Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring.
The views and opinions expressed in the podcast are those of the hosts and guests respectively and, unless otherwise stated, do not represent the position of any institution to which they are affiliated.
In the age of evidence-based medicine, we may be tempted to dismiss intuition – the quick and automatic thought process we call “sixth sense” or “gut feeling” – as unscientific guesswork. But in clinical decision-making, intuitive reasoning is just as important as the slower and more analytical causal reasoning that healthcare professionals are trained in. In fact, without it we would hardly be able to formulate new hypotheses.
Together with Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb, we explore the role of intuitive reasoning in the science of drug safety.
Tune in to find out:
How clinical and intuitive reasoning complement each other for optimal decision-making
How adverse drug reaction reporting forms could be improved to detect intuitive reasoning
How pharmacovigilance professionals can train their intuition
Want to know more?
Here are a few reading resources to get you started:
A study on real cases of intuition in family medicine concluded that automatic, non-analytical processes in clinical judgment extend beyond first impressions.
The dual-process theory highlights the importance of physicians’ intuition and the high level of interaction between analytical and non-analytical processes in clinical reasoning.
Gut feelings may help general practitioners efficiently navigate the often complex and uncertain diagnostic situations of general practice.
In a discussion paper on intuition and evidence, professor Trisha Greenhalgh suggests that the experienced practitioner should follow clinical hunches as well as applying the deductive principles of evidence-based medicine.
If you’d like to hear more from the Netherlands pharmacovigilance centre Lareb, check out this interview with Linda Härmark on patient reporting.
Got a story to share? We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!
I would really like to know why it's actually somebody reporting. Is it because he has the feeling he has to? Or is it because he really has the feeling I'm looking at something very special now? And if that's the case, of course I want to know it. Why he or she thinks they're actually dealing with a new signal.
Federica Santoro
Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. Albert Einstein is thought to have said, I believe in intuitions and inspirations. I sometimes feel that I am right. I do not know that I am. I bet we can all relate to that statement. Who among us hasn't been in a situation where we can't quite explain why, but we just have a feeling that we're on the right track? Or on the other hand, that something is terribly wrong. Some call it a hunch or sixth sense, others call it a gut feeling. Well, whatever you call it, it's undeniable that intuition is a crucial component of decision-making, not least in healthcare. My name is Federica Santoro, and my guest today is Eugene van Pijnbruck. Eugene heads the science and research department at the Netherlands Pharmacovigilance Center Lareb and teaches pharmacovigilance at the University of Groningen. But he was also a general practitioner for many years and has often wondered about the role of intuition in clinical practice. So tag along as we try to understand what intuition is, how it can be developed, and why it can benefit pharmacovigilance. So we'll be talking about intuition in pharmacovigilance today.
SPEAKER_00
Yes, I would like to add the word clinical reasoning and intuition because it's not only about intuition. I think you can only speak about intuition if you also take the clinical reasoning into account. Most information we get in pharmacovigilance derives from this clinical reasoning. But of course, there's also something like intuition in clinical medicine. And I think this intuition is something we don't take into account too often. Clinical reasoning we do, at least I hope we do, because um it should be there on our reporting forum.
Federica Santoro
Why is intuitive reasoning necessary? Is clinical reasoning not sufficient?
SPEAKER_00
I think there are two reasons. The first one is that clinical reasoning is aimed at finding a certain diagnosis. So the questions you pose as a doctor are aimed on finding a certain diagnosis. But in pharmacovigilance, we are also interested in finding new things. And finding new things might come along with a kind of intuitive feeling that something is wrong here. And I don't know if the questions I usually pose are sufficient. So maybe I should skip my initial ideas about a certain topic or a certain diagnosis in a patient. So it's not the normal cause of the disease, but maybe it's an adverse drug reaction. And what I would like to know is what the actual reason is for a doctor to consider an adverse drug reaction. Is it something he's seen before? Is it something that uh simply doesn't fit in the normal cause of the reaction? Is it uh maybe something that uh the patient uh spoke about? Those kind of information I think is important. Because we are aiming at finding new information anyway.
Federica Santoro
Absolutely. So do we have this kind of information nowadays in reporting forms?
SPEAKER_00
Um I think it's rather sparse. Not quite often. The information we have in reporting forms are mainly aimed at uh at causal reasoning, trying to detect information about a causal relationship between the suspected drug and the first drug reaction. But if we're going to detect something special, we also want to know why the reporter thinks this is special. And that's I think it's something more than just the causal reasoning. He might be triggered by something, the fact that he has seen a certain drug reaction a couple of times, or he doesn't expect a certain reaction in a certain condition, that kind of information. And that's also something that might help us as a pharmacovigilance center to realize maybe he's right, maybe we should consider the first drug reaction or not.
Federica Santoro
Can you give me an example of a situation in in medicine or specifically in pharmacovigilance where intuition was fundamental?
SPEAKER_00
I think that that in the early days of pharmacovigilance, the most classical example, for instance, is the discovery of focomedia associated with the use of thalodomide. There must be a moment in which uh a doctor must have thought, well, this is strange. We are dealing with a very rare condition. So it might not be purely coincidence we're dealing with. So at that moment, it might have been useful information to know why a doctor actually considers a possible adverse drug reaction and not merely just report it and wait until there were other adverse drug reactions or other reports. So this information is is vital. Maybe another one is a discovery of a visual field defect associated with VICO veteran. That must have been a moment in which a doctor must have thought, well, this is strange. I've seen two or three cases of visual field effects. And what actually makes me think about an adverse drug reaction, what is it? Is it a rare condition in this specific patient? Or given this patient and giving his or her underlying condition, I simply don't expect a visual field effect. That's vital information for us as well to know. Because otherwise we um we have to start over again. We'll have to combine all the cases we have. We'll have to think what kind of patients were they that were suffering from from epilepsy. But what kind of epilepsy was it? Was it a primary or a secondary one? And what was exact the underlying condition? And might this underlying condition possibly have explained the sternal vision or not, or this visual field effect? What is it? So this is something we should know, and not simply having an ADR reported in association with a certain drug.
Federica Santoro
So the way you talk about it, intuition sounds to me like uh a gut feeling, but it also sounds like going beyond what's written in medical textbooks and the literature and perhaps making that jump in and thinking to make connections that were not there previously. How do you think about intuition?
SPEAKER_00
I think intuition is a very important part of thinking in medicine. Usually, if you you want to look for a correct diagnosis, you start with posing questions that actually actually allows you to confirm a certain diagnosis. That's what we call clinical reasoning. So you have a dedicated set of questions and approaches, and what you actually try to do is to confirm this diagnosis, and what you actually want to avoid is making your wrong diagnosis. So the whole situation, the whole way of working actually allows you to name certain diagnoses. But sometimes, in finding these diagnoses, you also consider possible causes. These causes might be based on uh, for instance, infectious diseases, but also tumors, neoplasma, and only one of the possible causes is an adverse drug reaction. So it might be very well that you in your thinking you're focused on finding a certain uh clinical outcome related to an underlying disorder, and you did not actually take an adverse drug reaction into account, but suddenly you realize that this is something that should also be considered. So intuition in that respect is very important to uh to take notice of. But then the second step is why do you think my intuitive feeling actually points to what an adverse drug reaction? So you shouldn't stop by only thinking, well, this might be intuition. What's the actual reason behind it? So try to try to figure out for yourself why you have this intuitive feeling. Is it because you didn't expect a specific reaction in this patient, or is the underlying disorder insufficient to explain this clinical picture and so on?
Federica Santoro
British writer Sir Arthur Conan Doyle, best known for the Sherlock Holmes mystery novels, thought detectives and doctors had much in common. A detective hunts for clues to solve a crime, and similarly, a doctor will carefully examine subtle signs in a patient to diagnose a mystery illness. In both cases, the investigation requires deep analytical thinking. You lay out the available evidence and then try to find an explanation, or in the doctor's case a diagnosis, that fits in with the evidence. But this slower and more structured way of thinking is often complemented by a quicker and more automatic thought process, the gut feeling. Now, in the age of evidence-based medicine, intuition might be dismissed as unnecessary. But it's important to understand that intuitive reasoning is neither unscientific nor is it mere guesswork. Quite the opposite. The ability to understand something instinctively and sense the right course of action is what marks the expert out from the novice. Psychologists have been fascinated by intuition for decades, and many would agree that it is a highly creative process and essential to generate new hypotheses. What are the risks of reasoning intuitively?
SPEAKER_00
Well, first let me tell you that intuitive reasoning is important. But of course, there is a risk that you will make a wrong um you may make the wrong conclusion. That's a possibility. We all know that the moment we have seen certain cases or certain patients a couple of times in a short time span, we are more likely to make the same diagnosis once again. The moment I've seen in a short time span, let's say uh two or three patients with a Guy and Barret syndrome, I'm much more focused in detecting these patients once again. So that there is a reason that there is a kind of bias in intuitive reasoning. Uh, nevertheless, I think we need it because it's a very valuable tool. Because if you would have to use the clinical reasoning in every case, in every circumstance, it will simply take you a lot of time. And we know that in the clinical thinking we make use of two systems. We call that the dual process theory, in which the first system, system one, is more intuitive, automatic, quick, effortless reasoning. We make use of previous ideas we gathered from previous experiences with the patients. We call that exemplars, pieces of thought and memories which are stored and which we can easily retrieve to use again. And then we have a second system, so the first one is a very fast system, and we have a second system that's more an analytical system, a reflective system, more slow, will cost us more effort, and it's more used to verify the diagnosis. It's in fact the same approach as we use in causal reasoning. So in these systems, they work together, and depending on your experience, you use one system more than the other one. If you're new in the field, if you're a young doctor, if you're a novice, you will probably use the causal reasoning, so the system two more often. And if you're an expert, you are likely to use this intuitive reasoning, so the quick reasoning, recognizing patterns, recognizing these exemplars, heuristic reasoning, so that's an add-in problem solving. Probably you will recognize a rare diagnosis more, much more faster.
Federica Santoro
And is this something that is subconsciously developed with experience, or can it be consciously developed and learned?
SPEAKER_00
I think this intuitive reasoning, this system one reasoning is something that you will develop over time. The moment you get more experience, you will become an expert on the field. And then you might say from a conscious exercise, it will become a much more unconscious process, and that's what we call intuitive reasoning. But in fact, of course, it's nothing more, nothing less than recognizing a pattern. But you do that in an intuitive way. I think that's the main difference. But of course, the trick is that you actually want to know well, where does that intuitive feeling comes from? I think this is something we really have to really have to find out, also as a PV center.
Federica Santoro
Yeah, and also if it is something that can be learned, how would you advise pharmacovigilance professionals then to take as much as possible out of their intuition?
SPEAKER_00
I think we have to make a distinction between the intuition and the reasoning by our reporters and intuition and reasoning as a pharmacovigilance center. I think that's an important distinction in respect to our reporters. If it's about clinical reasoning, we simply should ask for follow-up information, look for a discharge letter, see whether or not the narrative will provide us this information, and if it's about intuitive reasoning in our reporter, it's a little bit more bothersome to retrieve that information because it's unconscious and not outspoken and probably not reported on a reporting form. So we simply have to ask. So I think that asking for the motive to report is something that might really help us to understand what the considerations were in the reporter to think about a possible adversary reaction. It is also something we might learn from. If we're talking about clinical reasoning and intuition in the pharmacovigilance itself, I think we'll have to have our own questions or dedicated questions for certain clinical pictures. We should work on that as well. So what do we ask in case of well the aforementioned visual field effect? How can we be sure that this is indeed a visual field effect? What should we do if we get a report of a pulmonary embolism of a Stephen Johnson syndrome? What's the information we need? On the other end, over the course of time, we will also develop our own intuitive reasoning. And I think what we should do is we should realize why we think this is a signal or not. I think this is something we all have to be aware of. And I don't think we must stop by saying we think it's a signal, but always try to explain why that's the case. Our young colleagues won't be able to learn from us.
Federica Santoro
So going back to the reporters, then that's an important point you raised that perhaps the question as to why they report should be included more. Are there any countries, any scenarios now where that question is included in reporting forums?
SPEAKER_00
As far as I know, actually asking for a motive is not something that has been done routinely. You might do that by asking follow-up information, but it's not a question that's being posed on the reporting forums. But for me, I would really like to know why it's actually somebody reporting. Is it because he has the feeling he has to, because we are waiting for reports, or is it because he really has the feeling I'm looking at something very special now? And if that's the case, of course I want to know it. I want to know why he or she thinks that they're actually dealing with a new signal. What's the reason behind it? And I think that's much more valuable as just doing our causality assessment in our center. We just want to learn from the reporters as well.
Federica Santoro
And of course, you and the pharmacovigilance center you work for have an interest in patient reporting. So you teach me that patients add special value to pharmacovigilance by picking up information that perhaps healthcare professionals don't pick up on. And on the other hand, this whole discussion on reasoning makes me think healthcare professionals are trained in clinical reasoning. Patients are not. So, what kind of thought process goes through the head of patients and what value does that add for pharmacovigilance?
SPEAKER_00
I think you raise a very important point, is that what we consider as a doctor to being a signal might very well differ from the ideas patients have about what a sickle actually entails. If I see in a summary of product characteristics or the patient leaflet that dizziness is being mentioned as a possible first recurrence, I might very well think that, well, of course, that's nice, it's being labelled, I'm very satisfied, it's there, everybody can take notice of it. But for a patient, reporting dizziness might very well mean that he or she is extremely dizzy, can't go to work, can't get out of bed anymore, so really hampering their uh their daily activities, having a strong influence on the quality of life, and this is something we simply don't realize. So for them it's a signal, for us it should be a signal. So this is really information that is important for us to know as well. So if we got a report from a patient mentioning dizziness as such, I think in these cases we might very well ask for the motive. Why did you actually report it? Because you had to, or because you had a feeling that this was an extreme case of dizziness. You've never seen this before, and you don't think the information provided in the SMPC is sufficient. So if that's the case, I want to know it. So it's um the motive as such is important. It goes beyond this intuitive reasoning. Maybe the patient simply is unsatisfied by the fact that it's not mentioned properly. So, but nevertheless, it's information I want to know.
Federica Santoro
And do you see this the question of why people report? Do you see this question added to reporting forms in the near future?
SPEAKER_00
Oh, I think we'll have to think we'll have to consider how we should actually pose this question in the right way. But I'm convinced that in some cases we might ask for the motive in a follow-up question, for instance, simply by asking follow-up information from our patients and asking questions like how did you experience this adverse recreation? Was there a special reason why you actually reported it? Something like that. But I think this is something we will have to look into in more detail because you you want the patients to to report freely. If you ask for motivation, you might you might give them the impression that we had certain feelings about the the adverse drug reaction or their report. So how we actually pose the question should be I think we should take a very close look at that.
Federica Santoro
So that's what you think can go wrong if you ask them for their motivation to report, that they can be just put off from reporting altogether?
SPEAKER_00
What I think is that you really have to consider how you actually pose that question. If you simply ask why did you report this, they might feel a little bit embarrassed, for instance. So think about how you actually ask it. Were there any special reasons? What are your thoughts about this ADR? It might shed a different light on the adverse drug reaction on the report.
Federica Santoro
When pharmacovigilance systems first developed and reports of adverse drug reactions were few, professionals in the field relied strongly on intuitive and clinical reasoning, both their own, as they poured on the cases one by one, and that of the doctors who had filed the report. But as more and more information flowed into our databases, it became impractical to review reports one by one, meaning we had to come up with new solutions. And so, statistical methods like disproportionality analysis were born. These methods offer a convenient way to sift through large collections of data, but do not take intuitive or clinical reasoning into account. So the risk is that we reduce reports to a simple drug-adverse drug reaction combination and neglect the underlying clinical picture. That, says Eugene, would be a big mistake. So as we develop even more sophisticated methods to analyze and interpret data, we must also remember that behind every report lies a rich and complex clinical story. There is a trend towards increased automation in pharmacovigilance. Some people are very much in favor of incorporating automated processes, artificial intelligence in pharmacovigilance. Others not so sure or a bit hesitant about it. Perhaps they have doubts as to whether it will ever entirely replace human intelligence. Given this, where do you think intuitive reasoning fits in a future that is increasingly automated?
SPEAKER_00
Um I think if you are looking to intuition, it is also about kind of meet a message, the message behind the message you're actually looking for. Sometimes you have a feeling when you read the report, well, this patient was she wasn't very happy with the situation, or there was possibly a conflict behind it, or she was unsatisfied with the treatment of their healthcare professional. So I think it might take a very long time before we actually can reach that level of interpretation using artificial intelligence. We still have to look as human beings to our narrative and to interpret and to think about what we actually see on paper. So in the nearby future, there will possibly be some great steps being taken in respect to things like text recognition, for instance. But for the actual interpretation and looking for the the message behind the report, I think we need our uh own human intelligence to do that.
Federica Santoro
So there will be no robots that think intuitively?
SPEAKER_00
Intuitively, um no. I don't think, at least for the next five or ten years, I don't see that uh this type of developments in pharmacovigilance.
Federica Santoro
So what would be your word of advice for novice pharmacovigilance professionals? How would you tell them to use their intuition?
SPEAKER_00
I think a very important element in being trained in pharmacovigilance is to discuss the cases with your colleagues, ask those with more experience, with previous experience in pharmacovigilance, discuss on meetings, ask the healthcare professionals, but be sure that there is plenty of interaction about your thoughts and other thoughts of your colleagues on the reports being forwarded to you. Because, like in the clinical practice, also intuition and reasoning in pharmacovigilance is something that has to be trained over time. And it's only the training and the experience that will actually help you in becoming a skillful and astute pharmacovigilance expert.
Federica Santoro
Sounds good. So dare to ask questions, I guess.
SPEAKER_00
It's post questions, dare to ask questions, not only to your colleagues, but also to the patients reporting to you and to the doctors reporting to you. You really need that insight in their thought processes as well. It's not only your own center, your own ideas, but please take care of everything that has been done before the reports actually were sent to you as a center. It's a pity if we skip all the efforts and thinking processes being carried out by our reporters and just ignore them. Now they are very valuable and they should have a very prominent place in pharmacovigilance.
Federica Santoro
That's all for now, but we'll be back soon with more conversations on medicine safety. If you'd like to know more about clinical reasoning and intuition, check out the episode show notes for useful links. If you like drug safety matters, subscribe to it in your favorite podcast player and leave us a review so other listeners can find us. In addition to these in-depth conversations with experts, we run a parallel series called Uppsala Reports Long Reads, the best stories from our pharmacovigilance magazine in audio format. So do check those out too. Any comments or suggestions for the show are welcome. Look for Uppsala Monitoring Center on Facebook, LinkedIn, or Twitter and come talk to us there. For drug safety matters, I'm Federica Santoro. I'd like to thank Eugene van Pleinbrook for the interview, Matthew Barwick for post-production support, and you for listening. Till next time.
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