WEB-RADR

Recognising Adverse Drug Reactions
WEB-RADR Recognising Adverse Drug Reactions

FACTS & FIGURES

Start Date
End Date
Call
IMI1 - Call 9
Grant agreement number
115632

Contributions
IMI Funding
2 270 000
EFPIA in kind
2 754 044
Other
1 047 576
Total Cost6 071 620

Summary

WEB-RADR researchers are working together to detect new drug side effects by mining publicly available web and social media content. Thanks to the development a mobile application where patients will be able to directly report potential medicine side effects and also receive reliable information on their drugs, medicine manufacturers and regulators will be able to intervene earlier in case of adverse drug reactions (ADRs), and thus reduce potential harm to patients.

Pharmacovigilance is the monitoring of the safety of medicines to reduce the risks and increase the benefits of treatments. This also includes the monitoring and reporting of adverse drug reactions (ADR), i.e. side effects that can be experienced during treatment.

Today, patients experiencing ADRs report these side effects to their physician. However, paper-based report forms are not always available and are often perceived as inconvenient and complex. This reporting process is slow and inefficient, and side-effects are not detected until a sufficient volume of reports has been received.

Launched in September 2014, WEB-RADR is a three-year IMI project that will harness the power of social media and new technologies for pharmacovigilance purposes.

 

Cutting-edge research to improve side-effect reporting

WEB-RADR works on the principle that innovative pharmacovigilance practices should rely on innovative communication technologies. This project responds to the rapid adoption of smartphones, mobile applications (apps) and social media to discuss health and medicine issues.  

In order to move towards a mobile, fast and accurate ADR reporting, the following changes are required:

  • a new regulatory framework for social media mining for ADRs;
  • increased patient engagement in awareness and reporting of safety concerns;
  • an improvement in the technology behind data and information mining.

WEB-RADR has set itself the goal of delivering a mobile app for both healthcare professionals and the public to report suspected adverse drug reactions to their National Competent Authority (NCA). This will help investigate the potential of social media data to identify potential drug safety issues. All social media data used within the project will be appropriately anonymised to protect data privacy.

In addition to reporting suspected ADRs, the app could also serve as a platform to provide accurate and timely information on medicines to patients, clinicians, and caregivers.

Through these efforts, WEB-RADR is expected to greatly increase the number of ADRs reported and identified via social media, thus allowing a faster response to harmful side effects.

The project will also develop text mining techniques for publicly available data on social media sites to complement existing methods of signal detection. Improved text mining algorithms will enable more reliable mining of social media data, allowing NCAs to detect, extract, and analyse potential ADRs reported in unstructured free text by social media users. Such advancements will benefit patients and healthcare professionals, as well as organisations concerned with patient safety, including regulators and the pharmaceutical industry.

 

Pharmacovigilance for patient benefit and technology advancement

This project will allow a faster response to ADRs, ensuring that harmful side effects are identified quickly and thereby critically increasing patient safety.

Patients will be able to directly report ADRs, increasing involvement in their own treatment, and be involved in the drug safety process. This will also allow patients to access official, reliable and regulator-approved information on their treatments.

WEB-RADR will also contribute to the competitiveness of the European pharmaceutical sector by advancing information technology (IT) expertise in a rapidly growing technology area, harnessing the benefit of a diverse European patient pool to rapidly gain information on ADRs.

 

A hub for patients, regulators, pharmaceutical companies and IT experts

Improving pharmacovigilance relies on collaboration involving a wide range of stakeholders.

As pharmacovigilance is a highly regulated environment, the involvement of regulators is crucial to ensure that any outputs are implemented at EU level. Pharmaceutical manufacturers have a responsibility to ensure the safety of their products, and therefore have a key role to play in this process.  As the end-users of both medicines and ADR reporting products, patients provide essential input to ensure the efficacy of the method and tools.  IT expertise, particularly in data mining and analysis, is the key technical component of this project.

Through its consortium, WEB-RADR gathers leading industry and academic pharmacovigilance experts, national and European regulators, patient and SME representatives working together to improve drug safety.

Achievements & News

Contribute to WEB-RADR’s surveys on apps
IMI project WEB-RADR has launched a pair of surveys, one for healthcare professionals and one for patients and consumers of medicines. ###The goal of the surveys is to gather opinions on an app that people can use to report adverse drug reactions (side effects) and receive safety information about medicines. The results will help the project to improve the app they have already developed and raise awareness about reporting side effects and receiving safety information. The project will also use the results to quantify the main facilitators and barriers for a mobile app as a tool of two-way risk communication, and determine whether there are differences in preferences and expectations between stakeholder groups (type of patient, healthcare professionals, countries). The surveys are available in seven languages: Croatian, Dutch, English, French, German, Portuguese, and Spanish. The deadline for contributing to the survey is early September. (July 2016)

WEB-RADR launches Croatian version of side effect reporting app
Croatia has become the third country in Europe to benefit from the WEB-RADR mobile app for reporting suspected adverse drug reactions (side effects). ### The Croatian app, which is available via both Apple’s App Store and Google Play was launched by HALMED, Croatia’s Agency for Medicinal Products and Medical Devices, at a conference in Zagreb. The mobile application allows patients, healthcare professionals, carers and others to directly report ADRs as well as receive the latest information concerning medicinal products using their mobile devices. ‘After HALMED was the first in the world to begin using the online application of the World Health Organization (WHO), the introduction of our mobile application represents the logical continuation of our efforts to apply new digital technologies in order to make the ADR reporting system more accessible to patients and health care professionals. Croatia, the United Kingdom and the Netherlands are the first member states of the European Union which have implemented such applications, and a mobile application meant for use in all the other member states of the European Union will be developed based on our experiences,’ said Darko Krnić, Head of HALMED’s Department for Pharmacovigilance and Rational Pharmacotherapy.
Read HALMED’s press release 

WEB-RADR side effect reporting app goes Dutch
IMI’s WEB-RADR project has launched a Dutch version of its smartphone app that patients, carers and healthcare providers can use to report side effects of medicines. ### Like the UK version of the app, which was launched last year, the Dutch app allows users to quickly and easily report side effects and find out about reported side effects. In addition, users can set up alerts to receive the latest information on specific medicines. The app is available for iOS and Android phones. Information submitted via the Dutch app is collected by the Netherlands Pharmacovigilance Centre Lareb. Lareb is responsible for collecting and analysing information on reported adverse drug reactions in the Netherlands. Collecting, registering and analysing information on side effects in this way provides those responsible for monitoring medicines safety with vital information that can be transformed into guidelines on medicines if needed. WEB-RADR is planning on releasing a Croatian version of the app later this year. The project is also developing a generic version of the app which will be available for adoption by countries who wish to use the technology to supplement existing reporting mechanisms.

WEB-RADR launches mobile app for medicines safety monitoring
July 2015 - IMI project WEB-RADR has launched a smartphone app that will make it easier for patients, carers and healthcare professionals to report side effects of medicines. ###The app, which is available via the UK iTunes App Store and Google Play, is the only app that allows people to report side effects directly to the UK Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme. The MHRA uses the scheme to collate and review reports of suspected adverse drug reactions, and if needed, make changes to the warnings and advice given to people taking a medicine or vaccine. Users can select specific medicines or vaccines to track and receive news and alerts about them.  In a video, UK Life Sciences Minister George Freeman commented: ‘The Yellow Card Scheme has played a vital role in the safety of medicines for the last 50 years and the launch of this new mobile app brings it into the 21st century. By making the scheme accessible to researchers, healthcare professionals and millions of patients, it will not only improve the safety of reporting but ultimately better protect people's health and support research.’ WEB-RADR will draw on user feedback to develop the app further and adapt it for additional countries. Over the coming year, the WEB-RADR project will launch versions of the app in the Netherlands and Croatia, and by the end to the project will have a generic version of the app which will be available for adoption by Member States who wish to use the technology to supplement existing reporting mechanisms.
 - For more information on the app, read the MHRA press release

WEB-RADR discusses mobile technologies and pharmacovigilance
IMI’s WEB-RADR project has held its first workshop on the use of mobile technologies and social media in pharmacovigilance. ###The goal of the event was to lay the foundations for future collaboration with consumers, patients, healthcare professionals and medicines regulators throughout the WEB-RADR project. During the event, the 80 participants discussed issues such as:
- the application of mobile technologies to facilitate adverse drug reaction (ADR) reporting and access to information on medicines;
- the potential use of public social media as a data source together with analytical tools to supplement existing signal detection approaches;
- personal data protection and ethical considerations;
- the elaboration of recommendations to aid policy development on the future use of mobile technologies and social media as new tools in pharmacovigilance.
The goal of the WEB-RADR project is to develop a mobile app for patients and healthcare professionals to report suspected adverse drug reactions to national EU regulators, and investigate the potential for publicly available social media data for identifying drug safety issues.

Participants Show participants on map

EFPIA companies
  • Amgen NV, Brussels, Belgium
  • AstraZeneca AB, Södertälje, Sweden
  • Bayer AG, Berlin, Germany
  • Glaxosmithkline Research And Development LTD, Brentford, Middlesex, United Kingdom
  • Janssen Pharmaceutica NV, Beerse, Belgium
  • Novartis Pharma AG, Basel, Switzerland
  • Sanofi-Aventis Research and Development, Chilly Mazarin, France
  • UCB Biopharma SPRL, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • (UK) Department of Health, Leeds, United Kingdom
  • Academisch Ziekenhuis Groningen, Groningen, Netherlands
  • Croatian Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
  • Stichting Lareb, 's Hertogenbosch, Netherlands
  • Stiftelsen WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
  • University College London, London, United Kingdom
  • University of Liverpool, Liverpool, United Kingdom
Small and medium-sized enterprises (SMEs)
  • Epidemico Limited, Irishtown, Ireland
  • SRDC Yazilim Arastirma ve Gelistirme ve Danismanlik Tic. Ltd. Sti., Ankara, Turkey
Patient organisations
  • European Organisation for Rare Diseases, Paris, France
Non EFPIA companies
  • European Medicines Agency, Canary Wharf, London, United Kingdom

CONTACT

Project coordinator
David Lewis
Novartis Pharma AG
41 61 324 35 89
david-1.lewis[at]novartis.com
Managing entity
Phil Tregunno
Department of Health
44 203 080 6696
phil.tregunno[at]mhra.gsi.gov.uk