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Work Package 6 focussed on risk communication about medicines. Information was collected on communication practice in the EU network to understand channels and tools used, with frequency, strategy, and engagement approaches. Research was also conducted on the knowledge, attitudes and preferences of target audiences towards different communication tools and channels in Member States to determine the effectiveness of different risk communication methods. Using this information, WP6 developed a series of recommendations that can be used and adapted by National Competent Authorities (NCAs). 

SCOPE WP6 - Risk Communications Introductory document

This document was created to provide an overview of work delivered by SCOPE Joint Action Work Package 6 – Risk Communications.

Click here to access this document. (8 pages PDF.)

‘Risk Communication - Proposals for Improvement’ document

This document was intended to give positive reflections and advice based on NCAs, healthcare professionals and citizens’ experience, which could be considered for implementation by Member States.

Click here to access ‘Risk Communication - Proposals for Improvement’ document. (25 pages PDF.)

Good Practice Guide- Web-based safety information

The purpose of this document is to guide NCAs who do not have a fully established website, into developing a useful and accessible platform for presenting safety information. The important considerations in developing a web platform are discussed, and case studies are reported for NCAs to reference. For MSs with more established systems, this document also provides some guidance on how these systems might be optimised going forward.

Good Practice Guide - Web-based safety information - click here to access this document. (73 pages PDF.)

Web-based Safety Information Shortened version - click here to access this document. (52 pages PDF.)

Patient and Consumer Consultation report

WP6 consulted with patients and consumers organisations, and their views were gathered with help of an ’aide-memoire’. 

Click here to access Patient and Consumer Consultation report. (12 pages PDF.)

Risk Communication on Medicines: Report from the Workshop

This report presents a summary of presentations, breakout sessions, and panel discussions from the Risk Communications on Medicines Workshop in June 2016.

Click here to access this report. (17 pages PDF.)

The National Strategy for Implementation of Recommendations on Risk Communication: Key Actions document

Following from the Risk Communications on Medicines Workshop in June 2016, all suggestions provided by the audience were compiled in an evaluation report. One of the recommendations from the audience was to summarise the suggestions for improvement document in a bullet point format to accompany the other WP6 documents. Based on the results gathered from the survey and the comments received from the workshop, the summary of key actions document was developed.

This document aims to guide NCAs in the process of implementing the recommendations from SCOPE WP6, as the level of complexity, and the resources needed differ for the various key actions suggested. 

Click here to access the key actions document. (7 pages PDF.)

Survey reports delivered by Work Package 6 –Risk Communications:

The Topic 1 survey asked Member States a series of questions in order to explore their existing risk communication systems, while Topic 4 addressed more specifically how Member States approached web-based risk communication. The responses were collated and analysed, and are presented in the two reports below.

Click here to access SCOPE Work Package 6 Survey Report Audit of national methods of communication.

Click here to access SCOPE Work Package 6 Survey Report Web-portals.

The third survey was issued to healthcare professionals in 9 Member States. Information on their behaviour, knowledge and preferences in relation to risk communication methods was collected and presented in a report.

Click here to access SCOPE WP6 Healthcare Professional Survey - Medicines Safety Communications and  their Effectiveness.

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