Abstract
Multiple groups have described strategies for clinical implementation of pharmacogenetics (PGx) that often include internal laboratory tests that are specifically developed for their implementation needs. However, many institutions are not able to follow this practice and instead must utilize external laboratories to obtain PGx testing results. As each external laboratory might have different ordering and reporting workflows, consistent reporting and storing of PGx results within the medical record can be a challenge. This might result in patient safety concerns as important PGx information might not be easily identifiable at the point of current or future prescribing. Herein, we describe initial PGx clinical implementation efforts at a large academic medical center, focusing on optimizing three different test ordering workflows and two distinct result reporting strategies. From this, we identified common issues such as variable reporting location and structure of PGx results, as well as duplicate PGx testing. We identified several opportunities to optimize our current processes, including—(1) PGx laboratory stewardship, (2) increasing visibility of PGx tests, and (3) clinician and patient education. Key to the success was the importance of engaging clinician, informatics, and pathology stakeholders, as we developed interventions to improve our PGX implementation processes.
Highlights
Pharmacogenetics (PGx) is a pillar of precision medicine that aims to improve healthcare by using genetics to guide prescribing towards safer, more effective medication outcomes
Despite clinical guidelines and Food and Drug Administration-approved package labeling that provides recommendations for select medications based on genotype, pharmacogenetic implementation efforts across the United States are varied in depth and scope [1,2]
Preliminary searches of laboratory tests, problem list entries, and clinical notes began by using names of germline pharmacogenes, with guidelines from Clinical Pharmacogenetics Implementation Consortium (CPIC) or germline genes included in the Food and Drug Administration (FDA) Pharmacogenomic Biomarkers table
Summary
Pharmacogenetics (PGx) is a pillar of precision medicine that aims to improve healthcare by using genetics to guide prescribing towards safer, more effective medication outcomes. Despite clinical guidelines and Food and Drug Administration-approved package labeling that provides recommendations for select medications based on genotype, pharmacogenetic implementation efforts across the United States are varied in depth and scope [1,2]. Pharmacogenetic implementation pioneers frequently developed research-based programs where patients consent to broad panel-based testing that is integrated into electronic systems, to guide drug prescribing [3,4,5,6]. Others developed inpatient clinical programs where single drug-gene pairs were selected and implemented within a specific practice setting, such as CYP2C19 testing for percutaneous coronary intervention [7,8,9]. In the majority of cases of these early adopters, the institutions identified a single source for PGx testing, such as internal PGx testing panels, which were customized to the needs of their project, institution, and population
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