With USP <800> and revisions to USP <797> becoming official on November 1, 2023, sterile compounding experts have received numerous questions from hospital pharmacy leaders inquiring about the new standards. In this podcast, we answer the top 10 questions received across the country providing valuable information regarding current sterile compounding hot topics including: procedural areas, competencies, cleaning, lab reporting, COA (Certificate of Analysis) and DVO (Dose Vial Optimization).
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Thanks for joining us in this episode of pharmacy hot topics where we sit down with our experts and discuss what is currently top of mind in the world of pharmacy. My name is Sarah Weiser and joining me for today's episode is Abby Roth, microbiologist at Pure Microbiology, Annie Lambert, clinical program manager at Simplify Plus, and my co-host Melanie Horn, system sterile compounding coordinator at Sutter Health. We'll discuss the top sterile compounding questions or sterile compounding experts working with an industry have received since USP 800 and revisions to USP 797 became official on November 1st, 2023. Welcome and thanks for joining us today. Thanks so much for having us, Sarah. Yes, thank you. We're thrilled to be here. Thank you, Sarah. Awesome. I'm excited to get this started. So we'll start off with our first question. It's related to immediate use compounding. Where does that apply? And does it refer to procedural areas like the OR? Yeah, this topic of immediate use is definitely coming up a lot as folks are trying to figure out a little bit more about the updated requirements. And I think a good place to start for immediate use compounding is, you know, what is compounding? And so thinking about the definition of compounding and then kind of looking to in your facility and see where that is happening. So in the OR, it definitely could apply or other procedural areas. Thinking about medication being drawn up into a syringe in anticipation of need for a case or procedure coming up or combining different components either in an IV bag or within the syringe itself. So specifically thinking about the OR, I think that that might be intimidating for some folks because they haven't been in the OR before or those providers can be have a lot of different preferences and things that they want to work with. So a couple of tips there or think about, you know, when is it actually happening? If it's happening sort of immediately before administration, then that may not fit the definition of compounding, really thinking more about if it's being used, if they're preparing things in anticipation of that procedure, if it's going to be sitting around a little bit, then you definitely want to consider some of those compounding definitions and standards. There are other ways that you can also can get around that by thinking about are there 503B outsourced products that could help minimize the need for compounding or that manipulation right within those procedural areas. There are certainly pros and cons to those options as well. Bigger picture here is that in the new USP 797 chapter, there are a lot more requirements around having more of a program around immediate use compounding wherever that may be occurring. So that does require having policies in place, training and competency for any staff who are performing immediate use compounding and I think that's where it really kind of feels like it's opening up a big can of worms and who could that include? Whether that's, you know, pharmacists in the emergency department or procedural areas, nursing staff, provider staff, lots of other folks, and then also looking beyond those inpatient areas to even those ambulatory areas too. Last thing that I want to add here is don't get too hung up on the kind of is it compounding question. Remember that anywhere medications are prepared really should be done with aseptic technique, good hand hygiene and medication safety practices. So kind of splitting hairs about what you're doing may get in the way of just overall good medication safety practices. So keep that in mind. Awesome. Thank you for sharing those helpful tips and tricks especially for our very operative experts and other more unique special areas that you talked about where the workflows might be a little bit different. On to the next common question. So do disinfecting agents for inside the primary engineering control have to be sterile and where do you store them? Yeah, this is another big change. We're all used to cleaning our hoods and our PECs but now the requirement is that those products, anything that goes inside of the PEC really needs to be sterile. That's a cleaning agent, cleaning product. Certainly we have reusable cleaning tools that also need to be cleaned. So the requirement is that any cleaning, disinfecting, or those four recital agents also need to be sterile. And even if you're not using ready-to-use formulations, if you're diluting those out, then you also need to use sterile water to dilute those agents. Kind of getting back to why. Again, why is this important? Well the PEC, that's really the direct compounding area, is that the closest spot, the part of the main environment where we are preparing those CSPs and we want to keep that as clean as possible. And so we use sterile gloves, we disinfect regularly and now using sterile cleaning agents. It's further reducing the risk of additional unnecessary bio burden coming into that area. So some other workflow things that are probably coming up for folks are how do I keep this product sterile, this cleaning agent sterile, and where do I store it? Some of these hoods are really small, there's not a lot of real estate in there. And so just want to clarify a couple of those questions. So all the sterile agent needs to be opened within the ISO 5 space inside the PEC and make sure, of course, you're disinfecting it before you put it in there. Which seems like you shouldn't need to say it, but disinfecting a cleaning agent before you put it in. Opening it in the sterile ISO 5 area and then putting on an expiration date or beyond you state per your manufacturer specifications. They should be providing some references for that. And then once it's opened, you can either keep it there inside the PEC, but I said if you're you're running out of room, then you can seal it up and then bring it back out into the ISO 7 space. But make sure again that you want to you're moving it back and forth between your ISO 7 and your ISO 5 that you're always disinfecting it. Abi, do you have any other thoughts or questions that are coming up for you in this area? Yeah, Annie, this has been one of the really interesting conversations that I've been having lately and having visited a few locations and seeing multiple bottles of cleaning agents being stored in a primary engineering control is a little bit concerning. So I know the whole idea here is to maintain or hoping to maintain the sterility of those agents, but we have to remember too that by keeping all of those bottles in there, that's going to affect the airflow of the primary engineering control and could ultimately end up affecting the airflow within the direct compounding area. So it is critical that if you are going to store the agents in there, which you don't have to, they can be stored outside of the ISO 5, that you make sure that you're doing a dynamic airflow smoke pattern test with your certifier to show that those bottles are not going to interfere with the airflow within that PEC. So that's really one of the biggest concerns that I've kind of seen so far of just bottles of agents and then also hanging of bags of sterile wipers, like not the like preset resealable ones, but the other just dry sterile wipers, bags hanging in there too. So all of those things we want to try to maintain the sterility, but we also can't overload our primary engineering controls and not have a space to work. Great points Abby. Thanks for sharing that perspective. I'm just picturing these hoods that are getting the direct compounding areas, getting smaller and smaller and smaller as we're adding heavy workflow systems and sterile cleaning agents and all these things. So we've got to keep keep that compounding area in mind too. All right. Well that was a great discussion. I really appreciated all of that insight directly about the PEC and so moving on into our next topic, let's think about competency and training requirements. What if an institution has pharmacists who check their compound sterile preparations remotely via an ID workflow technology? What training and competency is required for those pharmacists? Yeah thanks Melanie and I know many many folks are working to still implement these IV workflow technologies or figuring out how they're going to optimize their workflow with that. And I think the simple answer for this question is it's per your SOPs. That's what the chapter says. I mean it's very clear about if you're actively compounding or you're overseeing compounding but folks that are doing more of that sort of final verification check through an IV workflow technology system whether that's video verification or photos things like that. These team members may or may not have that kind of quote-unquote direct oversight of or actually be performing compounding. And so this question I think keeps coming up because people are trying to think about who needs the level of training and competency as it is described in the chapter including you know glit fingertip tests and things like that. So the longer answer I think is kind of again keep working through who's doing what and really look at those those job duties and that's the other thing that the chapter requires is that that your training and competency program must equip staff with the knowledge and skills they need to do their job and if pharmacists are performing those in process checks with your final verification how do they know what's expected of them? How do you know that they're completing their tasks consistently? When you implemented the system did you have a kind of a training sign off or competency documentation of that process? And so I think that's you know way to think about you know how do they really know what they're doing and that they're doing it correctly. I think we also have to think about staffing model considerations here just because you know in a perfect world that their pharmacists are you know maybe checking final products from you know decentralized locations or maybe even from home in the remote technology that we have now. We all know that the perfect world doesn't last very long and that there are you know weekends holidays weather related issues will those pharmacists ever be required to enter the IV room or have more direct oversight of compounders and you know if they do then you really need to think about that worst case scenario and making sure that they have their competencies and training and order to be able to gown up and glove up you know go in and do some compounding or kind of relating to our first question about that immediate use compounding will they be performing some of those things in a different setting as well. So there's not a cut and dry short and sweet answer here. I think is this the training and competency that's why we really have to think about your facility and what things what happens at your organization. I know Melanie you've had some other thoughts on this too questions coming up for you. What if you come across? Yeah absolutely I know in our organization we have tried to look at how we can tackle this to really have an end final check and who can visually inspect the CFP is using those IV workflow technologies going to be sufficient enough and adopting having our technicians play roles in looking at the final CFP inspecting it for you know all of those characteristics that you know pharmacists are usually doing in a final verification is there ever a possibility to have the whole team be part of that final check. What does that take to have our technicians able to perform those tasks in conjunction with the technology that we implement. So like you said it's not very prescriptive in what the requirements are but it's really a matter of how do we do this safely and implement good technologies to keep everyone with the highest level of CFP being released to our patients. So I think really good points you touched on there. Definitely I know our I know our state is considering that even in terms of scope of practice between technicians and pharmacists and so as the technology advances we hope that our our practices and our rules will advance as well so we'll have to keep an eye on that state by state also. Definitely, definitely yes and so in our next topic one of the things that we want to know about if it's been a hot topic is how does an organization determine if they should use fungal agar as a part of sampling rather than a general TSA type agar plates. What are some of the characteristics that neural compounders should look for in their media? Yeah I mean Melanie this has been kind of a never-ending topic of discussion and usually when I go in and work with different locations those that have or are using the fungal media don't really know why they're using it other than well this is what we were kind of told to do or this is what our lab recommended. So it's really important for each organization to base whether or not they're going to use that fungal media on risk so we want to take a look at what categories are you compounding. Are you going to be just doing category one and two and you're sticking by the chapter with the beyond-use states where we're not like pushing for anything longer or you're doing category three compounding and you have a little bit of a higher risk. Facility design could be important here. Do we struggle with ingress and microbial contamination problems and just do we have really a good overall microbial state of control because if we take a look at past trends and realize that we do struggle with fungal recovery or overall just other microbial ingress challenges maybe it makes sense to add it. So I would strongly recommend that if you're currently using fungal media but don't really know why go back and look at your data and have you had a lot of fungal recovery are you able to identify that recovery during certain times of the year and maybe if it just really happens in the spring in the fall maybe you don't really use it all year long but you add it in those times of year that are a challenge or have we had new construction and we're trying to learn what our facility has as its normal microorganisms in the space. So right after new construction and kind of starting up a new facility it might be beneficial to both use the TSA and the fungal media for a period of time to better understand sort of what you're recovering from a microbial standpoint. So that's kind of where we go from like when to use fungal media but I get a lot of questions still to you about just like what do I look for in media that we're going to use and one of the biggest things is to look for something that's terminally sterilized and it might seem I don't know kind of silly where you're like well I thought all media was sterilized or sterile and it should be sterile some of it's aseptically filled but some of it will also be terminally sterilized. So if we're starting with a terminally sterilized product it just makes us sure that we are starting with sterile media also along with that terminally sterilized media it's usually double or triple wrapped which makes it way easier to transfer into the clean room because nobody likes having to wipe something down multiple times to get it into the space. This is nice you can just shed a layer and transfer it. We sometimes then too will have room temperature storage which will extend the expiration date a little bit plus then you're not looking for refrigerator space and then the last kind of component is just taking a look at the certificate of analysis from the manufacturer and you can get that from the manufacturer's website. One word of caution that I always give when we talk about media and I say this jokingly but not always is that I could start a media manufacturing business in my garage tomorrow if I would like to. So I really strongly urge everybody to take a good look at who's producing your media and who do they supply. If they normally supply aseptic manufacturing it's probably a good bet that that's a good manufacturer of media to use. Sounds like there's lots of variation depending on the areas and types of compounding that's occurring which as we know requires some review and analysis that are at these sites by our leaders. So on to the next frequently asked question when and how are surface samples collected? All right so with surface samples USP 797 does require that they are going to be collected initially and then we're doing monthly surface sampling for category one and two CSPs and then weekly surface sampling for category three CSPs. So we find all of the information that we need for this in section six of USP 797 and the other thing that we have to keep in mind is that surface sampling really should be performed at the end of a compounding activity or a shift but before that area is cleaned and disinfected. We also have to now collect surface samples as part of the media fill test so it's critical that you have that included in part of your competency assessment as well. The last thing to mention just with the surface samples is that in the field I'm running across locations that are wiping the surface first and then collecting the sample when we're supposed to be wiping the surface afterward to remove any sort of residue. So if you're going to want to sort of assess your ability to clean you can create kind of a different sampling plan where after cleaning you can go in and collect a bunch of surface samples and then test sort of cleaning efficacy but we want to make sure that we're not wiping that surface first before we collect the sample because that totally defeats the purpose of the sample collection. Breaking down the timeline there Abby is definitely very helpful especially when thinking about the task driven teams that our departments you know have to work with to ensure compliance with all of these requirements. Yeah and Sarah it's been a huge challenge I think for a lot of places to implement even the monthly sampling and that has then I think resulted too and not really part of the topic but a lot of places are getting incubators and now looking to do their own incubation and analysis of these samples because of of this new requirement. So I mean are you seeing that as a challenge in your organization? Yes we have definitely had to flex a little bit in our workflows and processes to make sure that we are compliant and acquiring new skills and training people to make sure that they have the correct training to make sure that they are understanding what these requirements are and how we can utilize our own equipment but then also outsourced when able for sure. All right the next question we have here is what components should our sterile area leaders be looking for that makes up a good lab report? Yes good this is also an interesting question and it does kind of tie into what we just talked about with the surface sampling and some locations keeping that in-house to do that analysis versus you're likely going to outsource maybe your viable air collection every six months or every six months sampling to your certifier. So what should you see in those documents but also kind of applying some of the information that I'm going to share just to what you should be capturing even if you're doing all of this internally. So we do have a document it's from CEDA which is a controlled environment testing association so that's CAG 009 stands for CEDA application guide and that's titled viable environmental monitoring for sterile compounding facilities and this document has kind of a list of everything that should be part of the sample collection story and reporting. So when you are taking a look at your report I mean you want to look for things like you know do you have an indication on there of the media that was used a lot numbers the expiration dates why the sampling was done it is a good idea to include that on the report because if you have an inspector or survey or reviewing the report it's helpful for them to know was this part of routine monitoring was this part of an investigation I mean we should see action levels a couple of things that you'll notice from a date perspective and these are things that you want to go and like take a look at when were the samples collected when did they get put on test at the lab and when did they finish up analysis and it's kind of cool because you can take a look at those dates knowing what that turnaround time should kind of be and kind of be able to question like well these were sampled you know on the 9th but they didn't start incubation at the lab until the 13th what happened so we really should be seeing those dates on the report and then obviously you want to make sure that you have all of the results very clearly listed out and have the right units applied to them so for your air samples we should see the colony forming units or CFU per cubic meter of air and for surface it's probably going to be listed as like per device or per plate but one other big one that I will kind of mention too is just the identifications of the microorganisms and being sure that you're actually getting a genus level identification I've run across a number of lab reports recently where unfortunately the sterile compounders are only getting graham stains and not actually getting a full identification so there's a lot that could be included on those lab reports those are some of the highlights of things that you know you definitely want to be looking for I mean I think that's really helpful to kind of give us some checklist things to go through and you know as many of us took took a while to kind of understand what was in our certification reports I think the lab reports really kind of at next level too of there's we're getting just a lot more information and so we need to know what to look for so thanks for writing writing all that context yeah absolutely because you mentioned the certification reports those are challenging enough to read as it is because they're all different depending on you know the report that you're looking at from one company it looks totally different from another the lab reports are the exact same way and some have the information that you need some have missing information some have a lot of extra information that you really don't necessarily need and sometimes it's not always correct so still would recommend that you take your time take a look through those and if you have any questions reach out and ask the contract lab to clarify what you're seeing on that report yeah excellent point and really in all of the things that have changed and kind of looking through everything that we have kind of had questions around what do you all think is the what is the next year of sterile compounding really hold for us where are we going well let me shake my magic eight ball and see if I can come up with something here I think that's what we're all wondering and I think why we need to keep talking about it too so you know I guess my prediction if you will is that I really see a year of kind of check and adjust or plan do check and adjust we've we've all made plans to comply with the USP updates most sites have implemented but we know that there's still some variation across the states and in terms of enforcement and deadlines and timelines there we definitely know that the accreditation bodies like Joint Commission and ACHC and PCAB they will definitely be looking but then we need to really see how we we've you know those plans that we've made really shape up against those regulatory inspections and those accreditation surveys and so I hope that as we start to get into this inspection mode that we can also share those lessons learned so that we can you know as an industry continue to improve and I really see compliance with the USP standards as a journey it's it's not really a destination that we're going to get there and like we finally made it but we're always going to be continuing to improve to check and adjust certainly we have requirements for annual reviews and frequencies of things like that but I think we're just going to have to wait and see see what happens and then talk about it too so that's where I think we're heading Abby how about you I mean I I agree the regulatory landscape is going to drive a lot of what we see in in the next year and I think your mention of a just Annie is probably one of the most important points that everybody's going to have to sort of manage is that once we do finally get some of the states to let us know exactly how things are going to be enforced then we see some enforcement discretion and it's going to just continuously be that that adjustment specifically as far as where I think there's going to be a lot of focus and not to kind of be biased but I think it's going to be the micro stuff specifically with the the viable sample collection the surface sampling and the reading of the plates so taking that in-house and do you have incubators do you have really what would kind of be a lab space do you have training and competency on how to count colonies I think there's going to be a lot of look at that because we're really going from pharmacists and technicians doing more of that compounding role to branching over more and more into to micro and I know for a long time you've been reading glove fingertip and media fill tests but I'll tell you what reading a contact plate with 50 CAF you on it is not the same as reading a glove fingertip test with two CFU so I think we all need to be prepared for a lot more regular regulatory scrutiny on those aspects of things and also along even with things like sterility and endotoxin testing excuse me because we have a lot of changes just in the micro world related to those technologies and validation of those types of methods are really going to be something that we're going to be looked at yeah all excellent points and really kind of a horizon of you know improvement and learning and making adjustments I really appreciate what a great discussion we've all had I want to thank Abbey Ross Annie Lambert and my co-host Sarah Weiser for joining us today to discuss the top most frequently asked drill compounding questions if you haven't before I encourage you to check out ASHP's online resources including the ASHP Compounding Resource Center you can find member exclusive offerings such as guidelines best practices implementation checklist and webinars on hot compounding topics including revisions to USP 795 and 797 looking to connect with ASHP members on certain topics check out ASHP's connect community on compounding where you can ask fellow ASHP members questions and learn from their personal experiences thank you for joining us and if you enjoy this episode be sure to subscribe to the ASHP official podcast at ASHP official podcast 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 great or leave a review join us next time on ASHP official
