دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: Challenges and lessons learned from clinical pharmacogenetic implementation of multiple gene-drug pairs across ambulatory care settings.
المؤلفون: Cicali EJ; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA., Weitzel KW; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA., Elsey AR; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA., Orlando FA; Department of Community Health and Family Medicine, University of Florida College of Medicine, Gainesville, FL, USA., Vinson M; Florida State University College of Medicine, Orlando, FL, USA., Mosley S; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA., Smith DM; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA., Davis R; Division of Gastroenterology, Hepatology, and Nutrition, University of Florida College of Medicine, Gainesville, FL, USA., Drum L; Florida State University College of Medicine, Orlando, FL, USA., Estores D; Division of Gastroenterology, Hepatology, and Nutrition, University of Florida College of Medicine, Gainesville, FL, USA., Franciosi JP; Division of Gastroenterology, Hepatology, and Nutrition, Nemours Children's Hospital, Orlando, FL, USA.; University of Central Florida College of Medicine, Orlando, FL, USA., Hagen MG; Division of General Internal Medicine, Department of Medicine, University of Florida, Gainesville, FL, USA., Jerkins GJ; Department of Psychiatry, University of Florida Genetics Institute, Gainesville, FL, USA., Mercado ES; Department of Community Health and Family Medicine, University of Florida College of Medicine, Gainesville, FL, USA., Nainaparampil J; Department of Psychiatry, University of Florida Genetics Institute, Gainesville, FL, USA., Padron A; Department of Psychiatry, University of Florida Genetics Institute, Gainesville, FL, USA., Rosenberg EI; Division of General Internal Medicine, Department of Medicine, University of Florida, Gainesville, FL, USA., Wright A; Division of General Internal Medicine, Department of Medicine, University of Florida, Gainesville, FL, USA., Schmidt SO; Department of Community Health and Family Medicine, University of Florida College of Medicine, Gainesville, FL, USA., Mathews CA; Department of Psychiatry, University of Florida Genetics Institute, Gainesville, FL, USA., Cavallari LH; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA., Johnson JA; Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA. Julie.johnson@ufl.edu.
المصدر: Genetics in medicine : official journal of the American College of Medical Genetics [Genet Med] 2019 Oct; Vol. 21 (10), pp. 2264-2274. Date of Electronic Publication: 2019 Mar 30.
نوع المنشور: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: United States NLM ID: 9815831 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1530-0366 (Electronic) Linking ISSN: 10983600 NLM ISO Abbreviation: Genet Med Subsets: MEDLINE
أسماء مطبوعة: Publication: 2022- : [New York] : Elsevier
Original Publication: Baltimore, MD : Lippincott, Williams & Wilkins, c1998-
مواضيع طبية MeSH: Pharmacogenetics/*methods , Pharmacogenomic Testing/*methods , Precision Medicine/*methods, Ambulatory Care ; Clinical Trials as Topic/methods ; Cytochrome P-450 CYP2C19/genetics ; Cytochrome P-450 CYP2D6/genetics ; Florida ; Genotype ; Humans
مستخلص: 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.
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معلومات مُعتمدة: U01 HG007269 United States HG NHGRI NIH HHS; UL1 TR001427 United States TR NCATS NIH HHS
فهرسة مساهمة: Keywords: challenges; implementation; pharmacogenetics; pharmacogenomics; precision medicine
المشرفين على المادة: EC 1.14.14.1 (CYP2C19 protein, human)
EC 1.14.14.1 (Cytochrome P-450 CYP2C19)
EC 1.14.14.1 (Cytochrome P-450 CYP2D6)
تواريخ الأحداث: Date Created: 20190331 Date Completed: 20200317 Latest Revision: 20220210
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC6768772
DOI: 10.1038/s41436-019-0500-7
PMID: 30926959
قاعدة البيانات: MEDLINE
الوصف
تدمد:1530-0366
DOI:10.1038/s41436-019-0500-7