Clinical pharmacogenetics implementation: Approaches, successes, and challenges

Authors

  • Kristin W. Weitzel,

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    • Kristin W. Weitzel, PharmD is Associate Director, UF Health Personalized Medicine Program and Clinical Associate Professor, Pharmacotherapy and Translational Research. Her research and practice interests include clinical implementation of pharmacogenetics and educational innovation.
  • Amanda R. Elsey,

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    • Amanda R. Elsey, M.H.A. is Program Manager, UF Health Personalized Medicine Program.
  • Taimour Y. Langaee,

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    • Taimour Y. Langaee, M.S.P.H., Ph.D. is Research Associate Professor and Graduate Coordinator, Pharmacotherapy and Translational Research and Director of the Genotyping Laboratory, Center for Pharmacogenomics and Director of the CTSI Genotyping Core. His research interests are pharmacogenomics in cardiovascular disease; pharmacogenetics of dichloroacetate; clinical, genetic, and microbial interactions in inflammatory bowel disease; and microbial resistance to antibiotics.
  • Benjamin Burkley,

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    • Benjamin Burkley, M.S. is Scientific Research Manager, Center for Pharmacogenomics. His research focuses on metabolic and cardiovascular pharmacogenomics.
  • David R. Nessl,

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    • David R. Nessl, P.M.P., M.B.A., is Chief Technology Officer, Department of Pathology, UF College of Medicine. His primary interest is applying project management to building high-tech businesses.
  • Aniwaa Owusu Obeng,

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    • Aniwaa Owusu Obeng, PharmD is a member of the Charles Bronfman Institute for Personalized Medicine and Assistant Professor of Medicine, General Internal Medicine at the Icahn School of Medicine at Mount Sinai. She also serves as Clinical Pharmacogenomics Coordinator in the Department of Pharmacy at The Mount Sinai Medical Center. At the time of implementation and data collection, Dr. Obeng was a pharmacogenomics resident in the Center for Pharmacogenomics and UF Health.
  • Benjamin J. Staley,

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    • Benjamin J. Staley, PharmD is a Clinical Pharmacist, UF Health and adjunct Clinical Assistant Professor in the Department of Pharmacotherapy and Translational Research, College of Pharmacy. He specializes in quality improvement, patient safety and quality initiatives, and use of information technology to improve clinical processes.
  • Hui-Jia Dong,

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    • Hui-Jia Dong, Ph.D., H.C.L.D. (A.B.B.) is Technical Director, UF Health Pathology Laboratories. Her work primarily focuses on implementing new technologies in molecular laboratory diagnostics, new test development, and laboratory management.
  • Robert W. Allan,

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    • Robert W. Allan, M.D. is Medical Director, UF Health Pathology Laboratories and Associate Professor of Genitourinary Pathology, Hematopathology, and Surgical Pathology, UF College of Medicine. His research interests are principally in translational research for prostate, bladder, and kidneys.
  • J. Felix Liu,

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    • J. Felix Liu, Ph.D. is Director, Clinical Translational Science Information Technology Program and Courtesy Research Assistant Professor, Department of Pathology, Immunology and Laboratory Medicine, UF College of Medicine.
  • Rhonda M. Cooper-DeHoff,

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    • Rhonda Cooper-DeHoff, PharmD, M.S. is Associate Professor, Departments of Pharmacotherapy and Translational Research and Pharmaceutics, College of Pharmacy and Division of Cardiovascular Medicine, College of Medicine. She is Associate Director of the Center for Pharmacogenomics. Her research interests include hypertension, metabolic syndrome, diabetes, and pharmacogenomics.
  • R. David Anderson,

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    • R. David Anderson, M.D. is Associate Professor of Medicine, Director of Interventional Cardiology, and Director of the Cardiac Catheterization Laboratory, College of Medicine and UF Health.
  • Michael Conlon,

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    • Michael Conlon, Ph.D. is Director of Biomedical Informatics, Associate Director, and Chief Operating Officer of the UF CTSI.
  • Michael J. Clare-Salzler,

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    • Michael J. Clare-Salzler, M.D. is Professor and Chair, UF Department of Immunology, Pathology, and Laboratory Medicine. His research focuses on establishing the cellular, molecular, and genetic basis for the immunopathogenesis of autoimmune endocrine diseases.
  • David R. Nelson,

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    • David R. Nelson, M.D. is Professor of Medicine, Molecular Genetics, and Microbiology, Director of the CTSI, and Associate Dean for Clinical Research in the Division of Gastroenterology, Hepatology, and Nutrition, College of Medicine. He leads the CTSI and advances clinical/translational research efforts on campus. His personal research interests are immunopathogenesis and treatment of chronic hepatitis C and hepatocellular carcinoma.
  • Julie A. Johnson

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    • Julie A. Johnson, PharmD is Director, UF Health Personalized Medicine Program, Distinguished Professor of Pharmacy and Medicine, and Dean of the College of Pharmacy. Her research focus is pharmacogenomics, with particular focus on cardiovascular drugs, and clinical implementation of pharmacogenomics.

  • Kristin W. Weitzel and Amanda R. Elsey contributed equally to this work.
  • * Correspondence to: Dr. Julie A. Johnson, PharmD, UF College of Pharmacy, Office of the Dean, P.O. Box 100484, Gainesville, FL 32610. E-mail: johnson@cop.ufl.edu

Abstract

Current challenges exist to widespread clinical implementation of genomic medicine and pharmacogenetics. The University of Florida (UF) Health Personalized Medicine Program (PMP) is a pharmacist-led, multidisciplinary initiative created in 2011 within the UF Clinical Translational Science Institute. Initial efforts focused on pharmacogenetics, with long-term goals to include expansion to disease-risk prediction and disease stratification. Herein we describe the processes for development of the program, the challenges that were encountered and the clinical acceptance by clinicians of the genomic medicine implementation. The initial clinical implementation of the UF PMP began in June 2012 and targeted clopidogrel use and the CYP2C19 genotype in patients undergoing left heart catheterization and percutaneous-coronary intervention (PCI). After 1 year, 1,097 patients undergoing left heart catheterization were genotyped preemptively, and 291 of those underwent subsequent PCI. Genotype results were reported to the medical record for 100% of genotyped patients. Eighty patients who underwent PCI had an actionable genotype, with drug therapy changes implemented in 56 individuals. Average turnaround time from blood draw to genotype result entry in the medical record was 3.5 business days. Seven different third party payors, including Medicare, reimbursed for the test during the first month of billing, with an 85% reimbursement rate for outpatient claims that were submitted in the first month. These data highlight multiple levels of success in clinical implementation of genomic medicine. © 2014 Wiley Periodicals, Inc.

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