Myocardial Infarction, Stroke, Transient Ischemic Attack
Conditions
Keywords
pharmacogenomics, feasibility, community pharmacy, personalized medicine, clopidogrel, Plavix
Brief summary
The purpose of this study is to determine the feasibility of pharmacogenomics testing in a community pharmacy using clopidogrel as an example. The investigators hypothesize that this testing is feasible in this setting.
Detailed description
To determine if the study is feasible, we will examine the change in patient perception of pharmacogenomics testing (before and after the study), the percentage of patients interested in this service, the response rate of providers to pharmacist recommendations, the pharmacist time requirement, and reimbursement rate for pharmacist services.
Interventions
OTHERPharmacogenomics testing for clopidogrel responsiveness
Patients must come to the pharmacy for all visits. At the 1st visit, the patient will provide consent, a complete list of medications, a complete pre-study questionnaire, a copy of their insurance card, and a buccal swab (collected by the pharmacist). The swab will be sent to the testing facility for genotypic testing of CYP2C19. Upon receipt of the results of the results, the pharmacist will propose an intervention to the prescriber based on the patient's indication for clopidogrel and the identification of certain genetic variations atCYP2C19. All patients will be asked to return to the pharmacy for explanation of the results and implementation of any changes approved by the prescriber and to complete a follow-up questionnaire. After the visit to explain the results of testing, the patient's insurance will be billed electronically for a medication therapy management visit; patients without insurance will not be billed. Patients may opt out of billing to insurance at any time.
Sponsors
Kerr Drug
Laboratory Corporation of America
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prescribed clopidogrel (Plavix) by their prescriber * Aged 18 or older * Currently on clopidogrel therapy for one of the following indicated uses: post-ACS, Recent PCI with stenting, History of TIA or stroke
Exclusion criteria
* Are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients * Are taking clopidogrel for a reason other than stated in inclusion criteria * Are pregnant or nursing * Have an allergy to aspirin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Pharmacogenomics testing in a Community pharmacy | 3 months | Change in patient perception of testing, reimbursement for pharmacist time, provider acceptance, and amount of pharmacist time required will be measured as part of the provision of this service. |
Countries
United States
Outcome results
None listed