News

WORK PACKAGE 1 WORKSHOP REPORT PUBLISHED

The report from the second Innovative Medicines Initiative (IMI) WEB-RADR Work Package 1 workshop has been published.

 

The workshop, which took place on 19 October 2016, focused on the evaluation of the use of mobile technologies in pharmacovigilance to Recognise Adverse Drug Reactions (RADR), and the usefulness of social media data for pharmacovigilance.

 

The workshop informed about developments and outputs from the project, and dedicated breakout sessions allowed participants to focus on specific topics of interest. These will inform the final deliverables of providing recommendations for policy and governance for mobile device and social media use for a pharmacovigilance landscape into the future.

 

For the full workshop report, please click here.

WP1 publication in Therapeutic Innovation & Regulatory Science

WEB-RADR Work Package 1 colleagues from Sanofi, Novartis, Lareb and the EMA have published their work on social media monitoring in Therapeutic Innovation & Regulatory Science (TIRS).

 

The goal was to gather information on existing practices, guidance, and legal requirements on social media monitoring to identify potential safety issues related to medicines. To read this article, please click click here: Social Media Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape.

 

This work will inform the development of a future policy framework on the further use of social media as a new pharmacovigilance data source in the European Economic Area. In addition, this paper elaborates on some current practical case management issues encountered by companies based on the existing regulatory guidance.

Publication in Drug Safety – Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study

The WEB-RADR Work Package 3B team has published their findings from a qualitative study investigating the factors influencing the use of a mobile app for two-way risk communication. The results of the study will be of interest to pharmacovigilance experts, and app researchers and developers and will be used to improve WEB-RADR’s mobile apps.

 

The ‘Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study’ publication is in Drug Safety can be found here.

 

Key points (as highlighted in the article):

  • Factors influencing the use of an app for two-way risk communication concern what feedback would be given on adverse drug reaction reports and how safely these are stored and handled; what type of news, if any, would be provided through the app; other functions of the app; ease of use; the source (authority) behind the app; appropriate language and appeal of the app; and costs.
  • User characteristics (e.g. age, education, experience with apps) may moderate to what extent specific factors (e.g. functions, security) influence use of the app.
  • When designing or improving an app for two-way risk communication, pharmacovigilance experts, and app researchers and developers should consider the identified factors.

 

Ongoing research focuses on the quantification of the influencing factors and on associations between user characteristics and the direction of the influencing factors.

Work Package 1 Workshop, 19 October 2016

The WEB-RADR Work Package 1 (Government and Policy) organised a second workshop on 19th October 2016 at the European Medicines Agency, to discuss the use of mobile technologies and social media as new tools to generate evidence for the monitoring of the safety of medicines.

The aim of the workshop was to engage with consumers, patients, healthcare professionals and medicines regulatory authorities to discuss latest developments and to obtain input and feedback to maximise the utility and benefits of the project deliverables.

The day consisted of three sessions.

Session 1: WEB-RADR: where we have come from and what we have achieved

Session 2: How to optimise WEB-RADR deliverables

Session 3: Breakout sessions WEB-RADR

  • Patients and healthcare professionals – what do we want as WEB-RADR outputs?
  • Regulatory questions – what are the options?
  • How could social media monitoring support signal detection?
  • How to ensure future maintenance and sustainability of WEB-RADR?

 

The day was a great success and provided a platform for attendees to share their views and expectations to maximise the outputs of WEB-RADR in strengthening pharmacovigilance.

A workshop report will be completed summarising the day’s presentation and discussion topics.

Mobile App Survey for Healthcare Professionals and Patients

Work Package 3B of the WEB-RADR project has launched two surveys, for healthcare professionals and for patients and consumers of medicines, to determine opinions about a mobile app which can be used to report adverse drug reactions (ADRs) and to receive safety information about medicines.

 

The results of the survey will be used to improve WEB-RADR’s mobile apps, and to increase general knowledge about mobile two-way communication; the reporting of ADRs and availability of news and safety alerts about particular medicines.

 

Completing the survey is anonymous and will take approximately 15-20 minutes. The surveys are available in seven languages; Croatian, Dutch, English, French, German, Portuguese and Spanish.

 

Please follow the below links to the surveys or see Twitter posts of @WEBRADR. The surveys will close early September 2016.

Healthcare professional survey: https://www.unipark.de/uc/WEB-RADR/HCP/

Patients and consumers of medicines: https://www.unipark.de/uc/WEB-RADR/PT/

 

 

HALMED WEB-RADR app launch

The final WEB-RADR app was launched on 18 May 2016 by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED). WP3A continued to work diligently following the Yellow Card and LAREB app releases to complete and launch the HALMED app.

 

The HALMED app is available for worldwide download: App store and Google Play

 

news item was posted on HALMED’s website in Croatian and in English following the App Press release, photographs from the event can be seen below. 

 

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WEB-RADR General Assembly celebrates project half-way mark

The WEB-RADR General Assembly was hosted on 21 April at the Royal College of Physicians.

The meeting brought together representatives from each partner of the WEB-RADR consortium and, as Dr June Raine explained in her welcome, was organised to provide an opportunity for participants of each Work Package to provide updates on what they had achieved since the launch in September 2014, affirm the excellence in collaboration, and motivate partners to continue their good work to reshape the pharmacovigilance world.

Project Lead Phil Tregunno also highlighted milestones completed over the first 599-days of the project and the communication highlights (publications, presentations, website and Twitter activity).

Dr Robert Ball, representing the FDA, provided a view from the projects external General Advisory Board, and spoke of FDA initiatives related to WEB-RADR, and the need for collaboration and harmonisation.

The processes and results of social media data collection, classification and analytics (ADR detection and signal detection) were demonstrated by Work Packages 2A (Dr Nabarun Dasgupta, Epidemico) and 2B (Dr Johan Ellenius, UMC and Dr John van Stekelenborg, JNJ). Underpinning these results was Ms Victoria Newbould’s (EMA) explanation of WP1’s assessment of relevant EU data protection legislation, stakeholder needs, ethical aspects and plans to elaborate a policy framework.

Representatives of Work Packages 3A (Ms Carrie Pierce, Epidemico) and 3B (Dr Peter Mol, University of Groningen) displayed the three mobile apps (Yellow Card, LAREB and HALMED) that had been developed as part of the project and explained the key barriers and facilitators identified for two way risk communication.

University of Liverpool (Professor Simon Maskell) presented WP4’s assessment of the utility of the app, social media, and the integration of ADR data from multiple sources, alongside LAREB’s quality assessment tool.

After presentations and discussions about each Work Package, the meeting concluded with a lively discussion, with the key themes emerging from the day being; maximising the move to mobile technology and building on current learnings, the areas where social media is useful and how can this be captured and how this technology can be shared globally.

 

General Assembly All.jpg

 

The meeting was a huge success with fantastic contribution from all participants throughout the day, and served to focus the consortium on the months ahead, whilst recognising the significant achievements in the project so far.

Every member of the WEB-RADR consortium should be immensely proud of the work achieved to create lasting technical innovations in drug safety monitoring based on sound science which will potentially improve the public health of millions.

 

To follow the days progress, please see WEB-RADR’s Twitter posts: @WEBRADR

 

WEB-RADR General Assembly

The Innovative Medicines Initiative WEB-RADR General Assembly meeting will take place on Thursday 21 April 2016 in London.

 

The meeting will provide an opportunity for representatives of each partner in the consortium to meet and receive updates on the project.

 

Since the WEB-RADR launch in September 2014, WEB-RADR Work Packages have worked hard, with great commitment and energy. Each Work Package will present achievements and findings to date at the General Assembly meeting.

 

Should you have any questions, please contact WEB-RADR@mhra.gsi.gov.uk.

 

 

 

Lareb launch the Dutch version of the WEB-RADR app

The second WEB-RADR app has been launched!

The Dutch version of the WEB-RADR app was launched on 29 January 2016 by Lareb, Netherlands.

WEB-RADR WP3A have worked hard to create the app, allowing the public to report suspected adverse drug reactions to medicines to Lareb, in real-time.

The Lareb app is available for worldwide download, from Apple and Google Play stores:

App Store –  https://itunes.apple.com/ie/app/bijwerking/id1060529495?mt=8

Google Play – https://play.google.com/store/apps/details?id=nl.lareb

‘Aims and approaches of Web-RADR’ publication in the Expert Opinion on Drug Safety

Novartis WEB-RADR participants, Rajesh Ghosh and David Lewis, have published ‘Aims and approaches of Web-RADR: a consortium ensuring reliable ADR reporting via mobile devices and new insights from social media’ in the Expert Opinion on Drug Safety (14:12, 11845-1853, DOI: 10.1517/14740338.2015.1096342).

 

This paper provides a detailed look at Web-RADR; the project’s objectives, governance structure and new approaches to modernise pharmacovigilance practises.

 

The accepted article was published online (05-Oct-15): http://www.tandfonline.com/eprint/Z5QA48VnPRjMxaBpdmyy/full

Yellow Card App worldwide release

 

The WEB-RADR Yellow Card app has now been released worldwide and will be available for download in non-UK app stores. This update has been made in response to requests from app users who have purchased their mobile devices overseas.

 

App store –  https://itunes.apple.com/gb/app/yellow-card-mhra/id990237487?ls=1&mt=8

Google play – https://play.google.com/store/apps/details?id=uk.org.mhra.yellowcard&hl=en_GB

 

Please note that the MHRA is only able to accept reports of side effects experienced within the UK and any reports submitted which originate outside of the UK will not be stored on our database.

 

Should you have any questions about the App or the WEB-RADR project please do not hesitate to contact us at: WEB-RADR@mhra.gsi.gov.uk.

WP3B Poster: Barriers and facilitators for a mobile app to report Adverse Drug Reactions & receive information about drugs

WEBRADR’s WP3B presented their poster ‘Barriers and facilitators for a mobile app to report Adverse Drug Reactions & receive information about drugs’ at the FIGON Dutch Medicines Days 5 – 7 October 2015.

The poster displays preliminary results from the qualitative and multinational study carried out to explore barriers and facilitators of healthcare professionals and patients to using a mobile app for two-way risk communication and their perspectives on a mobile app prototype.

Please see the poster here: WEB-RADR WP3B FIGONDMD.

Social Media and Pharmacovigilance, British Journal of Clinical Pharmacology Publication

Many congratulations to Work Package 4 teams from University of Liverpool and Novartis for their publication ‘Social Media and Pharmacovigilance: A Review of the Opportunities and Challenges’ in the British Journal of Clinical Pharmacology (BJCP).

The accepted article can be found on the BJCP website: http://onlinelibrary.wiley.com/doi/10.1111/bcp.12717/abstract.

Innovative Medicines Initiative WEB-RADR Workshop Report

This workshop was the first of two workshops organised in the context of the Innovative Medicines Initiative (IMI) WEB-RADR project, which focuses on the evaluation of the use of mobile technologies in pharmacovigilance to Recognise Adverse Drug Reactions (RADR). The use of new technology is a great opportunity to empower patients to report and to provide reporters such as healthcare professionals, patients, consumers and carers with accurate, timely and up-to-date information on how to use medicines safely and effectively.

The project will develop a mobile app prototype in support of adverse drug reaction reporting and the provision of drug safety information to app users from medicines regulatory authorities. The mobile app will be subject to a user-based evaluation by focus groups based on a variety of stakeholders of different ages and medical backgrounds.

A second aspect of the project is to assess the usefulness of social media analytics. This includes gathering and aggregating unstructured information from social media with the aim to analyse and to detect potential safety issues related to medicines, which may not be identified through traditional methods in pharmacovigilance.

Whilst new technologies may provide powerful tools in adverse reaction reporting and the monitoring of the safety of medicines, challenges with regard to ethical principles, data protection safeguards, the accountability for data processing, the monitoring of the use of data and the need for enhancing data security and anonymity are also to be analysed. The aim is to develop a policy framework based on recommendations for potential future implementation and use of the WEB-RADR project deliverables.

The workshop provided a unique opportunity to exchange views and to discuss expectations with members of the European Medicines Agency’s Healthcare Professionals Working Party and the Patients’ and Consumers’ Working Party, the Pharmacovigilance Risk Assessment Committee and pharmacovigilance experts, representatives from Young People (Paediatric Committee) experts in the area of medical ethics and data protection and IMI WEB-RADR Consortium members. The outcome of the workshop will inform the WEB-RADR Consortium and the project deliverables.

The full workshop report can be found here 1st WEB-RADR Workshop Report.

WEB-RADR Yellow Card app launch 14th July 2015

The MHRA launched the first version of the WEB-RADR Yellow Card app on 14th July 2015, thanks to hard work from Epidemico and the WP3A team. The release has been covered widely by the press and links to articles can be found on our ‘Press & White Papers’ section.

There is a video on YouTube from our Minister, George Freeman, introducing the app – https://www.youtube.com/watch?v=OoSdiXINj1c

A press release about the app was also published on the MHRA website- https://www.gov.uk/government/news/digital-evolution-for-ground-breaking-yellow-card-scheme

The Yellow Card app is available to download in the UK, from Apple and Google Play stores:

App store –  https://itunes.apple.com/gb/app/yellow-card-mhra/id990237487?ls=1&mt=8

Google play – https://play.google.com/store/apps/details?id=uk.org.mhra.yellowcard&hl=en_GB

First Innovative Medicines Initiative WEB-RADR Workshop: mobile technologies and social media as new tools in pharmacovigilance

The IMI WEB-RADR consortium has hosted its first workshop on mobile technologies and social media as new tools in pharmacovigilance at the offices of the European Medicines Agency (EMA) in Canary Wharf.

The workshop was arranged by Work Package 1, which focusses on governance and policy, and took place on 10 December 2014. It set out to prepare the foundation for collaboration with consumers, patients, healthcare professionals and medicines regulators throughout the WEB-RADR project. More specifically, the goal was to provide a detailed understanding of the motivations for the project and the research areas, to stipulate the research aspects with the anticipated outcomes and to understand stakeholders’ needs and concerns thus also addressing key areas of data privacy and ethical considerations.

The workshop was the first of two meetings for direct dialogue with member organisations of EMA’s Patients and Consumer Working Party (PCWP) and Healthcare Professional Working Party (HCPWP), Young People representatives of EMA’s Paediatric Committee (PDCO), the chair and vice chair of the Pharmacovigilance Risk Assessment Committee (PRAC), pharmacovigilance experts from EU medicines regulators and US FDA, and consortium partners, as well as ethical and data privacy experts including a legal officer of the European Data Protection Supervisor (EDPS) office. It included discussions with more than 80 participants on:

  • 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 data source together with analytical tools to supplement existing signal detection approaches;
  • The scientific evaluation of the added value of the project deliverables;
  • 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.

From the FDA Centre of Drug Evaluation and Research (CDER) the workshop heard about the reasons why it is important to look into novel approaches in pharmacovigilance thus utilising emerging technologies and data sources based on FDA’s pilot projects (MedWatcher and MedWatcher Social) as well as FDA’s experience in guidance development in this area.

Members of the PCWP and the HCPWP provided important input on user needs and expectations based on a survey launched in preparation of the workshop as well as during the meeting. EURORDIS shared experience on the use of mobile apps from a patient’s perspective, whilst healthcare professional views were further elaborated on by the European Association for Clinical Pharmacology and Therapeutics (EACPT) and the European Academy of Paediatrics (EAP).

A key topic discussed at the workshop was related to data privacy and ethical considerations supported by experts from the Commission Nationale de l’Informatique et des Libertés (CNIL), the EMA and pharmaceutical industry. The legal officer of the EDPS office emphasised the importance of individuals to be empowered by means of transparency and awareness but also by retaining control over their own personal data at any time. This can be achieved based on data protection tools, which were further outlined by the legal officer at the meeting. In this context, reference was also made to the Commission’s Green Paper on mobile Health, which also addresses these aspects. Ethical considerations to be further expanded on as part of the project were highlighted by a medical ethicist and barrister from the UK.

A report from the workshop, together with the slides from the presentations and a recording of the meeting, are published on this website.

A second meeting, which is planned to be an open workshop, will be organised in the 3rd quarter of 2016 (end of year two of the project) and will see also the involvement of data privacy organisations.

In summary, the objectives of WEB-RADR are to:

  • Develop a mobile application (app) that healthcare professionals and patients can use to report suspected adverse drug reactions to medicines regulators in the EEA.
  • Assess the possibility for medicines regulators to provide accurate, timely and up to date information on medicines to patients, consumers, healthcare professionals and caregivers through the mobile app.
  • Explore the identification of potential safety issues with medicines from user comments in social media taking into account compliance with personal data protection legislation.
  • Develop recommendations as basis for a policy framework for the use of mobile technologies and social media in the context of pharmacovigilance and the monitoring of the safety of medicines.

New WEB-RADR Website Launched

The WEB-RADR website went live on 5 December 2014 . The launch of the project website, which offers a tool to disseminate information to stakeholders about the consortium and the project aims and objectives, is part of WP5’s (project management and communication) key deliverables.

The launch comes three months after the kick off meeting. The site will enable the project management  team to communicate effectively and efficiently with stakeholders, ranging from members of the public, medical professionals, national regulators and industry.

Overall, the project website will provide  a central resource for all information about the project over the course of the next three years.

WEB-RADR Webinar: mobile apps and social media as new tools in pharmacovigilance

The WEB-RADR webinar, dedicated to the use of mobile devices and social media in the context of pharmacovigilance,  took place on 28 October 2014 at the EMA offices in London. Members of the Healthcare Professional Working Group, Patients and Consumers Working Group, Pharmacovigilance Risk Assessment Committee, and IMI WEB-RADR consortium participated in the session.

Overall, the webinar provided stakeholders with a better understanding of project deliverables, and informed participants about the dedicated stakeholder workshop to be organised by the European Medicines Agency on the 10 December 2014.

The full webinar session is available here:

WEB-RADR Launch Meeting in London

On Friday 5 September 2014, 45 delegates from across the world met at the MHRA headquarters in London to participate in the launch workshop for the Innovative Medicines Initiative (IMI) WEB-RADR project.
Organised by the MHRA, who are the coordinators of WEB-RADR, the workshop comprised four sessions:
Session 1 – Effective project management of WEB-RADR
Sessions 2 and 3 – WEB-RADR Work Packages
Session 4 – Informal discussions on Work Packages – break-out session

The meeting provided an excellent opportunity to discuss the plans and collaborate with partners, who will be working together over the three-year project.

The enthusiasm of the consortium was clear through the discussions and debate that took place. WEB-RADR was recognised as a significant opportunity to benefit the world of pharmacovigilance.