IMI Programme Office: Why was a project like WEB-RADR needed in the first place?
David Lewis: Essentially, what we wanted to do was to support patients and healthcare professionals to report safety concerns about medicines. And then separately, but in a related sense, to help us analyse what was posted on social media to further evaluate drug safety.
IMI Programme Office: Which project achievements are you most proud of?
David Lewis: The delivery of the mobile app which enables patients, carers and healthcare professionals to report suspected adverse drug reactions (ADRs) and to receive information in return.
Phil Tregunno: Clearly the work around the content of social media was really important to us from a scientific perspective. Without the scientific research that was conducted within the project, there was a real risk of social media data being transposed into traditional pharmacovigilance systems and swamping traditional data, making it too noisy to detect safety issues. The policy recommendations that we have been able to produce will lead to a streamlining of that process that both benefits reporting and signal detection from a traditional sense but also means that companies can use social media data to detect safety issues in an appropriate way.
Secondly, the value around the mobile app and its adoption both within the European Union and in Africa, whereby we’ve been able to work with the World Health Organisation (WHO) to significantly enhance pharmacovigilance systems in Burkina Faso and Zambia through adoption of the tools that we developed. We believe that the outputs of the project will be sustainably used both inside the EU and outside going forward.
IMI Programme Office: How did the initiative to roll out the apps in Africa come about?
Phil Tregunno: On the external advisory board for the project, we had a representative from the WHO. An opportunity came up to test our sustainability and ability to roll out the app in new countries. Specifically, the ask from WHO was if could support the malaria programs in Burkina Faso and Zambia through delivery of the app to collect safety data. In discussion with IMI we agreed that it would be appropriate to test our ability to roll out the apps beyond the project, and we were able to do so in collaboration with local authorities in Burkina Faso and Zambia, and the WHO office.
IMI Programme Office: So in Europe there are three countries that have the app: Croatia, Netherlands and the UK, and in Africa there are two. Are there plans for future apps in other countries?
Phil Tregunno: Yes, we’ve had substantial interest from around the world, and 10 different authorities have expressed an interest in the app. We are really pleased to be able to say that the United Arab Emirates have just recently adopted the app. That again is an important step in the sustainability of the work of the project.
IMI Programme Office: Have the outputs of your project already led to concrete benefits to patients? For example, have there been new adverse drug reactions reported through the app?
Phil Tregunno: Indeed, the reports received via the mobile app have contributed to identification of new safety issues. The reports are part of the body of evidence that has been used to take forward safety issues as a result of our safety monitoring activities.
IMI Programme Office: And have there been concrete results arising from the social media monitoring?
David Lewis: In the Netherlands, one of the reports was concerning a generic medicine. Further evaluation revealed that there was clearly a signal with this particular medicine, so appropriate action was taken to deal with that.
Separately in the area of drug abuse, we looked into a misuse of a prescription drug by communities of students – an alerting agent that improves performance around examination time. We’ve done some in-depth research to follow patterns of use and threads of use and combinations of this medicine with caffeine. Social media has provided additional information to the traditional sources because as you might suspect, the students involved are not keen to share this information with doctors and pharmacists.
IMI Programme Office: Your project has really achieved a lot, would you say that it was transformative or groundbreaking in some aspects?
Phil Tregunno: From an EU perspective, it has been additive, in so far as the countries where we rolled out the app [Netherlands, Croatia, UK] already had online and paper-based reporting tools. The impact there in terms of numbers of reports was probably reflective of that. What was really valued by users was the information features that the app provides.
However, in the lower and middle-income settings that we were able to trial the app in, Burkina Faso and Zambia, the app was transformative, in so far as in Burkina Faso we saw that they received more adverse drug reaction reports in the six months following deployment of the app, then they had in all of time previously.
Of course, that is not solely due to the app, it is also due to the publicity and good work that the WHO team on the ground were doing and the local authority. But it is certainly fair to say that the tools can be transformational in the right settings, and that they have great potential for the future.
IMI Programme Office: Would all this have been possible without IMI and the public-private partnership that was established?
David Lewis: I don’t even believe we could have gotten off the ground and built the app within a significant period of time. It was the engagement of a consortium, the public-private partnership open dialogue, and the IMI funding structure that allowed us to do this in a very rapid time frame.
Phil Tregunno: I fully endorse that, and I think the power of the collaboration is in the adoption of our results, and acceptability of our recommendations. The feedback has been overwhelmingly positive since we presented our results and we presented them in numerous external events.
In terms of policy, there are a number of modules of guidance which define how the pharmacovigilance legislation in the EU should be operated and we hope our recommendations will be adopted in those guidance models later this year.
IMI Programme Office: In terms of sustainability of the project results, what happens next?
Phil Tregunno: There are three aspects to the sustainability. First, there is publication of data from the project, to enable further research and so there will be reference standards published arising from the project to enable others to continue the research.
Secondly, we have two recommendation papers pending publication, which will discuss all of the scientific deliverables. Alongside those, we have the policy recommendations that I have already mentioned.
Thirdly, there is the sustainability of the technology deliverables. We have a model for adoption of the tools and continued developments and enhancements of those tools beyond the project, which we are now in the process of implementing to enable other Members States and countries beyond the EU to benefit from the project.
IMI Programme Office: What was it like to be the coordinators of this project?
David Lewis: It was challenging, it was fun, and was a huge responsibility, and I felt privileged genuinely.
Phil Tregunno: It has been a privilege to be part of the project – the group of people that we have worked with have been hugely engaged and have been keen to deliver across the board for the good of public health. It’s been a fulfilling project to be a part of.
IMI Programme Office: Anything else to add?
Phil Tregunno: It is important to mention the significant work that the project did around data protection and data privacy requirements and the ethical considerations for the activities being considered. Very early on we engaged leading medical ethicists and lawyers to assist us with aspects related to that and particularly around the protection of personal data. That set a sound and robust framework for the analysis that we were doing to ensure that we were both operating within the law but also that we were conducting the work ethically and to standards that would be expected by the public. It would probably not be possible to underestimate the value that those activities had in providing a strong base for the project to work from.