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Work Package 6 – Risk Communications

Work Package 6 focused 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 assess 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). 

Objectives

  • This work package has developed a document on risk communication, highlighting areas of good practice and proposing areas for improvement in medicines risk communication. In addition, a guidance document for optimising the presentation of web-based safety information has been created.

Topics

Within Work Package 6, there were four individual topics which partners are working on:

  1. Audit of national methods of communications – lead: MPA
  2. Impact Assessment of risk communication – lead: HPRA
  3. Best Practice – lead: AIFA
  4. Web-portals – lead: MHRA

Outputs and results

European Member States were asked to complete two Work Package 6 surveys in order to identify their current methods and preferences in place for communicating risk as part of pharmacovigilance. 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. 

SCOPE WP6 Topic 1 Survey Report 2015

SCOPE WP6 Topic 4 Survey Report 2015

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. WP6 also consulted patients and consumers organisations, and their views were gathered via distribution of an ’aide-memoire’ and are presented in the Patient and Consumers Consultation Report.

Using information collected from NCAs, healthcare professionals, and patients and consumers, WP6 developed the following documents:

 - ‘Risk Communication - Proposals for Improvement’ - includes recommendations that can be used and adapted to available communication strategies by NCAs,

 - ‘Good Practice Guide - Web-based safety information’ - provides guidance on how to develop a useful and accessible platform for presenting safety information, and includes case studies.

Click here access WP6 materials.


Partners involved

Lead: AEMPS (Spain)

AIFA (Italy)

HALMED (Croatia)

HPRA (Ireland)

MHRA (UK)

MPA (Sweden)

NOMA (Norway)

Work Package 6 is examining risk communications practice in the EU network to understand the communication channels and tools used, with frequency, strategy, and engagement approaches
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