NEW YORK – Investigators at University of Florida Health are exploring the feasibility and cost-effectiveness of implementing pharmacogenomics in the emergency department.
Over five years, researchers will conduct a randomized clinical trial to assess whether PGx-guided care helps to reduce patient visits to the emergency department and how the intervention impacts costs. Researchers expect to launch the clinical trial later this month.
PGx testing is already available at UF Health, but it isn't widely used in the emergency department, said Sophia Sheikh, an associate professor in the emergency medicine department at UF College of Medicine-Jacksonville and an emergency medicine physician, who's one of the researchers leading the project. "It's available, but it's not being used often," she said.
The PGx project grew out of Sheikh's research into why some patients repeatedly land in the emergency department and whether some of these visits could be avoided. Sheikh noted that patients could be returning to the emergency department because they're not achieving the results they expect with a particular medication or they're experiencing side effects from it. These are precisely the areas that could be improved with tailored prescribing using PGx testing.
"I had an interest in looking at whether or not these genetic differences could be not the only driver but one of the potential drivers," Sheikh said. "Looking at the literature, I don't think anybody's answered that question."
If successful, the PGx project will lead to better outcomes and fewer side effects from medications for patients, resulting in fewer emergency department visits and lower healthcare costs.
The research team, armed with a $3.4 million grant from the US National Institutes of Health, will expand PGx resources for clinicians in the emergency department, launch the clinical trial, and evaluate the feasibility and clinical benefits associated with testing. Researchers also will assess how much it costs the hospital system to run this program based on medical claims data, in the hopes that PGx is either cost-neutral or cost-saving.
"If we show it's cost-effective, we think, along with the clinical effectiveness data, that might drive third-party payors and healthcare systems to consider implementing this at their institutions," said Julio Duarte, an associate professor in the pharmacotherapy and translational research department at UF College of Pharmacy and codirector at UF Health's Center for Pharmacogenomics and Precision Medicine, who's another project lead. His research focuses on implementing PGx testing within clinical practice.
Results from the clinical trial and cost-effectiveness assessment could also inform the design of a larger multisite study to explore the impact of PGx testing in a broader population, he added.
In this initial clinical trial, which will take place within the emergency departments at UF Health's Gainesville and Jacksonville campuses, researchers will randomize about 1,200 patients to receive either standard care or PGx-guided care. They will recruit patients who have visited the emergency department at least twice in the past year and who have been prescribed drugs that could be influenced by PGx variants.
Previous research has suggested that more than 90 percent of patients, generally, have at least one actionable pharmacogenomic variant. In another paper published in 2021, investigators at Duke University School of Medicine estimated that around one-fifth of US emergency department visits resulted in orders for drugs with associated PGx recommendations, most commonly the opioid pain medication tramadol.
Researchers at UF Health will monitor patients' rate of return visits to the emergency department and track if they experience adverse drug events or are hospitalized and for how long.
Participants in the trial will receive free PGx testing. They will provide a buccal swab to UF Health's pathology laboratory for genotyping using a PGx panel that UF Health developed in-house. Those who are randomized to the PGx-informed care arm will have testing immediately, while those receiving standard care will get tested after the trial is completed.
The PGx panel gauges 65 variants across 14 genes that have implications for drug response. The results are typically returned to clinicians through UF Health's electronic health record (EHR) system in a week or less, so doctors likely will have this PGx information for any follow-up visits that are recommended or while patients are hospitalized.
Researchers will primarily evaluate the impact of PGx testing on patients who receive drugs that are prescribed in the emergency department but will also consider how PGx variants are affecting patients' ability to metabolize drugs they recently received, since those could have led to adverse events that landed them back in the emergency room.
In expanding PGx resources, researchers will also have to add to the decision support tools within the EHR system. These tools notify clinicians when a patient may carry a PGx variant that reduces their ability to respond to a certain medication they've been prescribed and provide alternative recommendations to support clinicians as they make these decisions.
"We don't expect every medication prescriber to be a pharmacogenetics expert," Duarte said. However, it's ultimately still up to the clinician to decide what medication to prescribe a patient.
Researchers will add to the gene-drug pairs included in the decision support system, which are based on guidelines from the Clinical Pharmacogenetics Implementation Consortium (CPIC), an internationally recognized guidelines body, and information from the US Food and Drug Administration. They'll also incorporate alerts based on research conducted by Sheikh on how a patient's genotype might influence the severity of a drug-drug interaction.
For example, the CYP2D6 gene encodes an enzyme that activates opioids like tramadol, which means that patients with certain variants in this gene may not respond to the drug. Meanwhile, the antidepressant duloxetine is also known to inhibit the CYP2D6 enzyme, so a patient's CYP2D6 genotype may influence how to manage whether a patient can safely take both drugs.
The research team is also considering how PGx insights can be shared with clinicians outside of UF Health, since patients might see other providers beyond UF Health's emergency departments. Investigators are providing patients with a plastic card containing a QR code, which clinicians can scan to access PGx-guided medication recommendations for that patient.
The card hasn't previously been used clinically at UF Health.
"The goal is to be able to inform the care for the patient regardless of which institution they're visiting or what type of setting they're visiting," Sheikh said.