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Implementing pharmacogenetic testing in rural primary care practices: a pilot feasibility study

    Lynn G Dressler

    *Author for correspondence: Tel.: +828 620 1143;

    E-mail Address: lgdconsulting512@gmail.com

    Mission Health Personalized Medicine & Pharmacogenomics Program; currently Independent Consultant, LGDconsulting 512, Fairview, NC 28730, USA

    ,
    Gillian C Bell

    Mission Health Personalized Medicine & Pharmacogenomics Program, Asheville, NC 28801, USA

    ,
    Pearl M Abernathy

    Mission Health Personalized Medicine & Pharmacogenomics Program, Asheville, NC 28801, USA

    ,
    Karl Ruch

    Mission Health Personalized Medicine & Pharmacogenomics Program; currently OneOME, Minneapolis, MN,55405, USA

    &
    Sheri Denslow

    Mission Health, Mission Research Institute, Asheville, NC 28801, USA

    Published Online:https://doi.org/10.2217/pgs-2018-0200

    Aim: Assess feasibility and perspectives of pharmacogenetic testing/PGx in rural, primary care physician (PCP) practices when PCPs are trained to interpret/apply results and testing costs are covered. Methods: Participants included PCPs who agreed to training, surveys and interviews and eligible patients who agreed to surveys and testing. 51 patients from three practices participated. Results: Prestudy, no PCP had ever ordered a PGx test. Test results demonstrated gene variations in 30% of patients, related to current medications, with PCPs reporting changes to drug management. Poststudy, test cost was still a concern, but now PCPs reported practical barriers, including the utilization of PGx results over time. PCPs and patients had favorable responses to testing. Summary: PGx testing is feasible in rural PCP practices.

    Lay abstract

    Although genetic tests exist to predict response to drug therapy for commonly used drugs, test use among primary care physicians is low. Three commonly reported barriers to use of these tests include physicians not being well educated about these tests, physicians not being comfortable interpreting and applying test results and concern over cost of testing. This pilot feasibility study assessed physician and patient perspectives when these three barriers were addressed. Surveys demonstrated satisfaction with the testing experience. Results indicate 30% of patients had a genetic variation potentially affecting a currently used drug. Genetic testing is feasible in primary care.

    Papers of special note have been highlighted as: •• of considerable interest

    References

    • 1 Stanek EJ, Sanders CL, Taber KA et al. Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey. Clin. Pharmacol. Ther. 91(3), 450–458 (2012). •• Seminal article surveyingover 50,000 physicians and finding that education, training, comfort level withinterpreting results and cost of testing are the most common barriers tophysician adoption of pharmacogenomic (PGx) testing.
    • 2 Haga SB, Lapointe NM, Cho A et al. Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting. Pharmacogenomics 15(13), 1677–1686 (2014).
    • 3 Haga SB. Delivering pharmacogenetic testing to the masses: an achievable goal? Pharmacogenomics 15(1), 1–4 (2014).
    • 4 Volpi S, Bult C, Chisholm RL et al. Research directions in the clinical implementation of pharmacogenomics – an overview of US programs and projects. Clin. Pharmacol. Ther. 103(5), 778–786 (2018). • This paper summarizes a workshopand describes major US research programs in PGx implementation; reviews andsummarizes many of the barriers to PGx implementation as well as identifyingareas that are gaps in our knowledge base.
    • 5 Dunnenberger HM, Biszewski M, Bell GC et al. Implementation of a multidisciplinary pharmacogenomics clinic in a community health system. Am. J. Health Syst. Pharm. 73(23), 1956–1966 (2016).
    • 6 Lemke AA, Selkirk CGH, Glaser NS et al. Primary care physician experiences with integrated pharmacogenomic testing in a community health system. Per. Med. 14(5), 389–400 (2017).
    • 7 Scott SA. Personalizing medicine with clinical pharmacogenetics. Genet. Med. 13(12), 987–995 (2011). •• This review paper delves into a number of barriers to implementation ofclinical pharmacogenetics, with an indepth description of clinical utility, professionaleducation, regulatory and reimbursement concerns.
    • 8 Abubakar Amina, Olivia B. Precision medicine and pharmacogenomics in community and primary care settings. Pharmacy Today 24(2), 55–68 (2018).
    • 9 Kean MA, Pritchard D. Emerging models for clinical adoption of personalized medicine. J. Per. Med. 10 52–65 (2017).
    • 10 Hunt LM, Kreiner MJ. Pharmacogenetics in primary care: the promise of personalized medicine and the reality of racial profiling. Cult. Med. Psychiatry 37(1), 226–235 (2013).
    • 11 Teng K. Pharmacogenomics for the primary care provider: why should we care? Clev. Clin. J. Med. 78(4), 241–242 (2011).
    • 12 Teng KA, Longworth DL. Personalized healthcare in the era of value-based healthcare. Per. Med. 10(3), 285–293 (2013).
    • 13 Dawes M, Aloise MN, Ang JS et al. Introducing pharmacogenetic testing with clinical decision support into primary care: a feasibility study. CMAJ Open 4(3), E528–E534 (2016).
    • 14 Bartlett G, Zgheib N, Manamperi A et al. Pharmacogenomics in primary care: a crucial entry point for global personalized medicine? Curr. Pharmacogenomics Person. Med. 10(2), 101–105 (2012).
    • 15 Mckinnon RA, Ward MB, Sorich MJ. A critical analysis of barriers to the clinical implementation of pharmacogenomics. Ther. Clin. Risk Manag. 3(5), 751–759 (2007).
    • 16 Shuldiner AR, Relling MV, Peterson JF et al. The Pharmacogenomics research network translational pharmacogenetics program: overcoming challenges of real-world implementation. Clin. Pharmacol. Ther. 94(2), 207–210 (2013). • This is a seminar articlefrom leaders in the field about real world implementation through the lens ofthe Pharmacogenomics Research Network, the premier resource for the field.
    • 17 Weitzel KW, Aquilante CL, Johnson S, Kisor DF, Empey PE. Educational strategies to provide pharmacogenomics-based care. Am. J. Health Syst. Pharm. 73(23), 1986–1998 (2016).
    • 18 Roederer MW, Kuo GM, Kisor DF et al. Pharmacogenomics competencies in pharmacy practice: a blueprint for change. J. Am. Pharm. Assoc. 57(1), 120–125 (2017).
    • 19 Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement. Sci. 4, 50 (2009).
    • 20 Rogers E. Diffusion of Innovations (4th Edition). The Free Press, NY, USA, 10–35 (1995).
    • 21 Sanson-Fisher RW. Diffusion of innovation theory for clinical change. Med. J. Aust. 180(6 Suppl.), S55–S56 (2004).
    • 22 Dressler LG. Integrating personalized genomic medicine into routine clinical care: addressing the social and policy issues of pharmacogenomic testing. N. C. Med. J. 74(6), 509–513 (2013).
    • 23 Relling MV, Klein TE. CPIC: clinical pharmacogenetics implementation consortium of the pharmacogenomics research network. Clin. Pharmacol. Ther. 89(3), 464–467 (2011).
    • 24 Dressler LG, Deal AM, Patel J, Markey J, Riper MV, McLeod HL. Cancer pharmacogenomics, adoption by oncologists and patient benefit. Per. Med. 11(2), 143–153 (2014).
    • 25 Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol. Health 14, 1–24 (1999).
    • 26 O'Donnell PH, Bush A, Spitz J et al. The 1200 patients project: creating a new medical model system for clinical implementation of pharmacogenomics. Clin. Pharmacol. Ther. 92(4), 446–449 (2012).
    • 27 McKillip RP, Borden BA, Galecki P et al. Patient perceptions of care as influenced by a large institutional pharmacogenomic implementation program. Clin. Pharmacol. Ther. 102(1), 106–114 (2017).
    • 28 Khanna D, Fitzgerald JD, Khanna P, Sangmee B, Singh M. 2012 American College of Rheumatology Guidelines for Management of Gout Part 1: systematic non-pharmacologic and pharmacologic therapeutic approaches to hyperuricemia. Arthritis Care Res. 64(10), 1431–1446 (2012).
    • 29 Randel A. AAO-HNS Guidelines for tonsillectomy in children and adolescents. Am. Fam. Physician 84(5), 566–573 (2011).
    • 30 WHO. WHO Guidelines (2012) on the pharmacological treatment of persisting pain in children with medical illnesses. https://apps.who.int/iris/bitstream/apps.who.int.
    • 31 Shuldiner AR, Relling MV, Peterson JF et al. The pharmacogenomics research network translational pharmacogenetics program: overcoming challenges of real-world implementation. Clin. Pharmacol. Ther. 94(2), 207–210 (2013).
    • 32 Crews KR, Hicks JK, Pui CH, Relling MV, Evans WE. Pharmacogenomics and individualized medicine: translating science into practice. Clin. Pharmacol. Ther. 92(4), 467–475 (2012). • From one of the leaders in thefield at Mayo Clinic, this articles descirbes a comprehensive system forimplementation and evaluation. Eight major issues are addressed includingresources, governance, cliical practices, education, testing, knowledgetranslation, clinical decision support and translation.
    • 33 Levy KD, Decker BS, Carpenter JS et al. Prerequisites to implementing a pharmacogenomics program in a large health-care system. Clin. Pharmacol. Ther. 96(3), 307–309 (2014).
    • 34 Danahey K, Borden BA, Furner B et al. Simplifying the use of pharmacogenomics in clinical practice: building the genomic prescribing system. J. Biomed. Informatics 75, 110–121 (2017).
    • 35 Caraballo PJ, Bielinski SJ, St Sauver JL, Weinshilboum RM. Electronic medical record-integrated pharmacogenomics and related clinical decision support concepts. Clin. Pharmacol. Ther. 102(2), 254–264 (2017).
    • 36 Manzi SF, Fusaro VA, Chadwick L et al. Creating a scalable clinical pharmacogenomics service with automated interpretation and medical record result integration – experience from a pediatric tertiary care facility. J. Am. Med. Informatics Assoc. 24(1), 74–80 (2017).
    • 37 Alanazi A. Incorporating pharmacogenomics into health information technology, electronic health record and decision support system: an overview. J. Med. Syst. 41(2), 19 (2017).
    • 38 Dunnenberger HM, Crews KR, Hoffman JM et al. Preemptive clinical pharmacogenetics implementation: current programs in five US medical centers. Annu. Rev. Pharmacol. Toxicol. 55, 89–106 (2015). •• The authors focus onprograms that use pre-emptive PGx testing across the US, describing common threads and highlighting processes for implementation. Although many of the programs described are academic, they are still informative in the general community setting.