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Awareness Levels Toolkit

Within SCOPE Work Package 4, Topic 3 focused on increasing awareness levels of national spontaneous adverse drug reaction (ADR) reporting systems. The main aim was to enable and facilitate National Competent Authorities (NCAs) with a set of tools, template methodologies and good practice examples from NCAs, including their respective pharmacovigilance centres and regional monitoring centres where applicable.

The SCOPE toolkit that was subsequently developed based on an in depth EU survey report, included the creation of three guidance documents supported by an e-learning module for NCAs to consider various suggestions on how to strengthen their existing awareness raising strategies, encourage campaign work and how to measure effectiveness. The guidance contains identified best practice examples across EU in these areas to help increase the number and quality of suspected ADR reports to the national system. In addition to this, media materials intended for promoting the reporting of suspected ADRs, commonly referred to as suspected side effects, were also produced.

The media materials were used in a coordinated EU wide social media campaign led by the MHRA. The campaign took place via an ADR reporting awareness raising week from 7-11 November 2017 and was a first of its kind for suspected ADR reporting. The media materials SCOPE produced formed the centre of the awareness week. The animation was also broken down into smaller clips with key messages for NCAs to use over the week supported by key messages and three additional infographics (1, 2, 3) to raise awareness of the national ADR reporting system. Twenty four different tailored versions were produced for NCAs in multiple languages. The fourth document is the evaluation of the EU wide social media campaign.

NCAs can also have access to online software called Riddle as part of the awareness toolkit. This software can be used to quickly create interactive digital content that is easily shared and embedded into websites and social media. It easily allows NCAs to facilitate raising awareness through measuring and benchmark awareness levels, create surveys, opinion polls, lists, interactive stories, quizzes and reaction polls.

In addition to this, a 45 minute e-learning package about ADR reporting was developed to support healthcare professionals. An application was submitted to European Union of Medical Specialists (EUMS) in February 2017. EUMS covers 34 countries including National Associations of Medical Specialists and affiliated associations. In March 2017, the module received the highest order of accreditation from the European Accreditation Council for Continuing Medical Education (EACCME®). This means that doctors across EU are awarded with 1 EACCME credit (1 hour) for CME/CPD purposes upon completion of the ADR module recognised by National Accreditation Authorities.

Awareness Levels Materials

The below infographics and video can be used to promote the reporting of suspected side effects. Tailored versions of infographics were produced in different EU languages.

Infographic - Reporting suspected side effects - click here

Infographic - Reporting makes medicines safer - click here

Infographic - Reporting in EU is improving and leads to better medicines information - click here

Animation

Below is the SCOPE animation developed to promote reporting of suspected side effects which was used in the first EU wide social media ADR awareness week campaign in November 2017. The SCOPE animation can also be accessed directly on the MHRA's YouTube channel: https://youtu.be/3et5LdYLc8M.

E-learning for healthcare professionals and doctors (CME/CPD accredited) 

A 45 minute e-learning package about ADR reporting was developed to support healthcare professionals. In March 2017, the highest order of accreditation was given from the European Accreditation Council for Continuing Medical Education (EACCME®) run by the European Union of Medical Specialists (UEMS). UEMS covers 34 countries including National Associations of Medical Specialists and affiliated associations. Doctors across EU are awarded with 1 EACCME credit for Continuing Medical Education (CME) or Continuing Professional Development (CPD) purposes upon completion of the ADR module which is recognised by National Accreditation Authorities.

Duration

45 minutes CPD/CME accredited e-learning.

Click here to access this e-learning. 

Please click here to complete this short survey  upon completion of the ADR e-learning module or complete it below:

Please contact SCOPE team for the press release relating to the ADR e-learning module.

Awareness Levels E-learning module

Strategy Guidance for Increasing Awareness Levels on National ADR Reporting systems e-learning module

This e-learning module provides a guide on a strategy aimed at consideration by NCAs to increase the number and quality of suspected ADR to their national ADR reporting systems.

What does this e-learning module cover?

1. Introduction and how to shape your strategy to increase ADR awareness levels
2. How to focus resource and efforts to increase reporting through understating current status of ADR reporting including stakeholder analysis and the importance of benchmarking
3. Presentation of the SCOPE strategy and its four pillars  to raise awareness of national ADR reporting systems
4. 26 suggestions to consider when strengthening strategies to increase ADR awareness levels
5. An overview running an ADR campaign
6. An overview on the importance and how to measure success of campaigns to support the guidance documents above

Duration

Approximately 45 minutes completion time.

Click here to access this e-learning module.



Awareness Levels Guidance Documents

Document 1. Increasing Awareness of National Adverse Drug Reaction Reporting Systems: Best Practice Guide

This strategy guidance document aims to provide guidance for consideration by NCAs and their pharmacovigilance centres to increase the number and quality of reports of suspected ADRs entered into their national ADR reporting systems. The guidance refers to example case studies identified and developed from the information supplied by NCAs and pharmacovigilance (PV) centres from the SCOPE Work Package 4 survey on awareness levels.

The purpose of this guidance document is to:

 - Complement existing approaches used by NCAs to increase awareness levels

 - Highlight extra areas where NCAs can consider adding to their existing strategies

 - Highlight good practice from campaigns to increase suspected ADR reporting

 - Explore and highlight methods used by NCAs to evaluate their campaigns

 - Highlight examples of how regional centres are increasing awareness levels of suspected ADR reporting

Duration

53 pages PDF.

Click here to access this document.


Document 2. Raising and Measuring Awareness Levels for ADR Reporting Systems through Campaigns and Regional Monitoring Centres

This document provides an overview of campaigns run by NCAs to raise awareness of their national ADR reporting systems and how their effects on awareness are measured. Example case studies were identified from the response to the SCOPE survey on awareness levels. This guidance document aims to complement existing practice, provide some inspiration on approaches to consider, and to encourage NCAs to consider such campaign activities, including initiatives from regional monitoring centres. The guidance also aims to showcase approaches and tools to consider when measuring the success of an ADR campaign.

Duration

22 pages PDF.

Click here to access this document.


Document 3. Raising awareness of national ADR reporting systems: case studies by country

The document is a compilation of case studies showcasing examples of good practice shared by various NCAs within each MS. Examples are aligned to the numerous suggestions in the SCOPE guidance document and supporting e-learning module on raising awareness levels of ADR reporting. There are also examples of: how success is measured for campaigns; case studies of regional monitoring centre (RMC); and campaign case studies provided by an NCA or national Pharmacovigilance Centre within a particular MS. This means that the suggestions may be different and varied between NCAs.

Duration - 169 pages PDF.

Click here to access this document.



Document 4. An evaluation of the EU wide social media campaign to raise  awareness of national spontaneous ADR reporting systems

This document provides an overview and evaluation of the SCOPE social media campaign run by National Competent Authorites (NCAs), between 7-11 November 2016 to raise awareness of their national ADR reporting systems. This document is intended to measure the effectiveness of the SCOPE initiative and provide insight into future planning of such campaigns.

Duration - 24 pages PDF.

Click here to access this document. 


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