Intro

Federica Santoro 0:15

The end of the year is the perfect time to celebrate accomplishments and reflect on next steps. And that applies to the world of drug safety too. So, what did the pharmacovigilance community achieve in 2023? And which trends do we anticipate for 2024? My name is Federica Santoro, and this is Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. Joining me today in this special end-of-year episode is Angela Caro, pharmacist, epidemiologist, and president of the International Society of Pharmacovigilance ISO. When I phoned Angela at her office in Colombia a few weeks ago, she had recently returned from the society's annual meeting in Indonesia. A highlight on the global pharmacovigilance agenda. With hundreds of experts attending from all four corners of the world, ISOP's annual meetings are the perfect opportunity to sum up current trends and speculate on future developments in the field. And that's exactly what I asked Angela to do. Enjoy our conversation.

Welcome, Angela!

Federica Santoro 1:43

Hi Angela, and welcome to Drug Safety Matters. It's a pleasure to have you on the show. How are you today?

SPEAKER_01 1:49

For me, it's a pleasure to be here. Thank you so much for this invitation. I am really happy for being here with you.

The Bali meeting

Federica Santoro 1:56

So it's the 20th of November today, and barely two weeks ago, you were in Bali in Indonesia for the ISOP annual meeting. How did it go?

SPEAKER_01 2:07

Wow, it was very good. Additionally, to be in Bali, you know. It was great to have all these friends of um ISOP, all the people who worked in pharmacovigilance, talking about the most important topics in pharmacovigilance in this moment. And we had more than 40 countries, people from more than 40 countries, and more than 300 participants. It was a very successful annual meeting. We discussed a lot of topics, and I want to show you a little of that, how it was in this year.

Federica Santoro 2:42

Brilliant, and I'm looking forward to hearing more. So let's get started. Um,

Putting patients first

Federica Santoro 2:48

this year's annual meeting was the 22nd in the history of ISOP, and the theme was putting patients first in pharmacovigilance. So I had a look at the program, and I noticed the first day opened with a session on patient engagement, but you also invited speakers in other sessions to think about their topic from the patient's perspective. Why did the choice fall on this particular theme? Why did you feel it was particularly relevant now?

SPEAKER_01 3:21

I feel that we are totally connected with what has happened in the world about the patient's safety and the patient engagement. As you know, probably WESO proposed for this year the topic of patient engagement for the World Patient Safety Day. And as ISOP, we consider that it's so important to have the voice of the patients and to understand the point of view of the patients. I feel that we need to learn more about what the patients think, what the patients act, and how they consider what is the best way to take self-care. The patient has a lot of information that we probably don't catch in the best way, because I feel that we are totally focused in detecting what is the adverse reaction or what is the problem with the medication, but we usually don't realize that we have a person, a human being, suffering pain or suffering this adverse reaction. And when you consider that it's a person, and when you consider that they are living something that maybe you are not totally aware about what they are feeling, it's more difficult to make decisions about how to manage the problems with medications. And I am totally sure that nobody knows better a disease, a better treatment as a patient. The patient really knows how the adverse drug reaction happens. And we need to have this kind of interaction with patients for understanding in the best way how we could help the patient who is involved in a medication problem. For example, ISO consider very important to have more participation of patients inside of the society, more participation of scientific societies, leaders for patients. Because you know, in the last years, we could see more people leading about patient safety, patient safety movements. And if we are not in the same line with them, if we don't have all this information, we are losing a lot, a lot of knowledge that we could use if we have it.

Unconventional topics

Federica Santoro 6:00

And uh there's something else I noticed about the meeting program. There were plenty of familiar topics like drug safety in the elderly or medicines for women. But I couldn't help noticing there were other topics too that sometimes are considered on the fringes of pharmacovigilance, if I may say so. So topics like medical devices or eco-pharmacovigilance. What does their inclusion in the program say about how the field as a whole is developing?

SPEAKER_01 6:35

I feel that it represents how the society is moving, how ISOP is moving. Because in ISOP, maybe the audience don't know about, but we have 13 special interest groups. It means that we have uh very different topics for working, and this special interest group that we called SIGs, in that six, we have the possibility to interact with people who has a lot of experience in the field, but additionally, we have the possibility to include students or people in a younger career. It means that inside of the six, we develop different strategies, like, for example, write some articles, or for example, do some courses, or put some strategies about this kind of topics, and it represents what the society is doing. Then the selection of the different sessions was considering the six and considering the interest of the audience. For example, was very, very important the topic of herbal and traditional medicines, because we were in Indonesia, and when you see the hospitals, for example, in Bali, they use herbal and traditional medicines. Then to discuss how to do pharmacovigilance in that kind of products was very, very important. And ISOP in the special interest group has that specific information. And for example, in eco-pharmacovigilance, we have this interest. It is not totally new, but as you said, probably is not totally development that different topics that we have, but eco-pharmacovigilance is taking more and more relevance for the environment, for how to take care of the environment, then for us it's so important to show what society is doing in that kind of uh topics.

Federica Santoro 8:39

Very interesting.

This year's trends

Federica Santoro 8:41

And obviously, the meeting spanned several days. There were so many topics and there were sessions in parallel. If you had to summarize it, what other major trends emerged from the meeting and in the field of pharmacovigilance this year overall?

SPEAKER_01 8:58

I feel that we have uh different uh points of view about what pharmacovigilance is happening in this moment in the world. No doubt about that the use of artificial intelligence and machine learning was one of the most important topics. We could talk about this in other moments, but it is a very central topic for analyze the information, you know, is to have this data and become the data in information, then in knowledge, and finally in wisdom. Is that option to be very smart about how to use the information that we collect for real decisions in real life with real patients? Then is one of the topics that are taking more and more relevance with the time. Other important topic was about elderly patients. These patients uh, as you know, probably in the WE show is talking more about polymedication, to have this care for people who is using a lot of medicines, then it is taking relevance for verifying what is the best way to protect the patients from some problems with medications. And finally, the field of vaccines was very, very important in general, because probably after the pandemic, we have um different points of view about how to do this pharmacovigilance to vaccines.

Impact of COVID vaccines

Federica Santoro 10:30

And I'm glad you brought up the topic of vaccines and the pandemic because one of our followers on social media had a question exactly about that. He asks, what trends have been seen or are foreseen in the field due to the impact of the COVID-19 vaccines?

SPEAKER_01 10:51

It's wonderful to have that kind of questions from the audience. Yes, indeed, the coronavirus vaccine is an important moment in the pharmacovigilance in the world. As you know, all this experience that the data scientists take in the moment of the pandemic is so important for now understanding a best way or in a different way the pharmacovigilance. Starting in clinical trials, in how to complement the information of the clinical trials with the pharmacovigilance post market. The other important topic is about these particularities of different groups of patients, for example, all about the women's health and disorders, menstrual disorders, for example, and to understand what is the reality of this kind of patients in groups that are not the same for other kinds of groups. And I feel that one of the most important is the collection of data for have enough information for make decisions. Because, as you probably know, the vaccines were distributed very fast, and the information about the adverse events was collected in a very good way, but some countries had the possibility to analyze the information, and other countries don't have that possibility as fast as the developed countries. Then the possibility to have that information and use the information collected for one uh entity for take decisions in other entities or in other countries is very, very important too. Thanks for that.

Common challenges

Federica Santoro 12:43

Now, as usual, the annual meeting drew an international crowd of pharmacovigilance professionals. You said earlier how many different nationalities were present. And obviously, each person brings their own perspective of drug safety with experience from their own corner of the world. But despite these regional differences, did any common challenges emerge during the discussions?

SPEAKER_01 13:13

Yes. Um, some challenges are the same as always, for example, to have all the information, the reports, and the quality of the reports, the quality of the data is usual problems that we need to cover in all the world. But for example, the communication, we had a very good session about risk communication and how to involve the people, involve the audience, and um the knowledge about pharmacovigilance. Then the communication is a challenge around all the world, and it's a challenge in each language. Then, for example, just this literacy about pharmacovigilance is so important because the people, for sure now in COVID times, care a little more about what pharmacovigilance is, but it's more the information that could uh make the people afraid about the medications and not necessary to have a responsibility using medications. Then this kind of way to communicate the risk is very important in any kind and in any culture around the world. And other important topic that I was very happy to participate in that session was the session about low and middle-income countries challenges. We had the participation of Chantipal from WESHO, and she showed us um very good practices for some regulatory agencies. And when we finished this review with other people from Latin America, Asia, and Africa, we said that we have very common problems. And I particularly talked about the problem of the political situations and economic situations for low-income countries and how it is not a technical issue, it's not about medication, but it reflects how the regulatory agencies work, because if they don't have the support of the government, they have big problems to do pharmacovigilance. In some countries, the governments attack the process of pharmacovigilance. And it's so sad because, of course, the people of the regulatory agencies are doing the best, trying to be very technical, trying to collect information for decisions, but the governments sometimes are not helpful. This was a very interesting topic that we discussed for that kind of countries. And I want to add something: the professional development. We had a session specifically talking about the curriculum in the universities for pharmacovigilance. And around the world, we have the same problem. It's not possible to include in the curriculum because we don't have enough time, because different careers of healthcare had different points of view or different interests. Then it's so important for ISOP to work specifically in this kind of qualifications and certifications for verifying that the people who want to work in pharmacovigilance have all the knowledge for working that.

Federica Santoro 16:43

And so

Latin American challenges

Federica Santoro 16:45

we talked now about common challenges, but I'd like to zoom in for a moment into a specific region, the one where you live. You're based in Colombia, so I can't help but ask about pharmacovigilance in Latin America. What challenges come to mind when you think about drug safety in your region?

SPEAKER_01 17:06

For me, it's so important as a Colombian to talk about this particular topic. Latin America has different challenges, but I feel the highest is about the harmonization among the countries. Because if you want to produce, for example, a risk minimization plan, you need to change the plan for each country in Latin America. If you want to present something to Ecuador, it's different to present something to Colombia or presenting something to Bolivia. And you said, but it's the same molecule. Probably the use of the medicine is very similar in all the countries. Why you need to change it? And it's more for administrative things. It's something very sad because we have the same language, we could produce the same document, we could use the energy and the resources for help more patients. But as you need to change, as you as an industry need to change every RICS minimization plan for different countries and for different regulatory agencies, it takes a lot of time, a lot of resources. And I feel that maybe if we could have just one regulatory agency for all Latin America, it will be very, very easy. And it implies not just a best task for the industry, it implies additionally best time for the people who need the medications for the patients. And if you have a specific task force for all the countries, and if you have to do this administrative task just once, all the time and all the resources you could invest in have more energy and more resources for the patients. And additionally, for the governments inside of each country, do exactly the same processes 20 times in 20 countries, it's it's crazy. Then for me, the high topic is harmonization. Another important topic is to have this culture about patient safety. Because sometimes the pharmacovigilance is more recognized as a specific topic that I need to complete for the law, but not because I am really interested in the patients. Then if we could have this culture of patient safety, and I always talk about the same, it's the patient in real life, the patient who is in the hospital, the patient who is with the doctor with one specific medication. If we think about what they need, they need that all the healthcare professionals know about medication safety. It's also important that the people who work in pharmacovigilance in hospitals have all the information about how to use in the best way the medication. My particular topic, the topic that I love, is medication errors. We could have all the information, we could have the best produced medication, but if we don't have all the information in the patient, in the house of the patient, in a good labeling, we are not having nothing. Because it's probably that the people just use in the bad way the medication and don't have the effectiveness or have problems of safety because they don't know how to use it.

Federica Santoro 20:38

Well, thanks for that overview then of pharmacovigilance in your corner of the world. Um

Highlights of 2023

Federica Santoro 20:45

it's November now, but it will be December when the episode goes out, and we all know what the end of the year means. It's usually a time to look back and reflect and celebrate important achievements. So if we had to compile a list of pharmacovigilance highlights for 2023, what would you pick?

SPEAKER_01 21:08

Um, I feel that the one important topic is about what we are talking in all the episodes about patient engagement. Because we need to give more voice to the patient. We need to understand better what the patients want, what the patients need for having more information and for use in the best way the medicines, then I feel that patient engagement is one of that. I feel that medication errors is another important topic. As ISOP, we are working so hard in trying to define the best practices for the best use of medications and how to prevent these medication errors because we are trying to do the best in the production of medicines, the regulatory agencies are doing the best in post commercialization vigilance. Sometimes we are not totally aware about the impact of medication errors, and it is huge. Uh, the cost in money, but additionally, the cost in lives is so high. And we need to be focused and prevent and inspire to work with a lot of patients about um how to help and protect the patients in the best way for use the medications. And I feel that one topic that is important and continue being important with the time is communication. All this moment of the pandemic and how the information was given to the people about the use of vaccines was so so important for having these good results in vaccination. Then I feel that the topic of communication helped us to improve the good use of medications, include vaccines, that as you know is one of the most important medications.

Trends for 2024

Federica Santoro 23:07

So that was our look back at 2023, but what's ahead? What pressing issues will the pharmacovigilance community have to focus on in 2024 to stay relevant?

SPEAKER_01 23:21

Definitely the topic of artificial intelligence is so important, and the topic of the use of data scientists and the data science for having more analytics for understanding better the information will be a very important topic. And if I may, it's important to remind the audience that ISOP organize every year the Boston Seminar of Artificial Intelligence and Machine Learning, and this seminar talks about how to use all this information and all these new ways to analyze information for pharmacovigilance. Then it will be a topic that will be very important in 2024 and the next years for sure. The other important topic is about the pharmacovigilance in specific populations. It means, for example, the use of medicines in pediatrician or in elderly people, or particularly by gender in women. The way to analyze the information is different for each of that kind of groups. Then I feel that the pharmacobalance in the future will be more focused on particular considerations on particular populations. And additionally, the other important topic for the future is pharmacogenomics. Some information about how the medication is used or how it is effective or secure in particular races or in particular communities will be very, very important. Then the pharmacovigilance for specific groups of people, I feel, will be one of the most important topics for the future.

Federica Santoro 25:14

Well, I'm glad to hear we are in sync. A lot of the topics we discussed so far are things that we've covered on drug safety matters before. And if we haven't covered them yet, to be sure that there will be episodes coming in the future. We've already been thinking about covering artificial intelligence, diving deeper into herbal medicines, looking at medicine safety and pregnancy and so on. So it's lovely to see that we are in sync and uh we can turn to ISOP for useful inspiration and collaborations.

SPEAKER_01 25:49

Ah no, Federica, thank you so much for this invitation. For the International Society of Pharmacovilance, it's so important to have this partnership with the UMC and to share that kind of information and show what ISOP is doing with these different groups and the 13 special interest groups, the 14 chapters that we have in all the world. It's also important to have this communication with you and with all your audience. Thank you so much for this space.

Federica Santoro 26:17

Thank you for sharing your time with our listeners.

Outro

Federica Santoro 26:41

If you like our podcast, subscribe to it in your favorite player so you won't miss an episode, and spread the word on social media so other listeners can find us. Apart from these in-depth conversations with experts, we host a series called Uppsala Reports Long Reads. A selection of audio stories from UMC's Pharmacovigilance news site. So do check that out too. Uppsala Monitoring Center is on Facebook, LinkedIn, and Twitter. 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. For Drug Safety Matters, I'm Federica Santoro. I'd like to thank Angela Caro for her time, our listeners to Darshan from India for submitting questions, Matthew Barwick for post-production support, and of course, you and all the listeners who tuned in this year. We'll be back in January with more stories from the world of drug safety, and I hope you'll be there too. Until then, stay safe and enjoy the holiday season.