| Project Detail |
WEB-RADR is a consortium of leading experts in pharmacovigilance from regulatory agencies, research, academia and patient support groups. Together with EFPIA partners our aims will be to set policy & guidance and deliver robust information technology tools to address the potential for the reporting of adverse drug reactions (ADRs) through mobile applications and the recognition of drug safety signals from user comments in social media and the internet. The policies, guidance and tools delivered through WEB-RADR will be underpinned by extensive academic research and user testing to ensure the project meets the needs of all stakeholders, including patients.
Background
Reporting by healthcare professionals and patients by means of mobile devices and social media platforms to National Competent Authorities (NCAs) and marketing authorisation holders with subsequent transmission to EudraVigilance is a new, unexplored concept. The amount of information generated through social media requires a structured, scientific approach for monitoring, reporting, analysing and evaluation of ADRs. Whilst there are numerous benefits of the use of social media, the impact on healthcare professionals and patients and their behaviour towards the use of medicines needs to be further analysed. WEB-RADR will address these areas.
Leadership
WEB-RADR will be managed by the MHRA’s project management team that are also leading the EC Joint Action (Strengthening Collaborations for Operating Pharmacovigilance in Europe, SCOPE). This will enable the alignment and consistency of the two projects. The MHRA has extensive experience in managing successful pharmacovigilance and IT projects (E2B compliant web-forms for ADR reporting; integration with EudraVigilance; drug and medical dictionary mapping; integration with NHS electronic health records) as well as being a leading regulatory agency, helping to shape the current legislative framework.
Establishing clear policies and guidance for stakeholders in the use of these technologies, in line with legislative requirements, is of paramount importance to regulators and industry. The EMA will provide leadership in this area, supported by colleagues from MHRA, HALMED & LAREB. As the central regulatory agency for medicines policy in the EU it is natural for the EMA lead in this area as the outputs of WEB-RADR will have a direct bearing on future operations affecting EudraVigilance, Good Vigilance Practice (GVP) guidance, signal detection and risk communication. Expertise from a national perspective together with EFPIA input will also be essential.
Technical Platform
The development of technical platforms for both the reporting of ADRs via a mobile application and recognising drug safety issues from social media will be led by Epidemico who already offer a number of products through an ongoing partnership with the FDA. Working with SRDC and EFPIA sponsors, WEB-RADR will produce an online dashboard and data feed of data identifying ADRs from social media in multiple languages. A mobile app for direct reporting of ADRs to national authorities in E2B(R2) Individual Case Safety Report compatible format will be developed. To achieve this we propose to expand the prototype MedWatcher Social platform to include social media monitoring in the EU and the MedWatcher App for reporting ADRs.
Analysis
Led by UMC and working with SRDC, WEB-RADR will ensure the technical platform for gathering drug safety data from social media delivers meaningful and useable data in the EU pharmacovigilance setting. It is essential that data collected use standardised drug, product and medical terms. Mapping of the terms to ensure compatibility with EudraVigilance and NCA databases will be carried out so that terms in the Article 57 database and MedDRA are the basis for analysis. It is essential to detect and manage duplicate reports. A major effort in WEB-RADR will be the advancement of new methodologies to meet this challenge. UMC h |
