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. 2019 Oct;21(10):2264-2274.
doi: 10.1038/s41436-019-0500-7. Epub 2019 Mar 30.

Challenges and Lessons Learned From Clinical Pharmacogenetic Implementation of Multiple Gene-Drug Pairs Across Ambulatory Care Settings

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Free PMC article

Challenges and Lessons Learned From Clinical Pharmacogenetic Implementation of Multiple Gene-Drug Pairs Across Ambulatory Care Settings

Emily J Cicali et al. Genet Med. .
Free PMC article

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.

Keywords: challenges; implementation; pharmacogenetics; pharmacogenomics; precision medicine.

Conflict of interest statement

DISCLOSURE

The authors declare no conflicts of interest.

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