Web RADR
(Recognising Adverse Drug Reactions) is platform which provides technological
solutions for robust pharmacovigilance. Web RADR has its key contributions in
Governance and policy, Social media and Analytics.
Web RADR is
led by the European Medical Agency to provide its recommendation on developing
mobile based application and use of social media for monitoring adverse drug
reactions. Web- RADR goes in consultation with bodies like Eudravigilance- Expert
Working Group (EV- EWG), Patient’s and Consumer Working Party (PCWP).
Key
stakeholders in this project include Novartis Pharma, Janssen Pharmaceutica,
Sanofi-Aventis, UCB and Amgen
Web RADR along
with Epidemico (An organization with the capability to analyse and visualize
data, comprising of public health leaders, software experts and data scientist)
is now working its way to provide access to social media content by
visualization using technology by Epidemico in detecting signals. Analysis of
social media content through Big Data Analytics would be applied in forecasting
problems with marketed medicinal products, it would enable the regulators to
understand nature of safety signals and all of the content screening would be
done on data which would be publically available, without violating data protection
act adding further to this where social networking users would also have the
provision to opt out of data collection.
Through a recent it was determined
that in 2016, Facebook has highest number of threads with 2.2 Billion post,
Twitter following with around 318 millions tweets and You tube with 1.5 billion
videos.
Alongside
with screening digital content from social media, Web RADR in collaboration
with World Health Organization’s, Uppsala Monitoring Centre would be developing
analytical tool, which would help in extraction of relevant and quality data
from social media for screening and
would also focus on case triaging and linkage of duplicate reports.
Another
initiative led by Web-RADR is designing android/ IOS based apps with key
functions to report ADR and provide alerts. The apps would be linked with
various regulatory agencies and would provide tailored alerts to the users
about safety issues and warnings. The app would also facilitate anonymous ADR submissions
using customized reporting forms. Web-RADR would be making the app soon
available in different languages and additional products would be added in the
product list for easy recognition of suspect.
In UK almost 4000+ users have used Yellow
Card app with 400+ safety reports being sent to MHRA
Web- RADR ,
together with University Medical Centre Groningen and University College London
would analysing barriers for patient and healthcare professionals to use mobile
application for reporting ADR, studies through conjoint analysis where different
versions of app are tested on different levels of health, literacy and
usability on focussed population groups of patients adolescents, orphan disease
populations and elderly patients have been undertaken by the University.
Web-RADR
would also be conducting Scientific Impact Evaluation, together with University
of Liverpool to determine whether mobile based application and social media
content screening would be a value addition to Pharmacovigilance as output of
these activities would impact policy recommendations.
Reference:
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