Pharmacovigilance has come along in leaps and bounds in recent years, mainly through regulatory and legislative reforms. With WEB-RADR, though, monitoring the effects of medicines after authorization has entered a new era. In fact, WEB-RADR – developed through the Innovative Medicines Initiative – is going to make the reporting of adverse incidents significantly easier for patients, carers and healthcare professionals alike.
WEB-RADR was launched in the UK on July 14, as a free-access mobile app – available on both iOS and Android operating systems – building on the quick take-up of smartphones, apps and social media to discuss health and medicine issues. It operates under the UK’s Yellow Card Scheme, which is run by the Medicines and Healthcare products Regulatory Agency for pharmacovigilance purposes.
Today, patients generally report ADRs to their physician. Paper-based report forms are not always available, though, and are often seen as inconvenient and complex. Moreover the reporting process can be slow and inefficient, with side effects remaining undetected until sufficient numbers are filed.
WEB-RADR will also form part of a wider approach. This is about engaging patients to report not only adverse effects but also benefits and data that would allow measuring outcomes. Both, pharmacovigilance and reporting/measuring outcomes require tools for increased patients engagement and empowerment. IMI is facilitating steps towards this objective.
The UK is in some ways ahead of the pack because it already operates a one-stop reporting website. As an app, though, WEB-RADR is a clear breakthrough in the field of pharmacovigilance by cementing the UK systems’ place in the digital age. Not only does this simplify adverse event reporting, but WEB-RADR is also the only app that allows reporting directly to the Yellow Card Scheme. This represents an obvious triumph for patient safety in the UK.
While the app has been launched in the UK and is supported by UK authorities, it is, however, essential to stress that ultimately all patients will benefit from these types of approach. Social media websites and mobile phone apps enable and encourage users to create, share, and exchange information and experiences instantly, and are now used by over one billion people globally. WEB-RADR aims to develop new ways of using these technologies and channels of communication for pharmacovigilance purposes the world over.
Readied in September 2014, WEB-RADR was initially planned as a three-year project within the framework of IMI, the world’s biggest public-private partnership in life sciences. IMI is jointly financed by the European Union and EFPIA, although it is important to stress that EFPIA member companies contribute voluntarily and do not receive any funding from IMI or other contributors.
Since its inception, the aim of the IMI WEB-RADR project has been to harness the power of social media and new technologies for pharmacovigilance purposes. It works on the logical principle that innovative pharmacovigilance practices should rely on innovative communication technologies.
It has a number of novel and revolutionary applications beyond mobile reporting, such as the ability to create a watch list of medicines that can be tracked for regular news and alerts. What’s more, it has a flexible framework, which means that it can be updated at regular intervals based on user feedback.
There is no doubt that WEB-RADR represents a major advance in the future of ADR reporting. The UK’s adoption of this app puts it at the head of the pack in terms of improving pharmacovigilance in Europe. WEB-RADR’s aim, though, is to ensure that its mobile phone app is useable for the reporting of all ADRS to all EU regulators. It can only be hoped that soon other Member States will soon follow suit.