by brant bullard | Mar 29, 2015 | News
As a healthcare professional, are you aware of the pharmacogenomic information on FDA-approved drug labels?
Pharmacogenomic information can appear in different sections of the labeling depending on the actions. Drug labeling may contain information that describes risk for adverse events, drug exposure and clinical response variability along with many other things.
The FDA has a number of drugs with pharmacogenomic labeling. Below are a few that are prevalent in elderly patients.
(more…)
by brant bullard | Aug 1, 2014 | Metabolic Validation Program
Recently PGx Medical surveyed pharmacists across the country regarding Metabolic Validation. Below are a few responses.
93% of pharmacists said they think it is important to alert Medical Directors and DONs to residents that are currently on medication that have a BLACK BOX WARNING (Plavix, Codeine, Psych, Anti Depressants, etc) and that Metabolic Validation (pharmacogenomics) should be a part of a Pharmacy Consultant role.
An alarming 85.71% said their facility has never implemented a Metabolic Validation program for medication reduction or appropriate medication diagnosis.
42.86% pharmacists surveyed said 80% of the recommended med changes from Pharmacy Consultants are agreed to or implemented by the Medical Directors on average nationwide. 57.14% responded 50% or less med changes were agreed or implemented.
When asked the question: What percentage of residents in LTC facilities would you estimate might be currently taking meds, or enter the facility as a new resident on meds that they are not metabolizing properly, or could be eliminated without significant changes to their quality of life?40% of Pharmacists said 30% and higher.
67% agree that the Pharmacy Consultant should have the most influence in determining medicine regiment changes and appropriate med reductions for existing LTC facility residents.
PGx Medical would like to thank all the Pharmacists who took time to answer our survey. Your input is vital to what we do and we appreciate your feedback.
At PGx Medical we take our job very seriously. Our role as consultants is to help the healthcare community determine the right drug, right dose, for the right person. Through our unique tool “Metabolic Validation Testing” we strive to make it easy for healthcare professionals to incorporate personalized medicine into their patient care.
- Reduce side effects
- Increase clinical response
- Pinpoint appropriate medications for specific diagnosis
For more information on Metabolic Validation Testing and how you can incorporate it into your home, pharmacy or clinic, call 405-509-5112 or email: info@pgxmed.com. Our PGx Medical Team will be happy to assist you.
The PGx Medical Metabolic Validation program is available at no cost to the facility or residents with Medicare Part B and Medicaid (in select states).
PGx Medical
Individualized Care, Personalized Medicine
405-509-5112
Info@pgxmed.com
by brant bullard | Mar 31, 2014 | News
Pharmacogenomics is the science of determining how genetic variability influences physiological responses to drugs, from absorption and metabolism to pharmacologic action and therapeutic effect. With increasing knowledge of the molecular basis for a drug’s action has come the recognition of the importance of an individual’s genetic makeup in influencing how he or she may respond to a drug.
Genetic variants in drug metabolizing enzymes can have a significant effect on the way a person responds to a drug. They can speed up or slow down enzymatic activity, or even inactivate an enzyme. In some patients, known as rapid metabolizers, drugs are metabolized too quickly. As a result, the average dose of the drug may be broken down too quickly to be effective, and a higher dose may be needed. Conversely, where the metabolite of the drug is active, as in the case of codeine (see below), rapid metabolism may lead to excessive accumulation of the active metabolite, which may result in toxic levels. In slow metabolizers, a drug administered at the recommended dose can accumulate due to such slow metabolism, potentially reaching toxic levels in the patient’s system and leading to adverse reactions. Such patients may require a smaller dose. In conjunction with other factors, pharmacogenomics offers the potential to enable doctors to identify the patients who are rapid or slow metabolizers of certain drugs and to adjust dosing accordingly to achieve both effective and safe treatment.
- Rapid metabolizers may break down a drug too quickly and require higher doses.
- Slow metabolizers may build up toxic levels of the drug and require smaller doses.
Clinical Applications of Pharmacogenomics
Warfarin (Coumadin and generics), an anticoagulant, is a recent example of the clinical use of pharmacogenomics to improve dosing. Warfarin has a narrow therapeutic window and a wide range of inter-individual variability in response, requiring careful clinical dose adjustment for each patient. Genetic variants in the warfarin target, the vitamin K epoxide reductase (VKORC1), as well as the warfarin metabolizing enzyme, cytochrome P450 2C9 (CYP2C9), influence the variation in patient response. Patients with certain variants of these genes eliminate warfarin more slowly and typically require lower warfarin doses. In those individuals, a traditional warfarin dose would more likely lead to an elevated International Normalized Ratio (INR), a longer time to achieve a stable warfarin dose, and a higher risk of serious bleeding events during the induction or dose-titration period of warfarin therapy. (FDA News)
Another recent example involves ultrarapid metabolizers of codeine, who have multiple copies of the gene for cytochrome P450 2D6 (CYP2D6), the enzyme that converts codeine into morphine, its active metabolite.
Tests to identify the three genetic polymorphisms for warfarin, codeine, and carbamazepine described above are commercially available.
Read more at FDA.com
For more information on the PGx Metabolic Validation Program, contact:
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-509-5112
