Freedom of Information request on COVID-19 vaccination and the Yellow Card reporting scheme (FOI 21/946)
Published 25 February 2022
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10th September 2021
FOI 21/946
Dear
Thank you for your email dated 17th August 2021, where you requested information regarding the COVID vaccination and the Yellow Card reporting scheme.
6.Have all hospitals / GP’s / NHS trusts been informed of the yellow card reporting scheme?
7.If so, how was this carried out and when?
The MHRA recognises the importance of accessing the scheme and has a strong focus on technology for a wide variety or reporting mechanisms, for both healthcare professionals as well as for patients. One of the ways the Agency achieves this is by continually integrating Yellow Card reporting into clinical IT systems to make it easier to report and to drive reporting rates up. Currently, Yellow Cards integration is in 93 % of all GP clinical systems enabling the reporting of suspected adverse drug reactions directly to the MHRA from their systems. There is a data exchange also between NHS England and Improvement which send any suspected ADR related data to the MHRA for triage.
Alongside reporting in General Practice, there is also integration of Yellow Card reporting that is embedded into various clinical systems used by hospitals, Mental Health services, care homes and all UK prisons. This ensures that the clinical systems benefit from the integrated Yellow Card reporting from within the system have access to this method of submitting Yellow Cards directly.
Integration makes it easy to complete and send a Yellow Card because much of the information needed can be automatically populated from patient records. At the same time, electronic reporting provides a secure, fast, and convenient method for submitting information about suspected adverse drug reactions (ADRs) to the MHRA.
Another is the development of the Yellow Card app that is accessible to anyone to report suspected adverse drug reactions, being integrated into the NHS app. The app can also be used to access the latest safety information from the MHRA about medicines and medical devices on the Newsfeed. Search for medicines to see details of Yellow Card reports others have made. Medicines of interest can also be added to a Watch List to receive news and alerts about new side effects and safety advice as it emerges. Any emerging news of medicines information is also communicated, as necessary, through our alerts and via MHRA’s bulletin Drug Safety Update to healthcare professionals, also accessible via the app for patients.
Moreover, the Agency regularly conducts campaigns for the public, such as the annual ADR awareness week (#medsafetyweek) on social media that took place in November 2020, ensuring every year there is a different focus and theme. This year the #MedSafetyWeek will take place on the first week of November 2021, with a focus on vaccines and reporting side effects. For more information on campaign work please see here. This is supported by our five regional Yellow Card Centres that are commissioned to locally educate healthcare professionals and patient organisations.
With specific reference to awareness of reporting side effects in association with medicines, vaccines and incidents involving medical equipment relating to COVID-19 treatment the MHRA launched a new online reporting site, dedicated to reporting any suspected side effects. In addition to social media campaigns, we have issued a Drug Safety Update and a press release informing healthcare professionals and members of the public that reporting to the Coronavirus Yellow Card reporting site will enable the MHRA to rapidly identify new and emerging side effects. The general public and healthcare professionals have also been encouraged to report any suspected side effects to the vaccine to the MHRA via a Yellow Card on the televised press briefings.
The leaflets provided to UK recipients of the COVID-19 vaccines contain information on how suspected side effects can be reported to the MHRA and encourages reporting of any side effects of concern through the Yellow Card scheme. Information on Yellow Card reporting has been included in NHS training materials, as well as the materials available to individuals both before and after vaccination. Both vaccine recipients and healthcare professionals are strongly encouraged to report any suspicion of a side effect to the MHRA.
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