Pharmacogenetics Testing: Smart Medication Management

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Garrett Huxall, Pharm.D, CGP, FASCP Executive Director, PharmCareOK

As a pharmacy consultant with over 20 years of experience and now nursing home owner, I understand that medications and their side effects can critically impact a patients’ care. To aid physicians in their management and choice of medications for various disease states, I have been utilizing pharmacogenetics testing and it allows me to recommend proper medication therapy more quickly and accurately.   The tool from PGx Medical replaces the “trial and error” process consultants cannot afford in a nursing home setting.

I have numerous stories on how a pharmacogenetic (PGx) test report impacted my dosage recommendation or regimen changes. However, small adjustments in dosage or selection of a new pharmaceutical agent with guidance from the PGx report, have lead me to now select medications that can be properly metabolized. Where in the past, I would have just gone to the next drug and hoped for a better outcome.

Below are three case studies I have written:

Case Study #1 – [88 year old female Alzheimer patient that was on Aricept, Namenda and Zyprexa because she was frequently falling]. After getting the pharmacogenetics (PGx) test report, we determined she needed a few med changes based upon her genetic profile. There were certain mutations within her system that were not allowing the medication to provide therapy.  With the physician’s approval, we immediately transitioned her to a different drug, Geodon. She responded very well to this medication.  Now, we have even been able to reduce her dosage of Geodon and she has not fallen since.  This is a great outcome as she is on a lower dosage of medication than she was prior to us using the pharmacogenetics test results.

Case Study #2 – [Male patient, multiple med, pain regimen not providing therapy]. This patient was on Lortab, Asprin and an NSAID for several months. Patient continued to complain of strong pain and medication dosages were increased with no effectiveness in pain reduction. Upon requesting a pharmacogenetic test, patient was placed on Dilaudid. Once we reviewed the test results, we were able to lower his dose of Dilaudid, twice daily while continuing with Asprin.  Before the test he was taking Lortab, Asprin and an NSAID. We reduced the patients’ pain medications by 50% and he is doing much better. In reducing the medications by 50% we are also helping to eliminate many of the complications often associated with heavy dosages and large regimens of pain medications. We were also able to reduce the cost of treatment to medicare for this patient.

Case Study #3 – [Male LTC resident on multiple medications]. This patient was only on Allopurinol and was then prescribed Lipitor and had a reaction. They thought his reaction was more of a psychotic reaction so they prescribed him Geodon. The patient had a severe reaction and tried to strangle his father. He was then admitted to a Psych Hospital. We then ordered a pharmacogenetics test to determine if his body could even metabolize the medications.  By the enzymes we found, the Geodon or any of the new atypical drugs weren’t going to work for him.  So we put him on Thorazine and got him calmed down.  We then started reducing the Thorazine and now the patient is back on Allopurinol for gout and that is the only prescription medication he is taking. Great outcome!

Previously, without the PGx testing results to guide us, this change may have taken several different methods and a longer time frame to achieve results. It was very reassuring and validating to me that we were able to intervene on a much quicker basis and helped, which is a benefit to the clinical team and the medical director.

Educating the clinical team and medical directors at the facility on the value this tool provides is crucial, as there is no out of pocket costs for residents covered by medicare (and medicaid in select states). It’s important to reassure residents and family members that the medications they are taking are the most appropriate and able to provide proper therapy. A less medicated, cognizant, mobile resident allows for the home to be more efficient and profitable.

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

Proactive Pharmacogenetics: Standard of Care

Personalized Medicine has the potential to change fundamentally how health care is practiced.

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Proactive Pharmacogenetic Testing as a Standard of Care

In a case study by PPMI regarding St. Jude Children’s Research Hospital, they stated, “Our philosophy is that pharmacogenetic tests results should be a part of the EMR prior to drug prescribing. If a genetic test is ordered at the time a drug is prescribed, clinicians must wait for the test results, which are often only available after the patient has already started therapy. A pre-emptive approach allows time for the reporting and interpretation of genetic test results so that the information is available to guide clinicians making drug therapy decisions.

Pharmacogenetics has existed since the 1950s and genetic testing to guide the safe and effective use of medication, is finally becoming standard of care in many health institutions.

With the adoption of EMRs, it is now easier then ever to include pharmacogenetic data when making point of care therapy decisions.

PGx Medical focuses on the field of aging services to help address clinical concerns such as falls, dementia, sleep pain and overall staff efficiencies through medication management.  According to research from CMS the use of 9+ medications in elders increases the risk of adverse drug events (2010). Pharmacogenetics can play an important role in effective use of medications by optimizing drug dose, identifying responders and non-responders to medications, and avoiding adverse events by aligning medications with each persons unique genetic profile.

For hundreds of senior communities across the country, this is standard of care.  They perform a simple pharmacogenetic test (swab of the cheek) and with the PGx Medical program, within 48 hours they have a personalized report for that individual allowing them to properly prescribe medications for that individual that their body can metabolize.  This allows the resident to live a more active lifestyle and helps the clinical caregivers be more efficient.

With a tool like pharmacogenetics that is covered by Medicare B, why wouldn’t a healthcare professional include this as standard of care?  Better therapeutic decisions, better quality of life for the resident and a reduction in cost for unnecessary medications, re-hospitalization and a host of other expenses related to adverse drug events.

For more information on how you can implement this no-cost medication management tool into your aging services community, contact:  PGx Medical, info@pgxmed.com or 405-509-5112.

Source:  ashpmedia.org

 

 

 

 

 

Pharmacogenomic Information on Drug Labels

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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

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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?

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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