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.