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Smith, D. Max

https://orcid.org/0000-0003-3667-2936

Mayo Clinic

Georgetown University

Citations 3

Progress in Pharmacogenomics Implementation in the United States: Barrier Erosion and Remaining Challenges
Smith, D. Max , Aquilante, Christina L. , Deverka, Patricia A. , Devine, Emily Beth , Dunnenberger, Henry M. , Empey, Philip E. , Hertz, Daniel L. , Monte, Andrew A. , Moyer, Ann M. , Pratt, Victoria M. , Saulsberry, Loren , Oni‐Orisan, Akinyemi , Douglas, Michael P , Devine, Beth , Dunnenberger, Henry M , Empey, Philip E , Hertz, Daniel L , Moyer, AM , Patel, Jai N , Pratt, Victoria M , Saulsberry, Loren , Scott, Stuart A , Voora, Deepak , Woodahl, Erica L , Whirl-Carrillo, Michelle , Oni-Orisan, Akinyemi , Smith, D Max , Scott, Stuart A. , Whirl‐Carrillo, Michelle

Clinical Pharmacology & Therapeutics | June 5, 2025 | Volume: 118 | Issue: 4 | Pages: 778-789

10.1002/cpt.3736 Get It

Barriers to incorporating pharmacogenetics into routine clinical practice in the United States are well documented. Initial surveys by the Clinical Pharmacogenetics Implementation Consortium (CPIC) in 2009 and 2010 identified barriers across four key domains that have hindered the widespread adoption of clinical pharmacogenetic testing. These are presented verbatim as: (i) absence of a definition of the processes required to interpret genotype information and to translate genetic information into clinical actions; (ii) need for recommended drug/gene pairs to implement clinically now; (iii) clinician resistance to consider pharmacogenetic information at the bedside; and (iv) concerns about test costs and reimbursement. Over time, many of these challenges have been overcome, and clinical pharmacogenetic testing has subsequently reached broader implementation. Despite this progress, several barriers remain that block further adoption. This narrative review used authors' expertise and experience to identify and describe current barriers to pharmacogenetic implementation across seven domains in the United States: equity and inclusion; guidelines and supporting evidence; regulatory agency oversight; payer coverage and insurance; availability of quality pharmacogenetic tests; electronic health records; and provider and patient education. Within each domain, it revisits past successes and challenges and explores remaining barriers. We also propose solutions to address ongoing challenges across these domains, including further expansion of recommendations beyond pharmacogenetic‐specific guidelines, standards for designing clinical decision support tools, and broader pharmacogenetics education. Addressing these remaining obstacles directs work to enable broader adoption of clinical pharmacogenetic implementation to ultimately improve patient outcomes.
An Introductory Tutorial on Cardiovascular Pharmacogenetics for Healthcare Providers
Oni‐Orisan, Akinyemi , Tuteja, Sony , Hoffecker, Glenda , Smith, D. Max , Castrichini, Matteo , Crews, Kristine R. , Murphy, William A. , Nguyen, Nam , Huang, Yimei , Lteif, Christelle , Tantisira, Kelan G. , Cavallari, Larisa H. , Whirl‐Carrillo, Michelle , Duarte, Julio D. , Luzum, Jasmine A. , Nguyen, Nam H K , Friede, Kevin A , Aminkeng, Folefac , Voora, Deepak , Cavallari, Larisa H , Whirl-Carrillo, Michelle , Duarte, Julio D , Luzum, Jasmine A , Crews, Kristine R , Smith, D Max , Castrichini, Matteo , Oni-Orisan, Akinyemi , Murphy, William A.

Clinical Pharmacology & Therapeutics | May 24, 2023 | Volume: 114 | Issue: 2 | Pages: 275-287

10.1002/cpt.2957 Get It

Pharmacogenetics can improve clinical outcomes by reducing adverse drug effects and enhancing therapeutic efficacy for commonly used drugs that treat a wide range of cardiovascular diseases. One of the major barriers to the clinical implementation of cardiovascular pharmacogenetics is limited education on this field for current healthcare providers and students. The abundance of pharmacogenetic literature underscores its promise, but it can also be challenging to learn such a wealth of information. Moreover, current clinical recommendations for cardiovascular pharmacogenetics can be confusing because they are outdated, incomplete, or inconsistent. A myriad of misconceptions about the promise and feasibility of cardiovascular pharmacogenetics among healthcare providers also has halted clinical implementation. Therefore, the main goal of this tutorial is to provide introductory education on the use of cardiovascular pharmacogenetics in clinical practice. The target audience is any healthcare provider (or student) with patients that use or have indications for cardiovascular drugs. This tutorial is organized into the following 6 steps: (1) understand basic concepts in pharmacogenetics; (2) gain foundational knowledge of cardiovascular pharmacogenetics; (3) learn the different organizations that release cardiovascular pharmacogenetic guidelines and recommendations; (4) know the current cardiovascular drugs/drug classes to focus on clinically and the supporting evidence; (5) discuss an example patient case of cardiovascular pharmacogenetics; and (6) develop an appreciation for emerging areas in cardiovascular pharmacogenetics. Ultimately, improved education among healthcare providers on cardiovascular pharmacogenetics will lead to a greater understanding for its potential in improving outcomes for a leading cause of morbidity and mortality.