PREREQUISITES AND PLACEMENT IN THE CURRICULUM: Completion of all Phase 2 clerkships

PURPOSE:
Prepare healthcare students to have adequate foundational knowledge about pharmacogenomics and its application to individualized patient care. Precision medicine is defined as an approach to “disease treatment and prevention taking into account individual variability in genes, environment, and lifestyle for each person.” One of the core elements in precision medicine is pharmacogenomics. Pharmacogenomics is the study of how genes affect a person’s response to drugs. Genomic medicine educational curriculum is recommended for nongeneticist to ensure future physicians are competent to translate genetic related research and apply it to clinical practice. The National Human Genome Research Institute of the National Institutes of Health working with 30 different health professional organizations developed genomic EPA encompassing areas from diagnostic testing to treatment interventions (Vassy JL, Korf BR, Green RC). This elective will prepare healthcare students to have adequate pharmacogenomics foundational knowledge to optimize patient care. Students will develop skills to assess how genomic changes may causes different phenotypes and how to use this tool to target pharmacology therapy. This is an online course with a virtual face-to-face meeting once a week. Students will be expected to commit to four to five hours of work time per day to cover the following topics. There will be weekly quizzes, patient cases assignment, and students are expected to spend 2 half days at a clinic implementing
pharmacogenomics therapy.

OBJECTIVES:
1. Describe precision medicine and the fundamentals of pharmacogenomic interventions;
2. Assess how genetic polymorphisms affect drug treatment outcomes;
3. Identify the clinical utility of pharmacogenomics and use it to tailor drug therapy

INSTRUCTIONAL METHODS:
This is an online course with a virtual face-to-face meeting once a week. Students will be expected to commit to four to five hours of work time per day to cover the following topics. There will be weekly quizzes, patient cases, and face-toface sessions regarding pharmacogenomics and medical care. An optional clinical experience (1-2 half days) working with clinicians who implemented pharmacogenomic service.

Week 1 – Pharmacogenomics Introduction – Nuts and Bolts
1. Define precision medicine and pharmacogenomics;
2. Distinguish pharmacogenetics vs pharmacogenomics;
3. Explain genetic-related terminology and variant nomenclature;
4. Differentiate different types of genetic variants that pertain to pharmacotherapy;
5. Recognize that inter-individual variability exists in absorption, distribution, metabolism and excretion of drugs;
6. Discuss how genetic variants may alter clinically significant drug metabolizing enzyme function and pharmacokinetic parameters (drug-drug interaction, drug plasma concentration, efficacy, and toxicity of a drug);
7. Navigate evidenced-based pharmacogenomics databases containing information on human genetic variation and evidenced pharmacogenomics intervention.
Student responsibility: Quiz, patient cases, virtual face-to-face meeting, student reflectionpaper.

Week 2 – Clinical Utility of Pharmacogenomics in Neuropharmacology
1. Describe the impact of different genetically-mediated liver enzyme phenotypes on codeine and morphine PK, analgesic efficacy, and toxicity.
2. Explain the impact of CYP2C9*2 and CYP2C9*3 alleles on the metabolism, PK, and dosage requirements of phenytoin.
3. Evaluate the impact of genetic polymorphism on treatment outcomes and risk of adverse outcomes through examining the role of serotonin pharmacogenomics targets for predicting response to antidepressants.
4. Assess the relationship between neurotransmitter polymorphisms and antipsychotic response in schizophrenia.
Student responsibility: Quiz, patient cases, virtual face-to-face meeting, student reflection paper.

Week 3 – Clinical Utility of Pharmacogenomics in Cardiovascular Pharmacotherapy and
Drug Hypersensitivity Reactions
1. Develop a therapeutic plan (antiplatelet, lipid management, hypertension) for a given patient based on genetic profile and currently available evidence.
2. Assess the impact of CYP2C9 and vitamin K epoxide reductase in warfarin response in various patient ethnic groups.
3. Describe the gene-drug pairs that are associated with hypersensitivity reactions.
4. Design a risk assessment strategy to prevent drug hypersensitivity reactions.
Student responsibility: Quiz, patient cases, virtual face-to-face meeting, student reflection paper.

Week 4 – Pharmacogenomics Study Design – how to assess the evidence?
1. Describe common study designs used in assessing pharmacogenomics therapy.
2. Compare and contrast the candidate gene versus the genome-wide approach for genetic association studies.
3. Explain the limitation of conventional P <0.05 value in a genome wide approach study.
4. Identify challenges associated with conducting prospective pharmacogenomics based randomize-controlled trials.
5. Assess the validity of pharmacogenomics clinical trials Explain ethical concerns with pharmacogenomics care?
Student responsibility: quiz, virtual journal club, clinical work-flow design proposal, patient cases, student reflection paper (challenges to clinical integration of pharmacogenomics medicine).

Method of Evaluation: Overall Pass/Fail. Min pass 80% for quiz and patient cases.

Required Reading: Textbook: Pharmacogenomics-Applications to Patient Care. ACCP. 3rd Edition
PGX databases: https://cpicpgx.orq/. https://www.pharmgkb.org/guidelineAnnotations.
Primary literature readings for each week activity.

ADMINISTRATIVE INFORMATION:

Program Number: ELEC 494
Program Directors: Dr. Linda Chang, Dr. Radhika Sreedhar
Email: [email protected]
Duration: 4 Weeks

Updated:  12/08/20