by brant bullard | Apr 15, 2014 | News
As drug therapy experts, pharmacists are in a unique position to push the frontiers of pharmacogenetics in both the research and clinical practice environments.
Pharmacists are the logical information nexus to bring together information on patient health, medications being taken or considered, and potential genetic interaction with those medications.
In an attempt to avoid the adverse effects of drugs, or to ensure their efficacy, there is a growing capacity to connect individual differences in biochemistry causing these differences directly with personal genetic variations. More than 100 drugs now carry FDA pharmacogenetic information on the label, and this labeling trend will certainly grow. The application of such knowledge can be critical to a patient’s health, an application that requires testing and interpretation relative to medication. Pharmacogenetics may soon become common in pharmacy practice.
Community pharmacists are integral to patient care through MTM. Because of the relationships they have with patients, pharmacists are poised to assume the role of obtaining samples and providing clinical pharmacy services in response to pharmacogenetic test results. In fact, it is a natural extension of the MTM rubric for pharmacists to include the results of pharmacogenetic tests or the recommendation to test. ~pharmacist.com~
The field of pharmacogenetics presents a wide range of opportunities for pharmacists. Specific roles for pharmacists are likely to fall within three major domains: developing research methodologies and setting research directions, establishing the value of pharmacogenetic testing in clinical practice, and participating in education and infrastructure development that moves pharmacogenetic technologies toward implementation. ~JAPhA.com~
For more information on Pharmacogenetic Testing, contact:
PGx Medical
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com
by brant bullard | Apr 14, 2014 | News
Your genes tell your story. How tall you are and even how you look. They also play a key role in how your body responds to medicines.
The terms pharmacogenomics and pharmacogenetics are often used interchangeably to describe a field of research focused on how genes affect individual responses to medicines. Whether a medicine works well for you—or whether it causes serious side effects—depends, to a certain extent, on your genes.
Q: Why is a pharmacogenetic test done?
A: A pharmacogenetic test can be done before or after medicine has been prescribed. It can help predict how a patient will metabolize a drug, allowing the physician to adjust dosages to get maximum efficacy from a drug with minimum side effects.
Q: Are the results of pharmacogenetic tests confidential?
A: 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.
Q: How will pharmacogenetics affect the quality of health care?
A: 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.
Q How do I get a pharmacogentic test?
A: On a doctors order. Once your doctor orders the test, a simple swab is taken from the inside of your mouth and sent to a laboratory. Results are sent back to your doctor to help identify the optimal dose and/or medicine for each patient.
*Source: National Institute of General Medicine Science
For more information on pharmacogenetic testing, contact:
PGx Medical
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com
www.pgxmed.com
by brant bullard | Apr 6, 2014 | Metabolic Validation Program
Are you doing everything you can to provide the best healthcare and personalized care for your residents?
In a recent article on Senior Housing Forum, the author states, “From my perspective this is a win-win opportunity for every senior community, every resident and every physician. Better healthcare for your residents, reduced drug costs and a unique marketing tool for your communities.”
So let me ask you, if you could offer your residents personalized medicine that would improve their quality of life, would you do it?
Pharmacogenetics isn’t new but it is just now gaining the attention of healthcare professionals – especially in senior communities where the majority of residents are on multiple medications.
What makes this work in senior communities is that medicare and many senior HMO’s realize that this tool will save them money so they will cover the “once in a lifetime” test. The PGx Metabolic Validation Program has demonstrated that 25%-40% of residents would benefit from the test and be treated with a different medication based on Metabolic Validation.
The PGx Metabolic Validation Program is simple. On the physicians orders, a quick swab is taken of the inside of the resident’t mouth. Once the swab is analyzed and a report is generated, the physician can treat that resident on a personal basis. The report allows physicians to know which classes of drugs will be most effective, and the data can also provide guidance on dosage.
This test is no different than any other lab work and is kept in the residents file to help improve their quality of life and decrease the “trial & error” process. Which makes it very accepting for families and a unique marketing tool for homes. Better care and personalized attention.
For more information, or to schedule an implementation meeting, contact:
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-509-5112
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
405-509-5112
www.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
