Detecting and preventing the adverse effects of available pharmaceutical drugs – as well as their misuse – is a challenge for health authorities. The vast majority of referrals come from healthcare professionals and under-reporting of the issue is a problem. Individuals are often more likely to go online to express frustration than consult their doctor.
To address this, the EU and industry-funded WEB-RADR project has developed an app that enables users of pharmaceutical products to directly report adverse drug reactions (ADRs) to relevant health authorities, find out about reported side effects and opt to receive alerts on specific medicines. The success of the scheme has resulted in an 18-month follow-on initiative, due to begin in June 2018, which will aim to integrate the app into electronic healthcare systems across Europe.
The project team also found that gathering social media data on the misuse of medicines could be hugely valuable in understanding what preventive strategies should be taken. 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 into future guidance.
“The premise of this project was to review and better understand the value of mobile technology and social media for gathering information about medicines on the market, and in particular ADRs,” says project coordinator Phil Tregunno from the UK’s Medicines and Healthcare Products Regulatory Agency. “Over the years, we have received enquiries from both patients and medical professionals about the possibility of using mobile apps to report on ADR, and it is clear that regulators must maximise the opportunities presented by advances in technology.”
Untapped app potential
WEB-RADR provided an opportunity to take an evidence-based approach to these challenges. Mobile apps to facilitate ADR reports were quickly developed and rolled out across three EU countries – Croatia, the Netherlands and the UK – before attention turned to Africa. There, working with the World Health Organization, apps were launched in Burkina Faso and Zambia.
The project discovered that while the European studies did not result in significantly more ADR reports, the inclusion of a regulatory newsfeed providing related information added significant value for users. “We found real demand for this from both patients and professionals,” says Tregunno.
The African studies were much more transformational, in part because mobile networks are often far more developed than traditional telecommunications. Tregunno notes that Burkina Faso received more ADR reports in the first six months of the project than ever before.
The recently announced follow-on project will help meet growing interest and demand for the app. “There are at least 10 countries interested in implementing this technology and we really see an opportunity to enhance the impact of pharmacovigilance, particularly in low and middle-income countries,” says Tregunno.
Power of social media
WEB-RADR also assessed the potential for mining social media data for ADRs. “There is a lot of information to be found here but it has been unclear up to now how much of this could really be useful,” says Tregunno. “What we found in our analysis was that while a broad-based social media mining strategy was not effective compared to traditional methods, niche searches, for example on the abuse and misuse of medicines, could be valuable.”
WEB-RADR found that people are far more likely to discuss certain issues, like medicine misuse, on social media than with their doctor. Therefore, gathering this sort of data could strengthen our understanding of medicines that are being misused and how.
“Another recommendation would be for regulators to view relevant social media data as a safety signal,” Tregunno adds.
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 a leading medical ethicist, data-protection experts, plus patients and healthcare professionals to validate and challenge its thinking.
Tregunno notes that the involvement of both regulators and industry had enhanced WEB-RADR outcomes and would make implementation of its recommendations smoother.
The project was funded by the Innovative Medicines Initiative, a public-private partnership between the EU and industry.
- Project acronym: WEB-RADR
- Participants: Switzerland (Coordinator), UK, Ireland, France, Netherlands, Turkey, Croatia, Sweden, Belgium, Germany
- Project number: 115632
- Total costs: € 5 664 992
- EU contribution: € 2 270 000
- Duration: September 2014 to December 2017
Source: European Commission, Research and Innovation Information Centre