Ready or not, here it comes: Direct-to-consumer pharmacogenomic testing and its implications for community pharmacists

Gammal, Roseann S.; Mayes, Jason; Caudle, Kelly E.

doi:10.1016/j.japh.2019.06.008

Cited by 31 publications

(24 citation statements)

References 31 publications

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“…10 Since the latest pharmacist competencies in genomics were published, the profession has seen significant progress in the field, including the development of novel pharmacist-led clinical pharmacogenomics services, United States Food and Drug Administration approval of direct-to-consumer pharmacogenomic testing, and expansion of evidence-based pharmacogenomics clinical practice guidelines. [11][12][13][14] The pharmacy academy has also been introduced to the concept of "Entrustable Professional Activities" (EPAs)discrete, essential activities that all pharmacy graduates are expected to perform without direct supervision. 15 As newer areas of practice emerge (eg, clinical pharmacogenomics), mapping the associated core competencies to the EPAs will help define the pharmacist's role in those areas and provide a standard framework for pharmacy education.…”

Section: Introductionmentioning

confidence: 99%

Pharmacists Leading the Way to Precision Medicine: Updates to the Core Pharmacist Competencies in Genomics

Gammal

Lee

Petry

et al. 2022

American Journal of Pharmaceutical Education

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Genomics is increasingly becoming an important part of health care, and pharmacists are well-positioned to be practicebased leaders in pharmacogenomics and precision medicine. Competencies available through the Genetics/Genomics Competency Center provide a framework for pharmacogenomics instruction in both pharmacy school curricula and continuing education programs. Given the significant advancements in pharmacogenomics over the past decade, the 2019-2020 American Association of Colleges of Pharmacy Pharmacogenomics Special Interest Group updated the pharmacist competencies. The process used a systematic approach which included mapping pharmacogenomics-specific competencies to the Entrustable Professional Activities for pharmacists and seeking consensus from key stakeholders. The final result is an expansion to 30 competencies that reflect the contemporary roles pharmacists play in the application of pharmacogenomics in clinical practice. When implemented into curricula, these competencies will ensure that learners are "practice-ready" to integrate pharmacogenomics into patient care. Additional post-graduate training is needed for advanced roles in pharmacogenomics implementation, education, and research.

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Section: Introductionmentioning

confidence: 99%

Pharmacists Leading the Way to Precision Medicine: Updates to the Core Pharmacist Competencies in Genomics

Gammal

Lee

Petry

et al. 2022

American Journal of Pharmaceutical Education

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“…Another study of pharmacist‐led PGx services implemented in a rural primary care clinic found that referrals to the service for patients outside the original study population increased after study completion, possibly because of increased awareness of the pharmacist's role 27 . These findings suggests PGx may be an important area of training for ambulatory care pharmacists who are embedded in primary care clinics and community pharmacists 28 . The availability of pharmacists for PGx consultation has been described as key for facilitating the integration of PGx testing in physician workflows 21 .…”

Section: Discussionmentioning

confidence: 99%

Assessing the knowledge, perceptions, and practices of primary care clinicians toward pharmacogenetics

Johengen

Ward

Coe

et al. 2020

J Am Coll Clin Pharm

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IntroductionPharmacogenetics (PGx) testing is becoming increasingly available to patients and clinicians, but investigations of PGx testing in primary care and the pharmacist's role in educating clinicians have been limited.ObjectivesThe objectives of this study were to: (a) determine the utilization of PGx testing in primary care clinics, (b) identify how clinicians document and act on PGx test results, and (c) determine clinician interest in PGx education or consultation from pharmacists.MethodsA 16‐item survey was distributed via email. Eligible participants included physicians, physician assistants, nurse practitioners, and pharmacists who work in family medicine, general medicine, geriatric, or pediatric primary care clinics at one academic medical center. Descriptive statistics were used to characterize the frequency of PGx tests ordered in primary care clinics, provider comfort with PGx test interpretation, documentation practices, and interest in PGx education or consultation from pharmacists.ResultsThe overall survey response rate was 15.8% (n = 55). Most respondents were physicians (84%). Nearly 40% of respondents reported having a patient bring PGx test results to a visit, while only 9% reported ordering a PGx test. Documentation practices were variable, and response to PGx results was most commonly no change in therapy (52%). Only two (3.6%) respondents agreed with the statement, “I feel confident in my ability to interpret PGx test results,” and the majority reported interest in PGx education. Eighty percent of respondents reported they would be likely or very likely to consult a PGx‐trained pharmacist for help interpreting PGx results.DiscussionClinicians in this survey were more likely to have patients bring in results than to order PGx tests, did not feel confident in result interpretation, and expressed interest in working with pharmacists for PGx test interpretation. This research can help guide the development of PGx‐focused pharmacy services and education for clinicians who are encountering PGx testing in their practice.

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“…With roughly a decade of clinical PGx experience in the health-care system, pharmacists must understand that a patient’s genotype and phenotype information for key pharmacogenes may already be in existence in the health-care system. 46 Efforts need to be made to share and flag such data throughout the health-care system so clinicians do not make clinical recommendations that would go against what would be appropriate had PGx information been known.…”

Section: Clopidogrel Pgx and Community Pharmacy Modelsmentioning

confidence: 99%

“…[43][44][45] Further, DTC PGx testing presents new opportunities for community pharmacists to be deeply involved in DTC PGx work. 46 As DTC PGx testing becomes increasingly available, cost efficient, and visible in health systems and community pharmacies, clinical workflow models may need to further adapt to involve patient-gathered PGx data. In fact, as noted, community pharmacists may be the first clinicians in the care process to learn of PGx data if brought to the pharmacy by the patient via DTC testing.…”

Section: Introduction and Background Of Pharmacogenomics Across Health-care Settingsmentioning

confidence: 99%

Pharmacogenomics in the United States Community Pharmacy Setting: The Clopidogrel-CYP2C19 Example

Kisor

Petry

Bright

2021

PGPM

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Pharmacogenomics (PGx) is expanding across health-care practice settings, including the community pharmacy. In the United States, models of implementation of PGx in the community pharmacy have described independent services and those layered on to medication therapy management. The drug-gene pair of clopidogrel-CYP2C19 has been a focus of implementation of PGx in community pharmacy and serves as an example of the evolution of the application of drug-gene interaction information to help optimize drug therapy. Expanded information related to this drug-gene pair has been provided by the US Food and Drug Administration and clinical PGx guidelines have and continue to be updated to support clinical decision-making. Most recently direct-to-consumer (DTC) PGx has resulted in patient generated sample collection and submission to a genetic testing-related company for analysis, with reporting of genotype and related phenotype information directly to the patient without a health-care professional guiding or even being involved in the process. The DTC testing approach needs to be considered in the development or modification of PGx service models in the community pharmacy setting. The example of clopidogrel-CYP2C19 is discussed and current models of PGx implementation in the community pharmacy in the United States are presented. New approaches to PGx services are offered as implementation continues to evolve and may now include DTC information.

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Ready or not, here it comes: Direct-to-consumer pharmacogenomic testing and its implications for community pharmacists

Cited by 31 publications

References 31 publications

Pharmacists Leading the Way to Precision Medicine: Updates to the Core Pharmacist Competencies in Genomics

Pharmacists Leading the Way to Precision Medicine: Updates to the Core Pharmacist Competencies in Genomics

Assessing the knowledge, perceptions, and practices of primary care clinicians toward pharmacogenetics

Pharmacogenomics in the United States Community Pharmacy Setting: The Clopidogrel-CYP2C19 Example

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