Ask the Expert: What are strategies for implementing a pharmacogenomics clinic?


September 2016 - Vol. 13 No. 9 - Page #34

A clinical pharmacogenomics service can be implemented using different models in a variety of settings, including the hospital, outpatient clinic, and community pharmacy.1-4 In the hospital or outpatient clinic, integrating pharmacogenomics into clinical decision support (CDS) tools alerts a physician when a pharmacogenomic test is recommended for a medication that has been ordered for a patient without a genetic test result on file. If pharmacogenomic results are available in the EHR, an alert may be incorporated to warn clinicians of the risk for an adverse drug reaction or that a patient is unlikely to respond to a medication. The system can be programmed with alternative recommendations that are compatible with the patient’s genotype.

Alternatively, a separate database can be created that houses patients’ pharmacogenomic information and serves as a drug-gene information resource with interpretations of the pharmacogenomic test results and recommendations on how to proceed with treatment, analogous to currently available electronic drug information resources. In the community pharmacy setting, candidates for pharmacogenomic testing may be identified when dispensing medications to patients or through a medication therapy management (MTM) service. Consider developing pharmacogenomics services in partnership with medical geneticists and genetic counselors.

Activities performed by a clinical pharmacogenomics service may include:

  • Facilitating pharmacogenomic test orders
  • Interpreting genetic test results
  • Evaluating the literature to make evidence-based treatment recommendations guided by pharmacogenomics
  • Educating clinicians and counseling patients
  • Documenting interventions and patient outcomes
  • Developing the language for CDS tools and consultation notes
  • Leading or serving on committees to advocate for the implementation of pharmacogenomics

According to the ASHP Statement on the Pharmacist’s Role in Clinical Pharmacogenomics released in 2015,5 pharmacists “have a fundamental responsibility to ensure that pharmacogenomic testing is performed when needed and that results are used to optimize medication therapy.” With their broad knowledge of MTM and drug-drug interactions, recognizing drug-gene interactions and individualizing treatment according to a patient’s genetic makeup is a natural extension of a pharmacist’s role.6

In many of the pharmacogenomic implementation efforts occurring in the US, pharmacists serve as the driving force for assembling a multidisciplinary team. Key team members should include:

  • Clinician champions to provide insight on how to seamlessly incorporate pharmacogenomic testing into current workflow processes and develop treatment algorithms guided by pharmacogenomics
  • Informatics specialist(s) to assist in the design of the CDS tools
  • Lab personnel
  • Patients
  • Institutional leadership to provide a platform of support for implementation efforts

Depending on the lab resources available, pharmacogenomic testing may be performed internally or outsourced to a CAP/CLIA-certified commercial lab that can provide single-gene or multi-gene panel results. Keep in mind that reimbursement or coverage for pharmacogenomic tests performed by commercial labs varies and should be discussed with the patient before genetic tests are ordered. Educational outreach endeavors are essential for raising awareness among health care providers and the community on the benefits of pharmacogenomics.

A major resource for implementing pharmacogenomics into clinical practice, the CPIC guidelines (available at www.pharmgkb.org/) serve as a blueprint for integrating pharmacogenomics into patient care. Along with a compilation of the literature supporting a drug-gene pair, the supplement for each CPIC guideline houses workflow diagrams, sample CDS alerts, and consults that can be modified and tailored for use by institutions.

Finally, an important component to launching a clinical pharmacogenomics service is demonstrating its clinical utility. Data can be prospectively collected on how genetic results alter clinical management and drug-related outcomes. For example, a recent clinical study demonstrated that the CYP2C19-genotype guided antiplatelet therapy and reduced major adverse cardiovascular events.7

Conclusion
A broad knowledge of MTM and drug-drug interactions make pharmacists ideal candidates to manage pharmacogenomics services. Research and innovative practice models will continue to overcome the barriers to widespread adoption and drive pharmacogenomics into clinical practice, thus enhancing patient care.


Teresa T. Vo, PharmD, BCPS, is an assistant professor at the University of South Florida (USF) College of Pharmacy and College of Medicine, where she leads initiatives to implement pharmacogenomics.


Additional Resource:
Making the Case for a Pharmacogenomics Clinic

by Teresa T. Vo, PharmD, BCPS
PP&P February 2016

References

  1. 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.
  2. 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.
  3. Hoffman JM, Haidar CE, Wilkinson MR, et al. PG4KDS: a model for the clinical implementation of pre-emptive pharmacogenetics. Am J Med Genet C Semin Med Genet. 2014;166C(1):45-55.
  4. O’Donnell PH, Danahey K, Jacobs M, et al. Adoption of a clinical pharmacogenomics implementation program during outpatient care--initial results of the University of Chicago “1,200 Patients Project”. Am J Med Genet C Semin Med Genet. 2014;166C(1):68-75.
  5. ASHP statement on the pharmacist’s role in clinical pharmacogenomics. Am J Health Syst Pharm. 2015;72(7):579-581.
  6. Owusu-Obeng A, Weitzel KW, Hatton RC, et al. Emerging roles for pharmacists in clinical implementation of pharmacogenomics. Pharmacotherapy. 2014;34(10):1102-1112.
  7. Cavallari LH, Magvanjav O, Anderson RD, et al. Abstract 11802: Clinical implementation of CYP2C19-genotype guided antiplatelet therapy reduces cardiovascular events after PCI. Circulation. 2015;132:A11802. http://circ.ahajournals.org/content/132/Suppl_3/A11802.abstract?related-urls=yes&legid=circulationaha;132/Suppl_3/A11802. Accessed December 10, 2015.

Login

Like what you've read? Please log in or create a free account to enjoy more of what www.pppmag.com has to offer.

Current Issue

Enter our Sweepstakes now for your chance to win the following prizes:

Just answer the following quick question for your chance to win:

To continue, you must either login or register: