The last decade has seen substantial discoveries of genetic determinants of disease risk and drug response, along with staggering technological advances in genotyping, leading to the expectation that an individual's personal genome will eventually be part of their medical record, to guide care decisions across their lifespan. However, despite these advances, there has been minimal translation of this information to clinical practice. We recently launched a genomic medicine program at the University of Florida and Shands Hospital (the UF&Shands Personalized Medicine Program (PMP)), which seeks to advance the clinical utilization of genomic information to optimize patient care. Our program is built on three guiding principles. 1) There is a regulatory body that evaluates the literature to determine when the level of evidence is sufficient to warrant clinical implementation, and when this occurs, develops specific recommendations regarding use of the genetic information;2) the most efficient manner of implementation is through a broad, pre-emptive genotyping chip, such that information can be generated once, and used across the patient's lifespan;3) the program must be supported through specific informatics clinical decision support within the electronic medical record so the clinician receives clear recommendations to guide use of the genetic information. The UF&Shands PMP is currently focused on a pharmacogenetic example, but we have built the program for wider translation of pharmacogenetics and genetics findings into clinical practice. During the past year we established the institutional infrastructure necessary t support the PMP, and are now poised to expand the program, and use our experiences to implement similar programs in large, private health systems, and community healthcare settings.
Our specific aims are to:
Specific Aim 1. Expand and assess the impact of the clinical implementation of pharmacogenetic information to guide treatment decisions at UF&Shands through expansion to broader patient populations and to additional drug-genotype combinations on which clinical decisions are based.
Specific Aim 2. Implement and assess the PMP at diverse institutions outside the UF&Shands Health System, including a) the Orlando Health Heart Institute, a private cardiology group practice that is part Orlando Health, a large, private health system, and, b) a small community hospital through the Florida State University (FSU) College of Medicine practice network.
Specific Aim 3. To insure appropriate levels of knowledge about genomic medicine, develop and implement innovative genomic medicine educational programs for: 3a. physicians and other health-care providers;3b. health professions students;and 3c. patients. Implementation of genomic medicine into patient care has the potential to substantially improve outcomes of patients. Achieving these goals requires development and implementation of successful approaches for incorporation of genomic information into existing, complex healthcare systems, and documenting benefit of genomic medicine, each of which are addressed by our proposed aims.

Public Health Relevance

Use of genetic information to guide the treatment of patients has the potential to significantly improve patient outcomes, but there are not well-established models in place for how to do this in our current health systems. We propose to expand the genomic medicine program at the University of Florida and extend the program to other, private health systems in Florida, in order to document the methods for using genetic information in clinical care, along with documenting the benefits of using genetic information. We will also establish a variety of educational programs on genomic medicine, targeted at health care providers, health professions students, and patients.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HG007269-02
Application #
8682896
Study Section
Special Emphasis Panel (ZHG1-HGR-M (J3))
Program Officer
Madden, Ebony B
Project Start
2013-06-16
Project End
2017-04-30
Budget Start
2014-05-01
Budget End
2015-04-30
Support Year
2
Fiscal Year
2014
Total Cost
$978,729
Indirect Cost
$325,517
Name
University of Florida
Department
Pharmacology
Type
Schools of Pharmacy
DUNS #
969663814
City
Gainesville
State
FL
Country
United States
Zip Code
32611
Sperber, Nina R; Carpenter, Janet S; Cavallari, Larisa H et al. (2017) Challenges and strategies for implementing genomic services in diverse settings: experiences from the Implementing GeNomics In pracTicE (IGNITE) network. BMC Med Genomics 10:35
Cavallari, L H; Beitelshees, A L; Blake, K V et al. (2017) The IGNITE Pharmacogenetics Working Group: An Opportunity for Building Evidence with Pharmacogenetic Implementation in a Real-World Setting. Clin Transl Sci 10:143-146
Hamadeh, Issam S; Klinker, Kenneth P; Borgert, Samuel J et al. (2017) Impact of the CYP2C19 genotype on voriconazole exposure in adults with invasive fungal infections. Pharmacogenet Genomics 27:190-196
Moon, Jae Youn; Nagaraju, Deepa; Franchi, Francesco et al. (2017) The role of oral anticoagulant therapy in patients with acute coronary syndrome. Ther Adv Hematol 8:353-366
Johnson, J A; Caudle, K E; Gong, L et al. (2017) Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for Pharmacogenetics-Guided Warfarin Dosing: 2017 Update. Clin Pharmacol Ther 102:397-404
Cavallari, Larisa H (2017) Personalizing antiplatelet prescribing using genetics for patients undergoing percutaneous coronary intervention. Expert Rev Cardiovasc Ther 15:581-589
Empey, Philip E; Stevenson, James M; Tuteja, Sony et al. (2017) Multi-site investigation of strategies for the implementation of CYP2C19 genotype-guided antiplatelet therapy. Clin Pharmacol Ther :
Cavallari, Larisa H; Weitzel, Kristin W; Elsey, Amanda R et al. (2017) Institutional profile: University of Florida Health Personalized Medicine Program. Pharmacogenomics 18:421-426
Cavallari, Larisa H; Obeng, Aniwaa Owusu (2017) Genetic Determinants of P2Y12 Inhibitors and Clinical Implications. Interv Cardiol Clin 6:141-149
Roederer, Mary W; Kuo, Grace M; Kisor, David F et al. (2017) Pharmacogenomics competencies in pharmacy practice: A blueprint for change. J Am Pharm Assoc (2003) 57:120-125

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