Smartphone and social media adverse event project launched

The EU consortium’s members will include UK regulator the MHRA

The use of smartphone technology and social media for gathering information on suspected adverse drug reactions (ADRs) is to be evaluated by a new European consortium.

WEB-RADR’s founding members include pharma, academics and European medicines regulators like the UK’s MHRA and it is funded through the Innovative Medicines Initiative – a partnership between the EC and EFPIA.

The three-year project‘s goals include developing a mobile app for healthcare professionals and the public to report suspected ADRs to national EU regulators and investigating the potential for publicly available social media data to be used for identifying potential drug safety issues.

WEB-RADR will also make a series of recommendations on howsmartphone and social media should be used ethically and scientifically for international drug safety monitoring.

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.”

The project’s planned mobile app may also be used to send accurate, timely and up-to-date medicines information to patients, clinicians, and caregivers, the MHRA said.

In addition to ADRs WEB-RADR will assess social media and smartphones as tools for monitoring drug safety and will help develop new recommendations for medicines regulators and pharma on how these should be used alongside existing systems.

The MHRA has previously told pharma it wouldn’t have to ‘trawl the internet’ for ADRs, but WEB-RADR clearly signals that a more collaborative approach is on the cards – a direction of travel also pointed to by the FDA’s new open data ADR initiative in the US.

Source PMLive http://www.pmlive.com/blogs/digital_intelligence/archive/2014/september/smartphone_and_social_media_adverse_event_project_launched

Smartphone and social media adverse event project launched