This change has been made in response to feedback that mandatory reporting of all suspected ADRs in children was impractical and deterred reporting. The advice for reporting adverse reactions is now the same for adults and children.
When to report
A Yellow Card needs to be completed for any ADR that is:
- serious or results in harm and/or
- associated with newer drugs and vaccines identified by the black triangle symbol (▼).
A serious reaction is one that is fatal, life-threatening, disabling or incapacitating, causes a congenital abnormality or results in hospitalisation, or is medically significant for any other reason.
ADRs meeting the above criteria should be reported if they are suspected to be caused by medicines, vaccines, herbal or complementary products, including from misuse or overdose, or from use of unlicensed or off-label medicines.
Where harm occurs as a result of a medication error, a Yellow Card may be completed or the error can be reported via the National Reporting and Learning System.
A paper copy of the Yellow Card form can be found at the back of the print issue of MIMS. This will be updated for the next quarterly edition (December) to reflect the changes to reporting ADRs in children and adolescents.
Further information: MHRA Drug Safety Update, September 2014