Freedom of Information request on the yellow card reports within Northern Ireland between September to December 2019, and September to December 2021 (FOI 22/043)
Published 31 May 2022
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FOI 22/043
9th February 2022
Dear
Thank you for your email dated 12th January 2022, where you requested information on:
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The total number of Yellow Card reports received within Northern Ireland between September to December 2019 and September to December 2021.
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A breakdown of reporting figures for the time periods above, for Northern Ireland overall, the Belfast Trust and primary care with a breakdown of reporter type.
When considering the spontaneous Adverse Drug Reaction (ADR) data provided within this response, it is important to be aware of the following points:
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The fact that symptoms or events occur after use of a medicine or vaccine, and are reported via the Yellow Card Scheme, does not in itself mean that they are proven to have been caused by the medicine or vaccine. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.
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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 drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
Please find Table 1 below for the total number of spontaneous suspected Yellow Card reports reported within Northern Ireland within the two time periods requested.
Table 1 - Total number of spontaneous suspected Yellow Card reported within Northern Ireland from 01/09/2019 – 31/12/2019 and 01/09/2021 – 31/12/2021
| Time Period | Number of Yellow Card reports | Number of COVID-19 reports |
|---|---|---|
| 01/09/2019 - 31/12/2019 | 166 | - |
| 01/09/2021 - 31/12/2021 | 92 | 920 |
Please find enclosed data for the total number of Yellow Card reports for all medicines and vaccines reported within the Northern Ireland Health and Social Care Board (HSCB) (Table 2), and the Belfast Local Commissioning Group (LCG) (Table 3) broken down by the reporter type between 01/09/2019 and 31/12/2019 and between 01/09/2021 and 31/12/2021.
You also expressed interest in particular reporter types in the Belfast Trust; Table 3 provides a breakdown of the available reporter types however physiotherapist and optometrists are not currently available as individual reporter types. Instead they would be classed as ‘other healthcare professional’ or ‘hospital healthcare professional’. Furthermore, we currently do not have options for practice based pharmacists, GP pharmacists or non-medical prescribers. We are constantly looking for ways to improve our reporting system and will look to expand the available reporter options to be more diverse and include more specific options as per your interest.
The NI HSCB covers all of the LCG’s within NI, including Belfast LCG, Northern LCG, South Eastern LCG, Southern LCG and Western LCG. Belfast LCG covers the same geographical area as the Belfast Health and Social Care Trust, details of all the facilities and hospitals the Trust covers can be found on their website here. You can find more information regarding the Belfast LCG here.
It is important to note that this search was conducted based on the reporter postal address. Postal address is not a mandatory field when submitting a Yellow Card report for a medicine or vaccine. Therefore, the data provided may not be a true reflection of the number of Yellow Card reports submitted from Northern Ireland.
The MHRA continuously monitors the safety of medicines and vaccines through a variety of pharmacovigilance processes including the Yellow Card Scheme. As part of our signal detection processes all adverse reaction reports received by the Yellow Card Scheme are individually assessed and cumulative information reviewed at regular intervals.
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,
Vigilance and Risk Management of Medicines Division