Pioneering new approaches in precision medicine.
recision medicine means delivering the right treatments, at the right time, every time to the right person. It’s a promising idea that a growing number of UF Health patients benefit from thanks to scientific discoveries led by the UF Health Personalized Medicine Program.
Since launching in 2012, the program has led seven clinical implementations for gene-drug pairs, contributed to a growing evidence base in support of genotype-guided therapy and developed multiple education programs that are training current and future leaders in precision medicine. In addition, the UF College of Pharmacy operates the nation’s only training grant in genomic medicine and the only National Institutes of Health Implementing Genomics in Practice, or IGNITE, network site based in a pharmacy college.
NEW STUDY SUPPORTS GENOTYPING FOR PAIN MANAGEMENT
A physician’s roadmap to treating pain can be filled with twists and turns and sometimes uncertainty whether the final destination of pain relief is attainable. However, a new UF Health study examining a patient’s DNA may provide necessary direction for successful pain therapy.
Researchers in UF Health’s Personalized Medicine Program studied nearly 500 pain patients over a two-year period and found genotype-guided drug therapy improved pain control amongst poor or intermediate metabolizers of the drug-metabolizing enzyme CYP2D6 when prescribed certain opioids.
“We know pain is a major problem in this country and data show that most of the people persistently using opioids are trying to treat pain,” said Larisa Cavallari, Pharm.D., director of the Center for Pharmacogenomics in the UF College of Pharmacy and associate director of the UF Health Personalized Medicine Program. “This study is a piece of the puzzle that may help us better manage pain and enhance quality of life.”
Pain affects more Americans than diabetes, heart disease and cancer combined. Since the 1990s, a physician’s go-to pain treatment has been to prescribe opioids, such as hydrocodone or tramadol. While the medications help alleviate pain in some patients, others experience no relief, and overprescribing has been a factor contributing to a national epidemic of opioid misuse, overdose and death.
Several primary care physicians at UF Health approached the personalized medicine team in 2015 to initiate CYP2D6 genotype testing to help with opioid prescribing. The request sparked what is believed to be the nation’s first genotype-supported opioid therapy study.
“Unfortunately, we were seeing many patients with chronic pain suffering from negative drug effects, either from the drug itself or interactions with others,” said Siegfried Schmidt, M.D., Ph.D., FAAFP, a professor in the department of community health and family medicine at the UF College of Medicine. “Pharmacogenetic testing has provided us some answers why this is happening and helped us determine the right drugs, in the right dosages, at the right time for our patients. This is the future of medicine, and what I want to become reality for all of my patients.”
Study participants initially provided a DNA sample and completed a pain intensity survey. A pharmacist reviewed genetic test results and the patient’s list of medications to identify any factors that may influence response to opioid therapy. Genetic variations of CYP2D6 and competing medications that treat conditions apart from pain, such as depression and anxiety, can play a role in suppressing the CYP2D6 enzyme — rendering certain pain medications ineffective. The pharmacist then made recommendations to the physician based on genotype and other medications patients were taking.
“Our genotype-guided approached led to a reduction in patient-reported pain over three months in the people who we expected to benefit the most,” Cavallari said. “These findings add to the evidence base that pharmacogenetics testing improves outcomes and justifies broader implementation across health care.”
UF PRECISION MEDICINE CONFERENCE ATTRACTS NATIONAL AUDIENCE
The University of Florida’s emergence as a national leader in precision medicine is also evident every March when attendees from around the country travel to Orlando for the UF Precision Medicine Conference. The conference is led by Kristin Wiisanen Weitzel, Pharm.D., a clinical professor and associate director of UF Health’s Personalized Medicine Program. The 2018 event attracted more than 170 participants and speakers from 27 states and several countries, with an interest in learning the latest strategies and technologies for bringing genomic medicine and pharmacogenomics into practice.
Designed initially for pharmacists to gain knowledge and experience to engage in the emerging field, the conference expanded its footprint in three years to include a broader audience of physicians, pharmacists and other health care professionals who seek understanding in applying precision medicine in the clinic. Experts in genomic medicine and pharmacogenomics led three days of engaging and interactive sessions designed to introduce the latest strategies and technologies in precision medicine implementation.
“National interest in precision medicine and pharmacogenomics has never been stronger, but there are limited ways for clinicians to learn about the field and apply it to their practice,” said Julie Johnson, Pharm.D., dean and distinguished professor of the UF College of Pharmacy and director of UF Health’s Personalized Medicine Program. “The UF Precision Medicine Conference fulfills a vital need for improved education and training in health care.”
The fourth annual UF Precision Medicine Conference will take place March 7-8, 2019.
UF HEALTH PERSONALIZED MEDICINE PROGRAM: CLINICAL IMPLEMENTATIONS AND MILESTONES
June 2012CYP2C19 – clopidogrel (Gainesville)
July 2012PGY2 Residency Initiated
June 2013NIH IGNITE Grant Awarded
February 2014TPMT – thiopurines
May 2015CYP2D6 — opioids
March 2016First Precision Medicine Conference
April 2016CYP2C19 – clopidogrel (Jacksonville)
October 2016CYP2D6/CYP2C19 – SSRIs
January 2017CYP2C19 – PPIs
February 2018NIH Genomic Medicine Training Grant Awarded
UF RESIDENCY ONE OF ONLY TWO ASHP-ACCREDITED PHARMACOGENETIC PROGRAMS IN COUNTRY
Benjamin Duong is a self-described “IT guy.” He loves using informatics to improve health. Nine months into his pharmacogenetics residency at the UF College of Pharmacy, Duong is working with informatics experts at UF Health to develop clinical decision support to ensure genetic test results are populated appropriately in a patient’s electronic medical record and trigger alerts when necessary. He’s balancing this work with developing a customizable “how-to guide” for implementing pharmacogenetics or genomic medicine services, providing consults with UF Health patients and contributing to evidence-based research.
These diverse residency experiences can be expected in the UF College of Pharmacy’s Pharmacogenetics Residency Program. Led by a team of world-renowned clinicians and scientists, the program is one of only two pharmacogenetic residencies in the nation accredited by the American Society of Health-System Pharmacists. In earning accreditation, the residency has established that it meets the highest quality standards set by the profession.
“The ASHP accreditation validates that graduates from this residency are qualified to be a pharmacogenetics specialist,” Duong said. “Being under the guidance of UF faculty who are highly motivated leaders in the profession has been a tremendous benefit for me.”
Duong, a 2016 Pharm.D. graduate of the UF College of Pharmacy, appreciates how the UF pharmacogenetics residency can be tailored around a resident’s interest area, while at the same time teaching implementation strategies and techniques. He’s now been hired to help implement pharmacogenomics at the Nemours Alfred I. duPont Hospital for Children and Nemours Health System in Wilmington, Delaware.
FIRST-OF-ITS-KIND PHARMACOGENOMICS CONSULTATION SERVICE OFFERED AT UF HEALTH CLINIC
One of the nation’s first outpatient pharmacogenomics consultation services launched in September at UF Health Internal Medicine at Tower Hill in Gainesville. Led by Meghan Arwood, Pharm.D., a clinical assistant professor of pharmacotherapy and translational research in the UF College of Pharmacy, the pilot program helps clinicians tailor therapy around a person’s unique genetic profile.
“Providing pharmacogenomic consultations in a primary care setting is a novel idea at UF Health,” Arwood said. “We have an incredible opportunity to demonstrate the value of genetic-guided therapy to a new patient population and educate patients and physicians on these results.”
UF Health’s hospitals have traditionally offered pharmacogenomic consultations in select inpatient and outpatient programs. Arwood said adding face-to-face outpatient consults to the primary care setting marks a natural progression in expanding personalized medicine. Patients struggling with their medication regimens meet with her twice and participate in genetic testing. She will then make medication recommendations to the patient’s physician based on the test results and a medication history evaluation.
In the initial year, Arwood has primarily helped psychiatric patients suffering from depression or anxiety, but consult opportunities exist with cardiology, pain and gastrointestinal disorder patients too. She has found her consultations give reassurance to patients who may be questioning their medications or dealing with difficult side effects of a drug.
“Patients appreciate the peace of mind that these consultations offer them,” Arwood said.