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.
By collecting genetic samples from patients who have experienced suspected side effects, the Yellow Card Biobank aims to create a rich resource of genetic information that could help researchers to determine whether a suspected side effect was caused by a specific genetic trait.
In the video below our Chief Safety Officer explains that the Yellow Card Biobank study will help researchers to understand how a patient’s genetic makeup may increase their risk of harmful side effects from medications. A patient tells us why it’s so important to report on severe adverse reactions and the process involved.
The MHRA will be 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 secure research environment will enable approved researchers to access the data.
The initial phase of the project concentrates on two medicines:
Direct Oral Anticoagulants (rivaroxaban, dabigatran, apixaban, and edoxaban), which are commonly used blood thinners to prevent strokes.
Allopurinol, which is used to treat gout, kidney stones, and other types of kidney problems.
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.
Allopurinol has a known genetic link to the rare side effects of severe skin reactions, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome. The Yellow Card Biobank hopes to confirm existing 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 to get involved
If you are a patient who has experienced:
severe bleeding after taking a direct oral anticoagulant
a severe skin reaction (SJS, TEN or DRESS) after taking allopurinol
You can help by submitting a Yellow Card report using the Yellow Card website providing as much information as possible about your side effect. Your report will be reviewed by our team and if it meets the eligibility criteria we may send you a letter inviting you to take part. The letter 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 that patient’s choice to take part in the Biobank.
If you have already submitted a Yellow Card report in the past relating to either of the two topics, we may also contact you directly in the coming months to discuss the case further.
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.
What’s involved in taking part
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 via an online portal. This should take about 10-15 mins.
Fill in a questionnaire about yourself. Once you have signed up to the study using our online portal, you will immediately be asked to answer some questions about your background. This should take about 10-15 mins. Further questionnaires relating to health and well-being will be sent at a later time.
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.
Patient Advisory Group
We are looking for more people to join our Patient Advisory Group. This group is set up to hear your thoughts and feedback on the study, for more information on how to get involved with this group, please email: yellowcardbiobank@mhra.gov.uk
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 June Raine DBE, MHRA Chief Executive, said:
“We are excited by the upcoming launch of the Yellow Card Biobank, which demonstrates that we are at the absolute forefront of innovation in the field of drug safety monitoring. Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing. The Biobank will help us move towards our goal of personalised medicine - which, when achieved, means patients across the UK will receive the safest medicine for them, based on their genetic makeup. This has the potential to transform our safety monitoring activities – enabling us to meet a real need by using high-quality patient data to reduce side effects of medicines.”
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.”