Intro

Federica Santoro 0:15

Next week is a special week in the world of pharmacovigilance. It's the one time a year when drug regulators all around the world join forces in the name of medicine safety. This global campaign is known as Med Safety Week, and its aim is to encourage people to report side effects. And as it's led by us at Uppsala Monitoring Center, we thought it would be fun to celebrate it with a special two-part podcast here on Drug Safety Matters. My name is Federica Santoro, and in this first episode, I'm joined by Mittel Jadeja, specialist from the Yellow Card Strategic Development Team at the Medicines and Healthcare Products Regulatory Agency in the UK. In 2016, Mittel helped organize the very first international campaign to raise awareness of pharmacovigilance, basically the precursor to Med Safety Week. And he's been a constant presence on the Med Safety Week planning team ever since. I couldn't think of a better person to introduce the topic today. So I phoned him up in London and we chatted about under-reporting, why it's such an issue, and how communications campaigns can help. Enjoy the conversation.

Welcome, Mitul!

Federica Santoro 1:49

Hi Mittol and welcome to Drug Safety Matters. Delighted to have you on the show. How are you feeling today?

SPEAKER_00 1:56

Good morning, excellent. Thank you for

Why we need communications campaigns

SPEAKER_00 1:58

having me.

Federica Santoro 1:58

We've been collaborating for a number of years on the Med Safety Week campaign. But actually, before Med Safety Week, as we know it today, even existed, you were helping create communication campaigns already to raise awareness of pharmacovigilance. So why do we need such campaigns in the first place?

SPEAKER_00 2:21

Well, we all know we need medicines, and medicines are used by millions of people every day, and people benefit from them, but no medicine is entirely without harm. So and first, do no harm is the mantra for healthcare professionals and clinicians. But unfortunately it's difficult to actually predict in some instances who or when someone will experience an adverse drug reaction or even how serious it might be. So vigilance for the detection and prompt spontaneous reporting of suspected adverse drug reactions, commonly known as side effects, to national reporting systems like the yellow card scheme in the UK is basically the cornerstone of pharmacovigilance systems. And every report helps to gain further knowledge about the risks and benefits of medicines and how they're used in clinical practice. It also allows regulators like the MHARA to take action when necessary to minimize those risks of harm to patients. And patient safety is basically our top priority. However, all systems like this around the world are recognized to have an unknown and variable rate of under-reporting. And those are influenced by many different variable factors, mainly based around awareness levels about reporting systems. And that's not only with healthcare professionals but members of the public. And that's also coupled by being able to report things, detect them, the seriousness of the reaction, the ease of and kind of use of the extent of a product. And this can be stimulated by promotion or publicity about a product, as well as the safety culture of an organization. And under reporting, you know, there have been historical kind of estimates that indicate about 10% of serious reactions are actually reported, and between 2 and 4% of non-serious reactions are reported. And it's for that reason, you know, medicines regulators use a range of tools and different data sources to identify where events may be occurring more kind of frequently than is expected. There's also the kind of financial burden to the system. A European Commission report estimated that at about 79 billion euros. And of course, worldwide that would be much higher. And a more recent BMJ study in 2022 looked at adverse drug reaction admissions, multimorbidity and polypharmacy. And they looked at a month's analysis of medical admissions like that. And those authors estimated about 16.5% of those total admissions in the UK were accounted for because of adverse drug reactions. And the length of that stay was about six days. They also looked at that to say, you know, what percentage of those adverse drug reactions were classes avoidable? And that was 40%. And they extrapolated the cost in England alone to be about 2.2 billion to the National Health Service. So there's that financial element. But of course, most importantly, you know, adverse drug reactions can lead to harm in patients and the quality of life reduction. And then there's that knock-in effect about the loss of confidence in the health system. And with many of those being preventable, that's why it's so imperative for healthcare professionals to stay up to date with emerging advice as well as patients. They too should be empowered to take ownership of their health. So for those kind of inherent factors, we're always striving to strengthen reporting in as many ways as we can. And one of those ways is running regular campaigns to help us raise awareness that reporting helps regulators monitor the safety of healthcare products, you know, medicines and medical devices, depending on what country you're in, that are on the market to ultimately protect public health.

Barriers to reporting

Federica Santoro 6:07

Let's go a little deeper into the causes of under-reporting. You mentioned obviously that a lack of awareness is an important reason why people don't report side effects as much as they should. But what other bottlenecks exist? So what is stopping us really? And by us I mean patients and healthcare professionals from reporting more?

SPEAKER_00 6:32

I mean, first and foremost, for all kind of reporters, especially members of the public, and that of course includes patients, parents, and caregivers, they first need to know about the system, and that often may not be there, and a lot of regulators are criticized around that. But then also then what to report, how to report, why it's important, what happens to my report, and that kind of feedback leap mechanism is kind of sometimes absent. We also recommend that healthcare professionals talk to their patients about their medicines and they discuss, you know, the importance of taking the right medicine at the right time in the right way, in the right dose, carefully following instructions for use, etc. But also going that step further to say, what about side effects? What about the patient information leaflet when you do get that medicine? What do they do if they experience those problems and including about reporting them? And also being able to be vigilant around spotting and detecting those, especially with new products, serious reactions or rare reactions, or things that happen with a delayed onset or long-term use and the importance of capturing those. For healthcare professionals, I guess it is considered a professional duty of candor and care to their patients. And then for example, in the UK, that's supported for yellow card reporting to be as part of that code of conduct and best practice within many different guidelines for healthcare professionals. But it's also important that I guess pharmacovigilance doesn't get sidelined and that reporting becomes an integral part of clinical practice and culture. So integrating and making it easier to be able to do so within clinical systems does have an impact, and that's been seen quite um commonly across many different countries now. Med Safety Week and some CAMS campaigns have kind of helped to explain and demystify what pharmacovigilance is, what happens to a report, you know, what regulators do. Often there's that term of I've reported and it goes into a black hole. Don't know what happens to it. Uh there have been a few studies actually that have been probably quite old now, but Bill Inman explores some of the deadly sins of uh not reporting adverse drug reactions. And I think he looked at fear of litigation, lethargy, or kind of indifference that nothing will happen and what they're doing doesn't contribute to the general advancement of knowledge. A bit of ambition. So collecting and publishing their own case series in a journal, for example. The guilt probably of having caused something. Complacency even. So you know, the mistaken belief that only drugs are marketed that are totally safe and there's some knowledge gap there. An ignorance around the kind of need for reporting and um also a bit of diffidence, so about reporting a mere suspicion that something's happened. Also not being able to detect those adverse drug reactions and kind of link it. But also access to kind of forms and different modes of reporting also help. And kind of the legal liabilities and possible claims from from doing so. But you know, what we always say is um all reports are kept confidential and shouldn't be used for quality audits and so forth like that. It's about creating an open and just culture for reporting and if endowed, just report anyway.

Different reporters, different perspectives

Federica Santoro 9:46

So there are multiple reasons underpinning the issue of underreporting, and obviously that means to solve the problem we need to apply multiple interventions, and we'll get to that a little later. First, I wanted to ask you about the theme of this year's Med Safety Week. So Med Safety Week has been running now for several years, and each year we look at pharmacovigilance from a specific angle. For this year we've chosen the theme who can report. So that means we'll be focusing on different groups of reporters, patients, doctors, pharmacists, and nurses, and highlighting how each of them can help make medicine safer. But in your opinion, why is it important that regulators hear from all of these different groups? For example, what do patients have to say about side effects that we might not hear from doctors or from pharmacists and vice versa?

SPEAKER_00 10:48

I think it's a really good question. Um there are different levels of maturity of different regulators that have given the kind of authority to report for certain groups. But I think that involving different groups of reporters is essential for ensuring the safety and efficacy of medications and those treatments and being able to monitor them. It promotes a more holistic approach and uh accurate understanding of adverse drug reactions, and that eventually leads to better patient care and the early detection of potential risks, like I kind of explained, so they can be minimized before. And it's not just kind of doctor prescribing a medicine, patient taking it, and you know, that's it. Opportunities to identify reporting occurs at many different stages of a patient journey, and to be able to explain that through the different perspectives that they bring to that point of view is really important. There are a wide variety of nurses, students, non-medical prescribers, specialists, pharmacy teams, whether it be at dispensing, repeat prescriptions, use in specialist services, there's so many different specialities out there. And the importance of an open, transparent, and constructive dialogue about medicines and medicine safety is really important, including where to report the side effects and look for kind of trusted sources of information. But apart from giving those diverse perspectives, for example, the patient will provide the you know the first-hand insights into their symptoms, experiences, and healthcare professionals are bringing to the table that clinical expertise that has been so kind of the cornerstone of pharmacovigilance, you know, doctors reporting, etc. But that diversity helps gaining a comprehensive understanding of potential effects. And there are lots of other different actual ways that different reporters bring. So the accuracy and completeness from collecting multiple sources of information from different areas. Um patients may notice symptoms that might be overlooked by healthcare professionals and vice versa, potentially. And a comprehensive data set leads to more accurate assessments for those safety experts looking at that data. We know that patients report a lot earlier than healthcare professionals. Obviously, it's happening to them because it is an early warning detection system. That is really important. And it also, when you're looking at the comparative analysis between those data sets that come from different sources, it allows you to look at the frequency, severity, timing of side effects across different groups, which it can help identify patterns and kind of risk factors to that. And of course, there's a patient-centered care, they've got the unique perspective of the impact of those side effects on their quality of life, as I kind of said. And that feedback can make more informed decisions about their treatment and adjustments that might be needed for their medicines. Um there have been previous studies where the yellow card scheme has been looked for, healthcare professional reporting versus patient reporting as well. And one study showed that there were about 47 more signals when combining the data sets for both of those. Some signals were lost for the healthcare professional set, but fewer than those gains and healthcare professionals reporting different types and patterns of adverse drug reactions compared to patients as well. And that's been seen similar to other studies in the Netherlands as well when they started on that journey. Um it also gives a bit of accountability and trust, I think, involving different groups, fosters that transparency and trust in the healthcare system. It also allows you to collect feedback from various reporting groups for improving that medication safety cycle. So lots of different kinds of reasons, I guess.

Federica Santoro 14:20

To boil it down, it's a team effort.

SPEAKER_00 14:22

Absolutely.

Other interventions to prompt reporting

Federica Santoro 14:23

Okay, then back to what I mentioned earlier about uh it being a complex problem and so requiring complex interventions. Running communications campaigns and so raising awareness is certainly an important first step towards changing behavior, but as we know from experience, it's rarely enough. So, besides running campaigns, what else would you advise regulators to do to encourage people to report?

SPEAKER_00 14:54

It's something that we've looked at in depth, I think, from a European angle, I led a small work package on the strengthening collaboration of operational pharmacovigilance in Europe. And one of those work packages included how do you raise awareness and what strategies can you adopt as a regulator to get people to report. And that kind of followed on to an ICMRA project that I lead as well. So, and that is an international collaboration of medicines regulatory authorities, and there's a number of countries involved in that. And I guess what was adopted along those two different kinds of associations is that we looked at the strategy around facilitating, educating, promoting, and motivating reporters. And within that fall a number of different kind of pillars and themes that that and suggestions that were put together. So do go and look at that if you're interested. But in addition to those communication campaigns, regulators should kind of adopt a multi-pronged approach and that combines a number of key strategies to create robust ADR reporting systems. But at that same time, they've got to continuously develop the vigilant systems, ultimately enhancing their ability to detect those important patient safety signals. And I guess the first thing is engage with healthcare professionals across the board and associations and their respective bodies. Set up different networks. Medication safety officer network is one of them. There's a similar one for medical device safety officers. Working with your regional monitoring centres, if you haven't, or establish new ones, it's a really powerful tool, effectively low cost, and requires just a little bit of resource sometimes. We already talked about integration into clinical systems for healthcare professionals, and then that gives that kind of point of care consultation and being able to report that. Having patient-friendly reporting tools is really, really important. I mean, we've all come through the COVID pandemic, etc., and lots of reports have come through that. But just those basic things around a patient-friendly tool that people can report through, having an app for patients and healthcare professionals really helps on the go and web platforms that simplify that reporting process, you know, making it easy to understand, having links about information, having links about campaigns, side effects, how they can be conduits and champions to also promote for the scheme as well. Um being transparent around the inputs and outputs of the system. So being able to see what has been reported to your system also has helped. But the involvement of healthcare professionals, engaging with people in that reporting process, you know, they can educate patients during those consultations that we talked about, for example. Medicines use reviews and pharmacists are doing that. And the culture of reporting is actually a good sign of safety. Working or establishing reporting champions in different hospital organizations and different areas and really bringing them together around discussing medicine safety. Um, education training is another part of that, training programs for healthcare professionals on just basic things around how to recognise report and just reminding periodically, of course, about reporting systems can really, really help. But also working with postgraduate and undergraduate levels and ensure that those are kind of examined on in the core syllabuses. But I think what's where things are going more now is ensuring that there's a feedback loop to inform patients, healthcare providers about the events and incentivizing reporting, giving CPD credits as well as part of that recognition. And of course, having information in trusted sources for patients is really important. You know, it could be through Department of Health websites as well, and working with those stakeholders to have that information when someone is looking for it, um, but also global collaboration, working with other regulators as well, can improve data collection and assessments, and we've helped kind of build some capacity around that with UMC and WHO. Um, ensuring that it's safe for people to report, you know, encouraging that ability to kind of not whistle forward, but but say encourage reporting without any fear of litigation. I think in some countries that's still probably a bit of a mindset.

Global versus local

Federica Santoro 19:08

For years now, we can say you've been wearing two hats. On one hand, you're a member of the Med Safety Week planning team, and on the other, you're a campaign participant as an MHRA employee. And I can imagine it's not always easy to reconcile these two perspectives because as a planning team member, you're helping produce a global framework that needs to work across many different countries. But as a campaign participant, you're working basically alongside dozens of other regulatory agencies that are also taking part in the campaign. And just like them, you need to implement that global framework locally and adapt it to your setting. So, what did you learn from all that? What has that double role taught you?

SPEAKER_00 20:01

Lots and lots of learnings, I think. Um I guess the first thing as part of the planning team is making sure that there's clear communications between the pharmacovigilance team and the comms teams. And I think that goes for all kinds of communications anyway, that are around pharmacovigilance. There should be kind of clear objectives and goals. What do we want to achieve, why, and translating those into clear, effective, compelling messages that are easy to understand and make sure that the research is right behind that, to understand it from not only a national context but a global context of what you're trying to address, whether it be vaccines, medicines, pregnancy, different themes, looking at the sensitivities and the barriers and the audiences, um understanding that one size doesn't fit all and there are different cultures in different countries, and understanding that one campaign message won't necessarily work in that country, and why it might not, and what those sensitivities are. Having a roadmap that is flexible for that planning delivery, obviously working with UMC at the lead, they're looking at 8090 translations for different countries, and so language is a real clear problem there for being able to do that, and people need to be able to adapt that accordingly, so the messages need to be clear and thought about. Also, things like demystifying the myths, social media trolling and the importance of partnerships and collaborations with different countries, working across boundaries has also kind of taught us a lot. Um, implementing things nationally, I guess, is don't overlook your local teams, ask them, involve them, take that feedback on board, help them help you implement the campaign, you know, working with different stakeholders, and we've talked about some of those before. But also to work with patient groups and international partners, put some small funding behind it. go a long way but also from materials to working outside social media as well would really really help not to overcomplicate some of those messages is really important. Um be creative also. We've um produced quite a few animations for Med Safety Week and we're trying to keep that kind of light touch to it because it's a very very serious topic. You know someone has harmed from something and sometimes being able to um look forward and see what the impact might be from messages being taken the wrong way and making sure that they are right is really really important. So therefore the tone and the pitch, sensitivities, language, all that kind of thing as well as that feedback loop has to be there. But most importantly being able to monitor and evaluate and continuously approve is really important.

Federica Santoro 22:49

Plenty of considerations but I bet it's been fun for you to wear those two hats for years.

Future of #MedSafetyWeek

Federica Santoro 22:56

I'll wrap up with one final question. If we look to the future tell me a bit about your dreams for Med Safety Week. How would you like to see the campaign develop?

SPEAKER_00 23:07

That's a really good question. And it comes down to that continuous improvement doesn't it that we just spoke about we already have global recognition I think which is a great thing with 18 to 90 countries participating annually now. So it'd be good to have policy advocacy I guess for Med Safety Week from WHO or Global Health Days and then that list of international days and weeks you know for the United Nations even though both of those organizations have participate with us every year and support us for which we're really grateful for. But I think there's still a lot more to do to maximize the impact of its effectiveness and whether that means expanding its scope and trying different things that might be worth considering. But I think it would be nice to see this develop into kind of a a global framework across countries from a communications point of view. I was part of the Heads of Medicines Agency benchmarking or expert assessors for benchmarking across Europe. So you know it's around establishing and developing world class medicines regulatory frameworks operating to best practice standards. So if that was included or there was something like that in the future that would be really good. But for Med Safety week I think diverse campaign themes looking at other issues and keeping that fresh and relevant patient empowerment I think providing resources and tools that can help patients understand the medicines or potential risks, how to communicate with them use of global case studies as well you know showing the value of that would be lovely to do as well as being able to test those messages with patients as they've been developed more. But you know you've got to bear in mind that that's in so many different countries and how to coordinate that and you know some of the challenges are there around that and so um lots of different angles I think that we could explore or the next team could explore as well.

Federica Santoro 24:55

We won't get bored for sure. Lots of ideas to look at in the future well thank you very much Mito for this chat. It was so nice to have you on the show and I'm sure our listeners will find this valuable. Thanks again. Thank you very much Rodrigo

Outro

Federica Santoro 25:19

That's all for now but we'll be back in less than two weeks with the second part of this podcast where you'll hear from Med Safety Week advocates in Iraq, Luxembourg and Namibia about their experience with the campaign so don't miss it. MedSafety Week 2023 launches next Monday 6th November for the entire week regulators and other healthcare organizations in nearly 90 countries will be discussing medicine safety. If you'd like to join the conversation too follow the MedSafety Week hashtag online and check out the campaign website for free social media materials. We'll include the link in the show notes. 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 magazine 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 Mittel Jadeja for his time Matthew Barwick for post production support and of course you for tuning in. Till next time