At the conclusion of the first year of UF Health’s Personalized Medicine Program, the results are in: The program has successfully implemented a process for genetic testing that helps cardiologists identify which patients may benefit from a switch to an alternate anticlotting medication.
The researchers published a review of the program’s first year in the March edition of the American Journal of Medical Genetics. One of only a few institutions across the country implementing genomic medicine, UF Health aims to show that genetic information can be used as a conventional part of patient care.
“We found that we can take research findings and translate them into the patient care setting,” said Julie Johnson, Pharm.D., director of the UF Health Personalized Medicine Program and UF College of Pharmacy dean. “In this case, we focused on taking research findings that suggested we could use genetic information to help select the right drug for a patient — and then actually did it.”
Patients who undergo heart catheterizations — a procedure in which a thin tube is inserted into the left ventricle of the heart to look for potential heart problems — are often prescribed clopidogrel, an anticlotting medication also known commercially as Plavix.
In June 2012, UF Health began offering a genetic test that assessed how patients would respond to the drug. The test identified more than a quarter of the 1,000 patients who carry genetic traits that prevent them from metabolizing clopidogrel successfully, said Kristin Weitzel, Pharm.D., associate director of the Personalized Medicine Program. This means that the drug may be less effective for these patients, leaving them at greater risk for heart attack or stroke.
The Personalized Medicine Program, developed within the UF Clinical and Translational Science Institute, screens a patient’s genetic information to determine whether a specific drug can be used successfully. It is supported by a $3.7 million grant awarded by the National Human Genome Research Institute and builds upon a National Institutes of Health goal that a patient’s genetic information can be used to tailor his or her health care.
During 12 months, 1,097 patients were screened for this genetic trait at UF Health. Of these, 291 patients received percutaneous coronary intervention, a nonsurgical procedure used to treat narrowed arteries in the heart. The genetic test results were added to the patients’ electronic medical record. If the results showed a genotype that is associated with reduced conversion of the clopidogrel to its active form, cardiologists treating the patient would be alerted. The genetic testing, conducted by the UF Health Pathology Laboratories, led to a switch in medication for 56 patients.
The implementation of genomic medicine included changing the patient care flow to incorporate another laboratory test, working with the UF Health Pathology Laboratories to process the genetic tests, developing an alert within UF Health’s electronic health record system and training health care providers to use the genetic test.
“That we were able to successfully incorporate the procedure into the electronic medical record, to genotype that many patients within a 12-month period, and to implement changes based on their genotype result is a very positive success,” Weitzel said.
The program, initially supported by research dollars, transitioned to clinical billing in 2013. According to the study, 85 percent of the outpatient claims were reimbursed payment for the test during the first month of billing — including payment from Medicare.
By publishing the study’s results, UF Health hopes to share the program’s experience as well as strategies it used to address the challenges of implementing the procedure, said Johnson. Johnson is the principal investigator of the Personalized Medicine Program, and serves as chair for the National Human Genome Research Institute’s Implementing Genomics in Practice, or IGNITE, network. The network includes projects at Duke University and Mount Sinai as well as a coordinating center at the University of Pennsylvania.
The UF program is now turning its attention to other types of medications using the same process, including drugs to treat certain types of cancer in pediatric hematology and oncology. Additionally, Larisa Cavallari, Pharm.D., recently joined the University of Florida faculty and will play a leadership role in helping to extend the reach of the program to guide medication therapy based on genetics.
Weitzel said the program is also working with community-based health systems both locally and throughout Florida to implement this kind of testing within their patient care processes, starting with clopidogrel and eventually expanding to other drug therapies. The program directors are working with other health-care providers and UF students to better understand the intersection of pharmacology and genetics, and how it can apply to patient care.
The National Human Genome Research Institute’s grant will help fund the program for the next three years, and is listed as NIH’s award number U01HG007269. It builds upon infrastructure created by the Personalized Medicine Program with institutional support from UF and initial funding from the NIH under award numbers UL1TR000064 (National Center for Advancing Translational Sciences) and U01 GM074492 (National Institute of General Medical Sciences).