Reporting to the MHRA

Last updated: Monday, January 22, 2018

Many health professionals have a poor understanding of the Yellow Card Scheme and its role in pharmacovigilance, and so pharmacists should ensure that they are familiar with it. If the outcome of a clinical problem indicates that an ADR may have occurred, it is worth suggesting that a Yellow Card be submitted to the MHRA if the reaction meets their reporting criteria. For healthcare professionals the MHRA request that we report:

  • All reactions to new drugs, which have an inverted black triangle next to them in the BNF, in MIMS, or in their SPCs. (You can read more about the MHRA's approach to monitoring of black triangle drugs, and the current list of these drugs is here.) 

  • Any serious reaction to all other drugs including prescription and OTC medicines, vaccines and herbal products.

Patients, carers, or parents are asked to report any side effect that they, or a person in their care, may have experienced from a medicine.

Yellow Cards may be completed on paper (copies in back of BNF), electronically via the MHRA’s dedicated Yellow Card website, or via the MiDatabank software that all MI centres in the UK use – ask your tutor or your MI pharmacist to show you how this works.
Quick clinical question 
Can you report adverse reactions to herbal and homeopathic medicines via the Yellow Card Scheme? What about harmful incidents caused by medical devices?   Consider, then click for answer.
You can report reactions to homeopathic and herbal medicines via the same Yellow Card Scheme as for conventional medicines. There are three separate but complementary processes for reporting incidents related to (1) medical devices, (2) defective medicines, and (3) counterfeit medicines. You can see more details on these via the Yellow Card website.

The MHRA provides some free e-learning for healthcare professionals about the importance of national reporting systems for ADRs. It is a lengthy learning package, so you should allow about 45 minutes to complete it, but it is comprehensive and you can count it towards your CPD record.