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 | 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
by brant bullard | Mar 3, 2016 | News
Maintaining a healthy mind, body, and spirit is as important to the caregiver as it is older adults.
Making sure your elderly family member is taking the right medications is important to getting them up, out and active.
A recent survey of 17,000 Medicare beneficiaries found that 2 out of 5 patients reported taking five or more prescription medicines.
According to Drugwatch.com, adults 65 and older often take multiple medications, both prescription and over-the-counter (OTC) drugs. When people take more than one drug at the same time, it is called polypharmacy. While medications are intended to improve lives and relieve symptoms, in some cases they cause more problems.
Older adults may also fail to take the drugs in the proper way because they lose track of them, and sometimes certain drugs may interact with each other, causing additional symptoms and health problems.
By 2030, about 72 million people will be 65 or older. Today’s seniors live longer than before, which makes it important to make your extra years as fun-filled and pain-free as possible.
Adverse reactions attributable to prescription drug use cause an estimated 100,000 deaths and more than two million serious reactions in the United States each year, costing the healthcare industry more than $136 billion annually.
The PGx Medical Metabolic Validation Program can help reduce unnecessary medications and the risk for adverse drug reactions (ADR). A simple swab of the cheek can tell your healthcare provider what medications your body is able to metabolize which eliminates the trial and error process. This test can improve clinical outcomes and reduce the overall cost of prescription drugs by enabling better drug selection, earlier favorable results and lower rates of ADRs.
For more information, contact PGx Medical at (405) 509-5112 or info@pgxmed.com. www.pgxmed.com
by brant bullard | Nov 15, 2015 | Testimonials
Below are testimonials we’ve received from doctors, directors of nursing, pharmacists and government officials regarding our medication management program, via pharmacogenetic testing.
PGx Medical is the trusted and experienced resource for the implementation of pharmacogenetics in the field of aging services.
Pharmacogenetics aligns current and future medication with each persons unique genetic profile.
As we work alongside long-term care communities, clinics and pharmacies, we have the privilege of receiving success stories on how pharmacogenetics has impacted residents, patients, family and staff.
Pharmacogenetic Testing Addresses Clinical Concerns Such As Falls, Dementia, Sleep, Pain And Overall Staff Efficiencies.
We recently implemented pharmacogenetic testing and feel it is very easy to administer. The test results are helpful when dosing or treating our residents, and saves our staff time and frustration as providers by making sure our patients are on the correct medications. On average, approximately 90% of our patients need a dose change, med change or to discontinue a medication after testing.
We had one patient we had tried so many SSRI/SNRIs and after her PGx test, we were able to find the right medication regimen and now she feels great! We would recommend this program to anyone who has patients on multiple medications. ~Rachel Moore, PA-C~
I have found the pharmacogenetic test to be very useful for patients in my clinic practice as well as my nursing home patients. It is quick to use! In fact, my nurses do all of the work and then they go thru the results and alert me of the medications that are less likely to work for those patients. It takes no time for me at all! The paperwork is very minimal and nurses can fill it out. It takes less than a minute to swab the inside of both cheeks. Then it gets mailed off and the results come back in just a few days.
I had a patient in my clinic that had seen multiple doctors, a psychiatrist and several counselors for her depression. She had tried many medications to help her depression but she complained that none of them made her feel better. We did a pharmacogenetic test and found out that the patient had a gene mutation that kept ALL of the antidepressants from working. No wonder she never felt better with the medications! From the test results we found some alternative medications that could be used to treat her depression. She was so relieved that there was a really good reason for the previous anti-depressants not to work.
I had a patient who had shoulder surgery who kept complaining that the Hydrocodone did not help his pain. The Naproxen actually did better in controlling his pain. We did a pharmacogenetic test and found out that Hydrocodone does not work well for his pain but Naproxen works best. This is helpful information if he ever has to use pain medication again.
I had a patient who complained that his pain meds were not working at all and would ask for more and more. I suspected he was a drug seeker but could not prove it. We did a pharmacogenetic test on him and discovered ALL of the narcotics work well for him. We now know he is a drug seeker and treat him appropriately.
The PGx Medical Pharmacogenetic test is helpful if a patient is not responding to a medication as well as we think they should. This helps us chose appropriate medications that are more likely to work and avoid those that may cause problems for the patient. It is very helpful with resistant depression, psychosis and ADHD medication failures. I am even starting to use the testing first before prescribing any medication. Patients love the testing because we can avoid the medications that are not likely to work or those that could cause adverse reactions; they get on the right medications quicker with less trial and error. Insurances like it because it saves them money by getting quicker results without multiple medication changes.
Nursing Home surveyors encourage nursing homes to use the pharmacogenetic testing on patients to try to keep patients off of multiple medications and to use those that work well. It also decreases the adverse reactions and helps keep patients off of anti-psychotics or at least on minimal doses of anti-psychotics. ~ Dr. Jami Benton ~
“The PGx Medical pharmacogenetic test program has yielded great results at our home. It is now a fully implemented tool my clinical staff reviews with all of our residents. The reports are easy to understand with clear actionable recommendations. I am thankful we were allowed to be the first to have such a tool to use here at our home. Each resident deserves our very best.”~Treva, MD~
“Seems too good to be true, but always produces positive results. I utilize the testing daily now in my practice. For Geriatrics provides the tool for easy medication adjustments. The reports are not complex. Very beneficial for identifying the effectiveness of analgesics in residents who are unable to communicate. There are residents that we may have labeled as ‘drug seekers’, and when the DNA test report is returned we discover that the analgesic they were prescribed is not being metabolized in their body and they are getting no relief from their pain. So they have legitimate pain and the analgesic has not been effective in reducing their pain. This test only has to be performed on each resident one time in their life. That makes it very cost effective. And the reimbursement process has been very easy. The families love it! It tells them exactly what their loved one metabolizes and what is best for them”. The DNA Test results give confidence to the residents that they are being prescribed the correct medications. Yes, would highly recommend this program! CMS should mandate the test for all residents on Antipsychotics!” ~Dr. Mike M, Long Term Care Physician~
“It is important to me to ensure that each of our veterans in all of our State VA homes are cared for on an individual basis. I was excited to learn of the potential the PGx Medical Pharmacogenetic Program offered and I brought it forward to our administrative and clinical teams, as it seemed to be a ‘no brainer’ for our homes to implement. I’ve heard nothing but positive results and praises of both the Program and PGx Medical.” ~Maj Gen (ret) Secretary of Military and Veterans Affairs~
“This DNA Testing has been a Win-Win for both the residents and families! By utilizing the DNA test results we know exactly which medication is effective for the residents. It is a tremendous cost saver on medications. Not all people that we think are ‘pain seekers’ really are. We had one resident that kept begging for more and more pain meds. We did the DNA Swab Test on her and the test revealed that she was metabolizing zero percent of the pain medication. So she was truly in pain. We are such Believers in this program! It is a wonderful Marketing Tool! We can advertise that we provide the best care possible for residents on these medications!”~Brenda W. Clinical Manager~
“I was privileged to introduce the PGx Medical Pharmacogenetic Testing Program to the Oklahoma Department of Veterans Affairs. As a State Representative, I felt this program was in the best interest of each of our Veterans living in the seven ODVA homes, and to those who are in the homes caring for and assisting them everyday. This program has been exceptional and has produced wonderful results while helping the homes practice a level of personalized care that was previously unattainable. The program has also been clinically and economically beneficial to veterans living in homes.”~State Representative~
“I perform about 20 of the DNA Tests a week. The results are a tremendous help in my practice. The DNA Report provides an objective list to choose from to help my patients. Not knowing the metabolic profile of the patients increases the risk of side effects. It is hit and miss without the test. There is no trial and error period when you use the DNA swab testing. It allows me to select from a list of medications that will help my patients. I recommend this program to many other Doctors and patients. It gives you an individualized report with objective information to correctly order the right medication.”~Dr. Timothy B, Pain Management Specialist~
“We initiated this DNA Testing program in response to the CMS Directive to reduce our Antipsychotic usage. Through the metabolic reports, we have identified that residents were receiving antipsychotics that were actually adverse for them. These residents have shown a marked improvement in abilities and a reduction in side effects. The residents are doing so much better now that they are off these medications. The Family members are very excited about the results. All the medication changes have been positive. When the swab reports come back we have been amazed. We then understand why the residents have been exhibiting behaviors and mood swings. This program is very individualized. It has positive results for everyone, but first and foremost the residents. Our Administrator Markets this DNA Testing as a great program for our residents and the facilities. We have multiple Physicians that see our residents. Some of the Physicians were skeptical at first, but now they are really happy with the results. When we had our Survey, we had signed up with AssureRx but had not put the program into place. The Surveyors asked that we write a letter for them to take back to their Office about out Pending DNA Antipsychotic Program. They were so interested that the Surveyor called back and asked if we would fax them copies of the results. The Surveyor stated their Supervisors were very impressed with the individualized data provided.”~Jennifer H., Director of Nursing~
“The PGx Pharmacogenetic Test was easy for us to see the clinical value it offers, even before implemented. The implementation process that PGx offered was very simple, with very little interruption to our staff. As a pharmacist, the information is extremely valuable on my monthly med reviews and for all new residents upon admission. It helps address the issues of polypharmacy, unnecessary medications and more importantly is another tool to help assure that our residents are getting the best therapy for them. It is a great tool for any pharmacist to have.”~Valarie, DHP~
For more information on how you can implement pharmacogenetics into your community, clinic or pharmacy, contact us at:
PGx Medical
Empowerment at the Source of Treatment
Individualized Care – Personalized Medicine
405-509-5112
info@pgxmed.com
by brant bullard | Oct 7, 2015 | Metabolic Validation Program
Pharmacogenomic testing isn’t new, but reimbursements have increased the number of patients being tested.
Who pays for the cost of a pharmacogenetic test?
Pharmacogenomic testing has been around for decades, but up until a few years ago, most people couldn’t afford it. Now CMS (The Centers for Medicare and Medicaid Services) reimburses 100% for Medicare B patients and in select states, 100% for Medicaid patients. Private insurers cover testing based upon medical necessity. There is no cost to physicians, LTC facilities, pharmacies, consultants, or clinics.
Who should receive pharmacogenetic testing?
Pharmacogenetic testing should only be performed based upon medical necessity. Medical necessity is determined by the physician.
The following situations may qualify as medical necessity:
- Patients taking a large number of medications with the potential for serious adverse effects.
- Patients taking medications with a high risk of drug interactions.
- When patients do not respond to drug treatment and options are limited.
- Patients with an unexpected pattern of side effects to medications.
If you are interested in being tested, or you are a healthcare professional and would like to incorporate this program into your day-to-day patient care, contact:
PGx Medical
Individualized Care – Personalized Medicine
info@pgxmed.com
405-509-5112
www.pgsmed.com
