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About the Biobank

The Yellow Card Biobank is a collaboration between the MHRA and Genomics England. The goal is to improve understanding of how a patients genetic makeup may increase their risk of experiencing harmful side effects to medicines.

Adverse drug reactions, or side effects, continue to be a significant burden on the NHS and account for one in 6 hospital admissions.^{[footnote 1]} The Yellow Card Biobank forms part of a long-term vision for more personalised medicine approaches. By collecting biological 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. Ultimately it is hoped this would support the development of pharmacogenetic testing strategies.

If a patient under your care has experienced one of the side effects included in the pilot phase of the study, please report without delay to the Yellow Card scheme, providing as much information as possible.

Study details

Side effects covered in this pilot study are:

• severe bleeding events with a DOAC - apixaban, dabigatran, edoxaban, rivaroxaban see Drug Safety Update for a reminder on this risk
• rare severe skin reactions with allopurinol, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome

Once reported, the MHRA 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 study. The patient will be able to choose whether or not to take part. Having consented to participate the patient may then be asked to provide a blood sample for genetic analysis.

If you have already submitted a Yellow Card report in the past relating to either of the 2 study topics, we may also contact you directly in the coming months to discuss the case further.

Patients who report directly to Yellow Card will also be contacted to be included in the study.

How the biobank works

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 Englands secure research environment will enable approved researchers to access the data.

All the information collected about you and patients through Yellow Card Biobank will be de-identified before researchers see it. Details of our privacy policy can be found in the Biobank Privacy Policy.

If you have any questions about the biobank, you can email Yellowcardbiobank@mhra.gov.uk or call 0203 080 6600 (lines are open Monday-Friday, 9am-12pm excluding bank holidays. Calls are charged at the standard rate). For general queries or more information, contact info@mhra.gov.uk

Article citation: Drug Safety Update volume 18, issue 1: August 2024: 1.

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