Biobank

About Yellow Card Biobank

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 pilot.

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.

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.

Our vision

“We want genetic research into the causes of adverse drug reactions to become incorporated into Yellow Card reporting and for the evidence to be used to better minimise risk of side effects for patients.”

Aims and Objectives

1. To identify an effective way to create a Biobank within the Yellow Card system.

2. To provide researchers with access to genomic and clinical data so they can investigate how patients respond to medicines.

3. To investigate how a Yellow Card Biobank could operate in the long-term following completion of the pilot.

4. To include the views of the public, patients, healthcare professionals, and researchers in the development of the Yellow Card Biobank.

The initial phase of the project will concentrate on a medicine called Allopurinol, used to treat gout, kidney stones, and other types of kidney problems. 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. Confirming existing links between Allopurinol and adverse skin reactions, will help healthcare professionals make safer and more effective prescribing decisions in the future, see our press release for more information. More topics for the pilot phase will be confirmed soon.

How to get involved

If you submit a Yellow Card report concerning Allopurinol, it will go onto the Yellow Card scheme’s database for processing and analysis. Members of the Yellow Card Biobank team will then be able to identify this report in the database and check it against our inclusion criteria.

If you are a patient who has taken Allopurinol and experienced a severe skin reaction, you can help by submitting a Yellow Card report using the Yellow Card website. Please provide as much information as possible. Your report will be reviewed by our team and if it meets the eligibility criteria, we may contact you directly with more information.

If you are a healthcare professional and you have treated or know a patient who has experienced a severe skin reaction after taking Allopurinol, you can help by submitting a Yellow Card report using the Yellow Card website. Please provide as much information as possible. We may contact you directly to discuss the case further and may ask you to contact the patient to participate in the Yellow Card Biobank on our behalf. It will be that patient’s choice to take part in the Biobank.

Participant 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 pilot, for more information on how to get involved with this group, please email: 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.”

If you would like more information about Yellow Card Biobank recruitment, then you can email us and one of our team will be in touch as soon as possible: yellowcardbiobank@mhra.gov.uk