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Drug Safety: Frequently Asked Questions

Frequently Asked Questions

Do not alter the dosage amount or schedule of any drug you are taking without first consulting your medical provider or pharmacist.

How do I order DNA Prescription Drug Reaction Testing?

You can order testing directly if you have a physician prescription or your healthcare provider can request testing for you. We send a cheek swab collection kit with directions by mail. Use the return mailer to submit samples and receive results in ten days or less. Faster testing is available for an additional charge. Call a DNA testing consultant at (800) 523-3080 for details and to order.

Will DNA Prescription Drug Reaction Testing be covered by my medical insurance?

Insurance is now consistently reimbursing for pharmacogenetic testing in many diagnostic situations including adverse drug reactions or lack of response to medication, pain management, cancer management, and management of many co-morbid conditions.  Genelex has submitted multiple claims with several carriers, almost all of which were paid at an acceptable rate. Please note that we have seen coverage only for relevant medications and conditions not as a general screening. Contact your insurance provider about coverage prior to ordering if this is a concern. Even if it is not covered by insurance, most patients think that the once-in- a-lifetime expense is well worth it when the benefits of testing are considered.

The CPT codes are as follows if you would like to confirm eligibility in advance:

CYP2D6 CPT codes - 1 X 83891, 2 X 83892, 1 X 83900, 14 X 83914, 1 X 83909, 1 X 83912, 1 X 83912-26

CYP2C9 CPT codes - 1 X 83891, 2 X 83892, 1 X 83900, 5 X 83914, 1 X 83909, 1 X 83912, 1 X 83912-26

CYP2C19 CPT codes - 1 X 83891, 2 X 83892, 1 X 83900, 3 X 83901, 7 X 83914, 1 X 83909, 1 X 83912, 1 X 83912-26

CYP1A2 CPT codes - 1 X 83891, 2 X 83892, 2 X 83898, 2 X 83894, 1 X 83912, 1 X 83912-26

NAT2 CPT codes - 1 X 83891, 2 X 83892, 1 X 83900, 7 X 83914, 3 X 83901, 1 X 83909, 1 X 83912, 1 X 83912-26

DPD Enzyme CPT codes - 1 X 83891, 1 X 83892, 1 X 83898, 1 X 83894, 1 X 83912, 1 X 83912-26

UGT1A1 - 1 X 83891, 2 X 83892, 1 X 83898, 1 X 83894, 1 X 83912, 1 X 83912-26

 

How has DNA Prescription Drug Reaction Testing been used up to this point?

Pharmaceutical companies regularly use these tests in clinical trials, to exclude people from the trials. Medical centers around the country are also beginning to use these tests on their own patients to avoid adverse drug reactions (ADRs) and achieve more accurate prescribing.

Why is this testing just now becoming available?

There are many reasons. Key elements of this test have recently been developed. ADRs don't have an organized constituency like most diseases do, no American Cancer Society or March of Dimes. Many doctors do not realize the extent of the problem and the large pharmaceutical companies and insurers may have a difficult time becoming motivated to act because of the added initial costs. Genelex has made this test available to the public so people can benefit now from the recent advances in pharmacogenetics. We also wish to recognize that more people want to take greater responsibility for their own healthcare. We support that decision.

What is pharmacogenetics?

Pharmacogenetics is the study of how individual people respond to medicines based on their genetic makeup. When you take a drug or are exposed to an environmental toxin, enzymes in your liver, intestines and other tissues go to work to breakdown that drug so that it can be excreted. Your genes provide the instructions for making these enzymes, several of which may be involved in the breakdown and excretion of any particular drug. Your specific genetic makeup determines how these enzymes interact and whether they work faster or slower than average.

How are drugs processed by the body?

Drugs act on target sites in body tissues to cause a therapeutic effect. They are removed from the body by being converted into an inactive form. The P-450 family of drug metabolizing enzymes inactivates most prescription drugs. The most important and most thoroughly studied of these enzymes are CYP2D6 and CYP2C9. More than half of the population has at least one defect in these enzymes that can greatly increase the risk of an adverse drug reaction.

What are adverse drug reactions?

Adverse drug reactions (ADRs) depend on the type of drug or combination of drugs being taken. They have many causes and are often not well understood. Many ADRs occur because individual differences in drug metabolizing enzymes (DMEs) and other parts of the processing systems have not been taken into account when the drug was approved or prescribed. Three-fourths of all ADRs are dose-dependent, with many occurring at standard manufacturer-recommended doses. A 1998 medical report found adverse drug reactions to be the fourth leading cause of death in the U.S., at more than 100,000 annually.

Why don't you test the CYP3A4 pathway if so many drugs are metabolized through it?

Current studies show that although CYP3A4 varies genetically, these genetic variations do not appear to have important functional significance. Environmental factors appear to be far more important.

What are the most useful enzymes to test genetically?

  • CYP2D6 (cytochrome P450 2D6) is the best studied of the DMEs (drug metabolizing enzymes) and acts on one quarter of all prescription drugs. Approximately ten percent of the population have a slow acting form of this enzyme and five percent a super-fast acting form. Drugs that CYP2D6 are thought to inactivate include Prozac, Zoloft, Paxil, Effexor,hydrocodone , amitriptyline, Claritin, cyclobenzaprine, Haldol, metoprolol, Rythmol, Tagamet, tamoxifen, and the over-the-counter diphenylhydramine drugs, Allegra, Dytuss and Tusstat.
  • CYP2C9 (cytochrome P450 2C9) is the primary route of metabolism for Coumadin (warfarin), Amaryl, isoniazid, sulfa and ibuprofen. Clinical studies suggest that the use of genetic testing may be especially helpful with warfarin administration. Other drugs that are thought to be metabolized by 2C9 include, amitriptyline, Dilantin, Hyzaar, THC (tetrahydrocannabinol), naproxen and Viagra.
  • CYP2C19 (cytochrome P450 2C19) is associated with the metabolism of carisoprodol, diazepam, Dilantin, and Prevacid.
  • CYP1A2 (cytochrome P450 1A2) is associated with the metabolism of amitriptyline, olanzapine, haloperidol, duloxetine, propranolol, theophylline, caffeine, diazepam, chlordiazepoxide, Premarin, estrogens, tamoxifen, and cyclobenzaprine.
  • NAT2 (N-acetyltransferase 2) is a second step drug metabolizing enzyme that acts on isoniazid, and procainamide and Azulfidine. The frequency of the NAT2 "slow acetylator" in various worldwide populations ranges from 10% to more than 90%.

For additional information on these and other prescription drugs visit http://www.rxlist.com/top200.htm

Disclaimer
The content of this web site is for public use, free of charge, and for information only. It is not intended to be used in any other way. The authors disclaim any liability, loss, injury, or damage incurred as a consequence, directly or indirectly, of the use and application of any of the content of this web site.

The information presented on this site is intended as general health information and as an educational tool. It is not intended as medical advice. Only a physician, pharmacist, or other healthcare professional should advise a patient on medical issues and should do so using a medical history and other factors identified and documented as part of the health professional/patient relationship.




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What our clients say...

"I just wanted to call and tell you that my physician switched my medications based on my test results, and I cannot describe how much better I feel. You have made a believer out of me, my family, and my physician. I hope this testing becomes routine before anyone is placed on long term medication."
- PY, Eirie, CO