Clinical pharmacologists can help reach more patients with research through de-risking early phase studies in primary care and the community. Safety is paramount in first in human studies and clinical pharmacologists are qualified to be principal investigators on such trials. Investment in clinical pharmacology can also support a patient-centred, evidence-based approach to care - for example through managing multimorbidity, problematic polypharmacy and a personalised approach to the use of medicines.
The AGILE trial team pioneered expanding early phase research into primary care and the community. Beyond COVID-19, primary care is where the majority of disease burden lies and so creating platforms that are not reliant on recruitment through secondary care removes barriers to patient engagement with research. Moreover, widening participation in this way may address unacceptable health inequalities, ensuring recruitment is representative of the population for which the medicines are being developed. Investing in clinical pharmacology supports such research to go ahead because clinical pharmacologists are qualified to be principal investigators on first in human trials, mitigating against the higher risk associated with early phase research.
Through AGILE, we are filling a gap in potential treatments for COVID-19 by looking earlier in the disease – trying to stop people from getting sick to begin with. The pandemic has challenged us to think creatively about how we do research. We have been actively recruiting patients by embedding our work into primary care and the community - chasing up on positive test results and recruiting people with early symptoms.
We’ve seen lots of benefits for the patients and have been able to refer those who need further care onto services through the trial rather than putting additional burden on A&E departments. We’ve seen tremendous buy in from patients and primary care – even to the extent that we set up a portacabin in a GP car park! Our experience is that patients are much more aware of the benefits of research now and want to get involved. We have noticed that the healthy volunteer recruitment is much higher than usual, and we are starting to see this transferring over to other disease areas too.
There’s a real opportunity to build on this, and with more clinical pharmacologists the UK could do even more of this work.
- Dr Richard Fitzgerald, Director of the NIHR Royal Liverpool and Broadgreen Clinical Research Facility, consultant clinical pharmacologist, and one of the leads on the AGILE trial.
Investment in clinical pharmacology can also improve patient outcomes by addressing health challenges such as the growing burden of multimorbidity and problematic polypharmacy, and by realising the potential of personalised prescribing. Clinical pharmacologists are working across the health service to support an evidence-based approach to the safe and effective use of medicines.
As the population ages, people increasingly have multiple co-existing chronic diseases (i.e., multimorbidity)[1], necessitating the use of multiple medicines - over 1 million people take 8 or more medicines per day, this is referred to as polypharmacy. As the number of medications increases, so does the possibility of drug interactions and adverse drug reactions resulting in hospital admission and further morbidity[2][3] . Over 1.1 billion prescription items are dispensed in the UK community setting every year[4] . Although medicines have many proven benefits, 6.5% of all hospital admissions are caused by adverse drug reactions, and 237 million medication errors are made in the NHS every year[5][6] . The costs relating to these adverse reactions and medication errors is a significant burden on the healthcare budget (over £1.6 billion/year).
Clinical pharmacologists including Dr Lauren Walker, Dr Fran Bennett, Dr Andrew Scourfield, Professor Reecha Sofat and Professor Emma Baker are also working across the UK as the Polypharmacy Service Consortium, a collaborative venture between Clinical Pharmacologists, Clinical Pharmacists, Geriatricians and General Practitioners with a vision that “every medicine brings worthwhile benefit to the person for whom it is prescribed”. Their focus is to help the patients with complex polypharmacy, but also to support education and training of healthcare professionals. The coming challenge will be to address multimorbidity, to which polypharmacy is both a contributor and consequence. Moreover, as the natural history of COVID-19 is more precisely understood its contribution to multimorbidity will be too.
Professor Emma Baker and Dr Rupert Payne contributed to the National Overprescribing Review. Professor Baker is co-chair of the Polypharmacy subgroup of the Regional Medicines Optimisation Committee of NHS England, promoting best practice in polypharmacy. Emma Baker and Chris Threapleton contributed to NHS England policy on the structured medication review and GP contractual framework.
The genomic revolution is also likely to have a profound effect on the practice of medicine. The 100,000 genomes project has already highlighted the utility of using genomic data for diagnosis in rare diseases, and in identifying novel drug targets for targeted anti-cancer therapy. The 100,000 genomes project, which was developed as a transformational NHS-facing initiative, has led to re-structuring of genomics laboratory services, and the development of the NHS England Personalised Medicine Strategy. Pharmacogenomics is the study of how genetic variation affects drug response, both efficacy and safety. However, knowledge of pharmacogenomics is poor in the clinical community, and ability to engage with and implement the outcomes of this research may ultimately negatively impact patient outcomes.
Clinical pharmacologists, led by Munir Pirmohamed, working in collaboration with NHS England and Genomics England, are already playing a leading role in developing the plans for implementation of pharmacogenomics in the NHS, and are well-placed to support education and training of the wider NHS workforce. Pharmacogenomics is a tangible example of how genomics can be relevant to every individual as in our lifetime we will all require medicines in some form. As such, upskilling of the NHS workforce is important, and clinical pharmacologists are leading a working party with the Royal College of Physicians to define training needs for the use of pharmacogenomics in the NHS.
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References
- Whitty, CJM and Watt, FM (2020) Map clusters of diseases to tackle multimorbidity.
- Payne R (2014). Is polypharmacy always hazardous? A retrospective cohort analysis using linked electronic health records from primary and secondary care. Br J Clin Pharmacol 77 (6): 1073-1082.
- Rawle MJ, Cooper R, Kuh D, Richards M (2018). Associations Between Polypharmacy and Cognitive and Physical Capability: A British Birth Cohort Study. J Am Geriatr Soc 66(5): 916–923.
- NHS Digital. (2017) Prescriptions Dispensed in the Community, Statistics for England – 2006-2016 [PAS].
- British Pharmacological Society. (2016) Clinical Pharmacology and Therapeutics: The case for savings in the NHS.
- Policy Research Unit in Economic Evaluation of Health & Care Interventions. (2018) Prevalence and Economic Burden of Medication Errors in the NHS in England.