News
Dr. Jeff McCormack Endorses PGx Medical for Pharmacogenetics
Pharmacogenetics aligns current and future medications with each persons unique genetic profile.
“The promise of Pharmacogenetics is real and can provide tremendous clinical information for which any physician, practitioner or pharmacist can make adjustments to a patients medication regimen. What PGx Medical offers in partnering with clinicians and LTC communities eliminates a tremendous amount of the confusion and work surrounding the proper implementation of a successful pharmacogenetics program. Pharmacogenetics is a tremendous tool to help clinicians be more precise and efficient. PGx Medical is the partner with the experience you can trust.”
Jeff McCormack, Ph.D. , HCLD
Dean, College of Natural and Health Sciences
Lawson Professor of Microbiology and Immunology
Clinical Professor of Pathology, University of Oklahoma Health Sciences
PGx Medical Expands Company to Focus on Aging Services
Enhancing the Quality of Life Through Personalized Medicine
“With CMS phasing in new star ratings for quality measures, we wanted to focus on helping nursing facilities and home health companies find a solution before those changes take place”
PRWeb: Effective immediately – Oklahoma based PGx Medical takes innovative program to the next level by focusing on improving the quality of life in seniors through their pharmacogenetic program.
“It was an easy decision for our company. We saw a need and we are addressing it. With CMS phasing in new star ratings for quality measures, we wanted to focus on helping nursing facilities and home health companies find a solution before those changes take place,” said Clay Bullard.
Bullard, Founder and CEO of PGx Medical, is a person experienced in the challenges of medication management. Through a personal experience with a family member, Bullard quickly realized the trial and error process wasn’t providing much hope or direction for treatment – not to mention the financial burden and loss of valuable time. “The idea of avoiding trial and error and having a personalized treatment plan for pharmaceutical usage captivated me.” It is at that time he started his professional journey with what is now PGx Medical.
PGx Medical has a proprietary process that impacts quality, adds value and addresses clinical concerns such as falls, dementia, pain, medication management and overall staff efficiencies, via pharmacogenetics.
Pharmacogenetics aligns current and future medications with each person’s unique genetic profile.
Drug-related problems are common in the elderly and include drug ineffectiveness, adverse drug reactions, overdosage, underdosage, and drug interactions. This is one of the reasons PGx Medical made the decision to focus primarily on the field of aging services.
With over 43.1 million adults 65 and older and that number is growing rapidly, statistics show proper medications play a role in improving the quality of life for older Americans. In the LTC community population, medication-related problems currently cost $177.4 billion a year. (ascp.com).
Bullard adds, “ PGx Medical has spent years educating healthcare professionals on the benefits of pharmacogenetics, how it impacts current medications and it is a roadmap for the future. We never really focused our time on one targeted space. After working with clinicians in the field of aging services, we realized there is a need, not only for residents, but also for the clinical caregiver and the family member. You want your loved one to be up and active, living a quality life. That doesn’t happen if they are overmedicated or not receiving proper therapy from the medications they are taking.”
Pharmacogenetics is a one-time diagnostic lab reimbursed by Medicare B. PGx Medical partners and provides a solid program that includes education on pharmacogenetics and the testing process, assistance with implementation, and ongoing support. Providers across the country are using the PGx program to increase quality and enhance clinical outcomes via pharmacogenetics.
Medicare estimates 4.3 billion prescriptions were written in 2015 and studies show 65 percent of doctor visits result in a prescription. If ineffective medications continue to be prescribed, we as a nation will continue to deal with the negative outcomes.
For more information on pharmacogenetics, contact, Clay Bullard at cbullard@pgxmed.com or 405.818.9327, or visit www.pgxmed.com.
Dr. Linda Shell endorses PGx Medical in the implementation of pharmacogenetics within the field of aging services
As a nurse in long term care one of my concerns has been the prevalence of polypharmacy, the excessive use of medications. According to the NIH 50% of nursing home residents take 9 or more medications per day (2016). The problem is often related to the comorbid conditions of nursing homes elders such as heart disease, diabetes, chronic obstructive lung disease, and hypertension requiring multiple medication management. Many of the medications prescribed have not been tested in clinical trials with frail elders as research studies exclude nursing home residents related to their aging bodies and comorbid complexities. The problem of polypharmacy can also lead to serious interactions between multiple medications resulting in serious harm. Some medications increase the risk of confusion, falls, and behaviors in the cognitively impaired. Other risks of polypharmacy are excessive amounts of pills that must be passed by a nurse taking them away from resident care, therefore increasing the risk for a medication error and adverse drug event.
Interactions between medications prescribed, ineffective medications (too little and not enough), trial and error with multiple medications (trying to find the right fit), risk for side effects, cost of medications, time associated with med pass that takes nurse away from bedside, plus the impact on quality of life for residents, demands a new approach in assessing medication efficacy. Additionally, CMS regulations coming in 2018 regarding medication management and requiring diligent review, heightens the need for additional tools and resources for addressing the problem of polypharmacy.
A simple, straightforward solution is needed– one that offers providers a more effective tool that can align prescribed medications to the unique needs of each resident. I believe that pharmacogenetics testing provides such a solution.
Pharmacogenetic testing provides a very simple test that aligns a residents’ personal genetic profile with the medications they need. This alignment can enhance clinical impact and improve quality of life.
Testing starts with a doctor’s order and simple buccal swab. Within 72 hours a resident’s genetic profile is generated for assisting the physician in aligning present medications being taken, along with a roadmap for future medication prescribing. Reports are simple to understand and provide clarity for clinical teams plus peace of mind for residents and their families. It’s fully reimbursed for qualifying Medicare B participants.
When I’m asked “why pharmacogenetics testing makes sense?” my response is “based on the information available, and potential impact, why doesn’t it make sense?” Pharmacogenetics is an innovative tool that has the potential to transform the process of medication management in long term care, reduce polypharmacy, and ensure the efficacy of medications.
Dr. Linda M. Shell MA, RN
Legacy Market Services / LindaShell.com
Pharmacogenomic Information on Drug Labels
Pharmacogenomics can play an important role in identifying responders and non-responders to medications, avoiding adverse events, and optimizing drug dose. Drug labeling may contain information on genomic biomarkers and can describe:
- Drug exposure and clinical response variability
- Risk for adverse drug events
- Genotype-specific dosing
- Mechanisms of drug action
- Polymorphic drug target and disposition genes
The table below lists FDA-approved drugs with pharmacogenomic information in their labeling. The labeling for some, but not all, of the products includes specific actions to be taken based on the biomarker information. Pharmacogenomic information can appear in different sections of the labeling depending on the actions. For more information, please refer to the appropriate labeling guidance.
Biomarkers in the table include but are not limited to germ-line or somatic gene variants, functional deficiencies, expression changes, and chromosomal abnormalities; selected protein biomarkers that are used to select patients for treatment are also included.
This table does not include non-human genetic biomarkers (e.g., microbial variants that influence sensitivity to antibiotics), or biomarkers that are used solely for diagnostic purposes (e.g., for genetic diseases) unless they are linked to drug activity or used to identify a specific subset in whom prescribing information differs. For drugs that are available in multiple dosage forms, salts, or combinations, a single representative product is listed. In the case of combination products, the single agent associated with the biomarker is listed unless the agent is only approved as a combination product, in which case all agents are listed. ~FDA
See complete list of drugs at: FDA.com
For more information on pharmacogenetic testing, contact:
PGx Medical
info@pgxmed.com
405-509-5112
Congressional Leaders Address Misuse of Antipsychotic Drugs in Nursing Homes
Congressional Leaders are asking for tougher requirements for Long-Term Care Facilities that will affect the quality of life for more than a million nursing home residents in the years to come
In a recent letter to CMS, Centers for Medicare & Medicaid, Congressional leaders asked for tougher regulations in nursing homes across the country.
The letter, addressed to CMS Acting Administrator Andrew Slavitt, highlights critical issues that ensure care and safety for this vulnerable population.
Staffing Requirements:
Congress urges CMS to mandate 24-hour RN coverage and require that a facility employ at least one RN 24 hours a day, seven days a week to provide direct care, assessment and resident monitoring.
Antipsychotic Drugs:
The letter states, facilities report they are currently administering antipsychotics to over 281,000 residents. An estimated 88% of these residents have dementia and face a significantly increased risk of death from taking these drugs, according to FDA warnings.
Congress is asking for the right to be free from chemical restraints is fundamental tenet of the Reform Law, and the final nursing home regulations should meaningfully address the pervasive misuse of antipsychotics and other types of psychotropic drugs.
The letter also addresses, Binding Arbitration Clauses and Transitions of Care and states these are a few critical issues that some Congressional Leaders believe must be resolved as CMS promulgates changes that will have a significant and lasting effect on the safety and well-being of millions of current and future nursing home residents, as well as the integrity of the publicily funded programs that pay for a majority of nursing home care.
Read more – https://morningconsult.com/wp-content/uploads/2016/07/Final-Letter-to-CMS-on-LTC-Rule-July-2016.pdf
Will Consultant Pharmacists Become Pharmacogenomics’ Biggest Ally?
Blair Green Thielemier, PharmD, is an independent consultant pharmacist. She is the founder of Pharmapreneur Academy. More information about Dr. Thielemier can be found on her website at BTPharmacyConsulting.com
Pharmacy Times, published online, Friday, July 15
Although the goals of pharmacogenomics testing are lofty, they have the potential to change pharmacists’ practice. Reductions in trial-and-error medication costs and the number of patients on ineffective therapy could also save the US health system countless dollars.
So, why haven’t more practitioners and pharmacists embraced pharmacogenomic testing? The reason is multifaceted:
- We need to better identify patients who can benefit from it the most, specifically those with clinical concerns like dementia and pain.
- Practitioners are concerned the availability of testing data would render them more liable when injury occurs from an adverse drug reaction.
- There’s confusion about billing, ease of program implementation, and training to guide pharmacists and physicians through the process of interpreting test results.
However, I believe each of these issues can be solved by a single source: a consultant pharmacist intervention.
A consultant pharmacist can identify at-risk patients, work with their physicians to manage test results, and offer ongoing medication therapy management services afterwards. The consultant pharmacist can also decipher pharmacogenomics test results to determine whether patients have the proper enzymes to metabolize their medications.
One of the biggest barriers to implementing preemptive pharmacogenomic testing is reimbursement. Fortunately, there’s a company called PGx Medical specializing in serving the long-term care (LTC) market.
PGx Medical has been working with pharmacists since 2010 to provide these services under a Medicare-reimbursement model in the field of aging services. The company aligns current and future medications with each patient’s unique genetic profile, and then seamlessly integrates the pharmacogenomic information into the consultant pharmacist’s workflow.
Patients receiving care from LTC consultant pharmacists and physicians focused on LTC are identified and assessed through a Metabolic Validation Program. This means dollars aren’t wasted on unnecessary tests for low-risk patients—another common barrier to pharmacogenomic testing.
Part of the process is identifying a patient during normal medication reconciliation, and then recommending a physician order or standing test protocol. Once the physician orders pharmacogenomic testing, the patient is swabbed and the results are returned to the consultant pharmacist, who would then work with PGx Medical to view results and receive training on interpreting them. Finally, an implementation plan is put in place, and recommended changes are communicated to the ordering physician. Meanwhile, the consultant pharmacist has the patient’s results to refer to in the future as new medications are added.
It makes sense to entrust the health care professionals with the most training in the absorption, distribution, metabolism, and excretion of medications with patients’ pharmacogenomic data. As more pharmacists begin offering pharmacogenomic testing as part of their normal operations, personalized medicine will become more prevalent, and the need for companies like PGx Medical will become paramount.
For more information on pharmacogenomic testing, contact: PGx Medical, 405-509-5112 or info@pgxmed.com.
– See more at: PharmacyTimes.com