by brant bullard | May 15, 2014 | Metabolic Validation Program
Unlocking the future of medicine
A primary goal of personalized medicine is to provide the best medical treatment for each individual patient by determining which drug will have the best efficacy and have the least amount of toxicity and/or adverse effects. Furthermore, understanding interindividual variations of response to drug treatment, especially in patients with potential adverse reactions, might lead to biomarkers that can be used to predict the low incidence of idiosyncratic toxicity. Individualized medicine is usually based on the concept of pharmacogenomics that studies the influence of an individual’s genotype and/or SNPs on their response to a drug or medical treatment.
When drugs are prescribed, personalized medicine will use metabolic validation testing to predict how individuals will metabolize the compound. One example of this pharmacogenomics approach is the FDA approval of genetic tests that can predict the appropriate starting dose of the blood thinner warfarin (trade name Coumadin).
Because warfarin has a very narrow therapeutic range and because there is high inter- and intra-patient variability in response, finding the optimal dose can be challenging. While there are non-genetic factors that affect individual response, it is known that variations in two specific genes are associated with response to warfarin, and it has been suggested that pharmacogenomic-based dosing could speed up the determination of the appropriate initial therapeutic dose.
Medical School and Pharmacogenomics
Pharmacogenomics has been the major focus area to date; 84% of medical schools in the United Kingdom and 74% of U.S. and Canadian medical schools include pharmacogenomics in their curricula.
Source: Medscape.com
For more information on Personalized Medicine through Metabolic Validation Testing, contact:
PGx Medical
Individualized Care – Personalized Medicine
405-996-1564
info@pgxmed.com
by brant bullard | May 12, 2014 | Metabolic Validation Program
Before pharmacogenomics, healthcare providers used a “one size fits all” approach to treating individuals.
Now it has the potential to transform healthcare through, avoidance of drug side effects.
Metabolic Validation testing can determine whether you are a poor metabolizer, intermediate or ultra-rapid metabolizer.
The goal of metabolic validation testing (pharmacogenetic testing), is to have drug treatments that are specific to each person.
Today, healthcare providers have the ability to use genomic information to tailor medicine and/or treatments to the individual, and personalize their care.
Nurses are typically on the front line communicating with the patient, family and other healthcare professionals. It is important that they understand the impact and effectiveness of personalized medicine.
A nurse can play a big role in personalized medicine. They can help facilitate drug selection or dosage in treatment of an individual.
In 2007, the FDA revised the label on the common blood-thinning drug warfarin (Coumadin) to explain that a person’s genetic make-up might influence response to the drug. Warfarin and many other drugs now have a Black Box Warning to let healthcare professionals know patients may need to receive a lower dose or to change what medications they are receiving to avoid adverse drug reactions.
For more information on Metabolic Validation, contact:
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-996-1564
www.pgxmed.com
by brant bullard | Apr 30, 2014 | Metabolic Validation Program
As a healthcare professional, do you heed their warning?
Black Box Warnings:
A prominently displayed boxed warning, the so-called “black box,” is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these “black box” warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and postmarketing safety surveillance. In addition, we encourage health care providers to report drug reactions to the Food and Drug Administration’s MedWatch program. A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted. source: www.ncbi.gov
How can pharmacogenomics help?
Until recently, drugs have been developed with the idea that each drug works pretty much the same in everybody. But genomic research has changed that “one size fits all” approach and opened the door to more personalized approaches to using and developing drugs.
Depending on your genetic makeup, some drugs may work more or less effectively for you than they do in other people. Likewise, some drugs may produce more or fewer side effects in you than in someone else. In the near future, doctors will be able to routinely use information about your genetic makeup to choose those drugs and drug doses that offer the greatest chance of helping you.
Pharmacogenomics may also help to save you time and money. By using information about your genetic makeup, doctors soon may be able to avoid the trial-and-error approach of giving you various drugs that are not likely to work for you until they find the right one. Using pharmacogenomics, the “best-fit” drug to help you can be chosen from the beginning.
Pharmacogenomics may also help to quickly identify the best drugs to treat people with certain mental health disorders. For example, while some patients with depression respond to the first drug they are given, many do not, and doctors have to try another drug. Because each drug takes weeks to take its full effect, patients’ depression may grow worse during the time spent searching for a drug that helps. source: genome.gov
Pharmacogenomics or metabolic validation testing isn’t new and is being used in hundreds of healthcare facilities across the country. These tests help treat patients without the “trial & error” model we have used in the past. By doing this, physicians and pharmacist are able to treat patients the first time and help provide them a better quality of life.
For more information on Metabolic Validation Testing, contact:
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-996-1564
www.pgxmed.com
by brant bullard | Apr 2, 2014 | News
What is a Black Box Warning?
Boxed Warning:
This type of warning is also commonly referred to as a “black box warning.” It appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.
The FDA (Food and Drug Administration) approves a drug for marketing after determining that the drug’s benefits outweigh the risks for the condition that the drug will treat.
But even with a rigorous evaluation process, some safety problems surface only after a drug has been on the market and has been used in a broader population.
Adverse drug reaction:
An adverse drug reaction (ADR), also called a side effect, is any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.
The Black Box Warning is the strongest warning that the FDA requires. This warning is reserved for prescription drugs that pose a significant risk of serious or life-threatening adverse effects, based on medical studies. The Black Box Warning is included in the labeling or medical information of the prescription drug. Search Drug specific index
PGx Medical has implemented the Metabolic Validation Program (Pharmacogenetic Testing) in hundreds of clinics and homes across the country. This program helps reduce the risk of adverse drug reactions, maximize drug efficacy and individualize drug dose.
Pharmacogenetics uses information (such as DNA sequence, gene expression, and copy number) for purposes of explaining inter individual differences in drug metabolism (pharmacokinetics) and physiological drug response (pharmacodynamics), identifying responders and non responders to a drug, and predicting the efficacy and/or toxicity of a drug. Eliminating the “trial & error” process and improving quality of life.
For more information on the PGx Metabolic Validation Program, contact:
PGx Medical
info@pgxmed.com
405-996-1564
www.pgxmed.com
by brant bullard | Mar 23, 2014 | News
In December 2008, the New York Times ran a story about a woman from California who had been taking a drug called tamoxifen to help prevent breast cancer. After two years of taking the drug, her doctor ordered a new genetic test that showed that her genes were preventing the drug from working properly.
“You find out you’ve been taking this medication for all this time, and find out you are not getting benefit…I was devastated” says the women. She had to stop taking tamoxifen. The good news is that she found out that the drug was not helping her and her doctor can now prescribe a drug which will work in her body. The bad news is that she could have known this two years ago if she had taken the genetic test from Day 1.
Experts report that approximately $300 billion is wasted each year on drugs which apparently do not work in people who have certain genes. These people never receive the full benefit from these drugs. Others are getting dangerous side effects.
For example, the blood-thinning drug warfarin is one of the top twenty drugs prescribed in the US. It is used to help prevent blood clots. If a person’s genes prevent the drug from working correctly, warfarin becomes dangerous. It is one of the top three drugs that cause hospitalization or emergency room visits. If a person has genes that allow too much warfarin to get into the bloodstream, the blood cannot clot correctly and the person can have bleeding. On the other hand, if a person has genes that prevent enough warfarin from getting into the bloodstream, the person could develop serious blood clots. The way a person’s body reacts to warfarin, tamoxifen and other drugs depends on differences in their genetic makeup.
Genes provide your body with instructions for making enzymes. Enzymes are needed for your body to break down drugs so your body can get benefit from the medicine. You carry two copies of every gene: one from your mother and one from your father. Differences in these genes can affect the speed of different enzymes you have in your body. This affects how well your body is able to use medicines and how well drugs work in your body. Differences in your enzymes can affect how your body can metabolize (break down) a drug and how long the drug stays your body. Based on what type of genes you carry, you may be:
- a poor drug metabolizer
If you are a “poor metabolizer”, you do not break down drugs well. This may result in too much drug in the body which may lead to a dangerous side effect or even death. In some cases, your body may not be able to break down certain drugs to their working form and therefore the drugs will not work properly.
- an extensive or “normal” drug metbolizer
You metabolize drugs at the normal rate.
- an ultra-rapid drug metabolizer
If you are an “ultra-rapid” metabolizer, this means you break down drugs too fast, causing them to be of no use in the body. If medications do not work properly, conditions such as high blood pressure, blood disorders, and cancer will be left untreated and may even lead to death.
Genetic Tests for Drug Response
Researchers have now found more than 30 types of drug metabolizing enzymes in humans and mostly all of them vary between people.
The three main genetic tests available today include: CYP2D6, CYP2C9, and CYP2C1.
Read entire article at: Consumer Health
For more information on Genetic Drug Testing
(PGx Metabolic Validation Program) contact:
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-996-1564
