FOI release

Freedom of Information request (FOI 22/930)

Published 17 January 2024

FOI 22/930

26th September 2022

Dear

Thank you for your Freedom of Information (FOI) request dated 26 August 2022 where you requested the number of Yellow Card reports that have been submitted by the East Kent Hospitals University NHS Foundation Trust.

The below data is based on all spontaneous, UK Yellow Cards reported directly from any one of the hospitals registered on the East Kent Hospitals University NHS Foundation Trust website here. The hospital postal codes and hospital names were used to extract the data, please note that post code and hospital name are not mandatory fields and therefore a report may have been submitted from your trust without this information. Additionally, as reporters may have submitted their report using their personal postal address, we cannot be certain that this includes all reports submitted from the East Kent Hospitals University NHS Foundation Trust.

As requested, I can confirm that the MHRA has received a total of 1260 direct, UK, spontaneous, suspected adverse drug reaction (ADR) reports from the East Kent Hospitals University NHS Foundation Trust up to 20/09/2022. We have further provided a breakdown by number of reports received per year in the last 10-year period for the entire East Kent Hospitals University NHS Foundation Trust in the Table 1.

Table 1: Number of Yellow Card reports received from East Kent Hospitals University NHS Foundation Trust per year from 2012 onwards. *2022 includes only reports received between 01/01/2022 and 20/09/2022.

Year	Number of reports received
2012	33
2013	45
2014	56
2015	65
2016	52
2017	23
2018	26
2019	59
2020	73
2021	130
2022*	29

It is 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 or vaccine and may be stimulated by promotion and publicity about a drug or vaccine. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

Furthermore, please note it is important to realise that a report of a suspected ADR does not necessarily mean the reaction has been caused by the drug, only that the reporter had a suspicion it may have. The fact that symptoms occur after a drug is given does not mean that they have been caused by the drug itself, as underlying illnesses and other conditions may be responsible.

When the Yellow Card scheme was established, one of the key principles defined was that it would not be used for audit purposes as health professionals should send Yellow Cards on a voluntary basis. Any data provided should not be used in any way to attempt to identify the original reporter of the Yellow Card nor should the data be used for disciplinary or audit purposes.

I hope this information is useful and would like to thank you for your support of the scheme. Please do not hesitate to contact me if I can be of any further assistance or you would like further data in subsequent quarters.

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,

Patient Safety Monitoring