CYP2C19-clopidogrel Implementation Guide

This guide, created by experts in genomic medicine with real experience in implementing this genetic test in a clinical setting, will allow you to assess the current status of your implementation process to determine how best to configure your guide.

The steps below will allow you to choose among the information resources listed to help you complete and maintain a successful implementation of CYP2C19-clopidogrel testing.

DOWNLOAD a PDF of the CYP2C19 Guide

CYP2D6-opioids Implementation Guide

This guide, created by experts in genomic medicine with real experience in implementing this genetic test in a clinical setting, will allow you to assess the current status of your implementation process to determine how best to configure your guide.

The steps below will allow you to choose among the information resources listed to help you complete and maintain a successful implementation of CYP2D6-opioids testing

DOWNLOAD a PDF of the CYP2D6 Guide

THE FULL GUIDES

CYP2C19 - clopidogrel

STEP-BY-STEP

STEP 1: Gather Institutional Support for CYP2C19 Testing

With respect to clinical implementation of pharmacogenetics, gathering institutional support can be defined as follows:

  1. Collecting and disseminating institution-specific data to justify implementation (e.g. formulary considerations, medication-use frequency, specialty therapeutic areas, clinician expertise, patient demographics)
  2. Gathering evidence to support clinical utility of your implementation (e.g. primary literature, clinical practice guidelines, likelihood of a clinically actionable result, relevant patient outcomes associated with genotype-guided therapy)

Provided resources include an overview of the supporting evidence, clinical guidelines, relationship between the gene-drug pair, and sample data collection metrics that can be disseminated to raise stakeholder (e.g. physicians, pharmacists, laboratory specialists, informaticians, educators) and administrative support for the implementation.

 

Support Links

STEP 2: Develop CYP2C19 Genetic Test Ordering and Interpretation Process

Pharmacogenetic tests must be processed in a Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratory in order for the results to be used clinically, which means that it is crucial to establish a genetic test ordering and interpretation process in conjunction with an in-house or outside laboratory.

Provided resources include a summary/listing of pharmacogenetic testing platforms, relevant genetic variants, laboratories, and guidance on the translation from genotype to phenotype.

Support Links
Summary of CYP2C19 Platforms and Variants by Site
IGNITE Pharmacogenetics Working Group

STEP 3: Establish Reimbursement Source/Process for CYP2C19 Genetic Test

Obtaining reimbursement for pharmacogenetic testing often presents a challenge for stakeholders.

Provided resources include a glossary of payment and reimbursement terminology, guidance on using and applying for current procedural terminology (CPT) coding, and insight into reimbursement challenges.

Support Links

 

STEP 4: Integrate CYP2C19 Genetic Data into the EHR

In order to assist providers in interpreting and making clinical decisions upon pharmacogenetic test results, most established pharmacogenetic services collaborate with informaticians in order to integrate genetic test results into the electronic health record and develop/update clinical decision support (CDS).

Provided resources include CDS publications, sample laboratory reports, and CDS alerts containing interpretations of pharmacogenetic test results.

STEP 5: Develop Provider Education for CYP2C19 Testing

In an effort to increase provider knowledge of and comfort with pharmacogenetics and how it impacts patient care, continual education is essential and may include dissemination of: knowledge of and availability of pharmacogenetic testing, risks, benefits, and limitations of pharmacogenetic testing, interpretation and implications of the results, as well as provider training on the clinical workflow.

Provided resources include sample educational tools utilized by established pharmacogenetic programs to educate their providers on pharmacogenetic testing and results.

STEP 6: Development Patient Education for CYP2C19 Testing

In an effort to increase patient knowledge of and comfort with pharmacogenetics and how it impacts patient care, continual education is essential and may include dissemination of: knowledge of and availability of pharmacogenetic testing, risks, benefits, and limitations of pharmacogenetic testing, interpretation and implications of the results.

Provided resources include sample educational tools utilized by established pharmacogenetic programs to educate their patients on pharmacogenetic testing and results.

Support Links
Patient Education Brochure for CYP2C19-Clopidogrel
University of Florida Health Personalized Medicine Program

 

STEP 7: Establish Workflow for Clinical Pharmacogenetics Implementation of CYP2C19 Testing

When establishing the workflow for the clinical pharmacogenetics implementation, it is important to take all of the above steps and potential challenges into consideration, which can facilitate workflow optimization and expansion of the service to include additional gene-drug pairs.

Provided resources include sample clinical workflow diagrams and treatment algorithms from established pharmacogenetics programs.

CYP2D6 - opioids

STEP-BY-STEP

STEP 1: Gather Institutional Support for CYP2D6 Testing

With respect to clinical implementation of pharmacogenetics, gathering institutional support can be defined as follows:

  1. Collecting and disseminating institution-specific data to justify implementation (e.g. formulary considerations, medication-use frequency, specialty therapeutic areas, clinician expertise, patient demographics)
  2. Gathering evidence to support clinical utility of your implementation (e.g. primary literature, clinical practice guidelines, likelihood of a clinically actionable result, relevant patient outcomes associated with genotype-guided therapy)

Provided resources include an overview of the supporting evidence, clinical guidelines, relationship between the gene-drug pair, and sample data collection metrics that can be disseminated to raise stakeholder (e.g. physicians, pharmacists, laboratory specialists, informaticians, educators) and administrative support for the implementation.

 

STEP 2: Develop CYP2D6 Genetic Test Ordering and Interpretation Process

Pharmacogenetic tests must be processed in a Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratory in order for the results to be used clinically, which means that it is crucial to establish a genetic test ordering and interpretation process in conjunction with an in-house or outside laboratory.

Provided resources include a summary/listing of pharmacogenetic testing platforms, relevant genetic variants, laboratories, and guidance on the translation from genotype to phenotype.

Support Links

 

STEP 3: Establish Reimbursement Source/Process for CYP2D6 Genetic Test

Obtaining reimbursement for pharmacogenetic testing often presents a challenge for stakeholders.

Provided resources include a glossary of payment and reimbursement terminology, guidance on using and applying for current procedural terminology (CPT) coding, and insight into reimbursement challenges.

Support Links

 

STEP 4: Integrate CYP2D6 Genetic Data into the EHR

In order to assist providers in interpreting and making clinical decisions upon pharmacogenetic test results, most established pharmacogenetic services collaborate with informaticians in order to integrate genetic test results into the electronic health record and develop/update clinical decision support (CDS).

Provided resources include CDS publications, sample laboratory reports, and CDS alerts containing interpretations of pharmacogenetic test results.

Support Links

STEP 5: Develop Provider Education for CYP2D6 Testing

In an effort to increase provider knowledge of and comfort with pharmacogenetics and how it impacts patient care, continual education is essential and may include dissemination of: knowledge of and availability of pharmacogenetic testing, risks, benefits, and limitations of pharmacogenetic testing, interpretation and implications of the results, as well as provider training on the clinical workflow.

Provided resources include sample educational tools utilized by established pharmacogenetic programs to educate their providers on pharmacogenetic testing and results.

Support Links

STEP 6: Develop Patient Education for CYP2D6 Testing

In an effort to increase patient knowledge of and comfort with pharmacogenetics and how it impacts patient care, continual education is essential and may include dissemination of: knowledge of and availability of pharmacogenetic testing, risks, benefits, and limitations of pharmacogenetic testing, interpretation and implications of the results.

Provided resources include sample educational tools utilized by established pharmacogenetic programs to educate their patients on pharmacogenetic testing and results.

Support Links

 

STEP 7: Establish Workflow for Clinical Pharmacogenomics Implementation of CYP2D6 Testing

When establishing the workflow for the clinical pharmacogenetics implementation, it is important to take all of the above steps and potential challenges into consideration, which can facilitate workflow optimization and expansion of the service to include additional gene-drug pairs.

Provided resources include sample clinical workflow diagrams and treatment algorithms from established pharmacogenetics programs.