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
405-509-5112
www.pgxmed.com
by brant bullard | Apr 29, 2014 | News
Five Healthcare Trends that will Impact Senior Living 
By: Senior Housing News
The Affordable Care Act is causing a sea change in the healthcare industry at large, and several emerging trends are expected to impact the long-term care industry as well, including a movement toward in-home services.
Five trends in particular are worth noting, Senator Bill Frist, the keynote speaker for the National Investment Center for the Seniors Housing & Care Industry’s upcoming regional conference, told NIC in an exclusive interview.
“There is a definite rise in government sponsored healthcare,” Frist told NIC ahead of his speech he’ll give during a networking lunch at the regional conference this month on how the healthcare industry has transformed. “The implication for companies working in senior living is that they will be forced to comply with the government regulations that come with the government money.
” One aspect of the ACA that’s expected to impact the healthcare industry is the move toward value-based healthcare. This will lead to restructuring payment models, bundling care, and requirement outcomes evaluation, Frist said.
“Specifically, accountability for outcomes and a correlation with the cost of care will be a massive cultural change in medicine,” he said.
As healthcare systems develop data systems and analytics to identify patients at risk for hospital readmission in an effort to cut down on unnecessary rehospitalizations, the assisted living industry will also have to pay more attention to this data, Frist said.
There’s also a rise in the “patient-consumer”—a shift away from what Frist called the paternalism of medicine to a model that empowers patients and allows them to shop around. “The rise of consumerism imparts a need for branding in healthcare that we have not before seen,” he said.
For more information on metabolic validation for your Senior Community, contact:
PGx Medical
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com
www.pgxmed.com
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 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 | 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
