PGx Medical: A Year At A Glance 2016

2016 was a big year for PGx Medical with growth, new partnerships and a new website

Clay Bullard, President, PGx Medical

We want to start by saying “thank you” to our partners, clients and employees.  We are truly blessed to have such a wonderful team!

We kicked off January 2016 by adding bipolar and seizure to our list of medication classes giving healthcare professionals more information then ever before. With this addition, our program now offers the most comprehensive PGx test report on the market.

We have been in our new building for two years and have expanded our team. With the addition of a full time Client Service Coordinator and a Clinical Sales and Support Coordinator, PGx Medical continues to grow and expand as the market demands.

Throughout the year, I was privileged to speak to many senior communities, conferences and healthcare organizations about our program and how pharmacogenetic testing addresses key clinical concerns such as falls, dementia, pain, sleep and staff efficiencies.

In August, PGx Medical expanded our focus into the field of aging services. With the launch of a new website, a pilot program and partnership with Dr. Linda Shell, we were able to reach more healthcare professionals than ever before.

We also had the privilege to partner with physicians and pharmacists who understand the value of the program and use pharmacogenetics in their day-to-day patient care. These partners have been instrumental in educating others through online video, articles, local media outlets and case studies on outcomes based on changes from test results. We are appreciative and humbled by their willingness to share these stories.

During 2016, we partnered with one of the largest Oklahoma state agencies to manage their PGx Feasibility Pilot Program. Results and benefits analysis for the pilot will be available in Q1 of 2017. This is one of the largest pilot programs of its kind and we were honored to be able to partner with the State of Oklahoma.

Pharmacogenetic testing has received a lot of attention over the years under the umbrella of Precision Medicine, and we are excited to see that continue.  Future outlook is good and precision medicine will continue to grow and expand as new CMS regulatory requirements rollout 2017-2018 for unnecessary drugs.

We look forward to long-lasting relationships with current clients and new partnerships in the coming year.

Enjoy the holidays!  As always, you can contact us anytime with questions, comments or to schedule an appointment or speaking engagement.

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

 

Looking Forward: The future of Precision Medicine

Looking forward – what the future holds for precision medicine

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Outlook for precision medicine.

According to a recent article in Medical Device & Diagnostic Industry, medical technology took big leaps forward in 2016. So whats in store for 2017?

Personalized Medicine
We are seeing a trend in personalization in every sector. One area that has seen a lot of progress is in the mapping of the human genome and the understanding of how individuals react to specific drug treatments. Increased technical power and understanding of the human genome is now allowing targeted therapy to become a reality.

With over more than 60% of patients failing to achieve remission with the first anti-depressant they are prescribed, personalized medicine is a big piece of the puzzle.  Physicians and pharmacists can now review results from a simple no-cost buccal swab whether or not an individual can metabolize a medication, or may have drug interactions.  Technology and the scope of personalized medicine will continue to grow and expand.

Government reimbursements for personalized medicine is one factor that is expected to propel the demand from 2016-2022.

There are three beneficiaries from the advancements of personalized medicine — patients, the pharmaceutical industry, and society. As developments are made in the field of personalized medicine, patients will receive safer and more effective treatment; the pharmaceutical industry will gain increased efficiency, productivity, and better product lines; and society will gain from decreased health care expenditures as a consequence of the more precise allocation of limited health care resources.

Pharmacogenetics is an emerging field that’s helping physicians make better prescription decisions.  PGx Medical is the trusted and experienced resource for the implementation of pharmacogenetics in the field of aging services.

For more information on pharmacogenetics, contact:  PGx Medical, info@pgxmed.com or 405-509-5112

References: MD&DI.com, managedcaremag.com, 

Opioids and Pharmacogenetic Testing

Between 2000 and 2014, opiate-related overdose deaths in the U.S. increased 200%

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Opioid-related hospitalizations and ED visits spike in US. photo courtesy of healthcare dive

The rate of opioid-related hospitalizations and ED visits varied significantly by state, with the highest hospitalization rate occurring in Maryland and the highest rate of ED visits in Massachusetts.

According to an article in Healthcare Dive, Opioid-related hospitalizations and ED visits spike in US.

Between 2005 and 2014, the rate of opioid-related hospital stays increased 64.1% while opioid-related ED visits increased 99.4%.

But not all states were the same.  Opioid-related hospitalizations and ED visits varied by state with the highest ED visits being in Massachusetts and the highest hospitalization being in Maryland.

An opioid epidemic was declared in the U.S. by the HHS (U.S. Department of Health & Human Services) this past October due to a marked increase in the misuse of opioids over the past decade. The new statistical brief provides detailed, state-by-state data on overdose deaths, the rate of opioid-related hospitalizations and the rate of opioid-related ED visits. The brief did not differentiate between illegal opioid use, misuse of prescription opioids and compliant use of opioids.

HHS has urged providers to alter their prescribing practices, essentially making opioid medications a last resort. Meanwhile, hospitals and healthcare systems have started their own initiatives to address this national challenge, such as focusing on pain management alternatives or requiring across-the-board reductions in the number of opioid prescriptions.

Pharmacogenetics and Opioids:
Patients with CYP450 pharmacogenetic variations may respond differently to opioids, ranging from drug unresponsiveness to toxicity with elevated serum levels. The administration of opioids may be associated with adverse drug reactions including sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression. By performing pharmacogenetic testing, patients can be dosed appropriately to avoid experiencing dose-dependent side effect or lack of drug efficacy.

Results of pharmacogenetic tests allow patients to be dosed appropriately. Pharmacists can play a role in providing information to patients on selecting opioids where genetic testing may be useful. ~medscape.com

For more information on Pharmacogenetic Testing, contact:  PGx Medical, info@pgxmed.com or 405-509-5112.

Read entire article at: healthcaredive.com 

 

Precision Medicine: Filling Needs In LTC

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.”

alt = "precision medicine"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

 

Friday FOCUS on Pharmacogenetics

Welcome to our Friday FOCUS on Pharmacogeneticsalt = "Ftags"

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.

How do the New CMS regulations for LTC impact LTC Pharmacists?
 (Final Rule Published: Published October 4, 2016)

Below are several new items and new terminology that LTC pharmacy consultants need to be aware of.  PGx testing is a great tool to help validate and document these new regulations.

New terminology used by CMS is “person care plan”.  Pharmacogenetics, also known as personalized medicine is a great tool for “person centered care plans” and is currently used by communities, clinics and pharmacies across the country.  When pharmacists advise physicians on a person centered care plan with specific DNA guidelines, pharmacogenetics has documented reports that a pharmacist can provide to the facility for State Survey as evidence of a person centered care plan of action.

The same would apply to “comprehensive assessments” that are newly required and for the focus on reduction of psych medications.  CMS uses the language “residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs”.

How do you document clinically contraindicated for residents who need the meds, yet the facility is saying they have to get them off these meds?

Once a physician properly diagnoses the patient/resident, the clock starts in “gradual reduction requirements”; unless, you have evidence that it is the proper medication, at the right dosage, based on that individuals PGx test profile.

How do you know if the dose is right to begin with?  Is the patient an ultra rapid metabolizer? Are they an intermediate metabolizer?  Or do you just assume that everyone is an extensive/normal metabolizer and then wait to hear from the home that the meds are giving them therapy as intended.

Science has evolved way beyond “trial and error” methodology.  Pharmacogenetics is Person Centered  Care.  PGx Medical is the piece of the puzzle that has been missing in pharmacogenetics.  Some test results sit with no changes made or documented mainly due to education issues – or lack of.  PGx Medical is a consulting company that travels the country educating, implementing and following up with healthcare professionals to make sure the test results are understood and implemented, or documented that no change is required.  Partnering with PGx Medical to incorporate the testing program for your facilities can have a major impact in efficiencies, care plans and documentation that can help every LTC Pharmacy consultant.  CMS has increased the burden and workload to include the pharmacist, let us know how we can help.

Pharmacogenetics is a great tool to help manage medications.  This no-cost test will provide healthcare professionals with evidence-based reports unique to each individual resident based on their genetic profile.  Providing physicians, nurses and pharmacists with valuable information to help determine the best medical plan of action as it relates to medication management.  Whether it is psychotropic reduction, drug-on-drug interactions, or a report that helps reduce/increase dosages as appropriate for each individual, pharmacogenetics will provide you with the information needed to help guide you with current medications, and be a roadmap for future medications.

PGx Medical is the trusted and experienced resource for the implementation of pharmacogenetics in the field of aging services. Contact PGx Medical for more information, or to be part of an ongoing operational Pilot Program:

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