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PGx in the News

Dangerous Drug Combinations are Missed by Half of Pharmacies

By | Adverse Drug Reactions, PGx in the News, Provider | No Comments

A recent article in the Chicago Tribune “Pharmacies miss half of dangerous drug combinations” discussed their two year study on over 250 pharmacies to determine how often stores would dispense dangerous drug pairs without warning patients. The results showed that more than 50% of pharmacies prescribed dangerous combinations without notifying the patients.
 
According to the article, speed of medication delivery, fatigue and competition are major influences. For instance, one pharmacist said she filled out prescriptions every two seconds, showing pharmacists succumb to the demands of the customer’s, drug warnings are ignored and the prescribers make errors due to fatigue.
 
In response to the Tribune research, CVS, Walgreens and Wal-Mart each stated that they would take “significant steps to improve patient safety at its stores nationwide.” Combined, the initiative would impact 22,000 drugstores nationwide and involve additional training for 123,000 pharmacists and technicians, according to the article.
 
The “warning light fatigue” has implications for drug-gene interactions – the take away is “you can’t exclusively rely on your physician or your pharmacist.” As we look ahead, the Rxight genetic testing solutions and how our customers engage with them, may be more important than we ever considered.

South Dakota Health System Drives Costs Down with PGx Testing

By | PGx in the News, Provider | No Comments

Pharmacogenetic testing is becoming the new frontier in precision medication. It provides critical guidance to physicians when determining the most appropriate therapeutics and optimal dose of medications tailored to each individual patient. Despite the clear benefits of PGx, few health systems have implemented it as there are quite a few hurdles to overcome: convincing insurers to cover the cost, providing rapid turnaround of test results, and collecting more data on the cost effectiveness of a PGx testing program.

 

Avera Health, a health system in Sioux Falls, South Dakota, is finding solution to such challenges. Avera Health’s largest hospital, 545-bed Avera McKennan Hospital and University Health Center in Sioux Falls, performs pharmacogenomic testing on surgery patients to determine how well these patients metabolize opioid pain medications, according to TDR Insider
“Pharmacogenomic Testing a Success at South Dakota Health System” (Jan 2017).

 

For rapid turnaround of the testing, the lab performs genotyping and enters the data into the EMR so that the physician knows how the patient metabolizes medications in a timely manner. Such quick results lead to patients having the appropriate medication within 24 hours and to more data which can be presented to insurers. Our administration recognized the potential of pharmacogenomic testing to improve patient care and to reduce costs through quicker treatment success and fewer adverse effects,” said Krista Bohlen, PharmD, the Director of Personalized Pharmaceutical Medicine at the Avera Institute for Human Genetics. our laboratory reports the test results, then physicians follow the dosing guidelines published by the Clinical Pharmacogenetics Implementation Consortium (CPIC) and Pharmacogenetics Working Group of the Royal Dutch Association for the Advancement of Pharmacy,” Bohlen said. “In addition to these guidelines, we also evaluate primary literature.”

 

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Pharmacy Practice News: “Matching the Right Prescription to the Right Patient”

By | PGx in the News | No Comments

Pharmacogenetic testing is gaining traction as more gene-medication responses are being analyzed and are integrated into patient electronic health records. One of latest examples is the testing of cytochrome P450 2C19 (CYP2C19) and how the drug is used in antiplatelet and other pharmacotherapies.

 

According to  Pharmacy Practice News “PGx Helps Pharmacists Match Right Rx to Right Patient” (Feb 7, 2017), seven major health systems have been testing patients preemptively for cytochrome P450 2C19 (CYP2C19) genotype in patients undergoing percutaneous coronary intervention (PCI).

 

The findings were reported at the 2016 American Heart Association’s Scientific Sessions on behalf of the National Human Genome Research Institute-funded IGNITE (Implementing Genomics in Practice) Pharmacogenetics Working Group investigators, part of a consortium of 16 health systems that have implemented various pharmacogenomics tests to enhance therapeutic decision-making.

 

CYP2C19 Genotyping for Clopidogrel, PPI Pharmacotherapy

 

The most common drug-gene test is clopidogrel and CYP2C19. The IGNITE investigators reported that approximately 31% of patients had a variant that reduces clopidogrel activation and efficacy. More than half of those patients were put on an alternative medication treatment plan as a result. The patients who received a different treatment plan suffered fewer adverse reactions to the medications in comparison to the group that received clopidogrel treatment.

 

Other drug-gene tests include opioids and CYP2D6; thiopurines and thiopurine methyltransferase (TPMT); and simvastatin and SLCO1B1; proton pump inhibitor (PPIs) and CYP2C19.  Testing for PPI metabolism is particularly crucial, as there are a large number of patients receiving PPI pharmacotherapy, according to the article.

 

Pharmacists Play a Central Collaborative Role

 

“Pharmacists are right at the center,” noted James M. Hoffman, PharmD the chief patient safety officer at St. Jude Children’s Research Hospital in Memphis, Tenn, highlighting the collaboration required in integrating pharmacogenetic information to improve drug therapy. “We’re at a very different place than we were, say, five years ago. Now we have many more models of practice, with resources like CPIC (Clinical Pharmacogenetics Implementation Consortium).”

 

Integration of Rxight® PGx Testing

 

The integration of the Rxight® pharmacogenetic testing program into healthcare systems is a goal of MD Labs.  The Rxight® testing model is designed to provide a one-time test of 18 genes and their alleles to guide the patient and treatment team in tailoring pharmacotherapy to the patient’s unique genotype. Specifically, Rxight® analyzes the patient’s genetically modulated metabolism of over 200 medications and 50 clinically significant pharmacological classes including clopidogrel and other anti-platelet drugs, as well as simvastatin, common opioids, and PPIs in order to find the correct dose or a safer more effective therapeutic alternative – thus enhancing safety, reducing costs, and improving patient compliance.

The Human Genome and Era of Personalized Medicine

By | PGx in the News | No Comments

When the first human genome was sequenced early in the 2000’s, there was great hope that personalized medicine would soon become a reality.  The reason for optimism was that as more people had their genomes sequenced, the more data scientists and researchers would have on individual gene variation. It soon became apparent that certain genetic variations are responsible for people’s varied response to prescribed medications. This entails that one patient may handle a specific dosage and frequency of a drug treatment plan appropriately, while another patient may metabolize the medication in a completely different way and suffer severe adverse reactions. These differences are based on each individual’s genetic makeup.  It is this variation that has led to the field of pharmacogenomics, or pharmacogenetics, as it is often called.

 

With advances in gene sequencing techniques in the past five years or more, there has been a tremendous increase in the number of genomes sequenced and studied.  One particularly fruitful area has been the study of variation among humans in drug metabolism genes.

 

Genes are made of DNA.  The DNA sequence of the genes, determines the composition of proteins and enzymes that do most of the work of the cell. Simply put, every unique DNA sequence specifies how that unique protein is made.

 

Every human has drug metabolism genes (made up of DNA) that encode specific enzymes (made up of protein) responsible for metabolism of particular drugs or group of drugs. Through sophisticated techniques, advanced genome-wide studies have allowed scientists to make connections from gene variations (genotype) to specific symptoms due to treatment with a particular drug (phenotype). A simple explanation of the genotype-phenotype relationship is eye color.  You may have brown eyes, so that means your genotype codes for brown eyes, while your phenotype is the observed result of the gene’s expression.

 

Why Pharmacogenetic Testing?

Pharmacogenetics concerns itself with the study of gene variation and its effect on phenotype. The goal is to prevent side effects – phenotypes – that are damaging or dangerous.  In the past, drugs were prescribed by a trial and error process. This method is effective to a certain extent, but it can be costly, patients may suffer adverse reactions…  The study of pharmacogenetics and the process of pharmacogenetic testing, will eventually eliminate the trial and error process of prescribing medicines.

 

Pharmacogenetics testing helps physicians strategically target patient care based on the patient’s genetic code and is ushering in a new era of personalized medicine.  In the future, the promise of pharmacogenetics is to test every individual for drug metabolism gene variations to prevent uncomfortable or harmful side effects so that medicines can be used with more precision. The goal of personalized medicine is to usher in a new era of precision medicine and to strategically target patient care based on the patient’s genetic code.  These advances will help bring patients medicines that are prescribed with a knowledge of how the patients react to the medications.

 

 

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Plavix and genetic testing

University of Maryland Offers Genetic Testing as Standard of Care for Heart Stent Patients

By | PGx in the News, Provider | No Comments

Plavix (clopidogrel) is a blood thinner that is used to reduce the risk of heart disease and stroke.  It is a popular drug and is considered to be safe for most patients. However, there is real risk that patient may not be able to metabolize the drug appropriately, and thus receive no benefit from the medication – or, conversely – suffer adverse reactions to Plavix such as statin myopathy, according to researchers at the University of Maryland, as reported in November at the American Heart Association’s Scientific Sessions in New Orleans.

 

In response to these findings, the University of Maryland Medical Center has launched a program to conduct genetic tests for the liver enzyme CYP2C19 before prescribing Plavix and other medications to patients who have received a heart stent. The enzyme affects the patient’s ability to metabolize the drug. Sixty percent of the patients with reduced CYP2C19 function were given an alternative medication. The result was reduction of the percentage of heart attacks and death by nearly half compared with those who continued taking clopidogrel.

 

Alternative medications, while not statistically as effective at Plavix, were found to be adequate replacements, according to the UMMC researchers.  Thus, the trial and error process was reduced and patient receive the appropriate medication early in treatment.

 

“This is a true personalized medicine initiative,” says Mark R. Vesely, MD, an associate professor of medicine at UM SOM and an interventional cardiologist at UMMC who was a co-investigator of the study. “The test provides the ability to optimize therapy for a specific patient by helping us tailor our treatment based on the patient’s unique genetic profile.”

 

Source:  University of Maryland Medical Center “University of Maryland Medical Center Offers Genetic Testing as Standard of Care to Help Improve Outcomes for Heart Stent Patients” (January 2017).

PGx as Applied to ACS Protocol

PGx as Applied to ACS Protocol: Maximizing CMS Incentive Payments to Hospitals

By | CMS Cardiac Bundle, PGx in the News, Provider | No Comments

 
Anti-platelet pharmacotherapy is an established standard of care for Acute Coronary Syndrome (ACS) to reduce thrombotic risk. Incorporating pharmacogenetic testing and pharmacist engagement into the prescribing protocol allows the provider to understand the patient’s genetic phenotype to help determine whether the patient will achieve the optimal therapeutic outcome – and thus mitigate potentially serious adverse effects or sub-optimal treatment response.
 

Using PGx/ACS Protocol to Enhance Quality-Based Payments

 
The new PGx/ACS Protocol can help maximize CMS quality-based incentive payments. As discussed in Becker’s Hospital Review “How managing medications based on genetics can enhance quality-based payments” (January 17 2017), pharmacogenetic testing can reduce drug-related complications and readmission rates, thus sparing added costs to hospitals and providers.
 
A recent report out of the University of Illinois Hospital & Health Sciences System demonstrated that PGx reduced 90-Day ER and Hospital Readmission Rates by 68% leading to $2,043 savings per patient and almost $600K overall savings to UIC. This becomes even more important as the new CMS Cardiac Bundle takes effect this coming July.
 

Contact MD Labs for Information on the PGx/ACS Protocol and
its Turnkey PGx Testing Program

 
Contact MD Labs for details on the PGx/ACS Protocol and how to implement it with the Rxight® PGx program. A cornerstone of MD Labs’ Rxight® program is incorporating PGx trained and certified pharmacist as part of the protocol, as pharmacist involvement in patient care is proven to help reduce readmission rates.
 
MD Labs’ Rxight® Program provides turnkey implementation and includes pharmacist training in PGx and certification to conduct PGx consultations. Additionally, the Rxight® program is integrated within the hospital lab offerings for establishing collection procedures. DNA test kits are provided by MD Labs, and results are accessible via online provider and patient portals.
 
Assess your hospital’s cost saving opportunity by calculating the 90-day hospital readmission costs due to drug-related complications (clopidogrel and coumadin), over the last 3 years. Call MD Labs at 1-888-888-1932, or email info@Rxight.com to get started. Rxight.com

Mitigating the Dangers of Statin Myopathy with PGx Testing

By | PGx in the News | No Comments
  • Statins are the most commonly prescribed drugs in the United States and are extremely effective in reducing major cardiovascular events in the millions of Americans with hyperlipidemia, according to recent research in Journal of Pharmacogenomics and Pharmacoproteonomics: “Pharmacogenetics of Statin-Induced Myopathy: A Focused Review of the Clinical Translation of Pharmacokinetic Genetic Variants,” Talameh and, Kitzmiller (2014)

     

    Unfortunately, 25-60% of all users cannot tolerate or discontinue statin therapy due to statin-induced myopathy (SIM), and “[p]atients will continue to experience SIM at unacceptably high rates or experience unnecessary cardiovascular events (as a result of discontinuing or decreasing their statin therapy) until strategies for predicting or mitigating SIM are identified,” according to the research.

     

    A promising strategy for predicting or mitigating SIM is pharmacogenetic testing, particularly of pharmacokinetic genetic variants as SIM is related to statin exposure, the investigators stated, noting that research investments in pharmacokinetic genetic variants have the potential to make a profound impact on public health.” Future directions, specific to the research on pharmacokinetic genetic variants, could speed the translation into clinical practice.

     

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  • NPR: Personalizing Medical Treatment with Genetic Testing Data

    By | PGx in the News | No Comments

    Scientists are now using big data analytics to mine electronic health records for clues as to what treatments work best for different individuals, as discussed in a piece aired by National Public Radio on January 10 2016 “Electronic Health Records May Help Customize Medical Treatments.”

     

    The interview included Dr. Tracy Lieu, who heads the Kaiser Permanente research division in Oakland, Calif., Dr. David Ledbetter, the Chief Scientific Officer Geisinger Health System in Pennsylvania, and Dr. Harlan Krumholz, a professor of medicine at Yale University who researches cardiology and health care.

     

    While computerized medical records are hardly new (they date back to the 1970s), the potential now is that patients can proactively take part in mining the records, and that patients’ genetic information is key to this data mining, Leiu stated.

     

    “Even though this is primarily a research project, we’re identifying genomic variants that are actually important to people’s health and health care today,” Ledbetter added.

     

    Geisinger patient Jody Christ was also featured. She had volunteered to get the genetic screen during one of her routine medical visits, as her doctor had been concerned about her high cholesterol. Her screening – known as exome testing – told her and her providers that she had inherited a genetic trait that elevated her cholesterol. The genetic diagnosis led directly to a series of screenings.

     

    Krumholz is excited at the prospect of being able to look at physical symptoms in medical records and then look for genetic variations that could be responsible. While the system is not yet robust it bodes very well for the inclusion of PGx testing as a vital piece in the customization of patient electronic records.

     

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