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

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.

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Key information

Conditions

Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Infarction Ischemia Ischemic Attack, Transient Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Transient Ischemic Attack Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kerr Drug

Chapel Hill, North Carolina, 27517, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacogenomics testing for clopidogrel responsiveness

Other

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.

Other names: Personalized medicine, Pharmacogenetics

Primary outcomes

Feasibility of Pharmacogenomics testing in a Community pharmacy

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

Kerr Drug
Laboratory Corporation of America

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Dec 20, 2011
Registry last updated: Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed