Reporting to the MHRA
The Yellow Card Scheme run by the MHRA is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. The scheme relies on voluntary reporting of suspected side effects or medical device incidents to be reported by healthcare professionals and the public, including patients, carers and parents.
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 SmPCs. (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, blood factors, immunoglobulins 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.
There are three separate but
complementary processes for reporting incidents related to (1) medical devices,
(2) defective medicines, and (3) counterfeit medicines.
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 Medicines Information centres in the UK use – ask your tutor or your MI pharmacist to show you how this works.
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 Medicines Information 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.
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.
