Narrator - Dr. Abel 00:00 Welcome to HelixTalk, an educational podcast for healthcare students and providers, covering real life clinical pearls, professional pharmacy topics and drug therapy discussions. This podcast is Narrator - ? 00:12 provided by pharmacists and faculty members at Rosalind Franklin University, College of Pharmacy. Narrator - Dr. Abel 00:17 This podcast contains general information for educational purposes only. This is not professional advice, and should not be used in lieu of obtaining advice from a qualified health care provider. Narrator - ? 00:27 And now on to the show. Unknown Speaker 00:31 Welcome to HelixTalk. Episode 150 I'm your co host, Dr. Kane, Dr. Khyati Patel 00:37 and I'm Dr. Patel, and I had to wait because that 150 just sounded completely different. I can't believe we are here, absolutely. Speaker 1 00:45 And you know, Dr. Patel, the title of today's episode is, keep on going strong, a reflection of 150 HelixTalk episodes through the years. And really, the intent of today is to celebrate where we've come and gone and the fact that we've published now 150 HelixTalk episodes, and to kind of review some of our favorite episodes and why we love them. And for the audience, if we kind of sell these episodes a little bit and you're interested in them, you can actually go through our archives and listen to some of our favorite episodes as well, Dr. Khyati Patel 01:16 and kind of starting with the memory and history. Dr. Kane, you know, we've kind of come a long way from when we started these we used to have the summary of top 200 drug style episodes, and then we kind of morphed into a little bit more scientific, update focused articles, thereafters. And obviously, what is keeping us strong is wonderful collaborators, faculty members, contributors from across professions and even external contributors to the university who have come and added to what we have to provide to our listeners, and secondly, to our wonderful listeners who keep us going strong continue their quest of knowledge, give us recommendations and ideas on things that they want to listen to, and so we could do research and record for them. Speaker 1 02:11 Yeah. Dr. Patel, everything you said, you know, for us, it's about the listeners, it's about the collaborators that we've had. It's about the opportunities that the podcast has opened up for us and our creative outlet, our scholarly outlet, our ability to teach. You know, the podcast has done a lot of really neat stuff. It's hard to believe that it's been about eight years. So we published our first HelixTalk in April of 2014 and just to put some numbers to it, because I think it's fascinating. You know, we're at 150 episodes now. We did 14 non HelixTalk podcast episodes, almost as a pilot, and we've recorded about 92 hours worth of content. You know, that's four days worth. We've more or less hit 1.5 million total downloads every month, about 14,000 downloads of our episodes, and any episode we release within the first month or two, we typically hit about 4000 downloads per episode. So we're definitely getting a good scope of the episodes, which is the whole point. We want to have these free, accessible, medical education type podcast episodes available to anyone who wants to listen and learn and get better. Dr. Khyati Patel 03:26 Yeah, and I think the beautiful thing about this is that aside from the traditional mode of learning, which is maybe opening an article or opening a book or going into a database and sitting down and reading this really gives you the Bite Size need to know information as you are, maybe traveling to work or, you know, just working out on your treadmill, you can be productive and you can improve your knowledge. And I think it's great to be part of that learning process, not just for our audience, for ourselves too, where we dive deeper into certain topics and learn more about it. Clearly. Speaker 1 04:06 Dr. Patel, we've come a long way from just talking about top 200 drugs, and I think we'd be remiss if we didn't kind of acknowledge some of the other people who have really helped us get here right so obviously, the first two people that come to my mind, besides yourself. Dr. Patel, of course, is we've had two co hosts historically that were part of the HelixTalk team. So Dr. Nick weatherton was earlier on, and then Dr. Michael Shuman, both of those had huge contributions to a number of episodes throughout the years, and they were pivotal in helping HelixTalk grow and contributing their knowledge and expertise. And they they were definitely huge contributors to HelixTalk throughout the years. Dr. Khyati Patel 04:46 And their dear friend, dear colleague, and if they're listening, they should know that we miss them dearly during, you know, at the university, as well as you know, in this recording process. Yes, like you couldn't have said it better, they set up a really good file. Nation of what we are doing here today, but filling in their void quite not enough. But filling in their void are our other cop faculty guest contributors. We've had about 13 different faculty members who've been on helix top. Some of them actually have come back more often because they love us so much. Yeah. Speaker 1 05:19 I mean, just to name a couple, Doctor Lauren Angelo, we've had her on several times, and she literally is the author of APhA's immunization handbook. So we've, you know, tapped her knowledge in terms of immunization updates, also some self care topics as well. So she's been a regular contributor to the podcast as well. Dr. Khyati Patel 05:39 And then we've had Dr. Eric Walters, who is at the Pharmaceutical Sciences Department at the college, come and speak about the science of sugars and sweeteners. And this takes me back to, you know, my regular questions that I get from my patients in the world of diabetes, and he's actually the author of the sweetener book. And so it was fascinating to hear him talk about some of the science and research behind the sugars and the sweeteners and what's the taste perception. And aside from the faculty contributors, we reached out and tapped into our growing alumni pool. And so we were fortunate to have certain alumni come and talk about various aspects of professional pharmacy practice when certain new rules were published. For example, Dr. Dylan Moe came in reflected on the Illinois passing the mandated counseling by pharmacist rule. Dr. Solano came and reflected on Illinois pharmacists prescribing of hormonal contraceptive that just got approved. And then we've had some alumni from industry, like Dr. Koshkina who came and talk about her unique pathway that inspires some of the student listeners, if they were to branch out from their career development. And then last but not the least, we've had Dr. Hetal Patel, who provided a remarkable story of what it takes to be an independent pharmacy owner at such a young professional age. Speaker 1 07:13 And Dr. Patel, you know you and I don't know everything, and as wonderful as our college is both alumni and faculty, sometimes we do need to tap into external resources and pull people in that have expertise that we don't have available to us within the college. So we've had a number of external contributors outside of the college itself, and one of those would be students. So we've had a couple we had an episode where we had the interprofessional Community Clinic students come in and talk about the ICC clinic. We were actually able to have two pharmacists that were part of a New England Journal of Medicine publication about anti hypertensives and barber shops. So we had those two pharmacists on Dr. Lynch and Dr. blyler, we also had the dean of the Chicago Medical School, Dr. Chatterjee, talk about her role as dean, her career path, and also her position on the FDA vaccine and related biological Products Advisory Committee. And that was a super hot topic, because that's when we were talking about those mRNA vaccines for adolescents, and now we're talking about them in kids. So that's been very eye opening, and it's been amazing to have some of those contributors. Dr. Khyati Patel 08:29 And then most recently, we had the opportunity to collaborate with Mr. Garth Reynolds, he's the Illinois Pharmacists Association Executive Director, who came and talked about the relentless efforts of IPhA in advocating for pharmacists prescribing of the hormonal contraceptive and the entire process of the bill, what it took, and how instrumental a state organization like IPhA was in advocating for the profession and the pharmacist, no. Speaker 1 09:04 Dr. Patel, clearly, we haven't done it alone. And again, I just want to thank all of those guest contributors. It's been amazing to have their expertise on the podcast, to be able to share that with our 1000s of listeners who download our episodes. So I think we've kind of gone from a to z in terms of where the podcast has been and where we're going. I think Dr. Patel would be really neat to go through some of our favorite episodes and briefly summarize some of those episodes of why we like them. If there's any updates to those episodes, we can certainly get into that. And then for the listener, if you want to kind of dive into those episodes, our entire podcast archive is available to you. If you go to HelixTalk.com or website, or wherever you get your podcasts, you can still download all the way back to Episode one if you want. So I'm going to do my best to kind of sell and explain why some of these episodes are my favorite, and I hope the listeners think about going back to to the archives and listening to some of these. Dr. Khyati Patel 09:58 Let's get into it. I'm excited. Speaker 1 10:01 So Dr, one of my favorite episodes was episode number 50. The title was three shocking recommendations from chest 2016 that will blow your mind. And this is one of the first times that we started having some of our more unique titles for our episodes, which we've kind of adopted and stuck with. And this was a big deal because back in October 2016 this was really the first time that we saw guidelines starting to prefer doacs over warfarin. The time we kind of called these the no acts or novel oral anticoagulants. And really the most recent chest update in 2021 reaffirmed this with a stronger level of recommendation of a preference for doacs. So again, back in 2016 this was a really big deal, and we talked a lot about that. One thing that really sticks out in my mind about that was how we talked about the doac, NOAC acronym. Dr. Patel, do you remember any of that? Dr. Khyati Patel 10:53 Oh yeah, I remember swimming in the acronym soup. And literally, when I would mention this to my colleagues at the clinic, they would be looking at me with the deer in the headlights, because everybody was hearing this differently. So we had the NOAC, which was non vitamin K, oral anticoagulants. We had the soacs, kind of like a T silent, which was target specific oral anticoagulant. And then we also had doac, which was direct oral anticoagulants. And it seems like, you know, after those guidelines in 2016 that kind of became more of a preferred term, yeah. Speaker 1 11:28 And I would say, as an update to the episode, doac has definitely taken hold, at least in my clinical practice and where I've seen it in the literature. Would you agree with that? Dr. Patel, 100% Yeah. Just to highlight, you know the acronym NOAC originally was novel or new oral anticoagulant, but because we recognize that at some point these wouldn't be new or novel anymore, and also because no AC could be confused with no anticoagulant, like in a progress note, these guidelines back in 2016 redefined what The acronym meant. So we went from new or novel oral anticoagulant, as you mentioned, non vitamin K, oral anticoagulant, which is terrible. That's the worst acronym I've ever heard. So I'm really glad that everyone shifted to doacs as opposed to noacs, and we rejected the renaming or redefining of what NOAC meant Dr. Khyati Patel 12:20 since that time. You know, we used to call them like you said, Dr. Patel. They were quote, unquote novel at the time. Where do they stand now? Speaker 1 12:28 Well, just to put a couple numbers to it, so if we look at 2019 prescribing data, which is the most recent data was able to acquire, going from 2016 to 2019 so a three year period, apixaban went from the 125th most prescribed drug to the 52nd so 125 to 52 rivaroxaban has basically been around 100 plus or minus 10; dabigatran has become much less popular. So that was actually the first DOAC on the market, also the first DOAC to have a specific reversal therapy for it, and edoxaban has never really been popular in the U.S. Warfarin, basically is the same. So it started at maybe the 40th most prescribed drug, and now it's about the 50th most prescribed drug. So it and apixaban are about equally prescribed. It's still ridiculously common. So even though the doacs are becoming really, really common, we're still seen a ton of use of Warfarin in the United States, which is not that surprising, because there are some conditions where you can't use doacs And you have to use warfarin. Dr. Khyati Patel 13:29 And I bet more research is coming to treat those specific conditions for which doacs weren't previously treated. So as the evidence becomes more out there, we might see Warfarin kind of falling from the favor Exactly. Speaker 1 13:43 So that was my number one. What is your number one episode that comes to your mind? Dr. Khyati Patel 13:48 I guess not in any special order, but I've just kind of picked my top I really liked the episode 2930 and 31 which was therapeutic drug monitoring. And this was actually one of our first listener suggested topic that we wanted to do. I picked this one because obviously this is a bread and butter of the pharmacist, and what we do as part of in a professional team is manage and monitor the medications, lots and lots of inpatient, outpatient protocols that are managed by a pharmacist are based on this principle. So it was, it was actually really appreciated that the listeners reached out with this request. But tell you what we had so much to discuss, even though we had handful of drugs to talk about therapeutic drug monitoring, because we really delved into the science of it and the applicability of the drug levels for these agents. Speaker 1 14:47 And, you know, as a common theme to almost all of these they they have narrow therapeutic windows, which means that too little or too much is easy to have happen where it's hard to kind of get the. The Goldilocks dose or drug level for a patient. And many of these have drug interactions or unique kinetic considerations, where dosing them can be very difficult. One example was phenytoin. You know this is important, that you don't have seizures, but also at higher levels, it can cause a lot of cognitive impairment. So we have to find that perfect level. How we get the level itself between a total phenytoin and a free phenotype is actually really difficult, and I spend a couple hours just on phenytoin kinetics here at the university, when I teach this topic, and it also has Michaelis–Menten saturable metabolism, which means that you really have to be careful, especially when you increase your dose, because small increases in your dose can produce a very large increase in the drug level if you're near that saturation point, right? Dr. Khyati Patel 15:47 And some other examples were warfarin, as we all know it, has a lower therapeutic window. Therapeutic levels depend on what indication we're treating, but generally they are INR levels of two to three or 2.5 or 3.5 and then, similarly, you know, if, if your level is higher than these ranges, it increases the risk of bleeding. If it's lower than this ranges, it increases your risk of clotting. So it's really important that, as pharmacists, and you know, pharmacist driven protocols, that you're managing patients Warfarin within these recommended levels. Speaker 1 16:25 We also talked about digoxin, which is used mostly in heart failure, but also for rate control and atrial fibrillation, you know, kinetically, this has a fairly long half life, especially if you have renal impairment. It also has a prolonged distribution phase, so it takes a while to kick in when you're trying to use it in the hospital setting, which is why we load it. But even with a loading dose, it takes a couple hours to kick in at really high doses. You can see everyone remembers the blue, green visual halos. But really before that, you see nausea, vomiting, confusion. You can see all sorts of arrhythmias and Brady arrhythmias. And from a drug level standpoint, it depends on what you're treating. So for those with heart failure, we actually want their level to be about point five to one, because at higher doses, it was shown to potentially worsen clinical outcomes. But for afib, you have to drive the level up higher to produce a lower or reduction in heart rate. Typically we're going at levels of one and a half to two, much higher for those AFib patients. Then, of course, dosing is very complicated because it depends on your ideal body weight, which is based on your height and your sex, then also your renal function. So there's a lot of role for pharmacists here, with all of these nuances in terms of safely and effectively using digoxin. Dr. Khyati Patel 17:44 And last but not the least is lithium. You know, this one is used in acute as well as maintenance situations for bipolar disorders. And we have like, three different salts. And then, you know, all of these salts have more formulation so therapeutic monitoring and those transitions are something where pharmacists should be involved. We do draw trough levels, and the goal is point six to 1.2 again, this is a narrow window. Higher levels are associated, or actually okay in acute situation. So we're talking 1.2 to 1.5 in generally we draw this at steady state, so that's usually after four to five doses and 12 hours after the last dose. And so that's, that's how when we when we draw it. And the study said concentration is going to be different based on the formulation we are using. Usually the C max is lower in that controlled release product. And so that's associated with lower side effects and such. And so if the levels of lithium are higher, we're talking 1.5 to three. You can see things like confusion, agitation, hyperreflexia, like kind of like walking along the lines of serotonin syndrome, tinnitus, and then above three is where situations get really scary, and we can see things such as seizures, brain damage, coma or even death, Speaker 1 19:12 clearly a huge role for pharmacists and an understanding of pharmacokinetics. And I love that episode sequence as well, because it really highlights some of those must know pharmacokinetic considerations for really any pharmacist, inpatient, outpatient, regardless of your practice environment, these are must know things, Dr. Khyati Patel 19:31 alright, Doctor Kane on to your number two. Speaker 1 19:34 So my number two is episode 111 and the title was the basics of immune checkpoint inhibitors for non oncology healthcare providers. And I like this because I'm one of those non oncology healthcare providers. I don't consider myself knowledgeable about oncology topics at all. And we actually had the help of one of our at the time cop faculty members, Dr. Eris Tollkuci, to come on and talk to us about this. What really prompted it? Was that I had a patient in the ICU who had a side effect from this fairly new oncology drug class called immune checkpoint inhibitors, and it was neat to talk about it. Dr. Khyati Patel 20:09 Dr. Kane, what was, what was your patient situation? What was the patient in the ICU for? And how did you find that this drug was the one responsible for it? Speaker 1 20:19 Yeah, so a patient came in with HHS, which was hyperosmolar hyperglycemic state. Basically it's where you have a really, really high blood sugar. And this patient's blood sugar was about 1800 and they had never had a history of diabetes. It's similar to DKA, except you don't have the acidosis component. It's just a ridiculously high blood sugar level. And this patient was taking one of these newer drugs called immune checkpoint inhibitors or ICIs. There's kind of two different versions of it. Sometimes these are also called PD-1 or PD-L1 inhibitors. So basically, PD-1 stands for programmed cell death protein 1. PD-L1 is the ligand for the PD-1 receptor. And basically when cells become cancerous, they can overexpress PD-L1, the ligand which, in doing that, actually suppresses T cell function versus the cancer cell. So these drugs, these immune checkpoint inhibitors, are PD-1/PD-L1 pathway inhibitors; they work by turning that off so that the T cells are not suppressed by the cancer cells as much it revs up the immune system, and hopefully those T cells will attack these cancer cells. Dr. Khyati Patel 21:28 Some of the examples of these drugs, I think these, were both approved back in 2014 – Opdivo (nivolumab) and Keytruda (pembrolizumab). And I agree with you, Dr. Kane, besides hearing these brand names on TV commercials. I'm not familiar with them either. However, being a provider in the outpatient clinic, I was actually given a patient who had an oncology drug related hyperglycemia to manage, and it wasn't as severe as these two agents. These seem to be a little bit more severe, but in addition to causing higher blood glucose levels, they can also cause autoimmune like reaction after being on this drug for a long period of time. So we're talking about weeks or months into this therapy where patients can have, you know, skin reactions, dermatitis or rash GI issues like colitis and resulting diarrhea, and even endocrine issue where they could have type one diabetes, you know, beta cell destruction and loss of insulin function and pneumonitis and Speaker 1 22:34 Dr. Patel. This is tricky, because, like many other oncology medications, oftentimes these are given IV. So as an example, these immune checkpoint inhibitors are typically given every two to four weeks IV. So you might not even know that a patient is on these because it won't show up necessarily on a medication history list unless you specifically ask the patient about it, or you have records of their chemotherapy treatment regimen. So this should always be on your radar when you have a patient who has cancer that's getting what they call chemotherapy, and they're potentially having a side effect that could be associated with their oncology treatment. Every single patient I have, Dr. Patel that comes into the ICU, who I know, is getting active chemo, and they have some issue like a GI bleed or a hypertensive intracranial hemorrhage or anything. I always look at their chemo regimen that they were getting and see if that chemo regimen is associated with the side effect that brought them in, so that other healthcare providers who are as equally uninformed as I am, know that potentially their chemo regimen contributed to the reason that they came to the ICU. Dr. Khyati Patel 23:41 And I think this is a good learning moment for students and new practitioner alike, is to find out where in your electronic patient database your chemo regimens are residing, because they're not going to be part of your medication list, and always have an idea to check it. Speaker 1 23:57 And one thing I really love about this episode Dr. Patel is I unfortunately had a second patient a month ago who came into the ICU with drug induced pneumonitis, and they actually died despite us giving the therapy that you're supposed to give when someone has an immune checkpoint inhibitor pneumonitis. So we gave them high dose steroids and infliximab, and that regimen we gave them was based on what we talked about in the episode, which was, you go to these external resources like the NCCN guidelines or the ASCO or ESMO guidelines, and they actually walk you through grading the severity of the side effect and then the management of that side effect. And I listened to that episode while I was in the ICU. I went through the show notes, I went to those guidelines, and then that really helped me inform the treatment team, the ICU team, about the side effect of this regimen and what you're supposed Dr. Khyati Patel 24:50 to you know, this is a great example of the impact of listening to our episodes could have on your practice. You know, obviously you are. Supporter and contributor and host of this podcast. But we hear from listeners all the time. Oh, hey, I listened to this and I used it or this was really helpful. I had this case or patient come up. We hear those anecdotal examples all the time. Thank you for sharing that. Dr. Kane, so Unknown Speaker 25:21 Dr. How about your number two? My Dr. Khyati Patel 25:23 number two is Naloxone and pharmacist role. This was our episode 51 pharmacist to rescue. And this was published, I guess, intentionally, during American pharmacist month in 2016 October in the where we summarize, kind of like the available Naloxone formulations for harm reduction purposes. And really the focus was much more about professional advancement, and focusing on State of Illinois, as well as Wisconsin's recent approval where pharmacists could dispense Naloxone to the patient receiving high dose opioids or their family members without prescription, and that comes with an asterisk. You do still need a standing order. Speaker 1 26:08 Doctor, I know that you're involved in this quite a bit with a PHA and as a chapter advisor, would you mind just commenting on your role with that in the past couple years as it relates to Naloxone? Dr. Khyati Patel 26:20 Yeah, absolutely. You know, I was selfishly interested in this topic because I am a long lasting aphm member. Have been a PhD advisor. We do have an operation called Operation substance use disorder, where we are tasked to educate community about the potential dangers of various medications that could lead to this, and just advocating for the patient who are dealing with substance use disorders and finding them various resources in the community. And since this episode, you know, we've we've learned more about expanded access to Naloxone. We've learned more about harm reduction research that's going on, and really all the community partners have collaborated. So yes, pharmacists are allowed to dispense Naloxone, but now they're giving Naloxone to the community volunteers, to police departments, to first emergency responders, and a hope that it can really save lives. And here, Dean Rosencrantz, who wears a Master in Public Health Administration at our university, her and I are collaborating with our local health department, Lake County, where we are actually evaluating a program they have implemented, which is called a way out. It's a program that allows access to individuals with substance use disorders to just walk into a police station and say, Hey, I give up. I need help. There is no criminal or civil liabilities, and they are actually given medical help and supportive care. And we are now collaborating to see whether that program is fulfilling all its objectives and the goals that are in the project. And it's a very, very much an interprofessional in our community venture that we have. But, you know, fast forward to this episode was recorded with Dr. Schuman, him and I kind of did a CE workshop with, you know, for Naloxone, for the pharmacist, back in 2015 and since the establishment of this Naloxone prescribing authority in Illinois, it is under a standing order, which, luckily, Illinois public health department was on board. So rather than creating like a provider, specific standing orders, which is the case in Wisconsin. Illinois said, You know what, we're going to have the head of the, you know, health department, sign the order, and the pharmacist who are trained. So there needs to be a specific training that is developed by Illinois Pharmacists Association where they're going to be able to dispense and educate patients and their care, caregivers or family members about naloxone. Speaker 1 29:09 So Dr. tell I think that all of that is amazing. It sounds like especially 2015 2016 you had a lot of new initiatives and things like that. I would assume other states have kind of, over the last seven years, taking notice of states like Wisconsin and Illinois, what is the status of all of the Naloxone and prescriptive authority of pharmacists today compared to seven years ago? Dr. Khyati Patel 29:32 Right now, we are looking at a map almost all 50 states, including Washington, DC, allows pharmacists to display naloxone. The authority could be based on individual provider based standing order. It could be a statewide standing order. So those are some of the nuances that you need to check. But that's there. Some of these allowances are allowing community organizations to act as the frontline caregiver and administrator. Naloxone and provide Naloxone and education to the patient. We've seen some data that come out. Some of them are unfortunate data where, you know, there's not enough utilization by the pharmacist, meaning the pharmacists are not feeling comfortable enough to dispense it. However, there are a lot of training. There's opportunity to implement training programs and CE programs where pharmacists are brought up to speed and helping with harm reduction efforts in the community. And you know, not just the wide availability of naloxone in the community. What came out in 2016 was also the opioid prescribing guidelines by CDC, which really guided the prescribers on you know how to prescribe these opioid medications that are abused. They have abuse potential, and certain states even have laws where they're supposed to use a PMP before issuing a prescription. So we are seeing a stark reduction prescribing of the opioids. However, unfortunately, this hasn't really translated into reduction in drug related death, aka fatality data. Speaker 1 31:15 That's interesting. Hopefully the data will eventually show that these initiatives are taking hold. I'd be cautious to say that it's not working, just because it's a moving target. You know, the amount of opioids out there is going to be changing. So because of time, because things change over time, I think it's hard to definitively prove that a program is or is not working, and hopefully we'll get to that point right. Dr. Khyati Patel 31:37 And I think there is a methodological flaw in how we are collecting data, and so the drug related death data comes from the coroner's office, but you know, they're the people who are on the front line, the police departments, the community workers who are administering Naloxone, and the lives are saved. We don't have that data. So yes, we can look at the death data, but then the lives saved data, we just don't have a good mechanism to track those Speaker 1 32:03 absolutely well that my number three was all the way back to Episode 124 the title was The ABCs of EUAs, understanding FDA emergency use authorization. And this was really notable because we released it January 2021 this is roughly about a month after Pfizer and moderna mRNA vaccines were released, or at least available to the public, and especially at that time, I think most healthcare providers were not particularly knowledgeable about what exactly the emergency use authorization process was, or the EUA process, and so we kind of talked about that. So just to reiterate, EUA is where the FDA can grant access to a drug, device or biologic product in times of an emergency. And emergency truly means that the Health and Human Services head literally declares an emergency, like covid 19 and these authorizations, these EUAs are supposed to be short term, like less than one year, with the intent that the company is working on full FDA approval, and of course, the EUA can be reissued after that year. But again, the intent is that this is temporary until a full approval is possible. Dr. Khyati Patel 33:11 And I think the word, or the you know, acronym, EUA, was in the limelight since covid 19, but historically, we've had more EUAs. Like, for example, 2008 we had doxycycline for anthrax. You know, we had the testing us as well when Ebola outbreak was happening in 2015 and also the Zika testing UA back in 2016 Speaker 1 33:36 and of course, with covid 19, we've had so many new EUAs, especially since January 2021, hydroxychloroquine, we talked about that in a couple different episodes, and that UA has now been revoked, but everything from some of the immunosuppressants like baricitinib and Tocilizumab, tons of monoclonal antibodies, remdesivir, some of the new oral antivirals, like paxlovid, other vaccines now, with different levels of full FDA approval, or EUAs for certain age groups, it really runs a gambit. And there's a ton of stuff out there, and this is the drugs. We also have EUAs with covid 19 for diagnostic tests for certain PPE, personal protective equipment, ventilators and so much more. And it's all on that FDA website. Dr. Khyati Patel 34:21 And what is, what is, sort of the bottom line with EUA, Dr. Kane, like for healthcare professional, how are we supposed to use them? I think Speaker 1 34:29 the most important thing Dr. Patel is to recognize that on the EUA website, the FDA has the equivalent of what you would consider a package insert for all of these so as an example, if you wanted to know the criteria that was used to approve the mRNA vaccines for six months to four year old patients, you would be able to pull that data up in the clinical trials and Results section in the EUA for those vaccines, and you'd be able to see what they looked at. So as an example for that very young age group that approval was. Not based on clinical outcome. Data was based on antibody levels, which is fine, but you might like to know that, and you might like to see how those studies were designed and what endpoints they looked at, just like a package insert, the EUA is going to have similar data available for healthcare providers to look through. Dr. Khyati Patel 35:16 Yeah, I have pulled up some of these myself for drugs like, you know, paxlovid and stuff. And I tell you, it's a really good evidence based source to go to to look at the data. All right. Dr. Kane, you presented your top three episode, and I'm going to go and conclude with mine. And I it was really, really hard to sum everything up in three episodes, but I could not miss this one. And this was our university centennial celebration episode with niece of Dr. Rosalind Franklin. The episode title was Dr. Rosalind Franklin beyond photo 51 this was our episode 123, and it was published in December 2020, and you know, this was one of our pandemic, remote collaboration with the you know, namesake of our University, Dr. VAs and Franklin's niece. We took kind of a unique approach with this episode, where we took the excerpt from the recorded interview, kind of like went back and added our own commentary. So from like editing perspective, I also really liked it. And aside from celebrating the university and the timing, you know, this was a really good opportunity to learn about Dr. Franklin on more personal level, looking and listening about her research beyond just the structure of DNA, and kind of, you know, the surrounding controversy about her stolen work, because that's what we hear in pop culture, and kind of what lessons we took away from this discussion. And you know, as scientists and academicians, you know what impact her work has on us, Speaker 1 37:02 and I mean, the listeners don't know this, but we recorded that episode with the niece of Dr. Rosalind Franklin, who is also named Rosalind Franklin. She's on our advisory board at the University. She's also an entrepreneur. She's kind of a leadership coach, and empowers others with life and career advice. And the thing that the audience probably doesn't know is that she was literally in the Caribbean, hanging out on a beach, recording that episode with us. We were stuck indoors during the pandemic and the cold, and it was amazing that we were recording, you know, remotely, which was fairly new for us. Recording this episode with someone who was in such a wonderful place physically during that that episode, Dr. Khyati Patel 37:45 that was a stark contrast. But, you know, just the sheer opportunity that she gave us her time, and she represented Dr. Roslyn franklin, you know, and her thoughts and in this interview was amazing. And so, aside from the topic, you know, I think some of the guiding principles of Dr. Franklin's life were also shared. And that, you know, the whole thing about how Watson and Creek stole her photo 51 and based the double helix, you know, structure based on that, and they ended up getting the Nobel Prize, what we really learned is that she really didn't care about any of that. She really just chalked it up to poor leadership and communication from her supervisor, and really just kept on doing what she wanted to do the most is, you know, keep on doing her research and advance the human future. Speaker 1 38:39 And I think we'd be remiss if we didn't kind of mention that a lot of her other research was not necessarily with human DNA, but she did a lot with coal in terms of density and the structure of carbon. She looked at gas masks that use carbon based filters. That was actually helpful with World War One and World War Two. And then she did mostly her research was with viruses. So the tobacco mosaic virus, polio virus, it was her that discovered that it was a single stranded RNA virus, the tobacco mosaic virus. So she did a lot of other stuff that probably people don't think about when it comes to her research. Before she died, really. Dr. Khyati Patel 39:15 And I think the founding principles that you know shaped her career and left the legacy were her unstoppable tenacity, her ingenuity and the passion for science and, you know, ultimately assisting humanity. You know, she was a No BS, straightforward research person who was just sort of unstoppable. That's the kind of picture I got from talking with the needs Rosa and Franklin Speaker 1 39:42 absolutely agreed. We know. Dr. Patel, you picked three episodes. I picked three episodes. And it turned out that we, all you and I both had a shared episode that we just can't leave without talking about. And that episode is episode 137 the title of it was, it's time for PBM reform. How? P. PMS have hurt pharmacies and increased drug costs. I 100% Dr. Khyati Patel 40:04 agree with you. I got to learn so much, not just the acronyms, but so much from Dr. jolly and your research in understanding where all these shady practices are happening and coming from. And to Speaker 1 40:18 be honest with you, Dr. Patel, I didn't know a lot about pharmacy benefit managers or PBMs. I knew that there was kind of a negative connotation in the pharmacy world with them, but I didn't exactly know why. To be honest, I didn't really fully understand what they do. So to put it very simply, PBMs are hired by health insurance companies to handle drug insurance and reimbursement. So if I have Blue Cross, Blue Shield of Illinois health insurance, Blue Cross is actually not the company that handles my prescription drug in terms of what's on formulary and what the pharmacy receives for reimbursement, Blue Cross is going to farm that out to another company called a PBM, and that PBM is going to do all the work in terms of processing claims and seeing what the copay is and what's on formulary. All of that is not handled by your health insurance. It's handled by the PBM Dr. Khyati Patel 41:09 and honestly, with all these mergers that have been happening over the years, we have like, three PBMs that control three fourths of the entire PBM market. And really it's, it's this pharmacies are having less and less independence, and they kind of more just have to take it or leave it as to what the PBM contracts have to offer. And so pharmacies fall into some of these extortionary practices and things such as, you know, there are hidden fees inside the reimbursement. We call it the DIR fees, and there are a lot of claw backs we're sustaining that pharmacy business, unless you are a big chain pharmacy is it's not realistic. Speaker 1 41:55 And we also learned about how PBMs are leveraging deals with drug manufacturers to basically pad their own profits and not really pass those benefits or profits onto the patient to what they're supposed to do, which is decrease drug costs. So for at least me, I wasn't aware of how PBMs fit in the landscape, why they were hurting pharmacies, and now I'm baffled that this is legally allowed, and that this is the state of where pharmacy reimbursement has gotten to over the last several decades, right? Dr. Khyati Patel 42:27 And I think you know this, this episode in the discussion also created a stage for us, understanding these terminologies, understanding the shortcomings and understanding the advocacy efforts. Everything started with the Rutledge versus pharmaceutical Care Management Association Supreme Court case where, you know, it was started by Arkansas, and it was a law requiring PBMs to reimburse pharmacists to apprise equal to or higher than pharmacies wholesale cost. And the Supreme Court ended up uphelding The law, forcing PBMs technically to reimburse at a fair rate. And this was a good example of of the fact that PBMs were never regulated, and so a lot more states are now kind of creating similar cases and platforms and advocacy campaigns to demand that PBMs in their states are regulated, that we can hold them accountable for some of these bad practices that they're doing. Speaker 1 43:29 Just to give two quick examples of that, there's a new US Senate bill called the pharmacy benefit manager Transparency Act 2022, and the bill's intent, whether it will be passed or not, I don't know, but the intent is to ban unfair pricing schemes, to prohibit arbitrary clawbacks of payments made to pharmacies, and require PBMs to report to the FTC, the Federal Trade Commission, how much money they make through spread pricing and pharmacy fees. So essentially increasing transparency and preventing some of these bad practices that have become extremely commonplace that are truly hurting those, especially independent pharmacies. Dr. Khyati Patel 44:10 And then June 2022 which was the biggest deal, and I saw this on our state organization's website too, where FTC announced that they are launching an inquiry into PBM industry. They sent this notice to six different PBMs, and they will focus on these dir fees and clawbacks, and, you know, kind of methods of steering patients towards pharmacies that are owned by PBMs, right and unfair audits of the pharmacies, these very complicated measures and methods of pharmacy reimbursements and looking into prior authorization restrictions, administrative restrictions and impact of this manufactured rebates, where they're not letting the benefits come to pharmacies or the patient. They're going to look into all of that and. And this really started from Arkansas and pharmacists and independent pharmacy owners speaking up. And this is a good example of what advocacy can do for the profession. Well, Dr. Kane, this was amazing. This has been amazing to collaborate with you from day one on this platform to learn so much, to give so much back to our audiences and so thank you so much for your partnership. Thank you to the audience for always supporting us and listening. It has been Speaker 1 45:34 a wonderful pleasure. Dr. Patel, I echo that as well. It's been awesome having you on the podcast, and I'm looking forward to another 150 episodes for the listeners. If you want to listen to any of these, you can find them at HelixTalk.com, or wherever you get your podcasts. We're on Twitter at HelixTalk, and would really encourage you to listen to some of these favorite episodes of ours, a blast from the past, because they think you're going to find a lot of value in these. So with that, I'm Dr. Kane, and Dr. Khyati Patel 46:01 I'm Dr. Patel, and I'm going to say, listen hard. Narrator - Dr. Abel 46:06 If you enjoyed the show, please help us climb the iTunes rankings for medical podcasts by giving us a five star review in the iTunes Store. Search for HelixTalk and place your review there to Narrator - ? 46:17 suggest an episode or contact us. We're online at HelixTalk.com. Thank you for listening to this episode of HelixTalk. This is an educational production copyright Rosalind Franklin University of Medicine and Science.