by PGx Medical | Dec 19, 2017 | Uncategorized
If you’ve ever had a loved one suffer from an adverse drug reaction, you’ll understand this post.
Clay Bullard, President
PGx Medical
It is estimated that 6.7% of hospitalized patients have a serious adverse drug reaction with a fatality rate of 0.32%. These statistics do not include the number of ADRs that occur in ambulatory settings. Also, it is estimated that over 350,000 ADRs occur in U.S. nursing homes each year. ~FDA.gov
ADRs are one of the leading causes of morbidity and mortality in health care. So what can we do to stop this ever-growing problem? Or at least slow it down.
“One of the first areas we feel is the most important is education. Educating providers and patients on the tools and resources available to help reduce ADRs is crucial,” said Clay Bullard, President of PGx Medical.
Clay, who is the president and founder of PGx Medical, travels around the country educating healthcare professionals on pharmacogenetics testing. His story is personal and started several years ago when his wife, in her early 30’s at the time, was diagnosed with an aggressive, degenerative form of Rheumatoid Arthritis. Most all of the physicians they consulted were not providing much hope or direction for treatment, other than the standard “Let’s try this and see what happens”. As the father of two young daughters and a third one on the way, his response to the “trial and error” approach was not a calm one. “It is difficult to watch a love one suffer, not to mention the potential financial costs and loss of valuable time that this approach entails,” said Bullard.
During the process of working with physicians who had a different approach and plan, Clay was introduced to the science of Pharmacogenetics. The idea of avoiding “trial and error” and having a “personalized treatment plan” for pharmaceutical usage captivated him and started his professional journey with what is now, PGx Medical.
PGx Medical is a leader in the pharmacogenetics industry and focuses on the field of aging services. Studies show people age 65 and older make up 12 percent of the U.S. population, but account for 34 percent of all prescription medication use and 30 percent of all over-the-counter medication use. Among older adults, adverse reactions due to medication can be very serious, including falls, depression, confusion, hallucinations and malnutrition. ADRs increases exponentially after a patient is on 4 or more medications.
So why does a drug work for one person, and won’t work for someone else?
Pharmacogenetics is the study of inherited genetic differences in metabolic pathways which can affect individual responses to drugs, both in terms of therapeutic effect as well as adverse effects.
Individual patient response to medications is influenced by genetic variation in the enzymes responsible for drug metabolism as well as targeted receptors and transporters.
The majority of drugs enter the body and have to be metabolized before giving good therapy. Knowing what genetic variants are present or not, leads to more effective medication prescribing.
When a provider prescribes a medication, they take a lot of outside factors into account, but they don’t really know your unique genetic makeup. Pharmacogenetics is a simple swab of the cheek and will provide this important information to help make more informed decisions.
If you or a loved one is on multiple medications, ask your physician about pharmacogenetics testing. Or contact PGx Medical at (405) 509-5112 or info@pgxmed.com to request more information.
source: FDA.gov, medscape.com
by PGx Medical | Oct 10, 2017 | Uncategorized
Each of us have our own unique genetic profile. So why aren’t our treatment plans tailored to fit us?
Personalized Medicine Is Unique To Each Individual
Twenty years ago the “one size fits all” approach was pretty standard when it came to prescribing medications. But today with the advances in science, healthcare professionals are able to predict your medication response. This information allows doctors to treat each patient as a unique person and tailor treatment to fit.
Many things influence how our bodies respond to medications. Nutrition, drug interactions, environment and yes, genetics. Knowing our genetics can help create an effective treatment plan customized for each individual.
It has been estimated that genetics can account for 20% to 95% of variability in drug disposition and effects as much as 40-60% of adverse drug reactions.
Pharmacogenetic testing can assist in determining if a particular medication will be effective for you, or potentially harmful.
It can improve your quality of life by helping your provider determine the right drug, at the right dose, for your genetic profile. This helps lower costs on unnecessary medications and reduce the risk of possible side effects. This is important for all patients, but particularly in the long term care setting where elderly adults on average take 8 to 10 medications per day.
Now, more than 130 of the most commonly-prescribed drugs include pharmacogenetic guidance, with many including black box warnings.
PGx Medical focuses on educating and implementing pharmacogenetics in the field of aging services. For more information on pharmacogenetics, contact PGx Medical, info@pgxmed.com or 405-509-5112.
by PGx Medical | Jan 20, 2017 | Uncategorized
Welcome to our Friday FOCUS on Pharmacogenetics
Each Friday we will post new and relevant information regarding Pharmacogenetics. We hope you will find this useful and pass along to colleagues. If you should have any questions regarding pharmacogenetics, please feel free to reach out to us at PGx Medical, info@pgxmed.com or 405-509-5112.
One question we get asked a lot when we travel around the country educating healthcare professionals on pharmacogenetics is…
Who should be tested?
Even though our pharmacogenetic program is a once in a lifetime test and reimbursed by medicare and in some states medicaid…it isn’t for everyone.
If you have a resident at your LTC facility who isn’t taking any medications, there is no need to test that resident. The following are a few reasons why I resident would benefit from pharmacogenetic testing.
- Taking multiple medications. You are having problems that you write-off as side effects from your medication. It may be that your drugs are interacting. How would you know without a pharmacogenetic test? Drug interactions may make your drug less effective, cause unexpected side effects, or increase the action of a particular drug. Some drug interactions can even be harmful to you. The PGx Medical test result highlights potential drug-on-drug reactions so healthcare professionals can dose accordingly.
- You’ve been taking your medication but your condition is not improving. Have you ever heard the phrase, “let’s try it for a few weeks and see if you improve.” That is called trial and error and honestly, how physicians prescribed medicine because they didn’t know the genetic make-up of each patient. Now, pharmacogenetic testing can help guide healthcare professionals in proper prescribing by aligning medications with each person’s unique genetic profile. And the test report will show them more effective options.
- Your physician has prescribed an anticoagulant. The FDA recommends individuals be aware of pharmacogenetics prior to starting certain anticoagulants such as Plavix and Warfarin. Patients who are poor metabolizers of these medications may be at risk – or may not be receiving the full benefit of these drugs.
Pharmacogenetics can help identify genetic markers and can assist in individualization of treatment.
PGx Medical is the trusted and experienced resource for the implementation of pharmacogenetics in the field of aging services. Contact us for more information, or let us know if you would like to be part of a Patient-Centered Care Pharmacogenetic Pilot Program. In conjunction with Dr. Linda Shell, PGx Medical is presently enrolling provider organizations and communities. To see if you qualify, go to: www.pgxmed.com/pilotprogram.
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-509-5112
by PGx Medical | Jan 17, 2017 | News
Doctors look for clues when trying to determine if a patient might become addicted to opioid painkillers. Clinical risk factors such as medical history, family history, and other environmental or social clues can help.
Addiction is estimated to be about 40% to 60% heritable, meaning genetics likely account for about half of a person’s risk.
Overdose deaths continue to climb with 19,000 deaths related to prescription opioid painkillers
While pharmacogenetics is not the end all be all, it is a tool used by many healthcare professionals across the country to help guide them in proper prescribing. It can help physicians and pharmacist determine if a patient has the ability to metabolize a pain medication, therefore alerting them if a patient says they are not receiving therapy and need more.
“There might actually be something to that,” said Clay Bullard, president of PGx Medical. “We’ve had physicians tell us they had patients who would complain their pain medication wasn’t working and they needed more. After performing a pharmacogenetic test, they realized the patient wasn’t able to metabolize the medication – or they were a ultra-rapid metabolizer of their pain medication so they needed to adjust their dosage accordingly. On the other hand, we’ve had physicians tell us their concern was validated after performing a pharmacogenetic test. The patient did have the ability to metabolize the medication.” Bullard went on to say with opioids, one concern is with a poor metabolizer. The body doesn’t metabolize the medication the way the manufacturer intended so the drug sits in their body and can build up toxins which can be deadly.
Cytochrome P450 2D6 (CYP2D6) is a gene product responsible for the metabolism of many major drug groups, including opioids. “A pharmacogenetic (PGx) test, approved by the FDA, is available, which looks for specific changes in the gene and interprets whether you have a ‘good copy’ or a ‘bad copy. A good copy would be a functional allele, while a bad copy is a non-functional allele. These changes and their combinations help predict how well a person will metabolize a drug.
An individual’s genotype can help predict the CYP450 activity, which classifies them into one of the four metabolizer types. The incidence of poor and ultrarapid metabolizers varies greatly among various populations. For example, approximately 10% of Caucasians are PMs for CYP2D6.
The CYP450 testing is a once-in-a-lifetime test. The result will be part of your medical record and denotes your genetic capability of handling these drugs. This not only applies to pain medications but also to other medications such as anti-convulsive medications, cardiac medications and psychotropic drugs that are used for depression and anxiety control.
Hydrocodone, the most frequently prescribed drug in the U.S., is metabolized differently depending on an individual’s phenotype. An ultra-rapid metabolizer may get some pain control, but their hydromorphone levels are going to increase and they may complain of side effects. Physicians have to be aware of that and they may need to make dosing adjustments accordingly. Poor metabolizers may not get sufficient pain control. If a patient is complaining about a drug not being effective, or about side effects, and the physician is considering a dosing adjustment, genetic testing can guide them.
The potential risks relating to how pain medications are metabolized are exacerbated by drug diversion. Drugs are now one of the leading causes of death in this country. It’s important for physicians to be aware of the impact of genetic variation on metabolizing drugs and try to identify those patients who may be at risk. If someone says they always take a half dose of a drug because of its effect or somebody else says the drug doesn’t really work for them, it’s a warning sign.
Getting the nation’s opioid addiction epidemic under control is a top priority for U.S. public health officials as overdose deaths continue to climb — with nearly 19,000 deaths related to prescription opioid painkillers.
PGx Medical is the trusted and experience resource for the education and implementation of pharmacogenetics.
For more information on pharmacogenetic testing contact:
PGx Medical
info@pgxmed.com
405-509-5112.
source: medpagetoday.com, Dr Leland McClure
by PGx Medical | Dec 18, 2016 | Aging Services
In a recent article by Bill Kubat, LNHA – Move over patient-centered care, make way for precision medicine, Manju Beier explains how pharmacogenetics fills a need in LTC.
Several terms, including “precision medicine,” “stratified medicine,” “targeted medicine,” “pharmacogenetics” and “pharmacogenomics” are sometimes used interchangeably with “personalized medicine.” The American Medical Association describes personalized medicine as “health care that is informed by each person’s clinical, genetic and environmental information.”
Pharmacogenetics Fills a Need
To better understand its implications in long-term care, I visited with Manju T. Beier, PharmD, CGP. Dr. Beier is president and founder of Geriatric Consultant Resources, LLC, a firm that provides clinical expertise in pharmacotherapy and clinical pharmacology to geriatrics professional organizations, managed care organizations, and health care plans. Dr. Beier has been a frequent presenter at AMDA – the Society for Post-Acute and Long-Term Care Medicine conferences.
Dr. Beier explained that the recognition of PGx as a science with clear implications for patient-centered care has been facilitated by the convergence of several factors across all health care, including implications for long-term care:
•The need for improved therapeutics. Studies and numbers frequently cited by the FDA and other regulators include a 2001 study that showed that the response rates of patients to medications from different therapeutic classes ranged from about 80% for analgesics to about 25% for oncology, 52% for osteoporosis, 75% for cancer chemotherapy, 70% for Alzheimer’s disease, 38% for depression, 43% for diabetes, 50% for arthritis, 48% for migraine (prophylaxis), 40% for asthma, and 40% for cardiac arrhythmias. Varying response rates to medications may be explained by a variety of factors; perhaps underlying variability in pharmacogenetics is one of them.
• Increased focus on adverse drug reactions. An estimated 2.2 million adverse drug reactions occur each year in the United States, including more than 100,000 deaths. Older adults with polypharmacy are especially at risk.
• Increased emphasis on medication management. PGx is potentially useful for predicting dosing, toxic side effects, and therapeutic effects, and for eliciting drug-gene interactions.
• Effects on measurable outcomes. Clinical studies evaluating the impact of pharmacogenetic-guided dosing and monitoring on ED visits, hospitalizations, quality of life, and health care costs are few and far between but slowly making their way into the literature.
To move it from the hypothetical to the concrete, consider the following case as described by Dr. Beier in The Consultant Pharmacist (Beier MT. Pharmacogenetics: has the time come for pharmacists to embrace and implement the science? Consult Pharm 2013;11:696–711):
~ Mr. J is an 83-year-old patient who resides independently in a senior living community. His past medical history includes depression comorbid with dementia, hypertension, and type 2 diabetes. He has no known allergies to medications. He has taken several anti-depressants in the recent past, including amitriptyline, paroxetine, and citalopram for his major depressive disorder. However, he either failed to achieve an adequate response or exhibited intolerable side effects to these medications. His current daily medications include simvastatin 20 mg, glipizide 5 mg, sertraline 50 mg, donepezil 5 mg, aspirin 81 mg, lisinopril-hydrochlorothiazide 20 to 25 mg, and metformin 500 mg twice daily. At the request of the consultant pharmacist, and in light of his past history with medication intolerance for depression, the physician orders cytochrome P450 genetic testing.
The resident’s pharmacogenetic results indicate that he is an ultra-rapid metabolizer of the CYP2C19 pathway and could potentially need higher doses of sertraline, which is metabolized via CYP2C19. CYP2D6 is a minor pathway in the metabolism of sertraline, and the resident’s poor metabolizer status suggests the need for extra vigilance. Based on the consultant pharmacist’s recommendation, the physician increases the sertraline dose gradually while monitoring for response over the next several weeks.
Eventually, the patient achieves a significant reduction in symptoms at a dose of 150 mg/day. The ultra-rapid CYP2C19 status may explain why the patient previously did not respond to citalopram, also a CYP2C19 substrate. The citalopram dose was not increased beyond 20 mg daily, complying with FDA-recommended maximum dose limits set for citalopram in the elderly. Amitriptyline is converted to nortriptyline via CYP2C19, and both amitriptyline and nortriptyline are further metabolized via the CYP2D6 pathway. As an ultra-rapid metabolizer of CYP2C19 and a poor metabolizer of CYP2D6, the resident may have had increased levels of nortriptyline, potentially causing his intolerance to the medication.
Similarly, his intolerance to paroxetine may have been as a result of his poor CYP2D6 status. It is well recognized that older patients, especially with dementia, are more susceptible to the anticholinergic side effects from nortriptyline and amitriptyline. This, combined with a poor metabolizer status, could potentially increase the risk for adverse events from paroxetine as well, which exhibits some antimuscarinic activity and has recently been added to the Beers list as a generally inappropriate medication to use in the elderly. Changes were not made to donepezil, as he was clinically stable at the prescribed dose.
This case illustrates how pharmacogenetic testing and appropriate resultant interventions can enable a patient to be maintained in the environment they wish to call home. It also illustrates the need for collaboration across the inter- disciplinary team with patient assessment (note the involvement of the consultant pharmacist) to identify the appropriateness of testing and determining interventions based on those test results.
PGx Medical is the trusted and experienced resource for the implementation of pharmacogenetics in the field of aging services. For more information on pharmacogenetics or to schedule a speaker/educator, contact: PGx Medical, info@pgxmed.com, 405-509-5112.
Read entire article at: caringfortheages.com
