Pharmacogenomics Education, Research and Clinical Implementation in the State of Minnesota

Abstract

Several healthcare organizations across Minnesota have developed formal pharmacogenomic (PGx) clinical programs to increase drug safety and effectiveness. Healthcare professional and student education is strong and there are multiple opportunities in the state for learners to gain workforce skills and develop advanced competency in PGx. Implementation planning is occurring at several organizations and others have incorporated structured utilization of PGx into routine workflows. Laboratory-based and translational PGx research in Minnesota has driven important discoveries in several therapeutic areas. This article reviews the state of PGx activities in Minnesota including educational programs, research, national consortia involvement, technology, clinical implementation and utilization and reimbursement, and outlines the challenges and opportunities in equitable implementation of these advances.

A Scoping Review of Attitudes and Experiences with Pharmacogenomic Testing among Patients and the General Public: Implications for Patient Counseling

“…Pharmacogenomic (PGx) testing is increasingly entering mainstream clinical practice and is of great interest to patients and providers [ 1 ]. Numerous healthcare systems are implementing PGx programs [ 2 , 3 , 4 , 5 , 6 , 7 , 8 ], and statewide initiatives to implement PGx testing are also underway [ 9 , 10 ]. As the clinical utility and uptake of PGx has grown, conversations about PGx have shifted from “should we do PGx testing?” to “how should we best implement PGx testing?” As guideline-producing groups, such as the Clinical Pharmacogenetics Implementation Consortium [ 11 ], develop recommendations for how to best apply the scientific evidence, and as clinicians and implementation scientists [ 12 ] develop best practices for clinical implementation, there is one critical voice that must be heard: the patient.…”

Characterizing pharmacogenetic programs using the consolidated framework for implementation research: A structured scoping review

“…It also considers an institution’s readiness for implementation, which corresponds to leadership engagement, the availability of resources to support implementation, and stakeholder access to relevant educational material. Many centers established educational programs and developed dedicated programs or departments to support implementation ( 26 , 66 , 67 ). A positive learning climate was described by 35% of programs and ready access to information was positively referenced by 40% of institutes.…”

“…All of the sites recognized the need to educate clinicians about pharmacogenetics either within the context of specific studies or as part of deploying CDS tools within the EHR. The educational strategies deployed by different programs varied in their scale, content and methodological approach ( 66 , 67 ). Several sites made use of online resources which clinicians could access in their own time to support asynchronous learning.…”

Development and Implementation of In-House Pharmacogenomic Testing Program at a Major Academic Health System

“…There have been a number of medical centers in the United States and beyond that have undertaken the difficult effort of implementing pharmacogenomic testing in recent years, ( Gottesman et al, 2013 ; Bielinski et al, 2014 ; Shuldiner et al, 2014 ; Arwood et al, 2016 ; Eadon et al, 2016 ; Rosenman et al, 2017 ; van der Wouden et al, 2017 ; Cavallari et al, 2018 ; Rigter et al, 2020 ), including several medical centers in the state of Minnesota ( Bishop et al, 2021 ). The successful implementation of the PGx testing program remains, however, a challenging enterprise.…”

“…Additionally, the assay cannot describe with any confidence any CYP2D7 conversions or CYP2D6/CYP2D7 structural variations and the CYP2D6 CNV assay cannot determine the specific increased number of gene copies beyond duplication. Despite those limitations we are able to deliver CPIC based gene-phenotype-drug recommendations on 33 medications from 14 therapeutic classes to help patients cared for by at least seven clinical specialties (see Supplementary Table S8 for details), making our assay comparable to other medical centers and commercial vendors offerings ( Caudle et al, 2018 ; Haga and Kantor 2018 ; Tilleman et al, 2019 ; Bishop et al, 2021 ). As we build on our PGx testing expertise the next iteration of the assay will be planned and the increase in both gene and allele counts, with consideration for other CPIC recommended genes, genes that occur with reasonably high frequency in the US population, those that are associated with a phenotype that can influence medication selection (e.g., Factor 2 and Factor 5) and variants that may be more common in some of the unique ancestral populations (e.g., East African, Hmong) that currently reside in the Minneapolis-St. Paul metro area, will be considered.…”