June 19, 2025 • 34 mins
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.
Want to know more?
- Visit the official website of the 2025 ISoP Mid-Year Symposium to learn more about its sessions, speakers and chairs.
- Not patient but im-patient – read about Sara Riggare’s research on patient engagement and other topics.
- Listen to Henry Zakumumpa talk about his study on adverse event reporting quality in Uganda in this 2025 episode of Drug Safety Matters.
- Read about the PhD project of Tommy Emil Dzus, Improving causality assessment in pharmacovigilance for safe and sustainable use of medicines in health emergencies, at Oslo Metropolitan University, Norway.
- Sabine Koch is Head of the Department of Learning, Informatics, Management and Ethics (LIME), at Karolinska Institutet, Stockholm.
- Details on Mikael Hoffman's research can be found on his profile page on ResearchGate.
- Take a look at what’s in store for participants at the 24th Annual Meeting of ISoP in Cairo, on October 24–27, 2025.
- Visit the websites of the Drug Safety Research Unit (DSRU), ISoP, Centre Anti Poison et Pharmacovigilance du Maroc, and Uppsala Monitoring Centre, to find out more about their work.
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About UMC
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Fredrik Brounéus (00:17):
Welcome to Drug Safety Matters, a podcast
by Uppsala Monitoring Centrewhere we explore current issues
in pharmacovigilance and patientsafety.
I'm Fredrik Brouneus and you'relistening to a special episode
recorded at the mid-yearsymposium of the International
Society of Pharmacovigilance,ISoP, which was held here in
Uppsala about a month ago.
(00:37):
The theme of the symposium was"Improving Information Capture
for Safer Use of Medicines andwas a collaboration between ISoP
and Uppsala Monitoring Centre.
What you're about to hear isthe concluding fireside chat,
which I had the pleasure tomoderate, with Angela Caro Rojas
, president of ISoP, lindaHermark, director of the Drug
(00:59):
Safety Research Unit DSRU in theUK, rita Benabdallah of the
National PharmacovigilanceCentre of Morocco and member of
the ISoP Advisory Board.
And Daniele Sartori, seniorPharmacovigilance Researcher at
Uppsala Monitoring Centre.
In the episode show notes youwill find links to some of the
studies and people that werementioned during the discussion.
(01:20):
And now over to the stage at theconference venue here in
Uppsala, and in order ofappearance Angela, Ghita, Linda
and Daniele.
So, a warm-up question for thepanel: We've had two quite
intense days here.
Any personal takeaways,highlights, surprises?
Angela Caro Rojas (01:48):
I am really surprised how all the talks
think a little in patientengagement.
I feel that yesterday wasamazing the talk from Sara
[Riggare] about patients, and Ialways say the same: we are here
for the patients.
That is the reality.
We are here to support patientsin having a medication, safer
(02:10):
use, and I feel that we need tobe really focused in what the
patient is feeling, what thepatient is thinking and how we
could act in coherence of thesefeelings.
Every patient is different.
When I think about patients, Ithink about my mother.
She has diabetes.
(02:32):
It's a chronic disease butshe's very well controlled.
Everything is going well, butsometimes she feels tired of
taking a lot of medicines.
Or she says (02:43):
I don't want to control again my blood.
I forgot the medication and Isays "it happens to her.
That is my mom.
I try to be aware of what ishappening with her.
What happened with a lot ofpeople that don't have one
person to take care of them?
(03:04):
And maybe we are thinking aboutdatabases and how detect
signals and we are not thinkingabout what is the essential of
the use of the medicine in thehome of the people.
Then I feel that some, a lot ofthe of the talks here were
about think about the patient,Think about what the patient is
(03:28):
feeling and think how to helpthem in the real life.
And this is an obsession for meto think about in the real life
, what is happening and howcould prevent some preventable
damage.
Fredrik Brounéus (03:41):
Thanks, Angela .
Ghita?
Ghita Benabdallah (03:43):
So I totally agree with you, Angela, and for
me, I was very happy to see thatall stakeholders were here.
They were all well representedwith their input on how to
improve quality of data and toimprove patient.
So it was something that wasvery important and, of course,
(04:06):
with the presentation of Sara's,it was so inspiring and it's to
remind us our role ashealthcare professionals, as
parents, and it's very importantto keep in mind that our health
and the health of people isvery important, and it's
(04:29):
important to keep in mind thatwe need to be engaged in our
self-care.
We don't rely always onhealthcare professionals.
Linda Härmark (04:42):
I've thought about the theme of this
conference, how can you improvedata capture?
Because it all starts, if wewant to improve the lives of
patients, we need to have theright data to work with.
We need to have quality data,but it's also very difficult to
define what quality data is, andsometimes it's also very
dependent on the context or eventhe drug– event combination
(05:04):
that is reported.
So my idea is about how can wemore tailor-made the way we
collect information so weactually get the data that
really helps us do the goodanalysis 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 howcan we make sure that we collect
(05:26):
this data in a way so that aperson that actually needs to
give us the data also can giveit in a way that they think is
easy and they understand whyit's important to give this data
?
Fredrik Brounéus (05:40):
Thank you.
Daniele?
Daniele Sartori (05:42):
What I liked about these days was that there
was a lot of emphasis oncollaboration and we opened
yesterday saying, admitting,pharmacovigilance is a
collaborative undertaking, and Iquite reflected on the image of
the cogwheel that Sara Riggareput out and how different
(06:03):
stakeholders are dovetailedtogether and they of course move
at different speeds, withpatients moving impressively
fast and policy moving a bitslower.
And then today, someone (Iforget, I have a much better
memory for faces than names,sorry), but there was a metaphor
about data as oil and sort of.
(06:24):
I started thinking about, well,cogwheels and oil and how data
helps move this whole systemtogether.
And, as Linda said, what weought to do is to improve the
quality of the data that wecapture to best serve the
patients, and we've heard ofmany possible ways forward.
But again, thinking about whatwas said today about learning
(06:50):
health systems and how thesesort of compel us to ask
ourselves are we doing the rightthing?
Should we start thinking fromscratch?
And that sort of set the tonefor how I listened to the
conference.
Fredrik Brounéus (07:05):
I completely agree that this patient
perspective was quite striking.
So I would like to delve alittle deeper into that, and I
remember yesterday when MikaelHoffman, he told us that he's a
patient in his spare time and itjust struck me that it's a
(07:27):
hobby that I think many of usshare.
So, how many in here have takena medicine or a vaccine – ever?
Every one of us .
.
.
And how many have experiencedan adverse drug reaction, ever?
And how many have reported anadverse drug reaction as a
patient?
Well done, I have not, whichI'm quite a bit ashamed of,
(07:55):
since I'm working with#MedSafety Week.
So we're all part-time patients, so to say, and yet patient
engagement in pharmacovigilanceand the patient perspective can
still sound a bit difficult,challenging.
And why is that?
Linda Härmark (08:12):
I'm not sure that it is so far away.
I think it's very dependent onthe sector that you work in and
for the organization where youwork.
For the organization that Iworked at before I joined the
DSRU, which was the Netherlands'pharmacovigilance centre Lareb,
we very early embraced thevalue of the patient and patient
reporting and the patient voice, already in 2004.
(08:34):
We started with that and wealso, through the time we have
introduced spontaneous reportingfor patients.
We also had patientrepresentatives in our board so
they can actually also helpsteer the direction of the
organization.
We also thought about and askedwhat kind of information just as
Sara [Riggare] said, yeah, allthe days that she needs to
(08:56):
self-manage where is it possibleto find the information that
she needed?
Because I think the informationthat patients need about
adverse drug reactions cansometimes be very different from
what a regulatory system thinkis important.
They focus very much on therare in series, which is also
very terrible if it occurs.
(09:17):
But I think patients are veryinterested in more information
about frequently occurring butsevere that have a big impact of
the quality of life, becausethe chance that they will get a
common ADR is much larger thanthat they will be that one in
10,000 or one in 20,000.
(09:38):
And I think patients are veryinterested 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 sideeffect in any way?
So I think the patient'sperspective can also help you to
discover new areas where youwant to generate knowledge and,
in the end, I think thepatient's perspective can also
help you to discover new areaswhere you want to generate
knowledge.
And, in the end, I think it'salso very important to get the
(10:00):
knowledge to a place wheresomeone who wants to access it
also actually have access to it.
Fredrik Brounéus (10:08):
Angela.
Angela Caro Rojas (10:10):
I want to talk about the different
perspective.
Probably in low-incomecountries is a little difficult,
and I worked in a hospital forsomething like 10 years as a
medication safety officer andsometimes when you talk with
(10:30):
patients, the patient said Idon't know nothing about, and
for the nurses or thepharmacists it's very difficult
to give the information becausethe person probably is not well
prepared for receiving theinformation.
And I always talk aboutleadership.
(10:51):
I feel that the leadership isvery important.
When the patient could feelthat he or she has the
responsibility of their health,maybe they could make some
decisions about the health.
But sometimes it's people thatdon't know, people that are too
(11:20):
poor, people that don't have aperson to take care of them.
Then it's more difficult to sayyou have the possibility of
responding by yourself for yourmedicines.
I had a story when I wasstudying epidemiology that I
went to a very depressed areaand I had an interview with a
(11:44):
person that was maybe 80 yearsold.
She didn't know how to read andwe needed to draw a moon for
the medicines that she needed totake at night, and and a plate
of soup for the medication thatit was to be taken with food and
(12:05):
other kinds of things, and shewas very, very, very poor and
when we finished and we take allthis medicine that was expired,
we put it in garbage and saidthis is not possible, that you
are using this, it is expired.
(12:26):
And we explained some things.
At the end, she only had oneplantain in her kitchen.
Kitchen is just a table and shetook the plantain and said
please receive this as thanksfor your help.
And I said, oh my gosh, it'sthe only food that she has and
(12:48):
she's giving me because sheconsidered that it's important
what we are doing for her.
That experience changed my lifeand I feel like it's a lot of
help that the people need forusing the medicines.
She never thinks about anadverse reaction.
It is not a concept thatpatients could have, but the
(13:11):
point is we need to understandwhat is the reality of a lot of
patients, and, for sure, inlow-income countries is so
difficult, for people know aboutanything they are.
They are working for havingmoney.
It is that all.
Then, if they need to have amedication and they have the,
they are lucky and have thepossibility of have the medicine
(13:35):
.
How we are giving theinstruction for taking it, for
not having medication errors orfor inspiring them to have a
healthy life.
I feel that it's difficult totry to standardize patients and
say every patient knows.
I feel that we must understandrealities and look for the
(13:59):
support for every community.
If it is inside of a hospital,it's easier, because you could
teach them and invite them toreport and listen to them.
But outside and I feel thatmost of us are not in a hospital
most of us are using medicinesin our houses and we have a lot
(14:20):
of information right now andpeople who have a device and
internet have a lot ofinformation.
But we have millions of peoplethat don't have internet, don't
have any possibility of accessto the information.
Then healthcare workers inprimary care have a lot of
responsibility for informing howto use the medicine in the best
(14:41):
way and if the medicine is notworking, what to do, or if it is
giving some damage to them,what to do.
But it's a lot of differentpossibilities and it's a lot of
possible answers that we ascommunity on pharmacovigilance
need to do.
Fredrik Brounéus (14:59):
Ghita.
Ghita Benabdallah (15:00):
Yes.
So thank you, Angela, for allthese 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 withmany countries low and middle
income countries where a lot ofteaching is done, the
(15:22):
sensitization on the importanceof reporting ADR and explaining
why they have to do that, andsince the early 20s, as I said,
Angela, this concept of patientengagement was highlighted with
WHO, the World Alliance forPatient Safety, and there is a
lot of work that is done forthese countries and a lot of
(15:47):
sensitization explaining, and Ithink that things are going on
well and we can see that patientreporting is very important in
high-income countries, but alsoin the low-income countries, for
example, in Morocco, we havereports from patients because we
(16:07):
are talkative, as we said, wetalk a lot.
We have this possibility.
It's very important to havethis phone call when people can
call each time, every time, andthey can talk about this adverse
event and we can catch allinformation and have quality
data.
Fredrik Brounéus (16:27):
Thank you, Ghita.
Daniele Sartori (16:29):
Surely informing patients about the
importance of reporting helps us.
We collect reports and weanalyze them and it can help
them.
What struck me was a bit I sortof perceived that the
communication that we shouldhave with patients to be a sort
(16:50):
of a "help me, help you kind ofsituation.
So we want patients to give usthe information that we need to
do our job.
The patient also wantssomething in return, like what's
in it for them to reportadverse drug reactions.
Yes, this is important becausewe can help identify new signals
and so on.
But I feel like, ultimately,what we want to get is a
(17:13):
situation where we've gotpatients who are well-informed,
because we've learned yesterdaythat well-informed patients are
generally more satisfied withthe care that they receive.
And the example you gave,Angela, was really striking,
because in some cases you've gotpatients that are completely
unaware that adverse drugreactions are a possibility, but
(17:35):
then you've got patients wholive with chronic conditions who
are acutely aware of adversedrug reactions are a possibility
.
And so it feels like thecommunications that we deliver
to patients has to bebidirectional, to use a word
that I've learned today, in thesense that it has to be tailored
(17:56):
to the kind of community thatwe're trying to target, to
maximize benefits for them andto maximize benefits for us.
Fredrik Brounéus (18:05):
It really continues on the learning health
systems (18:09):
the primary patient engagement in health decisions
on the individual level toimprove health outcomes for the
patient, but then that secondarypatient engagement in the
broader system decisions on thegroup level to improve the
system.
Do we have a learning PV systemtoday or how could we better
(18:33):
make use of secondary patientengagement?
You gave an example, Linda, tohave patients on the board, but
are there other ways we could doit?
Angela Caro Rojas (18:49):
I have an example that I loved, it was
called "expert patient and it isa patient who has been with a
disease for I don't know 20years and has the guide for
other patients and it'swonderful because that person
really knows what he's saying.
This patient said ah, if youfeel this, the way that you
(19:12):
could solve it is that way andin a circle of confidence, when
we are having the same situationI mean, we are the patients
with this disease and we reallyunderstand what is happening
with the other and empathizewith this person it's very easy
(19:34):
to communicate.
I feel that everything in thelife is communication, and the
way to communicate with othersis first, have enough confidence
for saying what I am thinking,but additionally, to have this
feedback.
As you said, if we could havethis confidence with patients,
(19:57):
if we could offer them all theconfidence and all the tools for
communicating with us, it wouldbe easy.
And when I'm talking about thisexpert patient talking with
other patients, it helps us alot for the patients to identify
adverse reactions or otherkinds of mistakes that can occur
(20:19):
, because they know, they reallyknow what is happening inside
of the life of that person andprobably it's not exactly the
same, because every person isdifferent, but it's the most
similar that they can find.
Then I feel that to have thisconversation between patients
and between adverse reactionsinside of the same group could
(20:42):
be very helpful.
Linda Härmark (20:44):
I think there is quite a lot of patient
involvement in different partsof the life cycle of a drug.
I was lucky to be part of CIOMS11, which was about patient
involvement in drug developmentand safe use of drugs.
We identified how patients canparticipate in the different
steps throughout the whole lifecycle and I also think the
(21:06):
perception of involving patientsnowadays is a bit different
because now we also see aspatients also one of the experts
just as, like you know, the PVexpert and the other expert and
now we have also patient expertsthat have a special expertise,
have a special viewpoint whichthey look from, which actually
can contribute that in the endyou get a better product, what
(21:27):
that product might be.
It's not only in reviewing riskminimization materials, but it
can also be to see what kind ofoutcomes should we measure if we
have a clinical trial, what isreally a good outcome for
patients living with a certaindisease?
What would they be happy fromif that would be improved for
them?
So I think there's plenty ofchance.
I really feel that there is ashift in how also I think more
(21:49):
the scientific community look atpatient participation.
In the past it was a must.
You know, you write researchproposals and you must include a
patient representative.
Write research proposal and youmust include a patient
representative.
But now I think more and morepeople realize the actual value
that it can bring to yourproduct by including the patient
perspective.
Ghita Benabdallah (22:08):
There's the role also of the patient that
are in patient association andthose have a voice.
That is good.
I remember in Lar eb in 2012it's long time ago and it was
about patient reporting and somerepresentative patient
association were there and theirvoice was heard and it was very
(22:32):
important to have them and itwas like they have the
leadership for the other patientand when they were talking
about reporting and all thepatients were confident about
that and it was a good thing tohave other reports.
Fredrik Brounéus (22:51):
It's interesting that you bring up
now patient reporting as well,Ghita.
We have heard these past twodays also that patient reporting
is on the rise and thatsometimes, sometimes even that
healthcare professionalreporting is going down a bit.
bit was interesting alsobecause we heard Tommy Emil Dzus
(23:11):
told us about the study whichshowed them that the healthcare
professionals and the patients,their narratives, they
complement each other.
Angela Caro Rojas (23:19):
Exactly, exactly.
I love that study.
It was amazing.
I love the qualitative studiesa lot.
I am going more to thenarrative than the numbers.
I am not very interested innumbers right now.
I love to listen to people, whatthe people are feeling, but the
(23:41):
point is that it complementsour vision.
I mean, the healthcareprofessional's vision is a more
anatomic vision, but the peopleis experiencing what is
happening really.
Then the experience is veryimportant.
The person who is living with adisease or living with an
adverse drug reaction orsomething, is a person who has a
(24:05):
life, who needs to work, whoneeds to go with his family or
her family.
How I live in my experienceusing medicines is as important
as the number or the signal orthe symptom that the person is
(24:28):
having.
Then I feel that they both arecomplementary and maybe we need
to be focused more in what arethe expectations of the patient,
what are the feelings of thepatients, and not just about the
number.
Probably, if we are focusingboth, we could have more
(24:49):
information and maybe we couldfind that it is not an adverse
drug reaction, it is amedication error because
something happened and they usedit in a bad way or something.
Then I feel that probably weneed to open a new door of
qualitative research, thinkingabout what the people are
feeling and what are theproblems that we really need to
(25:12):
solve to that people, and notjust think about how it looks in
a statistic graphic.
Daniele Sartori (25:20):
Well, we've seen yesterday a good example of
qualitative research in HIV fordolutegravir [by Henry
Zakumumpa] and that to me wasquite interesting to hear that
some patients might feel like Idon't want to report because
then they're going to withdrawthe drug that works so well for
me.
So I'd rather endure adverseeffects.
Linda Härmark (25:40):
I think the whole movement on patient empowerment
and patients being more anactive part of their treatment
and maybe also sharing theirexperiences, what they have with
drugs, I think that willcontinue.
I'm not really sure if they'rereally going to report to our
reporting systems because ofcourse the numbers are
increasing, but I think thereare other ways that patients
share their experiences and Ithink it's important for us as a
(26:03):
community also to be able tocollect more the data where
people prefer to share it maybethan 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 challengefor the pharmacovigilance
community to see if patients aregetting more and more
interested in health and want toshare their information.
(26:25):
We also need to say how can wetap into their preferred ways of
sharing it?
Ghita Benabdallah (26:32):
The use of the new tools, the AI, to make
the reporting easy is one ofalso the explanation with the
increase of patient reporting.
Of course, the sensitizationand all the work that is done by
pharmacovigilance center, butthese new tools, the apps that
we have in the phone to make thething easy.
(26:53):
I believe that it is somethingthat we need to keep and using
this reporting system that goesdirectly to the
pharmacovigilance center.
It's important to keep in mindthat during the COVID we have
seen the increased, huge,increased number of patient
(27:13):
reports and something that wascan quantify so you can see the
impact of the importance ofpatient reporting.
It was very it's a huge numberthat was reported all over the
world, not only in specificcountries, so we can see this
impact.
Fredrik Brounéus (27:36):
I was wondering if we should imagine
that we're taking a little tripin a time machine here on stage.
So we've already heard somepredictions for 2030 and 2035
vision, so shall we aim evenfurther into the future, say
2040, just to stick our chin outthere.
(28:02):
And so, we're sitting again atthe fireside chat yes, after the
mid-year symposium, and I Iwould like to ask you what you
think would have been the themeof this 2040 symposium.
What are the hot topics andtrends and, if you like, what
(28:22):
topics are no longer hot?
Are we replaced by digitaltwins on stage?
Is there's a fireside ChatGPT?
Difficult, I know, and it willbe on the pod, so no pressure.
Daniele Sartori (28:39):
I'm always kind of guarded when we talk about
speculating about the future.
There's this concept aboutretrofuturism that I think is
very appealing, which is ourconception of the future in the
past.
And so, if you read, there's anItalian author, Salgari, that
wrote about the wonders of theyear 2000.
And then there was thiselectricity that was transmitted
(29:01):
by air, and then in the end –spoiler alert – the protagonist
succumbs to the effects ofessentially Wi-Fi.
But nowadays we know that Wi-Fiis fine, so obviously we tend to
sort of speculate quite wildlywhen we talk about the future,
but I thought that we that if Ihave to venture a bit into the
(29:25):
future, I think what we've heardtoday about where we see the
direction in which we're headingis that spontaneous reports
seem to fit their niche and theymay not always be fit for
purpose.
But where we're going, it seems, is that we're trying to
combine individual case safetyreports with other sorts of
(29:47):
evidence.
And we've seen that in theNetherlands with electronic
health records and we've seenhow population-level data can
help you informpharmacovigilance in individual
cases.
So the way that I view thefuture, heavily biased by these
past two days, is we're going ina direction where we're going
(30:13):
to incorporate more and more theusefulness of electronic health
records, sort of supplementingthe limitations of individual
case safety reports.
Linda Härmark (30:23):
I can maybe add to that because my thoughts are
very similar today and we talkedabout data quality, data
capture, data sources,methodology, and I hope in 15
years that we have actually madethat step, that we have a lot
of data sources that we can use,that we have good methodology,
so we can actually generate alot of useful knowledge about
adverse drug reactions inmedicine.
(30:43):
So I hope we would havediscussions around dissemination
of that knowledge.
How can we really get thatknowledge to a point in care
where it can be used?
How can we incorporate ourknowledge in these clinical
decision-making tools?
How can we ensure that peoplecan maybe do their own risk
profile that they can fill inyou know, I have this and this
(31:04):
and this and this.
What is my chance of havingthis, so that we are more on the
disseminating knowledge sideinstead of generating knowledge,
where we are a bit now.
Angela Caro Rojas (31:16):
I suppose and I want to think that maybe
we'll be more focused onhumanity.
I mean, we have enough tools, oftechnology and everything is
going well.
In that way, Then we could befocused more on humanity and how
to be more sensitive withpatients and how we could
understand the reality of thepatients, and I want to think
(31:38):
that we are working a lot incollaboration.
I want to think that in thatmoment, we have not just one
regulatory agency for Europe,but we have one regulatory
agency for all Africa and oneregulatory agency for all Latin
America, and the knowledgeinside of the agency could be
(31:59):
shared for all the world and iseasier to everyone.
And I want to think that inthat moment it's not inequity
and are more people helpingother countries, other regions,
and the collaboration is very,very important for everyone
there.
And the industry is focused insupport, the regulatory agency,
(32:24):
a regulatory agency, support,supporting the academy, and
everyone are working in the sameline because understood that
the most important is thehumanity, the people, who is
using the medicine.
I want to think about that, butI'm not sure.
Fredrik Brounéus (32:40):
Sounds hopeful .
Ghita?
Ghita Benabdallah (32:42):
I agree with you all, and for me also, it
would be, of course, thehumanity, but I wish that
countries low and middle incomecountries could discuss about
their big database with all thesignals that they will be able
to detect and to share, and tohave a strengthened
(33:06):
collaboration betweenpharmacovigilance and all the
other stakeholders and to keepthe role of pharmacovigilance
always at the high level.
And to not have new pandemicand don't discuss about new
vaccines, so things like that.
Fredrik Brounéus (33:27):
That was a very good closing remark.
Thank you! Please help me thankour great panel, Daniele,
Angela, Linda, Ghita.
That's all for now, but if you'dlike to learn more about the
mid-year symposium and thetopics and speakers, we've put
(33:49):
together some links for you inthe episode show notes.
Apart from the Drug SafetyMatters podcast, we have our
pharmacovigilance magazine,Uppsala Reports.
Visit uppsalareports.
(34:11):
org to stay up to date with news, research and trends in the
field.
And don't forget to subscribeto the newsletter for the latest
articles.
If you have any questions orsuggestions for the podcast or
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You can also visit our websiteto learn more about what we do
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(34:31):
For Drug Safety Matters, I'mFredrik Brouneus.
Thanks for listening.
.
Welcome to Drug Safety Matters, a podcast
by Uppsala Monitoring Centrewhere we explore current issues
in pharmacovigilance and patientsafety.
I'm Fredrik Brouneus and you'relistening to a special episode
recorded at the mid-yearsymposium of the International
Society of Pharmacovigilance,ISoP, which was held here in
Uppsala about a month ago.
(00:37):
The theme of the symposium was"Improving Information Capture
for Safer Use of Medicines andwas a collaboration between ISoP
and Uppsala Monitoring Centre.
What you're about to hear isthe concluding fireside chat,
which I had the pleasure tomoderate, with Angela Caro Rojas
, president of ISoP, lindaHermark, director of the Drug
(00:59):
Safety Research Unit DSRU in theUK, rita Benabdallah of the
National PharmacovigilanceCentre of Morocco and member of
the ISoP Advisory Board.
And Daniele Sartori, seniorPharmacovigilance Researcher at
Uppsala Monitoring Centre.
In the episode show notes youwill find links to some of the
studies and people that werementioned during the discussion.
(01:20):
And now over to the stage at theconference venue here in
Uppsala, and in order ofappearance Angela, Ghita, Linda
and Daniele.
So, a warm-up question for thepanel: We've had two quite
intense days here.
Any personal takeaways,highlights, surprises?
Angela Caro Rojas (01:48):
I am really surprised how all the talks
think a little in patientengagement.
I feel that yesterday wasamazing the talk from Sara
[Riggare] about patients, and Ialways say the same: we are here
for the patients.
That is the reality.
We are here to support patientsin having a medication, safer
(02:10):
use, and I feel that we need tobe really focused in what the
patient is feeling, what thepatient is thinking and how we
could act in coherence of thesefeelings.
Every patient is different.
When I think about patients, Ithink about my mother.
She has diabetes.
(02:32):
It's a chronic disease butshe's very well controlled.
Everything is going well, butsometimes she feels tired of
taking a lot of medicines.
Or she says (02:43):
I don't want to control again my blood.
I forgot the medication and Isays "it happens to her.
That is my mom.
I try to be aware of what ishappening with her.
What happened with a lot ofpeople that don't have one
person to take care of them?
(03:04):
And maybe we are thinking aboutdatabases and how detect
signals and we are not thinkingabout what is the essential of
the use of the medicine in thehome of the people.
Then I feel that some, a lot ofthe of the talks here were
about think about the patient,Think about what the patient is
(03:28):
feeling and think how to helpthem in the real life.
And this is an obsession for meto think about in the real life
, what is happening and howcould prevent some preventable
damage.
Fredrik Brounéus (03:41):
Thanks, Angela .
Ghita?
Ghita Benabdallah (03:43):
So I totally agree with you, Angela, and for
me, I was very happy to see thatall stakeholders were here.
They were all well representedwith their input on how to
improve quality of data and toimprove patient.
So it was something that wasvery important and, of course,
(04:06):
with the presentation of Sara's,it was so inspiring and it's to
remind us our role ashealthcare professionals, as
parents, and it's very importantto keep in mind that our health
and the health of people isvery important, and it's
(04:29):
important to keep in mind thatwe need to be engaged in our
self-care.
We don't rely always onhealthcare professionals.
Linda Härmark (04:42):
I've thought about the theme of this
conference, how can you improvedata capture?
Because it all starts, if wewant to improve the lives of
patients, we need to have theright data to work with.
We need to have quality data,but it's also very difficult to
define what quality data is, andsometimes it's also very
dependent on the context or eventhe drug– event combination
(05:04):
that is reported.
So my idea is about how can wemore tailor-made the way we
collect information so weactually get the data that
really helps us do the goodanalysis 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 howcan we make sure that we collect
(05:26):
this data in a way so that aperson that actually needs to
give us the data also can giveit in a way that they think is
easy and they understand whyit's important to give this data
?
Fredrik Brounéus (05:40):
Thank you.
Daniele?
Daniele Sartori (05:42):
What I liked about these days was that there
was a lot of emphasis oncollaboration and we opened
yesterday saying, admitting,pharmacovigilance is a
collaborative undertaking, and Iquite reflected on the image of
the cogwheel that Sara Riggareput out and how different
(06:03):
stakeholders are dovetailedtogether and they of course move
at different speeds, withpatients moving impressively
fast and policy moving a bitslower.
And then today, someone (Iforget, I have a much better
memory for faces than names,sorry), but there was a metaphor
about data as oil and sort of.
(06:24):
I started thinking about, well,cogwheels and oil and how data
helps move this whole systemtogether.
And, as Linda said, what weought to do is to improve the
quality of the data that wecapture to best serve the
patients, and we've heard ofmany possible ways forward.
But again, thinking about whatwas said today about learning
(06:50):
health systems and how thesesort of compel us to ask
ourselves are we doing the rightthing?
Should we start thinking fromscratch?
And that sort of set the tonefor how I listened to the
conference.
Fredrik Brounéus (07:05):
I completely agree that this patient
perspective was quite striking.
So I would like to delve alittle deeper into that, and I
remember yesterday when MikaelHoffman, he told us that he's a
patient in his spare time and itjust struck me that it's a
(07:27):
hobby that I think many of usshare.
So, how many in here have takena medicine or a vaccine – ever?
Every one of us .
.
.
And how many have experiencedan adverse drug reaction, ever?
And how many have reported anadverse drug reaction as a
patient?
Well done, I have not, whichI'm quite a bit ashamed of,
(07:55):
since I'm working with#MedSafety Week.
So we're all part-time patients, so to say, and yet patient
engagement in pharmacovigilanceand the patient perspective can
still sound a bit difficult,challenging.
And why is that?
Linda Härmark (08:12):
I'm not sure that it is so far away.
I think it's very dependent onthe sector that you work in and
for the organization where youwork.
For the organization that Iworked at before I joined the
DSRU, which was the Netherlands'pharmacovigilance centre Lareb,
we very early embraced thevalue of the patient and patient
reporting and the patient voice, already in 2004.
(08:34):
We started with that and wealso, through the time we have
introduced spontaneous reportingfor patients.
We also had patientrepresentatives in our board so
they can actually also helpsteer the direction of the
organization.
We also thought about and askedwhat kind of information just as
Sara [Riggare] said, yeah, allthe days that she needs to
(08:56):
self-manage where is it possibleto find the information that
she needed?
Because I think the informationthat patients need about
adverse drug reactions cansometimes be very different from
what a regulatory system thinkis important.
They focus very much on therare in series, which is also
very terrible if it occurs.
(09:17):
But I think patients are veryinterested in more information
about frequently occurring butsevere that have a big impact of
the quality of life, becausethe chance that they will get a
common ADR is much larger thanthat they will be that one in
10,000 or one in 20,000.
(09:38):
And I think patients are veryinterested 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 sideeffect in any way?
So I think the patient'sperspective can also help you to
discover new areas where youwant to generate knowledge and,
in the end, I think thepatient's perspective can also
help you to discover new areaswhere you want to generate
knowledge.
And, in the end, I think it'salso very important to get the
(10:00):
knowledge to a place wheresomeone who wants to access it
also actually have access to it.
Fredrik Brounéus (10:08):
Angela.
Angela Caro Rojas (10:10):
I want to talk about the different
perspective.
Probably in low-incomecountries is a little difficult,
and I worked in a hospital forsomething like 10 years as a
medication safety officer andsometimes when you talk with
(10:30):
patients, the patient said Idon't know nothing about, and
for the nurses or thepharmacists it's very difficult
to give the information becausethe person probably is not well
prepared for receiving theinformation.
And I always talk aboutleadership.
(10:51):
I feel that the leadership isvery important.
When the patient could feelthat he or she has the
responsibility of their health,maybe they could make some
decisions about the health.
But sometimes it's people thatdon't know, people that are too
(11:20):
poor, people that don't have aperson to take care of them.
Then it's more difficult to sayyou have the possibility of
responding by yourself for yourmedicines.
I had a story when I wasstudying epidemiology that I
went to a very depressed areaand I had an interview with a
(11:44):
person that was maybe 80 yearsold.
She didn't know how to read andwe needed to draw a moon for
the medicines that she needed totake at night, and and a plate
of soup for the medication thatit was to be taken with food and
(12:05):
other kinds of things, and shewas very, very, very poor and
when we finished and we take allthis medicine that was expired,
we put it in garbage and saidthis is not possible, that you
are using this, it is expired.
(12:26):
And we explained some things.
At the end, she only had oneplantain in her kitchen.
Kitchen is just a table and shetook the plantain and said
please receive this as thanksfor your help.
And I said, oh my gosh, it'sthe only food that she has and
(12:48):
she's giving me because sheconsidered that it's important
what we are doing for her.
That experience changed my lifeand I feel like it's a lot of
help that the people need forusing the medicines.
She never thinks about anadverse reaction.
It is not a concept thatpatients could have, but the
(13:11):
point is we need to understandwhat is the reality of a lot of
patients, and, for sure, inlow-income countries is so
difficult, for people know aboutanything they are.
They are working for havingmoney.
It is that all.
Then, if they need to have amedication and they have the,
they are lucky and have thepossibility of have the medicine
(13:35):
.
How we are giving theinstruction for taking it, for
not having medication errors orfor inspiring them to have a
healthy life.
I feel that it's difficult totry to standardize patients and
say every patient knows.
I feel that we must understandrealities and look for the
(13:59):
support for every community.
If it is inside of a hospital,it's easier, because you could
teach them and invite them toreport and listen to them.
But outside and I feel thatmost of us are not in a hospital
most of us are using medicinesin our houses and we have a lot
(14:20):
of information right now andpeople who have a device and
internet have a lot ofinformation.
But we have millions of peoplethat don't have internet, don't
have any possibility of accessto the information.
Then healthcare workers inprimary care have a lot of
responsibility for informing howto use the medicine in the best
(14:41):
way and if the medicine is notworking, what to do, or if it is
giving some damage to them,what to do.
But it's a lot of differentpossibilities and it's a lot of
possible answers that we ascommunity on pharmacovigilance
need to do.
Fredrik Brounéus (14:59):
Ghita.
Ghita Benabdallah (15:00):
Yes.
So thank you, Angela, for allthese 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 withmany countries low and middle
income countries where a lot ofteaching is done, the
(15:22):
sensitization on the importanceof reporting ADR and explaining
why they have to do that, andsince the early 20s, as I said,
Angela, this concept of patientengagement was highlighted with
WHO, the World Alliance forPatient Safety, and there is a
lot of work that is done forthese countries and a lot of
(15:47):
sensitization explaining, and Ithink that things are going on
well and we can see that patientreporting is very important in
high-income countries, but alsoin the low-income countries, for
example, in Morocco, we havereports from patients because we
(16:07):
are talkative, as we said, wetalk a lot.
We have this possibility.
It's very important to havethis phone call when people can
call each time, every time, andthey can talk about this adverse
event and we can catch allinformation and have quality
data.
Fredrik Brounéus (16:27):
Thank you, Ghita.
Daniele Sartori (16:29):
Surely informing patients about the
importance of reporting helps us.
We collect reports and weanalyze them and it can help
them.
What struck me was a bit I sortof perceived that the
communication that we shouldhave with patients to be a sort
(16:50):
of a "help me, help you kind ofsituation.
So we want patients to give usthe information that we need to
do our job.
The patient also wantssomething in return, like what's
in it for them to reportadverse drug reactions.
Yes, this is important becausewe can help identify new signals
and so on.
But I feel like, ultimately,what we want to get is a
(17:13):
situation where we've gotpatients who are well-informed,
because we've learned yesterdaythat well-informed patients are
generally more satisfied withthe care that they receive.
And the example you gave,Angela, was really striking,
because in some cases you've gotpatients that are completely
unaware that adverse drugreactions are a possibility, but
(17:35):
then you've got patients wholive with chronic conditions who
are acutely aware of adversedrug reactions are a possibility
.
And so it feels like thecommunications that we deliver
to patients has to bebidirectional, to use a word
that I've learned today, in thesense that it has to be tailored
(17:56):
to the kind of community thatwe're trying to target, to
maximize benefits for them andto maximize benefits for us.
Fredrik Brounéus (18:05):
It really continues on the learning health
systems (18:09):
the primary patient engagement in health decisions
on the individual level toimprove health outcomes for the
patient, but then that secondarypatient engagement in the
broader system decisions on thegroup level to improve the
system.
Do we have a learning PV systemtoday or how could we better
(18:33):
make use of secondary patientengagement?
You gave an example, Linda, tohave patients on the board, but
are there other ways we could doit?
Angela Caro Rojas (18:49):
I have an example that I loved, it was
called "expert patient and it isa patient who has been with a
disease for I don't know 20years and has the guide for
other patients and it'swonderful because that person
really knows what he's saying.
This patient said ah, if youfeel this, the way that you
(19:12):
could solve it is that way andin a circle of confidence, when
we are having the same situationI mean, we are the patients
with this disease and we reallyunderstand what is happening
with the other and empathizewith this person it's very easy
(19:34):
to communicate.
I feel that everything in thelife is communication, and the
way to communicate with othersis first, have enough confidence
for saying what I am thinking,but additionally, to have this
feedback.
As you said, if we could havethis confidence with patients,
(19:57):
if we could offer them all theconfidence and all the tools for
communicating with us, it wouldbe easy.
And when I'm talking about thisexpert patient talking with
other patients, it helps us alot for the patients to identify
adverse reactions or otherkinds of mistakes that can occur
(20:19):
, because they know, they reallyknow what is happening inside
of the life of that person andprobably it's not exactly the
same, because every person isdifferent, but it's the most
similar that they can find.
Then I feel that to have thisconversation between patients
and between adverse reactionsinside of the same group could
(20:42):
be very helpful.
Linda Härmark (20:44):
I think there is quite a lot of patient
involvement in different partsof the life cycle of a drug.
I was lucky to be part of CIOMS11, which was about patient
involvement in drug developmentand safe use of drugs.
We identified how patients canparticipate in the different
steps throughout the whole lifecycle and I also think the
(21:06):
perception of involving patientsnowadays is a bit different
because now we also see aspatients also one of the experts
just as, like you know, the PVexpert and the other expert and
now we have also patient expertsthat have a special expertise,
have a special viewpoint whichthey look from, which actually
can contribute that in the endyou get a better product, what
(21:27):
that product might be.
It's not only in reviewing riskminimization materials, but it
can also be to see what kind ofoutcomes should we measure if we
have a clinical trial, what isreally a good outcome for
patients living with a certaindisease?
What would they be happy fromif that would be improved for
them?
So I think there's plenty ofchance.
I really feel that there is ashift in how also I think more
(21:49):
the scientific community look atpatient participation.
In the past it was a must.
You know, you write researchproposals and you must include a
patient representative.
Write research proposal and youmust include a patient
representative.
But now I think more and morepeople realize the actual value
that it can bring to yourproduct by including the patient
perspective.
Ghita Benabdallah (22:08):
There's the role also of the patient that
are in patient association andthose have a voice.
That is good.
I remember in Lar eb in 2012it's long time ago and it was
about patient reporting and somerepresentative patient
association were there and theirvoice was heard and it was very
(22:32):
important to have them and itwas like they have the
leadership for the other patientand when they were talking
about reporting and all thepatients were confident about
that and it was a good thing tohave other reports.
Fredrik Brounéus (22:51):
It's interesting that you bring up
now patient reporting as well,Ghita.
We have heard these past twodays also that patient reporting
is on the rise and thatsometimes, sometimes even that
healthcare professionalreporting is going down a bit.
bit was interesting alsobecause we heard Tommy Emil Dzus
(23:11):
told us about the study whichshowed them that the healthcare
professionals and the patients,their narratives, they
complement each other.
Angela Caro Rojas (23:19):
Exactly, exactly.
I love that study.
It was amazing.
I love the qualitative studiesa lot.
I am going more to thenarrative than the numbers.
I am not very interested innumbers right now.
I love to listen to people, whatthe people are feeling, but the
(23:41):
point is that it complementsour vision.
I mean, the healthcareprofessional's vision is a more
anatomic vision, but the peopleis experiencing what is
happening really.
Then the experience is veryimportant.
The person who is living with adisease or living with an
adverse drug reaction orsomething, is a person who has a
(24:05):
life, who needs to work, whoneeds to go with his family or
her family.
How I live in my experienceusing medicines is as important
as the number or the signal orthe symptom that the person is
(24:28):
having.
Then I feel that they both arecomplementary and maybe we need
to be focused more in what arethe expectations of the patient,
what are the feelings of thepatients, and not just about the
number.
Probably, if we are focusingboth, we could have more
(24:49):
information and maybe we couldfind that it is not an adverse
drug reaction, it is amedication error because
something happened and they usedit in a bad way or something.
Then I feel that probably weneed to open a new door of
qualitative research, thinkingabout what the people are
feeling and what are theproblems that we really need to
(25:12):
solve to that people, and notjust think about how it looks in
a statistic graphic.
Daniele Sartori (25:20):
Well, we've seen yesterday a good example of
qualitative research in HIV fordolutegravir [by Henry
Zakumumpa] and that to me wasquite interesting to hear that
some patients might feel like Idon't want to report because
then they're going to withdrawthe drug that works so well for
me.
So I'd rather endure adverseeffects.
Linda Härmark (25:40):
I think the whole movement on patient empowerment
and patients being more anactive part of their treatment
and maybe also sharing theirexperiences, what they have with
drugs, I think that willcontinue.
I'm not really sure if they'rereally going to report to our
reporting systems because ofcourse the numbers are
increasing, but I think thereare other ways that patients
share their experiences and Ithink it's important for us as a
(26:03):
community also to be able tocollect more the data where
people prefer to share it maybethan 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 challengefor the pharmacovigilance
community to see if patients aregetting more and more
interested in health and want toshare their information.
(26:25):
We also need to say how can wetap into their preferred ways of
sharing it?
Ghita Benabdallah (26:32):
The use of the new tools, the AI, to make
the reporting easy is one ofalso the explanation with the
increase of patient reporting.
Of course, the sensitizationand all the work that is done by
pharmacovigilance center, butthese new tools, the apps that
we have in the phone to make thething easy.
(26:53):
I believe that it is somethingthat we need to keep and using
this reporting system that goesdirectly to the
pharmacovigilance center.
It's important to keep in mindthat during the COVID we have
seen the increased, huge,increased number of patient
(27:13):
reports and something that wascan quantify so you can see the
impact of the importance ofpatient reporting.
It was very it's a huge numberthat was reported all over the
world, not only in specificcountries, so we can see this
impact.
Fredrik Brounéus (27:36):
I was wondering if we should imagine
that we're taking a little tripin a time machine here on stage.
So we've already heard somepredictions for 2030 and 2035
vision, so shall we aim evenfurther into the future, say
2040, just to stick our chin outthere.
(28:02):
And so, we're sitting again atthe fireside chat yes, after the
mid-year symposium, and I Iwould like to ask you what you
think would have been the themeof this 2040 symposium.
What are the hot topics andtrends and, if you like, what
(28:22):
topics are no longer hot?
Are we replaced by digitaltwins on stage?
Is there's a fireside ChatGPT?
Difficult, I know, and it willbe on the pod, so no pressure.
Daniele Sartori (28:39):
I'm always kind of guarded when we talk about
speculating about the future.
There's this concept aboutretrofuturism that I think is
very appealing, which is ourconception of the future in the
past.
And so, if you read, there's anItalian author, Salgari, that
wrote about the wonders of theyear 2000.
And then there was thiselectricity that was transmitted
(29:01):
by air, and then in the end –spoiler alert – the protagonist
succumbs to the effects ofessentially Wi-Fi.
But nowadays we know that Wi-Fiis fine, so obviously we tend to
sort of speculate quite wildlywhen we talk about the future,
but I thought that we that if Ihave to venture a bit into the
(29:25):
future, I think what we've heardtoday about where we see the
direction in which we're headingis that spontaneous reports
seem to fit their niche and theymay not always be fit for
purpose.
But where we're going, it seems, is that we're trying to
combine individual case safetyreports with other sorts of
(29:47):
evidence.
And we've seen that in theNetherlands with electronic
health records and we've seenhow population-level data can
help you informpharmacovigilance in individual
cases.
So the way that I view thefuture, heavily biased by these
past two days, is we're going ina direction where we're going
(30:13):
to incorporate more and more theusefulness of electronic health
records, sort of supplementingthe limitations of individual
case safety reports.
Linda Härmark (30:23):
I can maybe add to that because my thoughts are
very similar today and we talkedabout data quality, data
capture, data sources,methodology, and I hope in 15
years that we have actually madethat step, that we have a lot
of data sources that we can use,that we have good methodology,
so we can actually generate alot of useful knowledge about
adverse drug reactions inmedicine.
(30:43):
So I hope we would havediscussions around dissemination
of that knowledge.
How can we really get thatknowledge to a point in care
where it can be used?
How can we incorporate ourknowledge in these clinical
decision-making tools?
How can we ensure that peoplecan maybe do their own risk
profile that they can fill inyou know, I have this and this
(31:04):
and this and this.
What is my chance of havingthis, so that we are more on the
disseminating knowledge sideinstead of generating knowledge,
where we are a bit now.
Angela Caro Rojas (31:16):
I suppose and I want to think that maybe
we'll be more focused onhumanity.
I mean, we have enough tools, oftechnology and everything is
going well.
In that way, Then we could befocused more on humanity and how
to be more sensitive withpatients and how we could
understand the reality of thepatients, and I want to think
(31:38):
that we are working a lot incollaboration.
I want to think that in thatmoment, we have not just one
regulatory agency for Europe,but we have one regulatory
agency for all Africa and oneregulatory agency for all Latin
America, and the knowledgeinside of the agency could be
(31:59):
shared for all the world and iseasier to everyone.
And I want to think that inthat moment it's not inequity
and are more people helpingother countries, other regions,
and the collaboration is very,very important for everyone
there.
And the industry is focused insupport, the regulatory agency,
(32:24):
a regulatory agency, support,supporting the academy, and
everyone are working in the sameline because understood that
the most important is thehumanity, the people, who is
using the medicine.
I want to think about that, butI'm not sure.
Fredrik Brounéus (32:40):
Sounds hopeful .
Ghita?
Ghita Benabdallah (32:42):
I agree with you all, and for me also, it
would be, of course, thehumanity, but I wish that
countries low and middle incomecountries could discuss about
their big database with all thesignals that they will be able
to detect and to share, and tohave a strengthened
(33:06):
collaboration betweenpharmacovigilance and all the
other stakeholders and to keepthe role of pharmacovigilance
always at the high level.
And to not have new pandemicand don't discuss about new
vaccines, so things like that.
Fredrik Brounéus (33:27):
That was a very good closing remark.
Thank you! Please help me thankour great panel, Daniele,
Angela, Linda, Ghita.
That's all for now, but if you'dlike to learn more about the
mid-year symposium and thetopics and speakers, we've put
(33:49):
together some links for you inthe episode show notes.
Apart from the Drug SafetyMatters podcast, we have our
pharmacovigilance magazine,Uppsala Reports.
Visit uppsalareports.
(34:11):
org to stay up to date with news, research and trends in the
field.
And don't forget to subscribeto the newsletter for the latest
articles.
If you have any questions orsuggestions for the podcast or
the magazine, please reach outon Facebook, LinkedIn, Bluesky
or X.
You can also visit our websiteto learn more about what we do
to promote safer use ofmedicines and vaccines for
everyone, everywhere.
If you like the podcast, pleasesubscribe to make sure you
won't miss an episode and spreadthe word so other listeners can
find us too.
(34:31):
For Drug Safety Matters, I'mFredrik Brouneus.
Thanks for listening.
.
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