Table 1.

Use Case Scenario: Implementation of Guiding Principles in University of Florida (UF) Health Precision Medicine Program (PMP)

Program Overview: The UF Health PMP, a pharmacist-led multi-disciplinary clinical implementation initiative established in 2011 has genotyped more than 10,000 patients to date. Seven unique gene-drug pairs have been implemented across inpatient and outpatient settings, including an established pharmacogenetics consult clinic. Currently, testing is available in all patient care areas, supported by 2 clinical pharmacogenetics specialists and trainees.
Stakeholders and Engagement	• Pharmacist-led multidisciplinary clinical implementation initiative engaging patients, pharmacists, providers, health system clinical and administrative leaders, and pathology.
Evidence Evaluation Strategy	• Evidence evaluated and assessed by an internal committee, similar to a Pharmacy and Therapeutics Committee, with representation from UF College of Pharmacy and UF Health clinicians.
Pharmacogenetic Testing Logistics	• Majority of testing performed by UF Health Pathology Laboratories.  • Launched initially with a preemptive genotyping focus, using chip-based genotyping that generated multiple genotypes, some of which were stored in a research database with a plan to migrate to the electronic health record (EHR) as sufficient clinical data emerge.17 Then transitioned to single-gene tests: cytochrome P450 (CYP)2C19, followed by thiopurine S-methyltransferase (TPMT) in 2014, CYP2D6 in 2015, and NUDT15 in 2019. In 2019, UF Health developed and launched a clinically focused multi-gene panel while still offering several single-gene tests.
Electronic Health Record Integration and Test Interpretation	• Laboratory results section in Epic EHR houses discrete genotype and phenotype results that trigger clinical decision support (CDS) alerts.  • The majority of alerts at UF Health are active, pop-up alerts that disrupt workflow appropriately (e.g., only fire for actionable gene-drug pair)  • Consultation notes are placed in the EHR by pharmacists with providers notified by Epic in-basket message.18  • Currently transitioning to the Epic Genomics to allow for consolidation of all genetics information into one profile, creation of multiple forms of CDS, and improved pharmacogenetic result readability within the patient profile.
Reimbursement Strategies	• Non-research clinical tests for ambulatory care patients are billed to insurance with pre-test patient education on potential out-of-pocket costs. Inpatient tests within UF Health are billed through Diagnostic Related Grouping (DRG). A portion of tests are covered by research funding.
Educational Strategies	• Patient education in face-to-face encounters, through print materials, and via a video sent to patients prior to their clinic appointment (available at https://youtu.be/b9FyOAEXzBw).  • Provider education includes traditional presentations, printed tip sheets to facilitate referrals and point-of-care decision making, and monthly patient case presentations of actual clinic patients to providers.
Program Maintenance Strategies	• A Research Electronic Data Capture (REDCap) database was created to track prospective data for quality improvement. The database tracks volume of patients with pharmacogenetic tests ordered, volume of patients seen in the consult clinic and associated billing information, pharmacogenetic test results, medication data, pharmacist recommendations made, medication changes in response to recommendations, and CDS alerts fired.  • The clinical workbench in Epic is used to monitor functionality of CDS alerts on a monthly basis, including alert frequency and provider’s actions after viewing the alert.  • A human-factor interaction approach was used to conduct a usability evaluation to evaluate and enhance the design of pharmacogenetics alerts.19