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Concepts Driving Pharmacogenomics Implementation Into Everyday Healthcare

Authors Giri J, Moyer AM, Bielinski SJ, Caraballo PJ

Received 5 July 2019

Accepted for publication 7 October 2019

Published 30 October 2019 Volume 2019:12 Pages 305—318


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Dr Martin Bluth

Jyothsna Giri,1 Ann M Moyer,2 Suzette J Bielinski,3 Pedro J Caraballo4,5

1Center for Individualized Medicine, Mayo Clinic, Rochester, MN, USA; 2Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA; 3Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA; 4Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA; 5Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA

Correspondence: Pedro J Caraballo
Center for the Science of Health Care Delivery, Mayo Clinic, 200 First Street SW, Rochester, MN 55904, USA
Tel +1 507 284 8586
Fax +1 507 284 5370

Abstract: Pharmacogenomics (PGx) is often promoted as the domain of precision medicine with the greatest potential to readily impact everyday healthcare. Rapid advances in PGx knowledge derived from extensive basic and clinical research along with decreasing costs of laboratory testing have led to an increased interest in PGx and expectations of imminent clinical translation with substantial clinical impact. However, the implementation of PGx into clinical workflows is neither simple nor straightforward, and comprehensive processes and multidisciplinary collaboration are required. Several national and international institutions have pioneered models for implementing clinical PGx, and these initial models have led to a better understanding of unresolved challenges. In this review, we have categorized and explored the most relevant of these challenges to highlight potential gaps and present possible solutions. We describe the ongoing need for basic and clinical research to drive further developments in evidence-based medicine. Integration into daily clinical workflows introduces new challenges requiring innovative solutions; specifically those related to the electronic health record and embedded clinical decision support. We describe advances in PGx testing and result reporting and describe the critical need for increased standardization in these areas across laboratories. We also explore the complexity of the PGx knowledge required for clinical practice and the need for educational strategies to ensure adequate understanding among members of current and future healthcare teams. Finally, we evaluate knowledge obtained from previous implementation efforts and discuss how to best apply these learnings to future projects. Despite these challenges, the future of precision medicine appears promising due to the rapidity of recent advances in the field and current multidisciplinary efforts to effectively translate PGx to everyday clinical practice.

Keywords: precision medicine, pharmacogenomics, clinical implementation, clinical decision support, delivery of health care, medication therapy management

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