Aim is to develop new ways of gathering information on suspected adverse drug reactions
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is leading a consortium of organisations including European medicines regulators, academics and the pharmaceutical industry in a three year project to develop new ways of gathering information on suspected adverse drug reactions (ADRs).
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. 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. 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.
The project is funded though the Innovative Medicines Initiative, a public private partnership between the European Commission and European Federation of Pharmaceutical Industries and Associations (EFPIA).
'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,' said Mick Foy, Group Manager in the MHRA’s Vigilance and Risk Management of Medicines division.
'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.'