Pharmacogenomics Implementation at the National Institutes of Health Clinical Center

被引:17
作者
Sissung, Tristan M. [1 ]
McKeeby, Jon W. [2 ]
Patel, Jharana [3 ]
Lertora, Juan J. [4 ]
Kumar, Parag [5 ]
Flegel, Willy A. [6 ]
Adams, Sharon D. [6 ]
Eckes, Ellen J. [7 ]
Mickey, Frank [2 ]
Plona, Teri M. [8 ,9 ]
Mellot, Stephanie D. [8 ,9 ]
Baugher, Ryan N. [8 ,9 ]
Wu, Xiaolin [9 ,10 ]
Soppet, Daniel R. [9 ,10 ]
Barcus, Mary E. [8 ,9 ]
Datta, Vivekananda [8 ,9 ,11 ]
Pike, Kristen M. [8 ,9 ]
DiPatrizio, Gary [2 ]
Figg, William D. [1 ]
Goldspiel, Barry R. [3 ]
机构
[1] NCI, Clin Pharmacol Program, Off Clin Director, Rockville, MD USA
[2] NIH, Dept Clin Res Informat, Ctr Clin, Bldg 10, Bethesda, MD 20892 USA
[3] NIH, Dept Pharm, Ctr Clin, Bldg 10, Bethesda, MD 20892 USA
[4] NIH, Clin Pharmacol Program, Ctr Clin, Bldg 10, Bethesda, MD 20892 USA
[5] NIH, Clin Pharmacokinet Res Lab, Ctr Clin, Bldg 10, Bethesda, MD 20892 USA
[6] NIH, Dept Transfus Med, Ctr Clin, Bethesda, MD 20892 USA
[7] NIH, Med Surg Specialties Serv, Ctr Clin, Dept Nursing, Bldg 10, Bethesda, MD 20892 USA
[8] Leidos Biomed Res Inc, CLIA Mol Diagnost Lab, Canc Res Technol Program, Frederick, MD USA
[9] Leidos Biomed Res Inc, Mol Characterizat Lab, Frederick Natl Lab Canc Res, Frederick, MD USA
[10] Leidos Biomed Res Inc, Genom Lab, Res Technol Program, Frederick, MD USA
[11] Leidos Biomed Res Inc, Mol Characterizat Lab, Canc Res Technol Program, Frederick, MD USA
关键词
pharmacogenomics; implementation; precision medicine; translation; PRECISION MEDICINE; DECISION-SUPPORT; INFORMATION; GUIDELINES; CONSORTIUM; PROGRAMS;
D O I
10.1002/jcph.993
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The National Institutes of Health Clinical Center (NIH CC) is the largest hospital in the United States devoted entirely to clinical research, with a highly diverse spectrum of patients. Patient safety and clinical quality are major goals of the hospital, and therapy is often complicated by multiple cotherapies and comorbidities. To this end, we implemented a pharmacogenomics program in 2 phases. In the first phase, we implemented genotyping for HLA-A and HLA-B gene variations with clinical decision support (CDS) for abacavir, carbamazepine, and allopurinol. In the second phase, we implemented genotyping for drug-metabolizing enzymes and transporters: SLCO1B1 for CDS of simvastatin and TPMT for CDS of mercaptopurine, azathioprine, and thioguanine. The purpose of this review is to describe the implementation process, which involves clinical, laboratory, informatics, and policy decisions pertinent to the NIH CC.
引用
收藏
页码:S67 / S77
页数:11
相关论文
共 15 条
[1]   Clinical Pharmacogenetics Implementation Consortium Guidelines for CYP2C9 and HLA-B Genotypes and Phenytoin Dosing [J].
Caudle, K. E. ;
Rettie, A. E. ;
Whirl-Carrillo, M. ;
Smith, L. H. ;
Mintzer, S. ;
Lee, M. T. M. ;
Klein, T. E. ;
Callaghan, J. T. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2014, 96 (05) :542-548
[2]   Evidence and resources to implement pharmacogenetic knowledge for precision medicine [J].
Caudle, Kelly E. ;
Gammal, Roseann S. ;
Whirl-Carrillo, Michelle ;
Hoffman, James M. ;
Belling, Mary V. ;
Klein, Teri E. .
AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 2016, 73 (23) :1977-1985
[3]   Implementation of inpatient models of pharmacogenetics programs [J].
Cavallari, Larisa H. ;
Lee, Craig R. ;
Duarte, Julio D. ;
Nutescu, Edith A. ;
Weitzel, Kristin W. ;
Stouffer, George A. ;
Johnson, Julie A. .
AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 2016, 73 (23) :1944-1954
[4]   The National Institutes of Health's Biomedical Translational Research Information System (BTRIS): Design, contents, functionality and experience to date [J].
Cimino, James J. ;
Ayres, Elaine J. ;
Remennik, Lyubov ;
Rath, Sachi ;
Freedman, Robert ;
Beri, Andrea ;
Chen, Yang ;
Huser, Vojtech .
JOURNAL OF BIOMEDICAL INFORMATICS, 2014, 52 :11-27
[5]   Preemptive Clinical Pharmacogenetics Implementation: Current Programs in Five US Medical Centers [J].
Dunnenberger, Henry M. ;
Crews, Kristine R. ;
Hoffman, James M. ;
Caudle, Kelly E. ;
Broeckel, Ulrich ;
Howard, Scott C. ;
Hunkler, Robert J. ;
Klein, Teri E. ;
Evans, William E. ;
Relling, Mary V. .
ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY, VOL 55, 2015, 55 :89-+
[6]   Next-generation sequencing to guide cancer therapy [J].
Gagan, Jeffrey ;
Van Allen, Eliezer M. .
GENOME MEDICINE, 2015, 7
[7]   Integrating pharmacogenetic information and clinical decision support into the electronic health record [J].
Goldspiel, Barry R. ;
Flegel, Willy A. ;
DiPatrizio, Gary ;
Sissung, Tristan ;
Adams, Sharon D. ;
Penzak, Scott R. ;
Biesecker, Leslie G. ;
Fleisher, Thomas A. ;
Patel, Jharana J. ;
Herion, David ;
Figg, William D. ;
Lertora, Juan J. L. ;
McKeeby, Jon W. .
JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION, 2014, 21 (03) :522-528
[8]  
Haerian Krystl, 2009, AMIA Annu Symp Proc, V2009, P218
[9]   Preemptive Pharmacogenomic Testing for Precision Medicine A Comprehensive Analysis of Five Actionable Pharmacogenomic Genes Using Next-Generation DNA Sequencing and a Customized CYP2D6 Genotyping Cascade [J].
Ji, Yuan ;
Skierka, Jennifer M. ;
Blommel, Joseph H. ;
Moore, Brenda E. ;
VanCuyk, Douglas L. ;
Bruflat, Jamie K. ;
Peterson, Lisa M. ;
Veldhuizen, Tamra L. ;
Fadra, Numrah ;
Peterson, Sandra E. ;
Lagerstedt, Susan A. ;
Train, Laura J. ;
Baudhuin, Linnea M. ;
Klee, Eric W. ;
Ferber, Matthew J. ;
Bielinski, Suzette J. ;
Caraballo, Pedro J. ;
Weinshilboum, Richard M. ;
Black, John L., III .
JOURNAL OF MOLECULAR DIAGNOSTICS, 2016, 18 (03) :438-445
[10]   Pharmacogenomics of severe cutaneous adverse reactions and drug-induced liver injury [J].
Kaniwa, Nahoko ;
Saito, Yoshiro .
JOURNAL OF HUMAN GENETICS, 2013, 58 (06) :317-326