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August 29, 2025 25 mins

Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas.

Tune in to find out:

  • Why we need a Patient Safety Day
  • How to prevent common medication errors in children
  • How to build child-friendly healthcare environments

Want to know more?

Visit the World Health Organization’s campaign website to learn more about World Patient Safety Day and download campaign materials.

You can also show support for the campaign by joining ISoP's free virtual event on September 18 and 19, or visit ISoP's YouTube channel to access recordings from previous Patient Safety Day events.

For more on paediatric pharmacovigilance and ISoP’s activities, check out these episodes from the Drug Safety Matters archive:


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About UMC
Read more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

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Transcript

Episode Transcript

Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Federica Santoro (00:15):
Welcome to Drug Safety Matters, a podcast
by Uppsala Monitoring Centre,where we explore current issues
in pharmacovigilance, andpatient safety.
My name is Federica Santoro andI'm delighted to be back on the
show after a long break.
Like many of you, I'm lookingforward to Patient Safety Day on

(00:40):
17th of September.
An annual highlight on thepharmacovigilance calendar.
Established by the World HealthOrganization in 2019, the day
is an excellent opportunity tospark conversations and inspire
action for better patient safety, and this year's campaign is
about the youngest – and perhapsmost vulnerable – patients of

all (01:01):
newborns and children.
To tell us more about thecampaign is Angela Caro Rojas,
president of the InternationalSociety of Pharmacovigilance
ISoP, who joined me online fromher hometown of Bogotá, Colombia
.
We discussed why we needawareness initiatives like this,

(01:21):
how to avoid common medicationerrors in children, and why you
should go digging in yourwardrobe for an orange garment.
I hope you enjoy listening.
Welcome back to Drug SafetyMatters, Angela.

(01:45):
It's fabulous that you acceptedour invitation to come back to
the studio and, this time, talkabout World Patient Safety Day.
How are you doing?

Angela Caro Rojas (01:55):
Thanks, thanks to you for this
invitation.
It's always a pleasure to bewith you and all the team of UMC
, so happy for being here.

Federica Santoro (02:03):
Fantastic.
Well, let's get into it.
Last time you were on the podwas at the end of 2023, so a
while back, and you had recentlyreturned from the annual ISoP
meeting in Bali.
And at the time we discussedtrends in pharmacovigilance,
looking forward to the future.
But this time we're going tofocus on an important occurrence

(02:24):
for the pharmacovigilanceworld: World Patient Safety Day,
which happens on the 17th ofSeptember.
And a lot of our listeners areperhaps going to mark that day.
So, first of all, maybe a naivequestion: why do we need a
Patient Safety Day at all?

Angela Caro Rojas (02:42):
We need it because sometimes we are not
aware about how complex thehealth systems are and in those
systems usually we have thepossibility to harm patients.
I mean, every professional inhealthcare is trying to do the
best, but the complexity of thesystems produces sometimes harm

(03:04):
in patients.
Then we need to work so hardfor having safer systems and for
having a best way to work withpatients, for having safer
solutions in health.

Federica Santoro (03:17):
And Patient Safety Day is an initiative by
WHO, the World HealthOrganization, and they've been
running this since 2019.
And they've picked differenttopics over the years, including
diagnosis or patient engagement.
Now, this year, the themethat's been chosen is "safe care

(03:38):
for every newborn and everychild.
What do you think about thatchoice?

Angela Caro Rojas (03:43):
It is a great choice because we are working
on different topics in patientsafety, but particularly kids
are so vulnerable.
This is a kind of populationthat needs more support in every
environment, for example, inambulatory care or in primary
care.
It's so important to take careof these kids that are most of

(04:06):
the time at home, but the parentneeds to take care of them.
And additionally, when they arehospitalised, they need more
support, and it's so difficultto standardise the attention for
this kind of patient.
Then it's a great idea from WHOto work on this this year.

Federica Santoro (04:25):
Absolutely.
So, children are an extremelyvulnerable population, and in
fact it's one of those groups ofpatients that we generally
refer to as "special populationsin pharmacovigilance.
They're a bit like the elderlyor pregnant women where drug
safety monitoring can be alittle extra challenging.
Now, as you say, safety –medical safety –encompasses a

(04:48):
lot of different aspects, but aswe are pharmacovigilance
professionals, we will focus ondrug safety in our discussions
today.
So, what makes, then,pharmacovigilance in the
paediatric population so tricky?

Angela Caro Rojas (05:04):
There are a lot of reasons.
First, I feel, the research.
When people are researchingsome new drugs, it's not ethical
to participate with kids in theresearch.
Then it's so necessary to adaptsome research for this
paediatric population.

(05:24):
And sometimes the research isin adults and we need to adapt
the results for paediatricpopulation.
Then research is one of thefirst topics, because we don't
have enough information abouthow the medication works in
paediatric patients.
The other point is theparticularities of paediatric

(05:45):
patients, for example, thematurity of the organs, the
maturity of the systems of thekids.
Then some medications workdifferently in these organs, in
these systems.
Then it's necessary to monitorexactly what is the effect of
the medication in the kid.
I feel that the most importantpoint is kids are very

(06:13):
vulnerable, not just because ofthe body but because of the
emotional field.
Then we need to be very carefulwith them and how to treat them

(06:39):
and it is so important tohighlight.

Federica Santoro (06:39):
And we'll go back also to that point you
mention of the emotions andtheir perception also of their
healthcare, and their engagementperhaps in their healthcare.
We'll go back to that pointlater, but first I wanted to
speak about medication errors inthis population.
Obviously, healthcare systemsare complex, as you said in your

(07:00):
introduction, and mistakes canhappen at different points.
Now because prescribing andadministering medicines to
children can be challenging,errors can happen in those
stages.
Are there medication errorsthat are observed more often in
children than in adults?

Angela Caro Rojas (07:09):
Yeah, the first topic that we see in this
population is overdoses.
As you know, the doses for kidsare very low, very specific,
and sometimes in prescription,dispensing or administration we
could have this probability ofoverdoses.

(07:32):
And to have this kind of dosescould give the patient toxic
effects or side effects.
Then we need to be sure thatevery person who is working or
managing medications is totallyaware that this medication is
for a kid.

(07:52):
And of course, if we are, asmedical doctors, prescribing, we
need to be sure about all theconditions of the patient, not
just the weight or not just howbig he is or she is.
It is most about all theconditions of the patient, if
they are having any problems,for example, in the maturity of

(08:14):
the organs, or if they arehaving a particular
pharmacodynamics orpharmacokinetics for this drug.
This is one of the mostimportant topics.
But the other topic thatinfluences the use of medicines
in kids is, for example, theavailability of pharmaceutical
forms.
For example, most of the drugsare coming in solid way, in

(08:37):
solid forms, and we need toprepare some specific medication
for kids for an easy use ofmedications, and it requires a
lot of skills for people whoprepare this medication, like
pharmacists or nurses.
And the other way is if we havea liquid form, for example for

(09:00):
oral use, sometimes it's not soeasy to have the exact measure
of the medication.
And you know, in primary careusually the mother or the
parents are the people who arein charge of giving the
medication, and sometimes thepeople don't know about it.
We had some cases of kids whodied because the parents

(09:25):
couldn't give, in the best way,the medication to them.
It is so sad because of course,the parents just want to care
for the kid, but as we don'tknow exactly how to act, we have
these problems of security forthese kids.

Federica Santoro (09:40):
Yes, and a lot of the errors you mentioned, it
sounds like, then, greaterawareness would already improve
the problem greatly.
But in general then, what canwe – healthcare professionals or
caregivers, right (youmentioned the parents and their
important role) – what can we do, then, to prevent harm to
children if a lot of theseerrors are preventable?

Angela Caro Rojas (10:03):
I feel that to have this conversation is one
very good first step, becausepeople need to understand that
it exists.
It is a problem.
Sometimes we are not awareabout that and we need to talk
about it.
We need to say this is aproblem, it exists.
Be very careful with your kids.
For sure, most of the parentsare considering drugs as a

(10:30):
possible risk for these kids,but sometimes we're not totally
aware.
Then the first topic is to teachabout this, for example, for
healthcare professionals.
In every conversation withparents, it's important to
inform about the risk.
The intention is not to createmore fear, but it's good for

(10:52):
people to know that they need todo the things in a very
specific way for having the bestresults, and it's the
responsibility of every one ofus who are interviewing some
patients.
Then I feel that the other wayis to design safer systems.
I mean inside of hospitals orwith community.

(11:14):
It's important to know that itis a good way to do the things,
it is the best way to do thethings.
Then we could design thesesystems in a safer way, for
example, with double checks.
For example, when you need togive some medication to your kid
, just double- check that youare reading it in the best way,

(11:35):
that you are having totallyclear what is the measure of the
medication that you are giving.
Not to use spoons, for example,if they are not graduated with
the measure.
It's better to use syringes forgiving the medication exactly
to the kids, or other tools.
Or, for example, useready-to-use medicine.

(11:56):
Sometimes, for example inhospitals, we need to prepare
the medication and if we havecentralised the preparation of
medications, for example in thepharmacy, it is easier to use
the medication in beds.
And to standardise process isvery important: that everyone

(12:16):
knows what is the right way todo something.
To standardise, for example,the preparation or the
dispensing of the prescription,to have some filters, that
everyone knows what is the rightway to act and everyone follows
it.
I feel that this is somerecommendation that we could

(12:37):
give.

Federica Santoro (12:37):
That's absolutely good pointers.
So greater awareness, smartersystems and standardised
procedures, if we were to sum itup.
Now, obviously, children livein different conditions around
the world.
Those who happen to live inlow- and middle- income
countries may face additionalchallenges, in addition to what

(13:00):
we just described.
So when a family is in lessfavourable socio-economic
circumstances, of course it maybe difficult for them to
prioritise medicines safety when, say, they don't even have
access to the medicines theirchildren need.
So in those delicate situations, how do we make sure that

(13:23):
pharmacovigilance doesn't justget forgotten?

Angela Caro Rojas (13:27):
I feel that sometimes we need to remember

the basic things (13:32):
for example, first, healthy habits, for
example, food and all theseconditions, for example,
exercise and other things thatcould keep kids healthy.
And, of course, if it is neededto go to the health systems, we
need to work on other thingsthat don't require most of the

(13:57):
resources.
For example, to be sure thatevery kid has vaccines or has
particular attention for theirnecessities, to verify that they
are growing in the best way and, as we said before, a lot of
humanity and understanding.

(14:18):
What are the fears of the kids,what are the anxieties, and not
just for the kid but for allthe family, because sometimes
the family couldn't supportenough the kids.
Then it's so important to teachparents about how to manage the
medication, how to manage thesefears of the kids.

(14:42):
Sometimes we need the supportof parents for administering the
medications.
Then it's necessary to be veryempathetic and to understand
what are the necessities of thekids.
These are things that you coulddo without resources, just with
your good attitude.
As a professional, andparticularly for medicines, I

(15:04):
feel that, as I said before, thevaccines, the right use of
vaccines – most of the peoplehave the possibility of having
access to vaccines.
Then it's so important toconsider it and to promote it.
But additionally, in all theother medicines that the kids
need, to try to prioritiseinside of the hospitals, first
the access to the kids and thenthe access to other people.

Federica Santoro (15:32):
We often advocate for greater patient
engagement in pharmacovigilance,and in fact that was one of the
themes in past Patient SafetyDays.
But the challenge with childrenis that they can't adequately
express their concerns oropinions.
So how do we make sure that,where possible, of course, that

(15:53):
the child's voice is heard?

Angela Caro Rojas (15:56):
I feel that communication is not about words
.
Communication is about tounderstand what other people are
feeling and the kids couldexpress a lot without words.
They could express fears, theycould express anxiety, they
could express how they arefeeling.

(16:18):
We need to understand what ishappening in their brains and I
feel that usually a mother knowswhat is happening with her kid
and, of course, parents ingeneral.
I feel that we could be moresensible, more perceptive with

(16:38):
what the kids need, but, ofcourse, when the kids have the
option to talk – I mean three,four or five years – we need to
hear them.
I mean, the problem is that wedon't want to hear sometimes
what the kids want, what thekids need, but they have these

(16:58):
rights and we need to be veryrespectful with those rights.
The perception of the kid aboutthe attention is so important
and you could see in someTikToks or other places, you
could see doctors that reallyare empathetic with the kids.
I saw some videos about peoplewho, for example, use these

(17:22):
dresses as superheroes or justtalk in a language that, for the
kids, is better.
It's a way to be sensible withthem and I feel that if everyone
perceives the necessity of thekids and acts as a parent, maybe
it's easier, the way that thekids could communicate.

(17:51):
For sure no one wants to feelany pain, but for the kids it's
more difficult.
If you don't need an injection,try not to put an injection to
them, you know.
If you have the possibility oforal forms of medicines, try to
use it before.
Just if it is absolutelynecessary to use an injection,
use it.
And try to have this moment,not the nightmare that usually

(18:14):
is for a kid.
Try to have it in the best way,inviting him to play.
You know, for kids play iseverything.
If you are playing that you aregiving a medicine probably it's
better for them.
And try to understand what arethe necessities of the kids and
try to interact with them inthat way.

Federica Santoro (18:36):
Yeah, so really listen and make sure you
adapt, I guess, yourcommunication.
And also just be mindful of thecontext, that it remains
positive and playful, as yousay, for them.
Exactly.
It's not easy, of course, but we often just
rush through the various momentsof our life because we don't
have enough time, but it wouldbe nice to pause and put enough

(18:59):
attention on these aspects too.

Angela Caro Rojas (19:01):
Mm-hmm.
Exactly, I feel that the key isto be aware we are working with
kids.
Of course most of the nursesand paediatricians have that
sensibility.
We need to think about, who isour patient, what is happening
in her or his brain, and what isthe best way to solve the

(19:27):
necessities of these kinds ofpatients, because the
necessities of them probably aredifferent from an adult.
Those necessities are morerelated with compassion, with
empathy.

Federica Santoro (19:42):
Feeling safe.

Angela Caro Rojas (19:42):
Yeah.
If they feel that they aresupported, that they are with a
good company, probably they feelbetter, not just because of the
drug, but because of the peoplewho are taking care of them.

Federica Santoro (19:56):
Yeah, and I guess that is true for any
patient, any age, right?
Especially true for the smallones.

Angela Caro Rojas (20:03):
Yeah, you're right.

Federica Santoro (20:04):
Yeah.
So, we are nearing the end ofthe interview.
How will ISoP mark PatientSafety Day this year?
I know you usually organisespecial activities to mark the
event.
Are there any specialactivities planned this time?

Angela Caro Rojas (20:21):
We usually have an open and totally free
event for everyone and for thisyear it will be on 18 and 19 of
September.
And it is a virtual event witha lot of speakers and talking
about the specific topic ofPatient Safety Day.

(20:42):
For this year, of course, itwill be about kids and
paediatric patients and we arehighlighting medications' safe
use in the paediatric populationand how to have a safer
attention for these kids.
And, additionally, it'simportant for the people to know

(21:04):
that every video of PatientSafety Day is in our YouTube
channel.
ISoP has a YouTube channel andyou could find in that channel
all the sessions for every yearabout Patient Safety Day.
It's a lot of information thatyou could use, and if you don't

(21:24):
have not the possibility ofjoining us in this celebration
in September, you could go tothe YouTube channel and you
could see all the videos ofpeople talking about the topic
of Patient Safety Day.

Federica Santoro (21:40):
Great to hear, and we will be sure to tune in
for that event and we will sharethe link in our show notes.
And also the link to yourYouTube archive, as you say, so
people can revisit events frompast Patient Safety Days if
they'd like to access thosematerials.
Is there any other way peoplewho want to engage with the
celebrations can do that, bothwith WHO's and ISoP's campaigns?

Angela Caro Rojas (22:06):
Usually on that day, 17th of September,
people use the orange colour asa reminder about Patient Safety
Day.
For example, I always wearorange and sometimes in some
hospitals they put some lightsin orange.

(22:28):
It is the way to say that weare committed with patient
safety.
Then I want to invite you allto, first, be aware about
Patient Safety Day, I mean onSeptember 17th.
Look for other activities, WHOactivities, and for other people
who work in patient safety whogive some information about this

(22:51):
.
Share with your colleaguesabout the importance of this
day, and everyone be aware thatsome kids are harmed or have
some risk just because we arenot aware that we need to have a
safer attention for them.
Then it's so important thatpeople talk about, learn a

(23:15):
little more about how to have asafer system and, additionally,
feel committed to having a saferattention for our paediatrician
patients.

Federica Santoro (23:27):
So many important aspects to discuss,
and we are so looking forward tothe online event – again, on
the 18th and 19th of September.
Tune in for that, and we willmake sure to wear our brightest
orange clothes to mark the dayas well.
Well, thank you so much forjoining the studio again, Angela

(23:47):
, and for this interesting chat.
I wish you a very pleasant andinsightful Patient Safety Day
ahead.

Angela Caro Rojas (23:54):
Thanks, thanks to you, my dear.
It is always a pleasure to behere and please, if you could
disseminate all thisinformation, it is very
important for us.
Thank you so much for yourusual support and for all the
team of UMC's support.
Thank you.

Federica Santoro (24:19):
That's all for now, but we'll be back soon
with more conversations onmedicines safety.
If you want to know more aboutPatient Safety Day and medicines

(24:40):
safety in children, check outthe episode show notes for
useful links.
And if you'd like morepharmacovigilance stories, visit
our news site Uppsala Reportsto stay up to date with news,
research and trends in the field.
If you enjoy this podcast,subscribe to it in your
favourite player so you won'tmiss an episode, and spread the
word so other listeners can findus, too.
Uppsala Monitoring Centre is onFacebook, LinkedIn, X and Blues
ky, and we'd love to hear fromyou.

(25:01):
Send us comments or suggestionsfor the show or send in
questions for our guests nexttime we open up for that.
You can also visit our websiteto learn more about how we
promote safer use of medicinesand vaccines for everyone,
everywhere.
For Drug Safety Matters, I'mFederica Santoro.

(25:22):
Thanks for listening and tillnext time.
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