A biobank scheme will be piloted in England to study links between patients' genomes and their risk of adverse drug reactions.
The Yellow Card Biobank, set up by the Medicines and Healthcare Products Regulatory Agency (MHRA) and Genomics England, aims to create a new resource to understand why people have reactions to certain medicines, and facilitate drug safety research. Adverse drug reactions currently cause one in every 16 NHS hospital admissions.
MHRA chief executive Dr Dame June Rhaine said: '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'.
From September, samples from volunteers who have experienced side effects will be collected and used to sequence their genomes. This information will be used to create a genetic database, allowing for the study of the relationship between adverse drug reactions and specific genetic variants.
The project will focus initially on two related conditions that can occur in patients taking allopurinol, a treatment for gout and kidney conditions. Small numbers of patients develop severe skin reactions, known as Steven-Johnson's syndrome or toxic epidermal necrolysis, which are potentially life-threatening. These conditions are very rare, affecting only one to two people per million, making the link between genetics and these drug reactions difficult to study.
The project builds on the MHRA's Yellow Card website, which facilitates reporting of adverse reactions to drugs and medical devices. By collecting large amounts of genetic data from a variety of patients, the biobank is 'part of a long-term vision for more personalised medicine approaches'.
The biobank will also help to develop pharmacogenetic testing strategies. By identifying genes associated with severe drug reactions, the genetic database will inform the development of future screening programmes and tests to predict if a patient is at high risk of adverse drug reactions before starting treatment.
Professor Matt Brown, chief scientific officer for Genomics England said: 'We hope that this is the first step towards redefining the future of drug safety'.
Future areas of focus for the Yellow Card Biobank project will be announced later.
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