Test2Learn Pharmacogenomics Certificate Program - April 11, 2023
Pharmacogenomic (PGx) information is in the FDA labeling for 300+ drugs and consensus clinical PGx guidelines have been published for over 35 commonly-used drugs. Several leading academic medical centers have launched implementation programs there is great interest in expanding these into the community setting, specifically into community pharmacies. Position statements from national organizations and several surveys of practicing clinicians demonstrate that they feel responsible for, and are eager to, deploy pharmacogenomics (PGx) in clinical practice. One such survey of community pharmacists by Tuteja et al reported all respondants “ had positive attitudes towards PGx and most (87%) felt it would decrease the number of adverse events, and optimize drug dosing. More than half (57%) felt that it was their role to counsel patients regarding PGx information. However, clinicians report low knowledge and confidence in using PGx information for adjusting dose or drug selection. This barrier must be overcome to achieve positive outcomes from new pharmacogenomics services.
Target Audience
Nurse
Nurse Practitioner
Pharmacist
Physician
Physician Assistant
Learning Objectives
Basic Concepts
1. Demonstrate understanding of basic genetic/genomic concepts and nomenclature
2. Describe advances in scientific knowledge and technology, which have led to innovations in personalized medicine.
3. Identify the role of behavioral, social and environmental factors (lifestyle, socioeconomic factors, pollutants, among others) to modify or influence genetics in the manifestation of disease.
4. Compare/contrast different PGx study designs.
5. Identify drug- and disease-associated genetic variations that facilitate development of prevention and treatment strategies and appreciate there are differences in testing methodologies and are aware of the need to explore these differences in drug literature evaluation
6. Assess predisposition to disease and selection of drug treatment by using family history. Role of Genetics in Disease
7. Describe the role of genetic factors in maintaining health and preventing disease.
8. Assess the difference between clinical diagnosis of disease and identification of genetic predisposition to disease (genetic variation is not strictly correlated with disease manifestation)
9. Recognize that pharmacogenomic testing may also reveal certain genetic disease predispositions (e.g., the Apo E4 polymorphism) Pharmacogenomics (PGx) and PGx Decision Making
10. Demonstrate an understanding of how genetic variation in a large number of proteins influences pharmacokinetics and pharmacodynamics related to pharmacologic effect and drug response.
11. Use online resources to assign haplotypes and predicted drug response phenotypes from genetic data.
12. Describe the influence (or lack thereof) of ethnicity in genetic polymorphisms and associations of polymorphisms with drug response.
13. Recognize the availability of evidence based guidelines that synthesize information relevant to genomic/pharmacogenomic tests and selection of drug therapy (e.g. Clinical pharmacogenomics implementation consortium)
14. Evaluate the availability of genetic testing under FDA, CLIA, and DTC regulations.
15. Evaluate PGx test reports through group-based activities and role-playing to demonstrate the PGx knowledge/skill-based competencies 1
6. Create a step-wise decision-making process for the integration of PGx with clinical variables known to impact PK/PD to make appropriate PGx-based recommendations for patients and populations.
17. List drugs/clinical situations where PGx testing is likely to be most useful clinically.
Ethics
18. Identify the potential physical and/or psychosocial benefits, limitations and risk of genomic/pharmacogenomic information for individuals, family members and communities, especially with genomic/pharmacogenomic tests that may relate to predisposition to disease.
19. Describe the increased liability that accompanies access to detailed genomic patient information and maintain confidentiality and security.
20. Explain the cost, cost–effectiveness and reimbursement by insurers relevant to genomic or pharmacogenomic tests and test interpretation for patients and populations.
21. Identify the need to refer a patient to a genetic specialist or genetic counselor Communication and PGx Care Models
22. Describe proper documentation of test results in electronic patient record
23. Adopt a culturally sensitive and ethical approach to patient counseling regarding PGx test results
24. Demonstrate patient and provider communication about PGx testing and test results and counseling through group-based activities and role-playing
25. Evaluate different models to integrate PGx in various practice sites
26. Discuss different strategies to engage with local practitioners to optimize the delivery of PGx services prior to implementation
27. Demonstrate proficiency in different types of sample collection practices for PGx testing, review of safety procedures for handling biospecimens and proper mailing
Pharmacogenomic (PGx) information is in the FDA labeling for 300+ drugs and consensus clinical PGx guidelines have been published for over 35 commonly-used drugs. Several leading academic medical centers have launched implementation programs there is great interest in expanding these into the community setting, specifically into community pharmacies. Position statements from national organizations and several surveys of practicing clinicians demonstrate that they feel responsible for, and are eager to, deploy pharmacogenomics (PGx) in clinical practice. One such survey of community pharmacists by Tuteja et al reported all respondants “ had positive attitudes towards PGx and most (87%) felt it would decrease the number of adverse events, and optimize drug dosing. More than half (57%) felt that it was their role to counsel patients regarding PGx information. However, clinicians report low knowledge and confidence in using PGx information for adjusting dose or drug selection. This barrier must be overcome to achieve positive outcomes from new pharmacogenomics services.
Philip Empey, PharmD, PhD
Lucas Berenbrok, PharmD
James Coons, PharmD
In support of improving patient care, the University of Pittsburgh is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician (CME)
The University of Pittsburgh designates this live activity for a maximum of 20.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Pharmacy (CPE)
This knowledge-based activity provides 20.0 contact hours of continuing pharmacy education credit.
Available Credit
- 20.00 ACPE PharmacyThe UPMC Center for Continuing Education in the Health Sciences is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a Provider of continuing pharmacy education.
- 20.00 AMA PRA Category 1 Credit™The University of Pittsburgh School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
- 20.00 Attendance