Federica Santoro 0:04

Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. This episode is part of the Uppsala Reports Long Reads series, where we select the most topical stories from our magazine, Uppsala Reports, and bring them to you in audio format. Our pick for today is the article 10 Critical Steps to Improve Patient Safety Worldwide, which appeared in issue 82 of Uppsala Reports in April 2020. How do we minimize the harm caused to patients by medicines and medical devices? A diverse group of people met in Italy last autumn to discuss that problem. What emerged was a 10-point plan showing the way forward for patient safety. Here's an account of the event written by Uppsala Reports Editor Jared Ross and read for us by Lee Bennett. But make sure you stay tuned to the end because after the read, you'll hear Jared talk to UMC Director Marie Lindquist. Among other things, they discuss the relevance of the plan as the world struggles to cope with the COVID-19 pandemic.

SPEAKER_02 1:23

Serious global challenges exist in recognizing and minimizing harms from medicines and devices. That is the message of a diverse multi-stakeholder group calling for urgent improvements in the detection, analysis, and reporting of harms in the interests of patient safety. The work of pharmacovigilance is driven by an ideal of patient safety that can never be reached but must always be pursued. For all the patient safety advances made in the past five decades by the WHO program for international drug monitoring and other stakeholders, the ongoing challenges of global pharmacovigilance are as important and as urgent as ever. The harms caused by medicines and medical devices are badly letting patients down, said Carl Hennigan, professor of evidence-based medicine and director of the University of Oxford's Center for Evidence-Based Medicine. Patient safety should be a priority for all healthcare systems, for all practitioners, and at the forefront of policy. But all too often it isn't. Within this context, a multidisciplinary group gathered recently to take stock of the pressing challenges facing the field and identified the most effective actions needed to protect patients around the world. Following that meeting, the group has now released a public statement of their common concerns, along with ten recommendations for improving patient safety worldwide. The four E's Forum, Exploring, Enhancing and Empowering Safer Medicines, Eriche, Sicily, was held jointly by Uppsala Monitoring Center, the University of Oxford Center for Evidence-Based Medicine, and the International School of Pharmacology, Giampaolo Vello from 7th to 9th october 2019. The theme of the meeting was improving the detection, analysis and reporting of harms in medicines, and over three intense days, health professionals, researchers, academics, journalists, patient advocates, and consumers worked to identify today's key problems and point to practical solutions. Eritcha was the site of the historic ERICHE Declaration on Communicating Drug Safety Information of 1997, which set out a vision of vigorous, open, ethical, patient-centered communications in medicine safety, said Marie Linqvist, Director of UMC. The four E's Forum builds on the first ERITA Declaration and the subsequent developments it inspired. The forum was structured to explore three distinct areas of modern patient safety pre-marketing approvals, post-licensing surveillance, and pharmacovigilance communication and dissemination. For each area, participants collaborated to develop a range of perspectives on how to ensure safety from the harms of medicines and devices. In the weeks following the forum, participants continued their work, distilling the discussions into an expression of common concerns and agreement. The statement, improving the detection, analysis, and reporting of harms in medicines and devices, represents valuable collaboration between the disciplines of evidence-based medicine and pharmacovigilance. It recommends action from multiple stakeholders, including industry, regulators, policymakers, and healthcare professionals aimed at addressing major deficiencies in current medicine safety systems and promoting higher levels of patient safety and awareness. But it's a long path from making a group statement to creating global regulatory and process change, Lindquist said. For all the advances in medicine, we still face a global problem of harms caused by medicines and devices, said Rebecca Chandler, medical doctor at UMC and one of the twenty-three signatories to the ERICE statement. There are multiple systemic issues that contribute to harms, and all stakeholders, including industry regulators, policymakers, academics, and healthcare professionals, need to always be challenging and improving their existing practices. To this end, the statement lays out a set of ten recommendations to improve global patient safety across the entire system, from research to regulatory and marketing authorization processes, to post licensing usage, to the way we communicate safety information to the public. Furthermore, the statement contends that patient safety requires constant vigilance of safety systems, structures, organizations, and processes, and calls for open, inclusive, and collaborative efforts to identify challenges and develop practical, implementable solutions that improve patient safety worldwide. The statement that emerged from Eriche provides clear recommendations on how to embed patient safety in research and regulation, said Hannigan. More importantly, for all those involved in improving care, the statement provides a roadmap for improving the detection and reporting of harms. Here are the group's ten recommendations for improving patient safety as listed in the statement. To improve the detection, analysis, and reporting of harms in the interests of patient safety, we recommend the following 1. Raise public and professional awareness of the harms from medicines and devices. 2 Shift the culture within regulatory and healthcare management systems from one of secrecy to one of transparency. 3. Enforce existing effective regulations, revise ineffective ones, and implement effective regulations in those areas lacking appropriate regulatory infrastructure. 4. Transfer from industry to healthcare systems the responsibility for providing information and support to healthcare providers on the use of medicines and devices. 5. Encourage and enable prescription and use of medicines and devices that are appropriate and tailored to the needs of individual patients. 6. Facilitate access to all relevant data. 7. Recognize case reports, including those written by patients, as a valid and important form of evidence of harms. 8. Improve baseline and continuing education of all stakeholders, including healthcare professionals, policymakers, and the public. 9. Recognize the importance of patients and carers, as well as healthcare professionals, in studying all aspects of therapy. 10. Establish and continuously develop effective communication with patients and other relevant stakeholders about the potential benefits and harms of interventions to improve the basis for shared decision making about treatments.

SPEAKER_03 7:44

Marie Linquist, welcome to Drug Safety Matters Podcast.

SPEAKER_00 7:48

Thank you very much.

SPEAKER_03 7:50

The original Erice Declaration on Communicating Drug Safety Information was issued in 1997 and it's been reviewed and expanded upon a couple of times since then. Why was it important to revisit it again in 2019?

SPEAKER_00 8:05

Obviously, a lot of things have happened over more than 20 years, and we know that not the least technology developments have just exploded. Something like social media didn't really exist in 1997, at least not in the way that we know it now. Not so many people had access to internet, smartphones didn't exist at that time. Given that the whole communication scene has exploded, I would say, uh over 20 years. People have access to much more information. The question is, do they have access to more knowledge? And that's uh one thing that I'm I'm very concerned with, not not the least now in Corona times as as it's called. So, yes, there was definitely a need to go and revisit and see how do we stand now in in this new world that we're living in today.

SPEAKER_03 8:55

The participants at the meeting and the signatories to the new Eriche statement, they represent a diverse range of interests and specialties. The output of the event is obviously important, but how critical was the process of making it all happen?

SPEAKER_00 9:10

Well, I think some people would say the process is all. I don't think I subscribe to that, but of course uh the process is important. Uh what what is seen as an end result, uh something that looks nice on a paper, uh of course that uh is important as well. But uh one of the most important things, and certainly when we we we're talking about communication, is to actually communicate and to get to know people and to see if we can understand each other a little bit better. So the whole process of actually doing it and getting together and uh meeting people who you don't normally meet and talk to, I think that's that's really essential.

SPEAKER_03 9:48

The most recent event, the Four E's Forum, was described as a foundation for future collaboration between two disciplines, evidence-based medicine and pharmacovigilance. What are the most important things these disciplines can learn from each other?

SPEAKER_00 10:02

One thing that we have to consider is that no discipline can say function in in isolation. The point with looking at things from either the say population perspective, looking at public health overall figures, how does we as a society deal with problems? That's one perspective. The other perspective is to look from from the point of view of the individual. How does an individual perceive their situation? What are the things that matter to that person? So those are broadly speaking the different perspectives. Both are needed. I think it's as as simple as that. You can't say that, for instance, safety of medicines can only be dealt with by epidemiological methods, or that it can only be dealt with by looking at individual case histories or case reports. You do need both, but you need different methods and different tools for different purposes, and you get different things out of it as well, and you you need to keep that in mind.

SPEAKER_03 10:58

You mentioned before as well that that another thing that's changed in the in the landscape is that we're now in corona times. The first reports of the coronavirus happen not so very long after the four E's forum. And since the statement has been issued, uh a lot has changed in the world. Does anything about the current pandemic change what's within the statement, or does it cast a different light upon the urgency of the of the issues we talked about?

SPEAKER_00 11:26

I think it's probably more the urgency that we do need change in in many, many different ways. Early on I had some hopes in the midst of of uh of the concern that people would really get together now and see how we can say work together from from all all disciplines and all parts of society to solve the problems we need to solve and to deal with them in in a caring and and at the same time rational and scientific way when when possible. But I think we have seen that it hasn't quite played out like that. Not totally. There are instances of really wonderful things uh that have happened, but also some examples uh that I would prefer not to think about.

SPEAKER_03 12:08

So can you expand a little on what you mean by some of the not so good things that have come out uh in recent times?

SPEAKER_00 12:15

We're talking about the need for information, and yes, of course, we do have need for information and need to get information out fast. The difficulty that I think has been shown is that information without explanation doesn't really help very much. And I think we have seen that uh it's easy that people can get more confused than helped by being just flooded by figures and statistics if we don't have a very good idea of how they have been derived, what do they actually mean, and how to interpret them. And then we come into the issue of trust. Do people on the whole trust the experts and authorities? Well, given that there are also political dimensions of this, we have seen that some doubts have been cast about the ability of experts to to be that, i.e. be able to tell us the truths as as we expect it. I think sometimes there is an impossible demand on scientists to be able to say absolutely what is right here and now what needs to be done. We don't have all the facts. So all all this sort of floating nebulous uncertainty in the midst of this flood of of actual information and and and figures, I think have shown that there is a need for better explanation and and who do we trust to give us that explanation? I think that's that's an issue. In some countries there is uh less trust in authorities than others, and I think only time will tell uh what is the best way forward.

SPEAKER_03 13:42

It strikes me as well from things that we've seen over recent months as well, that it's one thing for the medical or scientific community to communicate what they know, but it seems to be a very different thing for them to communicate what we don't yet know and what the process is for finding out about something new. That the public seems to struggle very much with that.

SPEAKER_00 14:04

Absolutely, and I think uh uncertainty, dealing with uncertainty is one of the most difficult things for human beings. Uh our whole life is uncertain. The only thing we know is that we're all going to die eventually. But we seem to be not very well equipped to to deal with the issues around uncertainty. We want to know exactly what's going to happen, and and of course we can't. To communicate around uh uncertainty is particularly difficult. People want to know, will I get this disease now? And if I do, uh how ill will I be? Will my mother die from it? What's going to happen to my school? Will it open or will it not? All these questions. And and then someone says, Well, we don't really know, and and it may be that uh we have reached a peak or or maybe not yet. That's not what people want to hear. So there is a conflict between our need to say be able to manoeuvre in in an uncertain world, we we want the answers, but but we can't get them. I think the only way is to be open about this and to actually say that we don't know. At the best we can provide a range around this figure that we are giving, but we really don't have the answers. And and we are sorry about that. We love we would love to have the answer. We are uh starting and running lots and lots of research projects. We are trying to find out, but today we don't have the answer. That is the only way forward that I can see to be absolutely open about that.

SPEAKER_03 15:28

So given all this, how would you like to see the work of the Foreys Forum and the Eriche statement be carried forward?

SPEAKER_00 15:35

I would like it to be carried forward in actions rather than words. We need words. We've just been talking about words and communication, so obviously that's important. But the real result is only when people actually act upon the words that we have put on paper and and do something in in their own areas and in their lives. We all uh came to this meeting, I'm sure, with uh a wish to do something in our different ways to reduce harms caused by medicines. That that's what we all had in common. We had uh say our different angles, our different perspective, and uh we now need to go back and in our different areas do whatever we can to uh improve safe use of medicines. That that's what we're here for. Someone working in in pharmacovigilance, uh having individual case reports as the main source of of data, fine. Do your best in getting those reports in and dealing with them and communicating what your findings are. If you're a pharmacoepidemiologist, well you have to go and do your thing and do even better studies and communicate them better as well. So I think for me, good words, essential, good acts also needed.

SPEAKER_03 16:48

Mary Linquist, thank you very much for joining us.

SPEAKER_00 16:50

Thank you.

Federica Santoro 16:55

That's all for now, but we'll be back soon with more long reads as well as our usual conversations with medicine safety experts. In the meantime, check out this episode's show notes for more information and visit upsalaports.org for more pharmacovigilance stories. If you like Drug Safety Matters, make sure to subscribe to it wherever you get your podcasts and send us comments and suggestions on social media. We love to hear from our listeners. You'll find Uppsala Monitoring Center on Facebook, LinkedIn, and Twitter. And you can join the conversation there with the hashtag Drug Safety Matters. Thanks again for listening.