Freedom of Information request on how many reports made to the Yellow Card Scheme are excluded from the published information (FOI 21/1292)
Published 31 May 2022
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FOI 21/1292
22nd December 2021
Dear,
Thank you for your email dated 07 December 2021 where you requested the following:
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How many reports made to the Yellow Card Scheme are excluded from the published information? Please can this be broken down by year over the last 5 years.
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What are the criteria to exclude these reports?
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What is the process for excluding reports?
As you are aware the MHRA receives reports of suspected adverse drug reactions to medicines and vaccines via the Yellow Card Scheme. In order to accept a report as valid on our database, a minimum level of information is required. These include an identifiable reporter, at least one patient identifier, an adverse reaction and a suspect medication or vaccine. The minimum level of patient information required to make a report valid would be a patient identifier such as age, age group, sex, initials, patient reference number, height, weight, or date of birth. All reports that meet this minimum level of information are included in any published data by the MHRA. No valid reports are removed from the published data; therefore, we are unable to provide a breakdown of excluded reports over the last 5 years.
When capturing the details contained within the Yellow Card reports the Agency uses a database which is dynamic, therefore there may be fluctuations in the number of reports due to duplicate cases being identified. For instance, where a report has been submitted for the same patient twice, for example when there has been a submission by the patient’s GP and their hospital doctor, these will then be merged into one report to avoid duplication. Reports are also reclassified when inaccuracies are noted or when updated information has been received by the reporter. These updates are necessary to ensure the accuracy of the reports on our database and ensures the reports received match what has been reported to the MHRA. These instances can account for fluctuations of numbers in the overall Yellow Card data.
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: info@mhra.gov.uk. Please remember to quote the reference number above in any future communications.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division