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IVPN Voice
He is Crashing: Disease, Drug, or Both?
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When a patient starts crashing in the ICU, the first question isn't always the easiest one: is this the disease, the drug, or both?
That question sits right at the intersection of critical care and pharmacovigilance, and it's exactly where our two IVPN communities meet.
In this joint episode of the IVPN Voice Podcast, "He is Crashing: Disease, Drug, or Both?", we bring together four perspectives from four countries:
Cohosts
Ruth Alex, PharmD — Clinical Preceptor, Gulf Medical University
Ahmed Hegazy, MD, MBBCh, MSc. PharMed— Managing Director, PVigilant Health | Senior PV Auditor
Guests
Dr. Toufic Chaaban — Clinical Assistant Professor & Program Director, Internal Medicine Residency, LAU
Aly Elzafrany — Lead Critical Care Pharmacist, Lewisham and Greenwich NHS Trust
Bedside decisions, causality assessment, and the grey zone in between — from the people who work in it every day.
Follow IVPN Critical Care and IVPN Pharmacovigilance for more.
#IVPN #Pharmacovigilance #CriticalCare #ClinicalPharmacy #PatientSafety #DrugSafety #ICU
Hello everyone and welcome to today's podcast titled He's Crashing Disease, Drug, or Both? I'm Ruth Alex representing the IVPN Critical Care Listserv, and I'll be co-hosting today's discussion alongside my colleague, Dr. Ahmed Hagazi from the IVPN Pharmacovigilance Listserv. Together, we'll explore a key challenge in critical care. When a patient suddenly worsens, how do we tell whether it's disease progression, medication-related harm, or both? Joining us today are two experts from the ICU frontline, offering complementary perspectives on this issue. Our first guest is Dr. Tofiq Shaban. He completed his medical degree at the Lebanese University School of Medicine, followed by internal medicine residency and pulmonary and critical care fellowships. He then pursued neurocritical care fellowship training at Ohio State University, Wexner Medical Center. He currently serves as clinical assistant professor at the Lebanese American University and program director for internal medicine residency. His work focuses on critical care, medical education, and interprofessional practice. We are also joined by Mr. Ali El Faronzi, lead critical care pharmacist and independent prescriber based in London. He holds an M farm from the University of Nottingham, completed his Master of Science at the University of Sunderland, and is currently undertaking a PG certification in the advanced critical care practice at UCL. His main interests include pharmacovigilance and the application of artificial intelligence to medication safety in critical care. Thank you both for being with us. And without further ado, I'll hand over to Dr. Hagazi to begin our discussion.
SPEAKER_00Thank you so much, Dr. Ruth. And it was really my pleasure to be with you and with Dr. Ali and with Dr. Tofik. And I would like to thank the IPPN, the team, led by my dearest colleague Kallien, and the rest of the team, which is something really amazing to have such a podcast focusing on really interesting topics, which is the effect of diseases and drugs on the patients, especially in the setting of intensive care. I remember from my search in publications and literature I found some interesting numbers. I found that a range between five to ten percent of acute hospital admissions are attributable to adverse drug reactions. And surprisingly, a range that varies from forty up to seventy percent of these admissions may be preventable. So paying attention early enough to any uh disease progression that might be treatment-related, harm or risk, or of course both, I believe this is something very important to pay attention uh to. And uh uh I would like to ask uh Dr. Tofiq my first question. When a critically ill patient you can see suddenly deteriorates. So from your experience and instinct, what is the first that will come to your mind? Could be a disease progression, might be due to medication or treatment related, or both. Please hello.
SPEAKER_01Uh first uh I would like to thank you for having me on this podcast. It's a real pleasure to be with you, and I would like to thank the IVPN uh network for food. Uh it's it's an interesting question. I think, like uh to be honest, the first thing that comes to mind usually is the disease that the patient was admitted with. But with you know, with experience and with uh multiple uh encounters, you start figuring out that you have to have a broader mind. So now uh I approach the uh the situation and I teach the residents to approach the situation first from with an open mind and also with uh a real like uh uh real dissection of what's happening. Does it make sense to be attributable to the disease? Are there other factors to be considered? And one of the major factors, as you said, is probably uh medication side effects. Uh and especially that to tell you the truth, sometimes the admission diagnosis is already uh uh like questionable. And sometimes the patient is admitted with what looks like uh, let's say an infection, and it ends up being something else that can be also drug related. And I believe the longer the patient stays in our ICU, the more we should think about uh really drug interactions, drug-related adverse events, uh uh, especially when they are not like really admitted yesterday or the day before. Uh, so this is something to be always kept in mind, I believe.
SPEAKER_00Yeah, yeah, that's really very uh very interesting, I believe, especially with the patients who are maybe polymedicated, elderly, that you anticipate uh they are quite vulnerable, yeah, to treatment harm. Yeah. So do you recall um maybe I I'll try to touch the feeling now. Maybe recall a moment uh when you realize no, this is not the disease or the illness anymore. This is the treatment. Uh remember anything.
SPEAKER_01I think like multiple times. But uh I guess like one one one really case that uh that was uh uh challenging a little bit. An Alzheimer patient was admitted to say prosthetic joint infection and who's um uh you know cephapim. Uh and we know that cefapim might be a culprit of cephalopathy, but it's it was just like his Alzheimer's probably is having delirium, it's because of the infection, but then all the markers of infection are improving, but the level of consciousness really worsening. First, you said it's probably delirium, uh uh, you know, and then we started the workup, and uh and then we we we did think about uh cefapim and cephalopathia. It took us a little bit of time to think about it uh because you think you know of the confounding of the patient's status. And uh like later we you know we did the EEG, we we we we changed the antibiotic and everything was okay. But I think like this is one of uh the common uh uh medication-related side effects that we face in our ICUs is the cefapinum and cephalopathy.
SPEAKER_00That's very interesting. You know, you reminded me of uh patient who was a very close family member. He was admitted in ICU, he got delirium, sometimes you call it ICU psychosis or whatever. Yes. And he started to be very agitated, and it was very difficult, and started to give him some medications. While we found that uh during the stay and some other medications, he got also, I think, uh acute kidney injury, and the urea is becoming high. And when they readjusted the medication, he started to be better. However, it took even time after he left the hostel to stay at home until he recovered completely, which is something really takes us to different ICU situations that um there are many, like what we mentioned now, even the patient who already have a kidney or inal failure, uh polymedicated, uh taking seditions. Uh I don't know. Uh sometimes maybe the night shift. Uh there are some uh critical scale situations, uh, and uh I would like answer from both of you, Dr. Tofik and Dr. Ali, about this. Uh, when you feel especially a high risk or error delayed uh the detection of the harm. So maybe Dr. Tofik, you can start, and I believe Dr. Ali has something good to add as well.
SPEAKER_01Yeah, uh sure. You know, there are vulnerable, I would call it high-risk clients and vulnerable uh patients. Uh like the patients who already have impaired metabolism because of kidney dysfunction and uh liver dysfunction, uh, will be at much higher risk, I believe. And especially if they have you know multiple problems with, as you said, the uh all the medications and everything. And there is there are the uh the vulnerable uh times where uh like I think the times where the the units, as you said, are understaffed, uh and the intershift uh you know the handover when uh like the team is changing, be it the nursing team or the uh physician's uh team, uh, or let's say weekends, holidays where you know things might be more prone to go wrong, especially if the clinical pharmacist is not uh uh available. So I I believe those are like the things I I I uh I find the most uh at risk. Okay, that's very interesting. Ali can uh can definitely give his perspective.
SPEAKER_00Yeah, Dr. Ali, please.
SPEAKER_03Well, firstly, uh thank you so much for inviting me here. It is such a pleasure to be amongst a panel of experts, really. Um and um and yes, uh when it comes to um situations um which it might happen, there's obviously loads of them. I think in critical care, you're really working with a um a very high complexity. Um, and oftentimes you're also not working with the most complete amount of information that you can get. Um and to add on top, there is a a need for an immediate decision making to happen because at the end of the day, there's a patient's life that is at risk. Um, and I think really that then puts people towards having some biases to uh to when it comes to decision making, such as having an anchor bias, um, which is to um just take a decision upon the first information that is available. And to add on top, um, sometimes you will have you will have made a correct decision, but that correct decision was correct two days ago. And obviously, due to alterations in physiology and pK PD characteristics, your patient's renal function has changed, um, your patient isn't what they were six hours ago. Um that decision was is now need or now needs to be revised. And I think um having this constant reflection and constant uh um sort of reviews of of um patients uh is a must within the intensive care. Um now obviously during times when there is uh uh as as Dr. Tafi had said, um night um night staff, for example, which uh you're you're operating on skeleton staff, uh holidays, aides, um that then becomes a uh uh um sort of a point where errors can definitely be made.
SPEAKER_00Okay, talking really about the night shift uh took me back to my young age. By the way, I love night shift. Uh I am the one who loves to stay so late. So maybe you need to ask the people are you an early bird or night owl? Uh and I believe in critical care, uh time is critical. Probably you say it critical because of the time is very critical. And I know that all physicians and pharmacists and nurses are so busy in the uh ICU settings, but talking about um something like uh reporting, to report a medication, error, adverse event, any risk that coming from medications. So uh I know it's um usually the part of the management is you manage the patient to uh ensure that the patient in uh in in a good shape improved and all vital signs and so are uh improved. But uh to report, which is something very important, uh is it really difficult for you in ICU practice? Um I don't know. Is it a time pressure? Is it um uh maybe someone say no it's not my part, uh maybe someone else. Uh so what do you think about reporting of side effects or adverse events? Um maybe ask Dr. you can start.
SPEAKER_03Yeah. Um I think it is very hard to um to say that uh uh um the way that the patient has deteriorated is certainly as a result of a drug. I think it is very hard to be definite about it, and I think that certainly adds up to how complex this is. Um the other element is um reporting in general is sometimes within certain teams is looked as as um as if you're blaming uh uh um someone for something. Um and instead of it being more of a learning practice, and this is what we need to do next time. Um and I think that adds again to the idea that um um or how difficult it is to consistently um report um medication um side effects, medication errors as well. Um the the but I really do think that the the the main reason why um um sometimes we don't really pick them up is as a result of just how much data there is to when you are really looking at the bed side. Um and I think Dr. Tafi really will will agree with that. It's just the there is there's monitors of of of blood pressures and uh and uh there's urine outputs that you have to take in, and then your patient's bowel function and bowel habits, uh, and how much aspirates from their Ng that there is. Um there's just and and then how much what's the neurological status of your patient? Um all of this is is incredibly difficult for uh for to be sort of intaking all at once without having sort of a correct system for it. Um so uh all of this combined um really lead to to uh to the to this difficulty of of uh being vigilant when it comes to uh to medication. What do you think, Tofi?
SPEAKER_01Yeah, yeah, I 100% agree. I think there is as you said, the the the time constraints parts, the the the really noise of the data that we have, uh and uh definitely the uh culture. And also in the culture, I would add something. It's not only about like the blaming culture and uh and uh fear of reporting or fear of like the consequences of reporting. But also sometimes people don't see the value of reporting. Like what happens after the report? It's important to be shown to all those who are working in the ICU how this report will lead to a better patient safety and a better patient care later on. Will it lead to a process change? Will it lead to uh uh a like uh how you know is it is it is reporting going to prevent this error from happening again or not? So I think this is something that we can work on if we want to change the culture, is to really show the value of uh of reporting, maybe.
SPEAKER_00Yes, I I really understand Dr. Tofi and Dr. Harry, is we have an issue of number one the level of awareness of the value of reporting. Uh because sometimes we say, yeah, is it just one report will count? And actually it is. And uh uh one of the uh points related to the culture, and I have some previous experience with this blaming culture that happened in a couple of countries that I worked for before, that people are afraid from any blaming or it's uh their fault, while it's mentioned in the leaflet the adverse event, and there is nothing to blame the doctor, of course, but again it is the culture. Uh the time, the time constraints is really a big issue, it's everywhere, I understand. But when we understand the value of reporting and train the doctors, the nurses, the assistants who can really help, I believe this will improve our reporting. Especially in the companies, in ministries of health or any health authorities, there are people who are doing some sort of what is called a causality assessment. Because even if the drug is not definite the cause of the problem, sometimes we call it it's a probable, it's a possible, uh, it's unlikely, or sometimes after the causality assessment we'll say it's not related. Based on this data, the expert and the statistician they analyze, and at the end they reach a level of risk association with the drug and then decision they they took it uh after that. Which uh maybe I say uh at a hostile setting, uh our goal, of course, is to take care of the patient and just report uh what we have, and then some other experts will manage this, but we need to really highlight and raise the awareness of the value of uh of reporting, which is something really critical in critical care setting as well.
SPEAKER_01So and uh I I I think I believe, as you said, that uh the the data might be used as a signal for more investigations uh by the authorities rather than as a final uh causality. Yeah, I agree.
SPEAKER_00Yes, yes, especially if in my hostel I have one case, maybe someone else in the same country, another case, while uh uh a doctor in Chile or in Canada or in South Africa. So that's why there is a global database that they have around 36 million adverse events uh affiliated to WHO in in uh Upsella city in Sweden, that they analyze everything there. Uh and from this, as you uh mentioned, Dr. Toafi, uh they check for the signals and see if it is a real risk or uh is not, or maybe in the future we don't have enough data yet.
SPEAKER_03I think as well to add to this, is the the in the UK, for example, here there is a um there's a yellow card scheme, which is essentially a uh sort of a central database that uh keeps reports of how common did uh a certain effect or an adverse effect uh was reported. Uh now this could be uh reported by patients, could be reported by pharmacists, can be reported by all healthcare professionals in general. And then the data becomes accessible for um everyone in terms of uh healthcare professionals to be looking uh at these reports. Uh it tells you um sort of what the common themes are, um, and then it uh the data is then used to add to the um summary of the product characteristics later on. Um so um I thought I thought that's a really good example of um of sort of how reporting can be um quite beneficial, actually.
SPEAKER_00Yes, totally agree, Dr. Ali. And the EluCard started in 1960, something which is quite old, and which is something really useful and helped a lot in discovering signals and risks and taking global actions. So I would like to hand over to my dearest colleague, Dr. Luth. So may I I'm sure that you have some number of very good questions to ask Dr. Tofik and Dr. Ali. Dr. Luth.
SPEAKER_02Thank you, Dr. Ahmed. Wow, I've just been so impressed, just listening, just trying to absorb how much ever I can and just to apply this to my practice. And I think this is very special that we have both an intensivist. And a clinical pharmacist. And I feel like everybody always talks about interdisciplinary work and interdisciplinary education and multidisciplinary practice. So, how important is interdisciplinary input in detecting harm of medications? Perhaps we can start with Dr. Tofiq.
SPEAKER_01I mean, it's I think it's clear now that it's essential to have the multidisciplinary input from everyone. First, from the physician, I think will notice a change in the status of the patient that is not expected or not within the norm of what the disease should look like, and would like to investigate for what's happening. The clinical pharmacist will have the expertise to try to, you know, figure out or identify a drug reaction, identify a drug interaction, or maybe suggest at least that it might be the drugs that are caused. Sometimes it's the bedside nurse who identifies the physiological changes that are happening, let's say an allergy to anomaliation or any deterioration in the patient's status. I believe it's now the standard of care to have this interdisciplinary uh care of the patients. And part of it is to really try to identify adverse drug reactions and prevent further harm from uh adverse drug reactions.
SPEAKER_02Um Dr. Ellie, what about you? What about practice in London?
SPEAKER_03There is a uh there's a really good saying here that says uh teamwork makes the dream work. And uh I think that is super true. When you have, as I said, when you have this an incredible amount of data that is coming at yourself, um, there is not a single person that is able to intake all of that. But even if they could intake all of this data, it is how you're going to apply it. Um and the reason why um the MDT is incredibly important is due to the uh difference in skill sets that you have within your team. So, yeah, so obviously your physicians, they're really good diagnosticians, um, they deal with the risk benefit, they deal with um with uh disease progression, they understand the physiology, they understand the the progression of disease in general. Your pharmacists they are incredible at um knowing how the drug works, how the drug is eliminated, how the drug uh could um function or could also be the cause for a certain adverse effect that could be happening. And as Dr. Tafi said, um the nurses, there they are the they are the people that actually tell you all about your patient. Um when the nurse comes through and says, I think this patient isn't what they were previously, that is usually a warning sign that should be taken um seriously, should be taken for um um at face value and um certainly be acted upon. Um and it's this combination of um of skill sets, but not just not just nurses, not just pharmacists, not just uh uh doctors, we also got your dietitians, your physiotherapists, um the the entire team is is all working for uh uh for your patients. So um it's important to really to listen to them, to um understand their concerns and act upon them.
SPEAKER_02Thank you, thank you, Dr. Ali. Yes, Dr. Dunfeek.
SPEAKER_01Yeah, yeah, I agree uh with Dr. Ali. I also to add something, it's especially important in a critical setting where really the patient's status is very tenuous, they are very sensitive, and they have totally different physiology than what we used to in like clinical trial on drugs uh in regular patients or ward patients. These are patients who have uh like really different pharmacokinetics, they might have like decreased kidney function or the opposite augmented renal creance. They might be uh they they are at higher risk of polypharmacy and they are at higher uh risk of deterioration. So I think this is where multidisciplinary input is even more crucial and essential.
SPEAKER_02Dr. Tafiq, I think this really shows us that you know respect is really important. And as I'm listening to you, I understand more how um of an important role these different healthcare professionals play together. Uh, moving on to a bit more of an interesting topic or an innovative topic, uh, we see a lot nowadays about proactive detection, um clinical decision support alerts, even AI in critical care medicine. So, Dr. Ellie, I see that you have an interest in AI. What can you tell us about the role of AI or different support systems in ICU practice?
SPEAKER_03I think that um certainly um AI has an enormous uh potential. Um I think that it'll only have enormous potential, but only if they are implemented intelligently within your systems. Um obviously um talking currently about systems being developed that have automated alerts for AKI, um, automated alerts for drug interactions or QT prolongation, um, and they can detect these problems at much earlier rates than what humans can do generally. Um but the technology itself also has some of its limitations. Um and one of the main ones that we really do see is alert fatigue with clinicians in general, when you get multiple alerts. Um, and this is where the electronic prescribing systems um have have their faults, where um multiple alerts come up and you um you find your clinicians and pharmacists alongside them as well, um, sort of brushing through them. Um so the the goal certainly shouldn't be the fact that you're creating more of these alerts. It should be that this is where the AI component comes in. There should be better alerts um that are uh clinically meaningful, uh they that are clinically prioritized and that they are clinically integrated to your workflow. So um ultimately I do think that um AI has this potential. Um it certainly um could enhance the clinical judgment, but should but will never be able to replace it, I think, in my opinion. Um so um currently, for example, we um there are lots of different uh um AI projects happening here, for example, at Imperial, uh where um they're developing uh an AI clinician. Um there are some systems that are being developed for uh delirium detection um within intensive care as well. Um so yeah, I think I think they do have this potential. I think they can only be done so if we are safely and and intelligently implementing them.
SPEAKER_02Um thank you, Dr. Ali. I think something interesting, both Dr. Ali and Dr. Tofiq, you've dipped your foot into academia. I think students love to use AI nowadays. So you can see students on ChatGPT, on Claude, on um all the new AI that even I don't know. And you see them sometimes even trying to um solve patient cases or come up with medication-related problems using AI. What is your point of view on this practice?
SPEAKER_03I think there's a there's a really nice term that I've recently been introduced to called cognitive surrender, and I think this is this is a uh a real risk that is happening. Um the main my or actually my main worry out of this is that we are teaching a generation of doctors, pharmacists, nurses um to um submit their critical thinking and submit their logical processes and submit their teachings to a uh uh sort of a program that is not yet authenticated within our healthcare system. That there are and to add on top of that, I think there is a real governance gap um within using of these, uh within using of these systems within uh hospitals. So obviously, yes, we did we did talk about the fact that they have their potential, but we also need to make sure that they are implemented safely. So um if we are from the the current students that we have within our universities, if they are currently using all these systems, then it will be incredibly hard for them to be to not be using it at the point when they are graduating and they are in front of a real patient. Um another result, I think what we need to do is we need to certainly devise a methodology for um for how, rather than restricting the use, for how to use it safely, for how to use it in the correct manner, uh, for which system to use, uh, for when to use it as well, um, in order for us to come at the safe point. But on top of all of this, we really need to be teaching critical thinking. I think this is an incredible part of intensive care that I'm I'm sure Dr. Tafi as well will will agree.
SPEAKER_01Yeah. Yeah, I uh I agree 100%. I think like uh teaching uh clinical reasoning and clinical think critical thinking is very important, and you can use even AI to teach uh actually clinical reasoning and critical thinking. And I believe like the the the mindset in education should shift, as you said, from not from you know it's not how to prevent them from using AI, it's how to teach them how to use AI uh as much as you can because you know it's it's an ever-evolving field, and it's very hard for us to keep up with uh uh what's coming from AI. But it's also uh really uh testing how they can critically appraise whatever they are receiving from AI. I think one of the competencies that we should start teaching is how to evaluate AI output uh from uh their uh from a point of view of a healthcare professional. And uh the worry I think is uh because they are not taught anymore because of AI, but it's a it's a fact, and it's just like you can't prevent them from using their smartphones and using uh any reference. You don't ask them to remember everything as long as they can use reference. It's just about how they trust the output and how they evaluate the output, I believe.
SPEAKER_02Wow, I love that. Um, I think you are so right. Um, we should really think about how to treat teach our future students to use AI wisely. I love that cognitive surrender. I'm going to use that, and people will think I'm really smart. Um, just to end the session, I'll just end it with a final question. If you have one key takeaway for ICU clinicians on pharmacovigilance or medication safety, what would it be? And we'll start with Dr. Tof.
SPEAKER_01Uh honestly, I used to say that if you have your if you have the resources, it's a must to have a clinical pharmacist in the ICU. Now I I say the same thing, but I removed the part about the resources because you should have the resources. If you want to start an ICU, you should have the resources, the human resources and the uh you know the infrastructure resources and the human resources should include at least an intensivist, outside nurse, a clinical pharmacist, in addition to other um uh uh probably team members.
SPEAKER_02And what about you, Dr. Ali?
SPEAKER_03I think uh I think um if if if there's uh if there's a one mindset shift uh that um I think ICU clinicians should adopt, um, it's certainly to interrogate your thinking, to interrogate the your biases, to interrogate the uh and to be or rather to interrogate, to be open to to um to the changes that are constantly evolving uh within the ICU setting. Um and to all the pharmacy students and to all the pharmacists that are looking to come into intensive care, if you're having um someone like Dr. Tofi, who's giving you a really good opportunity to be a part of their world round, is certainly to be proactive about it, certainly to read and learn and reflect and improve. Um and in order to make sure that we are a pivotal part and and and even more so than being a pivotal part, that we are a um the the norm to be part of these word rounds everywhere in the world. And thank you.
SPEAKER_02Thank you, Dr. Ali. Um Dr. Ahmed, um any parting words for us?
SPEAKER_00Yes, I would like to um echo what Dr. Ali said. I uh love uh teamwork makes the dream work. It's a teamwork, it is not uh one man show. Everyone is is doing and handling something uh uh for the sake of patience, uh for the sake of uh uh achieving the uh success, the improvement, the cure that we are looking for. So uh teamwork, teamwork, teamwork.
SPEAKER_02I love that, Dr. Ahmed. Uh thank you to all our speakers for sharing your insights and experiences. It's been an absolute pleasure. I think the quote of the day is teamwork makes the dream work. So, on behalf of IBPRINC Critical Care and Pharmaco Vigilance List Serv, we thank you, uh, our speakers, and we thank everyone listening. We hope this conversation encourages us to ask one extra question when we're practicing and caring for our sickest patients. Is it the disease? Is it the drug, or is it both? Thank you for joining us, and we'll see you next time.
SPEAKER_03Thank you. Thank you.