Emily J Cicali1, Kristin Wiisanen Weitzel1, Amanda R Elsey1, Frank A Orlando2, Michelle Vinson3, Scott Mosley1, D Max Smith1, Richard Davis4, Lori Drum3, David Estores4, James P Franciosi5,6, Melanie Gross Hagen7, Gabriel J Jerkins8, Elvira S Mercado2, Jaison Nainaparampil8, Adaixa Padron8, Eric I Rosenberg7, Ashleigh Wright7, Siegfried O Schmidt2, Carol A Mathews8, Larisa H Cavallari1, Julie A Johnson9. 1. Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA. 2. Department of Community Health and Family Medicine, University of Florida College of Medicine, Gainesville, FL, USA. 3. Florida State University College of Medicine, Orlando, FL, USA. 4. Division of Gastroenterology, Hepatology, and Nutrition, University of Florida College of Medicine, Gainesville, FL, USA. 5. Division of Gastroenterology, Hepatology, and Nutrition, Nemours Children's Hospital, Orlando, FL, USA. 6. University of Central Florida College of Medicine, Orlando, FL, USA. 7. Division of General Internal Medicine, Department of Medicine, University of Florida, Gainesville, FL, USA. 8. Department of Psychiatry, University of Florida Genetics Institute, Gainesville, FL, USA. 9. Department of Pharmacotherapy and Translational Research, University of Florida College of Pharmacy, Gainesville, FL, USA. Julie.johnson@ufl.edu.
Abstract
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.
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.
Entities:
Keywords:
challenges; implementation; pharmacogenetics; pharmacogenomics; precision medicine
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