FOI release

Freedom of Information request (FOI 22/1114)

Published 17 January 2024

FOI 22/1114

8th December 2022

Dear

Thank you for your email dated 11th November 2022, where you asked for information on the following:

• The number of Yellow Cards reported from Croydon Health Services staff, the types of incident reported (i.e. meds adverse effect, medical devices issue etc), and if possible the numbers of different healthcare professional types reporting.

I can confirm that the Medicines and Healthcare products Regulatory Agency (MHRA) received 239 spontaneous suspected Adverse Drug Reaction (ADR) reports directly from healthcare professionals within NHS Croydon CCG in 2021. The majority of these reports are for COVID-19 vaccines (219). The MHRA received less than 5 device incident reports directly from NHS Croydon CCG in 2021. Where results include less than 5 reports we are unable to provide further details to ensure patient and reporter confidentiality.

When considering the above figure, it is important to note that healthcare professionals can submit Yellow Cards on behalf of themselves. Furthermore, a report can sometimes have more than one reporter as it may have been submitted by both a patient and their healthcare professional.

The tables below show the total number of reports received in 2021 (01/01/202021 – 31/12/2021 inclusive), broken down by reporter type and by the number of adverse reactions within each System Organ Class (SOC). Please note that a single Yellow Card report may contain more than one adverse drug reaction.

The MHRA uses the Medical Dictionary for regulatory Activities (MedDRA) to code adverse drug reactions in our database. MedDRA is a clinically validated international medical terminology used for Medicines Regulation. MedDRA groups related adverse drug reaction terms in a hierarchical structure and the ‘System Organ Class’ (SOC) (the highest level in MedDRA) groups together reactions that affect similar system/organ in the body.

Table 1. NHS Croydon CCG - Spontaneous ADR reports received in 2021 broken down by reporter type

Reporter qualification	Number of ADR reports
Hospital Pharmacist	5
Other Pharmacy Professional	8*
Hospital Nurse	10
Hospital Healthcare Professional	10
Radiographer	11
Healthcare assistant	14
Pharmacist	19
Hospital Doctor	20*
Community Pharmacist	28
GP	42
Other Healthcare Professional	51*

*Other Pharmacy Professional – includes pre-reg pharmacist, pharmacy assistant.

*Other Healthcare Professional – includes optometrist, paramedic, medical student, dentist.

*Hospital Doctor – includes physician

Table 2. NHS Croydon CCG - Spontaneous ADR reports received in 2021 broken down by System Organ Class (SOC)

Reaction SOC	Number of ADR reports
Blood disorders	14
Cardiac disorders	12
Ear disorders	6
Eye disorders	12
Gastrointestinal disorders	49
General disorders	97
Hepatic disorders	^
Immune system disorders	12
Infections	15
Injuries	^
Investigations	11
Metabolic disorders	^
Muscle & tissue disorders	47
Neoplasms	^
Nervous system disorders	98
Psychiatric disorders	8
Renal & urinary disorders	^
Reproductive disorders	9
Respiratory disorders	26
Skin disorders	55
Surgical & medical procedures	^
Vascular disorders	18

number of reports less than 5.

Please be aware that the above figures have been extracted based on the reporters’ postal address. Hence, the accuracy of this data relies on the address being correctly provided in the original Yellow Card. Please also note that it is not mandatory to provide a postal address when submitting a Yellow Card to the MHRA. Therefore, if this is not provided or if the reporter has only provided their email address, the report will not be included in these data. With this in mind, the data provided may not reflect the true incidence of reporting to the MHRA from Croydon CCG.

When considering the above spontaneous data, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the vaccine, medicine or device only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a vaccine, medicine or device, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. 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 or compare the safety profile of different vaccines, medicines or devices. ADR and Device incident reporting rates are influenced by the seriousness of adverse reactions, their ease of recognition, the extent of use of a particular medicine or device, and may be stimulated by promotion and publicity. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
• These data should not be published on the internet (internal or external) and should only be used for your own purposes to help encourage ADR reporting via the Yellow Card scheme.
• These data 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 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.

Yours sincerely,

FOI Team,

Safety and Surveillance