NHGRI ISCC-PEG

Planning Committee for the ISCC-PEG Pharmacogenomics Learning Series:

• Philip Empey, PharmD, PhD, FCCP (University of Pittsburgh School of Pharmacy)
• Andrew Monte, MD, PhD (University of Colorado)
  
• Trina Walker, DNP, APRN, FNP-C (Creighton University)
• Nguyen Park, MS, PA-C (National Human Genome Research Institute)
• Jeneva Gularte-Rinaldo, PhD, RN (Samuel Merritt University)

Course Director

Spoorthy Reddy University of Colorado

Additional Content Reviewers

• Christina Aquilante, PharmD, Director of Pharmacogenomics for the Colorado Center for Personalized Medicine; Professor, Department of Pharmaceutical Sciences; University of Colorado
• Kathy Giacomini, PhD, Dean and Professor, School of Pharmacy; Co-Director UCSF-Stanford Center of Excellence in Regulatory Sciences and Innovation; University of California, San Francisco 
  

All healthcare professionals

LEARNING OBJECTIVES

• Review the nomenclature for PGx
  
• Review available evidence sources for pharmacogenomic recommendations. 
• Describe how Clinical Pharmacogenetic Implementation Consortium (CPIC) guidelines are developed, the components of a CPIC guideline and how CPIC guidelines can be used by clinicians to make specific prescribing decisions for patient care. 
• Retrieve the levels of evidence for gene/drug pairs.
• Integrate information from US Food and Drug Administration (FDA), CPIC, and PharmGKB into pharmacogenomic clinical decision making.

Planning Committee for the ISCC-PEG Pharmacogenomics Learning Series:

• Philip Empey, PharmD, PhD, FCCP (University of Pittsburgh School of Pharmacy)
• Andrew Monte, MD, PhD (University of Colorado)
  
• Trina Walker, DNP, APRN, FNP-C (Creighton University)
• Nguyen Park, MS, PA-C (National Human Genome Research Institute)
• Jeneva Gularte-Rinaldo, PhD, RN (Samuel Merritt University)

Course Directors

	Philip Empey, PharmD, PhD Associate Professor and Director, Pharmacogenomics Center of Excellence University of Pittsburgh School of Pharmacy
	Benjamin Brown American Society of Pharmacovigilance

Additional Content Reviewers

• Kelly Caudle, PharmD, PhD, Director, Clinical Pharmacogenetics Implementation Consortium
• Wendy Rubinstein, MD, PhD, Director, Personalized Medicine, Food & Drug Administration (Questions 1 and 3 only).  The review does not constitute an endorsement by FDA or any of its employees
  

All healthcare professionals

LEARNING OBJECTIVES

• Review available evidence sources for pharmacogenomic recommendations. 
  
• Describe the components of a CPIC guideline and how CPIC guidelines can be used by clinicians to make specific prescribing decisions for patient care. 
• Explain how evidence-based guidelines are developed by CPIC.
• Retrieve the levels of evidence for gene/drug pairs.
• Integrate information from FDA, CPIC, and PharmGKB into pharmacogenomic clinical decision making.
  

Planning Committee for the ISCC-PEG Pharmacogenomics Learning Series:

• Philip Empey, PharmD, PhD, FCCP (University of Pittsburgh School of Pharmacy)
• Andrew Monte, MD, PhD (University of Colorado)
  
• Trina Walker, DNP, APRN, FNP-C (Creighton University)
• Nguyen Park, MS, PA-C (National Human Genome Research Institute)
• Jeneva Gularte-Rinaldo, PhD, RN (Samuel Merritt University)

Course Directors

	Otito Frances Iwuchukwu, PhD, MA Associate Professor Fairleigh Dickinson University
	Jenny Nguyen, PharmD, APh, BCPS Clinical Pharmacogenomics Specialist Children's Hospital Los Angeles

Additional Content Reviewers

• Natasha Petry, PharmD, BCACP, Associate Professor, North Dakota State University and Sanford Health Imagenetics
• Vivian K. Kawai MD, MPH, Director of Pharmacogenomics, Vanderbilt University School of Medicine
  

All healthcare professionals

LEARNING OBJECTIVES

• Describe the components and practical aspects of standard pharmacogenomics implementation.
  
• Identify the roles of various healthcare professionals in implementation teams.
• Evaluate curated examples of successful implementation programs in different practice settings.
• Apply model principles of pharmacogenomics implementation using a familiar and readily implementable gene-drug or gene-disease pair case example for a clinical practice (or system).

Planning Committee for the ISCC-PEG Pharmacogenomics Learning Series:

• Philip Empey, PharmD, PhD, FCCP (University of Pittsburgh School of Pharmacy)
• Andrew Monte, MD, PhD (University of Colorado)
  
• Trina Walker, DNP, APRN, FNP-C (Creighton University)
• Nguyen Park, MS, PA-C (National Human Genome Research Institute)
• Jeneva Gularte-Rinaldo, PhD, RN (Samuel Merritt University)

Course Directors

Roseann S. Donnelly (Gammal), PharmD, BCPS   Associate Professor  Massachusetts College of Pharmacy and Health Sciences

Additional Content Reviewers

• Cyrine-Eliana Haidar, PharmD, BCPS, BCOP, FASHP, Clinical Pharmacogenetics Coordinator, St. Jude Children’s Research Hospital
• David Kisor, PharmD, FCP, Professor of Pharmaceutical Sciences and Pharmacogenomics, Manchester University
  

All healthcare professionals

LEARNING OBJECTIVES

• Differentiate between the delivery models for pharmacogenomic testing.
  
• Identify the benefits and limitations of direct-to-consumer (DTC) pharmacogenomic testing.
• Interpret DTC pharmacogenomic test results.
• Evaluate the clinical actionability of genetic variants detected by a DTC pharmacogenomic test using evidence-based resources.
• Determine when confirmatory clinical testing is needed when faced with DTC pharmacogenomic test results.
• Explain why confirmatory clinical pharmacogenomic test results may differ from direct-to-consumer pharmacogenomic test results for the same patient. 
• Discuss issues related to documenting DTC pharmacogenomic test results in the electronic health record. 

Planning Committee for the ISCC-PEG Pharmacogenomics Learning Series:

• Philip Empey, PharmD, PhD, FCCP (University of Pittsburgh School of Pharmacy)
• Andrew Monte, MD, PhD (University of Colorado)
  
• Trina Walker, DNP, APRN, FNP-C (Creighton University)
• Nguyen Park, MS, PA-C (National Human Genome Research Institute)
• Jeneva Gularte-Rinaldo, PhD, RN (Samuel Merritt University)

Course Directors

Karen Niemchick, PhD, MHS  Grand Valley State University

Additional Content Reviewers

• Joshua Peterson, MD, Vanderbilt University 
• Caleb Bupp, MD, Spectrum Health
  

All healthcare professionals

LEARNING OBJECTIVES

• Understand a basic cost analysis
• Compare benefits of genetic testing with traditional treatment. 
• Gain experience in accessing genetic test information.
  

Planning Committee for the ISCC-PEG Pharmacogenomics Learning Series:

• Philip Empey, PharmD, PhD, FCCP (University of Pittsburgh School of Pharmacy)
• Andrew Monte, MD, PhD (University of Colorado)
  
• Trina Walker, DNP, APRN, FNP-C (Creighton University)
• Nguyen Park, MS, PA-C (National Human Genome Research Institute)
• Jeneva Gularte-Rinaldo, PhD, RN (Samuel Merritt University)

Course Directors

	Sara Rogers, PharmD, BCPS   American Society of Pharmacovigilance Texas A&M University
	Benjamin Brown   American Society of Pharmacovigilance
	Christine Formea, PharmD, BCPS, FCCP, FASHP Children’s Hospital Colorado

Additional Content Reviewers

• Jai Patel, PharmD, BCOP, CPP, Levine Cancer Institute, Atrium Health
• Chet Robson, DO, MHCDS, FAAFP, Jasper Health
  

All healthcare professionals

LEARNING OBJECTIVES

• Define relevant reimbursement related terminology
• Review key components of payer coverage guidance for pharmacogenomics testing 
• Describe technical requirements for test reports 
• Understand special documentation requirements to show medical necessity