Pharmacogenetics Roll Out – Gauging Response to Service (PROGRESS) programme looks to establish the feasibility of providing an NHS-wide diagnostic service to identify genetic changes associated with commonly prescribed drugs.
Medicines are the most common therapeutic intervention in healthcare, yet the efficacy and safety of many drugs show considerable interpersonal variation. Some patients have been prescribed medication that does not work well, whereas others develop reactions to their medicines. Sub-optimal medicines use is a globally important problem that costs lives and large sums of money. This project will
- develop and validate an initial genetic test for NHS use
- develop a system to translate the laboratory findings into prescribing advice for use in primary care (GPs)
- work with a small number of GPs across the North West to test the system
- investigate the healthcare economics and implementation strategy to ensure the test is affordable for the NHSE and the way it can be adopted
- work with patient groups across England to understand how patients feel about this type of testing
The NW Clinical Lead for this project is Professor Bill Newman, Manchester University NHS Foundation Trust
The Pharmacogenetics Roll Out – Gauging Response to Service [PROGRESS] programmee is an NHS England (NHS-E) Funded transformation project led by researchers at the NHS Manchester University NHS Foundation Trust (MFT) and the NHS NW Genomic Medicine Service Alliance (NWGMSA), to investigate the feasibility of delivering pre-emptive pharmacogenetic panel testing in primary care in the NHS
It has been split into three distinct work packages, each of which deals with a different aspect of the programme.
Pharmacogenetics describes how we can leverage the knowledge of an individual’s genetic information to support medicines optimisation, better-informing medicine selection, and dosing.
Work Package 1 has focussed on the validation of the pharmacogenetic testing technology, involving a lab scientist at the NHS NW Genomic Laboratory Hub (NWGLH) assessing a number of commercially available pharmacogenetic panels to determine the appropriate choice for the clinical trial, based on factors including the robustness of testing, cost and turnaround time.
In Work Package 2 we have worked with health informaticians and digital experts to run a series of workshops with primary care doctors and pharmacists to develop an informatic solution that can communicate the results of the pharmacogenetic testing from the NWGLH to the primary care team. Initially, this will be through a standalone interface that will need to be logged in to, when informed that patients’ results are back, but later we aim to deliver that result directly into the EPR system used in the practice, e.g., EMIS or System One.
Work Package 3 is the PROGRESS Clinical Trial, a portfolio-adopted study, which will test the feasibility of delivering these pharmacogenetic results for real patients in primary care in the NHS and provide genotype-guided prescribing. Phase 1 of the PROGRESS Clinical Trial will initially begin at five primary care networks (PCNs) in the North West of England. Recruitment started in Summer 2023.
Patients who are being seen for a new prescription of one of the following classes of medicines will be invited to participate in the study: selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), statins or proton pump inhibitors (PPIs). They would then provide a blood sample which is sent to the NWGLH for testing and the results will be returned to the primary care team in 7 to 10 working days. The patient’s own primary care team will then be able to incorporate this guidance to inform the patient’s prescription.
For example, the patient may have attended with low mood and a prescription of citalopram was considered. If their pharmacogenetic results show that they are a CYP2C19 ultrarapid metabolsior, the system would recommend an alternative antidepressant which is more likely to be efficacious.
This will generate some useful evidence around the feasibility of delivery in primary care and the aim is to scale during 2023 to an extended national pilot with additional practices from other GMSA regions across England. Ultimately this will feed into national commissioning decisions about how we implement pharmacogenetics in the NHS
What does PROGRESS mean for patients?
We know that medicines are not always effective for many patients, or that some patients may experience harmful side effects while others do not. This can be due to several factors but one reason can be because of differences in our DNA, known as genetic variation. Pharmacogenetics is the study of how a person’s genes affect their response to medicines. PROGRESS is the first study to focus on how to deliver a pharmacogenetics service within the NHS. In practice, this means that a patient on the study will undergo a simple blood or saliva test when they see their GP before being prescribed a new medicine. Once the results are available, the GP or pharmacist at the surgery will be able to access bespoke prescribing recommendations so that any treatment is tailored to the person’s individual genetic profile. Importantly, the test only needs to be done once in a patient’s lifetime and the results will be available for healthcare professionals to help decide the best medicines for them now, and in the future.
Patients who take part in the study will play a hugely important role in shaping the future of healthcare in the NHS. If the study is successful, it could mean that pharmacogenetics will become a normal part of NHS healthcare, leading to improved safety and effectiveness of many commonly prescribed medicines.
The PROGRESS study signifies a paradigm shift in how we make prescribing decisions and treat patients with medicines, to create a system that makes pharmacogenetics a normal part of healthcare. The availability of this information will represent another tool to support medicines optimisation.
Pharmacy professionals, as experts in medicines, will be critical to making this a success and will have a wide range of key roles to play. Those who are involved with the study itself can identify patients for inclusion, for example through routine medication reviews. Practice pharmacists may also be the nominated healthcare professional who is notified of the genetic test results and to action any changes to the prescription. Similarly, they may expect to support clinicians and other practitioners with interpreting the results in the context of an individual patient, advising on prescribing decisions, monitoring requirements, or alternative treatments.
Looking to the future, if pre-emptive panel testing becomes adopted into routine healthcare across the NHS, results will need to be saved in patient medical records so that they will be available for use for prescribing decisions across all healthcare settings. These results will also need to be in a clinically relevant format for healthcare professionals to use without the need for specialist training. Pharmacists will need to be able to incorporate pharmacogenetic information that may have been requested months or years previously, for a new clinical scenario. Providing appropriate information and counselling patients about the rationale, benefits, and limitations of testing and any impact on their current or future treatment will also be a key role for pharmacy staff, who are already well-versed in talking to people about their medicines.
This will undoubtedly represent a significant change in practice, but one which all pharmacy professionals should be well placed to adopt and deliver with confidence.
A Frequently asked questions (FAQ) document has been developed by the project team and is available via NHS Futures.
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The DEVOTE Programme is a collaboration between industry, universities, and healthcare professionals, in support of the development and implementation of time-critical genomic testing technologies. The programme links with PROGRESS, in relation to identifying how pharmacogenetics can be used to improve patient outcomes when they need treatment with common medicines like anti-depressants and statins.
Significant funding has been secured which builds on the successful PALOH study where Professor Bill Newman and colleagues, working in collaboration with Genedrive, showed that point-of-care genetic testing could be used in neonatal units to prevent babies from losing their hearing.