Pharmacovigilance on the move

A new project has been launched to investigate novel ways to capture information about adverse drug reactions.

A consortium of organisations, led by the MHRA and including European medicines regulators, academics and the pharma industry have launched a three-year project to explore the use of smartphones and social media to gather information on suspected adverse drug reaction (ADRs).

The project, known as WEB-RADR, was prompted by the rapid adoption of mobile technology and social media for discussing issues with medicines and health.  The aim is to develop an app that can be used by healthcare professionals and members of the public to report suspected ADRs directly to national regulators.

This sort of communication could revolutionise pharmacovigilance especially in certain cases but I can’t see it being widely adopted.

There is already a bewildering array of apps fighting for space on every smartphone – what would make a patient choose to download this one? Personally, I install apps that I think I’m going to use regularly, if I don’t, they get deleted.

Even if the consortium manages to solve the tricky issue of getting patients to install the app, won’t the regulators be inundated with a massive number of trivial “complaints” – perhaps making it harder to spot the serious ADRs they need to identify? They’d certainly need a lot of resource to filter the responses.

Perhaps the app will be limited to those at greatest risk – either because of their specific treatment regime or disease profile. Then I could envisage it yielding valuable first alert data potentially much faster than conventional channels.

However, it would be important to establish a baseline to compare the feedback gathered this way with conventional pharmacovigilance programmes. The old and new systems would need to be run in parallel to provide meaningful comparisons.

Well – they are planning to take three years over the project…


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