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.
Provide an overview of national ADR reporting systems and identify best practice
Develop a toolkit for raising awareness of national ADR reporting systems
Within Work Package 4, there were five individual topics which partners were working on:
European Member States were asked to complete six Work Package 4 surveys in order to identify their current methods in place for ADR collection. The six surveys focused on: national reporting systems (Topic 1), medication errors (Topic 1a), patient reporting (Topic 2), awareness levels (Topic 3), reporting forms (Topic 4) and IT systems and special forms of reports (Topic 5). Responses were collated and analysed, and used to construct training deliverables for SCOPE Work Package 4.
WP4 delivered a series of ‘best practice’ guidance documents and e-learning modules focusing on duplicate detection, additional monitoring, medication errors, collaboration with patient organisations, feedback to patients, comparisons of reports from patients and healthcare professionals, IT systems, tools for measuring and improving quality of reports, awareness levels, telephone reporting, and paper forms.
Click here access WP4 materials.
WP4 created a web-based form for reporting of ADRs by European healthcare professionals, patients, and their carers. The form was designed using the internationally agreed standard for Individual Case Safety reports (ICSRs) to enable transmission of cases direct into national and EU databases. The system can also act as NCA database if required. The web-form offers a simple solution for any NCA wishing to implement a new reporting web-form, and can be tailored to NCA’s needs.
WP4 held a two-day training session in London on 13th-14th October. It was attended by 70 pharmacovigilance staff from 20 countries. Topics covered included telephone reporting, web-based reporting, how to carry out comparisons of data from different reporter groups, medication error reports, additional monitoring, duplicate detection, measuring and auditing quality of reports, collaboration with patient organisations, review of IT systems, and how to effectively raise awareness of ADR reporting systems through campaigns.
WP4 created a series of animated and interactive posters that have been used in an EU wide social media campaign to raise awareness of the national ADR reporting systems between 7-11 November 2016. NCAs used Facebook, Twitter and other social media platforms to inform the public about the importance of reporting and point them towards their national ADR system.
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.
- see the animation developed to promote reporting of suspected side effects animation below which can also be accessed directly on the MHRA's YouTube channel: https://youtu.be/3et5LdYLc8M.
Lead: HALMED (Croatia)
MHRA (United Kingdom)
SUKL (Czech Republic)