Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy

Conditions
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Stroke, Transient Ischemic Attack, Myocardial Infarction

Intervention / Treatment
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* Other: Pharmacogenomics testing for clopidogrel responsiveness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pharmacogenomics 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Pharmacogenomics testing in a Community pharmacy | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plavix, pharmacogenomics, feasibility, community pharmacy, personalized medicine, clopidogrel