Pharmacovigilance is the monitoring of the safety of medicines to identify new or changing risks to support the safe and effective use of medicines. This includes the monitoring and reporting of adverse drug reactions (ADRs), i.e. side effects that can be experienced during treatment. Patients experiencing ADRs and their healthcare professionals are requested to report these side effects to their national pharmacovigilance centre. However, paper-based report forms are not always available and are often perceived as inconvenient and complex. If more reports were submitted, this could facilitate the faster identification of risks.
To address this, IMI’s WEB-RADR project has developed a mobile app that allows users of pharmaceutical products to directly report ADRs to relevant health authorities, find out about reported side effects and opt to receive alerts on specific medicines. During the project, the app was rolled out across three EU countries – Croatia, the Netherlands, and the UK – and had about 10 000 downloads in those countries alone.
Thanks to collaboration with the World Health Organization, the app was also rolled out to support malaria programmes in two African countries: Burkina Faso and Zambia. The implementation of the app in those countries had a substantial impact, with Burkina Faso receiving more ADR reports in the first six months after the roll out than they had in all the time previously.
A dozen additional countries around the world have also expressed interest in the app and some have already adopted it. For example, in early 2018 the United Arab Emirates also launched the app.
The reports received via the app have already contributed to the identification of new safety issues with various medicines, enabling regulatory authorities in relevant countries to take appropriate action.
Social media data mining
The WEB-RADR project team also explored the value of social media data for pharmacovigilance. They found that in certain circumstances it could be hugely valuable and that people are far more likely to discuss issues like medicine misuse on social media than with their doctor. To mine this wealth of data, the team developed methods to detect, extract, standardise and analyse medicine-related information reported in unstructured free text by social media users.
This has already led to concrete insights. For example, thanks to social media mining, the team uncovered patterns of misuse of a particular medicine by communities of students who want to improve their performance around examination time. This has provided additional information to the traditional sources, because students would normally not share this information with their doctors and pharmacists.
WEB-RADR policy recommendations on the collection and use of data – both through the app and social media mining – have been passed on to the European Medicines Agency (EMA) for implementation in future guidance on how the pharmacovigilance legislation in the EU should be operated.
Ethical and data protection issues
A consistent area of concern for the project was potential conflicts over data gathering and privacy regulations, as well as ethical considerations about harvesting social media data. To address this, the researchers engaged leading medical ethicists and data protection experts to assist them. That set a sound and robust framework for the analysis that they were doing, ensuring that they were both operating within the law and conducting the work in accordance with the highest ethical standards.
Benefits for industry, academia and SMEs
The industry is already benefitting from the tools and resources developed within this project, especially from the guidelines on how they can use social media to monitor drug safety issues and improve their interaction with patients and carers.
The academic community has benefitted from the exchange of ideas and viewpoints with different stakeholders in the project, as well as from innovative research ideas and identification of new research areas. SMEs have also benefitted from the network formed within the project, and have expanded their businesses.
Finally, patients and healthcare providers benefitted from gaining a new, user-friendly way to report adverse drug reactions and receive official, reliable and regulator-approved information on their treatments via the mobile app.
In order to enable other countries in the EU and beyond to benefit from the tools developed in the project, the project partners have put in place a sustainability plan. Among other things, the project set up a management board that will support the growth of the mobile app as well as its continued development and enhancements beyond the lifetime of the project.
In line with IMI’s open innovation approach, the data and reference standards obtained during the course of the project will soon be published so that other researchers could build on the WEB-RADR work. Furthermore, the project’s scientific deliverables have been described in two scientific papers – as of August 2018, their publication is still pending.
Read the interview with project coordinators.