Welcome and introduction

Federica Santoro 0:15

Welcome to Drug Safety Matters , a podcast by Uppsala Monitoring Centre , where we explore current issues in pharmacovigilance , and patient safety . My name is Federica Santoro and I'm delighted to be back on the show after a long break . Like many of you , I'm looking forward to Patient Safety Day on 17th of September . An annual highlight on the pharmacovigilance calendar . Established by the World Health Organization in 2019 , the day is an excellent opportunity to spark conversations and inspire action for better patient safety , and this year's campaign is about the youngest – and perhaps most vulnerable – patients of all: newborns and children .

Federica Santoro 1:05

To tell us more about the campaign is Angela Caro Rojas , president of the International Society of Pharmacovigilance ISoP , who joined me online from her hometown of Bogotá , Colombia . We discussed why we need awareness initiatives like this , how to avoid common medication errors in children, and why you should go digging in your wardrobe for an orange garment . I hope you enjoy listening .

Hello, Angela!

Federica Santoro 1:41

Welcome back to Drug Safety Matters , Angela . It's fabulous that you accepted our invitation to come back to the studio and , this time , talk about World Patient Safety Day . How are you doing ?

Angela Caro Rojas 1:55

Thanks , thanks to you for this invitation . It's always a pleasure to be with you and all the team of UMC , so happy for being here .

Federica Santoro 2:03

Fantastic . Well , let's get into it . Last time you were on the pod was at the end of 2023 , so a while back, and you had recently returned from the annual ISoP meeting in Bali . And at the time we discussed trends in pharmacovigilance , looking forward to the future . But this time we're going to focus on an important occurrence for the pharmacovigilance world: World Patient Safety Day , which happens on the 17th of September . And a lot of our listeners are perhaps going to mark that day . So,

Why we need Patient Safety Day

Federica Santoro 2:35

first of all , maybe a naive question: why do we need a Patient Safety Day at all ?

Angela Caro Rojas 2:42

We need it because sometimes we are not aware about how complex the health systems are and in those systems usually we have the possibility to harm patients . I mean , every professional in healthcare is trying to do the best, but the complexity of the systems produces sometimes harm in patients . Then we need to work so hard for having safer systems and for having a best way to work with patients , for having safer solutions in health

Safe care for every newborn and every child

Angela Caro Rojas 3:16

.

Federica Santoro 3:17

And Patient Safety Day is an initiative by WHO , the World Health Organization , and they've been running this since 2019 . And they've picked different topics over the years , including diagnosis or patient engagement . Now , this year , the theme that's been chosen is "safe care for every newborn and every child . What do you think about that choice ?

Angela Caro Rojas 3:43

It is a great choice because we are working on different topics in patient safety , but particularly kids are so vulnerable . This is a kind of population that needs more support in every environment , for example , in ambulatory care or in primary care . It's so important to take care of these kids that are most of the time at home , but the parent needs to take care of them . And additionally , when they are hospitalised , they need more support , and it's so difficult to standardise the attention for this kind of patient . Then it's a great idea from WHO to work on this this year

Challenges in paediatric pharmacovigilance

Angela Caro Rojas 4:25

.

Federica Santoro 4:25

Absolutely . So, children are an extremely vulnerable population , and in fact it's one of those groups of patients that we generally refer to as "special populations in pharmacovigilance . They're a bit like the elderly or pregnant women where drug safety monitoring can be a little extra challenging . Now , as you say , safety – medical safety –encompasses a lot of different aspects , but as we are pharmacovigilance professionals , we will focus on drug safety in our discussions today . So, what makes , then , pharmacovigilance in the paediatric population so tricky ?

Angela Caro Rojas 5:04

There are a lot of reasons . First , I feel , the research . When people are researching some new drugs , it's not ethical to participate with kids in the research . Then it's so necessary to adapt some research for this paediatric population . And sometimes the research is in adults and we need to adapt the results for paediatric population . Then research is one of the first topics, because we don't have enough information about how the medication works in paediatric patients . The other point is the particularities of paediatric patients , for example , the maturity of the organs , the maturity of the systems of the kids . Then some medications work differently in these organs , in these systems . Then it's necessary to monitor exactly what is the effect of the medication in the kid . I feel that the most important point is kids are very vulnerable , not just because of the body but because of the emotional field . Then we need to be very careful with them and how to treat them and it is so important to highlight .

Federica Santoro 6:39

And we'll go back also to that point you mention of the emotions and their perception also of their healthcare, and their engagement perhaps in their healthcare . We'll go back to that point later

Common medication errors in children

Federica Santoro 6:41

, but first I wanted to speak about medication errors in this population . Obviously, healthcare systems are complex, as you said in your introduction, and mistakes can happen at different points . Now because prescribing and administering medicines to children can be challenging, errors can happen in those stages . Are there medication errors that are observed more often in children than in adults ?

Angela Caro Rojas 7:09

Yeah, the first topic that we see in this population is overdoses . As you know, the doses for kids are very low , very specific , and sometimes in prescription , dispensing or administration we could have this probability of overdoses . And to have this kind of doses could give the patient toxic effects or side effects . Then we need to be sure that every person who is working or managing medications is totally aware that this medication is for a kid . And of course , if we are , as medical doctors , prescribing, we need to be sure about all the conditions of the patient , not just the weight or not just how big he is or she is . It is most about all the conditions of the patient , if they are having any problems , for example , in the maturity of the organs , or if they are having a particular pharmacodynamics or pharmacokinetics for this drug . This is one of the most important topics .

Angela Caro Rojas 8:25

But the other topic that influences the use of medicines in kids is , for example , the availability of pharmaceutical forms . For example , most of the drugs are coming in solid way , in solid forms , and we need to prepare some specific medication for kids for an easy use of medications , and it requires a lot of skills for people who prepare this medication , like pharmacists or nurses . And the other way is if we have a liquid form , for example for oral use , sometimes it's not so easy to have the exact measure of the medication . And you know , in primary care usually the mother or the parents are the people who are in charge of giving the medication , and sometimes the people don't know about it . We had some cases of kids who died because the parents 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't know exactly how to act , we have these problems of security for these kids .

Federica Santoro 9:40

Yes , and a lot of the errors you mentioned, it sounds like , then , greater awareness would already improve the problem greatly

Preventing medication harm in children

Federica Santoro 9:49

. But in general then , what can we – healthcare professionals or caregivers, right (you mentioned the parents and their important role) – what can we do , then , to prevent harm to children if a lot of these errors are preventable ?

Angela Caro Rojas 10:03

I feel that to have this conversation is one very good first step , because people need to understand that it exists . It is a problem . Sometimes we are not aware about that and we need to talk about it . We need to say this is a problem , it exists . Be very careful with your kids . For sure , most of the parents are considering drugs as a possible risk for these kids , but sometimes we're not totally aware .

Angela Caro Rojas 10:35

Then the first topic is to teach about this , for example , for healthcare professionals . In every conversation with parents , it's important to inform about the risk . The intention is not to create more fear , but it's good for people to know that they need to do the things in a very specific way for having the best results , and it's the responsibility of every one of us who are interviewing some patients . Then I feel that the other way is to design safer systems . I mean inside of hospitals or with community . It's important to know that it is a good way to do the things , it is the best way to do the things . Then we could design these systems in a safer way , for example , with double checks .

Angela Caro Rojas 11:27

For example , when you need to give some medication to your kid , just double- check that you are reading it in the best way, that you are having totally clear 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 for giving the medication exactly to the kids, or other tools . Or , for example , use ready-to-use medicine . Sometimes , for example in hospitals , we need to prepare the medication and if we have centralised the preparation of medications , for example in the pharmacy , it is easier to use the medication in beds . And to standardise process is very important: that everyone knows what is the right way to do something . To standardise , for example , the preparation or the dispensing of the prescription , to have some filters , that everyone knows what is the right way to act and everyone follows it . I feel that this is some recommendation that we could give .

Federica Santoro 12:37

That's absolutely good pointers . So greater awareness , smarter systems and standardised procedures, if we were to sum it up .

Prioritising safety in resource-limited settings

Federica Santoro 12:48

Now , obviously , children live in different conditions around the world . Those who happen to live in low- and middle- income countries may face additional challenges, in addition to what we just described . So when a family is in less favourable socio-economic circumstances , of course it may be difficult for them to prioritise medicines safety when , say , they don't even have access to the medicines their children need . So in those delicate situations , how do we make sure that pharmacovigilance doesn't just get forgotten ?

Angela Caro Rojas 13:27

I feel that sometimes we need to remember the basic things: for example , first , healthy habits , for example , food and all these conditions , for example , exercise and other things that could keep kids healthy .

Angela Caro Rojas 13:47

And , of course , if it is needed to go to the health systems , we need to work on other things that don't require most of the resources . For example, to be sure that every kid has vaccines or has particular attention for their necessities, to verify that they are growing in the best way and , as we said before , a lot of humanity and understanding . What are the fears of the kids , what are the anxieties , and not just for the kid but for all the family , because sometimes the family couldn't support enough the kids . Then it's so important to teach parents about how to manage the medication , how to manage these fears of the kids . Sometimes we need the support of parents for administering the medications . Then it's necessary to be very empathetic and to understand what are the necessities of the kids . These are things that you could do without resources , just with your good attitude . As a professional , and particularly for medicines , I feel that , as I said before , the vaccines , the right use of vaccines – most of the people have the possibility of having access to vaccines . Then it's so important to consider it and to promote it . But additionally, in all the other medicines that the kids need, to try to prioritise inside of the hospitals, first the access to the kids and then the access to other people .

Ensuring children's voices are heard

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 Safety Days . But the challenge with children is that they can't adequately express their concerns or opinions . So how do we make sure that , where possible , of course , that the child's voice is heard ?

Angela Caro Rojas 15:56

I feel that communication is not about words . Communication is about to understand what other people are feeling and the kids could express a lot without words . They could express fears , they could express anxiety , they could express how they are feeling . We need to understand what is happening in their brains and I feel that usually a mother knows what is happening with her kid and , of course , parents in general . I feel that we could be more sensible , more perceptive with what the kids need , but , of course , 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 we don't want to hear sometimes what the kids want , what the kids need , but they have these rights and we need to be very respectful with those rights . The perception of the kid about the attention is so important and you could see in some TikToks or other places, you could see doctors that really are empathetic with the kids . I saw some videos about people who , for example , use these dresses as superheroes or just talk in a language that, for the kids , is better . It's a way to be sensible with them and I feel that if everyone perceives the necessity of the kids and acts as a parent , maybe it's easier, the way that the kids could communicate . For sure no one wants to feel any pain , but for the kids it's more difficult .

Angela Caro Rojas 17:53

If you don't need an injection , try not to put an injection to them, you know . If you have the possibility of oral forms of medicines , try to use it before . Just if it is absolutely necessary to use an injection , use it . And try to have this moment , not the nightmare that usually is for a kid . Try to have it in the best way, inviting him to play . You know , for kids play is everything . If you are playing that you are giving a medicine probably it's better for them . And try to understand what are the necessities of the kids and try to interact with them in that way .

Federica Santoro 18:36

Yeah , so really listen and make sure you adapt , I guess , your communication . And also just be mindful of the context , that it remains positive and playful , as you say, for them .

Angela Caro Rojas 18:47

Exactly .

Federica Santoro 18:48

It's not easy , of course , but we often just rush through the various moments of our life because we don't have enough time , but it would be nice to pause and put enough attention on these aspects too .

Angela Caro Rojas 19:01

Mm-hmm . Exactly , I feel that the key is to be aware we are working with kids . Of course most of the nurses and paediatricians have that sensibility . We need to think about, who is our patient, what is happening in her or his brain, and what is the best way to solve the necessities of these kinds of patients , because the necessities of them probably are different from an adult . Those necessities are more related with compassion , with empathy .

Federica Santoro 19:42

Feeling safe .

Angela Caro Rojas 19:42

Yeah . If they feel that they are supported , that they are with a good company , probably they feel better , not just because of the drug , but because of the people who 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 small ones .

Angela Caro Rojas 20:03

Yeah , you're right .

Federica Santoro 20:04

Yeah

ISoP's Patient Safety Day event

Federica Santoro 20:05

. So, we are nearing the end of the interview . How will ISoP mark Patient Safety Day this year ? I know you usually organise special activities to mark the event . Are there any special activities planned this time ?

Angela Caro Rojas 20:21

We usually have an open and totally free event for everyone and for this year it will be on 18 and 19 of September . And it is a virtual event with a lot of speakers and talking about the specific topic of Patient Safety Day . For this year , of course , it will be about kids and paediatric patients and we are highlighting medications' safe use in the paediatric population and how to have a safer attention for these kids . And , additionally , it's important for the people to know that every video of Patient Safety Day is in our YouTube channel . ISoP has a YouTube channel and you could find in that channel all the sessions for every year about Patient Safety Day . It's a lot of information that you could use, and if you don't have not the possibility of joining us in this celebration in September , you could go to the YouTube channel and you could see all the videos of people 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 share the link in our show notes . And also the link to your YouTube archive , as you say, so people can revisit events from past Patient Safety Days if they'd like to access those materials .

How to participate in the campaign

Federica Santoro 21:56

Is there any other way people who want to engage with the celebrations can do that , both with WHO's and ISoP's campaigns ?

Angela Caro Rojas 22:06

Usually on that day , 17th of September , people use the orange colour as a reminder about Patient Safety Day . For example , I always wear orange and sometimes in some hospitals they put some lights in orange . It is the way to say that we are committed with patient safety . Then I want to invite you all to, first, be aware about Patient Safety Day, I mean on September 17th . Look for other activities , WHO activities, and for other people who work in patient safety who give some information about this . Share with your colleagues about the importance of this day, and everyone be aware that some kids are harmed or have some risk just because we are not aware that we need to have a safer attention for them . Then it's so important that people talk about , learn a little more about how to have a safer system and , additionally , feel committed to having a safer attention for our paediatrician patients

Final remarks and goodbye

Angela Caro Rojas 23:27

.

Federica Santoro 23:27

So many important aspects to discuss , and we are so looking forward to the online event – again, on the 18th and 19th of September . Tune in for that , and we will make sure to wear our brightest orange clothes to mark the day as well . Well , thank you so much for joining the studio again , Angela , and for this interesting chat . I wish you a very pleasant and insightful Patient Safety Day ahead .

Angela Caro Rojas 23:54

Thanks , thanks to you , my dear . It is always a pleasure to be here and please , if you could disseminate all this information, it is very important for us . Thank you so much for your usual support and for all the team of UMC's support . Thank you .

Outro

Federica Santoro 24:19

That's all for now , but we'll be back soon with more conversations on medicines safety . If you want to know more about Patient Safety Day and medicines safety in children, check out the episode show notes for useful links . And if you'd like more pharmacovigilance stories, visit our news site Uppsala Reports to 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't miss an episode , and spread the word so other listeners can find us, too . Uppsala Monitoring Centre is on Facebook , LinkedIn , X and Blues ky , and we'd love to hear from you . Send us comments or suggestions for the show or send in questions for our guests next time we open up for that . You can also visit our website to learn more about how we promote safer use of medicines and vaccines for everyone , everywhere . For Drug Safety Matters , I'm Federica Santoro . Thanks for listening and till next time .