Drug Safety Matters

#38 Patient perspectives in PV: a fireside chat at the ISoP Mid-Year Symposium

• Uppsala Monitoring Centre

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This special episode was recorded at the mid-year symposium of the International Society of Pharmacovigilance (ISoP), 14–15 May 2025. Held in Uppsala, Sweden, the theme of the symposium was Improving information capture for safer use of medicines. The episode is an abridged recording of the concluding fireside chat, where Angela Caro Rojas (president of ISoP), Linda Härmark (director of the Drug Safety Research Unit in the UK), Ghita Benabdallah (national pharmacovigilance centre of Morocco, member of the IsoP advisory board), and Daniele Sartori (senior pharmacovigilance researcher at Uppsala Monitoring Centre), discuss patient engagement in pharmacovigilance.

The symposium was a collaboration between ISoP and UMC.

 

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Fredrik Brounéus:

Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Centre where we explore current issues in pharmacovigilance and patient safety. I'm Fredrik Brouneus and you're listening to a special episode recorded at the mid-year symposium of the International Society of Pharmacovigilance, ISoP, which was held here in Uppsala about a month ago. The theme of the symposium was "Improving Information Capture for Safer Use of Medicines and was a collaboration between ISoP and Uppsala Monitoring Centre. What you're about to hear is the concluding fireside chat, which I had the pleasure to moderate, with Angela Caro Rojas, president of ISoP, linda Hermark, director of the Drug Safety Research Unit DSRU in the UK, rita Benabdallah of the National Pharmacovigilance Centre of Morocco and member of the ISoP Advisory Board. And Daniele Sartori, senior Pharmacovigilance Researcher at Uppsala Monitoring Centre. In the episode show notes you will find links to some of the studies and people that were mentioned during the discussion.

Fredrik Brounéus:

And now over to the stage at the conference venue here in Uppsala, and in order of appearance Angela, Ghita, Linda and Daniele.

Fredrik Brounéus:

So, a warm-up question for the panel: We've had two quite intense days here. Any personal takeaways, highlights, surprises?

Angela Caro Rojas:

I am really surprised how all the talks think a little in patient engagement. I feel that yesterday was amazing the talk from Sara [Riggare] about patients, and I always say the same: we are here for the patients. That is the reality. We are here to support patients in having a medication, safer use, and I feel that we need to be really focused in what the patient is feeling, what the patient is thinking and how we could act in coherence of these feelings. Every patient is different.

Angela Caro Rojas:

When I think about patients, I think about my mother. She has diabetes. It's a chronic disease but she's very well controlled. Everything is going well, but sometimes she feels tired of taking a lot of medicines. Or she says: I don't want to control again my blood. I forgot the medication and I says "it happens to her. That is my mom. I try to be aware of what is happening with her. What happened with a lot of people that don't have one person to take care of them? And maybe we are thinking about databases and how detect signals and we are not thinking about what is the essential of the use of the medicine in the home of the people. Then I feel that some, a lot of the of the talks here were about think about the patient, Think about what the patient is feeling and think how to help them in the real life. And this is an obsession for me to think about in the real life, what is happening and how could prevent some preventable damage.

Fredrik Brounéus:

Thanks, Angela. Ghita?

Ghita Benabdallah:

So I totally agree with you, Angela, and for me, I was very happy to see that all stakeholders were here. They were all well represented with their input on how to improve quality of data and to improve patient. So it was something that was very important and, of course, with the presentation of Sara's, it was so inspiring and it's to remind us our role as healthcare professionals, as parents, and it's very important to keep in mind that our health and the health of people is very important, and it's important to keep in mind that we need to be engaged in our self-care. We don't rely always on healthcare professionals.

Linda Härmark:

I've thought about the theme of this conference, how can you improve data capture? Because it all starts, if we want to improve the lives of patients, we need to have the right data to work with. We need to have quality data, but it's also very difficult to define what quality data is, and sometimes it's also very dependent on the context or even the drug– event combination that is reported. So my idea is about how can we more tailor-made the way we collect information so we actually get the data that really helps us do the good analysis and do the things that we want to do. I think that's a really eye- opener for me, and also what Sabine [Koch] talked about how can we make sure that we collect this data in a way so that a person that actually needs to give us the data also can give it in a way that they think is easy and they understand why it's important to give this data?

Fredrik Brounéus:

Thank you. Daniele?

Daniele Sartori:

What I liked about these days was that there was a lot of emphasis on collaboration and we opened yesterday saying, admitting, pharmacovigilance is a collaborative undertaking, and I quite reflected on the image of the cogwheel that Sara Riggare put out and how different stakeholders are dovetailed together and they of course move at different speeds, with patients moving impressively fast and policy moving a bit slower.

Daniele Sartori:

And then today, someone (I forget, I have a much better memory for faces than names, sorry), but there was a metaphor about data as oil and sort of. I started thinking about, well, cogwheels and oil and how data helps move this whole system together. And, as Linda said, what we ought to do is to improve the quality of the data that we capture to best serve the patients, and we've heard of many possible ways forward. But again, thinking about what was said today about learning health systems and how these sort of compel us to ask ourselves are we doing the right thing? Should we start thinking from scratch? And that sort of set the tone for how I listened to the conference.

Fredrik Brounéus:

I completely agree that this patient perspective was quite striking. So I would like to delve a little deeper into that, and I remember yesterday when Mikael Hoffman, he told us that he's a patient in his spare time and it just struck me that it's a hobby that I think many of us share. So, how many in here have taken a medicine or a vaccine – ever? Every one of us ... And how many have experienced an adverse drug reaction, ever? And how many have reported an adverse drug reaction as a patient? Well done, I have not, which I'm quite a bit ashamed of, since I'm working with #MedSafety Week. So we're all part-time patients, so to say, and yet patient engagement in pharmacovigilance and the patient perspective can still sound a bit difficult, challenging. And why is that?

Linda Härmark:

I'm not sure that it is so far away. I think it's very dependent on the sector that you work in and for the organization where you work. For the organization that I worked at before I joined the DSRU, which was the Netherlands' pharmacovigilance centre Lareb, we very early embraced the value of the patient and patient reporting and the patient voice, already in 2004. We started with that and we also, through the time we have introduced spontaneous reporting for patients. We also had patient representatives in our board so they can actually also help steer the direction of the organization.

Linda Härmark:

We also thought about and asked what kind of information just as Sara [Riggare] said, yeah, all the days that she needs to self-manage where is it possible to find the information that she needed? Because I think the information that patients need about adverse drug reactions can sometimes be very different from what a regulatory system think is important. They focus very much on the rare in series, which is also very terrible if it occurs. But I think patients are very interested in more information about frequently occurring but severe that have a big impact of the quality of life, because the chance that they will get a common ADR is much larger than that they will be that one in 10,000 or one in 20,000.

Linda Härmark:

And I think patients are very interested in knowing what should I do when I get an ADR? How can I manage this? Should I stop? Should I continue with the drug? What are alternative treatments? Can I try and treat the side effect in any way? So I think the patient's perspective can also help you to discover new areas where you want to generate knowledge and, in the end, I think the patient's perspective can also help you to discover new areas where you want to generate knowledge. And, in the end, I think it's also very important to get the knowledge to a place where someone who wants to access it also actually have access to it.

Fredrik Brounéus:

Angela.

Angela Caro Rojas:

I want to talk about the different perspective. Probably in low-income countries is a little difficult, and I worked in a hospital for something like 10 years as a medication safety officer and sometimes when you talk with patients, the patient said I don't know nothing about, and for the nurses or the pharmacists it's very difficult to give the information because the person probably is not well prepared for receiving the information. And I always talk about leadership. I feel that the leadership is very important. When the patient could feel that he or she has the responsibility of their health, maybe they could make some decisions about the health. But sometimes it's people that don't know, people that are too poor, people that don't have a person to take care of them. Then it's more difficult to say you have the possibility of responding by yourself for your medicines.

Angela Caro Rojas:

I had a story when I was studying epidemiology that I went to a very depressed area and I had an interview with a person that was maybe 80 years old. She didn't know how to read and we needed to draw a moon for the medicines that she needed to take at night, and and a plate of soup for the medication that it was to be taken with food and other kinds of things, and she was very, very, very poor and when we finished and we take all this medicine that was expired, we put it in garbage and said this is not possible, that you are using this, it is expired. And we explained some things. At the end, she only had one plantain in her kitchen. Kitchen is just a table and she took the plantain and said please receive this as thanks for your help. And I said, oh my gosh, it's the only food that she has and she's giving me because she considered that it's important what we are doing for her. That experience changed my life and I feel like it's a lot of help that the people need for using the medicines. She never thinks about an adverse reaction.

Angela Caro Rojas:

It is not a concept that patients could have, but the point is we need to understand what is the reality of a lot of patients, and, for sure, in low-income countries is so difficult, for people know about anything they are. They are working for having money. It is that all. Then, if they need to have a medication and they have the, they are lucky and have the possibility of have the medicine. How we are giving the instruction for taking it, for not having medication errors or for inspiring them to have a healthy life.

Angela Caro Rojas:

I feel that it's difficult to try to standardize patients and say every patient knows. I feel that we must understand realities and look for the support for every community. If it is inside of a hospital, it's easier, because you could teach them and invite them to report and listen to them. But outside and I feel that most of us are not in a hospital most of us are using medicines in our houses and we have a lot of information right now and people who have a device and internet have a lot of information. But we have millions of people that don't have internet, don't have any possibility of access to the information. Then healthcare workers in primary care have a lot of responsibility for informing how to use the medicine in the best way and if the medicine is not working, what to do, or if it is giving some damage to them, what to do. But it's a lot of different possibilities and it's a lot of possible answers that we as community on pharmacovigilance need to do.

Fredrik Brounéus:

Ghita.

Ghita Benabdallah:

Yes. So thank you, Angela, for all these comments. I would just say that, regarding this lack of knowledge of regarding people about ADRs, there is a lot of work that is done and currently doing with many countries low and middle income countries where a lot of teaching is done, the sensitization on the importance of reporting ADR and explaining why they have to do that, and since the early 20s, as I said, Angela, this concept of patient engagement was highlighted with WHO, the World Alliance for Patient Safety, and there is a lot of work that is done for these countries and a lot of sensitization explaining, and I think that things are going on well and we can see that patient reporting is very important in high-income countries, but also in the low-income countries, for example, in Morocco, we have reports from patients because we are talkative, as we said, we talk a lot. We have this possibility. It's very important to have this phone call when people can call each time, every time, and they can talk about this adverse event and we can catch all information and have quality data.

Fredrik Brounéus:

Thank you, Ghita.

Daniele Sartori:

Surely informing patients about the importance of reporting helps us. We collect reports and we analyze them and it can help them. What struck me was a bit I sort of perceived that the communication that we should have with patients to be a sort of a "help me, help you kind of situation. So we want patients to give us the information that we need to do our job. The patient also wants something in return, like what's in it for them to report adverse drug reactions. Yes, this is important because we can help identify new signals and so on.

Daniele Sartori:

But I feel like, ultimately, what we want to get is a situation where we've got patients who are well-informed, because we've learned yesterday that well-informed patients are generally more satisfied with the care that they receive. And the example you gave, Angela, was really striking, because in some cases you've got patients that are completely unaware that adverse drug reactions are a possibility, but then you've got patients who live with chronic conditions who are acutely aware of adverse drug reactions are a possibility. And so it feels like the communications that we deliver to patients has to be bidirectional, to use a word that I've learned today, in the sense that it has to be tailored to the kind of community that we're trying to target, to maximize benefits for them and to maximize benefits for us.

Fredrik Brounéus:

It really continues on the learning health systems: the primary patient engagement in health decisions on the individual level to improve health outcomes for the patient, but then that secondary patient engagement in the broader system decisions on the group level to improve the system. Do we have a learning PV system today or how could we better make use of secondary patient engagement? You gave an example, Linda, to have patients on the board, but are there other ways we could do it?

Angela Caro Rojas:

I have an example that I loved, it was called "expert patient and it is a patient who has been with a disease for I don't know 20 years and has the guide for other patients and it's wonderful because that person really knows what he's saying.

Angela Caro Rojas:

This patient said ah, if you feel this, the way that you could solve it is that way and in a circle of confidence, when we are having the same situation I mean, we are the patients with this disease and we really understand what is happening with the other and empathize with this person it's very easy to communicate.

Angela Caro Rojas:

I feel that everything in the life is communication, and the way to communicate with others is first, have enough confidence for saying what I am thinking, but additionally, to have this feedback. As you said, if we could have this confidence with patients, if we could offer them all the confidence and all the tools for communicating with us, it would be easy. And when I'm talking about this expert patient talking with other patients, it helps us a lot for the patients to identify adverse reactions or other kinds of mistakes that can occur, because they know, they really know what is happening inside of the life of that person and probably it's not exactly the same, because every person is different, but it's the most similar that they can find. Then I feel that to have this conversation between patients and between adverse reactions inside of the same group could be very helpful.

Linda Härmark:

I think there is quite a lot of patient involvement in different parts of the life cycle of a drug. I was lucky to be part of CIOMS 11, which was about patient involvement in drug development and safe use of drugs. We identified how patients can participate in the different steps throughout the whole life cycle and I also think the perception of involving patients nowadays is a bit different because now we also see as patients also one of the experts just as, like you know, the PV expert and the other expert and now we have also patient experts that have a special expertise, have a special viewpoint which they look from, which actually can contribute that in the end you get a better product, what that product might be. It's not only in reviewing risk minimization materials, but it can also be to see what kind of outcomes should we measure if we have a clinical trial, what is really a good outcome for patients living with a certain disease? What would they be happy from if that would be improved for them? So I think there's plenty of chance.

Linda Härmark:

I really feel that there is a shift in how also I think more the scientific community look at patient participation. In the past it was a must. You know, you write research proposals and you must include a patient representative. Write research proposal and you must include a patient representative. But now I think more and more people realize the actual value that it can bring to your product by including the patient perspective.

Ghita Benabdallah:

There's the role also of the patient that are in patient association and those have a voice. That is good. I remember in Lar eb in 2012 it's long time ago and it was about patient reporting and some representative patient association were there and their voice was heard and it was very important to have them and it was like they have the leadership for the other patient and when they were talking about reporting and all the patients were confident about that and it was a good thing to have other reports.

Fredrik Brounéus:

It's interesting that you bring up now patient reporting as well, Ghita. We have heard these past two days also that patient reporting is on the rise and that sometimes, sometimes even that healthcare professional reporting is going down a bit. bit was interesting also because we heard Tommy Emil Dzus told us about the study which showed them that the healthcare professionals and the patients, their narratives, they complement each other.

Angela Caro Rojas:

Exactly, exactly. I love that study. It was amazing. I love the qualitative studies a lot. I am going more to the narrative than the numbers. I am not very interested in numbers right now.

Angela Caro Rojas:

I love to listen to people, what the people are feeling, but the point is that it complements our vision. I mean, the healthcare professional's vision is a more anatomic vision, but the people is experiencing what is happening really. Then the experience is very important. The person who is living with a disease or living with an adverse drug reaction or something, is a person who has a life, who needs to work, who needs to go with his family or her family.

Angela Caro Rojas:

How I live in my experience using medicines is as important as the number or the signal or the symptom that the person is having. Then I feel that they both are complementary and maybe we need to be focused more in what are the expectations of the patient, what are the feelings of the patients, and not just about the number. Probably, if we are focusing both, we could have more information and maybe we could find that it is not an adverse drug reaction, it is a medication error because something happened and they used it in a bad way or something. Then I feel that probably we need to open a new door of qualitative research, thinking about what the people are feeling and what are the problems that we really need to solve to that people, and not just think about how it looks in a statistic graphic.

Daniele Sartori:

Well, we've seen yesterday a good example of qualitative research in HIV for dolutegravir [by Henry Zakumumpa] and that to me was quite interesting to hear that some patients might feel like I don't want to report because then they're going to withdraw the drug that works so well for me. So I'd rather endure adverse effects.

Linda Härmark:

I think the whole movement on patient empowerment and patients being more an active part of their treatment and maybe also sharing their experiences, what they have with drugs, I think that will continue. I'm not really sure if they're really going to report to our reporting systems because of course the numbers are increasing, but I think there are other ways that patients share their experiences and I think it's important for us as a community also to be able to collect more the data where people prefer to share it maybe than to try and change their behavior and channel them to us, because then we will never be fully successful. I think so. I think it's also a challenge for the pharmacovigilance community to see if patients are getting more and more interested in health and want to share their information. We also need to say how can we tap into their preferred ways of sharing it?

Ghita Benabdallah:

The use of the new tools, the AI, to make the reporting easy is one of also the explanation with the increase of patient reporting. Of course, the sensitization and all the work that is done by pharmacovigilance center, but these new tools, the apps that we have in the phone to make the thing easy. I believe that it is something that we need to keep and using this reporting system that goes directly to the pharmacovigilance center.

Ghita Benabdallah:

It's important to keep in mind that during the COVID we have seen the increased, huge, increased number of patient reports and something that was can quantify so you can see the impact of the importance of patient reporting. It was very it's a huge number that was reported all over the world, not only in specific countries, so we can see this impact.

Fredrik Brounéus:

I was wondering if we should imagine that we're taking a little trip in a time machine here on stage. So we've already heard some predictions for 2030 and 2035 vision, so shall we aim even further into the future, say 2040, just to stick our chin out there. And so, we're sitting again at the fireside chat yes, after the mid-year symposium, and I I would like to ask you what you think would have been the theme of this 2040 symposium. What are the hot topics and trends and, if you like, what topics are no longer hot? Are we replaced by digital twins on stage? Is there's a fireside ChatGPT? Difficult, I know, and it will be on the pod, so no pressure.

Daniele Sartori:

I'm always kind of guarded when we talk about speculating about the future. There's this concept about retrofuturism that I think is very appealing, which is our conception of the future in the past. And so, if you read, there's an Italian author, Salgari, that wrote about the wonders of the year 2000. And then there was this electricity that was transmitted by air, and then in the end – spoiler alert – the protagonist succumbs to the effects of essentially Wi-Fi.

Daniele Sartori:

But nowadays we know that Wi-Fi is fine, so obviously we tend to sort of speculate quite wildly when we talk about the future, but I thought that we that if I have to venture a bit into the future, I think what we've heard today about where we see the direction in which we're heading is that spontaneous reports seem to fit their niche and they may not always be fit for purpose. But where we're going, it seems, is that we're trying to combine individual case safety reports with other sorts of evidence. And we've seen that in the Netherlands with electronic health records and we've seen how population-level data can help you inform pharmacovigilance in individual cases. So the way that I view the future, heavily biased by these past two days, is we're going in a direction where we're going to incorporate more and more the usefulness of electronic health records, sort of supplementing the limitations of individual case safety reports.

Linda Härmark:

I can maybe add to that because my thoughts are very similar today and we talked about data quality, data capture, data sources, methodology, and I hope in 15 years that we have actually made that step, that we have a lot of data sources that we can use, that we have good methodology, so we can actually generate a lot of useful knowledge about adverse drug reactions in medicine. So I hope we would have discussions around dissemination of that knowledge. How can we really get that knowledge to a point in care where it can be used? How can we incorporate our knowledge in these clinical decision-making tools? How can we ensure that people can maybe do their own risk profile that they can fill in you know, I have this and this and this and this. What is my chance of having this, so that we are more on the disseminating knowledge side instead of generating knowledge, where we are a bit now.

Angela Caro Rojas:

I suppose and I want to think that maybe we'll be more focused on humanity.

Angela Caro Rojas:

I mean, we have enough tools, of technology and everything is going well. In that way, Then we could be focused more on humanity and how to be more sensitive with patients and how we could understand the reality of the patients, and I want to think that we are working a lot in collaboration. I want to think that in that moment, we have not just one regulatory agency for Europe, but we have one regulatory agency for all Africa and one regulatory agency for all Latin America, and the knowledge inside of the agency could be shared for all the world and is easier to everyone. And I want to think that in that moment it's not inequity and are more people helping other countries, other regions, and the collaboration is very, very important for everyone there. And the industry is focused in support, the regulatory agency, a regulatory agency, support, supporting the academy, and everyone are working in the same line because understood that the most important is the humanity, the people, who is using the medicine. I want to think about that, but I'm not sure.

Fredrik Brounéus:

Sounds hopeful. Ghita?

Ghita Benabdallah:

I agree with you all, and for me also, it would be, of course, the humanity, but I wish that countries low and middle income countries could discuss about their big database with all the signals that they will be able to detect and to share, and to have a strengthened collaboration between pharmacovigilance and all the other stakeholders and to keep the role of pharmacovigilance always at the high level. And to not have new pandemic and don't discuss about new vaccines, so things like that.

Fredrik Brounéus:

That was a very good closing remark. Thank you! Please help me thank our great panel, Daniele, Angela, Linda, Ghita.

Fredrik Brounéus:

That's all for now, but if you'd like to learn more about the mid-year symposium and the topics and speakers, we've put together some links for you in the episode show notes.

Fredrik Brounéus:

Apart from the Drug Safety Matters podcast, we have our pharmacovigilance magazine, Uppsala Reports. Visit uppsalareports. org to stay up to date with news, research and trends in the field. And don't forget to subscribe to the newsletter for the latest articles. If you have any questions or suggestions for the podcast or the magazine, please reach out on Facebook, LinkedIn, Bluesky or X. You can also visit our website to learn more about what we do to promote safer use of medicines and vaccines for everyone, everywhere. If you like the podcast, please subscribe to make sure you won't miss an episode and spread the word so other listeners can find us too. For Drug Safety Matters, I'm Fredrik Brouneus. Thanks for listening..

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