FOI release

Freedom of Information request on Yellow Card reporting (FOI 21/664)

Published 29 December 2021

7th July 2021

FOI 21/664

Dear

Thank you for your email dated 9th June 2021 requesting a link to view the number of reports submitted to the Yellow Card scheme.

Further to your request you may be interested to view the link to our Interactive Drug Analysis Profiles (iDAPs):

https://yellowcard.mhra.gov.uk/idap

These list all Adverse Drug Reaction (ADR) reports received to date for each drug substance and can be filtered as required based on your search criteria. Each iDAP contains complete data for all spontaneous suspected adverse drug reactions which have been reported for that drug substance to the MHRA, via the Yellow Card scheme from healthcare professionals and members of the public. They also include reports from pharmaceutical companies. I can confirm iDAPs provided on the website are regularly updated, there is a time lag of around one month from receipt of a report to it appearing in the iDAP.

When considering spontaneous data, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the medicine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a medicine, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular medicine, and may be stimulated by promotion and publicity. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

The MHRA also publish a weekly summary of Yellow Card reporting for reports received in association with the newly introduced coronavirus vaccines. The report summarises information received via the Yellow Card scheme and will be published regularly to include other safety investigations carried out by the MHRA under the COVID-19 Vaccine Surveillance Strategy. The summary contains Vaccine Analysis Prints for the Pfizer/BioNTech vaccine, COVID-19 Vaccine AstraZeneca, COVID-19 Vaccine Moderna and where the brand of the COVID-19 vaccine was not specified. The Vaccine Analysis Prints contain a complete listing of all suspected adverse reactions that have been reported to the MHRA via the Yellow Card scheme. Analysis prints for routine vaccines are also available on request.

You may also be interested to see the link to the 2019 CHM (Commission on Human Medicines) annual report. This will provide further information on the number of reports received in 2019 as well as an overview of the trends in ADR reporting to the Yellow Card scheme. Please be aware the 2020 CHM annual report is currently being finalised and will soon be published.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.

Yours sincerely,

FOI Team,

Vigilance and Risk Management of Medicines Division