Establishment of a Pharmacogenetics Service Focused on Optimizing Existing Pharmacogenetic Testing at a Large Academic Health Center

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.

Pharmacogenomic Clinical Decision Support: A Review, How‐to Guide, and Future Vision

“…REVIEW interaction), and alert response (i.e., accepting or rejecting the triggered alert). 15,25,40,[72][73][74][75][76][77][78][79] Specifics will vary based on institutional policy but the culmination of the design and feedback phases generally consists of a presentation of submission for approval of the project to an overseeing committee. Often this will be the institution's Pharmacy and Therapeutics (P&T) Committee or similar equivalent.…”

“…Each member will be familiar with the types of objective measures valuable to patient care and the clinician workflows. Metrics for CDS that have been used include the number of alerts triggered, clinical response (i.e., changing therapy in accordance with the anticipated PGx interaction), and alert response (i.e., accepting or rejecting the triggered alert) 15,25,40,72–79 . Specifics will vary based on institutional policy but the culmination of the design and feedback phases generally consists of a presentation of submission for approval of the project to an overseeing committee.…”

“…Metrics for CDS that have been used include the number of alerts triggered, clinical response (i.e., changing therapy in accordance with the anticipated PGx interaction), and alert response (i.e., accepting or rejecting the triggered alert). 15 , 25 , 40 , 72 , 73 , 74 , 75 , 76 , 77 , 78 , 79 Specifics will vary based on institutional policy but the culmination of the design and feedback phases generally consists of a presentation of submission for approval of the project to an overseeing committee. Often this will be the institution’s Pharmacy and Therapeutics (P&T) Committee or similar equivalent.…”

Revisiting Secondary Information Related to Pharmacogenetic Testing

“…As clinical evidence continues to accumulate, the number of associations of PGx variants (and non-PGx variants) with responses to multiple medications as well as disease risk linked to their endogenous roles (Nebert and Dalton, 2006) will likely expand as presaged by the growing ACMG list. Although secondary findings have been known for some time, reports of different group's experiences with implementing PGx testing do not mention challenges related to management of secondary findings (Pasternak et al, 2020;Luczak et al, 2021). This lack of mention may be due to inadequate evidence of many PGx secondary findings, the limited number of validated secondary findings, or a lack of reporting by clinical PGx testing laboratories (due to absence of standards on reporting).…”

Pharmacogenomics: From Basic Research to Clinical Implementation

“…The authors found that PGx-led medication changes added minimal short-term cost to patient care and emphasized potential long-term benefits, including improved dosing and reduced adverse drug reactions. Pasternak et al [ 9 ] conducted a retrospective review of medical records and provided a detailed assessment of documented PGx testing. These authors used this review to develop several recommendations for improving clinical PGx testing, including the establishment of a clinical PGx consult service involving pharmacists and clinicians and the application of standardized CPIC terminology.…”