Freedom of Information request (FOI 22/923)
Published 17 January 2024
© Crown copyright 2024
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-19-september-2022/freedom-of-information-request-foi-22923
FOI 22/923
20th September 2022
Dear
Thank you of your email dated 21st August 2022, where you requested the number of direct Yellow Card reports received from 6th October 2021 to date, by the four reporter groups: patients, doctors, nurses, pharmacists. The information you have requested can be found in Table 1 below.
As you may be aware the Yellow Card Scheme is the UK system for collecting and monitoring information on suspected Adverse Drug Reactions (ADRs). The Scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and currently relies on voluntary reporting of suspected ADRs by health professionals and patients. There is also a legal obligation for pharmaceutical companies to report serious ADRs associated with their products to the MHRA. The purpose of the Scheme is to provide an early warning that the safety of a product may require further investigation.
Table 1. Summary of the number of direct Yellow Card reports received between 06.10.2021 – 15.09.2022 for patients, doctors, nurses, and pharmacists.
| Reporter qualification | Number of direct reports |
|---|---|
| Patients | 86995 |
| Doctors | 11122 |
| Nurses | 4605 |
| Pharmacists | 6610 |
| Total | 109332 |
Please note that within each of the reporter categories you specified, there are multiple possible qualifications. The qualifications that have been considered for each reporter category are stated below:
-
Patients – patient, parent, carer, consumer or other non-health professional.
-
Doctors – hospital doctor, general practitioner (GP), physician, dentist.
-
Nurses – nurse, hospital nurse.
-
Pharmacists – pharmacist, community pharmacist, hospital pharmacist, pre-registration pharmacist, pharmacy assistant.
Please note that when you previously requested this information the data provided did not include Yellow Card reports pertaining to suspected side-effects following COVID-19 vaccination in order to prevent the possible identification of reporters. However, the data provided in table 1 relates to all directly reported Yellow Cards, including those where the report pertained to suspected side-effects following COVID-19 vaccination. Please consider this when reviewing the numbers.
Please also 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 to drugs for a number of reasons. ADR reporting rates may be influenced by the seriousness of reactions, their ease of recognition, extent of use of a particular drug or vaccine and promotion and publicity about a drug/vaccine. The fact that symptoms occur after a drug is given does not mean that they are caused by the drug itself as underlying or undiagnosed illnesses and other factors may be responsible.
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