Overview of the PRN

The ACCP Pharmacokinetics/Pharmacodynamics/Pharmacogenomics (PK/PD/PG) PRN was originally established in 1997 as the PK/PD PRN. Pharmacogenomics was added in 2011 to reflect increasing member interest in this area. The PK/PD/PG PRN provides a forum for networking with clinicians and/or researchers focused on PK/PD/PG-related aspects of research and patient care. Educational programming is designed to keep members current on the latest PK/PD/PG trends in practice and research that span population PK/PD/PG analyses, innovative modeling, drug metabolism studies, clinical research, and clinical implementation of precision medicine. The PRN currently has more than 300 members, including over 100 members who identify as students or trainees.

Opportunities and Resources for Resident and Fellow Members of the PRN

The PK/PD/PG PRN has many opportunities and resources for resident and fellow members, including:

• Serving on the Programming and Outreach committees
• Networking with experts in the PK/PD/PG community at the PRN Business Meeting of the ACCP Annual Meeting
• Access to an updated list of training opportunities in the field of PK/PD/PG ranging from PGY2 residencies and fellowships to master’s degree and Ph.D. training programs
• Attending webinars and career guidance panels organized by the Outreach Committee
• Applying for the M. Kelli Jordan Travel Award, which provides trainees (student, resident, or fellow) the opportunity to share their research at the PRN Business Meeting as well as a stipend to support the cost of registration and travel expenses for the ACCP Annual Meeting
• Connecting with the PK/PD/PG PRN community on social media via Twitter (@pkpdpg) and LinkedIn (ACCP PK/PD/PG PRN)

Current Clinical Issues

In recent years, consumers have increasingly embraced direct-to-consumer (DTC) genetic tests to gain insight into their health, given the ease of access, sample collection, and cost. From a simple cheek swab or saliva sample, DTC test reports may provide information on polygenic risk scores, disease carrier screening, and/or pharmacogenomic results – which pharmacists are uniquely positioned to help patients navigate. However, DTC genetic tests for health-related information have largely been unregulated over the past decade until recently, when the U.S. Food and Drug Administration (FDA) took a series of actions.

Summary of the FDA’s actions toward DTC genetic tests

Earlier this year, members of the PK/PD/PG PRN released a commentary in the Journal of the American College of Clinical Pharmacy (JACCP) highlighting pharmacists’ need to be prepared to educate patients on the results of DTC genetic tests when relevant to optimizing treatment.⁸ To demonstrate how pharmacists might encounter such results in any practice setting, this article discussed key considerations and the application of DTC pharmacogenomic test results through a patient case transitioning from acute care to ambulatory care to a community-based care setting. Many educational opportunities are available to ensure pharmacists have the knowledge to interpret and educate patients on pharmacogenomic test results, including the Applied Pharmacogenomics Certificate Program offered through the American College of Clinical Pharmacy (ACCP). The Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and the Pharmacogenomics Knowledge Base (PharmGKB) resources can help pharmacists access the latest pharmacogenomic-guided treatment recommendations. Of note, when patients present with DTC pharmacogenomic test results, the FDA currently recommends confirmatory testing be performed by an independent laboratory before any treatment decisions are made, except for the 23andMe® CYP2C19 test results for clopidogrel and citalopram response.^3,6 The regulatory landscape for DTC genetic testing is ever-evolving, making it important to stay up to date on new FDA recommendations. The FDA maintains a list of approved DTC genetic tests.⁹ For health-related pharmacogenomic DTC genetic test results, patients should be referred to a medical geneticist or genetic counselor. Learn more about how to approach and address DTC genetic test results at the 2021 ACCP Annual Meeting!

References

1. Wagner JK. Understanding FDA regulation of DTC genetic tests within the context of administrative law. Am J Hum Genet 2010;87:451-6.
2. Pollack A. F.D.A. orders genetic testing firm to stop selling DNA analysis service. New York Times November 25, 2013. Available at https://www.nytimes.com/2013/11/26/business/fda-demands-a-halt-to-a-dna-test-kits-marketing.html. Accessed September 30, 2021.
3. U.S. Food and Drug Administration (FDA). FDA Authorizes First Direct-to-Consumer Test for Detecting Genetic Variants That May Be Associated with Medication Metabolism. October 31, 2018. Available at https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-direct-consumer-test-detecting-genetic-variants-may-be-associated-medication. Accessed September 28, 2021.
4. U.S. Food and Drug Administration (FDA). Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research on Agency’s Warning to Consumers About Genetic Tests That Claim to Predict Patients’ Responses to Specific Medications. November 1, 2018. Available at https://www.fda.gov/news-events/press-announcements/jeffrey-shuren-md-jd-director-fdas-center-devices-and-radiological-health-and-janet-woodcock-md. Accessed September 28, 2021.
5. U.S. Food and Drug Administration (FDA). FDA Issues Warning Letter to Genomics Lab for Illegally Marketing Genetic Test That Claims to Predict Patients’ Responses to Specific Medications. 2019. Available at https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-genomics-lab-illegally-marketing-genetic-test-claims-predict-patients. Accessed September 28, 2021.
6. U.S. Food and Drug Administration (FDA). Table of Pharmacogenetic Associations. 2020. Available at https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations. Accessed September 28, 2021.
7. U.S. Food and Drug Administration (FDA). 23andMe [letter]. Atlanta: CDC, 2020. Available at https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf. Accessed September 28, 2021.
8. Gammal RS, Smith DM, Wiisanen KW, et al. The pharmacist’s responsibility to ensure appropriate use of direct-to-consumer genetic testing. J Am Coll Clin Pharm 2021;4:652-8.
9. U.S. Food and Drug Administration (FDA). Direct-to-Consumer Tests. Atlanta: CDC, 2019. Available at https://www.fda.gov/medical-devices/vitro-diagnostics/direct-consumer-tests. Accessed September 28, 2021.

Written by:

Teresa T. Ho, Pharm.D., BCPS

Reviewed by:

Jim Stevenson, Pharm.D., M.S., BCPP

D. Max Smith, Pharm.D., BCPS