Do you read the FDA black box warnings?

As a healthcare professional, do you heed their warning?

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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

The Affordable Care Act is causing a sea change in the healthcare industry

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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

Making Informed Decisions For Your Patients

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Validation

Who doesn’t want validation for the work they are doing?  As a healthcare professional it is important to know that the medications you are prescribing your patients are working.  If not, you begin the “trial & error” process.  But by giving a patient a drug that doesn’t metabolize in their system, it could cause adverse reactions or just not metabolize so the patient never improves.

If you’re not 100% sure your patients are taking medications that are working, how can you make an informed decision?

Health care professionals go to work every day wanting to provide the highest quality, safest, most appropriate care for their patients. The bottom line is that patients should not go to a hospital or other health care setting with a fear that their health will not improve. Unfortunately, in the past there was no way of knowing for sure that a drug wasn’t working.  A patient may try multiple drugs before they found one that worked.  That isn’t the case any longer.

At PGx, we recognized a need for personalized medicine and we also understand that we are just touching the surface of what is yet to come.

Making More Informed Treatment Decisions for Your Patients
Not all patients respond appropriately to a standard, One Size Fits All dose.  Pharmacogenetic testing provides a lifetime of protection against drug toxicity or lack of drug efficacy. This simple test will help you determine a patient’s drug sensitivity allowing you to provide better care.

Implementing the Program
The PGx  Metabolic Validation Program allows a healthcare professional to gain insightful information via a simple buccal swab.  The swab is then analyzed at the laboratory and a report is sent directly to the medical facility to be utilized when treating the patient.  This once in a lifetime test will help physicians make informed decisions when treating patients to:  reduce side effects, increase clinical response and gives health care physicians collaborative access to pinpoint appropriate medications for specific diagnoses.

We’ve made it easy to incorporate pharmacogenetics into your clinic, company, pharmacy or center.  The ultimate goal for PGx Medical is to help you provide better healthcare and improve quality of life for your patients or residents. 

If it costs your facility nothing, can yield life changing benefits, makes staff and consulting jobs easier and can be completed in less than a day, what is the downside and why would you not want this tool for your patients?

For more information on how you can implement this no cost program into your facility, email: info@pgxmed.com, call 405-509-5112 or go to www.pgxmed.com.

How doctors can help treat patients with pharmacogenetics

In what ways can a doctor use pharmacogenetics to help treat their patients?

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Pharmacogenetics can be used by doctors to identify the optimal dose and/or medicine for each patient.

The right dose
Dosage is usually based on factors such as age, weight, and liver and kidney function. But for someone who breaks down a drug quickly, a typical dose may be ineffective. In contrast, someone who breaks down a drug more slowly may need a lower dose to avoid accumulating toxic levels of the drug in the bloodstream. A pharmacogenetic test can help reveal the right dose for individual patients.

The right drug—for depression
Depression can be treated with a variety of different medicines, and it is often time-consuming and difficult to find the drug(s) that works best for each person. In the future, genetic testing may take some of the guesswork out of choosing a drug regimen. These tests are likely to involve analyzing a person’s liver enzymes, especially those in the cytochrome P450 family, which are largely responsible for processing antidepressants.

The right drug—for cardiovascular disease
Statins, the most widely prescribed drugs worldwide, help prevent cardiovascular disease by reducing the level of “bad” cholesterol in the bloodstream. While statins work well for many patients, responses are highly variable and doctors must adjust the dosage for each person.

Researchers have discovered that variants in a number of molecules—including those that break down or transport statins, as well as the statins’ molecular target in the cholesterol production pathway—contribute to the variable response among individuals. Using results of genetic tests, doctors may one day be able to prescribe the right dose from the start and more quickly reduce their patients’ risk of dangerous cardiovascular events such as heart attack and stroke.

For more information on pharmacogenetic testing, contact:

PGx Medical
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com

www.pgxmed.com

Source:  www.nigms.nih.gov

 

The Pharmacist Role in Pharmacogenetics

As drug therapy experts, pharmacists are in a unique position to push the frontiers of pharmacogenetics in both the research and clinical practice environments.

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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