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Implementation of pharmacogenetics: The University of Maryland personalized anti-platelet pharmacogenetics program

Authors

  • Alan R. Shuldiner,

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    • Alan R. Shuldiner, MD is the John L. Whitehurst Professor at the University of Maryland School of Medicine, Associate Dean of Personalized Medicine, Director of the Program for Personalized and Genomic Medicine, and Head of the Division of Endocrinology, Diabetes and Nutrition. He leads a multidisciplinary clinical and translational research program that includes protocols conducted at the Amish Research Clinic in Lancaster, PA, the University of Maryland, and Baltimore Veterans Administration Medical Center.
  • Kathleen Palmer,

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    • Kathleen Palmer, RN is the Clinical Research Manager for the Program for Personalized and Genomic Medicine at the University of Maryland School of Medicine.
  • Ruth E. Pakyz,

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    • Ruth Pakyz, BS is Program Manager for the Program for Personalized and Genomic Medicine at the University of Maryland School of Medicine.
  • Tameka D. Alestock,

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    • Tameka Alestock, MS is a Clinical Research Coordinator for the University of Maryland School of Medicine Program for Personalized and Genomic Medicine and the Division of Cardiovascular Medicine.
  • Kristin A. Maloney,

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    • Kristin Maloney, MS, MGC is a certified Genetic Counselor at the University of Maryland Center for Medical Genetics and Personalized Medicine and is a member of the University of Maryland School of Medicine Program for Personalized and Genomic Medicine. Her current position includes both research and clinical responsibilities.
  • Courtney O'Neill,

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    • Courtney O'Neill, MSN, RN is a Cardiac Catheterization Nurse and Clinical Research Coordinator at the Baltimore Veterans Administration Medical Center. She has 8 years of critical care and research experience. She collaborates with Drs. Vesley and Robinson to develop research protocols at that facility and with the University of Maryland research team.
  • Shaun Bhatty,

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    • Shaun Bhatty, MD is a Cardiology Fellow at the University of Maryland Medical Center.
  • Jamie Schub,

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    • Jamie Schub, MS is Research Study Coordinator for the University of Maryland School of Medicine Program for Personalized and Genomic Medicine.
  • Casey Lynnette Overby,

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    • Casey Lynnette Overby, PhD is an Assistant Professor in the Program for Personalized and Genomic Medicine and a member of the Center for Health-related Informatics and Bio-imaging at the University of Maryland School of Medicine. Her research seeks to develop new approaches for interpreting genome information. She also seeks to understand processes and factors associated with the successful integration of these approaches into healthcare settings.
  • Richard B. Horenstein,

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    • Richard B. Horenstein, MD, JD is an Assistant Professor at the University of Maryland School of Medicine and a member of the Program for Personalized and Genomic Medicine. He is a physician scientist with over 12 years of experience performing clinical and basic studies including a genotype related clopidogrel dose escalation study in collaboration with NIH and FDA scientists. He also served as site-PI of the NHLBI sponsored COAG Trial.
  • Toni I. Pollin,

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    • Toni I. Pollin, PhD is an Associate Professor at the University of Maryland School of Medicine and a member of the Program for Personalized and Genomic Medicine. She is a human geneticist and genetic counselor with 15 years of research experience in the area of the genetics of common complex diseases such as diabetes and its cardiovascular complications, including study leadership, management and statistical analysis and interpretation.
  • Mark D. Kelemen,

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    • Mark Kelemen MD, MBA is Clinical Associate Professor of Medicine in the Division of Cardiovascular Medicine and Senior Vice President and Chief Medical Informatics Officer of the University of Maryland Medical System. He leads the implementation of advanced clinical decision support and electronic health records for the health system.
  • Amber L. Beitelshees,

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    • Amber Beitelshees, PharmD, MPH is an Assistant Professor at the University of Maryland School of Medicine and a member of the Program for Personalized and Genomic Medicine. Her expertise resides in clinical pharmacology, pharmacogenomics, public health, and translational research.
  • Shawn W. Robinson,

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    • Shawn W. Robinson, MD is Cardiology Section Chief for the VA Maryland Health Care System. He is board certified in both general cardiovascular diseases and in advanced heart failure and transplant cardiology. He has over 15 years of experience serving as co-investigator on several acute and chronic heart failure clinical trials. His research effort in the area of pharmacogenomics investigates how various genetic polymorphisms influence myocardial function and treatment.
  • Miriam G. Blitzer,

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    • Miriam G. Blitzer, PhD, is Professor at the University of Maryland School of Medicine. She is Head of the Division of Human Genetics in the Department of Pediatrics. She is a board-certified in clinical biochemical genetics. She co-directs the medical school curriculum that focuses on medical genetics.
  • Patrick F. McArdle,

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    • Patrick McArdle, PhD is an Assistant Professor at the University of Maryland School of Medicine and a member of the Program for Personalized and Genomic Medicine. He is an epidemiologist with extensive experience in human subjects research with a focus on genetic epidemiology, particularly the analysis and interpretation of genome-wide genetic data and complex phenotypic data.
  • Lawrence Brown,

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    • Lawrence A. Brown, MD is a Staff Pathologist at the Baltimore VA Medical Center, and Assistant Professor of Pathology at the University of Maryland School of Medicine.
  • Linda Jo Bone Jeng,

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    • Linda Jo Bone Jeng, MD, PhD is an Associate Professor in Medicine, Pathology and Pediatrics at the University of Maryland School of Medicine and a member of the Program for Personalized and Genomic Medicine. She is Director of Genomic Medicine in the Translational Genomics Laboratory. She is board-certified in clinical genetics and clinical molecular genetics.
  • Richard Y. Zhao,

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    • Richard Y. Zhao, PhD is a Professor of Pathology and Microbiology-Immunology at the University of Maryland School of Medicine and a member of the Program for Personalized and Genomic Medicine. He is the Director of the Translational Genomics Laboratory where the CYP2C19 clinical tests are performed. He has nearly 20 years of experience in molecular diagnostics and molecular pathology.
  • Nicholas Ambulos,

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    • Nicholas P. Ambulos, Jr., Ph.D. is Executive Director of the University of Maryland School of Medicine Research Cores and Technical Supervisor of the Translational Genomics Laboratory. He is also a member of the Program for Personalized and Genomic Medicine.
  • Mark R. Vesely

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    • Mark R. Vesely, MD is an Assistant Professor of Medicine at the University of Maryland School of Medicine and a member of the Program for Personalized and Genomic Medicine. He is Director of the Interventional Cardiology Fellowship Training Program and the Baltimore VA Medical Center Cardiac Catheterization Lab. His major clinical focus is interventional cardiology where he provides invasive diagnostic and interventional therapeutic care for the entire range of clinical cardiac pathology, most prominently ischemic heart disease and congestive heart failure with an expanding focus on structural and valvular heart disease. He has been involved in clinical research for over 10 years. He has held the position of principal investigator on numerous studies and trials as well as being a sub-investigator on many others.

  • Conflict of interest disclosure: Dr. Shuldiner receives support from NIH for anti-platelet pharmacogenomics research, and is a consultant to United States Diagnostic Standards, Inc. and Merck, Inc. Other authors have no conflicts of interest to declare.
  • * Correspondence to: Alan R. Shuldiner, M.D., University of Maryland School of Medicine, 685 West Baltimore Street, Room 379, Baltimore, MD 21201. E-mail: ashuldin@medicine.umaryland.edu

Abstract

Despite a substantial evidence base, implementation of pharmacogenetics into routine patient care has been slow due to a number of non-trivial practical barriers. We implemented a Personalized Anti-platelet Pharmacogenetics Program (PAP3) for cardiac catheterization patients at the University of Maryland Medical Center and the Baltimore Veterans Administration Medical Center Patients' are offered CYP2C19 genetic testing, which is performed in our Clinical Laboratory Improvement Amendment (CLIA)-certified Translational Genomics Laboratory. Results are returned within 5 hr along with clinical decision support that includes interpretation of results and prescribing recommendations for anti-platelet therapy based on the Clinical Pharmacogenetics Implementation Consortium guidelines. Now with a working template for PAP3, implementation of other drug-gene pairs is in process. Lessons learned as described in this article may prove useful to other medical centers as they implement pharmacogenetics into patient care, a critical step in the pathway to personalized and genomic medicine. © 2014 Wiley Periodicals, Inc.

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