>> Welcome to the ASHP Advantage Podcast, engaging the experts on ASHP official, featuring conversations with top-level practitioners about the latest issues in pharmacy and healthcare. >> Hello, and thank you for joining us in this episode of Pharmacy Hot Topics, where we sit down with content matter experts and discuss what is currently top of mind in the world of pharmacy. My name is Mike Anyo. I'm Senior Director of Pharmacy Practice and Quality with the American Society of Health System Pharmacists, and I have an excellent lineup of experts today to talk about sterile compounding. I'm joined by Patti Keenely, who is Director of Accreditation and Medication Safety at Cardinal Health. Glenn Guard, the National Director of Sterile Compounding and Pharmacy Compliance at Auction Care Health in Chicago, and Abby Roth, Microbiologist at Pure Microbiology in Allentown, Pennsylvania. Today's episode is part of ASHP Advantage podcast series, Engaging the Experts, Featuring Conversations with Top Level Practitioners. This episode is supported by Pfizer, USA, and is for informational purposes and not approved for continuing education credit. Thank you for joining us today. Let's get started talking about today's topic, which is compliance with USP Chapter 787, specifically with the immediate use provisions in the chapter. Patti, I'm going to start with you. What is the status of immediate use? Is there anything different in the requirements for the new revision compared to the former version of 797? Yes, there are a mic. There's a couple of things that are distinctly different and really a little bit more forgiving and permissive for us to use. Certainly the same things that are there about competency and making sure people are knowing what they're doing and things like that. But a couple of things did change. One is that the preparation involves not more than three different sterile products. So prior to this, there was a limitation of three areas in there. So for example, if you needed a component, if you had a vial of cephasilin and the diluent and the bag, that would be three right there. But now we're talking about, and that still would be three in the current one. But we're talking about situations like, let's say an ICU at night that needs to make a bicarb drip or a furosemide drip where there may be multiple vials of one drug, that only counts as a single component. So that's a little bit more forgiving than it was. The other thing that's different is that administration has to begin within four hours. It used to be one hour. Now, in most acute care situations, I think what we've found is most people are keeping that one hour for the vast majority of acute care areas because one hour was plenty of time in order to make that IV, for example, and start to administer it. But those are the two big differences that are there from the 2008 to the 2023 versions. I think Patty, I just wanted to bring up here and maybe you can clarify too. I've gotten a lot of questions on, is the container closure considered one of your products? What if you're using an empty bag and how that's to be interpreted? I've never even heard that come up before. However, that wasn't the discussion. It was really the components like the drug and the IV that's there. But I guess if it was an issue that that container closure might compromise something, that it's certainly something worth considering. The idea of compromising is an interesting one, Patty, and it actually segues very nicely into the next question for Abby. So we're extending what the BUD was from one hour to four hours. Are there microbiologic concerns? Are there particular environmental considerations that we should have for immediate use compounding? Well, I will say that the change from that one hour to four hours, I mean, yes, it's more forgiving on the time to be able to now be able to care for a patient. But from a micro perspective too, it really was taking into consideration the growth phase of the bacteria that we'd be seeing in these products. So, typically, we don't see exponential growth starting until about four hours. And for some species, it could be even longer. So that's one of the reasons that we saw that time change and why it wasn't something to really be getting super upset about. But as far as the other microbial kind of considerations here, a lot of this comes back to aseptic technique and making sure that in doing the immediate use preparations, we're taking aseptic technique into consideration as far as monitoring goes, unless you decide that you're going to be doing your immediate use preps in the stat hood as I will use as the example that we run across quite a bit, then there's really no need for monitoring. But if you have that hood that you're going to be using and it's getting certified and you're treating it like a primary engineering control like you are otherwise, I would really consider doing some monitoring in there, even though it's not particularly clear in the chapter on how that would work. But it would be part of a segregated compounding area and you use it for stat, maybe there's a lot of what ifs on how you're utilizing that hood. And aside from that, there are some requirements in the chapter for the space, the immediate compounding space, whether it's in a clean room or PEC or if it's on a tabletop somewhere, there are still some requirements. So that's not necessarily going to contribute to contamination, but it should be a clean and orderly space where people are free from distractions and hopefully that contributes to a good aseptic technique. So that actually becomes a training and competency issue and glad I'm going to turn to you because we've seen some changes with the chapter with the BUDs, but also a training and competency with regards to immediate use. Can you talk about that? Yeah, Michael, and I'm glad you brought up the area where these are prepared. We want to make sure that the areas are not near sinks or where they could be contaminated easily near blood products, biological fluids, make sure that they're not potentially going to be mixed up. And something earlier that Abby asked about with container closures, the chapter talks about for immediate use, taking into consideration stability as well. So if you're going to be using a certain type of syringe or CSC device or whatever it might be in preparing that immediate use prep, you want to make sure that that's considered. Even though you might be administering it immediately or within an hour or four hours, some medications have immediate reactions to certain container closures. And to your direct question about training, the chapter really does outline the need, the must statements for proper training for those individuals who will be preparing medications through immediate use, making sure that they have proper aseptic technique, they're following the appropriate processes and procedures. It's also important for your organization if you don't already have some sort of nurse prep or anesthesia preparation policies in place that those are developed. And along with those policies, trainings are developed. The chapter is clear that you have to have both didactic training as well as demonstrate competency. And so I've seen lots of organizations tackle this in different ways. It's important to note also the chapter doesn't have a set requirement other than initially. Some accreditation bodies do have more frequent requirements, but at a minimum you're going to need to ensure that anyone who prepares immediate use medications has that baseline training, education, and demonstration of the knowledge. And I've seen organizations complete this in a variety of ways for new hires. It's a lot easier as they're onboarding, shadowing someone. And for those that are existing, I've seen some success with a skills lab day or a timeframe where a room is set up and individuals rotate in and conduct that visual demonstration and are signed off on proper immediate use technique. So this is, or was a very hot topic during the webinar that this group recently participated in and the recording will be up on ASHP learning management system e-learning website soon. But there were a lot of questions about hospital adjacent areas, ambulatory surgery centers, infusion centers, and are all those staff required to complete these competencies and how to do them. So I'd encourage our listeners if they didn't participate in that webinar to go ahead and look it up and there's a little bit more detail provided there. I'm going to turn back to Patty with something that I think our listeners may find confusing and maybe we should have started here, but there's differences here. There's nuance, right? So there's the immediate use provision. There's preparation per manufacturer labeling. And there's the active administration. And all three have different, there's an impact on the chapter for each of these. It's a little bit different. Do you walk us through the differences between those and how organizations might go about making sure they're complying with the chapter for these? Yeah, I would definitely suggest to people to look at the wording that's in 797. And it's right at the beginning of it. One of the first things that they talk about is administration. And administration, by definition in the chapter, means direct application of a sterile product or preparation to a single person. So that's one thing that needs to be there. It's not something that we're going to do a batch of or anything like that. But if there is information about administration, it's totally out of scope of the chapter. Now we have to make sure that people recognize that you can't just say everything's administration because we certainly have other things that are defined as compounding that's in there. But it gets even a little bit trickier, as you mentioned, because there's also a section called preparation per approved labeling. And this means that the package insert, for example, would have to provide you with all of the information that you'd need. The diluent, the strength, the container closure system, the storage time, and there's really very few package inserts that provide that. Again, that would need to be only when we're talking about using it for a single dose for an individual patient. One thing that may be helpful is Kevin Hanson and I wrote an article in March 2024's pharmacy purchasing and products on kind of pulling out all of those pieces of where is the difference between administration and compounding, what kind of storage times are we talking about, and what might you want to include in your policies and procedures. And this even another piece that needs to be considered, and I know you'll want to talk about it, is the violin bag systems, and how do they play into this as well? Yeah, that's a great question, and Glenn, I'm going to ask you about that. So talking proprietary bag and vial systems for immediate use. So that one, can you talk to us a difference? Tell us the difference between when is that compounding and when is that immediate use? And then what are the requirements behind each as far as the immediate use provisions and competency or training? Sure, so when they're docked outside of an ISO 5 environment, not inside of a PC, that is considered immediate use. So everything we've been talking about as far as training, the area where those can be talked, and the time after docking and hanging or administering to the patient, that all applies in those scenarios. For compounding of them, doing them inside of a primary engineering control, docking them ahead of use, that would have to apply to compounding, it's spelled out that that is considered compounding in the chapter, and so all of the training requirements would have to be met for those devices as well. The question came up on our frontline conversation, if I just am having someone dock proprietary bag and vial systems inside of a hood, can I develop some sort of media fill, or do I need a media fill for that, and it's a really tricky, interesting question. I certainly think that Abby brought up a good point that it is unusual that someone would only be doing that and you can guarantee that, and so I would always err on the side of caution would be sorts of situations, and really take into consideration the bigger picture, making sure that these individuals are knowledgeable and trained and able to help out with other things than just proprietary bag systems, if they're in that room operating in a hood, they have to have gowning and garbage, and cleaning competencies and demonstrations. In my mind, it just makes sense to have that full category to media fill for your teams there, even if they're just going to be doing something like docking a bag and vial. I think one thing, Glen, you mentioned with the bag and vial systems is that we're doing this in a PEC, we're following the chapter. The one thing that we have to be clear on though is that we're not necessarily following the BUDs, so we still are able to use the BUDs that are provided in the labeling for that. I mean, I've gotten questions about those bag and vial systems about like, well, it says isoclast5, can I do this in a segregated compounding area, and if I do it in a segregated compounding area, do I have the 12 and 24 hours, what BUD do I assign, so all that's spelled out in the chapter, but everybody needs to be aware that the BUD language for those are a little bit different than everything else. Well, that's very interesting. The reason for that is that the manufacturers have gone to the FDA with the data to support that, so that's why we can use those longer BUDs for that. You can use as long as everything else is in place. You can use everything that's in the package insert, as Abby mentioned. I think one final piece of that in consideration for BUD, if those bag vial systems, is once they're activated, taking that into consideration, making sure that when you're docking them, you're not accidentally snapping it and grabbing that solution, going to the medication, and taking the account of the BUDs. So there seems to be, okay, so my take home from this conversation or this portion of our conversation is read the manufacturer labeling, right? That's really important to make sure you're following that. But there does seem to be, on the surface, there seems to be a conflict, right, from what Patty was discussing with, following the manufacturer labeling. If those elements that are required within the chapter are all present, all four of them, I could potentially prepare commercially manufactured products per labeling on a desktop somewhere and get 24-hour BUD out of it, but based on, in that case, maybe it's an expiration. I know the language hits kind of screwy, but Abby, can you explain to me why maybe I could use a product that I prepared the same way I would prepare something for immediate use to get a four-hour BUD, but if I follow the manufacturer labeling, why would I get 24 hours in the microbial proliferation still a concern? Well, of course it is, but again, all the studies are going to be done by that manufacturer in order to be able to even provide that dating time frame. And it could be some things where they have, you know, if there's preservative systems within those medications where they have done antimicrobial effectiveness testing and we're able to show that we have specific time frames that we're able to go out to and obviously with that testing, depending, especially with multi-dose vials, that's, you know, up to 28 days. It's kind of a different conversation, but there are studies that have to get done in order to be able to support some of that dating. And we have to remember that a lot of that information in the package insert is only about stability, not about the sterility limits. That's true. We always have to remember that we have to do the lesser of that, the shorter of that, whether it's the stability of that drug deal you unclotured system container versus these sterility limits. We can kind of think of that as the storage time that's there in 797. Well, I also will say that just because you can doesn't mean you should, so it really comes back to the comfort level of where are you preparing this and is this a good idea to go out to that length of time that you're provided potentially. I think that's a good point. It's always the patient with the patient in mind and, you know, unless there is an operational, you know, gain to be had, you know, why prepare something a week before you need it. You know, if you're running batches more frequently than that or, you know, if you have the option of preparing something even in a segregated compounding area in an ISO 5 PEC, why would you not do that instead of doing immediate use preparation? In fact, that's actually the last question I have for all of you. I know when the chapter revision was first proposed and this extension from one hour to four hour VUDs, there were some concerns that the pharmacy compounding programs would become obsolete, who needs a pharmacy if you can just have someone on the floor prepare CSP? Have we, what, maybe seven months in, eight months into the new chapter? Is that a valid concern? Have we seen any movement out of pharmacy compounding? Well, I think there's certainly some, you know, rumblings that people have had, but we have to remember, first of all, it's our responsibility to do that as part of that pharmacy service in the health system. But another thing to remember is that accreditation organizations, Joint Commission in particular has already said that they would find that unacceptable to turf everything to nursing because there's a requirement in the standards that talk about pharmacy's responsibility to do that. So certainly we have immediate use and preparation for administration because we have to take care of patients, right? But our responsibility as running a pharmacy in a health system, we really need that oversight of all of these sterile products and preparations. Yeah, I agree with that. And in a lot of the sites that I visited, we're not seeing this huge turnover of compounding go to nursing. That's really not what I have noticed along the way. And I mean, again, just speaking from a microbial risk perspective, that really shouldn't make anybody feel great to just turn everything over to immediate use, as I said before, just because it's an option does not mean that this is going to be the safest option overall, especially when we have better controls in place to ensure the safety of the medications that go out. Yeah, it's sort of a scary thought or proposition, Michael, when I hear that. But I think, you know, as we all are here, health care providers, we want to do what's right for our patients, and we know that that's not the right thing. I think from a regulatory accreditation standpoint, there will be a lot of pushback or inflexibility to move to a world where nurses are preparing all medications as immediate use. There's always going to be a place for pharmacy and a need for clean rooms in a health system, especially for more complex, complicated medications or therapies. I also look at this as an operational perspective, but with a nursing shortage and as much as nurses do for our patients, I just don't think it's a reality for them to now then take on all of these medication preparations on the floor. So I think there's a lot of forces that would work against this, I hope, and it wouldn't become a reality. And, you know, one other thing that comes up, we've always focused so much on nursing, and that's really been, you know, since the 2008 version. That's really all we were talking about from an immediate use perspective, but it's clear that there's plenty of other practitioners and health systems who also perform immediate use and need that documented competency, anesthesia is right there at the top of that. And I realized, you know, that may be a tough struggle in some organizations, but it needs to be addressed. And there's others too, imaging, perfusionists, ED, the EMTs, there's all other people. You really need to take a look in your entire organization about who's doing this. Is that appropriate? You know, could it be moved to pharmacy? And then for those people who need it to have that documented competency? That's a good point. And in addition to accreditation organizations, I think state boards of pharmacy may have a differing opinion too on whether nurses should be preparing, or any of the locations you mentioned, Patty, should be preparing. Well, that is all the time we have today with our guest here. I do encourage your listeners, again, if you were unable to attend the webinar, this group had some fantastic responses to some really challenging questions. So go ahead and look up that webinar. But I want to thank each of you, Patty, Glenn, Abby, for joining us today for this great discussion. We hope you enjoyed today's conversation, and be sure to subscribe to ASHP podcast through your favorite podcast provider. Thank you. Thanks for joining us for the ASHP Advantage podcast, Engaging the Experts. 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 for more expert perspectives on ASHP official. [MUSIC]
