FOI release

Freedom of Information request on yellow card reports submitted by the Cornwall Partnership NHS Foundation Trust (FOI 22/782)

Published 21 December 2023

FOI 22/782

12th July 2022

Dear

Thank you for your Freedom of Information (FOI) request dated 15 June 2022 where you requested the total number of Yellow Card reports that have been submitted by the Cornwall Partnership NHS Foundation Trust.

The below data is based on all spontaneous UK cases reported directly by healthcare professionals, from any one of the Community Hospitals registered on the Cornwall Partnership NHS Foundation Trust website here. The hospital postal code was used to extract the below data, please note that post code is not a mandatory field when submitting a Yellow Card 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 email or postal address, we cannot be certain that this includes all cases reported by staff within the Cornwall Partnership NHS Foundation Trust.

As requested, I can confirm that the MHRA has received a total of 121 direct, UK, spontaneous, suspected adverse drug reaction (ADR) reports from healthcare professionals from the Cornwall Partnership NHS Foundation Trust up to 04/07/2022. The search criteria has been based off of the postcodes of the 12 Community Hospitals and the Trust’s postcode. We have further provided a breakdown by number of reports received by years in the Table 1.

Report received by the MHRA (year)	Number of reports received
1991-1995	9
1996-2000	22
2001-2005	22
2006-2010	18
2011-2015	19
2016-2020	11
2021	20

Table 1: total number of reports received from Cornwall Partnership NHS Foundation Trust

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.

Please also note that 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,

Vigilance and Risk Management of Medicines Division