Establishing a Framework for the Use of Social Media in Pharmacovigilance in Europe.

The Innovative Medicines Initiative (IMI) WEB-RADR (Web-Recognising Adverse Drug Reactions) project looked at opportunities and challenges in using social media in pharmacovigilance as a rapidly evolving source of large, real-time data, which could provide new information on the actual use of medicines and potential safety issues. Two of the objectives were to develop principles for continuous monitoring of the safety of medicines without overburdening established pharmacovigilance systems and to propose a regulatory framework on the use of social media in pharmacovigilance. As a starting point, a review of existing legal requirements and regulatory guidance on social media use in pharmacovigilance was performed based on a survey conducted in 2014-2015. Furthermore, input from two large stakeholder workshops and evidence gathered from the research performed by WEB-RADR on the analysis of social media data were taken into consideration. Whilst analytical results of WEB-RADR indicated limited value of social media in detecting or confirming signals for a majority of the drugs studied, it is important to establish a regulatory framework for the use of social media in pharmacovigilance. Thus, the screening and reporting of suspected adverse reactions remains an important pillar in monitoring the safety and efficacy of medicines and the identification of new safety issues. Principles as to how social media can be used in pharmacovigilance are absolutely needed to provide clarity to patients, healthcare professionals, medicines regulators and the pharmaceutical industry.

Social Media Monitoring and Adverse Drug Reaction Reporting in Pharmacovigilance: An Overview of the Regulatory Landscape.

In the context of the European Union's Innovative Medicines Initiative (IMI) project titled Web-Recognizing Adverse Drug Reactions (WEB-RADR; http://web-radr.eu ), which focuses on the assessment of new data sources and the optimization of the collection of information on suspected adverse reactions in pharmacovigilance, a survey was performed in 182 countries/jurisdictions in 2014 to 2015. 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. The survey response rate was 100%. The results revealed that 80% of the surveyed countries do not have such necessities despite the fact that 63% of these countries have an established national pharmacovigilance system. Among the countries having an established pharmacovigilance system, only 29% have specific requirements, most countries do have similar provisions as set out in the EU guidelines on Good Pharmacovigilance Practices (GVP). A small subset of countries within the European Economic Area (EEA) have requirements that exceed those stated in GVP, namely, Italy, France, Sweden, and the UK. Outside the EEA, Turkey and the United States have also developed further guidance. The outcome of the survey will inform the development of a future policy framework on the further use of social media as new pharmacovigilance data source in the EEA. In addition, this paper elaborates on some current practical case management issues encountered by companies based on the existing regulatory guidance.