FOI release

FOI 21/099 - FOI request - yellow card reports

Published 24 March 2021

Thank you for your FOI request dated 28th January 2021, whereby you requested the following information for the past 12 months:

1. How many ADR reports did the yellow card scheme receive?
2. Can you provide a breakdown of total ADR reports by degree of harm, ie, non-serious, serious and fatal?
3. Can you provide a breakdown of total ADR reports by reporter, ie, pharmacists, doctors, nurses, other healthcare professionals, and members of the public?
4. Can you provide a breakdown of total ADR reports by where the medicine was obtained, ie, on prescription, bought in a pharmacy, bought in another shop, via the internet, taken by mother during pregnancy?
5. What were the 10 most reported medicines?
6. In what proportion of yellow card reports did the reporter think the reaction occurred as a result of a mistake made in the prescription, dosing, dispensing or administration of the medication?
7. How many yellow card reports have been recorded for each of the COVID-19 vaccines currently in use in the UK.

When considering spontaneous suspected ADR 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 or vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the medicine or vaccine. 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. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. 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 data provided below and attached is for all UK spontaneous data, received between 01/01/2020-31/12/2020. I can confirm that the total number of ADR reports received by the MHRA in 2020 is 40924, of which 28118 were considered serious, 11241 were considered non-serious and 1565 were reported in association with a fatal outcome.

An ADR report is considered ‘serious’ according to two criteria; firstly, a reported reaction can be considered serious according to our medical dictionary. Secondly, whether the original reporter considers the report to be serious whereby they can select based on 6 criteria1.

As with any serious suspected ADR, reports with a fatal outcome are fully evaluated by the MHRA, including an assessment of post-mortem details if available, to consider whether the medicine may have caused the event, or whether the event and fatal outcome were likely to be purely coincidental and due to underlying illness. Any emerging evidence relating to possible risks associated with medicines and vaccines, would be carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.

Further to points 3, 5 and 6 of your request, please find tables 1-3 in the attached excel spreadsheet as requested.

With regards to point 4 of your request, unfortunately, we are unable to provide this data within this response due the way in which this information is collected and held on our database. It would involve manual review of each report, reading the free text that was reported and manually adding to a category. This would fall under the FOIA cost exemption (section 12).

Further to your request for Yellow Card data in relation to COVID-19 vaccines, I can confirm this is currently published and updated on a weekly basis. We have been proactively monitoring the safety of all approved COVID-19 vaccines for safety in near real-time monitoring at population level. Our adverse reaction assessment report alongside analysis prints showing the suspected reaction reported for each vaccine, can be found here:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions

I hope the information provided is helpful. The MHRA encourages the use of Yellow Card data however wishes to ensure that the data is studied and applied appropriately, and that any conclusions/interpretations take into account the above information. For this reason, if you wish to use this information for a publication, we request that you engage with the MHRA prior to publication and provide a copy of the report. Additionally, we would be interested to know the outcome of your information request, even if you do not use this data.

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

The MHRA information supplied in response to your request is subject to Crown copyright. The FOIA only entitles you to access to MHRA information. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information

If you have a query about this email, please contact us. If you are unhappy with our decision, you may ask for it to be reviewed. That review will be undertaken by a senior member of the Agency who has not previously been involved in your request. If you wish to pursue that option please write to the Communications Directorate, Medicines and Healthcare products Regulatory Agency, (via this email address). After that, if you remain dissatisfied, you may ask the Information Commissioner at:

The Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF

Copyright notice The information supplied in response to your request is the copyright of MHRA and/or a third party or parties and has been supplied for your personal use only. You may not sell, resell or otherwise use any information provided without prior agreement from the copyright holder.