First and foremost, I'll say I have no commercial relationships to disclose. As we all know, our bodies need adult multivitamins every day, and it holds true even with parenteral nutrition support, and usually in parenteral nutrition, they're given as a commercial brand multivitamin, 10 mL, additive to PN orders. But these are all the required adult parenteral MVIs. You can also get them in single-entity dosing, with the exception of biotin, panathenic acid, riboflavin, vitamins A, D, and E. Parenteral trace elements are as important as well. How we practice, which may be different than other organizations, we don't necessarily for all of our patients put all of the trace elements in the TPN. We make decisions, especially for the patients we're managing at home, decisions on whether they need all five or just two, et cetera. In critical illness, we deal with a lot of liver transplants, and sometimes we'll exclude copper and manganese in the early beginnings of TPN. But at the end of the day, it doesn't matter if it's a multivitamin or a multitrace element. We can collect lab samples, but they can be difficult to collect. They require fasting often, and measurements of serum or plasma levels don't necessarily show us that we have adequate body stores or micronutrient adequacy. We think it's best overall as providers that we know what to look for when we are assessing our patients looking for these micronutrient deficiencies. Micronutrient deficiencies are supporting evidence for malnutrition diagnosis. The Aspen and the American Academy of Nutrition and Dietetics utilizes six characteristics currently with evidence or research being done on whether or not to include micronutrient deficiencies. They also may correlate with lab measurements and or a medical or diet history. We also know from Aspen micronutrient guidelines that they're all essential for human metabolism. We know that they are important for the utilization of macronutrients as well as every enzyme activity in the body, and therefore, they should be delivered in recommended daily amounts. When we're looking at areas to assess, it should be a part of a head-to-toe examination with skin looking at petechiae, dermatitis, pellagrous dermatosis, paleo, cirrhosis and wounds, hair looking for alopecia, light in color, corkscrew hair on the arms, with nails looking for spoon-shaped or bows or transverse lines, poor blanching, flaky nails, clubbing or splinter hemorrhages. For the eyes, we want to look for Beto spot, caramellitia, pale conjunctivitis, with the nose, nosolabia, seborrhea. And then looking at the mouth, oral cavity, teeth and lips for chelosis, angular stomatitis, fungi, bloody gums, mouth lesions, dental caries and glossitis as well as pale gum color. And for the neck, assessing for enlarged parotid or enlarged thyroid. So just to give you a few examples of what you're looking at, here in these pictures you can see what cirrhosis looks like, dry, scaly, flaky skin, which could be a deficiency in vitamin A or an essential fatty acid deficiency or from dehydration. There of course are non-nutrient causes as well, such as environmental and or hygiene factors or aging. Follicular hyperkeratosis is what you're seeing here in the pictures. Basically there's an excessive development of keratin that's in the hair follicles. It results in these rough cone-shaped elevated papules resulting from closure of hair follicles with a white plug of sebum. This is where you'll have a deficiency in vitamin A or C or essential fatty acid deficiency. In general, malnutrition is the strongest association. And then with petechiae, as you can see there, there are small hemorrhagic spots on the skin. Could be a deficiency in vitamin C or K. Of course there's non-nutrient causes as well, such as hematologic disorders, liver disease, and anticoagulant overdose. And then like when you're looking at the scalp and hair, you want to see that the hair is shiny smooth and not easily plucked. You want to assess for color, texture, distribution, alopecia. This could be a potential nutrition deficiency in protein, zinc, essential fatty acids, or even a biotin deficiency. Of course there's non-nutrient causes for alopecia, such as male pattern baldness, cancer treatment, Cushing disease, medications, hypothyroidism, infections. Lightened hair color could be a copper, selenium, or a protein deficiency. Of course chemical alterations could be a non-nutrient cause. And then corkscrew hair on the arm could be copper or follicular hyperkeratosis from scurvy in the elderly, as well as non-nutrient causes of being chemical alteration. I put this picture of sites of absorption up that I took from our nutritional management of intestinal rehabilitation and transplantation booklet. And basically we should just look at our patients and know what their absorptive capacity is because that can depend upon what's remaining in the intestine and the colon. The quality of the intestinal lumen and the colon also will affect absorption ability. There are factors that do inhibit absorption, such as increased bile acid wasting. Fat soluble vitamins require bile acid salts for absorption. Consumption of insoluble fiber increases small intestinal transit time. Primary luminal disease, pancreatic insufficiency, poor blood flow to the gut, protein losing enteropathy, and rapid transit. We also have factors that enhance micronutrient absorption. So of course, when we have increased metabolic requirements, such as in growing, pregnancy, lactation, exercise, as well as increased small bowel mucosal mass, intrinsic factor in corticosteroids, increased vitamin 12 absorption, cellulose and pectin increased intestinal villus height and thickness, and dietary fat increases our ability to absorb fat soluble vitamins. Micronutrients also have a response to inflammation. When we have C-reactive protein and it's elevated in a response to an inflammatory state, those are times we do not want to make corrections to vitamin and trace element deficiencies. It's not recommended and it actually may increase morbidity and mortality. What you'll see in an inflammatory state is decrease in micronutrients of vitamin A, vitamin C, vitamin D and E, as well as B6, zinc, selenium, iron, and transferrin. There is no change in the B vitamins of B1, 2, and 3, and B12 and folate as well. And then copper and ferritin actually increase in inflammation. The biggest point to make in all this in dealing with micronutrient deficiencies is we all know we've been dealing with supply chain issues, not just with medicines, but also the products needed for PN for compounding. So we're often left to look for alternative therapies. We may be less familiar with those therapies. We may be less evidence-based or clinically inferior. In a paper I reviewed in April of 2019, the Mayo Clinic actually shared their experience of a rapid coordinated shift to using multi-chamber bagged PN products after Hurricane Irma and Maria when they had compromised PN product shortages, specifically amino acids. What you're seeing on the screen is the framework they used where they created a decision tree if multi-chamber PN should be used and appropriate for their patients. And if they felt that it wasn't, they put a consult in to their nutrition support services. They then determined if compound PN was appropriate. If they didn't feel compounding PN was appropriate, then they advised on an alternative plan. Amy Mayo then goes on to say in this paper that the rapid operationalization of a new product and significant practice change is possible as long as you have early engagement with stakeholders and immediate comprehensive operational and therapeutic assessment. Communication was important not only prior to, but during the implementation. As you can see on the end, they had a feedback loop to act on any areas for improvement. Aspen has also created a multi-chamber bag video series for clinicians to get familiar with multi-chamber bagged PN. For some hospitals with small amounts of TPN, multi-chamber bags may be an appropriate and cost-effective option instead of doing compounding PN for a small number of patients. All clinicians should know and be aware of other options for PN for their patients. Just a few other considerations to consider for shortages is to think about those with increased needs who have limited absorptive capacity with IV shortages. You want to have plans in place for oral supplementation and to be aware of interactions between supplementation. As an example, not to give copper and zinc when a patient is taking iron to avoid chelation. Working with your inpatient pharmacy team is important so you understand the projected length of these shortages, the reserves you have on stock, and ration that allocation to prioritize those who are higher in need for those products. With multivitamins, you may want to give those three times per week to all your patients except for those that have absorptive problems or your pediatric patients. You also want to have a conversation with your outpatient pharmacies with patients being discharged on PN either to a facility or to a skilled facility or to home so that you're aware of any shortages outside in those community pharmacies. And then one last consideration is to increase your frequency of lab work during shortages to assure that PO supplementation is adequate. So if your standard workflow is every six months get some of these lab values on micronutrients, you might want to change it to three months during the shortages. And then lastly, Aspen does continue to work with a variety of, with the FDA, pharmaceutical manufacturers, other healthcare organizations to act on these shortages and to collaborate to resolve these shortages. On these two slides I've pulled off from Aspen's website what they recommend for, what they recommend doing when there's electrolyte and mineral product shortages. Assess your patients as to the indication for PN, do they really need parenteral nutrition, or can they get nutrition from the oral or enteral route? Consider switching to oral or enterally administered mineral supplement products when oral enteral intake is initiated, of course, except for your patients that have malabsorptive disorders. Reserve intravenous minerals for those patients receiving PN or those with a therapeutic medical need for the intervention. Limit the use of mineral additives and IV fluids to patients with disease states and clinical conditions for which they are appropriate. And then use commercially available IV mineral products as much as possible for replacement therapy. When there's prolonged shortages, mineral products that the FDA may approve for temporary importation with these products, it's very important that providers read the DEAR Healthcare Professional Letter accompanying these products so they understand them. They want to observe for increase in deficiencies with ongoing shortages. Increase your awareness and assessment for signs and symptoms of mineral deficiencies. If you're compounding for a few PNs in your hospital, maybe organizing with the hospitals in the area and creating a centralized pharmacy where you can decrease supplies going to all the smaller hospitals. Include PN component shortages and outages in the healthcare organization's strategies and procedures for managing medication shortages and outages. Make sure that severe drug product shortages are reported, and reporting of any patient problems with these shortages. Thank you for your time. Thank you, Diane. So next we're going to address some of the macronutrient shortages, and that is going to be presented by Dr. Diana Mullerin. She is a clinical pharmacy specialist in nutrition support at Vanderbilt University Medical Center in Nashville, Tennessee. She is a board-certified nutrition support and critical care pharmacist, and also a fellow of the American College of Critical Care Medicine. She's obviously actively involved with SCCM and Aspen as well, and has served as the chair of the Nutrient Shortages Subcommittee for Aspen's Clinical Practice Committee since 2020. So this is a great place for her to be and to hear from, and we will bring her up. Thank you. 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 perineral 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 underreporting 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 have any, 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. Dose, 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 gonna be okay for a little bit longer. But a patient who's 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 enteral protein, 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 U.S. 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 gonna 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. I'm not gonna 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 wanna 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 a 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 date 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 brands of, or several different manufacturers, I should say. We do have dextrose shortages that occur, but we just don't have it as 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 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 okay. Assume it's not okay. 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. 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 and 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, consultnutritionsupport. 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. Thank you, Diana. Our final presentation today is going to be discussing at-risk patients. And that will be given by Dr. David Evans. He's a trauma acute care and critical care surgeon at Ohio Health Grant Medical Center in Columbus, Ohio, and the medical director of the system nutrition support team at Ohio Health, which is a 14 hospital network, as well as its transfer center. He has served as an investigator in multiple clinical trials and critically ill patients focused in the areas of nutrition and infection. And it's the author of over 130 peer reviewed publications. So please help me in welcoming Dr. Evans. Thank you. I'm excited to be here today and follow some great talks. I brought you some cases. So we're gonna frame our structure around that. These are my disclosures today. So the first case is gonna be an acute ICU patient where we have a limited ability to provide internal feeding. And then we're going to talk about what I'll call a chronically critically ill patient and talk about the implications for shortages in those patients. So let's start with our acute one. So this is a, I'm going to take you through one of my trauma calls. So this is a patient, it's Saturday night, we're in Ohio. And that's the car that they've been pulled out of. And no, that's not snow on the ground. That's the fire foam from putting the car fire out. So they bring this patient to our trauma center. It's a 31-year-old male, high-speed MVC. Airbags went off, seat belt went off, or was there, and there was a seat belt sign. They're in hemorrhagic shock. They're tachycardic, they're hypotensive. They got a CT scan. The spleen is bleeding. They go to the OR. You see this open book, pelvic fracture. The pelvis is separated wide open. So it's going to be a bad one. It's going to be a patient who bleeds a lot. Those are the blood products that we gave the patient on the floor at the end of the case, all those empty bags. So you clearly have massive transfusion. Then we get to starting kind of the secondary stabilization. We've got a brain injury, an ICP monitors put in, bilateral open femur fractures have been treated with external fixators, those bars and screws and rods. So very sick patient. Still the morning after, hypotensive. Receiving some blood products on and off. Doesn't end up needing levophed, but came close. Hypothermic, anemic, acidotic. So how did the next few days go? Well, as you can tell, there's a lot to fix. So pretty much every day, the patient's going to need another trip to the operating room. I know it's small here, but this is the flow sheet. 11 liters of blood product go in that first night. Then it trickles down after that. We have the NG tube inputs charted, which is our rough surrogate for how the tube feeding was going. Clearly on the third day of tube feeds, there's a typo because we didn't give 5,000 milliliters of tube feeds. But leave it, see there's no perfection in clinical medicine. We always have to make some assumptions and some rounding. So they get their pelvic angio, they get the ICP monitor. Then finally they get the pelvis stabilized and then they get kind of the cleanup, the arm fix, things like that. So here we are, we had a goal RD recommendation of 1,500 milliliters or 2,300 kcals per day. We actually got 1,280 in and that was probably better than we often would have in this patient. On day 10, we do indirect calorimetry and find out that at least by day 10, our calorimetry tells us we should be doing 3,200 kcals per day. We don't know where we would have been all those other days, but clearly very hyper-metabolic. So, uh-oh, we're 10,000 kcals below in our delivery of what was prescribed. We're 19,000 kcals behind. And I don't mean to overemphasize calories, but just to put the context here, we're 19,000 calories short of where we would be on the resting energy expenditure. And uh-oh, now our patient has an ileus, they have a fistula from their pancreas. And so, we order perineural nutrition. We choose a three-in-one four-oil, or a three-in-one formula with a four-oil emulsion. But there's three opportunities here really to highlight. One is, you know, could we have done better? Some of those orthopedic operations, we didn't need to hold the two feets. We could have kept them running up to and through the operating room, but we fall into those bad habits of the NPO at midnight. What else could we do? We actually have a protocol for volume-based feeding. We try to empower nursing to be able to titrate up the two feets and play catch-up. We don't do a good job of it. I'll be honest and transparent with you about that, but we do have that protocol. And would there have been an opportunity for earlier supplemental perineural nutrition? I think so, and it's beyond the scope of today, but there is evidence to support that as well. Clearly, we know that our patient's mortality is best when we get to about 80% of their goal calories, so we're falling behind. The other thing that we're losing is we're losing muscle. Every day in the ICU, we're losing muscle. So by day seven, we've lost about 15 to 20% of our muscle mass, no matter how you measure it. By day 14, 25 to 30% of our muscle mass is lost. So what are our challenges? Well, first of all, we very rarely offer supplemental perineural nutrition. One of the challenges is that the NST team is how we really start PN, and they're not consulted. So they didn't know about it, so they don't have that opportunity. The other angle, especially with these intubated trauma patients, we often have, and this was a young person, presumably they're adequately nourished, but we have a lot of elderly patients as well. And when they're intubated, when they have a TBI, we often are missing those pre-admission weights. We're missing the nutrition history. We often don't do a good job of circling back to family to ask those questions about how have you been eating recently? What, have you had recent weight loss? And as a tertiary center, many of these patients were not in our primary care population, and so we don't have that kind of longitudinal data. It's getting better as our computer connections are improving and more systems are using the same EMR system that we do. But I think we're still starving too many patients. And then the other barrier is that we have a really high census on our NST team. If I start ordering the supplemental pre-neural nutritions, they are gonna freak out, because they're already overworked and underappreciated. So definitely a barrier. But this is data from emergency general surgery patients in a SICU showing, and I think this is a good kind of follow-up to the previous presentation, we can kind of cherry-pick those patients that are at highest risk. In this case, they used NUTRIX scores. So to identify patients who are gonna have a significant survival advantage with the early use of supplemental pre-neural nutrition. But how are the shortages impacting me? Well, in reality, I kind of live in an idealistic world. I kind of make it somebody else's problem. And when I was asked to talk about this, I thought, I'm not an expert on drug shortages. But as I sit back and I think about it, well, we have really been, I think, to the point made already, we've basically been practicing in this environment for my whole career. And so I think I do know a thing or two about it, which kind of surprised me, because like I said, I've never thought of this. But Hurricane Maria, in particular, 2018, we had a huge impact, at least to our hospital, on the amino acid supply shortage. We actually looked at this. We divided our patients into two periods. We looked at a moderate shortage, which was kind of the first and the last month of our problems, and then the severe shortage. And we actually looked at the patient's calorie and protein delivery and reviewed their charts, compared what we were doing versus the goals, and analyzed this, and actually presented it here in this building four years ago. Kind of hard to believe. So here's what we found. 289 patients during that period of time. About 2 3rds of them were in the severe shortage period. We had patients, so first of all, we gave less PN, 10.9 versus 11.7 days. We gave less protein. So during the severe shortage, 19.7 grams of protein per day short of our goal during the less severe period, 4.8. And our calorie delivery, so in the mild shortage, we were spot on. We gave patients two calories more per day than we had recommended. During our bad shortage, we were 219 calories short. So definitely dealing with some numbers there. And I'll show you some clinical outcomes data in a moment. Now, a little more recently, we had a lipid shortage. This was at my new organization. We're using Caps Pharmacy. You see, we're kind of central in Southeastern Ohio. Our pharmacy, though, comes from Cleveland. So every night, the stuff gets made in Cleveland, brought down through the state. And, you know, we had some tough choices. We had to either change our lipid away from our preferred bags, and I apologize. I use the word pre-mix all the time, and I'm interested to learn more, so slap me. I forgot the answer, but yeah, you gotta stop. Yep, I will stop. I'm being corrected, so apologies for that. So we also reduced our lipid doses. But I felt like this is really impacting our ICU patients. So let's take a little bit of a journey, because the other problem is we're still in evolution in terms of what do we even believe about what the ICU patients actually need? Well, a lot of us, I mean, not me, but in the world, a lot of us are still kind of back in the 2016 Aspen SCCM guidelines, which were actually holding lipids in the first week of practice. And even then, it was actually the most controversial guideline in that document. Only 64% of the attendees or the guideline committee members agreed with that recommendation, even though it went into the document. And a lot of it had to do with the availability of the lipids at the time. And at the time, they only had 100% soy oil lipid. By 2022, Aspen didn't make it kind of a top-line recommendation, but in their updated guideline, it's kind of hidden in there, that ILEs are safe and they can be included at the time of initiation, even within the first week of the ICU. So clearly, in a six-year period, a pretty significant change in what they're saying. Well, also behind the scenes, Aspen was recommending in the past that the lipid doses be less than one gram per kilo per day. And that was based on the experience with soy. But now, recommending generally as long as you, basically, the dose that's recommended in the lipid package insert, which is gonna be greater than one gram per kilo per day, except for interlipid. And not to hold it in the first week in the ICU. And that this other concern, and it's already been addressed, that we've changed our practice to the point that we kind of aren't even sure what we believe in now, because we deal with so many shortages. So what about, you know, when amino acids were short, we actually were able to increase our calories from lipid, because we did have the new lipids. And so we were able to drive up the lipid delivery. And we showed, and this is data we also published, that it was safe and effective in our transaminate, you know, we were scared at the time. Oh, we're giving more lipid. Are we gonna hurt livers? Whatever. No, it was fine. So we, good data. And actually, less inflammation, C-reactive proteins were lower. So we definitely pivoted there. Now a major concern that I have is the use of propofol. Now I'm having trouble getting perineral, like TPN lipids in, because I have patients on so much propofol that there's no room for therapeutic perineral lipid. So unfortunately, propofol's like all over the place in my ICU. I tried to find some good data on this, was disappointed. The only people who I could find published on this were actually in the South American country of Columbia. They reported that their propofol use had gone up five times since the COVID pandemic. Our ventilator liberation bundle, which is kind of indirectly related to this, is also a mess. And this group reported they were 68% compliant before COVID, after COVID happened, even on the non-COVID patients, compliance dropped to 51%, and it was 32% on the COVID positive patients. Why? Because don't wanna go in the room, don't wanna risk an accidental self-extubation with a pause of sedation. You know, we just, we've lost our way, unfortunately. And so we have too many patients who are receiving basically all of their lipid calories from propofol. So my concern is we're holding and are underdosing the best lipid that's depriving our patients of our therapeutic benefit. We know that fish oil containing ILEs, and this is data published in 2022, and I know it's a lot on the screen, but basically at the top we see soy or soy MCT with no reduction in length of stay, soy or olive or soy and olive, no reduction in length of stay, but we do get a reduction in length of stay when we use a fish oil containing ILE. And then finally, infectious complications. So we have the same kind of data. So, you know, there's something to that. Now we also, and apologies again, I've got the pre-mixed here, gonna break the habit. So we made extensive use of pre-mixed bags. University of Wisconsin did a nice job of writing this up. They did two papers looking at both electrolyte, phosphate shortages, lipid shortages, all of it. So these pre-mixed bags have a significant role in your management of shortages. What else? And I'm gonna steal a moment or two over, that's okay, sorry. So electrolyte shortages. So we have patients who are in danger of refeeding phenomena, refeeding syndrome. And, you know, we know as we give carbohydrates, we see that intracellular shift of electrolytes. And so we really need to be on it, giving patients electrolytes. And I just wanted to point out that Aspen in 2020 made a really nice document about refeeding syndrome risk assessments. And since I was asked to talk about patients at risk in a shortage, these are the patients at risk in a shortage. We need to be on it with them. We had some fun with this. We thought, well, you know, we can do all that, but we can also look at imaging. If somebody has no muscle, when you look at their initial trauma CT scan, their initial general surgery, bowel perforation CT scan, they're going to be at risk. And we quantified this and actually found that those patients who had low muscle density, when they, these are all perinatal nutrition patients, low muscle density, longer ICU stays, longer time on the ventilator. And on the next slide, much more likely to develop hypophosphatemia with the initiation of TPN. So clearly these are patients who are at risk. And if we're in a shortage environment and we're being stingy, we're going to have trouble. So we also were interested in, you know, what kind of harm have we seen? This is not specifically the ICU, but many of these patients were in the ICU. Back in 2014, kind of the fallout of that earlier drug shortage we talked about, mostly amino acids, we saw a negative impact on length of stay and the overall cost of hospitalization when we were in a shortage. So got to wrap it up here. Case number two, chronic critical illness. This is a patient who had a gram patch repair. It leaked. When it leaked, it eroded the colon. Now they've had a colostomy, open abdomen. It's a mess. They're on CRRT. This is their abdominal wound where they dehist, had to have some mesh sewn in. So it's a hypermetabolic patient. Now this patient's also going to be at risk for trace mineral deficiencies, which I think the conclusion of this talk is it's hard to know when we're going to have issues here, so we just need to be careful. I think we have some long-term monitoring recommendations. Clearly, we know that every three to six months, even in an outpatient, these need to be monitored. Burn patients is where we know the most. We lose trace minerals. The silver dressings are chelating copper, for example, and CRRT is a big burn, or a big risk. This is one of our burn protocols. We're monitoring zinc, selenium, copper on a weekly basis, and actually often empirically replacing it. There's data showing that you're going to lose these trace elements in CRRT. This is just good serum data from Switzerland. I've stole the Vanderbilt protocol that's being presented at this meeting with the whole team here as authors. And the burn ICU, the CV ICU, these are the patients who are going to be at risk when we can't feed them. So basically, in most ICU patients, antioxidants are no longer recommended, but those select populations, we still need to be very aware. I love the story of selenium, but I'm going to skip it in the interest of time. Basically, to tell you that there's been a lot of really good data that tells us that selenium for most patients isn't needed. And then the final part is we were going to have this, but now we don't. We were going to have iron that we could put in for our own nutrition, but they stopped commercializing it. So sorry, too bad. And then I will share this because it's fine. So with the unconventional lipid situations, we have used some lovasa, that's a prescription, FDA approved fish oil supplement. We've got one patient, I don't support this, but she's putting an ounce of Crisco down her J tube every day because she didn't want to deal with the lipids. And then we have done the safflower oil skin rub, which has been described to treat essential fatty acid deficiencies. But I think this has already been pointed out well that we're short. And then I will end with, I've been told I can still invite you to this. The registration's closed, but if anybody wants to talk lipids more, join us for more discussion and we'll take it from there. So 6 p.m. Thank you, Dr. Evans. Thank you.

micronutrient deficiencies

macronutrient deficiencies

parenteral nutrition

vitamin supplementation

trace elements

critical care

amino acids shortages

lipid administration

alternative therapies