Pharmacogenetic testing is considered one of the most promising clinical applications arising from genomics research, with the potential to reduce adverse drug responses and improve efficacy of drug treatment. Because pharmacogenetic tests address a specific question about drug therapy, they have generally been viewed as having fewer ethical and social implications than other types of genetic testing. Yet some policy concerns will need to be addressed before pharmacogenetic tests can be introduced appropriately into clinical practice. A key concern is the potential for pharmacogenetic tests to generate ancillary clinical information unrelated to the drug treatment question for which testing is done - an informational """"""""side effect."""""""" The ancillary information generated by pharmacogenetic tests is variable, and may include information about disease predispositions, prognosis, and drug responses other than those for which testing is performed. For example, testing for statin response might reveal information about risk of Alzheimer's disease or macular degeneration. These issues raise several questions: What would a reasonable person want to know about the scope of testing and access to test results? Should information about other potential uses of a test result be made available to the patient? Which health care professionals should routinely have access to pharmacogenetic results? This project will explore these policy challenges through the following specific aims: 1) determine the legal obligations of health professionals with respect to sharing of pharmacogenetic information and disclosure of ancillary clinical information;2 &3) assess attitudes of the public and health professionals toward disclosure of different types of ancillary information related to pharmacogenetic testing and related issues of informed consent, counseling, and sharing of pharmacogenetic information among health professionals through focus groups and surveys, and 4) develop a stakeholder consensus regarding appropriate policies for counseling, informed consent and disclosure of ancillary information related to pharmacogenetic testing.

Public Health Relevance

- The results of this study will help to ensure the appropriate clinical integration of pharmacogenetic testing, and inform related issues arising with the increasing use of genetic testing for the general population, including risk communication and the appropriate roles of health professionals as we enter the era of genomic medicine in the US. This study will also help inform determinations of whether new health infrastructures for pharmacogenetics are required beyond current systems for successful population-wide integration.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Research Project (R01)
Project #
5R01GM081416-02
Application #
7684219
Study Section
Ethical, Legal, and Social Implications of Human Genetics Study Section (ELS)
Program Officer
Long, Rochelle M
Project Start
2008-09-05
Project End
2011-08-31
Budget Start
2009-09-01
Budget End
2010-08-31
Support Year
2
Fiscal Year
2009
Total Cost
$394,706
Indirect Cost
Name
Duke University
Department
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Haga, Susanne B; Kantor, Ariel (2018) Horizon Scan Of Clinical Laboratories Offering Pharmacogenetic Testing. Health Aff (Millwood) 37:717-723
Haga, Susanne B; Moaddeb, Jivan; Mills, Rachel et al. (2017) Assessing feasibility of delivering pharmacogenetic testing in a community pharmacy setting. Pharmacogenomics 18:327-335
Mills, Rachel; Ensinger, Megan; Callanan, Nancy et al. (2017) Development and Initial Assessment of a Patient Education Video about Pharmacogenetics. J Pers Med 7:
Haga, Susanne B (2017) Update: looking beyond the 100,000 Genome Project. Per Med 14:85-87
Haga, Susanne B; Mills, Rachel; Moaddeb, Jivan et al. (2017) Primary care providers' use of pharmacist support for delivery of pharmacogenetic testing. Pharmacogenomics 18:359-367
Haga, Susanne B (2017) Educating patients and providers through comprehensive pharmacogenetic test reports. Pharmacogenomics 18:1047-1050
Haga, Susanne B; Mills, Rachel (2016) A review of consent practices and perspectives for pharmacogenetic testing. Pharmacogenomics 17:1595-605
Haga, Susanne B; Mills, Rachel; Moaddeb, Jivan et al. (2016) Patient experiences with pharmacogenetic testing in a primary care setting. Pharmacogenomics 17:1629-1636
Haga, Susanne B; Moaddeb, Jivan (2016) Proposal for a pharmacogenetics certificate program for pharmacists. Pharmacogenomics 17:535-9
Haga, Susanne B; Mills, Rachel; Moaddeb, Jivan (2016) Evaluation of a pharmacogenetic educational toolkit for community pharmacists. Pharmacogenomics 17:1491-502

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