FOI release

Freedom of Information request on the Yellow Card reports submitted by healthcare professionals for the Northern Ireland commissioning groups (FOI 22/811)

Published 4 January 2024

FOI 22/811

27th July 2022

Dear

Thank you for your FOI request dated 29 June 2022 where you asked for data on the number of Yellow Card reports received from healthcare professionals for the Northern Ireland commissioning groups. As part of your FOI you requested further breakdown of the data into;

• Total number of reports over the last 5 years

• Reporter qualifications

• Seriousness of reports, including fatal reports

• Patient age breakdown

• Top reported suspect drugs and reaction

• Sources of reports

Following your request, we have provided the data for UK, spontaneous, suspected Adverse Drug Reaction (ADR) reports from healthcare professionals in Northern Ireland for all suspect drugs and vaccines, excluding COVID-19 vaccines from 2017 up to 18 July 2022. Where tables state data is for the year 2022, this is referring to 1 January 2022 to 18 July 2022. Please note that the accuracy of the data relies on the postcode being provided by the reporter, where reporters have only provided an email address and not a postal address these reports will not be included in the numbers provided below.

Regarding your request to additionally have the above breakdown for COVID-19 vaccines we are handling this request separately due to the volume of work required and will be providing data on the COVID-19 vaccines for all Yellow Card Centres in the same format when appropriate. The MHRA publish a summary of Yellow Card reporting for the coronavirus vaccines which can be found here: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting. Tables 1-5 within this publication contain details on suspected ADR reports received for each part of the UK.

When considering the Yellow Card data provided within this response, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by the drug or vaccine, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug 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 drug or vaccine. 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 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. For these reasons the above data should not be used as a basis for determining incidence of side effects. During assessment we take into account of the variable levels of reporting as part of our monitoring procedures.

Table 1: Total number of UK, spontaneous, suspected ADR reports received from healthcare professional reporters from Northern Ireland Primary Care Trusts per year, excluding COVID-19 vaccines.

Reporter Primary Care Trust	Year report received
2017	2018	2019	2020	2021	2022
Belfast Commissioning Group	81	115	135	76	59	82
Northern Commissioning Group	32	36	42	42	26	28
South Eastern Commissioning Group	16	26	24	13	9	13
Southern Commissioning Group	43	33	48	38	31	38
Western Commissioning Group	46	31	59	65	36	42

Table 2: Total number of UK, spontaneous, suspected ADR reports received from healthcare professional reporters from Northern Ireland Primary Care Trusts by year split by reporter qualification, excluding COVID-19 vaccines.

Reporter Primary Care Trust	Year report received
2017	2018	2019	2020	2021	2022
Community pharmacist	15	15	11	11	3	3
GP	33	25	25	16	3	8
Hospital doctor	58	61	47	39	18	31
Hospital healthcare professional	7	3	12	2	0	1
Hospital nurse	23	26	31	23	13	4
Hospital pharmacist	34	35	89	88	32	31
Midwife	2	1	3	3	5	1
Nurse	11	20	7	7	25	19
Pharmacist	12	15	48	24	32	75
Physician	1	0	1	0	0	1
Other healthcare professional*	24	41	35	21	31	29

*Other Healthcare Professionals include Chiropodists, Coroner, Dentists, Healthcare Assistants, Medical Students, Optometrists, Other Healthcare Professionals, Paramedic, Pharmacy Assistant, Pre-reg Pharmacist, Radiographer

The following data in Table 3 is related to seriousness. A suspected ADR report is considered ‘serious’ according to two criteria; firstly, whether the original reporter considers the report to be serious. The seriousness criteria for ADR reporting were determined by a working group of the Council for International Organizations of Medical Sciences (CIOMS) and are defined as 6 possible categories which are documented on the Yellow Card. Reporters are asked to select one of the following criteria by ticking the appropriate box on the Yellow Card. The criteria are: (1) patient died due to reaction (2) life threatening (3) resulted in hospitalisation or prolonged inpatient hospitalisation (4) congenital abnormality and (5) involved persistent or significant disability or incapacity or (6) if the reaction was deemed medically significant. In addition to this, seriousness of reaction terms has also been defined by the MHRA in our medical dictionary. Therefore, an ADR report can be serious because the reporter considers the reaction to be serious or because the reaction term itself is considered serious in our medical dictionary.

Table 3: Total number of UK, spontaneous, suspected ADR reports received from healthcare professional reporters from Northern Ireland Primary Care Trusts by year split by seriousness, excluding COVID-19 vaccines.

Reported severity	Year report received
2017	2018	2019	2020	2021	2022
Non-serious	111	131	158	153	97	122
Serious	108	110	149	81	64	81
Fatal**	6	9	5	6	2	1

**Fatal reports are automatically classified as a serious report and therefore will also be included in the count for serious reports.

Table 4: Total number of UK, spontaneous, suspected ADR reports received from healthcare professional reporters from Northern Ireland Primary Care Trusts by year split by patient age group, excluding COVID-19 vaccines.

Age Group	Year report received
2017	2018	2019	2020	2021	2022
Under 18	32	39	30	25	8	24
18-24	12	10	14	15	14	5
25-34	19	14	30	21	13	14
35-44	18	27	36	27	28	23
45-54	33	32	45	34	22	22
55-64	37	38	50	32	18	14
65-74	31	42	55	33	22	17
75-84	19	25	25	13	18	13
over 85	9	7	8	11	5	3
No age	9	7	14	23	13	68

Please note that table 5 provides the suspect drug name as reported. This field allows the input of both a specific brand name, or the substance name if the brand is unknown. Therefore, the list will include brand names and substance names interchangeably.

Table 5: Top 10 reported suspect drugs of UK, spontaneous, suspected ADR reports received from healthcare professional reporters from Northern Ireland Primary Care Trusts, excluding COVID-19 vaccines.

Suspect drug name as classified	Number of reports
Omnipaque	84
Imraldi	53
Monofer	38
Apixaban	24
Adalimumab	20
Bexsero	20
Kaftrio	19
Dupilimab	15
influenza virus	15
Sofrovimab	15

Table 6: Top 10 reported suspect ADRs of UK, spontaneous, suspected ADR reports received from healthcare professional reporters from Northern Ireland Primary Care Trusts, excluding COVID-19 vaccines.

Reaction (PT)	Number of reports
Rash	89
Urticaria	75
Nausea	71
Dyspnoea	56
Headache	53
Vomiting	52
Pruritus	51
Anaphylactic reaction	39
Product substitution issue	38
Erythema	36

Table 7: Total number of UK, spontaneous, suspected ADR reports received from healthcare professional reporters from Northern Ireland Primary Care Trusts by year split by report source, excluding COVID-19 vaccines.

Reported Source	Year report received
2017	2018	2019	2020	2021	2022
App	0	0	0	0	10	12
EYC	166	175	249	206	133	180
MiDataBank	1	10	5	9	5	3
Paper	52	56	53	19	13	8

Please note that if you plan on sharing this data more widely, or publishing this data, please can you provide us with a copy prior to publication to ensure the correct interpretation and confidentiality of the data provided.

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