RIGHT DRUG. RIGHT DOSE. RIGHT PERSON.
You must read this part to understand our process. If you decide to order a drug compatibility test, you will be required to give informed consent and make certain important choices regarding your test.
Which Genes are tested?
At Personalized Prescribing Inc., we test for 3 metabolic genes- CYP2D6, CYP2C19, and CYP2B6. Additionally, our comprehensive analysis includes testing for 106 SNPs across 58 predominantly pharmacodynamic genes.
Which Drugs are covered by these Genes?
At Personalized Prescribing, we provide recommendations for the drugs that have been clinically validated at the highest level by independent consortia on pharmacogenetics (CPIC & DPWG). This is done to prevent a “false positive” in which a gene that is not clinically validated may produce a result that is not accurate and may lead to a negative health outcome. However, in some cases, we may provide you with clinical annotations that have not yet reached the highest level of clinical validation by the above-mentioned independent consortia. In this case, we will disclose this information to you and your healthcare professional, and with very clear disclaimers.
The drugs that we provide recommendations for can be found on our searchable Drug List.
The Difference between Genetic Information and Drug Recommendations
There is a big difference between the terms “genetic information” and “drug recommendations”, particularly for the use of this drug compatibility test.
“Genetic Information” refers to the actual genetic code found in DNA. We all have the same genes, but it is our unique variations in these genes that make us different. For the purpose of this drug compatibility test, the term “genetic information” will refer to the unique genetic variations as determined by our laboratory from your DNA sample. These genetic variations are written as either a single mutation (ex. 1029A>C) or as a combination of mutations within the same gene, also called a haplotype (ex. *17). A haplotype is a combination of mutations within a gene.
“Drug Recommendations”, for the purpose of this drug compatibility test will refer to the clinically validated recommendation provided by Clinical Pharmacogenetics Implementation Consortium (CPIC) or Dutch Pharmacogenetic Working Group (DPWG) for each particular drug covered by this test. Your genetic information (as defined above) is used to determine which drug recommendation to provide in your test results. Drug recommendations are not considered genetic information, as they do not contain any reference to your unique genetic code. An example of a drug recommendation would be, “Elevated CYP2C19 and normal CYP2D6 enzyme activity. Consider alternative drug NOT metabolized by CYP2C19. If a tricyclic is warranted, utilize therapeutic drug monitoring to guide dose adjustments”.
Patients taking the drug compatibility test are entitled to receive any information about their health that is produced by the test (Healthcare Consent Act). However, test subscribers must understand the consequences of knowledge of any or all parts of their health information. Subscribers may request access to some or all of their information; in that case they are responsible for any and all consequences stemming from the information they obtain. Because of this, please read the next part of our disclosures and disclaimers very carefully.
Important Disclaimers for Anyone Considering Taking this drug compatibility test:
Lab Testing:
Drug compatibility testing is extremely accurate, and our laboratory is CAP certified (the highest level of accreditation for laboratories under the FDA). However, like all testing there is a small possibility of delay or error.
System Security
To the best of our ability, Personalized Prescribing Inc. will ensure that any and every system that we maintain control over remains completely secure. However, no system is 100% secure. We will never sell, share, or disclose your personal information, health information, or genetic information to anybody without your consent. However, it is extremely unlikely yet possible that your information could be taken from our system without our permission (i.e. hacked).
Knowledge of Your Genetic Information
Although the genetic information produced in this pharmacogenetic test does not confer any type of risk of developing a certain disease currently, there is a possibility that new scientific discoveries of the future could determine an association with the genetic information produced in this test and a risk of developing a certain disease.
Genetic Anti-Discrimination Act
Because of the Genetic Anti-Discrimination Act passed in April 2017, no person or entity may discriminate against any individual based on their genetic information.
Consult Your Doctor
Never make any changes to your medication without first consulting your doctor. There may be factors other than your genetics that affect your response to medication. Please share the results of this drug compatibility test with your prescribing physician and or your pharmacist. You may request that the report is not shared with you, but only shared with your healthcare professional.
Privacy and Confidentiality
All the information that you provide is kept private and confidential, and information is only used on an aggregate level (for research and statistical purposes) to improve our services, showcase medication response patterns via research publications, and inform the care of future patients. For example, healthcare professionals and researchers may want to know statistically, the percentage of patients with genetic variation who responded well to medication.
