Article date: September 2014
We are publishing new guidelines for reporting suspected adverse drug reactions (ADRs) in children and adolescents aged under 18 years via the Yellow Card Scheme. The advice on which suspected ADRs to report in children is now the same as for adults (ie, we are no longer requesting all suspected ADRs to be reported for children):
Yellow Card reporting guidelines for ADRs in adults or children
Please complete a Yellow Card for:
- all suspected ADRs that are serious or result in harm. Serious reactions are those that are fatal, life-threatening, disabling or incapacitating, those that cause a congenital abnormality or result in hospitalisation, and those that are considered medically significant for any other reason
- all suspected ADRs associated with new drugs and vaccines (identified by the black triangle symbol: ▼)
This new guidance responds to feedback that the previous guidelines - asking all suspected ADRs in children to be reported - were impractical and deterred reporting. If you are in any doubt as to whether a suspected ADR was serious or harmful, please complete a Yellow Card anyway.
Importance of reporting paediatric ADRs
Watch out for suspected ADRs in children and neonates, which can be different from those in adults. Knowledge about ADRs in children is less well established because:
- action of a drug and its pharmacokinetics in children (especially in the very young) may be different from that in adults
- drugs may not have been extensively tested in children
- many drugs are not specifically licensed for use in children and are used either ‘off-label’ or as unlicensed products
- drugs may affect the way a child grows and develops or may cause delayed adverse reactions which do not occur in adults
- suitable formulations may not be available to allow precise dosing in children or they may contain excipients that should be used with caution in children
- the nature and course of illnesses and adverse drug reactions may differ between adults and children
Call for reporting
Please continue to use Yellow Cards to report suspected ADRs to medicines, vaccines, and herbal or complementary products, whether self-medicated or prescribed. Yellow Cards should also be completed for suspected ADRs associated with misuse, overdose, or from use of unlicensed or off-label medicines. ADRs where harm occurs to the patient as a result of a medication error are also reportable as a Yellow Card or through the local risk management systems into the National Reporting and Learning System (NRLS). If reported to the NRLS, these will be shared with the MHRA. If the NRLS is not available and harm occurs, report using a Yellow Card.
The quickest way to send a Yellow Card is via our website: www.mhra.gov.uk/yellowcard
Further guidance on what to report can be found here.
Article citation: Drug Safety Update volume 8 issue 2, September 2014: Y1