The Medicines and Healthcare products Regulatory Agency (MHRA) has announced new simplified guidance for healthcare professionals reporting suspected adverse drug reactions (ADRs) in children to its Yellow Card Scheme.

Changes to the guidelines follow a recent workshop with paediatric specialists, healthcare professionals and patient organisations who concluded that reporting all suspected ADRs in children was considered impractical for busy healthcare professionals and potentially acted as a barrier to reporting.

The new guidance is simpler and aligned with the reporting guidelines for adults. It asks that healthcare professionals report all suspected ADRs that are serious, medically significant or result in harm, and all those that are associated with newer drugs and vaccines identified by the black triangle symbol ▼.

This guidance applies to medicines, vaccines, herbal or complementary products, whether self-medicated or prescribed, and includes suspected ADRs associated with misuse and unlicensed medicines.

It also places greater importance on the reporting of medication errors in children resulting in suspected ADRs, and provides information on why reporting these reactions in children and neonates is particularly important.

Director of Vigilance and Risk Management of Medicines, Dr June Raine said:

“We strongly encourage healthcare professionals to help improve adverse drug reaction data by reporting suspected adverse drug reactions in children and neonates using the new simplified guidance.

“The effects of medicines in children can be different to adults and in order to widen our knowledge on any possible side effects in this young age group for existing and new drugs, it is vital that we receive reports.

“The quickest way to send a Yellow Card is online at Healthcare professional should inform patients about the Scheme and encourage them to also report themselves.”

Dr Hilary Cass, President of the Royal College of Paediatrics and Child Health, said:

“Reporting adverse reactions quickly and accurately is key to ensuring medicines are safe and effective for children and young people. These new guidelines should help speed up the process and mean that healthcare professionals are not put off by complex forms and unclear processes  The key message is – if you suspect a serious adverse drug reaction in a child – it must be reported and the best way of doing so it via the online Yellow Card.”


Posted on the UK MHRA website on 25 September 2014