UF Health Researchers Probe Benefits of Precision Medicine

AACP Article
An NIH grant is supporting a project to measure the feasibility of implementing strategies such as pharmacogenetic testing in the emergency room.
 

By Joseph A. Cantlupe

Dr. Julio Duarte, an associate professor at the University of Florida College of Pharmacy, is a firm believer that effectively zeroing in on individual genetic profiles can unleash significant improvement in overall healthcare for patients. And he’s got pain on his mind. Duarte specializes in the field of pharmacotherapy and translational research. In those areas, Duarte focuses on precision medicine, which specifies disease treatment and prevention strategies to individual patients.

Duarte and his colleague Dr. Sophia Sheikh, an associate professor of emergency medicine at UF College of Medicine in Jacksonville, have received a five-year, $3.4 million grant from the National Institutes of Health (NIH) to identify patient populations for whom precision medicine techniques may improve clinical outcomes and reduce healthcare costs. To evaluate possible health and economic impacts, there is probably no better place than the emergency department. Patients often seek evaluation at EDs for proper diagnosis and treatment and may suffer pain, for instance, that can range from mild discomfort to life-threatening conditions. "It’s a place where we think precision medicine could have a really big impact," he noted. "If we could get the right drug the first time we should reduce return visits, and since this is such a high-cost healthcare environment, we could potentially also save a lot of money."

A Genetic Link?

Patients go to the emergency room in part because of the availability and convenience, depending on their geographic location. But because it is so big and specialized, it is much more expensive to run. And there are those patients who are considered super users who visit the emergency room repeatedly and impact an outsized portion of healthcare resources. Many more are visiting with pain as a significant reason.

Emergency department visits have increased in the U.S. in recent years, from 12.5 million in 2012 to 14.3 million in 2022, according to the Journal of the American Medical Association Network. Findings from NIH indicate that among patients who visit the emergency department, anywhere from 49 percent to 78 percent cite pain as the reason.

“We’re looking at a number of potential drug interactions that could impact a person’s reasons for coming back to the emergency department,” Sheikh said in a university statement. “Maybe they’re not achieving the results they should be with a particular medication. Could there be a genetic reason for why they’re not able to metabolize a certain medication? This may be just one piece of the puzzle, but I think it’s an important piece that hasn’t really been delved into.”

Medication impacts each person differently. “Not everyone responds to medications the same—two people who seemingly might be the same age, the same sex, the same size— prescribed the exact same drug and same dose but they may have different responses,” Duarte pointed out. “There are a lot of reasons for this, but one big reason depends on the patient’s genetics. There are lots of enzymes in our body that are responsible for metabolizing these drugs and then clearing them out from the body. If you have any genetic variance that affect this, you are going to respond very differently, and that makes things more complicated at the drug’s site of action.”

As they carry out the study, Duarte and Shiekh will expand a computer-based decision support that exists within the electronic health record system at UF Health. The system will alert clinicians when patients may be at an increased risk of side effects from medication based on their genetics.

UF Health Picture

 

For those needing to receive care outside of UF Health, patients will be provided with a card containing a QR code, which clinicians can scan to view personalized drug recommendations for that patient. “It’s like a credit card with your results printed on a card,” Duarte said. “You can simply scan the QR code and it will take you to a website that provides recommendations based off of your patients’ results, allowing dissemination outside of your health system.”

A randomized clinical trial of patients with and without pharmacogenetic testing will determine if the testing is truly reducing emergency room visits. A cost-effective analysis will show the potential economic value of a precision medicine approach. “The average ED visit is over $5,000, and our hypothesis is that pharmacogenetic testing would be either cost neutral or cost saving because these tests would be only a few hundred dollars,” Duarte added, “and the results are good for a lifetime.” They intend to start recruiting for a trial early this year. He said that the data this project gathers will inform future clinical implementation effects and larger, multisite clinical trials, ultimately leading to a better understanding of the benefits of personalized drug therapy and other precision medicine techniques in the ED.

randomized clinical trial

The University of Florida has been studying precision health medicine from multiple angles since 2011, the university said. It has partnered with the UF College of Pharmacy to create the new annual Precision Health Initiative Pilot Grant opportunity. The idea is to encourage groundbreaking clinical and translational research. These competitive awards provide one year of support for researchers at the University of Florida and Florida State University.

Dr. Julio Duarte“It’s a place where we think precision medicine could have a really big impact. If we could get the right drug the first time we should reduce return visits, and since this is such a high-cost healthcare environment, we could potentially also save a lot of money.”

Dr. Julio Duarte

Duarte said the university is also involved in a pilot program involving pharmacogenetics and cancer care. “It’s not widespread yet but we’re hoping that oncologists find value in pharmacogenetic testing that could predict adverse drug effects, and it could be expanded,” he said. “Patients will send genetic samples for testing and help oncologists decide what medication to use.”

The FDA, which has guidelines for pharmacogenetic testing and houses a genomics office, “has been a strong proponent for pharmacogenetics,” Duarte added. “There are certain circumstances where they’ll ask companies to provide that information as part of new drug applications. They are mostly in cases where the FDA feels there is a reasonable risk that there is going to be a pharmacokinetic or pharmacodynamic interaction.”

Sheikh said that “this multidisciplinary research spanning two UF Health campuses serves as a powerful example of the positive impact of collaboration. This project shows how we can work together to try to improve healthcare for our patients, finding answers or solutions to some of the problems facing our healthcare system. This collaborative approach leads to great things for the University of Florida and for the people we serve.”

Duarte said that while the research is promising, it is not without obstacles. One of the problems is that insurance companies and Medicare are reluctant to pay in precision medicine scenarios. “There’s no real appetite for widespread implementation of pharmacogenetic testing because payers don’t want to pay for it,” Duarte said. “We think the best way to start implementation is to identify the groups that are most likely to benefit. Hopefully payers will see the benefit and then it can expand from there. Pharmacogenetics is not this sort of panacea that’s going to help you predict the response for every patient, but it’s another piece of information you can use to do a better job selecting the right drug for your patient.” P

Joseph A. Cantlupe is a freelance writer based in Washington, D.C.