Contemporary Opportunities and Challenges for teaching Pharmacogenomics to Student Pharmacists

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1 Contemporary Opportunities and Challenges for teaching Pharmacogenomics to Student Pharmacists Kristin Weitzel, Pharm.D., FAPhA Associate Director, UF Health Personalized Medicine Program Associate Chair and Clinical Associate Professor, Pharmacotherapy and Translational Research University of Florida College of Pharmacy

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3 Pharmacy Education Standards on Pharmacogenomics?? ACPE DRAFT Accreditation Standards for the Doctor of Pharmacy degree. Available at:

4 Pharmacist Competency Map. Genetics and Genomics Competency Center. Available at: 2.org/competency/pharmacist

5 Pharmacogenomics Competencies for Pharmacists Developed in 2002 and updated in 2012 by 10 pharmacy and pharmacy-related organizations Describe pharmacist-specific knowledge necessary to achieve the competencies outcome Focused in: Basic genetic concepts Genetics and disease Pharmacogenomics/pharmacogenetics Ethical, legal and social implications. Available at: Genetics/Genomics Competency Center for Education (

6 Desired Outcome With the knowledge of genetics/genomics pharmacists may recommend and interpret the results of pharmacogenetic tests and make therapy recommendations based on test results. Pharmacists and pharmacy graduates should possess competent knowledge and skills to seek coordination and collaboration of care with an interdisciplinary team of health professionals when assessing genetic information. Available at: Genetics/Genomics Competency Center for Education (

7 ASHP Statement on the Pharmacist s Role in Clinical Pharmacogenomics Available at:

8 UF Health PMP launched June 25, Targeted CYP2C19 testing in the cath lab

9 UF Health Personalized Medicine Program CYP2C19-Clopidogrel TPMT-thiopurines IL28B/IFNL3-interferon CYP2D6-Codeine, tramadol

10 UF Health Personalized Medicine Programs Project Aims Extend UF program: new clinical & gene/drug pairs Aim 1 Current PGx Aim 2 testing External expansion Aim 3 Education of students, clinicians, patients

11 UF Health Personalized Medicine Program Education and Training Health care professionals Continuing education and in-service/training programs Interprofessional health science center students Didactic and experiential education Patient education and community outreach

12 Salari K et al. PLOS One. 2013;8:e An emerging debate in academic medical centers is not about the need for providing trainees with fundamental education on genomics, but rather the most effective educational models that should be deployed.

13 Teaching and Learning Strategies Incorporate personal genotype evaluation Allow students to engage with and apply pharmacogenomic and genomic data in new ways Translation of raw genetic data to clinically useful form Application to real-world scenarios Promote development of applications-based clinical knowledge and skills Case-based learning Active engagement, flipped classroom model Patient-centered activities Interprofessional Accessible to traditional and distance education students

14 Clinical Applications: Pharmacogenomics and Genomic Medicine Two Health Professional Elective courses 8 weeks 1 credit hour each First offered in Fall 2014

15 Clinical Applications: Pharmacogenomics and Genomic Medicine Pharmacogenomics Bioethics and Informed Consent PGx and PGx Studies Evidence-Based Approach to Clinical PGx Cardiovascular PGx 1 Cardiovascular PGx 2 Oncology PGx Pain Management PGx Clinical Implementation Genomic Medicine Intro to Genomic Medicine and Genomic Medicine Studies Principles of Genetics and Genomics in Clinical Practice Direct-to-Consumer Genomic Testing Genomic Medicine Implementation Complex Diseases 1 Complex Diseases 2 Family History Role of the Genetic Counselor

16 Personal Genotype Evaluation Clinical Applications in Pharmacogenomics Course Optional Students were provided with de-identified DNA dataset if they opted out Under research informed consent (approved by IRB) Performed in Core Genotyping Laboratory using custom genotyping chip Selected pharmacogenetic SNPs with likely clinical relevance CYP2C19, TPMT, VKORC1, CYP2C9, etc. Avoided SNPs that had implications for disease risk Instructors were not aware which students participated

17 Course Format Fully online course Weekly out-of-class preparation Recorded lecture, readings Focused on knowledge and skills needed to apply pharmacogenomic/genomic data clinically Applications-based

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20 Course Format In-Class Activities 1 weekly webinar (GoToWebinar) with instructor webcam Attendance required; sessions recorded for students unable to attend Case-based, patient-centered learning activities Students randomized and called on during each live class session to respond to questions via conference line or computer mic/speakers Student participation and responses incorporated into grading

21 How do you interpret and act on discordant allele results clinically? Explain this to me in clinician-friendly terminology. What other info do you need? What patient-specific factors influence choice of antiplatelet therapy for RF? Based on presentation, genotype (from pre-case activity), and other patient-specific factors, provide a drug therapy recommendation for this patient s antiplatelet therapy below, including drug, dose, and duration of therapy.

22 In lay language, explain to Jameer the significance of the 9p21 and 4q25 findings in his genetic test results. How would you counsel Jameer about each of these findings in relation to his cardiovascular risk assessment and potential cardiovascular drug therapies? What findings in family history are relevant to breast cancer risk? Is a referral to a genetic counselor necessary? Why or why not? Should Mrs. C get a BRCA test? Why or why not? Is BRCA testing likely to be covered by Mrs. C s insurance? Why or why not?

23 Translating Raw Genetic Data to Clinically Relevant Information

24 Lessons Learned Approach was positively received by students Course evaluations Feedback questions on Final Exam Interactive distance-education model worked Case-based instruction model allowed for discussion of practice-based issues involved with pharmacogenomics and genomic medicine Incorporating test results into clinical patient care Reimbursement Test ordering and interpretation Regulatory and ethical issues

25 Challenges and Strategies Challenge: Determining how best to integrate and present the content Strategy: Transitioning course back to 16-week format Integrate genomic medicine and pharmacogenomics concepts Logically tie together the clinical applications Coordinating informed consent, genotyping, and resulting process Short turnaround Time-intensive personal communication

26 Continuing Education Program accredited for physicians, pharmacists, nurses with online enrollment workflow launched February 2015 Strategy: Online Enrollment Workflow

27 Challenges and Strategies Relatively limited course capacity Students Class size Active learning components of course

28 Strategy: Open online course to UF and non-uf students

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30 APPE/Post-Graduate Educational Experiences APPE in Personalized and Evidence-Based Medicine Provide opportunities for students to build on knowledge and skills acquired through didactic education and introductory pharmacy practice experiences and apply them in patient care and other activities within a clinical pharmacogenetics service. 4 weeks Elective rotation Non-patient care

31 APPE/Post-Graduate Educational Experiences Assigned patient care/clinical time Approximately 2 days/week Anticoag, hep C, gastro clinics, and pediatric hem/onc service Assist with patient care in clinical implementations Monitor EPIC in-basket alerts for genotype tests ordered for CYP2C19- clopidogrel patients, TPMT, IL28B Daily literature monitoring Assist with identification of new studies Assessment studies for clinical relevance using appropriate resources Faculty discussions: Clinical perspective on individual drug-gene pairs; clinical implementation, evidence-based medicine, electronic health records, clinical pathology, reimbursement environment for PGx testing; data monitoring and usage

32 APPE/Post-Graduate Educational Experiences PGY2 Residency in Pharmacogenetics Started in 2012; ASHP candidate status for accreditation Goals and objectives Patient safety Informatics Drug information Pharmacogenetics Clinical laboratory testing Developing, implementing, and evaluating clinical services Research Cardiology, oncology, pain management/family medicine Previous residents current positions

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34 Discussion