CEimpact Podcast
The CEimpact Podcast features two shows - GameChangers and Precept2Practice!
The GameChangers Clinical Conversations podcast, hosted by Josh Kinsey, features the latest game-changing pharmacotherapy advances impacting patient care. New episodes arrive every Monday. Pharmacist By Design™ subscribers can earn CE credit for each episode.
The Precept2Practice podcast, hosted by Kathy Schott, features information and resources for preceptors of students and residents. New episodes arrive on the third Wednesday of every month. Preceptor By Design™ subscribers can earn CE credit for each episode.
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CEimpact Podcast
What's New from the FDA and Why It Matters
The FDA remains a powerful driver of change in pharmacy practice through its approvals, policies, and public health actions. This episode highlights timely FDA developments and emerging areas of focus that pharmacists need to be aware of—from regulatory shifts to new communication initiatives. Tune in to stay informed on FDA activity that could influence the way you practice and care for patients.
HOST
Joshua Davis Kinsey, PharmD
VP, Education
CEimpact
GUEST
Mary Ross Southworth, PharmD
Principal
S&S Consulting Partners
Joshua Davis Kinsey has no relevant financial relationships to disclose.
Mary Ross Southworth is a consultant for Travere, Unicycive, Liquidia, and Mineralys. All relevant financial relationships have been mitigated.
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CPE INFORMATION
Learning Objectives
Upon successful completion of this knowledge-based activity, participants should be able to:
1. Recognize current FDA topics and areas of focus relevant to pharmacy practice.
2. Describe how current FDA priorities may impact medication use, pharmacist responsibilities, or patient care.
0.05 CEU/0.5 Hr
UAN: 0107-0000-25-296-H03-P
Initial release date: 9/22/2025
Expiration date: 9/22/2026
Additional CPE details can be found here.
Hey CE Impact subscribers, Welcome to the Game Changers Clinical Conversations podcast. I'm your host, josh Kinsey, and, as always, I'm excited about our conversation today. From medication safety alerts to compounding policy shifts, the FDA's actions have a direct and immediate impact on how pharmacists practice every day. In this episode, we'll break down five current FDA topics that matter to pharmacy what's happening, why it matters and what you need to know. And it's so great to have Mary Ross Southworth with us today. Mary Ross, thanks for joining us.
Speaker 2:Thank you so much for having me.
Speaker 1:Yeah, so for our listeners, just to get to know you a little bit, take a couple of minutes and tell us a little bit about yourself, maybe your career path and what you're doing now, and just kind of let us get acquainted with you.
Speaker 2:Absolutely so. I am a pharmacist by training and I started my career as a clinical pharmacist at the University of Illinois at Chicago. My clinical practice area was in heart failure and transplant, which was a really great experience, good foundation for sort of clinical care, and that really served me well throughout the rest of my career. I did that for about seven years and then moved to the FDA. Where I started in the FDA was in the Office of Surveillance and Epidemiology.
Speaker 2:In that role I did a lot of work with adverse event reports, analyzing them, identifying safety signals for drugs and sort of working them up to see what needed to happen from the FDA's perspective to sort of convey any new safety information.
Speaker 2:I did that for about four years and then the bulk of my 20-year career at FDA was spent as the deputy director for safety in the Division of Cardiology and Nephrology and that division is really the clinical heart of drug development at the FDA. That division reviewed INDs and NDAs for drugs for heart and kidney disease and that sort of meant that we regulated clinical trials in that area, worked with drug manufacturers to develop their drugs for good uses, using good trial techniques, making sure that the patient was protected during the trials and then we would review new drug applications. That's the marketing application that leads to drug approval and drugs being marketed, and then monitored the safety and efficacy of the drugs in the post-marketing period. My main focus was on the safety side of things, but really I touched most of regulation of drugs in that role. I recently retired from the FDA earlier this year and now I have a consulting business where I consult with mostly drug manufacturers on drug safety, drug development, pharmacovigilance type activities.
Speaker 1:That's great. Yeah that's awesome. I always find it so interesting. You know I feel like we were told a little bit about it in pharmacy school, but just the many different things you can do with a pharmacist degree Like it's. Just it's so wide and varied and you know it's. I just always find it interesting to see when someone took a non-traditional path and and you know how they ended up in that role. So really interesting.
Speaker 2:It's a great, great, great degree to get. It opens a lot of doors for you.
Speaker 1:Yeah, very versatile and yeah, just, and it's really interesting too to see how it progresses over time.
Speaker 2:You know, like even just with myself, how the different roles that I've been in with the same degree, you know, and they're vastly different. But yeah so, and I'm always coming across pharmacists and the people that I, you know, groups that. I talk to. Yes, very well represented.
Speaker 1:Exactly, exactly, and it's a small pharmacy world, that's for sure. So well, again, thank you so much, mary Ross, for being here. We really appreciate you giving us your time. And just to kind of circle back to setting the stage for the topic for today. You know, internally we had been talking about. You know there's been several FDA hot topics that have kind of come out, and you know. So we decided to put them all together and create this episode and just kind of really talk about some of the things, some of the most impactful recent events that have happened, just to kind of talk about those and how they affect practice. So again, thank you so much for giving of your time. I know how much retirees love their free time, so we appreciate you giving back to us.
Speaker 1:All right, so let's just jump in. I've kind of got these broken down. We've identified five topics for today and we're just going to kind of take them one at a time and just kind of break it down and talk a little bit about it. So I'm going to set the stage for each of them and then Amir also is going to give some additional background and then we'll just kind of converse about each topic. So the first one we're going to talk about today is GLP-1 compounding and the evolving policies from the FDA on this. So, for those of you that aren't aware, the FDA recently released statements that clarified the end of allowances for compounding GLP-1 receptor agonists like semaglutide and trisepatide, because the shortages on those medications have resolved, and so we all know that there was an allowance for compounding those products as long as there was a shortage. So that shortage has been resolved officially, and so the guidance has been shared that we can no longer compound those. So let's just kind of talk about that for a little bit.
Speaker 2:Sure. So the GOP1 class is really a game changer in and of itself, I think you know, first approved for diabetes and then expanded to weight loss, for which it is very, very effective, and then, it seems like every you know, every few months there's a new indication for these drugs so when they were first.
Speaker 2:You know, especially when the weight loss indications came out, there was a huge demand for these drugs, which you know, and the drug manufacturers couldn't keep up. So there was a huge shortage and so that led to compounding of these products and that was allowed or tolerated by the FDA because, you know, they really do pay a lot of attention to drug access. They want people to have access to the drugs that they need and so for a long time these compounds were compounded by pharmacies and mostly, I think, commercially. Or, you know, looking at the market, the major market for that is weight loss, you know, if you look at the compounding sort of arena, there.
Speaker 2:So now the drug manufacturers have sort of caught up with demand, they're able to supply the markets and the FDA is signaling now that they are going to sort of caught up with demand. They're able to supply the markets and the FDA is signaling now that they are going to sort of have a lower tolerance for allowing patients or allowing compounders to make these, to make, make and sell these compounded products. And, as a matter of fact, earlier this year they they posted a like a sort of an alert that told people that you know, there were some problems with some of the compounding medications. They might not be labeled correctly, the dosing may be confusing, leading to dosing errors. There could be, and there had been some adverse events that were reported based on the compounding.
Speaker 2:So the FDA is definitely monitoring these, the safety of those compounded products, and they're you know, and they're starting to you know at least signal in the in the public domain that they're, that people should be to cease compounding. The FDA has the most authority over 503B compounders, which are the big bulk compounders, and they the things they can do if they choose to enforce these regulations. They will send warning letters or inspect facilities and that's sort of their hammer. As far as preventing these compounders from compounding the smaller compounders are mostly that would be under the 503A regulations are mostly under the purview of the state boards of pharmacies.
Speaker 1:The FDA doesn't have quite the reach to those, but they're definitely trying to signal that compounding is not going to be tolerated anymore in general, yeah, yeah, what I feel like I have seen some like marketing and promos for products that are like combining it with something else to kind of skirt some. Some of that like guidance can use that a little bit so obviously it's a big business, right?
Speaker 2:I mean, I mean these people, you, if you're on any sort of social media, you see ads for that sort of thing all over the place, and so people are skirting the regulations and that that can be a way to sort of get around it. The regulations say you cannot compound a copy of the of the drug.
Speaker 2:But if you add a vitamin to it or a, you know of the drug. But if you add a vitamin to it or a, you know anti-nausea medication to it. That is a way that you make that product not a copy, and so that's.
Speaker 1:That is a way that people are trying to skirt around. Okay, okay, interesting. And so you mentioned too that the 503A and the 503B, so they also also. Did they update any sort of guidance in those like around the documents related to that, or is that it? Was it just simply the like statement that they released?
Speaker 2:I, so I don't know that they. They have not put out any new guidance.
Speaker 1:Got it okay.
Speaker 2:Specifically saying this. I think what I perceive is that they are coming at this. So you know, the FDA is resource constrained and so really, you know and you can imagine how many compounders we're talking about here.
Speaker 2:There's no way that the FDA could go sort of enforce across all of those. So I think that they really do try to focus on safety issues with these and so if they are alerted to safety problems with a particular product, that is going to prompt a regulatory action, meaning an inspection or a warning letter. That is sort of the activity that you're seeing around the FDA right now. There's other things. You know. The drug manufacturers are also. You know I see them ramping up lawsuits against compounders. I also see the drug manufacturers looking at alternative prescribing models, like direct-to-consumer prescribing models. So this is a very shifting landscape. You have a huge demand by the public to get for these drugs and the FDA simply doesn't have the resources to go after every single one of these. So I think it will be mostly through concerns about safety and announcements to that effect.
Speaker 1:Yeah, and you know you mentioned the direct to consumer and I know for a fact from you, know, speaking with others, that that is an option. You can actually call the manufacturer from whatever you're prescribed and you can choose to pay cash out of pocket and receive it directly from them, and it's a significantly lower rate than even if it's like a copay, sometimes through insurance or anything.
Speaker 2:Yeah, same thing yeah.
Speaker 1:Yeah.
Speaker 2:I mean, honestly, to get it straight from the manufacturer is going to be your best bet. I mean you just you know I love a compounding pharmacy. I mean they're wonderful and they fill a huge need, but sometimes you just don't know exactly what you're getting.
Speaker 1:Well, yeah, I mean because there's bad apples in every batch right, and so, unfortunately, as the saying goes, one rotten apple spoils the entire batch and so, unfortunately, there is, you know, some negative thoughts around compounding because there have been some bad ones in the mix.
Speaker 1:But I think you know the take home here is really that you know the shortage is resolved and so you know where you were comfortably compounding under that guidance, that there was a shortage that no longer exists. So you know, to our compounding pharmacy listeners, I think it's just important to really make sure that you're watching any sort of future updates. And you know one thing too is if you're going to cease production which you know, we would advise so that you're not getting under suspicion or under the watchful eye of the FDA. So, but you know, prepare your patients for those transitions, like you said. Like what are the options now? Switch them back to the manufacturer company, work with them and their PCPs to get prior authorizations if needed, so that we can get them covered by insurance, or work with them directly with the manufacturer, like I said. So I think that's another role that we have to step up in as pharmacists is making sure that our patients still have access to the medication and not just saying, well, can't do it anymore, so yeah.
Speaker 2:I think that's good advice.
Speaker 1:Yeah, that's great. Okay, well, was there anything else in that topic that you wanted to talk about?
Speaker 2:No, I think that about covered it.
Speaker 1:Okay, sums it up Okay, great. So let's move on kind of a great segue to the next topic, which is talking about drug shortages. So obviously, if you have been in pharmacy for the last several years, you know that there has been a lot of shortages and quite a large number, especially affecting different practice sites. So sometimes it's affecting more community pharmacies, sometimes it's affecting more of the health system based in patient pharmacies. But there has been a lot of active drug shortages. The FDA continues to report and monitor those and they're working with manufacturers and stakeholders to mitigate supply disruptions. So let's just kind of delve into the whole world of drug shortages for a few minutes, yeah so it turns out, making drugs is really hard, yeah, and complicated.
Speaker 2:You know it doesn't just show up in a bottle and there's lots of things to think about. You know, the excipients that go into drugs, the containers that hold IV fluids, the closure systems, the connection systems, all of these go into a finished drug product systems. All of these go into a finished drug product. And you know manufacturers run these manufacturing lines very tightly for cost, for cost control, and so, like one thing goes wrong, your line goes down and suddenly you can have a shortage. So that that, I think, plays a huge role in some of the more sort of the ramp up of shortages, as you've seen over time some of the more sort of the ramp up of shortages, as you've seen over time.
Speaker 2:Another thing that you might not think of weather events.
Speaker 1:I was going to say catastrophic events, yeah, like.
Speaker 2:Hurricane Maria. When it came through it took out some peritoneal dialysis facilities and that was. You know there was so much effort went into the drug manufacturer and the FDA to try to again maintain supply of drug. You know you can't have patients not going having their peritoneal dialysis solution. So it is a drug shortage. It gets a lot of attention from the FDA and I am pleased to say that the FDA team that deals with drug shortages is largely pharmacists. They lead and are reviewers on the drug shortage team. They're a great, great group and they work very closely with drug manufacturers, pharmacists you know the reporters, the people that make the drug to try to anticipate and plan for shortages that can be sort of predicted. And you know, if they are alerted to a certain shortage that could come down the line, they work with the clinical review divisions and multidisciplinary teams at FDA to figure out are there alternatives.
Speaker 1:You know can we have?
Speaker 2:alternate sources? Can we use regulatory discretion in order to sort of bolster supply while we sort of take care of the underlying issue that's leading to the shortage? The shortage database. There's an FDA shortage database. That is fantastic. I'm sure pharmacists that you know are out there practicing are probably familiar with it. It's very up to date with sort of what is in, what is in shortage and I they count a lot on pharmacists to alert them to problems in the field. They, I consider pharmacists sort of the cornerstone of monitoring and handling this, for you know, retail pharmacists, hospital pharmacies, infusion pharmacies you know they're the ones really who have their hands on these drugs and know how hard it might be to get them.
Speaker 2:So this is something. This is a place where pharmacists have a huge role, and the FDA. Really, you know, their main goal in this is to at least predict and try to you know, risk, mitigate shortages as much as they can.
Speaker 1:Yeah, that's great. One quick question I have on this is you know, another role that I think about pharmacists having in this space not only just being you know the initial signalers of looks like there's, you know there's a problem, there's a shortage, we can't get it, and you know then that leads to further watchful eyes and guidance and whatnot. But another role that I think pharmacists have in this space is, when there is an active shortage, making recommendations for what to use instead, or you know what's the closest alternative, or what are we going to do in this case? And just like with, you know, tenaglutide and trusepidide, and determining that some compounding could be done or whatever. But is there in the list that you're referring to that FDA maintains?
Speaker 2:does it also give alternative options, or does it stray away from giving that kind of guidance. Not on their public-facing website, no. But as soon as they are alerted to a shortage, they work with the clinical review division. For example, if there was a shortage of ACE inhibitors or of an ACE inhibitor, they would come to me because I'm, you know, part of the cardiology division, and they would work. They would say what else could be used. You know, how? Does you know? Is the labeling different for these things? So it's on the from an internal process, from the FDA. They definitely are looking at alternatives and medical necessity and and but not. But they wouldn't specifically recommend alternatives on that website.
Speaker 1:They wouldn't specifically recommend alternatives on that website, sure, okay. So I think take home from this is to stay up to date with you know, reviewing that list that the FDA maintains, alert them if you see something or expect you know, start seeing something go into a shortage mode. And then also, like I said, I think it's just we are the medication experts as pharmacists, so it is our role in general, regardless of your practice site. I mean, you think of mostly, you think of community pharmacy, with dispensing it directly to the patient and having to worry about the shortage and figuring out what the alternative is. But just as much so an inpatient. When you have a patient who needs XYZ and you can't get it, you know what's the next best thing. So I think that's a really big space that pharmacists should really step up and making sure that they're researching and determining what the alternative should be and being ready for when that shortage is you know, full blown.
Speaker 2:Yeah, I agree completely, yep.
Speaker 1:Yep, okay. Well, let's move on to our next topic then. This one is one that I think is just a hot topic in general in the country, spanning all professions yeah, everything, period, it's not just pharmacy. But we're going to talk a little bit about artificial intelligence and pharmacy and drug regulation. So, just to kind of set the stage, the FDA released a draft guidance outlining the use of AI or artificial intelligence and machine learning, and the development, regulation and surveillance of medical products. So if we want to talk just a little bit about AI and how it's affecting something, Just like everyone is learning to use AI, so is the FDA.
Speaker 1:Sure sure.
Speaker 2:I recently read that there are over a thousand AI-enabled medical devices that have been cleared by the Center for Devices, and so it's definitely in practice, and so I think that in the device world is where you see a lot of of regulation being considered although it certainly has application for drug development and also, I think, in the drug safety world, has a lot of potential use there. I think what you'll see, and there are a few guidances that the FDA has released on AI, but I think when you look at them you'll see that the FDA is really very much in the infancy of trying to figure out how to regulate AI.
Speaker 2:And so I think what they're focusing on is to make sure that the AI is, you know, fit for the context that it's, you know, meant to sort of produce an effect, that the evidence that the AI is generating is reliable and traceable, and that, you know, the training or protocols around the AI are well-documented and can be sort of audited, and just to make sure that everything's sort of documented and reliable. I think the latest from the FDA does ask for a lot of feedback on AI because, you know, fda is sort of a small number of people.
Speaker 2:They don't know everything that's happening in the AI world, and so I think they have solicited, you know, feedback on AI in all you know any kind of aspect of drug development, so that they can, you know, figure out how to regulate it appropriately and you know not to burden, not with too much burden, but to protect patient safety, to protect good regulatory decision-making, to protect good evidence generation.
Speaker 1:Yeah, yeah, and I think you know, I think you said it several times, but I think the key there is reliable. Just, you know, in general, we know that you can't just take what AI generates as the gospel. You have to be sure that you are double checking. And you know, if you know, now, with creation of education, the space that I'm in, you know, we disclose if AI was used in any form, if it was used to summarize content or to create a case-based study or something like that, and so I think that is also, I'm sure, kind of where the FDA is currently just kind of trying to step and figure out, like how do we, how do we control it, make sure it's reliable, disclose it, you know, whatever.
Speaker 2:So make sure it's real, make sure somebody is overseeing you, know what's going on and is accountable for it. Yes, yeah exactly.
Speaker 1:Yeah, Okay, Great information there. I think you know we are all heading into probably the next decade where AI will just explode and we all need to just kind of hold on because I don't think we can predict anything in that space right now.
Speaker 2:See how it gets applied, I think it's definitely an efficiency boost and so it has great potential.
Speaker 1:but you just you know, as a regulator, you want to make sure it's all on the up and up and you know the results that are factual, yeah.
Speaker 1:Makes sense. Yep, okay. So let's move on to topic number four, and this one, I think, is something that we've heard about for a long time. Four, and this one, I think, is something that we've heard about for a long time, and I've heard about it ever since I was a kid, because my sister was super sensitive to it and it would make her bounce off the wall. So we weren't, she wasn't allowed to have any kind of red dye number three. But, yeah, so we're moving to talking about a ban on red dye number three. So the FDA has finalized its decision to revoke the use of FD&C red number three in food and ingested drugs due to longstanding carcinogenicity concerns. So, yeah, let's talk about that one.
Speaker 2:Yeah, this was an interesting topic. So, red dye number three has been banned for a long time and topical in cosmetic products. But this, as you said, this new ban is really it's for drugs and ingestibles and is based on it was prompted by a petition that was submitted to the FDA in 2022 that sort of asked FDA to reconsider the data and also the inconsistency between not allowing it in topicals and cosmetics but yet still allowing it in drugs and ingestibles, and so you know, the basis of concern is from animals, it's and it's. You know, it's a signal, a safety signal for a tumor, but it's not a very straight, it's not necessarily something that's been seen in humans. So, just to describe sort of the levels of evidence that you're dealing with here, you know I'm not sure that it's a complete slam dunk, that it causes cancer, but you know, I think that the FDA probably realized that they are extremely inconsistent with, you know, sort of regulating this in different ways in the topical and ingestible space, so they have decided to ban it.
Speaker 2:You will note that they have the ban is not immediate, they're sort of phasing it in over time and that sort of goes back to the drug shortage topic because, as you might imagine, a manufacturer probably has barrels and warehouses at red dot number three that they've already bought and you know extracting it right now from all drugs would certainly lead to some drug shortages.
Speaker 2:So I mean it was you know, that's why you see sort of these phased in approaches. I think that the dye space in general is also shifting sands because the new administration has made some statements about their concerns about synthetic dyes, and so I think this is one area to sort of like pay attention to, because I think things are evolving. Sure, from a pharmacist point of view, I think you know looking at, you know counseling your patients that drugs may look different, you know suspensions may look different, is probably something that they would want to convey to their patients I think that they're very, very used to doing that, you know for just for different generics and and sort of allaying patients anxiety about that. But yeah, I think that's, I think you, and I think you will probably see more die action over the coming years based on my read of the administration's communications.
Speaker 1:Interesting. Okay, and just to clarify the current date I think the final date is January 18th of 2028, I think is the the final phase, like you said. So like you mentioned a couple years really to kind of get those out. And that makes sense because, like you said, they either have back stock I mean, think about, just in general, your otc shelves you have back stock of products. So if you had to like immediately go pull them and you know nothing was to replace them, there'd be shortages. So and I think it'd be interesting for me I'm not asking you this because I didn't prep you for this and I'm sure there's no quick answer but I just I wonder how many products actually are affected by this. Like, I can think of a few that are very red and histamine in general. You know that probably certainly still uses that, but also has a dye-free product as well. But yeah, I just I also just wonder how many it's actually showing up in.
Speaker 2:Yeah, you know I, you know there are whole departments in all of pharmaceutical industries that are that are charged with sort of predicting these sorts of things. And so you know I, I would imagine probably some have already made the switch, anticipating that this would come about. And you're right, I mean, it's not everybody's going to have had that sort of foresight, so yeah, yeah. Just see how it comes about yeah.
Speaker 1:Yeah, it'd be interesting to see how it plays out. So, again, on that one, stay tuned, be sure that you're keeping up to date as pharmacist, you're keeping up to date as pharmacists and, again, one of the key things is to relay the message to patients, to the public, and make sure that if there is a shortage that comes out of this, that you're ready with an alternative to recommend for whatever their needs are. Okay, and our last topic, mary Ross, is on FDA safety warnings in general. So the FDA has added a new safety warning about severe itching following the abrupt discontinuation of long-term cetirizine or levocetirizine, with updates to both OTC and prescription labeling. So that's kind of the one that we're focusing on. But I'd love, just from my general knowledge, to learn about FDA safety warnings in general and like how often do these come out and what should we do about them when we hear them as pharmacists, and so forth?
Speaker 2:Sure, yeah, this is, this was sort of my bread and butter when I worked at the FDA. It really is a clinical issue. So this and it reflects sort of responsibilities that both the pharmaceutical manufacturer and the FDA have. We they have. They perform pharmacovigilance, so they collect reports of adverse events that happen to people sort of out using drugs in the wild and monitor for things that sort of pop up and show some sort of plausibility or reported with at a high rate of, you know, sort of out of the realm of normal reporting and based on that, fda and manufacturers work up these safety signals and try to determine whether the drug causes these adverse events and if they do, the FDA reviews it and they will make changes to the drug labeling. That's really the primary way that safety information is conveyed to the prescribers and to patients, and so those kinds of safety labeling changes happen all the time.
Speaker 2:But you don't, because you know you don't know everything. When a drug gets approved, you know a larger patient population needs to use it to sort of bring these things, bubble these things up to the surface. To the surface, you know, it's just part of the natural life cycle of a drug. Um, so to say, the label. Changes happen a lot, whether the pa, whether the fda, actually makes a statement about it. So, like this was, I think this was a drug safety communication of some sort. Um has a lot to do with the seriousness of the average event, so if it's like death or death or causing hospitalization or organ dysfunction, that's going to lean more towards perhaps conveying something to the public in a communication. I think in this case it was.
Speaker 2:You know, there's so many people that take this drug that you know they probably felt some you know, some you know obligation to get the news out there. For this particular safety issue, the itching with the cetirizine, it seems very rare because this was based on sort of small number of cases that were reported into the FAERS database. But you know it has biological plausibility and the reviewers you know, after looking at the cases and sort of you know other data, probably realized that it probably it was likely caused by the drug.
Speaker 2:And so they, you know they're, I think. I think the warning said that they were in the process of updating labels for these.
Speaker 1:Sure.
Speaker 2:But in the meantime was sort of saying to prescribers and patients hey, this might occur, be on the lookout. And they get offered a risk mitigation, which was to try to, you know, to taper it over time perhaps that might reduce the chances of that happening.
Speaker 1:Right, as opposed to an abrupt stop. So, yeah, yeah, so it's interesting that I enjoyed hearing that when they make an actual announcement, it's usually, you know, because of something bigger and, in this case, more than likely because of the use of this by a large number of people, but, you know, typically because it has a severe outcome that they're worried about. So, yeah, so it's interesting because, like you said, there's probably hundreds of these happening all the time. It just doesn't always necessarily come to light with a big announcement. So, yeah, okay, okay. That's all that I had on my list.
Speaker 1:Anything else that you wanted to add from your years of experience with the FDA or any other perspectives or anything I thought this was a great slate of topics to bring forward Good nice varied, varied number of topics. Yeah.
Speaker 2:It was good and I think we hit on some good information for pharmacists to sort of absorb and understand how some of these decisions and guidances and announcements by FDA have impact on their yeah and how they're, how they're determined, how they're made.
Speaker 1:You know the process behind it. You know is interesting to me to kind of pull back the curtain a little bit and see how the FDA is working and then understand better, you know, when they're making an announcement or relaying this information. So, okay, well, as I always like to do with my guest, mary Ross, I like to kind of summarize everything up. So some great take-home points from all of this. I think the biggest take-home points that I have from it is just, it continues to reiterate the fact that pharmacists are the medication experts and we need to be the ones that are on the front line making the decisions about alternatives. If there's a drug shortage or if there is a perceived issue with a medication or you know a terrible side effect or whatnot, we are the, we're the experts. We should be determining.
Speaker 1:You know, does this apply to my patients? If so, what are the changes, what are the alternatives, what options do I have? So I think it's important that we're paying attention and we're listening and that we're also ready to take action and using our knowledge to make some informed decisions. The other one, I think, would be hold on to your britches for AI, because it's not going anywhere and it's only going to get probably a bumpier ride before it gets smooth. But I think again, I am hopeful and love utilizing AI and just also love hearing about all the different ways in which it's going to impact pharmacy. So I'm most excited to kind of hear the future of all of that. So what would you say is our game changer here, mary Ross? What's the big take-home point you'd like to make sure the learners take away from today?
Speaker 2:I think the FDA touches so many things you know, devices, foods, drugs, and it's really difficult for even for somebody who worked there for 20 years to keep up with all of these initiatives. But pharmacists are the first line. They're the ones that the patients usually talk to first, even perhaps before their doctor, and so I would just encourage pharmacists to maybe not, you know, subscribe to everything from the FDA, but just know that it's a good resource for questions when their patients come in. There's so much information on websites for the FDA, but just know that it's a good resource for questions when their patients come in. There's so much information on websites for the FDA and, you know, pharmacists are the frontline, and so they should be aware that they should, you know, can use it as a resource sort of definitive resource.
Speaker 1:That's great Prepared and be aware that it exists and also take the initiative to. You know, sign up for a couple of newsletters. I know we don't love our inboxes being flooded with things, but yeah, you know, sign up for a couple of newsletters. That, I think, would keep you in the loop and that's a great first step.
Speaker 2:Particularly the safety. You know, the safety, the label changes and the safety label changes, I think, are the ones probably I would prioritize if I was a pharmacist, really, because those are things that sometimes get publicized. Patients, you know, hear about it and they don't, you know, and pharmacists can help put context around sort of what's being, what's being warned about, and help you know, help them, help them figure it out for their own lives. How are they going to manage this?
Speaker 1:Right.
Speaker 2:Does it really apply to you or did?
Speaker 1:you just you heard something and you worried or whatever. So, yeah, that's great, great feedback. So you heard it straight from the source Try to get a newsletter update on the safety outcomes. So yeah, that's great. Well, mary Ross, thank you so much again for giving us your time. This was great. I loved kind of digging into these topics with you and it was just really enjoyable. So, thank you so much.
Speaker 2:Thanks for having me and it's a pleasure to be able to provide some of the information behind the curtain about FDA.
Speaker 1:Yeah, thank you so much. If you're a CE plan subscriber, be sure to claim your CE credit for this episode of Game Changers by logging in at ceimpactcom and, as always, always have a great week and keep learning. I can't wait to dig into another game changing topic with you next week.