FOI release

Freedom of Information request on information regarding the population of the UK that actively uses the Yellow Card reporting service (FOI 21-345)

Published 28 June 2021

4th May 2021 FOI 21/345

Thank you for your FOI request dated 2nd April 2021, whereby you requested information regarding the population of the UK that actively uses the Yellow Card reporting service.

Overall ADR reporting rates are variable and are influenced by several factors such as 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. It is important to note that Yellow Card data cannot be used to derive ADR rates or compare the safety profile of drugs or vaccines. During assessment we take into account of the variable levels of reporting as part of our monitoring procedures.

We have in place a Yellow Card strategy that works to increase awareness, actively promote and make reporting to the scheme more accessible for everyone. More information about the Yellow Card scheme and the campaigns we have run can be found via the Yellow Card website.

Specifically for Covid-19 vaccines, suspected side effects can be reported via the dedicated Coronavirus Yellow Card reporting site or through the Yellow Card app. 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 which are also available on-line. We have also optimised website search functionality and worked with media outlets to encourage them to carry messages about reporting of side effects. Additionally, we are currently running a targeted social media campaign in the coming weeks and would encourage anyone seeing this who has not already done so to report through the Coronavirus Yellow Card site.

The Coronavirus Yellow Card site has been designed to enable both self-reporting, and for people to report on behalf of others. Where people do not have access to the internet, they can request a family member or carer to report on their behalf, or alternatively discuss their experience with a healthcare professional, who can report for them.

For more information on our approach to use of Yellow Card data during COVID-19 vaccine safety surveillance please refer to our Covid-19 surveillance strategy which can be accessed in the ‘Report of the Commission on Human Medicines Expert Working Group on Covid-19 vaccine safety surveillance’.

We are working with public health bodies and encouraging all healthcare professionals and patients alike to report any suspected ADRs to the Yellow Card scheme. The MHRA has also worked with its partners within the health system, such as devolved administrations, NHS, Public Health England, JCVI and the National Immunisation Service so that planned Covid-19 vaccination programme communications included information about the Yellow Card scheme. The MHRA also has a strong strategic focus in facilitating electronic reporting and making reporting more accessible for patients through the app and time efficient for healthcare professionals by integrating Yellow Card reporting into clinical IT systems. The MHRA also commissions five regional Yellow Card Centres (YCCs) to support the education and promotion of Yellow Card reporting in their region, including reporting for Covid-19 treatments and vaccines. They are involved in various programmes which improve ADR reporting, including the establishment of nominated hospital pharmacists or pharmacy technicians as ‘Yellow Card Champions’. YCCs also work with devolved administrations and local healthcare professional bodies as well as local patient organisations to increase awareness and education about the importance of Yellow Card reporting for patient safety.

Yours sincerely, FOI Team Vigilance and Risk Management of Medicines Di