Edith Nutescu, PharmD, stands at the intersection of patient-centered pharmacogenomics and anticoagulation care. In a multifaceted role that includes research, administrative oversight, and providing care to underserved patients, Nutescu is focused on taking traditional anticoagulation therapy to the next level by developing ways to incorporate novel agents into current practice models. She is also a pioneer in personalized medicine by bringing anticoagulation care to the patient bedside. Supported by several grants, Nutescu’s research promotes the pharmacist’s evolving role in anticoagulation therapy.
“We are pushing the envelope and bringing new models of clinical care to pharmacists for future anticoagulation management,” said Nutescu, who is based at the University of Illinois at Chicago (UIC) College of Pharmacy.
Newly approved antithrombotic medications and breakthroughs in genetics are creating a practice model change where traditional management of anticoagulation with agents such as warfarin is becoming outdated. “One of the major challenges we face is coming up with new ideas and innovations to move us forward,” said Nutescu. With expertise in pharmacology, pharmacokinetics, and the pharmacodynamics of the various antithrombotic agents, pharmacists are well positioned to take the lead in this endeavor.
Nutescu’s interest in anticoagulation began during her primary care specialty residency at UIC in 1995. After completing her residency, she founded the antithrombosis clinic at UIC in 1996. Over the years Nutescu has grown the clinic from one pharmacist to a team of seven clinical pharmacists who average around 50 to 55 patients per day, which translates to about 8,000 to 9,000 patient visits per year. Pharmacists at the clinic provide medication therapy management services to an underserved patient population. “Pharmacists in this clinic are responsible for everything from counseling patients at the time of initiating medication to monitoring, dose adjustments, follow-up, and prepping patients for surgeries,” said Nutescu, who is the clinical director of the clinic.
For anticoagulants to be used safely and effectively, periodic monitoring and education are essential. Yet many minority patients have barriers, such as lack of transportation, which limits their access to care. In February 2013 Nutescu was awarded a 4-year grant from the National Institutes of Health and the National Heart, Lung, and Blood Institute to evaluate barriers to anticoagulation care and determine whether self-testing is a good option for minority patients. Her goal is to design a culturally competent behavioral intervention coupled with self-testing. By measuring outcomes, Nutescu will investigate whether self-testing in this population can be successfully implemented.
This project “couples nicely” with the mission of UIC’s antithrombosis clinic, which serves an inner-city, underserved minority population comprising mainly African American and Hispanic patients, Nutescu said in an interview with Pharmacy Today. “There is a huge need for this from a disparities research perspective. If we can show that self-testing works in minority underserved patients, then the next step is to roll this out on a larger scale in this patient population,” she added.
Nutescu is also evaluating how novel anticoagulants such as rivaroxaban (Xarelto—Bayer, Ortho–McNeil Janssen), apixaban (Eliquis—Pfizer; Bristol-Myers Squibb), and dabigatran (Pradaxa—Boehringer Ingelheim) are being used in practice. This group of new agents does not require routine monitoring and dose adjustment, making it a “more convenient and less complex model of care compared to warfarin where patients have to come to clinic periodically to get their blood tested,” Nutescu explained.
Funded by a grant from the APhA Foundation, this project looks at “what goes on in actual practice and evaluates patient quality of life by comparing the new anticoagulants with traditional drugs such as warfarin,” said Nutescu. “We will use this data to guide future models of care.”
Nutescu and Christine Rash, PharmD, a pharmacy resident at UIC, will study whether the new agents are being used appropriately and safely and whether appropriate patient education, follow-up, and monitoring are being provided, such as whether renal function and liver function are checked on time and if the patient was screened for drug interactions.
“Gathering this data from patients who come to the UIC antithrombosis clinic and other clinics will allow us to guide contemporary management models to incorporate new agents for thrombosis management,” Nutescu told Today. She hopes that the knowledge gained through this study will allow them to help other anticoagulation clinics “retool their practices and show what the future model of anticoagulation care will look like,” Nutescu remarked.
Nutescu and her team are among the first in the country to incorporate personalized medicine into managing anticoagulation therapy. In August 2012, UIC launched a warfarin pharmacogenomics service. As Co-Director, Nutescu provides administrative oversight and conducts research on how the service affects patient outcomes. “Most of the work up to this point has been conducted in the lab, studying how certain genotypes affect dosing requirements,” Nutescu explained. “We are taking pharmacogenomics to the patient bedside and measuring the impact of personalized medicine and warfarin on actual patient outcomes.”
Here’s how it works. Every patient who is admitted to the UIC health system and is newly initiated on warfarin is genotyped with the goal of preventing adverse consequences with inappropriate dosing. A pharmacist with the pharmacogenomics consult service evaluates the patient’s genotype along with pertinent clinical factors and makes dosing recommendations daily for up to 1 week or until discharge.
Approximately 70% of hospitalized patients newly initiated on warfarin receive follow-up care at the antithrombosis clinic upon discharge. The antithrombosis clinic pharmacists incorporate the available pharmacogenetic data for further dose refinement until a stable dose is reached. They also work closely with the pharmacists on the inpatient pharmacogenetic consult service to provide a smooth transition of care for patients. “We track the data to ensure that the service helped improve outcomes such as time to reach therapeutic international normalized ratio (INR), level of INR on discharge, level of INR at the first antithrombosis clinic visit, time in therapeutic range, and any complications such as the rate of bleeding and thrombosis in these patients,” said Nutescu. According to preliminary data, patients are reaching therapeutic INR targets at a faster pace. “We hope that this will improve the overall time in therapeutic range for these patients and improve safety of warfarin therapy,” Nutescu explained.
With the evolving health care landscape and rapid advances in new drugs and pharmacogenomics, Nutescu believes that pharmacists can make a great impact on patients in terms of developing new care models that capitalize on research advances. “Given the current challenges we have with our health care system, we are moving toward patient-centered care and are working to address the gap in therapy for certain under-represented minority patient populations,” said Nutescu. “There is a tremendous need for traditional anticoagulation care models to move to the next level.”
In addition to new care models, personalized medicine could also create new opportunities for pharmacists in the future. “As we move the science from the bench to the patient bedside, more and more pharmacists will find themselves having to brush up on pharmacogenomics and learn how to incorporate this information in guiding safe therapies and selecting the right drugs, dosing, and monitoring,” said Nutescu. “Our training and expertise as pharmacists best positions us for patient care in anticoagulation, but it also positions us to lead research in this area.”