Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADR.

Over a period of 3 years, the European Union's Innovative Medicines Initiative WEB-RADR project has explored the value of social media (i.e., information exchanged through the internet, typically via online social networks) for identifying adverse events as well as for safety signal detection.

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.

Recommendations on the Use of Mobile Applications for the Collection and Communication of Pharmaceutical Product Safety Information: Lessons from IMI WEB-RADR.

Over a period of 3 years, the European Union's Innovative Medicines Initiative WEB-RADR (Recognising Adverse Drug Reactions; https://web-radr.eu/ ) project explored the value of two digital tools for pharmacovigilance (PV): mobile applications (apps) for reporting the adverse effects of drugs and social media data for its contribution to safety signalling. The ultimate intent of WEB-RADR was to provide policy, technical and ethical recommendations on how to develop and implement such digital tools to enhance patient safety.

Correction to: Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance.

In the original publication of the article, the trend line for non-EEA cases in figure 4 is incorrect. In this correction, the original Fig. 4 (Fig.

Characteristics, Quality and Contribution to Signal Detection of Spontaneous Reports of Adverse Drug Reactions Via the WEB-RADR Mobile Application: A Descriptive Cross-Sectional Study.

Introduction: Spontaneous reporting of suspected adverse drug reactions is key for efficient post-marketing safety surveillance. To increase usability and accessibility of reporting tools, the Web-Recognising Adverse Drug Reactions (WEB-RADR) consortium developed a smartphone application (app) based on a simplified reporting form.

Objective: The objective of this study was to evaluate the characteristics, quality and contribution to signals of reports submitted via the WEB-RADR app.

Correction to: Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance.

Correction to: Drug Saf DOI 10.1007/s40264-017-0569-3.

Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance.

Introduction: Medication errors recently became the focus of regulatory guidance in pharmacovigilance to support reporting, evaluation and prevention of medication errors.

Objective: This study aims to characterise spontaneously reported cases of medication errors in EudraVigilance over the period 2002-2015 before the release of EU good practice guidance.

Methods: Case reports were identified through the adverse reaction section where a Medical Dictionary for Regulatory Activities (MedDRA) term is reported and included in the Standardised MedDRA Query (SMQ) for medication errors.

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.

Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention.

A medication error is an unintended failure in the drug treatment process that leads to, or has the potential to lead to, harm to the patient. Reducing the risk of medication errors is a shared responsibility between patients, healthcare professionals, regulators and the pharmaceutical industry at all levels of healthcare delivery. In 2015, the EU regulatory network released a two-part good practice guide on medication errors to support both the pharmaceutical industry and regulators in the implementation of the changes introduced with the EU pharmacovigilance legislation.