The integration of pharmacogenetic (PGx) testing into primary care is rapidly evolving. It has been estimated that one-fourth of outpatients are taking medications containing PGx information in their product labels, the majority of which are prescribed by primary care physicians. Our previous work from the parent R01 (R01 GM081416, Haga, PI) indicated that the general public is very interested in PGx testing. However, physicians are less enthusiastic about integrating PGx testing into clinical practice, due lack of awareness of available tests, lack of knowledge about genetics and drug response, lack of conclusive clinical evidence, questions about when to order testing and for which drugs or patients, and concerns regarding coverage and reimbursement. Thus, to improve physician knowledge, address issues about how and when to integrate PGx testing into clinical care, and to facilitate integration of PGx testing into therapeutic decision-making this renewal proposal will focus on assessing delivery models of PGx testing. We will implement and evaluate two delivery models of PGx testing into primary care practices: physician-initiated testing and pharmacist-initiated testing. Each practice will be provided an educational intervention (seminars, Intranet module, and pocket guide of drugs with applicable PGx testing). In the physician-initiated group, physicians will also have on-call pharmacist support. In the pharmacist-initiated group, a pharmacist based within the practice will identify prescribed drugs with available PGx testing through chart review and provide specific information and recommendations about PGx testing to the ordering physician. The proposed study aims to evaluate the delivery of PGx testing from three perspectives: physician, patient, and practice setting. Effectiveness of the delivery models will be evaluated by the number of dosage adjustments and adverse responses for new and recent prescriptions (less than 1month) of target drugs and number of office visits in each practice during the 6- month intervention period compared to the 6 months prior to the intervention and the 6 months following the intervention in order to assess change and durability of any changes (Aim 1). Providers in each practice will be surveyed at the start and conclusion of the study to assess changes in knowledge and attitudes of PGx testing and perceived value of and barriers to testing (Aim 2). Similarly, we will follow-up with patients offered PGx testing to explore the perceived value and risks of testing, factors influencing their decision about testing, , and their satisfaction with treatment based on the test result (Aim 3). We will also perform an economic analysis to evaluate and compare the costs associated with each delivery model as well as costs associated with targeted medications, associated monitoring costs, and adverse drug events (Aim 4). These results will provide essential information on the uptake, impact, barriers, and cost of two delivery models for integration of PGx testing in primary care practices.

Public Health Relevance

By increasing physician knowledge and awareness of PGx testing and by providing physicians with primary or secondary pharmacist support on PGx testing, we hope to identify and overcome barriers to the uptake of appropriate PGx testing and to facilitate a seamless integration of PGx testing in primary care practices to improve clinical outcomes.

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Research Project (R01)
Project #
5R01GM081416-07
Application #
8729587
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Long, Rochelle M
Project Start
2007-07-01
Project End
2015-08-31
Budget Start
2014-09-01
Budget End
2015-08-31
Support Year
7
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Duke University
Department
Type
Schools of Medicine
DUNS #
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; 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
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

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