Personalized Medicine: One Size Doesn’t Fit All

Physicians have long relied on a range of resources—including medical literature, their own research and experience, and pure gut feelings to treat patients.  But that one-size-fits all approach doesn’t take into account a patients unique characteristics.

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With personalized medicine available now, patients can receive individualized care according to their own genomic make-up.

Medicine as we know it revolves around “standards of care,” the best courses of treatment for the general population.

A growing number of healthcare clinicians are calling for a more personalized approach tailoring medicine to fit each individual; Right Drug, Right Dose, Right Person.

It is important to remember that genes can provide information that can lead us to make more informed decisions about our healthcare and medication therapy.

Education is the key.  Consider patient’s with depression, 38 percent of whom do not respond to the first drug they are prescribed.  With personalized medicine, or metabolic validation testing, healthcare professonals don’t have to prescribe medications on a “trial-and-error” basis.  They will be provided a guide for dosing depending on that individuals genetic makeup.

“One day, patients will say, ‘I’m not an average patient.  I am who I am.  You need to understand who I am before you prescribe whatever treatment you plan to prescribe,'” says Edward Abrahams, president of the Washington, D.C.-based Personalized Medicine Coalition.

Personalized Medicine is changing the world of healthcare.

For more information on Metabolic Validation testing (Pharmacogenomics), contact:
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-509-5112

Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medicine

Our current lack of ability to predict an individual patient’s treatment success for most diseases and conditions means that clinicians have no choice but to follow a less than optimal approach to prescribing drugs and other treatment options.

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Margaret A. Hamburg, M.D. Commissioner of Food and Drugs 

A patient being treated for high blood pressure, for example, might be placed on one of a number of blood pressure medications. The patient’s doctor makes a decision about what medication to prescribe based on only general information about what might actually work for that particular patient. If the medication does not work after a few weeks, the patient might be switched to another medication. This somewhat “trial-and-error” approach can lead to patient dissatisfaction, adverse drug responses and drug interactions and poor adherence to treatment regimens.

The goal of personalized medicine is to streamline clinical decision- making by distinguishing in advance those patients most likely to benefit from a given treatment from those who will incur cost and suffer side effects without gaining benefit.

The term “personalized medicine” is often described as providing “the right patient with the right drug at the right dose at the right time.” More broadly, “personalized medicine” may be thought of as the tailoring of medical treatment to the individual characteristics, needs and preferences of a patient during all stages of care, including prevention, diagnosis, treatment and follow-up.

Personalized medicine generally involves the use of two medical products – typically, a diagnostic device and a therapeutic product – to improve patient outcomes. A diagnostic device is a type of medical device. Diagnostic devices include both in vitro tests such as assays used in measurement of genetic factors and in vivo tests, such as electroencephalography (EEG), electrocardiography (EKG), or diagnostic imaging equipment.

Pharmacogenomics:
Pharmacogenomics (PGx), the study of variations of DNA and RNA characteristics as related to drug response, is one of the most exciting areas of personalized medicine today. The field arises from the convergence of advances in pharmacology (the science of drugs) and genomics (the study of genes and their functions). Patients typically have variability in response to many drugs that are currently available. It can be difficult to predict who will benefit from a medication, who will not respond at all, and who will experience adverse effects. PGx seeks to understand how differences in genes and their expression affect the body’s response to medications.

More specifically, PGx uses genetic information (such as DNA sequence, gene expression,
and copy number) for purposes of explaining interindividual 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.

Advances in PGx have opened new possibilities in drug discovery and development. PGx has allowed for more tailored treatment of a wide range of health problems, including cardiovascular disease, cancer, and HIV/AIDS. FDA’s Center for Drug Evaluation and Research (CDER) has supported pharmacogenomics for more than a decade by providing regulatory advice, reviewing applications, and developing policies and processes centered on genomics and individualized therapeutics.

With the help of personalized medicine, the health care management paradigm will focus on prevention, moving from illness to wellness, and from treating disease to maintaining health. By improving our ability to predict and account for individual differences in disease diagnosis, experience, and therapy response, personalized medicine offers hope for diminishing the duration and severity of illness, shortening product development timelines, and improving success rates. At the same time, it may reduce healthcare costs by improving our ability to quickly and reliably select effective therapy for a given patient while minimizing costs associated with ineffective treatment and avoidable adverse events.

Read more at:  FDA.gov

For more information on Personalized Medicine via Metabolic Validation Testing:

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

www.pgxmed.com

Depression in Nursing Home Residents

Depression affects more than 6.5 million of the 35 million Americans aged 65 years or older.

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Depression in elderly people often goes untreated because many people think that depression is a normal part of aging and a natural reaction to chronic illness, loss and social transition.

Treatment Once diagnosed, 80 percent of clinically depressed individuals can be effectively treated by medication.  Medications can be beneficial for elderly individuals in treating the symptoms of depression.

But according to NAMI (National Alliance on Mental Illness) research has shown that some depressed individuals may need to try more than one medication to get an optimal response.

But by playing the “trial & error” game, many seniors are living with depression while trying to figure what medication is metabolizing in their body and what isn’t. By doing a simple (once in a lifetime) metabolic validation test which involves a simple swab of the mouth, physicians can now determine what medications will work for each individual resident.  This allows better, more personalized care for the resident and most importantly, a better quality of life.

According to a 2013 Clinical Gerontologist study done by Tracy Chippendale, PhD, OTR/L, “Depressive symptoms are expected to become a leading cause of the global burden of disease, second only to cardiovascular disease, by the year 2020.” Given these ominous statistics, it’s time for nursing home staff to start thinking about what they can do within their own facilities to potentially ease the burden and help their nursing home residents feel less depressed.

The PGx Medical metabolic validation test is reimbursed by medicare so there is no cost to the facility, and no cost to the resident or their family.

For more information, contact:

PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com

405-509-5112

Source:  NAMI.com
Source:  digicareins.com

Will Personalized Medicine Transform Healthcare?

Before pharmacogenomics, healthcare providers used a “one size fits all” approach to treating individuals.

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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
405-509-5112

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.