Biobank
About Yellow Card Biobank
The Yellow Card Biobank is a collaboration between the Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England. Its goal is to improve understanding of how a patient’s genetic makeup may increase their risk of harm from side effects of medications. The Biobank is currently recruiting patients who have experienced side effects from specific medicines for a research project called the Yellow Card Biobank study.
What’s involved in taking part
Report your potential side effect by filling in a Yellow Card providing your contact details and selecting “Yes” to being contacted by the Biobank team
Get invited if you meet the study criteria you will be invited to join the Biobank study by your preferred contact method
Read Patient Information and Sign a Consent form. You will be asked to read some information about the Yellow Card Biobank and confirm you agree to take part in the study online, or by post if you prefer. This should take about 10-15 mins
Fill in a questionnaire about you and your health. This should take about 15-20 mins
Provide a saliva sample using a kit posted to your home
If you have reported a Yellow Card in the past you may be contacted.
Visit our Resources Page to access our videos with subtitles in Hindi, Mandarin, Urdu, Bengali, and Welsh.
The side effects we are studying
The initial phase of the project concentrates on two medicines:
GLP-1 medicines prescribed to support weight loss and diabetes management, alongside other indications.
Direct Oral Anticoagulants (rivaroxaban, dabigatran, apixaban, and edoxaban), commonly used blood thinners to prevent strokes.
GLP-1 medicines have a rare potential side effect of acute pancreatitis (inflamed pancreas). The Yellow Card Biobank is investigating whether the risk of acute pancreatitis from GLP-1 injections for weight loss and Type 2 diabetes may be influenced by an individual’s genes. Find more information about this topic here. See our press release for more information.
Direct Oral Anticoagulants have been linked to severe bleeding, which can be potentially serious and life threatening. The Yellow Card Biobank is exploring whether some people are at a higher risk of severe bleeding due to their genetic makeup, with the overall aim of reducing the occurrence of serious side effects. See our press release for more information.
How to get involved
If you are a patient who has experienced:
Acute pancreatitis while taking GLP-1 medicines
Severe bleeding after taking a direct oral anticoagulant
You can help by submitting a Yellow Card report using the Yellow Card website providing as much information as possible about your side effect, and selecting “Yes” when asked whether you wish to receive information about the Biobank. Your report will be reviewed by our team and if it meets the eligibility criteria we may invite you to take part using your preferred contact method. The invitation will provide you with more information on what taking part means and next steps.
If you are a healthcare professional you can help by submitting a Yellow Card report using the Yellow Card website, providing as much information as possible about the patient’s side effect. We may contact you directly to discuss the case further and may ask you to contact the patient on our behalf to ask if they will participate in the Yellow Card Biobank. It will be the patient’s choice whether or not to take part in the Biobank.
If you have already submitted a Yellow Card report in the past we may also contact you.
Why the Biobank is important
Adverse Drug Reactions (ADRs), or side effects, continue to be a significant burden on the NHS and account for 1 in 6 hospital admissions. The Biobank forms part of a long-term vision for more personalised medicine approaches; understanding the underlying mechanism of an adverse reaction would support the development of pharmacogenetic testing strategies prior to a doctor prescribing a medicine, so patients across the UK will receive the safest medication for them, based on their genetic makeup.
Other topics we are working on
We have closed recruitment for patients taking Allopurinol and experiencing a severe skin reaction, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome. The Yellow Card Biobank hopes to confirm existing genetic links between Allopurinol and severe skin reactions, which will help healthcare professionals make safer and more effective prescribing decisions in the future. See our press release for more information.
How the project works
The MHRA are responsible for patient recruitment and sample collection. Genomics England will work alongside the MHRA to sequence and analyse genomes from patients and add this genomic data to the National Genomic Research Library, a secure national database of de-identified genomic and health data. In addition, Genomics England’s research environment will enable approved researchers to access the data.
In the video below our Chief Safety Officer explains more about the Yellow Card Biobank.
How we will protect your data
At the Yellow Card Biobank, data security is our highest priority. We use industry-standard tools and techniques to prevent any unauthorised access and regularly undertake security tests. To find out more about your rights, how we protect and use your data please go to our Biobank privacy policy.
Contact us
If you would like more information about the Yellow Card Biobank, please email us and one of our team will be in touch as soon as possible: yellowcardbiobank@mhra.gov.uk
Dr Alison Cave, MHRA Chief Safety Officer, said:
“Evidence shows that almost a third of side effects to medicines could be prevented with the introduction of genetic testing. It is predicted that adverse drug reactions cost the NHS more than £2.2 billion a year in hospital stays alone.
Information from the Yellow Card Biobank will help us to better predict those most at risk of adverse reactions - enabling patients across the UK to receive the safest medicine for them, based on their genetic makeup.”
Professor Matt Brown, Chief Scientific Officer for Genomics England, said:
“We are thrilled to embark on this transformative partnership with the MHRA, as we delve into the genomics of severe adverse drug reactions. Many of these reactions are influenced by underlying genetic risk factors, substantially heightening an individual’s vulnerability. By joining forces with the MHRA, we are poised to gain greater understanding of these genetic influences – discoveries that will be vital if we are to move to harness the power of genomics to proactively protect patients from these harms. Together, we hope that this is the first step towards redefining the future of drug safety.”