Intro

Federica Santoro 0:15

Doctors, pharmacists, and nurses are key players in pharmacovigilance. But all too often they lack the time or the knowledge to report adverse drug reactions. So how do we make sure pharmacovigilance doesn't get sidelined but becomes an integral part of clinical practice? Well, first of all, by rethinking how we teach the science in universities. My name is Federica Santoro, and this is Drug Safety Matters, a podcast by Uppsala Monitoring Centre, where we explore current issues in pharmacovigilance and patient safety. Joining me today is Michael Reumerman, medical doctor, clinical pharmacologist, and recent PhD graduate at another UMC, the Amsterdam University Medical Centres in the Netherlands. For the last few years, Michael and his colleagues have been exploring better ways to teach pharmacovigilance to healthcare students. So I called them up in Amsterdam to hear all about it. From the learning by doing approach to student-run clinics and much more. I hope you'll enjoy the conversation and that you'll find it inspiring.

Welcome, Michael!

Federica Santoro 1:40

Hello Michael and welcome to Drug Safety Matters. Thank you. So we are talking about pharmacovigilance education for healthcare professionals today. And as usual, we asked our social media followers to submit some questions.

Reporting barriers

Federica Santoro 1:57

And I say we start with Sudarshan from India who tends to pose excellent opening questions. In your thesis, you call pharmacovigilance a blind spot in future prescribers. What is stopping healthcare professionals from reporting adverse drug reactions?

SPEAKER_01 2:16

Yeah, I also think that's a great opening question, and this has bothered me also a lot, I think. And I think a lot of research has been done on this topic, and they pretty much show two main reasons why this is not done by healthcare professionals. One is more to do with skills and knowledge of the one who has to report it. And the other thing is something to do with time and maybe some different care priorities. And I've also seen this during my junior doctor times when I was working on a the medical ward. And there your main priority on that ward is basically keeping your patient alive and providing for the individual patient needs. And when you report something, it's more or less for the whole population to benefit. A lot of hospitals nowadays more focus on that individual patient. And I think we should go to a more broader, more population level, but that's still not regularly done at this moment. So that's the main reason why it's not done by a lot of healthcare professionals. And I think education should be a major contributor at least to the knowledge and skills part.

Federica Santoro 3:31

And we'll dig into the education part of it in a minute, because that's been the core of your research. But now

One-size-fits-all solutions

Federica Santoro 3:39

that you've listed the hurdles to reporting, let's try and see how we can possibly overcome them. Because Sudarshan had a follow-up question. He asks: Can a one size fits all approach work? Maybe a simple pre-filled form with checkboxes and minimal data entry requirements, considering they're so short on time?

SPEAKER_01 4:05

Well, I wish it would be that easy, unfortunately. I think healthcare professionals, the first thing they should do is they have to detect the ADR first. And I already think that there's a big problem in that thing. Then they should also manage the ADRs, and after that they should report it. And of course a minimal entry field or simple checkboxes can help with that. But I think we should also focus on the first topic, basically detecting adverse drug reactions, before we only focus on the reporting side. So I think it should need multiple steps, basically.

Federica Santoro 4:48

Multiple interventions, yes. And another

Reporting triggers

Federica Santoro 4:51

one of our listeners, and actually a past guest on the podcast, Mohammed from Egypt, asks, what other triggers can we use then to encourage healthcare professionals to report? If, as you say, pre-filled forms is not really the answer.

SPEAKER_01 5:06

Yeah. If you want to encourage healthcare professionals, they should know what pharmacovigilance center do with their reports. So I think information about what happens when a report comes in is really, really important. And quite often I also get these questions from colleagues or specialists in the in the hospital, and they also ask me what so what happens in this in this pharmacovigilance center, because I think most healthcare professionals still see it as a black box. So a report goes in and something comes out, but what actually happens in there? So I think one of the tasks should also be what is happening in between, and opening up that black box to show what actually being done with it. So they know some examples from the past, from the teledomite example, but what happens nowadays? And I think we should focus on that to get healthcare professionals involved.

Federica Santoro 6:04

Right.

Problem with PV education

Federica Santoro 6:05

So moving on to the core of your research now: education of healthcare professionals. What is the problem with how they are taught pharmacovigilance, both in the Netherlands and elsewhere?

SPEAKER_01 6:18

Yeah, I think we should change a lot actually. The funny thing is my first article was basically it had the title to Urgently Change or Modernize Pharmacovigilance Education. And I still stand by that even though that article, I think it's about six years ago. And usually the first thing that comes in mind is teachers want more time for educating uh pharmacovigilance in their curricula. But that's not necessarily the well the best solution. I think pharmacovigilance should be thought more of as a as a skill and not so much as knowledge. And I see a lot of e-learnings and and lectures and uh knowing definitions by heart that that has nothing to do with pharmacovigilance in a hospital. So you want students engaged in well detecting, managing and and reporting adverse drug reactions because that's something that they're actually gonna do later on. So please uh focus on that in during our education and have students involved in that and not just knowledge and those kind of questions, because I don't think that will help them in the long run. Maybe they'll they'll finish their test, okay, but that's not something that they'll do afterwards.

Federica Santoro 7:35

They need to know how to apply that knowledge.

SPEAKER_01 7:38

Definitely, yeah.

Responsibility

Federica Santoro 7:39

My colleague Elki, a pharmacovigilance education specialist actually, has a question for you. She wonders who is responsible for healthcare professionals' pharmacovigilance education in different countries, especially in low and middle income ones, if you know?

SPEAKER_01 7:57

Yeah. Well, this is also a good question, and I've also wondered this myself. I don't actually know this was not in my PhD thesis, but I've got a couple of opinions about that. So I think when it comes to teaching clinical aspects, at least to doctors, physicians should be involved in that. They should design the education. And the reason for this is that sometimes other healthcare professionals also get involved, and I think they're great specialists in their field and know a lot about pharmacovigilance or or medication safety, but sometimes it does not apply to the doctor's working environment, and we should also keep that in mind, because if you learn something you want to practice it at your workspace, and if it's such a different um different situation that's actually happening on your workplace, then you probably won't apply it in that workplace. So I think a physician will be able to look at the current workplace and see how pharmacovigilance can fit into that. So I think uh a physician with enough knowledge about pharmacovigilance and interest in pharmacovigilance is at least needed to be in the lead with designing the the education. And I think a lot of healthcare professionals can also be involved in giving the education, but the design should also be by a physician. At least when we're talking about education for physicians.

Real-life education

Federica Santoro 9:26

And so you've said the problem is basically that there's too much focus on knowledge at the moment and not so much on skills. And uh the solution you propose in your thesis is real life education. What is it?

SPEAKER_01 9:44

Yeah, so real life education is a term that we couple to education that has students have maximal perceived responsibility for a real clinical task. And it has also has to be an authentic task. And what I mean by that is the maximal perceived responsibility is students should feel that if they don't do things it won't be done. And they have the responsibility to do this. Of course they're not responsible legally or whatever, so it'd be supervised by a supervisor and he or she is responsible for that, but they should feel their own responsibility because that's what increases their intrinsic motivation to do the task and also learn from it. Additionally, we think they should have an authentic task, so something that they will do later on when they're finished studying. So if they should be able to report an ADR later on, then we should also think they should have the authentic task of reporting it during their study so they can learn it on the job. And we also coupled a term that it's called learning by doing, and that basically uh says what it is. We should have students learn while they do it. I think that's the best thing for it, and that's what we call uh real life education.

Federica Santoro 11:07

Sounds like that approach is valuable not only for pharmacovigilance but for many other areas of study. Definitely. Um

Student-run clinics

Federica Santoro 11:15

much of your research has focused on junior healthcare professionals, I noticed. For example, you advocate the creation of student-run clinics. Why?

SPEAKER_01 11:26

Yeah, I think junior doctors or the junior healthcare professionals, well, there are future doctors and future pharmacists. So I think we should give them the best education possible. And what I always think of is how should I what education would I like to have? And that's basically doing authentic tasks. I wanted to be a doctor, so I wanted to be educated doing doctor things. And that's what a student-run clinic basically is. You learn by doing it with the real patients in an authentic setting, and that's something I wanted to do, and that's why as a student I also started in a student-run clinic, and I'm still, well, basically supervising these student-run clinics, so that's why I think we focus so much attention to this uh amazing uh intervention in education.

Adverse drug event managers

Federica Santoro 12:18

Another thing I found interesting in your research is you tested teams of adverse drug event managers, a sort of pharmacovigilant superhero. That's how I visualized it in my head. What's the advantage of a role like that in a hospital?

SPEAKER_01 12:35

Yeah, so the term adverse drug event manager was not uh thought of by us. I think a group in Denmark started it, and we saw that at an international congress, and we thought, wow, this is amazing. An adverse drug event manager, and we thought, well, isn't this a great solution for students? Because we want students to be uh pharmacovigilance experts, they should do this while they're studying. So we started the term union adverse drug event manager, and that's basically students who do the well pretty much the same task but on the supervision of our uh clinical pharmacologist, and then it helps a lot of people because the students, while they're they're learning while doing the job, the patients in our hospital they get their adverse drug reactions reported because we have a massive underreporting in our hospital, and also in the Netherlands, there's a massive underreporting, and at the same time, healthcare professionals they're obligated to report these adverse drug reactions, but they don't do it because they don't have the time. So we're helping three groups at the same time. We're helping students because they can learn, patients because their ADR can be reported, and also the healthcare professionals we are supporting them in their pharmacovigilance obligation. So it's a win-win-win situation.

Federica Santoro 13:56

Indeed.

Interprofessional teams

Federica Santoro 13:58

Um, and now when we say healthcare professional, people may think mostly of doctors, but the term actually refers to anyone who provides healthcare treatment or advice, including pharmacists and nurses. And in fact, you ran a whole study on how to get nurses to report. And you also worked on interprofessional teams of healthcare students that could do medication reviews together. So my question is: why is that kind of interprofessional collaboration important for you?

SPEAKER_01 14:35

The thing is that the prescribing medication but also pharmacovigilance nowadays is not just the job of one healthcare professional, but it's usually collaboration between different kinds of healthcare professionals. That's what is called interprofessional collaboration. The funny thing is that we expect this interprofessional collaboration. However, all these kinds of students they're educated in a mono-professional way. So the pharmacist goes to a pharmacy school, the medical students go to a medical school and they never see each other, they never work with each other, but when they're finished with their education, we expect them to work together, and we find that strange. So we think that if you have students work together during their education on the same task, and where students can apply and contribute equally, they can learn with each other and also learn from each other. So they they know what competences each of these healthcare professionals have. They can see that a doctor has knowledge about guidelines and patient care and a pharmacist, they know a lot more about medication, so maybe after they finish graduating, they will work more closely together and actually know what a pharmacist is and what a doctor is. And that's why we also wanted to test this. And it's a massive new topic in education, so a lot more will be done on this topic.

Unique perspectives

Federica Santoro 16:04

And when it comes to pharmacovigilance specifically, do you feel different groups of healthcare professionals bring a unique perspective? What can doctors offer when evaluating or identifying and reporting ADRs that perhaps pharmacists and nurses cannot, and vice versa?

SPEAKER_01 16:23

Yes, I think that's definitely the case. We see it a lot in our pharmacovigilance program where we receive uh three ADR reports from the Netherlands Pharmacovigilance Center LAREP each week, and students from the medical degree and also from the pharmacy degree they work on these ADR reports and try to assess them and find the mechanism behind the ADR. And we see a real big difference because the pharmacy students they can explain the mechanism behind the ADR much better, and the doctors they can explain why a patient is having this drug with this indication, and more so think about what we should do with the medication. So a pharmacist could say, Well, we just stop the medication, but a doctor will then say, Well, that's okay, but then the comorbidity or the indication is not treated properly, so we should do something about that. And that interaction is really important. So everybody can contribute, but they all have their own specialty in that.

Federica Santoro 17:32

Very interesting, thank you.

Challenges

Federica Santoro 17:35

What challenges did you face when setting up and running your studies?

SPEAKER_01 17:40

Yeah, so most of our studies are also uh part of the student-run clinic, and in Amsterdam, I think we have one of the largest student-run clinics that is not focused on providing free care because student-run clinics are mostly based in America where they provide care for uninsured patients. But in our student-run clinics, I think about a thousand students each year participate on all different kinds of projects. Some are pharmacovigilance-based, some are polypharmacy-based or other topics. Yeah, we started in 2012 and we have quite a lot of experience. But I think the most important thing is uh having students that perceive responsibility and really providing that and not saying, Well, I will just do this for you. No, let the students do it themselves because they have to learn. You can probably do it yourself, and sometimes it's a bit quicker, but you want students to learn from it, and that's the most important thing. So don't uh say, Well, I'll just do it quickly. No, let the students do it. And that's something that you should keep in mind when setting up these projects.

Federica Santoro 18:52

Being able to delegate that responsibility, even if, as you say at the beginning, it takes longer, you'll gain time in the long run. Definitely, yeah.

Evaluation

Federica Santoro 19:01

On to the evaluation now. This is a question again from Mohammed from Egypt. He wonders how we should measure the effectiveness of educational interventions. And I know, I mean, measuring effectiveness of interventions is a challenge in many fields. Can we rely on the quantity and quality of reports alone? He asks. Because there may be no ADRs to report when we run our evaluation.

SPEAKER_01 19:30

Definitely. Well, just as you said, it's difficult to basically evaluate education, mostly because there are so many aspects you can think of. Well, in our studies we focused on learning aspects, so what have students learned from doing this? So with the pre-post interviews and evaluation, so what have they learned after doing this? And either with a control group or not. But unfortunately, there's still no uniform method of seeing if students have actually learned something. There are a lot of questionnaires, but there's no one good questionnaire for evaluating education. So I think that's something that we should focus on in the upcoming years. And on the other side, in education it's also difficult to evaluate clinical outcomes. The quantity and the quality of ADR reports, that's a clinical outcome, and we also focused on that, but I think we should get it a bit broader than that. So don't only focus on ADR reports, because for a physician, a lot of aspects already happen before reporting. Because before a doctor can report, they should detect an adverse drug reaction and they should also manage and treat it. Those are also very important aspects to to look at and to evaluate because reporting is not the only thing that's important in pharmacovigilance, but also helping the patient to have less side effects. So treating them, detecting them is also, I think, a very relevant outcome measure when we're talking about educational interventions.

Federica Santoro 21:13

Hmm. So we have to be careful about capturing those aspects which perhaps can't be neatly summarized in a number, but are really important to measure anyway. Definitely, yes.

Dutch success

Federica Santoro 21:24

And uh on the topic of evaluation, I have to ask, how have your interventions worked in the Netherlands so far?

SPEAKER_01 21:32

Yeah, so I think our interventions have stimulated a lot of students to think differently about pharmacovigilance. And I think most of them who participated in our projects they are pretty much aware of ADRs when they are in the emergency or on a ward or in an outpatient clinic. And additionally, our projects have also well made about a thousand ADR reports in the last um couple of years. So I think that's More than uh the whole of Amsterdam has uh reported. But I also think that a lot more ADRs are detected now because of our teams, our pharmacovigilance specialists or however you can call them. So I think those are important outcomes, learning outcomes, but on the other side also a lot of ADR report.

Translating solutions

Federica Santoro 22:19

And I know you said earlier that there is a lot of underreporting in the Netherlands as well, but I think we can agree that your country has a long history of drug safety monitoring and a pretty advanced pharmacovigilance system, but that's not true for every country in the world. How would you translate your solution, your real life interventions, to other healthcare settings?

SPEAKER_01 22:47

I imagine that starting a student-run clinic or starting real-life pharmacovigilance education, it can seem pretty overwhelming, and I totally agree because yeah, it costs a lot of time. But what I notice and what my colleagues notice is when you get infected with the the virus basically, then you won't stop ever. So I encourage everybody to start at least. But especially when we look at pharmacovigilance, yeah, we want to help other countries and other teachers to really start with this real-life pharmacovigilance education. And that's why we were commissioned by the European Open Platform for Prescribing Education to develop education that can be incorporated all around the world. And this uh this open platform is I think it's gonna be live in the summer, and it's a platform for uh pharmacotherapy teachers, but also pharmacovigilance is in there, of course. And that's where we started a project that's called uh Dr. Vigilance. Doctor Vigilance is basically a role model for teachers but also for students, and it will show them how they can be involved in these kinds of um educational interventions. So, um, how can they start up their adverse drug event managers in their own hospital? What do you need for that? Manuals or blueprints. So those will all be available for free for all teachers all around the world so they uh can incorporate it into their own curriculum. And it's all focused on clinical education primarily for doctors. So I hope at the end of the year it will be available and everybody uh can incorporate it.

Federica Santoro 24:35

That's great to hear. And obviously, we are spreading the word about your work. So I hope many in the pharmacovigilance community will feel inspired to take similar initiatives in their own hands and develop programs like you did. Um

Most impactful change

Federica Santoro 24:52

here's a follow-up question from my colleague Magnus, who's also a pharmacovigilance education specialist, and well, who actually suggested the idea for this podcast. As you said, the real life clinical exercises that you came up with are they're great, but it may not be feasible to apply them everywhere. So, Magnus asks, if you were only allowed to make one minor but impactful tweak in your undergraduate curriculum, what would that be?

SPEAKER_01 25:25

Um I've already talked about it, and I think the most valuable thing is to have students feel the maximal perceived responsibility for their work. I think that's the magical question, and that will basically let students be inspired and have the intrinsic motivation to uh really work. For example, an internship of uh like three months, probably they'll see a lot of adverse drug reactions during the three months. I can't believe that you won't see anything. I always say, well, if you can't see an ADR in three months, you're not looking correctly. So um but if you see this ADR and it's an important one, why don't you report it yourself under supervision of a colleague or uh supervisor, and afterwards let the supervisor just talk to you about this ADR and let the student basically assess that ADR themselves. I know a pharmacovigilance center will also do this, but let the student do it themselves so they really know about that ADR and what is happening at the pharmacovigilance center. And that's just one change that doesn't cost a lot of money, time, but it's letting the student do it themselves. And I think if you want to change one thing, that's an easy way and an easy intervention that everybody can do all around the world.

Federica Santoro 26:48

Thank

WHO Guide to Good Prescribing

Federica Santoro 26:49

you. You end your thesis with concrete tools, you mentioned the Doctor Vigilance resources. You also end with very clear recommendations for future practice, including a suggestion to update the WHO guide to prescribing. First of all, what is this guide and how would you like to update it?

SPEAKER_01 27:11

Yeah, so the the WHO uh guide to good prescribing and the and also the teacher's guide to good prescribing, there are two manuals that provide students and teachers with a model that helps them to structure the process of uh prescribing and therapeutic reasoning. And this model was uh made I think about twenty-five years ago, and it consists of six consecutive steps. And if you follow these six steps as a prescriber, you will at least think about the most relevant topics uh in prescribing basically. But this guide is twenty-five years old and is missing quite a lot of things in there, uh planetary health, uh but also a large proportion of pharmacovigilance uh activities are also missing. And um the WHO six step has six steps, of course, and three steps are really important, I think, for pharmacovigilance. And uh the third step is basically uh choosing the most suitable treatment for your patient. And I think a major update will be if this would also include looking at drugs that have limited amount of side effects for that patient. So for example, a pianist they don't want to have jitters because well then their hobby or their their work is not feasible anymore. You can't do that. But other patients won't mind jitters that much because they have work or hobbies that don't have that. So you should really look at your patient and then look at the side effects and see if they're relevant for that patient. So another thing that I think is missing in the sixth step is patient information. Every doctor, when they prescribe a medication, they should also give information about possible side effects. They are legally obligated to do that, but we should also think about the nocebo effect and also think about how you would explain these side effects. Because if you uh list all these side effects, then patients are probably not gonna take the medication anymore. Then you won't get any side effects, that's the best part about it, but the the treatment won't help then. So I think training students about what to tell about ADRs or possible ADRs is really important. And finally, the sixth step is basically monitoring your response. And what I see nowadays in in students is that they mostly focus on the positive effects of drugs, but we should also focus on the negative, the the side effects. And also when a patient has a side effect, we should report the ADR. And those aspects are not really incorporated in this uh sixth step, and I would like them to be more promoted in this method, so every student will know that this is really important when we're prescribing medications, and I think that is lacking at this moment. However, yeah, it's not only up to me to change this um manual.

Updating the guide

Federica Santoro 30:19

So there are no plans to update the guides anytime soon, as far as you know.

SPEAKER_01 30:24

Yeah, I I know there are um plans to uh update this um manual, and my uh co-promoter, he is leading a team that is actually updating this, but it's uh collaboration between the whole world. So uh there are more participants who are willing to change this uh this model. I think the base is good, but it should include more topics, such as pharmacovigilance, of course.

Federica Santoro 30:50

Well, thank you, Michael, for taking the time to answer all of my questions, but also all of our listeners' questions. I'm sure they'll find it valuable. Thanks for being with us today.

SPEAKER_01 31:02

No problem. It was uh very nice to have uh talked about this topic.

Federica Santoro 31:06

And best of luck with your future research.

SPEAKER_01 31:09

Thank you very much.

Outro

Federica Santoro 31:17

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 pharmacovigilance education and Michael's research, check out the episode's show notes for useful links. If you like our podcast, subscribe to it in your favorite player so you won't miss an episode. And spread the word on social media so other listeners can find us. Apart from these in-depth conversations with experts, we host a series called Uppsala Reports Long Reads, a selection of audio stories from UMC's pharmacovigilance magazine. So do check that out too. Uppsala Monitoring Center is on Facebook, LinkedIn and Twitter. And we'd love to hear from you. Send us comments or suggestions for the show, or send in questions for our guests next time we open up for that. For Drug Safety Matters, I'm Federica Santoro. I'd like to thank Michael Reumerman for his time, Matthew Barwick for post-production support, and Magnus Ekelu for pitching the idea. Magnus also contributed questions for the interview, along with listeners Sudarshan, Mohammed, and Elki. So a big thanks to them too. Last but not least, thank you for tuning in. Till next time!