MHRA and Novartis lead consortium to develop adverse drug reaction app

By Dan Stanton contact

- Last updated on GMT

MHRA and Novartis lead consortium to develop adverse drug reaction app
The drug industry and regulators have teamed up to develop a smartphone app to make the gathering and reporting of adverse drug reactions easier.

The project, known as web-RADR, is looking to capitalise on the uptake of smartphones and social media, creating an app which will make reporting and sharing of adverse drug reactions information easier.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is spearheading the project, the consortium consists of the EMA, HALMED (Croatian agency) and Lareb (Netherlands ADR reporting centre) alongside IT experts, academia, patient groups and seven European Federation of Pharmaceutical Industries and Associations (EFPIA) companies led by Novartis.

Mick Foy, Group Manager in the MHRA’s Vigilance and Risk Management division told in-Pharmatechnologist.com there are two main issues when discussing ADR reporting and why health professionals and patients don’t report.

“The first is access to user friendly forms and the second is good feedback once a report has been sent,”​ he said. “The development of the mobile App through web-RADR will help address these by providing a form that can easily completed on the device people have in their pockets and also enabling them to access high quality, authorised material on medicines they are interested in hearing about.”

Despite being in its infancy, the project has been split across six work packages, he continued: 1) Policy development led by EMA; 2) Social media technical platform led by IT firm Epidemico; 3) social media analytics led by WHO’s Uppsala Monitoring Centre; 4) mobile app technical platform led by Epidemico; 5) mobile app user based evaluation led by University of Groningen; and 6) scientific impact evaluation led by University of Liverpool.

Changing Technology

The project is set to take three years to complete, so we asked Foy how the technology would remain relevant.

“One of the objectives of the project is to keep up to date with changing technologies to ensure WEB-RADR remains current,”​ he said. “For example the social media side is currently focussed on Facebook and Twitter, but during the course of the project new social media sites and technologies will no doubt emerge.”

Pharma has been increasingly adapting to the increased use of smartphone technology and social media platforms. The former, for example, has seen apps developed to help fight against counterfeit drugs​ and grant access to compliance requirements​ for safety professionals.

Social media, meanwhile, is becoming increasingly important in clinical trial monitoring and reporting with companies such as Pfizer using such platforms to carry out virtual trials​.

Related topics: Regulatory & Safety, Regulations

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