Pharmacogenetic Testing

Everyone has unique, complex genetic characteristics. We typically think of these as things that determine how we look physically, or whether we are likely to develop certain diseases and disorders.

However, genetics also affects how we respond to most commonly prescribed medications. More than 75% of people have genetic variations that determine how their bodies process drugs. Because of these genetic differences, two people can take the same dose of the same drug, but respond in very different ways.

Many patients take multiple medications prescribed by different healthcare providers for various health and illness issues. The routine course of therapy for achieving medication results is to modify dosage, or to change medications with careful consideration of other medication drug-drug interaction possibilities. There is no wonder that achieving optimal drug efficacy - and avoiding Adverse Drug Reactions (ADRs) - is such a significant healthcare challenge. Whether a medicine works well for you, or whether it causes serious side effects, depends to a certain extent on your genes.

The terms Pharmacogenomics and Pharmacogenomics are often used interchangeably to describe a field of research focused on how genes affect individual responses to medicines. Pharmacogenomics (PGx) is the study of how a persons unique genetic makeup affects their response to medications, and is one of the most exciting areas of Personalized Medicine today. Pharmacogenomics Testing is the solution for Personalized Medicine therapy in the right dosages for many of the most common drugs - and for better medication management. In recent years, pharmacogenetic testing as a routine clinical tool in patient care has become more commonplace. Advances in technology have made testing more accurate, quicker to implement in a clinical laboratory setting, and less costly. These factors, combined with great strides in our interpretation of genetic data have led to a revolutionary way in how a physician approaches patient care.

Doctor Solutions Group makes Pharmacogenetic Testing readily available to healthcare providers across a broad range of medical specialties. We are experts at bringing Molecular diagnostic testing services to physicians and their patients.

Primary Care / Family Practice
Internal Medicine
Pain Management
Cardiovascular
Oncology
Mental Health
Nursing Home Care

What are the goals of Pharmacogenetic Testing?

Avoiding serious Adverse Drug Reactions (ADRs) and drug-drug interactions
Replacing traditional drug choice and dosage trial-and-error treatment plans
Optimizing a clinician’s drug choice based on a patient's unique genetic information
Helping decrease overall healthcare costs

What are the benefits of Pharmacogenetic Testing?

Increased Patient Safety
Improved Patient Outcomes
Decreased Adverse Drug Reactions
Patient Relief, Life Improvement, Life Saving
Lower Patient Medication Expenses
Lower Healthcare Costs
Selection of appropriate medication therapy
Maximize drug efficacy
Protection from non-productive toxic medication treatment

What do metabolizer phenotypes mean?

Knowing a patient’s genetic profile can help a prescriber adjust patient drug therapy to improve therapeutic outcomes and reduce the risk of adverse drug events (ADE). Our pharmacogenetic test report categorizes a patient into one of four metabolizer categories for each genetic pathway.

Statistics on Adverse Drug Events:

82% of American adults take at least one medication and 29% take five or more. (CDC).
Adverse Drug Events (ADE) cause over 700,000 emergency department visits each year. (CDC).
Nearly 120,000 patients each year need to be hospitalized for further treatment (CDC).
Over 100,000 people die each year due to adverse drug events (FDA).
4th leading cause of death, Ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents and automobile deaths (FDA).
ADEs cause injuries or death in 1 of 5 hospital patients. (New England Journal of Medicine).
$3.5 billion is spent on extra medical costs dues to ADEs annually (CDC).
75% of the US population doesn’t metabolize medications “normally” (FDA)
Approximately 2.2 million adverse drug events occur annually in the U.S. (CDC)
The FDA lists more than 100 drugs that have a Black box warning suggesting a PGX be performed prior to taking (FDA)
1/3 of all clinically significant drug interactions are caused by drug/gene interactions, not drug/drug interactions (CDC)
ADVERSE DRUG EVENTS ARE PREVENTABLE

What does PGx mean?

PGx is the abbreviation for Pharmacogenetics, which is the study of variations of DNA and RNA characteristics as related to drug response, and is one of the most exciting areas of Personalized Medicine today.

How do I get a Pharmacogenetic Test?

Ask your doctor to order a test from a DSG medical laboratory partner.

Do the labs assume full liability for the results?

Yes

What labs does DSG use for PGx Testing?

DSG has partnerships with multiple labs CLIA certified around the country.

Will this test be covered by a patient's insurance?

Medicare, Tricare, VA and most Private insurance companies have previously covered the cost for people with certain conditions. Independent financing is also available if required.

Are the results of pharmacogenetic tests confidential?

While pharmacogenetic tests are designed to help people, some fear that the results could be used against them, such as to discriminate against them in a job setting or to deny them health insurance coverage. A person's genetic information is protected through the Health Insurance Portability and Accountability Act (HIPAA), which was passed by Congress in 1996. Many states also have laws in place that protect the privacy of health information, including genetic data.

How will pharmacogenomics affect the quality of health care?

In the future, Pharmacogenomics will increasingly enable doctors to prescribe the right dose of the right medicine the first time for everyone. This would mean that patients will receive medicines that are safer and more effective, leading to better health care overall. Also, if scientists could identify the genetic basis for certain toxic side effects, drugs could be prescribed only to those who are not genetically at risk for these effects. This could maintain the availability of potentially lifesaving medications that might otherwise be taken off the market.

How will pharmacogenetics affect the design, development, and availability of new medicines?

Pharmacogenetic research can lead to safer, more effective medicines and better health care. Pharmacogenomic knowledge will enable pharmaceutical companies to design, develop and market drugs for people with specific genetic profiles. Testing a drug only in those likely to benefit from it could streamline its development and maximize its therapeutic benefit. The FDA, which monitors the safety of all drugs in the United States, considers Pharmacogenomics to be a valuable tool in the development of new medical products. To date, the FDA has approved a number of genotyping kits relevant to Pharmacogenomics, including one that screens for variants in the cytochrome P450 enzymes, which process many kinds of drugs. In most cases the FDA encourages, but does not require, companies to submit Pharmacogenomic data with new drug applications. This data is only required for medicines that were developed based on Pharmacogenomics.

In what ways can doctors use pharmacogenetics to help them treat their patients?

For many diseases, there are a variety of treatment options. Pharmacogenomics can help doctors pick the right one for each patient. Pharmacogenetics can be used by doctors to identify the optimal dose and / or medication option for each patient. Dosage is usually based on factors such as age, weight, and liver and kidney function. But for someone who breaks down a drug quickly, a typical dose may be ineffective. In contrast, someone who breaks down a drug more slowly may need a lower dose to avoid accumulating toxic levels of the drug in the bloodstream. A pharmacogenetic test can help reveal the right dose for individual patients.

What does CYP450 mean?

This is a group of enzymes in the liver that are responsible for metabolizing approximately 90%-95% of all medications prescribed.

Don't most prescribed medications work for the majority of the population?

No. Just as genes contribute to whether you will be tall or short, black-haired or blond, your genes also determine how you will respond to medicines. Genes are like recipes—they carry instructions for making protein molecules. As medicines travel through your body, they interact with thousands of proteins. Small differences in the composition or quantities of these molecules can affect how medicines do their jobs. These differences can be due to diet, level of activity, or the medicines a person takes, but they can also be due to differences in genes. By understanding the genetic basis of drug responses, scientists hope to enable doctors to prescribe the drugs and doses best suited for each individual.

According to researchers at the New England Journal of Medicine,3 it is estimated that commonly prescribed medications may not work in up to 60 percent of patients. People with gene variations that affect the CYP450 Liver enzyme family are more likely to have medication problems than people without these variations. Problems can include adverse drug reactions including death in some cases or inefficacy of medications.

Which patients should be recommended to take a PGx test?

If the patient answers "yes" to any of the questions below, we would recommend PGx test.

Are you currently taking 2 or more medications?
Are you taking any long term prescribed medications?
Have you or a blood relative ever been hospitalized for taking a medication?
Have you or a blood relative in your family ever felt ill after taking a new medication?
Has your doctor changed your dose of medication due to a lack of response or adverse reaction to a medication?
Do you feel your prescribed medication is ineffective or doesn't leave you feeling better?
Do you suspect a prescribed medication that you are currently taking is causing any side effects or an adverse reaction?
Are you taking or considering the medicines Tamoxifen or Plavix?
Are you taking any medicines for your heart?

How long does it take to get PGx test results back?

PGx Test results are ready within 3-5 business days. Doctor access results either through a secure web portal using their login credentials, or via a HIPAA Compliant secure email account.

How is a PGx test performed?

A PGX test is simple swab of the inside of a patient's cheek that is sent to a diagnostic lab to determine the patient's gene variations and how the patient will metabolize certain prescription medications based on these gene variations.