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. 2020 Sep;3(6):1028-1037.
doi: 10.1002/jac5.1250. Epub 2020 May 2.

Assessment of the clinical utility of pharmacogenetic guidance in a comprehensive medication management service

Idaliz Rodríguez-Escudero  1 , Julio A Cedeño  1 , Ileana Rodríguez-Nazario  1 , Gledys Reynaldo-Fernández  2 , Leyanis Rodríguez-Vera  2 , Niretzy Morales  3 , Braulio Jiménez-Vélez  4 , Gualberto Ruaño  5 , Jorge Duconge  1
Affiliations

Assessment of the clinical utility of pharmacogenetic guidance in a comprehensive medication management service

Idaliz Rodríguez-Escudero et al. J Am Coll Clin Pharm. 2020 Sep.

Abstract

Introduction: Pharmacists are poised to be the health care professionals best suited to provide medication-related consults and services based on a patient's genetics. Despite its potential benefits, the implementation of pharmacogenetic (PGx) testing into primary clinical settings has been slow among medically underserved populations. To our knowledge, this is the first time that PGx-driven recommendations have been incorporated into a Comprehensive Medication Management (CMM) service in a Hispanic population.

Objectives: The aim of this study is to evaluate the clinical utility of adding PGx guidance into pharmacist-driven CMM.

Methods: This is a pre- and post-interventional design study. Patients were recruited from a psychologist's clinic. A total of 24 patients had a face-to-face interview with a pharmacist to complete a CMM, Personal Medication Record, and Medication-Related Action Plan (MAP) blind to PGx findings. Collected buccal DNA samples were genotyped using drug-metabolizing enzymes and transporters (DMET) Plus Array.

Results: The pharmacist generated new MAPs for each patient based on PGx results. Genetic variants that could potentially affect the safety and effectiveness of at least one drug in the pharmacotherapy were identified in 96% of patients, for whom the pharmacist changed the initial recommendations. Polymorphisms in genes encoding for isoenzymes CYP2D6, CYP2C19, and CYP2C9 were identified in 83%, 52%, and 41% of patients, respectively. Pharmacists performing CMM identified 22 additional medication problems after PGx determinations. Moreover, they agreed with the clinical utility of PGx in the studied sample based on perceived value of adding PGx to traditional CMM and its utility in the decision-making process of pharmacists.

Conclusions: The study confirmed the critical role to be played by pharmacists in facilitating the clinical usage of relevant genetic information to optimize drug therapy decisions as well as their involvement on many levels of these multidisciplinary implementation efforts, including championing and leading PGx-guided CMM services.

Keywords: clinical decision support; cytochrome P450; pharmacogenetics.

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Conflict of interest statement

CONFLICT OF INTEREST Gualberto Ruaño is a founder and medical director of the Genomas, Inc. The authors have no further conflict of interest to declare.

Figures

FIGURE 1
FIGURE 1
Flow diagram to illustrate the inclusion of participants in this study. A total of 38 eligible patients who met inclusion criteria were approached regarding participation in this study. Two patients declined to participate, resulting in 36 subjects enrolled. Seven patients had incomplete genotypes (eg, poor call rates), leaving only 29 with full data. Another five patients excluded from further analysis due to lack of complete clinical data or increased ALT/AST. ALT, alanine aminotransferase enzyme; AST, aspartate aminotransferase enzyme; CDS, clinical decision support; CMM, comprehensive medication management
FIGURE 2
FIGURE 2
Allele and diplotype frequency distributions across the three genetic loci of interest (ie, CYP2C9, A and B; CYP2C19, C and D; and CYP2D6, E and F, pharmacogenes) in the study cohort
FIGURE 3
FIGURE 3
Number of prescription drugs by classes and major metabolic pathways (ie, drug-gene pairs) in the current pharmacotherapy of patients that are prone to DGIs, as predicted by PGx test results plus CDS reports. ARBs, angiotensin II receptor blockers; CDS, clinical decision support; DGI, drug-gene interaction; H2, histamine type2 receptors; NSAIDs, nonsteroidal antiinflammatory drugs; PGx, pharmacogenetic; PPIs, proton-pump inhibitors
FIGURE 4
FIGURE 4
Comparison of the total number of each individual MRP, identified before (blue) and after (green) the PGx test results plus CDS reports became available. Asterisk (*) represents a significant difference (two-tailed Wilcoxon signed rank test). CDS, clinical decision support; MRP, medication-related problem; PGx, pharmacogenetic
FIGURE 5
FIGURE 5
Comparison of total number of pharmacotherapy-related recommendations before (blue) and after (green) the PGx test results plus CDS reports became available. Asterisk (*) represents a significant difference (two-tailed Wilcoxon signed rank test). CDS, clinical decision support; PGx, pharmacogenetic
FIGURE 6
FIGURE 6
Boxplot of the ranked values corresponding to the total (overall) number of MRPs, identified before and after the PGx test results and subsequent CDS reports became available (ie, pre- and post-PGx). Significant difference found by two-tailed Wilcoxon signed rank test (P = .004). CDS, clinical decision support; MRP, medication-related problem; PGx, pharmacogenetic
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