D. Max Smith Pharm.D.,James M. Stevenson Pharm.D., MS,Teresa T. Ho Pharm.D.,Christine M. Formea Pharm.D.,Roseann S. Gammal Pharm.D.,Larisa H. Cavallari Pharm.D.
Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy
Abstract
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.
Multisite investigation of strategies for the clinical implementation of pre-emptive pharmacogenetic testing
Julio D. Duarte, Rachel Dalton, Amanda L. Elchynski, D. Max Smith, Emily J. Cicali, James C. Lee, Benjamin Q. Duong, Natasha J. Petry, Christina L. Aquilante, Amber L. Beitelshees, Philip E. Empey, Julie A. Johnson, Aniwaa Owusu Obeng, Amy L. Pasternak, Victoria M. Pratt, Laura B. Ramsey, Sony Tuteja, Sara L. Van Driest, Kristin Wiisanen, J. Kevin Hicks, Larisa H. Cavallari & IGNITE Network Pharmacogenetics Working Group
Genetics in Medicine volume 23, pages2335–2341 (2021)
Key Considerations for Selecting a Genomic Decision Support Platform for Implementing Pharmacogenomics
Cook KJ, Duong BQ, Seligson ND, Arn P, Funanage VL, Gripp KW, Kirwin SM, Lawless ST, Lee MM, Robbins KM, West D, Blake KV. Key Considerations For Selecting a Genomic Decision Support Platform For Implementing Pharmacogenomics. Clin Pharmacol Ther.
First published: 13 July 2021
PMID: 34254671.
Strategies to Integrate Genomic Medicine into Clinical Care: Evidence from the IGNITE Network
How to Integrate CYP2D6 Phenoconversion Into Clinical Pharmacogenetics: A Tutorial
Cicali EJ, Elchynski AL, Cook KJ, Houder JT, Thomas CD, Smith DM, Elsey A, Johnson JA, Cavallari LH, Wiisanen K. Clin Pharmacol Ther.
2021 Jul 7. doi: 10.1002/cpt.2354. Online ahead of print.
PMID: 34231197
Adverse Cardiovascular Outcomes and Antihypertensive Treatment: A Genome-Wide Interaction Meta-Analysis in the International Consortium for Antihypertensive Pharmacogenomics Studies
McDonough CW, Warren HR, Jack JR, Motsinger-Reif AA, Armstrong ND, Bis JC, House JS, Singh S, El Rouby NM, Gong Y, Mychaleckyj JC, Rotroff DM, Benavente OR, Caulfield MJ, Doria A, Pepine CJ, Psaty BM, Glorioso V, Glorioso N, Hiltunen TP, Kontula KK, Arnett DK, Buse JB, Irvin MR, Johnson JA, Munroe PB, Wagner MJ, Cooper-DeHoff RM.
Clin Pharmacol Ther.
2021 Jul 7. doi: 10.1002/cpt.2355. Online ahead of print.
PMID: 34231218
Recommendations for Clinical CYP2D6 Genotyping Allele Selection: A Joint Consensus Recommendation of the Association for Molecular Pathology, College of American Pathologists, Dutch Pharmacogenetics Working Group of the Royal Dutch Pharmacists Association, and European Society for Pharmacogenomics and Personalized Therapy
Pratt VM, Cavallari LH, Del Tredici AL, Gaedigk A, Hachad H, Ji Y, Kalman LV, Ly RC, Moyer AM, Scott SA, van Schaik RHN, Whirl-Carrillo M, Weck KE. J Mol Diagn. 2021 Jun 9:S1525-1578(21)00164-1.
doi: 10.1016/j.jmoldx.2021.05.013.
Online ahead of print.
PMID: 34118403 Review.
Moving Pharmacogenetics into Practice: It’s All About the Evidence!
Luzum JA, Petry N, Taylor AK, Van Driest SL, Dunnenberger HM, Cavallari LH. Clin Pharmacol Ther. 2021 Jun 8. doi: 10.1002/cpt.2327. Online ahead of print. PMID: 34101169 Review.
Determining the potential clinical value of panel-based pharmacogenetic testing in patients with chronic pain or gastroesophageal reflux disease
Elchynski AL, Cicali EJ, Ferrer Del Busto MC, Hamilton A, Chang KL, Schmidt SO, Weiner B, Davis R, Estores D, Max Smith D, Wiisanen K, Johnson JA, Cavallari LH.
Pharmacogenomics J. 2021 Jun 1. doi: 10.1038/s41397-021-00244-6. Online ahead of print.
PMID: 34075203