Gastroenterology
development with the optimisation of medical resources, and a substantial increase in the efficiency of appointments. One study found that IBD drug administration accounts for 39 percent of a patient’s time in hospital, equating to more than 140 minutes per patient.9
predicted to cost the NHS £720 million, half of which is allocated to relapsing patients,10
are potentially significant cost savings to be made from self-administering medication.
Establishing the point of point-of-care TDM The development of self-administered medication is still in the early days, but it is certain to shape the future of IBD therapy. With this, TDM testing strategies must evolve too, as administering drugs at home negates the need for patients to visit hospitals so frequently. However, given the time and investment that it takes to validate procedures, healthcare institutions need to carefully consider how they can meet the needs of this evolving service in this transitional phase of remote therapy. Currently, there is also not sufficient data to show that point-of-care TDM tests are comparable to conventional laboratory- based assays, in terms of reproducibility, cost, efficacy and quality assurance.
A window into the future of patient-led TDM sampling Until such a time as suitable point-of-care tests become available, alternative – but equally innovative – solutions enabling reactive or proactive remote TDM sampling are likely to take precedent over point- of-care to coincide with the introduction of patient-led therapy, and progress is already underway to determine the efficacy of this approach. A study at the Royal Devon and Exeter NHS Foundation Trust compared patient-led remote intracapillary pharmacokinetic sampling – or fingerPRICKS – to conventional venepuncture for TDM.12 Blood samples were collected via both methods, and sent to the hospital’s laboratory to be analysed on the IDKmonitor Total Anti- drug ELISAs (BIOHIT HealthCare). The analytes measured have also been shown to be stable for seven days at room temperature, allowing time for transport to the laboratory.13
The
study reported that sampling was equivalent to traditional methods for the most widely used drug and anti-drug antibody levels, including for adalimumab and infliximab. More than 87 percent of the patients agreed that intracapillary testing was easy and 69 percent preferred it to conventional sampling.
there With IBD
The fingerPRICK study provided one of the first insights into remote TDM sampling in the NHS, showing how it could be successfully used as a key adjunct to telemedicine, which became popular during the COVID-19 pandemic. More work is needed to understand exactly where remote TDM could fit into or improve the patient pathway; it’s likely that samples will need to be taken periodically and analysed prior to any appointments, offering clinicians the opportunity to discuss the results and tailor treatment plans accordingly. But, once established, clinicians can take comfort in the fact that this process will rely on pre-existing robust platforms, and assays will be subject to the same quality management procedures as other laboratory-based tests – including UKAS and ISO 15189 regulations – ensuring analytical accuracy. There are also potential cost benefits
of implementing remote sampling, by freeing up time and space in clinical care settings, which is likely to offset the cost of establishing a new workflow with home testing packs. The method of non-clinic sampling for TDM is still in its infancy. However, it will coincide nicely with the parallel evolving story of orally administered IBD therapies in the coming years, developing an end-to-end solution for patients. This will follow the NHS’s wider long-term plan to address patient pathway inefficiencies with remote monitoring for more conditions.14
It is
almost certain that the IBD community will move in this direction, particularly as technology is already emerging to support the introduction of specific options for remote TDM of IBD management. For instance, the SmarTest faecal calprotectin home test (BIOHIT HealthCare) already enables patients with Crohn’s disease or
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www.clinicalservicesjournal.com 45
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