Pharmacogenomics Implementation at the National Institutes of Health Clinical Center

Tristan M Sissung; Jon W McKeeby; Jharana Patel; Juan J Lertora; Parag Kumar; Willy A Flegel; Sharon D Adams; Ellen J Eckes; Frank Mickey; Teri M Plona; Stephanie D Mellot; Ryan N Baugher; Xiaolin Wu; Daniel R Soppet; Mary E Barcus; Vivekananda Datta; Kristen M Pike; Gary DiPatrizio; William D Figg; Barry R Goldspiel

doi:10.1002/jcph.993

Pharmacogenomics Implementation at the National Institutes of Health Clinical Center

J Clin Pharmacol. 2017 Oct;57 Suppl 10(Suppl 10):S67-S77. doi: 10.1002/jcph.993.

Authors

Tristan M Sissung¹, Jon W McKeeby², Jharana Patel³, Juan J Lertora⁴, Parag Kumar⁵, Willy A Flegel⁶, Sharon D Adams⁶, Ellen J Eckes⁷, Frank Mickey², Teri M Plona⁸, Stephanie D Mellot⁸, Ryan N Baugher⁸, Xiaolin Wu⁹, Daniel R Soppet⁹, Mary E Barcus⁸, Vivekananda Datta^{8

10}, Kristen M Pike⁸, Gary DiPatrizio², William D Figg¹, Barry R Goldspiel³

Affiliations

¹ Clinical Pharmacology Program, Office of the Clinical Director, National Cancer Institute, Rockville, MD, USA.
² Department of Clinical Research Informatics, NIH Clinical Center, Bethesda, MD, USA.
³ Pharmacy Department, NIH Clinical Center, Bethesda, MD, USA.
⁴ Clinical Pharmacology Program (2006-2016), NIH Clinical Center, Bethesda, MD, USA.
⁵ Clinical Pharmacokinetics Research Laboratory, NIH Clinical Center, Bethesda, MD, USA.
⁶ Department of Transfusion Medicine, NIH Clinical Center, Bethesda, MD, USA.
⁷ Medical Surgical Specialties Service, Clinical Center Nursing Department, NIH, Bethesda, MD, USA.
⁸ CLIA Molecular Diagnostics Laboratory, Cancer Research Technology Program, and Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., Frederick, MD, USA.
⁹ Genomics Laboratory, Cancer Research Technology Program, and Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., Frederick, MD, USA.
¹⁰ Molecular Characterization Laboratory, Cancer Research Technology Program, and Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc., Frederick, MD, USA.

Abstract

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.

Keywords: implementation; pharmacogenomics; precision medicine; translation.

Publication types

Review

MeSH terms

Biomedical Research / organization & administration*
Decision Support Systems, Clinical
Genotype
Humans
Medical Informatics
National Institutes of Health (U.S.) / organization & administration*
Organizational Policy
Pharmacogenetics / methods*
United States

Grants and funding

ZIA BC010627-13/Intramural NIH HHS/United States