FOI release

Freedom of Information request (FOI 22/1096 and FOI 22/1097)

Published 17 January 2024

2nd December 2022

FOI 22/1096 and FOI 22/1097

Dear ,

Thank you for your Freedom of Information (FOI) requests dated 3rd November 2022 where you requested the number of adverse event reports submitted by psychiatrists and psychologists in 2019, 2020 and 2021.

When considering the below spontaneous adverse drug reaction (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 suspect drug, only that the reporter had a suspicion it may have been. When any medicine is given to patients, some recipients will inevitably experience illness following its use. The fact that symptoms occur after use of a vaccine or medicine, 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. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular vaccine, and may be stimulated by promotion and publicity about a 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. For these reasons the enclosed data should not be used as a basis for determining incidence of side effects.

Please kindly see the below Table 1 for the number of adverse event reports submitted by psychiatrists or psychologists in 2019, 2020 and 2021.

When submitting a Yellow Card, it is mandatory for healthcare professional reporters to select their healthcare profession from a list of values. The MHRA uses standard qualifications set by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Unfortunately, the set does not include the granular detail of psychologist or psychiatrist and so, any psychologist or psychiatrists reporting will fall within one of the available groups depending on where they are based and what they selected when reporting.

Reporters are able to provide further details on their speciality when reporting to the Yellow Card scheme, but please note that this is not mandatory. This information is collected in a free text field and therefore entries within that field may vary between reports. For the purpose of this response, we have provided reports where the reporter has specified their speciality has been reported as a ‘Psychiatrist’ or ‘Psychologist’.

The MHRA may have received further reports from psychiatrists or psychologists who did not specify this further detail within their submission, and as such these reports will not be included within this response. Cases which do not match the pattern of text used in the search above will also not be included within this response.

Table 1: Total number of UK spontaneous suspected ADR reports submitted by reporters which list their specialty as psychiatrist or psychologist

Year	Number of adverse event reports submitted by psychiatrists or psychologists
2019	15
2020	5
2021	*

• Where less than 5 reports have been received, an asterisk has been used to conceal this number in order to comply with data protection laws and protect patient/reporter confidentiality.

We 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

Medicines and Healthcare products Regulatory Agency