Thank you. All right, good afternoon, everyone. My name is Diana Mulherin, and I am going to bring us on to macronutrient shortages. These are my disclosures. So shortages are a big deal. Almost all of us are affected by shortages. Macronutrient shortages are common, and they affect almost every hospital as well, mainly amino acids and lipids. And shortages are also very costly. It was estimated in a 2022 survey that pharmacy work hours cost over $350 million per year simply due to shortages. Shortages are caused by a variety of different things, anything that you can think of. And if one step of the drug production process is disrupted, for PN products specifically, it often results in a shortage because there are so many vulnerable aspects of the drug manufacturing process. There have been numerous shortages over the existence of perinatal nutrition. And with macronutrient shortages specifically, we've been plagued by these intermittently since the early 2000s. It has become the new normal, and so most of us are practicing in a constant barrage of shortages. And some of us may have only been practicing in this environment throughout our entire careers. So sometimes I wonder, do we even really know what the standard of practice is because we're so used to practicing under all of these shortages? And what that can lead to is patient harm. The most infamous example of this is in the 2011 medication shortage crisis, where we had shortages of almost everything, specifically for macronutrient shortages. Amino acids were in a severe shortage, and a lot of hospitals resorted to using a 503B outsourcing pharmacy to obtain amino acids for their PN compounding. The specific pharmacy that was used had multiple areas of breach with their technique for sterilizing the amino acids. And this resulted in an outbreak of serratia, and nine people died during this time. This is, I think, the only example of patient harm that I could find related to macronutrient shortages. So is it because there is no problem and we're not causing harm? I think probably not. I think we are under-reporting the errors that are happening, and it's also really difficult to, you know, causality is difficult to establish in these shortages. These are some general considerations from Aspen that Diane has already gone over, so I won't spend much time there. But anyone can access this information. You may have to log in or create a login for Aspen to be able to access it, but it is free. These are some other considerations that I would consider. So I think one of the biggest mistakes that I see is that people just don't know what they're ordering. When you have a new product that you're using, you may not have enough time. It might feel stressful to have to switch from day to day. But if you're ordering PN, it is your responsibility to know what you're ordering. So thoroughly learn about the products that you're using. And if you're substituting something and you've never used this product before, learn everything you can about the product because every product is different. Check with the manufacturers to make sure you have up-to-date stability and compatibility data for that drug because all brands have different compatibility and stability data. Do not apply data from one brand to another brand. Assess the status of the shortage regularly. It can change quickly, and you want to be on top of it and avoid using the shortage strategies for any longer than you have to. So pharmacists, check with buyers and distributors and manufacturers to get up-to-date information on the shortage. And then any dieticians and physicians, please stay on your pharmacist to do that because everyone's trying to do the best that they can. But we need to stay up-to-date with the information so we can get back to normal practice ASAP. Don't follow advice on social media or listservs without confirming what you have seen. So just don't blindly do something because someone said it was a good idea. Make sure it is a good idea from reputable sources. And make sure that it will work for your patient population. Not every step of managing shortages will work for every patient population. Also, do not assume that there is no harm occurring simply because we haven't seen it or you haven't been looking for it. Changes in PN practice can easily cause harm, and they probably do, and we are not looking for it. So looking at amino acid shortage considerations specifically, think about different concentrations or manufacturers. Also, consider having multiple different products on your formulary available for use if possible. I think some hospitals, just for simplicity, may only have like a 15% amino acid formulation on their formulary. But in the case of a shortage, you should think about having a 10% as well so that you're able to reserve some product for the patients that actually need to be volume restricted. Consider the use of multi-chamber bags, which have already been mentioned. There are pros and cons to this. Make sure if you're not used to using these bags that you know everything about them because they are not the same as compounded PNs. There are a lot of differences. You can have them work, probably, for most ICU patients. You have to make sure that you get the right product. So they now come in a higher protein, up to 80 grams per liter, and lower dextrose, even down to 100 grams per liter of dextrose. And so if you're in an ICU and you need to resort to this, these are probably two important formulations of multi-chamber bags to have on your formulary during the shortage. Also, avoid using the term premix, which I'll talk about in a second. Consider dosing your amino acids at the lower end of the range for critically ill patients. So this is 1.2 grams per kilo per day. In this way, you'll be able to reserve higher protein for patients that have a clear indication to receive higher protein, such as those with high output from ostomies, patients on CRRT, burns, trauma, or patients with obesity. These are some other strategies that I thought of that I would also consider. Some institutions may start protein at goal on day one in their PN. And you could consider not doing that, because that'll save you a little bit of amino acid for every new start. You can delay PN initiation in some patients and kind of push that out further than you may normally do. But do this in order to be able to reserve earlier starts for patients who have malnutrition or who are at high nutrition risk so that you can treat patients with these higher risks appropriately. If you can defer PN, then do so. For example, some examples that I thought of, if a patient is in the medical ICU with ARDS and they're on trophic feeds, you can probably let that ride out a little while longer if it's day 10. Because we know from that certain primary literature that these patients are probably going to be OK for a little bit longer. But a patient who is at high nutrition risk, such as in the SICU, that has had surgery and they're not even able to get trophic EN because they're not tolerating it, don't defer PN in these patients. So think about it on a patient by patient basis. If you can supplement with enteroprotein, do that. Also, work really closely with all the teams at your hospital that are in charge of placing advanced feeding tubes. Don't let PN be a bridge to making a decision. So I feel like on our team, we get asked a lot of times to start PN, and it's because of this or that. And at the end of the day, the gut would still work, but we just haven't made a great decision on how to get access. Don't do this when there's a shortage. You need to get access. These are comparisons of what's available for multi-chamber bag PN products. Just know that they're different, and these are only for central vein. What I have up here is only for central administration, but there are peripheral formulations available. But just know what you're ordering and how to use it appropriately. These are pros and cons to consider during if you do have to switch to multi-chamber bags just for your reference. Moving on to lipids, review the entire portfolio. Again, make sure you know what is available. There are many different lipid formulations available on the US market, which is great, but they are different. They have different oil sources, and they are dosed differently, potentially, depending on how you're dosing it. So utilize multiple products if you can, because this will help stretch your supply out and allow you to provide PN to patients who need it for longer. Most adult patients can go without a fat source in their PN for a little bit, but remember that neonates cannot. And so you need to be able to prioritize if you're a hospital that treats both populations, prioritize your pediatric patients. If you can withhold lipids, you can do that, but just make sure it's only for patients who are actually getting an adequate fat source to prevent essential fatty acid deficiency. And this is not going to be for some patients in the ICU. If they're malnourished or they have other risk factors for essential fatty acid deficiency, do not withhold lipids. Patients need lipids. They cannot go on PN for a long duration without lipids, or else they will develop essential fatty acid deficiency. This is an overview of lipid formulations that are available. Again, I'm not going to go into all of the details, but please note that they're very different. They contain different amounts of fats from different sources, and there are pros and cons to using each of these. And as you're considering these different products for use during a shortage, just know that the compatibility and stability data is not interchangeable, and the dosing is not necessarily interchangeable either. Contact the manufacturer for up-to-date compatibility and stability data. Some other considerations is use a lower dose of lipids if you can, if it's appropriate. And this way, you can reserve higher doses of lipids for patients who would benefit more from that. For example, if a patient has poor glycemic control, you want to make sure that you're giving lipids every day to that patient, because otherwise, more of their calories will have to be made up from dextrose, and that would be bad in a patient that had poor glycemic control. So in this case, we would be changing to dose the fat based on essential fatty acid needs. So instead of a gram per kilo per day of lipids, you may dose it a lot lower, or even intermittently, in order just to meet essential fatty acid needs. Do not resort to using topical fat sources. The data is not great. It's very mixed. The results are mixed, and the data is not well established. Do everything you can not to do that. Repackaging of lipids is not recommended. However, if you find yourself having to do this, do it in the safest way possible. So if you repackage it, it must be done in the pharmacy. It must be done under sterile conditions. You have to maintain a by-use state of 12 hours per container. So do not resort to practices that are not safe and could put our patients at increased risk of harm. There is no shortage recommendation from Aspen for dextrose. Most hospitals will use dextrose 70% in water. For PN compounding, there are several different manufacturers, I should say. We do have dextrose shortages that occur, but we just don't have a shortage recommendation. I would say use the general guidance that was presented in the earlier slides of this presentation and by Diane. But also, if you have to, you could consider, you know, using a different manufacturer. You can use different bag sizes. Of course, multi-chamber bag, PN products. As a last resort, you could use a lower concentration of dextrose, but this would increase the volume required to formulate your PN. Some final thoughts before I finish. If you are in a shortage and you're changing your dosing strategy, make sure you are accounting for the dosing that you, the changes that you've done. So if you change your lipid approach, then you need to account for that with dextrose. And I know this seems very straightforward, and you're probably like, this is simple. Of course, you would do that. But I see this all the time when we get transfers from other hospitals. So if you decrease the lipids, you still need to give the patient their goal calories, or at least shoot for that. And so just remember that that will change the calories, and you need to account for that. So if you go to intermittent lipids, it's going to substantially increase the amount of dextrose that should be in the PN formula. And this is just an example up here on this slide for, if you want to see it worked out. Report the shortage. We don't report shortages, because it takes time. But here are two places that you can report it. Also, report near misses or any adverse event that occurs to ISMP. Even if it did not adversely affect the patient, even if it's a potential error, we should report it. And then I'm going to finish with some take-home points. You can, again, refer to Aspen's shortage considerations for guidance. Anyone can access this. They are updated regularly. They all need to be updated currently, but we will be working on that. Educate yourself. Know what you're ordering. Do not assume compatibility and stability data is the same among products, even if it's the same amino acid concentration. Different brands of that same concentration will have different stability and compatibility data. If you have no data, then don't assume that it's OK. Assume it's not OK. So don't just, you know, we don't make this stuff up in our heads, right? So assume the worst to protect our patients. Remember that lipids are different among products, so pay attention to those differences as you're switching products. And monitor your patients. I promise you, errors are happening, and we're just not seeing them. If you start, it's just like malnutrition, right? If you aren't looking for it, then you really won't see it. So we really need to be looking for this, and track the errors, and report it, and report harm in close calls that occur. And finally, again, I want to remind everyone, do not rely on social media to get your information without checking your source. But if you are going to rely on social media, this is our Instagram page, Consult Nutrition Support. It's mine and my colleague, Sarah Kogel. We do use evidence to support everything that we recommend. And so if you need a little bit more nutrition knowledge in your life, please follow us.

macronutrient shortages

amino acids

lipids

healthcare strategies

patient safety