CPxP Exam Content Outline

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Certified Pharmacogenomics Pharmacist (CPxP)

Official Examination Content Outline

This document provides the official content outline for the Certified Pharmacogenomics Pharmacist (CPxP) examination. The exam certifies that a pharmacist possesses the specialized knowledge and skills to effectively translate a patient's genetic information into evidence-based, personalized medication plans to improve therapeutic efficacy and reduce adverse drug events.

Examination Specifications

Name of Credential Certified Pharmacogenomics Pharmacist (CPxP)
Certification-Issuing Body The Council on Pharmacy Standards (CPS)
Designation Awarded CPxP
Target Population Pharmacists who interpret and apply pharmacogenomic test results in clinical practice.
Examination Length 120 multiple-choice items
Administration Time 3.0 hours

Examination Content Outline

The CPxP examination is weighted according to the six domains listed below, covering the full scope of pharmacogenomics practice, from foundational genetic science to clinical implementation and patient education.

Domain 1: Foundational Genomic and Genetic Principles 15%
Domain 2: Pharmacogenomic Testing and Interpretation 20%
Domain 3: Clinical Application and Therapeutic Decision-Making 30%
Domain 4: Practice Implementation and Patient Education 15%
Domain 5: Informatics, Data Science, and Technology in PGx 10%
Domain 6: Ethics, Regulatory, and Health System Integration 10%

Domain 1: Foundational Genomic and Genetic Principles (15%)

Task 1: Apply principles of clinical genetics and nomenclature.
  • Define basic genetic terms, such as gene, allele, genotype, and phenotype.
  • Differentiate between different types of genetic variants.
  • Interpret standard gene nomenclature, including star allele nomenclature.
  • Explain how genetic variation can arise and be maintained in a population.
Task 2: Evaluate the function of key pharmacokinetic pharmacogenes.
  • Describe the function and genetic variability of key CYP enzymes (e.g., CYP2D6, CYP2C19, CYP2C9).
  • Describe the function of Phase II metabolizing enzymes and transporters (e.g., UGTs, TPMT, SLCO1B1).
  • Explain how genetic variants can lead to different metabolizer phenotypes.
  • Recognize the importance of phenoconversion.
Task 3: Evaluate the function of key pharmacodynamic pharmacogenes.
  • Explain how genetic variants in drug targets can alter drug response.
  • Describe the role of VKORC1 in the warfarin pharmacodynamic pathway.
  • Describe the function of HLA genes and their association with hypersensitivity reactions.
  • Explain the role of drug transporters in drug disposition and toxicity.
Task 4: Evaluate the genetic basis of idiosyncratic drug reactions.
  • Describe the strong association between specific HLA alleles and severe cutaneous adverse reactions (SCARs).
  • Identify the HLA-B*57:01 allele as a risk factor for abacavir hypersensitivity.
  • Identify the HLA-B*15:02 allele as a risk factor for carbamazepine-induced SJS/TEN in certain populations.
  • Recognize the importance of pre-emptive genotyping for certain HLA-associated reactions.
Task 5: Apply principles of population genomics and ancestry.
  • Understand that the frequencies of pharmacogenetic variants can differ significantly among ancestral populations.
  • Apply knowledge of population-specific allele frequencies when interpreting test results.
  • Describe the ethical and social implications of using race or ethnicity in pharmacogenomics.
  • Recognize the importance of increasing diversity in genomic research.
Task 6: Differentiate between pharmacogenomics and other omics technologies.
  • Define pharmacogenomics and differentiate it from pharmacogenetics.
  • Describe the role of other omics technologies (e.g., proteomics, metabolomics) in personalized medicine.
  • Understand how multi-omics data can be integrated to provide a more complete picture of drug response.
  • Recognize the current and future applications of omics beyond pharmacogenomics.

Domain 2: Pharmacogenomic Testing and Interpretation (20%)

Task 1: Evaluate appropriate pharmacogenomic (PGx) tests.
  • Determine when a PGx test is clinically indicated based on the patient and the planned drug therapy.
  • Differentiate between reactive (single-gene) and pre-emptive (multi-gene panel) testing strategies.
  • Select the most appropriate test based on the specific drug-gene interaction of concern.
  • Understand the difference between clinical-grade genetic tests and direct-to-consumer (DTC) tests.
Task 2: Evaluate various PGx testing platforms and laboratory operations.
  • Differentiate between genotyping and sequencing technologies, including next-generation sequencing (NGS).
  • Recognize the strengths and limitations of different testing platforms, such as whole-genome vs. panel-based tests.
  • Assess the CLIA certification, CAP accreditation, and other quality metrics of a testing laboratory.
  • Understand that a "no variant detected" result on a targeted panel does not rule out the presence of a rare variant.
Task 3: Translate genotype results into clinical phenotypes.
  • Use standardized tables (e.g., from CPIC) to translate a diplotype into a predicted phenotype.
  • Calculate a CYP2D6 activity score based on the assigned values of the patient's alleles.
  • Assign a metabolizer status phenotype (e.g., poor, intermediate, normal, ultrarapid).
  • Consider non-genetic factors (phenoconversion) that may alter the predicted phenotype.
Task 4: Interpret a pharmacogenomic test report.
  • Identify the key components of a PGx laboratory report.
  • Evaluate the drug-specific recommendations provided on the report.
  • Assess the quality and evidence base of the interpretations provided by the lab.
  • Cross-reference the lab report with primary literature and clinical guidelines.
Task 5: Apply standards for variant classification.
  • Understand the principles of variant classification according to ACMG/AMP standards.
  • Differentiate between pathogenic, likely pathogenic, uncertain significance, likely benign, and benign variants.
  • Utilize public databases such as ClinVar to assist in variant interpretation.
  • Recognize the importance of re-evaluating variants of uncertain significance over time.
Task 6: Assess the clinical validity and utility of PGx tests.
  • Define and differentiate between analytical validity, clinical validity, and clinical utility.
  • Assess the clinical validity of a test by evaluating the strength of the gene-drug association.
  • Critically appraise the evidence for the clinical utility of a test in improving patient outcomes.
  • Prioritize the implementation of PGx tests with demonstrated clinical utility.

Domain 3: Clinical Application and Therapeutic Decision-Making (30%)

Task 1: Apply guidelines for cardiovascular drugs.
  • Apply CPIC guidelines to guide antiplatelet therapy based on CYP2C19 genotype.
  • Utilize VKORC1, CYP2C9, and CYP4F2 genotypes to guide initial dosing of warfarin.
  • Use SLCO1B1 genotype to guide statin selection and dosing to reduce the risk of myopathy.
  • Recommend alternative therapies for patients with high-risk genotypes.
Task 2: Apply guidelines for psychiatric drugs.
  • Apply CPIC guidelines to guide the selection and dosing of SSRIs and tricyclic antidepressants based on CYP2D6 and CYP2C19 genotypes.
  • Utilize PGx information to manage therapy with other psychotropic medications, such as antipsychotics.
  • Use PGx to explain a patient's previous treatment failures or intolerances.
  • Integrate PGx data into a comprehensive approach to psychiatric medication management.
Task 3: Apply guidelines for pain management drugs.
  • Apply CPIC guidelines to avoid the use of codeine and tramadol in CYP2D6 ultrarapid and poor metabolizers.
  • Use CYP2D6 genotype to guide the dosing of other opioids, such as hydrocodone and oxycodone.
  • Utilize CYP2C9 genotype to guide the dosing of certain NSAIDs.
  • Make specific therapeutic recommendations to ensure both effective analgesia and patient safety.
Task 4: Apply guidelines for oncology drugs.
  • Apply CPIC and other guidelines to guide the dosing of thiopurines and fluoropyrimidines.
  • Understand the role of somatic (tumor) genetic testing in guiding targeted cancer therapies.
  • Differentiate between germline PGx for toxicity and somatic mutations for efficacy.
  • Utilize PGx to reduce the risk of severe, life-threatening toxicities with chemotherapy.
Task 5: Manage drug-drug-gene interactions in the context of polypharmacy.
  • Synthesize a patient's PGx results, clinical data, and full medication list to create a holistic plan.
  • Evaluate how a single genetic variant can impact multiple drugs in a patient's regimen.
  • Assess the combined impact of multiple genetic variants on a patient's overall drug therapy.
  • Resolve complex cases involving ambiguous results or conflicting data.
Task 6: Manage PGx considerations in special populations.
  • Adapt PGx recommendations for pediatric patients, considering developmental changes in gene expression.
  • Apply PGx principles in geriatric patients, accounting for polypharmacy and comorbidities.
  • Evaluate PGx data in specific therapeutic areas such as oncology and psychiatry.
  • Respond to new PGx-based FDA safety alerts and recalls.

Domain 4: Practice Implementation and Patient Education (15%)

Task 1: Design a clinical PGx implementation program.
  • Conduct a needs assessment and build a business case for a new PGx service.
  • Develop a strategic plan for a phased implementation of PGx testing.
  • Establish a governance structure, such as a PGx committee, to oversee the program.
  • Develop standardized workflows for ordering tests, interpreting results, and making recommendations.
Task 2: Provide patient counseling on PGx results.
  • Explain the purpose of pharmacogenomic testing in patient-friendly language.
  • Communicate the patient's specific test results and what they mean for their medication therapy.
  • Counsel on the specific medication changes that are recommended based on their results.
  • Address any questions or concerns the patient may have about their genetic information.
Task 3: Educate providers and other healthcare professionals.
  • Develop and deliver educational presentations on pharmacogenomics to physicians, pharmacists, and nurses.
  • Create concise educational materials, such as tip sheets and newsletters.
  • Provide one-on-one "academic detailing" or consultation for providers with specific questions.
  • Serve as a subject matter expert and resource for the entire healthcare organization.
Task 4: Implement interprofessional training programs.
  • Design and deliver training programs to nurses, physicians, and genetic counselors on their roles in the PGx process.
  • Develop a "super user" program to build expertise within clinical departments.
  • Foster a collaborative, team-based approach to the implementation of PGx.
  • Use a train-the-trainer model to scale educational efforts across a large organization.
Task 5: Implement telehealth delivery of PGx counseling.
  • Utilize telehealth platforms to provide remote PGx consultations and patient counseling.
  • Adapt communication and educational techniques for a virtual environment.
  • Ensure that the delivery of telehealth services is compliant with all legal and privacy regulations.
  • Use digital tools to share PGx information securely with patients and providers.
Task 6: Implement culturally competent and health-literate patient education.
  • Tailor all verbal and written communication to the patient's level of understanding.
  • Engage interpreters for patients with limited English proficiency.
  • Ensure that care plans are culturally sensitive and respectful of patient beliefs about genetics.
  • Employ universal precautions for health literacy and the teach-back method in all patient interactions.

Domain 5: Informatics, Data Science, and Technology in PGx (10%)

Task 1: Integrate PGx into Electronic Health Records (EHRs) and clinical decision support (CDS).
  • Collaborate with informatics teams to build PGx alerts and guidance within the EHR.
  • Design CDS that is interruptive for high-risk, pre-emptive scenarios.
  • Develop a process for entering structured PGx results into the EHR.
  • Troubleshoot CDS alerts, including managing alert fatigue.
Task 2: Utilize bioinformatics tools for variant interpretation.
  • Use online databases (e.g., PharmGKB, CPIC) to find evidence for drug-gene associations.
  • Utilize tools to translate genotypes into phenotypes and clinical recommendations.
  • Evaluate the evidence supporting the information in various PGx knowledgebases.
  • Use bioinformatics tools for PGx data visualization.
Task 3: Apply big data and AI/ML approaches to pharmacogenomics.
  • Understand how real-world data (RWD) from EHRs and claims can be used to discover and validate PGx associations.
  • Describe the use of artificial intelligence and machine learning in predicting drug response.
  • Analyze data from large-scale biobanks to understand population-level PGx.
  • Evaluate the potential of AI-driven tools to enhance clinical decision support.
Task 4: Manage data privacy, interoperability, and cybersecurity.
  • Ensure that all storage and sharing of PGx data is compliant with HIPAA and other privacy regulations.
  • Promote the use of interoperability standards (e.g., FHIR) for the exchange of genetic data.
  • Implement cybersecurity measures to protect sensitive genetic information.
  • Develop policies and procedures for the secure sharing of PGx data with patients and other providers.
Task 5: Evaluate the role of PGx in drug development.
  • Understand how PGx is used in clinical trials to stratify patients and identify responders.
  • Describe the process for incorporating PGx information into a new drug's FDA label.
  • Evaluate how PGx can be used to "rescue" a drug that failed in clinical trials.
  • Recognize the growing importance of PGx in the drug development pipeline.
Task 6: Manage PGx-based drug safety crises.
  • Develop a plan for responding to a new FDA safety warning based on pharmacogenomic data.
  • Implement a process for identifying and notifying patients who may be at risk.
  • Manage a large-scale intervention, such as a recall or revised prescribing guidelines.
  • Communicate effectively with patients and providers during a safety crisis.

Domain 6: Ethics, Regulatory, and Health System Integration (10%)

Task 1: Manage ethical considerations in pharmacogenomics.
  • Apply ethical principles of autonomy, beneficence, and justice to PGx testing.
  • Manage the process of informed consent, ensuring the patient understands the scope of testing.
  • Develop a policy for the management of incidental findings and the return of results.
  • Address patient concerns about genetic privacy and the potential for discrimination.
Task 2: Implement strategies to address health equity and access.
  • Analyze how disparities in access to PGx testing can exacerbate health inequities.
  • Develop strategies to ensure equitable access to testing for underserved and diverse populations.
  • Advocate for the inclusion of diverse populations in genomic research.
  • Ensure that PGx implementation programs are designed to be equitable.
Task 3: Evaluate regulatory frameworks for PGx testing.
  • Understand the role of the FDA in regulating PGx tests and drug labels.
  • Describe the role of CLIA in ensuring the analytical validity of laboratory-developed tests.
  • Compare the U.S. regulatory framework to international counterparts (e.g., EMA, PMDA, Health Canada).
  • Stay current with the evolving regulatory landscape for genetic testing.
Task 4: Implement health system-wide PGx strategies.
  • Contribute to the development of institutional policies and procedures for PGx.
  • Participate in a multidisciplinary PGx steering committee or workgroup.
  • Collaborate with laboratory, informatics, and clinical teams to create an integrated program.
  • Advocate for the adoption of PGx at the institutional level.
Task 5: Evaluate economic and reimbursement models for PGx.
  • Understand the current coverage policies of CMS and major commercial payers for PGx testing.
  • Evaluate the pharmacoeconomic evidence supporting the cost-effectiveness of PGx testing.
  • Develop a business case to justify investment in a PGx program.
  • Navigate the billing and coding process for PGx tests and associated clinical services.
Task 6: Collaborate with interprofessional care teams.
  • Serve as the primary PGx expert for physicians, nurses, genetic counselors, and other providers.
  • Communicate complex genetic information in a clear and actionable manner.
  • Integrate PGx recommendations into the patient's overall care plan.
  • Foster a team-based approach to the implementation of personalized medicine.

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