PRN OPINION PAPER: Application of precision medicine across pharmacy specialty areas

Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/149551/1/jac51107_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/149551/2/jac51107.pd

Expanded Clinical Pharmacogenetics Implementation Consortium Guideline for Medication Use in the Context of G6PD Genotype

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is associated with development of acute hemolytic anemia in the setting of oxidative stress, which can be caused by medication exposure. Regulatory agencies worldwide warn against the use of certain medications in persons with G6PD deficiency, but in many cases, this information is conflicting, and the clinical evidence is sparse. This guideline provides information on using G6PD genotype as part of the diagnosis of G6PD deficiency and classifies medications that have been previously implicated as unsafe in individuals with G6PD deficiency by one or more sources. We classify these medications as high, medium, or low to no risk based on a systematic review of the published evidence of the gene-drug associations and regulatory warnings. In patients with G6PD deficiency, high-risk medications should be avoided, medium-risk medications should be used with caution, and low-to-no risk medications can be used with standard precautions, without regard to G6PD phenotype. This new document replaces the prior Clinical Pharmacogenetics Implementation Consortium guideline for rasburicase therapy in the context of G6PD genotype (updates at: www.cpicpgx.org)

Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy.

There is growing interest in utilizing pharmacogenetic (PGx) testing to guide antidepressant use, but there is lack of clarity on how to implement testing into clinical practice. We administered two surveys at 17 sites that had implemented or were in the process of implementing PGx testing for antidepressants. Survey 1 collected data on the process and logistics of testing. Survey 2 asked sites to rank the importance of Consolidated Framework for Implementation Research (CFIR) constructs using best-worst scaling choice experiments. Of the 17 sites, 13 had implemented testing and four were in the planning stage. Thirteen offered testing in the outpatient setting, and nine in both outpatient/inpatient settings. PGx tests were mainly ordered by psychiatry (92%) and primary care (69%) providers. CYP2C19 and CYP2D6 were the most commonly tested genes. The justification for antidepressants selected for PGx guidance was based on Clinical Pharmacogenetics Implementation Consortium guidelines (94%) and US Food and Drug Administration (FDA; 75.6%) guidance. Both institutional (53%) and commercial laboratories (53%) were used for testing. Sites varied on the methods for returning results to providers and patients. Sites were consistent in ranking CFIR constructs and identified patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and the identification of champions as most important for implementation. Sites deployed similar implementation strategies and measured similar outcomes. The process of implementing PGx testing to guide antidepressant therapy varied across sites, but key drivers for successful implementation were similar and may help guide other institutions interested in providing PGx-guided pharmacotherapy for antidepressant management

ACCP Commentary: Recommended basic science foundation necessary to prepare pharmacists to manage personalized pharmacotherapy

In recent years, the United States Food and Drug Administration has approved revised labeling for several existing drugs to include pharmacogenomic information, marking an important step toward more personalized medicine. In addition, it is anticipated that many newly approved drugs may be restricted to use in individuals with certain genotypes. In response to the wealth of pharmacogenomic data generated during the past decade and its implications for pharmacy practice, the American College of Clinical Pharmacy Educational Affairs Committee was charged with describing the basic science foundation necessary to prepare future pharmacists to manage personalized, pharmaco-genetically driven therapy. The committee identified four key areas deemed essential components of a pharmacy curriculum related to advances in genomics: personalized medicine concepts and terminology, with a focus on genomics; genomic applications in basic and applied pharmaceutical sciences; biotechnology; and bioinformatics. Each section of this commentary contains one or more broad curricular outcomes to be achieved, suggested implementations to address each outcome, and benchmark performance indicators of learning outcomes for recent graduates from doctor of pharmacy educational programs. There was unanimous agreement among committee members that the curricular outcomes described are the minimum expectation for future pharmacists to provide optimal patient care in the era of personalized medicine. Material taught in each area should evolve with progress in the field, particularly for gene-drug response associations, biotechnology, and bioinformatics. As the areas of proteomics, metabolomics, and epigenetics evolve along with their implications for personalized drug therapy, they should also be incorporated into the curriculum. Self-directed learning behaviors should be encouraged, when possible, to better prepare students to advance their skills and knowledge with the science. Faculty development will likely be necessary for the widespread education of pharmacy students in personalized medicine. It is our hope that this commentary will serve as a useful resource for academicians involved in curricular content development for pharmacy students

ACCP Commentary: Recommended basic science foundation necessary to prepare pharmacists to manage personalized pharmacotherapy

In recent years, the United States Food and Drug Administration has approved revised labeling for several existing drugs to include pharmacogenomic information, marking an important step toward more personalized medicine. In addition, it is anticipated that many newly approved drugs may be restricted to use in individuals with certain genotypes. In response to the wealth of pharmacogenomic data generated during the past decade and its implications for pharmacy practice, the American College of Clinical Pharmacy Educational Affairs Committee was charged with describing the basic science foundation necessary to prepare future pharmacists to manage personalized, pharmaco-genetically driven therapy. The committee identified four key areas deemed essential components of a pharmacy curriculum related to advances in genomics: personalized medicine concepts and terminology, with a focus on genomics; genomic applications in basic and applied pharmaceutical sciences; biotechnology; and bioinformatics. Each section of this commentary contains one or more broad curricular outcomes to be achieved, suggested implementations to address each outcome, and benchmark performance indicators of learning outcomes for recent graduates from doctor of pharmacy educational programs. There was unanimous agreement among committee members that the curricular outcomes described are the minimum expectation for future pharmacists to provide optimal patient care in the era of personalized medicine. Material taught in each area should evolve with progress in the field, particularly for gene-drug response associations, biotechnology, and bioinformatics. As the areas of proteomics, metabolomics, and epigenetics evolve along with their implications for personalized drug therapy, they should also be incorporated into the curriculum. Self-directed learning behaviors should be encouraged, when possible, to better prepare students to advance their skills and knowledge with the science. Faculty development will likely be necessary for the widespread education of pharmacy students in personalized medicine. It is our hope that this commentary will serve as a useful resource for academicians involved in curricular content development for pharmacy students

Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for and Nonsteroidal Anti‐Inflammatory Drugs

Theken KN, Lee CR, Gong L, et al. Clinical Pharmacogenetics Implementation Consortium Guideline (CPIC) for and Nonsteroidal Anti‐Inflammatory Drugs. Clinical Pharmacology & Therapeutics. 2020;108(2):191-200.Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used analgesics due to their lack of addictive potential. However, NSAIDs have the potential to cause serious gastrointestinal, renal, and cardiovascular adverse events. CYP2C9 polymorphisms influence metabolism and clearance of several drugs in this class, thereby affecting drug exposure and potentially safety. We summarize evidence from the published literature supporting these associations and provide therapeutic recommendations for NSAIDs based on CYP2C9 genotype (updates at www.cpicpgx.org)