Smartphones and social media to gather drug safety data
Smartphones, apps and social media will be used in a European drive to find new ways of gathering information on suspected adverse drug reactions.
The UK's medicines regulator the Medicines and Healthcare products Regulatory Agency (MHRA) is to lead a consortium of organisations, including European medicines regulators, academics and the pharmaceutical industry in a three year project.
The project, known as WEB-RADR, is in response to the rapid adoption of smartphones, apps, and social media for discussing issues with medicines and health. The project also addresses the discussion about how far the pharmaceutical industry should monitor digital communications for reports of adverse events - as it is obliged to pass on any reports it receives to regulators.
It will work to develop a mobile app for healthcare professionals and the public to report suspected ADRs to national EU regulators. It will also investigate the potential for publicly available social media data for identifying potential drug safety issues. The consortium stresses that all social media data used within the project will be appropriately anonymised to protect data privacy.
In addition to reporting suspected ADRs, the app could also serve as a platform to send accurate, timely and up to date medicines information to patients, clinicians, and caregivers.
WEB-RADR will also examine the value of these new tools for monitoring drug safety. It will help to develop recommendations for medicines regulators and the pharmaceutical industry internationally on how these should be used alongside existing systems.
This project is funded though the Innovative Medicines Initiative, a public private partnership between the European Commission and European Federation of Pharmaceutical Industries and Associations.
Mick Foy, Group Manager in the MHRA's Vigilance and Risk Management of Medicines division said:
"The growing use of smartphones and tablets by patients and healthcare professionals creates a need for reporting forms to be provided on these platforms to ensure regulators receive ADR reports that are easy to access and complete.
"Additionally the recent growth of social media platforms such as Facebook, Twitter and the many specialist sites and blogs has given rise to many people sharing their medical experiences publicly on the internet.
"Such data sharing, if properly harnessed, could provide an extremely valuable source of information the monitoring the safety of medicines after they have been licensed.
"WEB-RADR will deliver recommendations for international drug safety monitoring as to how these resources should be used ethically and scientifically."
The project is part of the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
