by brant bullard | May 29, 2014 | Metabolic Validation Program
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.
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
by brant bullard | May 27, 2014 | Metabolic Validation Program
CDC report says most common medications are for heart disease and high cholesterol
Prescription drugs are playing an increasingly larger role in U.S. life, with nearly half of all Americans taking one or more medications.
Among adults, the most common prescription drugs are for cardiovascular disease and high cholesterol.
Those are two of several key findings in the federal government’s annual comprehensive report on the nation’s health that was released in May.
The relationship between Americans and their prescriptions is complex, according to the report produced by the U.S. Centers for Disease Control and Prevention.
On the one hand, more people than ever are receiving effective treatment for chronic conditions like diabetes, high blood pressure, elevated cholesterol levels and depression.
But doctors and pharmacists also find themselves struggling with unintended consequences of drug use, such as prescription narcotics abuse and the advent of antibiotic-resistant germs.
“Isn’t that the case with all forms of medical technology?” said Julia Holmes, chief of the analytic studies branch at the CDC’s National Center for Health Statistics. “It results in great benefit to people who are ill and disabled, but there’s always the potential for inappropriate use.”
The report — titled “Health, United States, 2013” — found the percentage of Americans taking prescription drugs has increased dramatically. During the most recent period, from 2007 to 2010, about 48 percent of people said they were taking a prescription medication, compared with 39 percent in 1988-1994.
Prescription drug use increased with age. About one in four children took one or more prescription drugs in the past month, compared to nine in 10 adults 65 and older, according to the study.
“This is really not earth-shattering news. There’s an increasing number of people with chronic illnesses, and the primary management tool available for dealing with chronic illness is medication,” said William Lang, vice president of policy and advocacy for the American Association of Colleges of Pharmacy.
One in 10 Americans said he or she had taken five or more prescription drugs in the previous month. That raises concerns about potential drug interactions, said Anne Burns, senior vice president for professional affairs at the American Pharmacists Association.
“We know that the number of adverse drug events a patient is likely to experience increases as the number of medications they are taking increases,” Burns said. “You’ve got everything from potential interactions between medications to timing issues taking a variety of medications throughout the day.”
People who took five or more drugs in the past month tended to be older. Only 10.8 percent of people taking that many drugs were between 18 and 44, while 41.7 percent were between 45 and 64 and 47.5 percent were 65 and older.
Drugs to manage cholesterol, high blood pressure, heart disease and kidney disease are the most widely used medications among adults, the CDC report found.
In particular, the use of cholesterol-lowering drugs among people 18 to 64 has increased more than sixfold since 1988-1994, due in part to the increased use of statins. Also, nearly 18 percent of adults 18 to 64 took at least one cardiovascular drug during the past month.
The CDC report noted some headway in efforts to combat the development of antibiotic-resistant bacteria. Prescriptions of antibiotics for cold symptoms during routine medical visits declined 39 percent between 1995-1996 and 2009-2010.
But the report also found a tripling of overdose deaths due to prescription narcotics. Painkillers taken among people 15 and older caused 6.6 deaths for every 100,000 people in 2009-2010, compared with 1.9 deaths per 100,000 in 1999-2000.
There has been a fourfold increase in antidepressant use among adults, but Holmes said that’s not necessarily a bad thing.
Seeking help for a mental health disorder isn’t as stigmatized as it once was, she noted. In addition, companies have introduced more effective antidepressants, and researchers have found that antidepressants also can be used to treat panic and anxiety disorders.
“If antidepressants enable people to function fully in their social roles, that’s a good thing,” Holmes said.
Interestingly, even though more people are taking prescription medications, the annual growth in spending on drugs has declined. The CDC reported that spending growth slowed from 14.7 percent in 2001 to 2.9 percent in 2011.
Many popular medications have gone off patent, including cholesterol-controlling statin drugs and other medications used to treat high blood pressure or heart disease, Burns said. Increased use of generic forms of these drugs has helped control spending on medication.
PGx Medical’s Metabolic Validation testing can help decrease the number of “unnecessary drugs” based on individual metabolic validation. But most importantly, it will help healthcare professionals determine the right drug, right dose, for the right person providing a better quality of life for each patient.
For more information, contact:
PGx Medical
Individualized Care – Personalized Medicine
Info@pgxmed.com
405-509-5112
www.pgxmed.com
Source: consumer.healthday.com
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
405-509-5112
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
405-509-5112
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
405-509-5112
www.pgxmed.com
