LONDON—The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)—an executive agency of the United Kingdom’s Department of Health—is leading a consortium of organizations, including European Union (EU) 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 and social media for discussing issues concerning medicines and health.
The focus of WEB-RADR is pharmacovigilance and the value of social media and apps for contributing to this, states an MHRA spokesperson, with the primary focus on medicines taken by the population, rather than those under development by pharmaceutical companies. However, he notes, “the MHRA monitors the safety of unlicensed medicines, or those used ‘off-label,’ i.e., used for a purpose not specified in the product information already, and it is possible that information on such medicines may be collected through the project.”
WEB-RADR 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 to identify potential drug safety issues. All social media data used within the project will be appropriately anonymized 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. Reports of suspected ADRs from the public received via an app developed for WEB-RADR will be treated in the same way as ADR reports received from existing paper or web-based reporting methods. ADR reports are not specifically validated, but are individually reviewed by scientific and/or medical staff as well as used to detect potential safety issues.
There are a number of deliverables expected over the course of the three-year project, the MHRA spokesperson notes, including the intention to deliver a U.K. version of the mobile app over the first six months of the project. There will be interim policy decisions to support this; however, final recommendations will be delivered toward the end of the project based upon user and stakeholder feedback, in combination with evaluation of the scientific value of the data generated. However, it is intended that there will be information shared on progress throughout the project.
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 (IMI), a public-private partnership between the European Commission and European Federation of Pharmaceutical Industries and Associations (EFPIA).
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 for 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 IMI is 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 EU and the EFPIA. The MHRA is responsible for regulating all medicines and medical devices in the United Kingdom by ensuring they work and are acceptably safe.