Reactions Weekly
Springer International Publishing
image
UMC: use appropriate COVID-19-related terms for ICSRs
DOI 10.1007/s40278-020-78200-x, Volume: 1803, Issue: 1,

Table of Contents

Highlights

Notes

UMC: use appropriate COVID-19-related terms for ICSRs

The Uppsala Monitoring Centre (UMC) is encouraging the use of common coding principles when completing individual case safety reports (ICSRs) for recipients of COVID-19 treatments. Sharing of relevant adverse event reports with minimal delays in reporting is crucial to improve understanding about treatment efficacy and safety.

The MedDRA 23.0 release has been updated with COVID-19-related terms; using the appropriate terms when coding the indication of use is particularly important. For identification and analysis of COVID-19-related cases, the following details are particularly useful: patient age patient sex relevant medical history reaction outcome results of tests or procedures cause of death narrative, sender's diagnosis and sender's comments

If the patient was treated as part of a clinical trial, the report type should indicate the source, along with the study name and number. If the treatment was given for an unapproved indication or off-label, these terms can also be captured under therapeutic response and additional information fields.

The UMC notes that the recommended implementation of the updated MedDRA 23.0 is 4 May 2020 or when all translations are available

Reference

1 

Uppsala Monitoring Centre. How to capture ICSRs for COVID-19 treatments. Internet Document : 29 Apr 2020. Available from: URL: https://www.who-umc.org/global-pharmacovigilance/covid-19/how-to-report-icsrs-for-covid-19-treatments/

https://www.researchpad.co/tools/openurl?pubtype=article&doi=10.1007/s40278-020-78200-x&title=UMC: use appropriate COVID-19-related terms for ICSRs&author=&keyword=&subject=News Item,