of the NDC logging rules until these barcodes are universally available. Other things that pharmacists can do is educate others in your organization about the issue. Not many pharmacists within a health system are really aware of what the workflows are in an IV room. Few people actually even go into an IV room because of the sterility requirements. So there's really an importance to educate folks on that. And then also educate your contacts outside of your organization that can impact this change. There may be other organizations you are part of, there may be nursing organizations and others that you may be able to help impact this change. And then finally, add your name as a champion for the IV accuracy at thrive coalition.org. That will help put a large number of pharmacists behind this effort as Mark continues his efforts to push this forward. - Thanks, Kevin. In summary, we have attempted to identify how bar coding including lot number and expiration dates on immediate drug packages is a foundational meeting to support safe and efficient medication use processes. We've described specifically how the expanded barcodes support quality, safety, efficiency. And we've attempted to describe how the USP state boards of pharmacy and the FDA impact the creation and use of those medications on barcodes. We have wanted to identify the barriers and implementation of expanded barcodes on immediate packages and suggest ways to impact needed change. And we're grateful that you've listened. - Thank you, Mark. I'd like to, I'll finish up with a few comments here. Personally, I am in transition, I'm currently in a transition to retirement. But as a pharmacist, I've always focused on not just advancing practice, but advancing pharmacy impact on patient care. I see we cannot grow our house with expanded clinical roles until we shore up our foundation, which I see clearly as the barcode identifiers on all of our drug products. I've therefore focused my volunteer efforts over the last several years to address this foundational need that will support expanded automation, efficiencies and safety in pharmacy practice. Toby Clark was a mentor to me in my early in my career. Toby had a vision and saw the need to advocate within the ASHP for the creation of the section of pharmacy informatics. Toby was the first to receive the distinguished service award from the section of pharmacy information and technology. Toby consistently provided a simple piece of advice that has served me well. Whenever in a difficult or conflicting situation, I use this advice, which is it should be all about the patient. This has always helped me identify the solution and get past the roadblocks. It certainly has supported me through this barcode effort. Mark Neuenschwander has also been a steady advocate for barcodes throughout his long and distinguished career. It takes someone like Mark to maintain a steady pulse to pull and push us all to make best use of technology. Yes, barcodes are technology and we are all extremely dependent on them. I encourage you all to support Mark by registering your support with the Thrive Coalition. Thank you. Thank you guys for a very informative podcast. I know I learned a lot. That's all the time we have for our podcast though. And I want to thank Mark and Kevin for joining us today for the second part of our discussion on barcodes on unit of use medication packages. Thanks for tuning in for this session of informatic bytes. If you haven't before, I encourage you to check out ASHP informatics resources. You can find member exclusive offerings in the informatics resource center, including articles, standards and guidelines, as well as practice tools for pharmacy informatics and healthcare technology related topics. Be sure to follow @ASHP official podcasts for more episodes and informatic bytes from the section of pharmacy informatics and technology. Thank you for listening to ASHP official, the voice of pharmacists advancing healthcare. Be sure to visit ashp.org/podcast to discover more great episodes, access show notes and download the episode transcript. If you loved the episode and want to hear more, be sure to subscribe, rate or leave a review. Join us next time on ASHP official. (upbeat music) (upbeat music)
