LAUNCH OF INNOVATIVE GENETIC BIOBANK FOR DRUG SAFETY
The Medicines and Healthcare products Regulatory Agency (MHRA) is set to pioneer a ground- breaking initiative, becoming the world's first drug safety regulator to pilot its very own genetic ‘biobank’ on June 1 2023.
aimed at comprehending how an individual's genetic makeup can impact the safety of prescribed medications.
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Working alongside the existing Yellow Card reporting site for suspected side effects and adverse incidents related to medicines and medical devices, this biobank marks a significant stride towards personalized medicine. Scientists will utilize the genetic data repository within the biobank to discern whether a specific genetic trait caused a side effect from a medication.
Adverse Drug Reactions (ADRs) or side effects continue to impose a substantial burden on the NHS, accounting for one in 16 hospital admissions. Understanding the underlying mechanisms of these adverse reactions will support the development of pharmacogenetic testing strategies, ultimately preventing rather than reacting to adverse drug effects.
n partnership with Genomics England, the MHRA is introducing the Yellow Card biobank, a cutting-edge genetic research resource
It is hoped the research generated from this resource will enable development of interventions such as screening tests for patients that can be used by healthcare professionals to personalise medical treatment to individuals, according to their genetics.
For example, more information about how people with a certain genetic make-up have responded to medicines in the past, will enable healthcare professionals to prescribe the most effective and lowest risk medication to patients with similar genetics, and will allow patients at a low risk of harm to maintain access to medicines they need.
The biobank pilot launched on June 1, 2023, with participant recruitment commencing in September 2023. Genetic material sequencing of participants will commence in Spring 2024, and initial research findings are expected to be published in 2025. Genomics England will support the MHRA by managing the sequencing and storage of genetic material using their established and secure infrastructure.
The pilot phase will initially focus on the medicine allopurinol, used to treat gout, kidney stones and other types of kidney problems, and the related rare side effect of severe skin reactions, including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
Dr.June Raine DBE, MHRA Chief Executive expressed excitement about the Yellow Card biobank's launch emphasizing that genetic testing could prevent nearly a third of adverse reactions to medicines.
The biobank aligns with the long-term vision of personalized medicine, ensuring patients across the UK receive the safest and most effective medications based on their genetic profile.
The Yellow Card biobank is a visionary endeavour that holds tremendous potential for the future of drug safety, with its role in shaping personalized medicine approaches and enhancing patient care.
scottishpharmacist.com 29
GENETIC TESTING COULD PREVENT NEARLY A THIRD OF ADVERSE REACTIONS TO MEDICINES
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