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.