Challenges and lessons learned from clinical pharmacogenetic implementation of multiple gene-drug pairs across ambulatory care settings

被引：61

作者：

Cicali, Emily J. ^{[1
]}

Weitzel, Kristin Wiisanen ^{[1
]}

Elsey, Amanda R. ^{[1
]}

Orlando, Frank A. ^{[2
]}

Vinson, Michelle ^{[3
]}

Mosley, Scott ^{[1
]}

Smith, D. Max ^{[1
]}

Davis, Richard ^{[4
]}

Drum, Lori ^{[3
]}

Estores, David ^{[4
]}

Franciosi, James P. ^{[5
,6
]}

Hagen, Melanie Gross ^{[7
]}

Jerkins, Gabriel J. ^{[8
]}

Mercado, Elvira S. ^{[2
]}

Nainaparampil, Jaison ^{[8
]}

Padron, Adaixa ^{[8
]}

Rosenberg, Eric I. ^{[7
]}

Wright, Ashleigh ^{[7
]}

Schmidt, Siegfried O. ^{[2
]}

Mathews, Carol A. ^{[8
]}

Cavallari, Larisa H. ^{[1
]}

Johnson, Julie A. ^{[1
]}

机构：

[1] Univ Florida, Coll Pharm, Dept Pharmacotherapy & Translat Res, Gainesville, FL 32611 USA

[2] Univ Florida, Coll Med, Dept Community Hlth & Family Med, Gainesville, FL USA

[3] Florida State Univ, Coll Med, Orlando, FL USA

[4] Univ Florida, Coll Med, Div Gastroenterol Hepatol & Nutr, Gainesville, FL USA

[5] Nemours Childrens Hosp, Div Gastroenterol Hepatol & Nutr, Orlando, FL USA

[6] Univ Cent Florida, Coll Med, Orlando, FL 32816 USA

[7] Univ Florida, Dept Med, Div Gen Internal Med, Gainesville, FL USA

[8] Univ Florida, Dept Psychiat, Genet Inst, Gainesville, FL 32611 USA

来源：

GENETICS IN MEDICINE | 2019年 / 21卷 / 10期

基金：

美国国家卫生研究院;

关键词：

pharmacogenetics; pharmacogenomics; implementation; challenges; precision medicine; UNIVERSITY-OF-FLORIDA; VALIDATION; INVENTORY; SEVERITY; DISTRESS; GENOTYPE; CHILDREN; OUTCOMES; THERAPY;

D O I：

10.1038/s41436-019-0500-7

中图分类号：

Q3 [遗传学];

学科分类号：

071007 ; 090102 ;

摘要：

Purpose: Incorporating a patient's genotype into the clinical decision-making process is one approach to precision medicine. The University of Florida (UF) Health Precision Medicine Program is a pharmacist-led multidisciplinary effort that has led the clinical implementation of six gene-drug(s) pairs to date. This study focuses on the challenges encountered and lessons learned with implementing pharmacogenetic testing for three of these: CYP2D6-opioids, CYP2D6/CYP2C19-selective serotonin reuptake inhibitors, and CYP2C19-proton pump inhibitors within six pragmatic clinical trials at UF Health and partners. Methods: We compared common measures collected within each of the pharmacogenetic implementations as well as solicited feedback from stakeholders to identify challenges, successes, and lessons learned. Results: We identified several challenges related to trial design and implementation, and learned valuable lessons. Most notably, case discussions are effective for prescriber education, prescribers need clear concise guidance on genotype-based actions, having genotype results available at the time of the patient-prescriber encounter helps optimize the ability to act on them, children prefer noninvasive sample collection, and study participants are willing to answer patient-reported outcomes questionnaires if they are not overly burdensome, among others. Conclusion: The lessons learned from implementing three gene-drug pairs in ambulatory care settings will help shape future pharmacogenetic clinical trials and clinical implementations.

引用

页码：2264 / 2274

页数：11

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