PACE: A Pharmacist Implemented Pharmacogenomics Service in the Program of All-inclusive Care for the Elderly
Study Details
Study Description
Brief Summary
The aim of this study is to evaluate and describe the feasibility of implementing a pharmacist-led pharmacogenomics service for the Program of All-inclusive Care for the Elderly (PACE), a community-based practice setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
To determine if a pharmacogenomics (PGx) service can become a component of everyday practice, feasibility assessments are needed. While some researchers have begun to assess the feasibility of implementing PGx into pharmacy practice in community-based practice settings, none that we are aware have assessed such feasibility for the Program of All-inclusive Care for the Elderly (PACE). The primary objective of this feasibility study is to evaluate the processes that were involved in implementing a pharmacist-led PGx service for PACE and to describe process-related challenges and solutions associated with implementation. Secondary objectives include: describe pharmacists' roles in the implementation process; report aggregate PGx test results, including genetic variants and drug-gene interactions; and describe pharmacists' recommendations to personalize drug regimens for PACE participants and prescribers' acceptance of these recommendations.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study group Participants enrolled in PACE who underwent pharmacogenomics testing as part of their medical care and also consented to the use of their de-identified data for research purposes. |
Outcome Measures
Primary Outcome Measures
- Implementation Primary [24 months]
Qualitative description of process-related challenges and successes as assessed by observation
Secondary Outcome Measures
- Implementation Secondary [24 months]
Qualitative description of pharmacists' roles as assessed by observation
- Pharmacogenomic Testing [24 months]
Quantitative description of pharmacogenomic testing results as assessed by analysis of genotype and phenotype
- Pharmacist Recommendations [24 months]
Qualitative and quantitative descriptions of pharmacists' pharmacogenomic-based recommendations to prescribers as assessed by evaluation of consultations
- Prescriber Acceptances [24 months]
Qualitative and quantitative descriptions of prescribers' acceptances of pharmacists' recommendations as assessed by responses and post-consultation drug profile reviews
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant enrolled in PACE contractually receiving pharmacy services from Tabula Rasa Healthcare (CareKinesis Pharmacy) during the project time period (May 2014 through June 2016); and
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PACE prescriber ordered a pharmacogenomics test for the participant as part of clinical care; and,
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PACE participant consented to a pharmacogenomics test; and,
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CareKinesis pharmacist provided a consultation directly to PACE prescriber based on the participant's pharmacogenomics test results.
Exclusion Criteria:
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Participant dis-enrolled from PACE prior to receiving pharmacogenomics test results and/or prior to CareKinesis pharmacist providing consultative services; or,
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Participant did not complete the pharmacogenomics test.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tabula Rasa HealthCare
- Coriell Life Sciences
Investigators
- Principal Investigator: Kevin T Bain, PharmD, MPH, Tabula Rasa HealthCare
Study Documents (Full-Text)
None provided.More Information
Publications
- Evans WE, Johnson JA. Pharmacogenomics: the inherited basis for interindividual differences in drug response. Annu Rev Genomics Hum Genet. 2001;2:9-39. Review.
- Evans WE, McLeod HL. Pharmacogenomics--drug disposition, drug targets, and side effects. N Engl J Med. 2003 Feb 6;348(6):538-49.
- Ferreri SP, Greco AJ, Michaels NM, O'Connor SK, Chater RW, Viera AJ, Faruki H, McLeod HL, Roederer MW. Implementation of a pharmacogenomics service in a community pharmacy. J Am Pharm Assoc (2003). 2014 Mar-Apr;54(2):172-80. doi: 10.1331/JAPhA.2014.13033.
- Haga SB, Allen LaPointe NM, Moaddeb J, Mills R, Patel M, Kraus WE. Pilot study: incorporation of pharmacogenetic testing in medication therapy management services. Pharmacogenomics. 2014 Nov;15(14):1729-1737.
- Haga SB, LaPointe NM, Cho A, Reed SD, Mills R, Moaddeb J, Ginsburg GS. Pilot study of pharmacist-assisted delivery of pharmacogenetic testing in a primary care setting. Pharmacogenomics. 2014 Sep;15(13):1677-86. doi: 10.2217/pgs.14.109.
- Hocum BT, White JR Jr, Heck JW, Thirumaran RK, Moyer N, Newman R, Ashcraft K. Cytochrome P-450 gene and drug interaction analysis in patients referred for pharmacogenetic testing. Am J Health Syst Pharm. 2016 Jan 15;73(2):61-7. doi: 10.2146/ajhp150273.
- Moaddeb J, Mills R, Haga SB. Community pharmacists' experience with pharmacogenetic testing. J Am Pharm Assoc (2003). 2015 Nov-Dec;55(6):587-594. doi: 10.1331/JAPhA.2015.15017.
- Tannenbaum C, Sheehan NL. Understanding and preventing drug-drug and drug-gene interactions. Expert Rev Clin Pharmacol. 2014 Jul;7(4):533-44. doi: 10.1586/17512433.2014.910111. Epub 2014 Apr 19. Review.
- Welch BM, Kawamoto K. Clinical decision support for genetically guided personalized medicine: a systematic review. J Am Med Inform Assoc. 2013 Mar-Apr;20(2):388-400. doi: 10.1136/amiajnl-2012-000892. Epub 2012 Aug 25. Review.
- PHARM-GENOME-PACE 1173