Pharmacogenetic (PGx) testing can inform drug dosing and selection by assessing genetic variants known to impact risks of adverse response or non-effectiveness. Although multiple delivery models for PGx testing are currently being explored or used, it is not clear which models are most effective and can be implemented widely. Further, the availability and delivery of PGx testing, particularly in the outpatient settig, may vary considerably due in part to providers' knowledge and experience with testing. Pharmacists can play a key role in delivering PGx testing and interacting with both patients and providers. Through our previous research in this R01, we found having a pharmacist based in a primary care practice positively impacted physicians' use of PGx testing. In addition, PGx testing is beginning to be offered in community pharmacy settings. We propose to evaluate the impact of community pharmacist-delivered PGx testing as a stand-alone service or part of medication therapy management (or MTM). We intend to compare the effect of PGx alone and PGx with MTM from the pharmacy perspective (to assess impact on workflow/operations) and patient perspective (to assess acceptance of testing, understanding of results, medication adherence, and overall satisfaction with delivery model). We will gather data to assess the clinical utility o testing with respect to dosing or medication changes and medication adherence. A total of 20 North Carolina-based pharmacies will be recruited from the Community Pharmacist Pharmacogenetic Network (CPPN), a collection of community pharmacists who are interested in learning more about and utilizing PGx in their pharmacy. Using a cluster trial design, pharmacies will be randomized to the 'PGx+MTM Group' or the 'PGx-Only Group.' Since the proposed study will be implemented in a real-world setting, it will reflect the actual challenges faced by community pharmacists offering this new service. Eligible patients must have an active or new prescription for the select drugs for which PGx testing is available. All participating pharmacists will be required to complete a 2-part training module to be developed in Aim 1. In addition, all pharmacies will be provided with a patient educational toolkit and provider resources to facilitate both discussion about PGx testing with patients and interpretation of test results. Given the lack of evidence regarding the utility and feasibility of various approaches to delivering PGx testing, this study will provide valuable data regarding the feasibility of a pharmacist-delivered approach in a community pharmacy setting.
With the expanding number of pharmacogenetic (PGx) tests that have been developed and the drug labels that have been revised to include information about PGx, it is essential to determine how best to deliver these tests to optimize patient acceptance, test utilization and clinical benefit. We will explore the feasibility and patient satisfaction with the provision of PGx testing in a community pharmacy setting, with the pharmacist playing a central role in the delivery of testing and patient counseling.
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