Freedom of Information request (FOI 22/1105)
Published 17 January 2024
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FOI 22/1105
6th December 2022
Dear
Reports to MHRA Yellow Card monitoring system
Thank you for your email dated 7 November 2022 where you highlighted a recent MHRA press release and asked whether it is MHRA policy to acknowledge receipt of individual Yellow Card reports received and to convey the outcome of our investigation to the individual who submitted the report.
Upon submission of a Yellow Card report via the Yellow Card website, each reporter should receive an automated email confirming receipt of their submission which contains their unique Yellow Card reference number.
Reporters of Yellow Cards do not receive further correspondence regarding the outcome of any MHRA investigation into their Yellow Card report. Yellow Card reports are not assessed on an individual basis and therefore the MHRA do not assign an outcome to individual Yellow Cards. After entry onto the database, Yellow Card reports are cumulatively assessed by a team of physicians, pharmacists and scientists, with expertise in assessing the benefits and risks of medicines. Further information on what the MHRA does with Yellow Cards can be found within this document.
The MHRA are continuously working to improve the feedback loop between ourselves and Yellow Card reporters. The Agency is transparent in the data we receive via the Yellow Card scheme, and we hope to build on this further in future by continuing our work with external organisations to improve our transparency and feedback on the Yellow Card scheme. interactive Drug Analysis Profiles (iDAPs) are available online and enable you to interact with the data received by the Yellow Card scheme so you can understand more about the types of reactions that have been reported, and at a high level about who experienced the side effects. Outputs of reporting also include emerging safety issues communicated to healthcare professionals through our monthly bulleting called Drug Safety Update. Case studies are also available on our website which demonstrate the importance of reporting to the Yellow Card scheme and how a single Yellow Card report submission can make a difference. The Yellow Card app is also available for download which allows users to create a watchlist for alerts to medicines of interest.
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: [email protected]. Please remember to quote the reference number above in any future communications.
Yours sincerely,
FOI Team,
Safety and Surveillance Group