FAQs

A signed order is required to process a test. This can be approved by an MD, DO, nurse practitioner or physician’s assistant. In some states, pharmacists may also order this and other tests.

In the metabolism of drugs, an individual can be classified in one of five categories (metabolism phenotype) for each gene, based on the activity of these pharmacogenomic proteins as defined by the Clinical Pharmacogenetics Implementation Consortium (CPIC):

Normal (formerly extensive metabolizer) (NM/EM)

• Fully functional enzyme activity.

Intermediate metabolizer (IM)

• Decreased enzyme activity (activity between normal and poor metabolizer).

Poor Metabolizer (PM)

• Little to no enzyme activity.

Rapid/Ultrarapid Metabolizer (UM)

• Increased enzyme activity compared to normal metabolizers.

By considering an individual’s genetics relative to drug metabolizing enzymes, targets, receptors and transporters, healthcare providers can now apply this information to prescribing for optimal drug therapy.

2.2 million serious adverse events occur per year, according to a report published by the Journal of the American Medical Association. These ADEs lead to approximately 1.3 million emergency room (ER) visits per year, and $3.5 billion excess spend of medical costs. ^[1]

1 – National Human Genome Institute  – National Institutes of Health (NIH)  www.genome.gov

Until recently, medications have been developed with the idea that each drug works pretty much the same in everybody. However, genomic research has changed that “one size fits all” approach and opened the door to more personalized approaches to using and developing medications.

Depending on your genetic makeup, some medications may work more or less effectively for you than they do in other people. Likewise, some medications may produce more or fewer side effects in you than in someone else. As this science continues to evolve, healthcare providers will be able to routinely use information about your genetic makeup to choose those medications and drug doses that offer the greatest chance of helping you. 

PGx may also help to save you time and money. By using information about your genetic makeup, healthcare providers may be able to avoid the trial-and-error approach of giving you various medications that are not likely to work for you until they find the right one. UsingPGx, the “best-fit” drug to help you can be chosen from the beginning.

Nearly every test returns information that could, at some point, be beneficial to you, your physician, and your pharmacist. While this does not necessarily mean a PGx test will be relevant to a medication you are currently taking, nearly everyone tested will have a variation in their genes that applies to how your body processes medications.

RxGenomix is not a laboratory, but rather a PGx services company. RxGenomix partners with clinical testing laboratories that are accredited by the College of American Pathologists and meet the certification requirements for high complexity testing established under the Clinical Laboratory Improvement Amendments. RxGenomix then works with pharmacists and other healthcare providers to help them integrate the PGx testing process into their practice and provide enhanced clinical services to their patients.  

Some commercial insurance plans offer coverage for testing, but not all. Medicare also offers coverage for patients who qualify. 

Each human being has some 30,000 genes in their DNA. Our current PGx testing looks at just 45 of those. That’s it. We’re only testing for variations in these few genes that affect how your body processes medications, or doesn’t.

Some of the more common conditions treated by these medications include, but are not limited to:

• Chronic or acute pain
• blood pressure (elevated)
• depression
• anxiety
• other mental health conditions
• diabetes
• cholesterol (elevated)
• cancer
• arthritis
• acid reflux
• peptic ulcer
• acid reflux
• migraines
• thyroid disorders
• asthma/COPD
• heart attack

Genes tested include, but aren’t limited to, the Cytochrome P450 enzymes—CYP2D6, CYP2C9, CYP2C19, CYP3A4/5, and others. Other proteins, such as VKORC1 and SLCO1B1 represent drug targets and transporters, respectively. Click here for a complete list of genes tested.

Pharmacogenomics (PGx) uses information about a person’s genetic makeup, or genome, to choose the medications and drug doses that are likely to work best for that particular person. This new field combines the science of how medications work, called pharmacology, with the science of the human genome, called genomics.

The test itself is painless and non-invasive, taking only a minute or two. The sample is collected by rubbing a swab inside each cheek for about 30 seconds and sending it off to the lab. That’s all there is to it.

Our testing produces a report that tells us if the genes responsible for putting a medication to work in your body are functioning properly. If they’re not, a common drug that’s safe for most could be ineffective or even dangerous for you. PGx testing is really the only way to know this before you begin taking a drug.

The Food and Drug Administration (FDA) currently has pharmacogenomic information listed in the package labeling of more than 250 medications, including many of the most prescribed, and this number continues to grow. Testing can apply to prescription medications, over-the-counter medications, herbal supplements, nutraceuticals and recreational medications. 

RxGenomix respects your privacy, and that includes your genetic information. Even though this testing will only look at a very small set of genes limited to drug metabolism, only those involved in delivering the best healthcare for you will have access to this information and it will be used solely to create a more personalized medication plan for you. For more information, you can read about our complete privacy practices here.

ACCREDITATION INFORMATION

CEI is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education (CPE). The following course is approved for 8.0 contact hour of CPE credit (.8 CEUs). The ACPE Universal Activity Number for this activity is: 0107-0000-20-352-H01-P (pharmacists).

Available: December 21, 2020
Expiration Date: December 21, 2023

ON DEMAND: CEImpact is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Obtain CPE credit by completing the course, followed by the exam and evaluation (if applicable). Once successfully completed, your course will appear in your Completed Courses tab. Access your CPE statement of credit at www.MyCPEMonitor.net.

To obtain 8.0 contact hours of CPE credit for completing this course, CEImpact provides you with two (2) opportunities to complete the exam. The learner will not receive CPE credit after two failed attempts.

TARGET AUDIENCE

• Pharmacists

ACPE ACTIVITY TYPE

Knowledge-based

ACTIVITY FEE

There is a fee of $299 associated with this activity.

SYSTEM REQUIREMENTS

The course is designed to work with any current web browser. If you have any technical difficulties, please contact CEimpact at: [email protected].

FACULTY

D. Max Smith, PharmD, BCPS
Clinical Pharmacogenomics Specialist
MedStar Health

David Kisor, BS, PharmD, FCP
Professor and Director
Manchester University Pharmacogenomics

Behnaz Sarrami, MS, PharmD
Director of Consulting
Missouri Pharmacogenomics Consulting LLC

John A Galdo, PharmD, MBA, BCPS, BCGP
CEimpact
Ross Bridge Pharmacy

D. Max Smith, David Kisor and Jake Galdo report no actual or potential conflicts of interest in relation to this continuing pharmacy education course.

Behnaz Sarrami is a Consultant for Missouri Pharmacogenomics Consulting, LLC.

At the completion of this activity, pharmacists will be able to:

1. Describe the pharmacists’ role in pharmacogenomics
2. Discuss the state of pharmacogenetic implementations across the industry
3. Recognize basic mechanisms of the expression of genetic information as traits
4. Describe the major types of genetic variation (poor, normal, or ultrarapid metabolizer)
5. Compare and contrast different types of genetic tests and application
6. Provide specific examples that establish the relationship between altered drug disposition and polymorphic cytochrome P450 enzymes
7. Describe how polymorphic genetic variation can be utilized to predict an individual’s response to drug therapy
8. Detail ethical, legal, and regulatory concerns surrounding pharmacogenetic testing
9. Review regulatory activity, especially FDA guidance and rulemaking impacting pharmacogenomics
10. Describe the potential limitations of pharmacogenomic testing
11. Discuss legal considerations of PGx and broader genetic testing (GINA, consent, HIPAA, etc.)
12. Describe the role of various pharmacogenetic resources available to support clinical application
13. Discuss strategies to identify whether a drug-gene pair is ready for clinical use
14. Recognize the value that pharmacogenetics can bring to patient care
15. Develop a pharmacotherapy regimen based on patient characteristics
16. Apply guidelines and other evidence to patient cases across multiple medical specialties and subspecialties (e.g., behavioral health, cardiology, oncology, pain management)
17. Identify variations in genetic response among racial or ethnic groups
18. Apply guidelines and other evidence to patient cases across multiple medical specialties and 30 subspecialties (e.g., behavioral health, cardiology, oncology, pain management)
19. Identify variations in genetic response among racial or ethnic groups
20. Describe the roles and responsibilities of clinical laboratories
21. Establish criteria for selecting a PGx laboratory
22. Compare and contrast PGx lab testing vs Direct-to-Consumer genetic testing
23. Detail the key components required in a pharmacogenomic test for clinical practice
24. Describe utilization of PGx in terms relevant for healthcare providers and payors
25. Utilize clinical decision support tools to inform therapeutic recommendations
26. Apply evidence-based literature to therapy recommendations
27. Create strategies to develop and deliver pharmacogenetic recommendations to prescribers
28. Describe the applicability of pharmacogenomics for patients
29. Counsel a patient on their test results

Current testing and reporting includes no more than 45 genes out of nearly 30,000 in the human body. We are only looking at the genes that have a known impact on how your body processes medications.

RxGenomix will collect some key information about you, such as age, ethnicity, biological sex, history of certain health conditions, your medication history, and information about your physical and mental health, wellness and lifestyle.  These are all used to help create the best medication plan for you. Click here for a full statement of our privacy policies.

RxGenomix has developed a comprehensive clinical decision support tool that allows for rapid review of pharmacogenomic results, and alternative medication recommendations.  Pharmacists are able to contemplate numerous clinical considerations including genetics, disease state, lifestyle factors, drug-drug interactions, medication cost, and Beer’s list criteria. Pharmacists create a Medication Action Plan (MAP) detailing therapeutic change recommendations to the patient’s care plan. MAPs are then delivered to the patient’s treating provider as part of a collaborative consultation between the provider and a PGx-trained pharmacist. 

Yes. Your DNA won’t change, so your results today will be stored securely and could help inform treatment decisions for years to come. The DNA sample itself will be destroyed according to all applicable laws and regulations. For our full privacy policy, click here.

We may disclose your information to others involved in your care, including healthcare providers, laboratories, bioinformatics partners, the health system or clinic where your own provider practices, and other providers that you or your healthcare provider have designated to receive your information. Click here for a full statement of our privacy policies. 

No. After the lab has completed the analysis for our PGx panel, all material samples will be destroyed in accordance with applicable laws and regulations. We will only retain the data set related to your pharmacogenomic genes, not the source genetic material. For our full privacy policy, click here.

If you are a benefit provider (employer, insurer, third-party administrator, etc.) we can help you start a program for those you serve. Contact us at (615) 814-2911 and we will work together to determine your needs, answer your questions and send you more information.

The RxGenomix population analytics tools can take the prescribing and healthcare claims data and turn it into actionable intelligence for a pharmacogenomics program. The tools will allow you to stratify your population and identify those for whom testing could do the most good, and produce an estimated return on investment.

No.  Federal congressional regulations, most notably the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the Genetic Information Non-Discrimination Act (GINA) prohibit employers from accessing patient-level data or using genetic information in employment and health insurance decisions. Where RxGenomix is engaged with employers, data is de-identified and aggregated to ensure compliance with law and patient-level data protection.

RxGenomix has built a Personalized Medication Hub which agnostically integrates through a secure API with the healthcare ecosystem. There are numerous Electronic Health Record (EHR) applications in the marketplace, each requiring a nuanced and unique approach to integration. RxGenomix is committed to an exceptionally high level of data security and, as such, each integration is contemplated on a case-by-case basis. Over time, RxGenomix will continue to scale its interoperability strategy for rational data exchange. 

Once you are registered and approved as a provider by RxGenomix, you will be granted access to the RxGenomix Hub, a secure online portal for both accessing test results and clinical decision support tools.

RxGenomix has a network of pharmacists specifically trained in applying pharmacogenomics. We also offer a thorough training program for pharmacists, should you have a particular pharmacist you’d like to involve in your program.

If you are a healthcare provider interested in offering testing to your patients, contact us today at (615) 814-2911. We will work together to determine your needs, answer your questions and send you more information. This includes pharmacists, MDs, DOs, physician’s assistants and nurse practitioners.