How to Implement a Pharmacogenetics Service at your Institution

Abstract

The vast majority of patients possess one or more pharmacogenetic variants that can influence optimal medication use. When pharmacogenetic data are used to guide drug choice and dosing, evidence points to improved disease outcomes, fewer adverse effects, and lower healthcare spending. Although its science is well established, clinical use of pharmacogenetic data to guide drug therapy is still in its infancy. Pharmacogenetics essentially involves the intersection of an individual's genetic data with their medications, which makes pharmacists uniquely qualified to provide clinical support and education in this field. In fact, most pharmacogenetics implementations, to date, have been led by pharmacists as leaders or members of a multidisciplinary team or as individual practitioners. A successful large-scale pharmacogenetics implementation requires coordination and synergy among administrators, clinicians, informatics teams, laboratories, and patients. Because clinical implementation of pharmacogenetics is in its early stages, there is an urgent need for guidance and dissemination of shared experiences to provide a framework for clinicians. Many early adopters of pharmacogenetics have explored various strategies among diverse practice settings. This article relies on the experiences of early adopters to provide guidance for critical steps along the pathway to implementation, including strategies to engage stakeholders; evaluate pharmacogenetic evidence; coordinate laboratory testing, results interpretation and their integration into the electronic health record; identify reimbursement avenues; educate providers and patients; and maintain a successful program. Learning from early adopters' published experiences and strategies can allow clinicians leading a new pharmacogenetics implementation to avoid pitfalls and adapt and apply lessons learned by others to their own practice.

Keywords: Implementation; Pharmacogenetics; Pharmacogenomics; Pharmacy.

Figure 1.

Interpretation of Pharmacogenetic Test Result in the Electronic Health Record The electronic health record (EHR) is an optimal tool to assist prescribers in interpreting the pharmacogenetic test result. If results are deposited as discrete results, clinical decision support alerts can fire at appropriate times. This figure was adapted from Dunnenberger HM, Crews KR, Hoffman JM, et al. Preemptive clinical pharmacogenetics implementation: current programs in five US medical centers. Annu Rev Pharmacol Toxicol. 2015;55:89–106.

Figure 2.

Patient Facing Genetic Profile Within EPIC’s Genomic Module, a genomics profile can be created to display all genomic information for the provider and/or the patient. Above is an example of what the profile looks like in the patient view.

Figure 3.

Sample Health Best Practice Advisory This is an example of an alert that fires when certain proton pump inhibitors are ordered (e.g., omeprazole) and the individual is a CYP2C19 Ultrarapid Metabolizer. This figure is used with permission from Epic.’

Figure 4:

Pharmacogenetic Testing LCD Approval Status by State Local coverage determination (LCD) for pharmacogenetic testing and ten of the twelve MACs in the US have adopted similar policies for coverage of pharmacogenetic testing to date.

Figure 5.

Clinical Decision Making Process for Pharmacogenetic Testing The clinical workflow should ideally integrate 4 elements to support a successful implementation: 1) patient identification; 2) pharmacogenetic test ordering; 3) interpretation and application of test results (e.g., drug therapy changes); and 4) patient education This figure has been reprinted with permission from Weitzel KW, Duong BQ, Arwood MJ, Owusu-Obeng A, Abul-Husn NS, Bernhardt BA, Decker B, Denny JC, Dietrich E, Gums J, Madden EB, Pollin TI, Wu RR, Haga SB, Horowitz CR. A stepwise approach to implementing pharmacogenetic testing in the primary care setting. Pharmacogenomics. 2019 Oct;20(15):1103–1112.

Figure 6.

One- and Two-Visit Models for Pharmacogenomic Testing A pharmacogenetics consult clinic may follow a one- or two-visit model depending on the setting. Components of what makes up each visit are described in the figure above.