References
- Cicali EJ, Weitzel KW, Elsey AR, et al. Challenges and lessons learned from clinical pharmacogenetic implementation of multiple gene-drug pairs across ambulatory care settings. Genet Med. 2019;21(10):2264–2274. doi:10.1038/s41436-019-0500-7.
- Weitzel KW, Elsey AR, Langaee TY, et al. Clinical pharmacogenetics implementation: approaches, successes, and challenges. Am J Med Genet C Semin Med Genet. 2014;166C(1):56–67. doi:10.1002/ajmg.c.31390.
- American Society of Health System Pharmacists. ASHP statement on the pharmacist’s role in clinical pharmacogenomics. Am J Health Syst Pharm. 2015;72(7):579–581. doi:10.2146/sp150003.
- Zellmer WA, ed. Pharmacy Forecast 2016–2020: Strategic Planning Advice for Pharmacy Departments in Hospitals and Health Systems, December 2015. Bethesda, MD: ASHP Research and Education Foundation; 2017. Available from: https://www.ashpfoundation.org/-/media/REF/Research/PDFs/2016_PharmacyForecast_Report.ashx?la=en&hash=50295F3AF81810FC184EB67E2793CD3ED6AC8754. Accessed February 28, 2021.
- The clinical pharmacogenetics implementation consortium (CPIC®). Guidelines. Available from: https://cpicpgx.org/guidelines/. Accessed February 28, 2021.
- Relling MV, Klein TE, Clinical Pharmacogenetics CPIC. Implementation consortium of the pharmacogenomics research network. Clin Pharmacol Ther. 2011;89(3):464–467. doi:10.1038/clpt.2010.279.
- Caudle KE, Gammal RS, Karnes JH, et al. PRN OPINION PAPER: application of precision medicine across pharmacy specialty areas. J Am Coll Clin Pharm. 2019;2(3):288–302. doi:10.1002/jac5.1107
- Liu M, Vnencak-Jones CL, Roland BP, et al. A tutorial for pharmacogenomics implementation through end-to-end clinical decision support based on ten years of experience from PREDICT. Clin Pharmacol Ther. 2021;109(1):101–115. doi:10.1002/cpt.2079.
- Sissung TM, McKeeby JW, Patel J, et al. Pharmacogenomics implementation at the national institutes of health clinical center. J Clin Pharmacol. 2017;57:S67–S77. doi:10.1002/jcph.993
- Dunnenberger HM, Crews KR, Hoffman JM, et al. Preemptive clinical pharmacogenetics implementation: current programs in five US medical centers. Annu Rev Pharmacol Toxicol. 2015;55(1):89–106. doi:10.1146/annurev-pharmtox-010814-124835.
- Wang L, Weinshilboum R. Pharmacogenomics in practice. Clin Pharmacol Ther. 2019;106(5):936–938. doi:10.1002/cpt.1600.
- Petry N, Baye J, Aifaoui A, et al. Implementation of wide-scale pharmacogenetic testing in primary care. Pharmacogenomics. 2019;20(12):903–913. doi:10.2217/pgs-2019-0043.
- 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 Inform Assoc. 2017;24(1):74–80. doi:10.1093/jamia/ocw052.
- Cavallari LH, Weitzel KW, Elsey AR, et al. Institutional profile: University of Florida health personalized medicine program. Pharmacogenomics. 2017;18(5):421–426. Epub 2017 Mar 27. doi:10.2217/pgs-2017-0028.
- Ramsey LB, Prows CA, Zhang K, et al. Implementation of pharmacogenetics at Cincinnati Children’s Hospital Medical Center: lessons learned over 14 years of personalizing medicine. Clin Pharmacol Ther. 2019;105(1):49–52. doi:10.1002/cpt.1165.
- Johnson JA, Elsey AR, Clare-Salzler MJ, Nessl D, Conlon M, Nelson DR. Institutional profile: University of Florida and Shands Hospital personalized medicine program: clinical implementation of pharmacogenetics. Pharmacogenomics. 2013;14(7):723–726. doi:10.2217/pgs.13.59.
- Empey PE, Stevenson JM, Tuteja S, et al.; IGNITE Network. Multisite investigation of strategies for the implementation of CYP2C19 genotype-guided antiplatelet therapy. Clin Pharmacol Ther. 2018;104(4):664–674. doi:10.1002/cpt.1006.
- Van Driest SL, Shi Y, Bowton EA, et al. Clinically actionable genotypes among 10,000 patients with preemptive pharmacogenomic testing. Clin Pharmacol Ther. 2014;95(4):423–431. doi:10.1038/clpt.2013.229.
- Hoffman JM, Haidar CE, Wilkinson MR, et al. PG4KDS: a model for the clinical implementation of pre‐emptive pharmacogenetics. Am J Med Genet. 2014;166C(1):45–55. doi:10.1002/ajmg.c.31391
- Ji Y, Skierka JM, Blommel JH, et al. Preemptive pharmacogenomic testing for precision medicine: a comprehensive analysis of five actionable pharmacogenomic genes using next-generation DNA sequencing and a customized CYP2D6 genotyping cascade. J Mol Diagn. 2016;18(3):438–445. doi:10.1016/j.jmoldx.2016.01.003.
- Haidar CE, Relling MV, Hoffman JM. Preemptively precise: returning and updating pharmacogenetic test results to realize the benefits of preemptive testing. Clin Pharmacol Ther. 2019;106(5):942–944. doi:10.1002/cpt.1613.
- Vo TT, Bell GC, Owusu Obeng A, Hicks JK, Dunnenberger HM. Pharmacogenomics implementation: considerations for selecting a reference laboratory. Pharmacotherapy. 2017;37(9):1014–1022. doi:10.1002/phar.1985.
- Nagy M, Eirini Tsermpini E, Siamoglou S, Patrinos GP. Evaluating the current level of pharmacists’ pharmacogenomics knowledge and its impact on pharmacogenomics implementation. Pharmacogenomics. 2020;21(16):1179–1189. doi:10.2217/pgs-2020-0076.
- Tuteja S, Haynes K, Zayac C, Sprague JE, Bernhardt B, Pyeritz R. Community pharmacists’ attitudes towards clinical utility and ethical implications of pharmacogenetic testing. Pers Med. 2013;10(8):793–800. 7. doi:10.2217/pme.13.85
- Schwartz EJ, Issa AM. The role of hospital pharmacists in the adoption and use of pharmacogenomics and precision medicine. Pers Med. 2017;14(1):27–35. doi:10.2217/pme-2016-0063
- Hundertmark ME, Waring SC, Stenehjem DD, et al. Pharmacist’s attitudes and knowledge of pharmacogenomics and the factors that may predict future engagement. Pharm Pract (Granada). 2020;18(3):2008. doi:10.18549/PharmPract.2020.3.2008.
- American Pharmacists Association. Oath of a pharmacist. Available from: https://www.pharmacist.com/About/Oath-of-a-Pharmacist. Accessed May 6, 2021.
- Caudle KE, Gammal RS, Whirl-Carrillo M, Hoffman JM, Relling MV, Klein TE. Evidence and resources to implement pharmacogenetic knowledge for precision medicine. Am J Health Syst Pharm. 2016;73(23):1977–1985. doi:10.2146/ajhp150977.
- McDonagh EM, Whirl-Carrillo M, Garten Y, Altman RB, Klein TE. From pharmacogenomic knowledge acquisition to clinical applications: the PharmGKB as a clinical pharmacogenomic biomarker resource. Biomark Med. 2011;5(6):795–806. doi:10.2217/bmm.11.94.
- US FDA. Table of pharmacogenomic biomarkers in drug labeling. Available from: https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling. Accessed February 28, 2021.
- US FDA. Table of pharmacogenetic associations. Available from: https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations. Accessed February 28, 2021.
- Roederer MW, Kuo GM, Kisor DF, et al. Pharmacogenomics competencies in pharmacy practice: a blueprint for change. J Am Pharm Assoc. 2017;57(1):120–125. doi:10.1016/j.japh.2016.08.014.
- Alexander KM, Divine HS, Hanna CR, Gokun Y, Freeman PR. Implementation of personalized medicine services in community pharmacies: perceptions of independent community pharmacists. J Am Pharm Assoc. 2014;54(5):510–517. doi:10.1331/JAPhA.2014.13041
- O’Connor SK, Michaels N, Ferreri S. Expansion of pharmacogenomics into the community pharmacy: billing considerations. Pharmacogenomics. 2015;16(3):175–180. doi:10.2217/pgs.14.183
- Dunnenberger HM, Biszewski M, Bell GC, et al. Implementation of a multidisciplinary pharmacogenomics clinic in a community health system. Am J Health Syst Pharm. 2016;73(23):1956–1966. doi:10.2146/ajhp160072.
- Hicks JK, Stowe D, Willner MA, et al. Implementation of clinical pharmacogenomics within a large health system: from electronic health record decision support to consultation services. Pharmacotherapy. 2016;36(8):940–948. doi:10.1002/phar.1786.
- Bright DR, Klepser M, Murry L, Klepser D. Pharmacist provided pharmacogenetic point of care testing consultation service: a time and motion study. J Pharm Technol. 2018;34(4):139–143. doi:10.1177/8755122518756651
- Moaddeb J, Mills R, Haga SB. Community pharmacists’ experience with pharmacogenetic testing. J Am Pharm Assoc. 2015;55(6):587–594. doi:10.1331/JAPhA.2015.15017
- Dressler LG, Bell GC, Ruch KD, Retamal JD, Krug PB, Paulus RA. Implementing a personalized medicine program in a community health system. Pharmacogenomics. 2018;19(17):1345–1356. doi:10.2217/pgs-2018-0130.
- Smith DM, Peshkin BN, Springfield TB, et al. Pharmacogenetics in practice: estimating the clinical actionability of pharmacogenetic testing in perioperative and ambulatory settings. Clin Transl Sci. 2020;13(3):618–627. doi:10.1111/cts.12748.
- Padgett L, O’Connor S, Roederer M, McLeod H, Ferreri S. Pharmacogenomics in a community pharmacy: ACT now. J Am Pharm Assoc. 2011;51(2):189–193. doi:10.1331/JAPhA.2011.10178
- Owen JA. Integrating pharmacogenomics into pharmacy practice via medication therapy management. J Am Pharm Assoc. 2011;51(6):e64–e74. doi:10.1331/JAPhA.2011.11543
- Haga SB, Moaddeb J, Mills R, Voora D. Assessing feasibility of delivering pharmacogenetic testing in a community pharmacy setting. Pharmacogenomics. 2017;18(4):327–335. doi:10.2217/pgs-2016-0175
- Papastergiou J, Tolios P, Li W, Li J. The innovative Canadian pharmacogenomic screening initiative in community pharmacy (ICANPIC) Study. J Am Pharm Assoc. 2017;57(5):624–629. doi:10.1016/j.japh.2017.05.006
- Breaux S, Desrosiers FAD, Niera M, Sinha S, Nislow C. Pharmacogenomics at the point of care: a community pharmacy project in British Columbia. J Pers Med. 2021;11(1):11. doi:10.3390/jpm11010011
- Gammal RS, Mayes J, Caudle KE. Ready or not, here it comes: direct-to-consumer pharmacogenomic testing and its implications for community pharmacists. J Am Pharm Assoc. 2019;59(5):646–650. doi:10.1016/j.japh.2019.06.008
- Bright DR, Worley M, Porter B. Patient perceptions of pharmacogenomic testing in the community pharmacy setting. Res Soc Admin Pharm. 2021;17(4):744–749. doi:10.1016/j.sapharm.2020.06.022
- Gibson ML, Hohmeier KC, Smith CT. Pharmacogenomics testing in a community pharmacy: patient perceptions and willingness-to-pay. Pharmacogenomics. 2017;18(3):227–233. doi:10.2217/pgs-2016-0161
- O’Connor SK, Ferreri SP, Michaels NM, et al. Exploratory planning and implementation of a pilot pharmacogenetic program in a community pharmacy. Pharmacogenomics. 2012;13(8):955–962. doi:10.2217/pgs.12.67.
- Ferreri SP, Greco AJ, Michaels NM, et al. Implementation of a pharmacogenomics service in a community pharmacy. J Am Pharm Assoc. 2014;54(2):172–180. doi:10.1331/JAPhA.2014.13033.
- Bright DR, Kisor DF, Smith A, Conaway M, Yu M. Implementation of a pharmacogenetic management service for post-myocardial infarction care in a community pharmacy. Pers Med. 2015;12(4):319–325. doi:10.2217/pme.15.7
- Brown SA, Pereira N. Pharmacogenomic impact of CYP2C19 variation on clopidogrel therapy in precision cardiovascular medicine. J Pers Med. 2018;8(1):8. doi:10.3390/jpm8010008.
- Roden DM. Clopidogrel pharmacogenetics - why the wait? N Engl J Med. 2019;381(17):1677–1678. doi:10.1056/NEJMe1911496.
- Pereira NL, Farkouh ME, So D, et al. Effect of genotype-guided oral P2Y12 inhibitor selection vs conventional clopidogrel therapy on ischemic outcomes after percutaneous coronary intervention: the TAILOR-PCI randomized clinical trial. JAMA. 2020;324(8):761–771. doi:10.1001/jama.2020.12443.
- Clopidogrel. DailyMed. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01b14603-8f29-4fa3-8d7e-9d523f802e0b. Accessed February 3, 2021.
- Approval Package for Plavix. U.S. Food and Drug Administration. Center for drug evaluation and research; November 17, 1997. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020839_s000.pdf. Accessed February 4, 2021.
- Plavix®(clopidogrel bisulfate tablets). U.S. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020839s040lbl.pdf. Accessed February 5, 2021.
- FDA Drug Safety Communication. Reduced effectiveness of plavix (clopidogrel) in patients who are poor metabolizers of the drug. Available from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-drug-safety-communication-reduced-effectiveness-plavix-clopidogrel-patients-who-are-poor. Accessed February 5, 2021.
- Plavix®(clopidogrel bisulfate tablets). U.S. Food and Drug Administration. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020839s042lbl.pdf. Accessed February 5, 2021.
- Swen JJ, Nijenhuis M, de Boer A, et al. Pharmacogenetics: from bench to byte–an update of guidelines. Clin Pharmacol Ther. 2011;89(5):662–673. doi:10.1038/clpt.2011.34.
- Scott SA, Sangkuhl K, Gardner EE, et al. Clinical pharmacogenetics implementation consortium guidelines for cytochrome P450-2C19 (CYP2C19) genotype and clopidogrel therapy. Clin Pharmacol Ther. 2011;90(2):328–332. doi:10.1038/clpt.2011.132.
- Johnson JA, Roden DM, Lesko LJ, Ashley E, Klein TE, Shuldiner AR. Clopidogrel: a case for indication-specific pharmacogenetics. Clin Pharmacol Ther. 2012;91(5):774–776. doi:10.1038/clpt.2012.21.
- American College of Cardiology. TAILOR-PCI: genotype-guided antiplatelet therapy post PCI misses mark. Available from: https://www.acc.org/latest-in-cardiology/articles/2020/03/24/16/41/sat-9am-tailor-pci-clinical-implementation-clopidogrel-pharmacogenetics-acc-2020. Accessed March 25, 2021.
- Hughes S. TAILOR-PCI: clopidogrel genotyping trial narrowly misses endpoint. Available from: https://www.medscape.com/viewarticle/927712. Accessed February 9, 2021.
- Claassens DMF, Vos GJA, Bergmeijer TO, et al. A genotype-guided strategy for oral P2Y12 inhibitors in primary PCI. N Engl J Med. 2019;381(17):1621–1631. doi:10.1056/NEJMoa1907096.
- Pereira NL, Rihal C, Lennon R, et al. Effect of CYP2C19 genotype on ischemic outcomes during oral P2Y12 inhibitor therapy: a meta-analysis. J Am Coll Cardiol. 2021;14(7):739–750. doi:10.1016/j.jcin.2021.01.024
- Brandom R. Body blow: how 23andMe brought down the FDA’s wrath. Available from: https://www.theverge.com/2013/11/25/5144928/how-23andme-brought-down-fda-wrath-personal-genetics-wojcicki. Accessed February 9, 2021.
- FDA News Release. FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism. Available from: https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-direct-consumer-test-detecting-genetic-variants-may-be-associated-medication#:~:text=Today%2C%20the%20U.S.%20Food%20and,to%20metabolize%20some%20medications%20to. Accessed May 3, 2021.
- U.S. Food and Drug Administration. Letter to 23andMe Inc. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193492.pdf. Accessed February 9, 2021.
- O’Connor SK, Ferreri SP, Michaels NM, et al. Making pharmacogenetic testing a reality in a community pharmacy. J Am Pharm Assoc. 2012;52(6):e259–65. doi:10.1331/JAPhA.2012.12108
- Kisor DF, Bright DR, Conaway M, Bouts BA, Gerschutz GP. Pharmacogenetics in the community pharmacy: thienopyridine selection post-coronary artery stent placement. J Pharm Pract. 2014;27(4):416–419. doi:10.1177/0897190014522496
- Bright DR, Greco AJ, Langervelt A, Kisor DF. Clinical implementation of personalized medicine in community pharmacies: considerations for clinicians. Per Med. 2017;14(6):471–475. doi:10.2217/pme-2017-0050
- Hilden MP, Bright DR, Kisor DF, Christensen H. Pharmacogenomics: a practical primer for senior care pharmacists. Sr Care Pharm. 2019;34(6):363–369. doi:10.4140/TCP.n.2019.363