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.
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
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:
- Collecting and disseminating institution-specific data to justify implementation (e.g. formulary considerations, medication-use frequency, specialty therapeutic areas, clinician expertise, patient demographics)
- 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 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.
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.
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.
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:
- Collecting and disseminating institution-specific data to justify implementation (e.g. formulary considerations, medication-use frequency, specialty therapeutic areas, clinician expertise, patient demographics)
- 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.
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.
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.
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.
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.
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.