FOI release

Freedom of Information request (FOI 22/1054)

Published 17 January 2024

11th November 2022

FOI 22/1054

Dear

Thank you for your email dated 24th October 2022, where you requested data regarding the number of Yellow Card reports that have been submitted to the MHRA, from Torbay Hospital, over the past few years.

Further to your request, I am pleased to provide you with the below data which has been extracted from our system using the address ‘Torbay Hospital’ and the postal code ‘TQ2 7AA’. The data shows the total number of spontaneous suspected Adverse Drug Reaction (ADR) reports which have been received from Torbay Hospital from the start of 2019. The MHRA has received a total of 178 ADR reports between 01/01/2019 and 07/11/2022. It is important to note that address is an optional field when completing a Yellow Card report, so reporters may have only provided details such as email addresses when submitting a report, therefore the number of reports received could be higher.

Please see Table 1 which details the total number of ADR reports received from 2019, broken down by year of submission. We have also included Table 2 which demonstrates the number of ADR reports received respective to the reporter qualification. This has been broken down into various reporter groups. Please note that the field titled ‘other’ includes healthcare assistants, medical students and other healthcare professionals. It is also important to note that the qualification field is not always filled out accurately by the reporter.

Table 1. All direct UK spontaneous suspected ADR reports received from 01/01/2019 up to and including 07/11/2022 from Torbay Hospital, broken down by year.

Year of Submission	Number of Cases
2019	48
2020	35
2021	65
2022	31

Table 2. Direct UK spontaneous suspected ADR reports received 01/01/2019 up to and including 07/11/2022 from Torbay Hospital, broken down by reporter qualification.

Reporter Qualification	Number of Cases
Physician	66
Pharmacist	45
Nurse	24
Radiographer	23
Dentist	5
Hospital Healthcare Professional	5
Other	11

If you plan on sharing or publishing the data within this response more widely, please provide us with a copy beforehand so we can ensure correct interpretation.

Following your request, I also feel it would be apt to highlight some resources to encourage Yellow Card Reporting. Firstly, MedSafetyWeek which is an annual MHRA social media campaign and uses Drug Safety Update to ask healthcare professionals and organisations to support in raising awareness locally across your healthcare setting with your colleagues, patients, carers and stakeholders. This #MedSafetyWeek ran from 7th November to 13th November, and we advised people not to wait for someone else to report their suspicions. The annual #MedSafetyWeek forms part of an international effort to raise awareness about the importance of reporting suspected adverse reactions by national medicines regulatory authorities from 80 countries across the globe and their stakeholders. It is led by Uppsala Monitoring Centre (UMC), a World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. Please see the following link for further information: https://yellowcard.mhra.gov.uk/MedSafetyWeek.

Drug Safety Update outlines various things that healthcare professionals can do to support MedSafetyWeek and thus raising awareness of the scheme and encouraging reporting throughout the year, including:

• Don’t delay in reporting suspected adverse drug reactions to the Yellow Card scheme or via the Yellow Card app (download from the Apple App Store or Google Play Store)

• Report suspected reactions to COVID-19 vaccines and medicines to the Coronavirus Yellow Card reporting site or Yellow Card app

• Consider a discussion about common ‘side effects’ with your patient.

• Highlighting the importance of reading the product information that comes with the medicine – it lists possible reactions and advises them on what to do, including self-reporting side effects to the Yellow Card scheme.

• Discussing if any products display a black triangle (▼) highlighting that the medicinal product subject to additional monitoring and that all suspected adverse drug reactions to these products should be reported to the Yellow Card scheme to allow quick identification of new safety information.

• The purpose of the Yellow Card scheme being to monitor the safety of all healthcare products in the UK not just for adverse reactions associated with vaccines or medicines. Reports can also be made for blood factors and immunoglobulin products, herbal products or complementary therapies such as homeopathies, medical devices (including software, apps and artificial intelligence), and e-cigarettes including their refill containers (e-liquids).

Furthermore, although we encourage the use of electronic reporting via the Yellow Card website and app, there are also Yellow Card forms and various downloadable materials and resources available,

such as accredited e-learning modules and materials to help raise awareness locally. These can all be accessed via the Yellow Card Website.

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 Group