BACKGROUND: In polypharmacy patients, medication therapy management (MTM) services provide a comprehensive review of current medications and future treatment goals. Pharmacogenetics (PGx) may further optimize the identification of potential drug therapy problems (DTPs); however, the clinical utility of PGx information with a clinical decision support tool (CDST) in an MTM setting in identifying DTPs has not been systematically assessed. OBJECTIVE: To assess the clinical utility of an MTM service enhanced by pharmacogenetic test results and a clinical decision support tool. METHODS: This study was a post hoc analysis of the data obtained from an open-label, randomized, observational trial. Polypharmacy patients eligible for MTM service were randomly assigned to 3 intervention arms: standard MTM (SMTM), MTM incorporating CDST (CMTM), and CMTM further enhanced by PGx test results of CYP450 and VKORC1 enzymes (PGxMTM). Allocation for this post hoc analysis was based on patient adherence to the research protocol and completion of a PGx test. The number of DTPs per patient was compared across the 3 arms using analysis of variance. In addition, the frequency of serious DTPs as a categorical variable (grade 3 or above vs. lower grade) was compared across the 3 arms between PGx driven and non-PGx driven DTP recommendations. Statistical significance was tested using the chi-square test. The level of agreement between the DTP seriousness and the acceptance made by prescribers was presented as Cohen's kappa coefficient. RESULTS: Numbers of patients after cohort reallocation based on completion of PGx testing were 104, 180, and 58 for the SMTM, CMTM, and PGxMTM arms, respectively. On average, 3.08 DTPs were identified for each patient, which was nearly identical across all 3 arms. Blinded clinical pharmacists considered seriousness (grade 3 or 4) in 31% of the PGxrelated DTPs in comparison with 4.9% of the non-PGx DTPs (P < 0.001). The more serious (i.e., grade 3 or above) DTP recommendations were more likely to be accepted by prescribers with the odds ratios of 1.95 (P = 0.05) and 2.39 (P = 0.15), when the analysis was performed for all DTPs and DTPs from the PGxMTM arm only, respectively. CONCLUSIONS: MTM enhanced by PGx testing and the clinical decision support tool did not increase the number of DTPs identified. However, PGx testing and the decision support software helps pharmacists determine more serious DTPs, and resulting subsequent recommendations were more readily accepted by a prescriber. Future study of the patient safety outcomes and overall health care costs associated with the utility of the decision support is warranted.

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Cardiovascular disease (CVD) accounted for over 17.6 million deaths in 2016 and is expected to exceed 23.6 million by 2030. 1,2 Between 2014 and 2016, the direct and indirect costs associated with this burdensome disease reached $351.2 billion. CVD is a disease of concern, given the associated clinical and financial hardships. In October 2019, the Institute for Clinical and Economic Review (ICER) released a final evidence report on the effectiveness and value of 2 additive therapies used to reduce the risk of major adverse cardiovascular events (MACE): rivaroxaban and icosapent ethyl. Rivaroxaban, a direct-acting oral anticoagulant, has been approved as adjunct to aspirin to reduce the risk of MACE in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). 3 These indications are supported by the COMPASS trial, which showed that the combination of rivaroxaban and aspirin reduced the rate of MACE compared with aspirin alone. 4 Icosapent ethyl, an ethyl ester of eicosapentaenoic acid, was approved to reduce the risk of MACE among patients on statin therapy with elevated triglycerides and established CVD or at high risk for CVD. 5 The indication is supported by the REDUCE-IT trial, which showed icosapent ethyl reduced composite outcomes (cardiovascular death, myocardial infarction (MI), stroke, coronary revascularization, or unstable angina) versus placebo. 6 Rivaroxaban's COMPASS trial is representative of a Medicare population with CVD, with 75% of patients aged ≥ 65 years and taking multiple medications (e.g., angiotensin-converting enzyme inhibitors, beta blockers, and statins). 4 The reduction in the primary outcome yielded a number needed to treat of 76. Conversely, COMPASS found a 1.2% absolute increased risk in major bleeding, and a number needed to harm of 83 was reported. However, there was no significant difference in the rate of severe bleeding events. ICER reports with high certainty that rivaroxaban and aspirin "provides a small-to-substantial net health benefit in patients with CAD, PAD, or both