Pharmacists advancing role in pharmacogenomics

Abstract

The APhA House of Delegates (HoD) adopted several exciting policy statements during the 2018 APhA Annual Meeting and Exposition. The policy statements shared the central themes of improving pharmacy practice and patient outcomes. One policy statement in particular focused on “The Use of Genomic Data Within Pharmacy Practice.” This cutting-edge policy demonstrates the dedication of APhA’s membership to optimizing therapeutic outcomes for the patients that we serve. This column focuses on some key components of the genomics policy statement. The policy statement begins by placing emphasis on genomics as an essential aspect of pharmacy practice. This demonstrates that our membership is composed of individuals that are willing to use innovative tools and methods to ultimately improve the lives of our patients. Furthermore, it demonstrates our appreciation of the efforts of countless pharmacists, other clinicians, and scientists that have worked tirelessly to advance the clinical utility of genomic tools and resources. For example, the U.S. Food and Drug Administration features a Genomics and Targeted Therapy Group that maintains a freely accessible table of pharmacogenomic biomarkers that are published within the labeling materials of currently approved drugs (https://www.fda.gov/Drugs/ScienceResearch/ucm572698.htm). The table reveals that genomic insights are included within the prescribing materials for more than 100 drugs that are currently prescribed/dispensed within 18 therapeutic areas. Genomics is indeed an essential aspect of pharmacy practice, and pharmacists are best suited to provide medication-related consultation and services based on the pharmacogenomic biomarkers within the labeling of drugs. Genomics techniques and applications have proliferated over the past 15 years, leading to multiple subdisciplines of omics (lipidomics, transcriptomics, metabolomics, proteomics, etc.). Furthermore, the methods of clinical genetics testing have expanded to broader approaches that are similar to the aforementioned omics techniques (genome-wide association studies, whole-exome sequencing, next-generation sequencing, etc.). However, the effect sizes and clinical impact of pharmacogenomic variants have generally been larger than effects that have been observed for many variants that have been investigated for associations with clinical diseases.1Maranville J.C. Cox N.J. Pharmacogenomic variants have larger effect sizes than genetic variants associated with other dichotomous complex traits.Pharmacogenomics J. 2016; 16: 388-392Crossref PubMed Scopus (41) Google Scholar Thus, pharmacogenomic variants are among the most clinically informative genetic variants. Moreover, many of the pharmacogenomics biomarkers that are clinically useful occur frequently across the population and are associated with potentially harmful adverse drug events.2Relling M.V. Klein T.E. CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network.Clin Pharmacol Ther. 2011; 89: 464-467Crossref PubMed Scopus (722) Google Scholar, 3Ingelman-Sundberg M. Pharmacogenomic biomarkers for prediction of severe adverse drug reactions.N Engl J Med. 2008; 358: 637-639Crossref PubMed Scopus (118) Google Scholar, 4Alfirevic A. Pirmohamed M. Genomics of adverse drug reactions.Trends Pharmacol Sci. 2017; 38: 100-109Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar Therefore, pharmacists are viewed as essential for the successful clinical implementation of pharmacogenomics.5Arwood M.J. Chumnumwat S. Cavallari L.H. Nutescu E.A. Duarte J.D. Implementing pharmacogenomics at your institution: establishment and overcoming implementation challenges.Clin Transl Sci. 2016; 9: 233-245Crossref PubMed Scopus (58) Google Scholar, 6Giri J. Curry T.B. Formea C.M. Nicholson W.T. Rohrer Vitek C.R. Education and knowledge in pharmacogenomics: still a challenge?.Clin Pharmacol Ther. 2018; 103: 752-755Crossref PubMed Scopus (29) Google Scholar, 7Larson E.A. Wilke R.A. Integration of genomics in primary care.Am J Med. 2015; 128: 1251.e1-5Google Scholar The successful clinical implementation of pharmacogenomics requires that clinicians have evidence-based guidelines and data supporting the use of such guidelines within the context of clinical care. Pharmacists have played significant roles in the development of evidence-based practice guidelines for the clinical implementation of pharmacogenomic biomarkers.2Relling M.V. Klein T.E. CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network.Clin Pharmacol Ther. 2011; 89: 464-467Crossref PubMed Scopus (722) Google Scholar, 8Relling M.V. Krauss R.M. Roden D.M. et al.New Pharmacogenomics Research Network: an open community catalyzing research and translation in precision medicine.Clin Pharmacol Ther. 2017; 102: 897-902Google Scholar, 9Caudle K. Klein T. Hoffman J. et al.Incorporation of pharmacogenomics into routine clinical practice: the Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline development process.Curr Drug Metab. 2014; 15: 209-217Crossref PubMed Scopus (284) Google Scholar These guidelines are written by members of the Clinical Pharmacogenetics Implementation Consortium (CPIC) and made freely available on their website (https://cpicpgx.org/guidelines). CPIC guidelines are written in a clinician-friendly format and have been endorsed by several professional health care societies. Moreover, pharmacists have essential roles as leaders of or contributors to large research efforts focused on evaluating the impact of implementing pharmacogenomics within clinical care.10Hoffman J.M. Haidar C.E. Wilkinson M.R. et al.PG4KDS: a model for the clinical implementation of pre-emptive pharmacogenetics.Am J Med Genet Part C Semin Med Genet. 2014; 166: 45-55Google Scholar, 11Shuldiner A.R. Palmer K. Pakyz R.E. et al.Implementation of pharmacogenetics: the University of Maryland personalized anti-platelet pharmacogenetics program.Am J Med Genet Part C Semin Med Genet. 2014; 166: 76-84Google Scholar, 12Weitzel K.W. Elsey A.R. Langaee T.Y. et al.Clinical pharmacogenetics implementation: approaches, successes, and challenges.Am J Med Genet Part C Semin Med Genet. 2014; 166: 56-67Crossref Scopus (138) Google Scholar The National Institutes of Health’s Implementing Genomics in Practice (IGNITE) network features pharmacogenetics as one of its 6 designated working groups.13Weitzel K.W. Alexander M. Bernhardt B.A. et al.The IGNITE network: a model for genomic medicine implementation and research.BMC Med Genomics. 2016; 9: 1Crossref PubMed Scopus (146) Google Scholar Therefore, pharmacists are contributing to efforts that will maximize the usefulness of pharmacogenomics within pharmacy practice by contributing to the development of evidence-based guidelines and to the evaluation of their utility in clinical care. The costs of genomics testing approaches are falling at unprecedented rates. However, clinician access to genomic results and the interpretation thereof pose challenges to their clinical implementation. The APhA HoD policy supports both pharmacist access to clinically actionable genomic results and reimbursement for the pharmacist’s cognitive services for interpreting genomic reports. As previously mentioned, the costs of genomic tests are rapidly declining, and the interpretation of genomic results remains a primary challenge.14Lu J. Campeau P. Lee B. Genotype–phenotype correlation—promiscuity in the era of next-generation sequencing.N Engl J Med. 2014; 371: 593-596Crossref PubMed Scopus (66) Google Scholar, 15Hayden E.C. Technology: the $1,000 genome.Nature. 2014; 507: 294-295Crossref PubMed Scopus (313) Google Scholar, 16Mardis E.R. The $1,000 genome, the $100,000 analysis?.Genome Med. 2010; 2: 7-9https://doi.org/10.1186/gm205Crossref Scopus (202) Google Scholar Therefore, pharmacist access to clinical genomic reports and reimbursement for cognitive services remain as key opportunities to ensure that pharmacogenomics implementation occurs to improve outcomes for the patients we serve. Finally, the APhA HoD policy suggests that student pharmacists and practicing pharmacists receive education and continuing education respectively to ensure that our constituency is prepared to meet the challenge of implementing cutting edge genomics within clinical care. This is important because data have shown that many health care providers feel inadequately trained to evaluate or interpret pharmacogenomics data.17Just K.S. Steffens M. Swen J.J. Patrinos G.P. Guchelaar H.J. Stingl J.C. Medical education in pharmacogenomics—results from a survey on pharmacogenetic knowledge in healthcare professionals within the European pharmacogenomics clinical implementation project Ubiquitous Pharmacogenomics (U-PGx).Eur J Clin Pharmacol. 2017; 73: 1247-1252Google Scholar, 18Stanek E.J. Sanders C.L. Taber K.A.J. et al.Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey.Clin Pharmacol Ther. 2012; 91: 450-458Crossref PubMed Scopus (321) Google Scholar, 19McCullough K. Formea C. Berg K. et al.Assessment of the pharmacogenetics educational needs of pharmacists.Am J Pharm Educ. 2011; 75: 51Crossref PubMed Scopus (132) Google Scholar Personally, I have witnessed a rise in courses with a focus on genomics within PharmD curricula, PhD programs, residencies, fellowships, certificate programs, and continuing education courses. I am encouraged that we are positioning the pharmacy profession to use genomics to meet the challenge of improving clinical outcomes for the patients that we serve. Elvin T. Price, PharmD, PhD, FAHA, Associate Professor, Virginia Commonwealth University School of Pharmacy and Institute for Inclusion, Inquiry, and Innovation, Richmond, VA; 2018–19 APhA–APRS Chair, Basic Sciences Section