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