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Work Package 4 – ADR Collection

Work Package 4 focused on national schemes for the spontaneous reporting of adverse drug reactions (ADRs) and aimed to provide National Competent Authorities (NCAs) with a full understanding of and best practice in systems for collecting ADRs. Information was gathered from European NCAs to understand their national pharmacovigilance IT system capabilities as well as implementation of patient reporting, types and reporting forms developed, and electronic reporting developments including those from clinical healthcare systems. This information was used to create a toolkit for raising awareness of ADR reporting systems, best practice guidelines, and other learning materials which supported delivery of a training course for NCAs. SCOPE produced an animation and three infographics (123) to raise awareness of national ADR reporting systems.

Work Package 4 – ADR Collection outputs:

Active Approach to Comparisons of ADR Reports from Patients and HCPs White Paper

Additional Monitoring Best Practice Guide and E-learning Module

Awareness Levels Toolkit

Collaboration with Patient Organisations to Promote and Support Patient ADR Reporting Document

Duplicate Detection Best Practice Guide and E-learning Module

Feedback to Patient ADR Reports Document

IT Systems for ADR Reporting: Best Practice Guide

Medication Errors Document

Paper ADR Reporting Forms Guidance

Telephone Reporting Toolkit

Tools for Measuring and Improving Quality of Reports in National ADR Databases Document

Work Package 4 - ADR Collection Survey reports

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