#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara Vidlin - Drug Safety Matters

Episode Transcript
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Fredrik Brounéus (00:11):
Welcome to Drug Safety Matters, a podcast
by Uppsala Monitoring Center,where we explore current issues
in pharmacovigilance and patientsafety.
I'm Fredrik Brouneus and todayI'm looking forward to learning
more about pregnancy-relatedpharmacovigilance.
There are many reasons why useof medicinal products during
pregnancy requires specialattention.

(00:31):
First and foremost, we want tobe sure that the medicine is as
safe as possible for both thepregnant person and the unborn
child.
Unfortunately, the safetyprofiles of medicines used in
pregnancy are often incomplete,which makes it difficult for
patients and healthcareprofessionals to make informed
decisions.
Here at Uppsala MonitoringCenter, our research section has

(00:53):
a team that is currentlyfocusing their efforts on
pregnancy-relatedpharmacovigilance.
Today we have Data ScientistsSara Vidlin, Levente Papai and
Senior PharmacovigilanceScientist Lovisa Sandberg from
this team in the Drug SafetyMatters studio to talk about
complexities and challenges ofpregnancy-related
pharmacovigilance and aboutdeveloping solutions for

(01:15):
tackling those challenges.
Hi and welcome to the studio.
So with me around this table,or this round table here in the
studio, we have, from left toright: Levente

Levente Pápai (01:32):
Hello, welcome.

Lovisa

Lovisa Sandberg (01:34):
Hello.

and Sara .
.
.

Sara Vidlin (01:35):
Hi.

You are all part of a UMC research
initiative with a special focuson pregnancy-related
pharmacovigilance, or PV as wesay for short.
So let's start from thebeginning here.
What do we mean when we saypregnancy-related PV?

Well, first of all, pharmacovigilance can be
defined as the science andactivities relating to the
detection, the assessment,understanding and prevention of
adverse effects or any othermedicine- or vaccine- related
problem.
So with pregnancy relatedpharmacovigilance we mean those

(02:17):
efforts, but when they arepregnancy- related, so focused
on safety in the pregnantpersons themselves and their
fetuses, or individuals exposedto the medicine and vaccine
while still in the womb.

I guess it's also safe to say that medicine
safety during pregnancy has hada profound impact on the
development of pharmacovigilanceas a whole, right?

So, the thalidomide tragedy was actually
a main reason for the birth ofmodern pharmacovigilance.
In the late 1950s, thalidomidewas used to treat morning
sickness during pregnancy,especially during the first
trimester.
However, by the early 1960s itbecame apparent that the
medicine caused severe birthdefects, such as underdeveloped

(03:07):
limbs, so fo comelia.
Consequently, thalidomide waswithdrawn.
This tragic event highlightedthe need for improved processes
in both the approval and safetysurveillance of medicines.
It also called for globalcollaboration, as it was clear
that sharing experiences was keyto identify early signs of

(03:29):
safety issues.
This led to the formation ofthe WHO Programme for
International Drug Monitoringand the establishment of a
common global database foradverse event reports, which
bears the name VigiBase.

(03:50):
Today, over 150 membercountries contribute to this
database by sharing adverseevent reports to enhance global
pharmacovigilance.
So, despite the significantinfluence of the thalidomide
tragedy on pharmacovigilance, weare still very much behind when
it comes to pregnancy-relatedpharmacovigilance.

We will get back to why we're still behind,
because I know there aremultiple reasons for that.
But before we go down that path, could you perhaps tell us
about some of the reasons whyspecial considerations are
needed?
Why is this such a specialpatient group?

Yes.
So first off, it is importantto recognize that pregnant
persons also need medication.
For instance, they might have achronic condition that doesn't
pause during pregnancy, such asepilepsy, or they could develop
a specific issue to thepregnancy, such as gestational
diabetes.
And of course, they might catchany acute disease also during

(04:52):
the pregnancy and that could bean infection, for example.
And we know it is common to usemedicines during pregnancy.
So, some studies have shownthat over 80% of pregnant
individuals use at least onemedication during their
pregnancy, and also we know thatpolypharmacy, or using several
medicines, has become morecommon.

(05:13):
An important consideration hereis that the pregnant body may
react differently to medicinesand vaccines as compared to the
non-pregnant, and this mayinfluence both the effect of the
medicine and also the risk ofadverse reactions.
And this is due tophysiological changes in the
pregnant body that may influence, for example, the uptake, the
distribution and the eliminationof a medicine and, for example,

(05:39):
the blood volume increases andthis may affect the distribution
of medicines, and an increasedrenal blood flow, or blood flow
through the kidneys, mayincrease the rate of elimination
.
Also, there are changes inenzyme activity that may affect
the metabolism, and anotherexample is changed levels of

(06:00):
certain proteins which mayaffect protein-binding medicines
.
So both the pharmacokineticsand the pharmacodynamics are
affected and this couldinfluence both, like I said, the
effect of the medicine but alsothe risk of adverse reactions.
But of course, the mainconsideration here is that there
are two lives to consider andthat serious outcomes in the

(06:24):
prenatally exposed child mayhave lifelong consequences, and
not only for one person but fora whole family.

Yeah, once again, at the same time, it's
important to emphasize thatmedication may be crucial for
the pregnant individual, sodiscontinuing an ongoing
treatment or refraining fromstarting the new medication may
even be more harmful than therisk of an adverse reaction,
both for the fetus and for thepregnant individual.
So pregnant individuals andtheir health professionals

(06:54):
should ideally understand thebalance between benefits and
risks when deciding whether totake a medication or when
choosing between differenttreatment options.
This knowledge is essential formaking an informed decision.

So could you perhaps give a clinical example
of this kind of benefit-riskbalance considerations?

Yes, take epilepsy as an example.
There are known risks of majorcongenital malformations in the
child due to transplacentalexposure of certain
anticonvulsants.
On the other hand, there arealso serious risks for both the
pregnant person and also thebaby if experiencing severe
seizures during the pregnancy.

(07:39):
In this case, treatment may benecessary despite risks.
But it is still of utmostimportance to understand if the
safety profiles betweendifferent options, in this case
anticonvulsants, differ, to beable to choose the most
appropriate medicine.

I noticed that you said that pregnant
individuals and their healthcareprofessionals should ideally
know the benefit-risk balance oftreatment options.
And I mean you say ideally,because this is not always the
case, is it?

No, and unfortunately making informed
decisions on whether to use amedicine in pregnancy is
difficult because the safetyprofiles about use in pregnancy
are often very incomplete.
And especially at the time ofmarketing of a new medicine
there's very sparse safety dataon use in pregnancy, and the
limited information available,if any, is generally based on

(08:34):
non-clinical data.
And this is because pregnantpersons are generally excluded
from clinical trials due topotential safety concerns,
unless the medication isintended to be used specifically
in the pregnant population.
And also, those who becomepregnant during a clinical trial
are often withdrawn from thestudy, although the child is

(08:56):
often followed up for safetydata.
So there might be some datafrom these accidental exposures,
but this is not enough to fillthe knowledge gaps.

And sometimes quite wide knowledge gaps, as I
understand it, and in practicethe informed decisions are not
very informed, then

Yes, that's right .
Generally, at the time ofmarketing and for a considerable
period afterwards, there is aninsufficient knowledge about the
use of most medicines andvaccines during pregnancy.
It makes a challenge to trulymake informed decisions.
Recently, there has been agrowing debate about whether it

(09:35):
is more unethical to excludepregnant individuals from
certain clinical trials.
But still, post-marketingsurveillance, such as
spontaneous reporting andpregnancy registries, is crucial
to complete the safety profilesrelating to use in pregnancy.

Well, we can say that there are many layers
to this complexity.
In every decision about medicaltreatment during pregnancy,

there are two lives involved: the pregnant person and the (09:58):
undefined
unborn child.
Which adds a quite complicateddimension to the benefit-risk
balance to be considered by bothhealthcare professionals and
patients, which, in turn, isfurther complicated by the lack
of safety information available.

(10:20):
So, safety-wise, as you said,due to a lack of data from
clinical trials, the knowledgeon the risks of any given
medicine on pregnancy is behindalready from the start, and this
makes it, of course, even moreimportant for us to extract
every little drop of informationabout the safety of the

(10:41):
medicine once it's out on themarket and being used by
pregnant persons.
Could you tell us somethingabout the challenges here, as
seen from the pharmacovigilanceassessor's point of view?

If we now focus on spontaneous reporting systems,
the first issue for a PVassessor who wants to
investigate pregnancy issues isbasically finding the relevant
cases in the database.
And ironically, even though thespontaneous reporting systems
were introduced as a consequenceof the thalidomide tragedy,

(11:15):
unfortunately they are still notoptimized for these types of
reports.
And even though they maycapture them, the challenge is
to find them.
So if we look at VigiBase, theWHO Global Database of Adverse
Event Reports, now, thisdatabase contains over 40
million reports as of today andonly approximately 1% of those

(11:45):
relate to pregnancy.
So the burning question is howto find them.
It would have been quite easyif each report had a flag just
saying "is this a report aboutpregnancy, yes or no, and you
could just filter on that flag.
But, however, the challenge isthat in the electronic
transmission standard; so theglobal transmission standard for

(12:05):
individual case safety reportsis E2B, which is the most
commonly used format to exchangereports between databases.
So in this transmissionstandard there is not one
specific field to indicatepregnancy exposure like "yes,
this is a pregnancy exposure orno, this is not a report related

(12:27):
to pregnancy.
Sometimes some databases have alocal pregnancy flag indicating
that this is a case aboutpregnancy.
But these local flags, if theyexist, they are usually lost in
transmission of the reports whentransmitted to other databases.
So, for example, they will belost when transferred to Eudra

(12:51):
Vigilance or to VigiBase.
And although it's great thatthese local pregnancy flags
exist; I mean it's great becauseit means that someone somewhere
in the process have tried tomake it easier to report and
find these really valuablecases; there is also a risk that

(13:11):
they might lead to a falsesecurity that it is enough just
to tick this box.
But I would say it is notenough to tick a box.
I mean especially if theinformation later on is lost.
But even if it would bepreserved, more information will
be needed if the report is tobe useful down the line, like

(13:31):
exposure terms describing a typeof exposure or information on
the timing of exposure andsimilar.

So we could also add here that the standard
transmission format is quiteextensive and allows for many
different types ofpregnancy-related information to
be reported in many differentways, and this is really a good
thing.
But due to different reportingcultures, reporting guidelines
and coding practices across theglobe, and also over time, this
results in that not allpregnancy reports look the same

(14:02):
when collecting them in a commondatabase like VigiBase, and
this, together with thisnon-existence of a dedicated
pregnancy field, like Saramentioned, leads to challenges
finding the relevant cases.

This is possibly a naive reflection or
question, but how difficultwould it be to introduce such a
flag that would be transferablebetween databases, I mean, since
we obviously have lots of otherinformation that does travel
the distance?

Purely technically it's not difficult, but I guess
this will have to be somethingconsidered for future versions
of the transmission format.
In the current version, however, there is a possibility to
extend the format withadditional fields, and if this
is done in a harmonized way, itcould potentially be an option.

(14:56):
Meanwhile, but important though, it is very crucial to make
sure that a pregnancy flag meansthe same thing across databases
, so the scope of the flag mustbe very clear.
Are paternal exposures included?
Are exposures during laborincluded?

(15:16):
Are exposures duringbreastfeeding included?
Does it consider reports withadverse events in the pregnant
person or only those withadverse events in fetus?
And so on, and so on.

It's not just adding a flag.
I can see that, yeah.

One solution that we have explored at UMC is to
introduce an algorithm tosupport the identification of
pregnancy cases.
So this is because what wementioned already, because
pregnancy related informationcan be reported in multiple
fields indicating that thereport involves exposure during
pregnancy.
This makes it non-trivial toretrieve pregnancy cases.

(15:55):
Our approach was a rule-basedmethod, that is, it is a type of
algorithm that follows a set ofpredefined rules or conditions
to make decisions or performactions.
These rules are created byexperts and are based on logical
statements that define specificcriteria for inclusion or

(16:15):
exclusion.
In the context of identifyingpregnancy cases in VigiBase, the
rule-based algorithm works bychecking several fields for
pregnancy-related informationand flagging those as pregnancy
cases or unknown cases.
The process involves two mainsteps ruling out and ruling in.
In the exclusion step, itfilters out any reports that are

(16:38):
considered to be unlikely to bepregnancy cases, so, for
example, patient age.
In the inclusion step, thealgorithm identifies reports
that meet the criteria forpotential pregnancy exposure.
So, for example, it looks forreports where exposure during
pregnancy has been reported asan event, the route of

(16:58):
administration istransplacental, or a gestational
age is mentioned in the report.

So it's a sorting mechanism of sorts, that
first sort out all the casesthat cannot be related to
pregnancy, like you say, andthen searching through those
that remain to see if they arerelated to pregnancy.
But how do you go aboutensuring that a solution like
this is picking up the rightreports and, so to say, it's
specificity and sensitivity?

This is a very good question.
When it comes to findingrelevant pregnancy cases, we've
seen that many differentapproaches have been used in
different studies, and theapproach chosen depends, of
course, on the aim of the study.
So, for example, if it is moreimportant to capture all
potential cases but then riskingalso getting a few false

(17:47):
positives, so irrelevant casesas well, or if it's more
important to be very specific,that the cases retrieved really
are indeed relevant, at the costof then potentially missing
quite a few.
So in order to choose methods,it's good to know how it

(18:08):
performs.
So for us, it was veryimportant that the VigiBase
pregnancy algorithm that wedeveloped was thoroughly
evaluated, and this in order tounderstand how many of the true
pregnancy cases in the databasethat we can expect to find, and
also how many of the cases thatthe algorithm flags that are
actually indeed pregnancy cases.

(18:31):
In many cases, it's also, ofcourse, impossible to know the
real truth.
If you have a case with a30-year-old woman, you can never
with 100% certainty say thatthis is not regarding a pregnant
patient.
So we classify all cases aspregnancy cases or unknown.

(18:54):
But coming back to theperformance of the VigiBase
pregnancy algorithm, we foundthat 92% of all reports flagged
by the algorithm can be actuallyexpected to be true pregnancy
cases.
So this means that if youperform a search for pregnancy
exposures and then end up with,say, 100 reports, around 92 of

(19:17):
these will indeed be related topregnancy.

Yeah.

And looking at VigiBase as a whole, the
algorithm managed to find 75% ofall pregnancy cases when
looking at the whole database.
But worthy to note is that ifwe narrow down the analysis to
only reports submitted in thecurrent transmission format, E2B
, the algorithm actually managedto find 91% of all pregnancy

(19:45):
cases and I think it's veryimportant that you have this in
mind; the performance and thereasons also why certain cases
might be missed when you performa study.

That does sound like quite impressive
results from the algorithm.
Were you surprised?
Was this .
.
.
is this good?
Were you happy with the results?

I would say it's quite good because it's a
challenging program.

Yeah, speaking of challenges, did you find any
specific challenges orobstacles for the algorithm to
do its algorithm work, so to say?

So the main challenge for the algorithm in
VigiBase, which is a globaldatabase with reports dating
back to the 1960s even, is thatreports are quite inconsistently
reported, so using differentreporting formats and different
coding practices.
But besides that, the challengeis more referred to the quality
of the reports and mostlyrelate to the amount or clarity

(20:45):
of the information given.
So, for example, sometimes thepregnancy- related information
is given only in free text, forexample in the case narrative,
and while a narrativedescription is crucial to assess
a case report, if there's nostructured information
indicating pregnancy in thereport, the algorithm, as of

(21:07):
today, does not retrieve it.
And also, some reports lackspecific pregnancy information
and pregnancy exposure can onlybe inferred from several pieces
of information in the report.
And these reports are difficulteven for a human to interpret.
And we also have examples ofambiguous reports where the

(21:28):
pregnancy information has beenmiscoded as such or where it's
unclear if the pregnancy isconcurrent or historical; and
also reports where it's unclearwho the report is about, who the
report subject is.
So if it's the pregnant personor the child.
For instance, reports couldhave a patient age referring to

(21:49):
the pregnant person while theevents refer to the child, or
there could be a mix of eventsfor the pregnant person and the
child in the same report, andthese reports are very difficult
to handle and interpret.
But at the same time we seethese as challenges.
We also see the opportunitiesto develop the algorithm further
, and one idea could be toexplore the potential to use

(22:12):
more advanced methods, likelarge language models, to
incorporate also free textinformation in the algorithm.
So that could be something forthe future.

Before we got into talking about the algorithm
, we were talking aboutchallenges for PV assessors when
investigating possiblepregnancy issues, and well,
finding the cases obviously isthe first challenge that you
have to overcome, but it doesn'tend there, does it?

No, it doesn't.
Once the reports are retrieved,the next challenge is assessing
them.
So, as we have mentioned,according to our findings, these
reports often contain toolittle information or the
information is unclear ormisleading.
Assessing causality inpregnancy reports, especially
regarding outcomes in the baby,relies on different information

(23:05):
than usual causality assessments.
Key elements like time to onset, de-challenge and re-challenge
cannot typically be applied toprenatal exposure cases, so,
like mentioned, for example, thetiming of exposure in relation
to the gestational age iscrucial, and it's important to
understand who the reportsubject is – the pregnant person

(23:27):
or the child.
Additionally, it's essential toknow whether the exposure was
maternal or paternal, along withany comorbidities and medical
history.
Yet another challenge is how tospot the relevant cases for
analysis, such as in signaldetection.
At UMC, we have startedexploring statistical methods to
highlight issues that arereported more frequently than

(23:50):
expected within the pregnancypopulation.

Now, so far we have been talking about
VigiBase, the WHO GlobalDatabase of Adverse Event
Reports, as you said, but thereare other databases as well, and
do we see similar problems andsolutions – for example
algorithms – with regards topregnancy- related cases in

(24:17):
these databases?

Yeah, so for the same reason a similar algorithm
has, for example, been developedfor EudraVigilance, the
European database, and anotherone has been developed for
FAERS, the US FDA adverse eventreporting system, and actually
UMC recently participated in aworkshop held at the University

(24:40):
of Oslo involvingrepresentatives of all these
three algorithms and we comparedthe differences and
similarities between them.
And although they have the sameintention, they have somewhat
different scopes, for example,that one of them aims to capture

(25:07):
paternal exposures and avoidsnormal and unintended
pregnancies, while the other twodo not.
But this is still somewhatongoing work as we speak and we
are working on comparing andcharacterizing these three
different algorithms andpreparing to share the results
in a scientific article.

When you have different algorithms such as
these, is it possible to combinethem in one way or another to
improve their functionality?

I would say these three algorithms that we
compared are quite similar intheir method.
So, yes, we can learn from eachother and this is what we also
did during this workshop thatsome of the aspects used in one
of the other algorithms could beused to improve also the UMC
algorithm, and vice versa.
So, yes, that could in one waybe done.

So they would sort of cross-fertilize each
other, so to say yeah.
So technical innovations seem tobe quite important to make the
most of the data available.
Then, if we consider the PVprocess a bit more upstream, so
to say; let's say I'm a reporter, for instance, a doctor with a

(26:19):
pregnant patient who hasexperienced a suspected adverse
drug reaction, what can I, asthe doctor, do to help assessors
overcome some of the challengesthat you described?
What can I do when I'mreporting to make it easier for
the assessor to find this case?

I'm thinking, considering that under-reporting
is a major limitation ofspontaneous reporting systems,
with only a fraction of adversereactions being reported, the
most important is that you doreport this adverse event, and
especially when it comes topregnancy exposures, as the data
is so limited and the knowledgegap is so wide.

(26:58):
Of note here is that manycountries do allow for direct
patient reporting, meaning thatalso you as a pregnant
individual could share your ownexperiences in a report and
thereby contribute to increasedknowledge.
But then, thinking also of thechallenges to find your report

(27:18):
in the databases we have talkedabout, of help would be if you
clearly indicate that thisreport is about a pregnancy
exposure and of course,depending on the local system,
the means to do this may vary,but one example is, for example,
that you add the exposureduring pregnancy as an adverse

(27:39):
event.

So yeah, because you said that the
algorithm doesn't pick upinformation from the free text
field, so I need to find otherplaces to put this information.

If you have the possibility.
In some systems you may only beable to report free text and
then you just clearly have toindicate it there and then the
code during the next stephopefully do that for you.
But if you have the possibilityto add it in some structured
way, that is good also.
Then also, if you could havethe assessor in mind who will

(28:10):
analyze the report in the end.
So it's important – we havealso talked about that – that
you clearly indicate who thereport is about.
So is it about the pregnantperson or the child?
Or if both the pregnant personand the child have experienced
an adverse event, you shouldcreate two separate reports.
And finally, to also reportother information that is

(28:34):
relevant to the pregnancy, andhere, of course, we can
highlight the timing of exposurein relation to the gestational
age, as this is really crucialto understand whether the
exposure was, for example,during the organogenesis, so in
the first trimester or later, tobe able to assess the
biological possibility.

That was a lot of information, quite a lot to
keep in mind.
Are there any recommendationsor guidelines that can be
followed by reporters?

Guidelines on how to report pregnancy information
do exist, but these may notalways be tailored to or
accessible to the primaryreporter.
So I think we need more clearand harmonized guidelines, as
well as trainings on how to usethe guidelines correctly.
There have been some greatinitiatives in this area in

(29:32):
recent years, like the IMIConcePTION Project.
IMI ConcePTION have suggestedframeworks for data collection
to increase the quality ofpregnancy data and also how to
assess the quality of thepregnancy information in the
case reports.

Also, as briefly mentioned, coders at
pharmacovigilance centers havean important role in the
creation of reports, making surethat the reported information
is adequately represented in thereport.
For example, they may do thecoding of medicines and adverse

(30:06):
events to standardizedterminologies like WHOdrug and
MedDRA from free text entriesmade by the primary reporter.
Here, guidelines such as onefrom the ICH on the E2B format
and MedDRA Points to Considermay be helpful, but also the
local guidelines.

We'll make sure to add links to that in the
show notes that interestedlisteners can follow to find out
more.
It just strikes me that puttingpieces of this pregnancy PV
puzzle together must be such adifficult task.
I mean as any adverse pregnancyoutcome that may or may not be

(30:44):
related to a specific medicinemay not be noticeable until long
after the medicine was used.
And, for instance, when a childis born with some kind of birth
defect, any medicine that mayhave been caused or contributed
to this could have been taken bythe parent several months ago
without noticing any sideeffects at the time.

Yes, that is true .
In these cases we have toconsider recall bias, as it can
be difficult to remember allthese details of the pregnancy.
Another challenge with thosereports is the time that has
passed since the exposure.
It makes it hard to recognizeother influential factors or
alternative explanations.

Some events could appear also much later in
life, so, for example,neurodevelopmental disorders,
which could become apparentfirst when you're an adolescent
or even an adult, and then it'seven more difficult to remember
all the details about themedications used, like 15 years
ago, and any other relevantdetails around your pregnancy.

(31:47):
But nevertheless it's importantto report also these cases and
to then clearly indicate thatyou suspect the prenatal
exposure so that they can berecognized as pregnancy reports.

Obviously, individual case safety reports,
or ICSRs, and VigiBase arecentral to pregnancy-related
pharmacovigilance, but whatother data sources are being
used specifically forpregnancy-related
pharmacovigilance?

Yeah, well, just to mention a few examples,
we have nationalpopulation-based pregnancy
registries.
We have also registriesspecifically designed to follow
up specific medications orconditions such as epilepsy.
There are pregnancy cohortstudies and electronic
healthcare records, and each ofthese systems has its strengths

(32:40):
and limitations, but they mayalso complement each other.
So, for example, spontaneousreports are typically used to
generate early hypotheses orsignals, while other data
sources, like the pregnancyregistries, can be used to
confirm or refute thesehypotheses.

Okay, so we're nearing the end of this
interview now and I just havetwo more questions, and they're
both possibly huge, so apologiesfor that.

But the first is (33:08):
what's next in the pipeline for you this
research initiative at UMC withregards to pregnancy-related
pharmacovigilance?

And the other question is (33:20):
what do you think that we, the
pharmacovigilance community,should focus on to get ahead on
pregnancy and medicines safety?

Well, I can start with the first question.
So our next step is to try toexplore problems and needs that
national pharmacovigilancecenters have – within this area,
of course – and we hope to gaininsights into simply where next
to focus our attention so thatwe can have as much impact as

(33:57):
possible with any futurescientific research we want to
do.
So depending on where we seemost needs, that is where we
will continue development.
So our aim is to be able tosupport PV centers in their very
important work ofpharmacovigilance related to

(34:18):
pregnancy.

And how will you identify the needs?

We will try to talk to several centers.

Great, thank you.

Yes, and when it comes to your second question
, so about the PV community,it's really inspiring to see all
the current initiatives andactivity in this area and it
feels like the awareness of theneeds of this vulnerable
population is increasing.
But we are still behind, as wesaid in the beginning, and we

(34:47):
have a lot to do to continue toimprove the spontaneous
reporting systems to make themeven more useful.
For example, one of the mainopportunities we see is the need
for further harmonization ofreporting standards and also
awareness of, and adherence to,those standards and also
guidelines that already exist.

Again, see the show notes.
We'll add links and informationwhere you can read more about
standards and guidelines.
And thank you very much forcoming to the show Levente,
Sara, Lovisa,

Thank you.

It was a pleasure.

As always, I learned a lot, and also thanks
to my colleague, AlexandraCoutinho, who is sitting behind
us here in the studio, forproducing this episode.
Thanks a lot, take car e.
producing this episode.
Thanks a lot, take care.
And if you'd like to learn moreabout pregnancy-related

(35:44):
pharmacovigilance, we've puttogether some links for you in
the episode show notes.
Apart from the Drug UppsalaSafety Matters podcast,
uppsalareports.
org we have ourpharmacovigilance magazine,
uppsala Reports.
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(36:06):
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(36:29):
Matters, listeners can findBrouneus us too.
For DrugSafety Matters.
I'm Fredrik Brunius.
Thanks for listening.

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#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara Vidlin

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.css-14f5ked{margin:0;word-break:break-word;display:-webkit-box;-webkit-box-orient:vertical;box-orient:vertical;-webkit-line-clamp:2;overflow:hidden;}#36 Pregnancy-related pharmacovigilance – Levente Pápai, Lovisa Sandberg & Sara Vidlin