Sep 23
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Genelex honored in 2014 Tech Impact Awards

By News

 

Genelex

Genelex’s progress toward eliminating adverse drug events has been honored by Seattle Business magazine with a 2014 Tech Impact Award.

At the September 18 awards event, Genelex was given the silver award in the health category of the magazine’s 2014 Tech Impact Awards. Genelex joins both small and large tech luminaries, including Microsoft and T-Mobile, in being recognized as a technology leader.

“Through its genetic testing and support tools for doctors, Genelex Corporation is out to eliminate the fourth-leading cause of death in America: adverse drug reactions,” Seattle Business editors write in their October edition.

“The company’s effectiveness in tackling the issue has made it one of the fastest growing private companies in the Puget Sound region ­– and perhaps one of the most beneficial.”

Genelex Chief Operating Officer Kristine Ashcraft accepted the award, given during a reception at the Renaissance Seattle hotel.

“As a nation, we spend more on adverse drug events than we do on drugs,” Ashcraft says.

“At Genelex, we are so proud of the impact our software is having in reducing adverse drug events. But the real impact is on the thousands of patients who deserve the safest and most effective medicine that science can give them.”

The YouScript Personalized Prescribing System is designed to help physicians gain a full understanding of their patients’ genetic makeup and help avoid potential harmful drug-drug, drug-gene and drug-drug-gene interactions.

Founded in 1987 as a paternity testing laboratory, Genelex first began offering DNA drug sensitivity testing in 2000 and was a pioneer in this field, being one of the first labs to offer such services. Genelex first added the YouScript software to its testing services in 2007 and has been making strides in improving both since then, such as becoming integrated with the Allscripts electronic healthcare records system.

Read about all the Tech Impact Award winners on Seattle Business magazine’s website.

Sep 22
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New rule offers providers Meaningful Use flexibility

By News, YouScript Software

Health care providers have been granted a bit of flexibility in how they use certified electronic health records (EHR) technology in meeting federal Meaningful Use requirements for 2014.

The Centers for Medicare and Medicaid Services (CMS) have announced that providers will be allowed to use EHR technology certified to 2011 Meaningful Use standards to meet Stage-2 requirements, but for 2014 only. Starting in 2015, providers will only be able to use EHRs that meet 2014 standards to fulfill the Meaningful use Stage 2 requirements.

Stage 1 requirements, which providers could begin meeting in 2011, include implementing clinical decision support tools (such as YouScript Personal Prescribing software) and adding computerized provider order entry systems. Stage 2 focuses on: more rigorous health information exchange, increased requirements for e-prescribing and incorporating lab results, electronic transmission of patient care summaries across multiple settings, and more patient-controlled data.

Despite the new flexibility, the rule released August 29 has apparently not been well-received by all. Forbes reports that the American Medical Association, the Healthcare Information and Management Systems Society, the College of Healthcare Information Management Executives and a handful of other medical industry groups say that the full year of Meaningful Use Stage 2 requirement reporting required in 2015 would be too difficult for providers to meet. The year-long reporting period is a jump up from the 90-day one for the Stage 1 requirements.

The new rule has also sparked proposed legislation from a North Carolina Congresswoman that would shorten the reporting period to 90 days for 2015. The bill’s sponsor, Republican Representative Renee Ellmers, says the bill is designed to help hundreds of thousands of providers meet Stage 2 requirements in an effective and safe manner.

According to CMS data released in June, 264,538 Medicare-eligible medical professionals had attested to the Stage 1 requirements, compared to 106 that had already met Stage 2 requirements. For eligible hospitals, 4,054 facilities had met Stage 1 requirements, compared to four hospitals that had met Stage 2 by mid-2014. For more information on the EHR incentive program and more details on Stage 2 requirements, visit the CMS sites here and here.

Sep 18
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Study finds opioid use common amongst disabled Medicare recipients

By Cytochrome P450, News, Pain, Pharmacogenetics

A recent study illuminates the prevalence of opioid painkiller use in a particularly vulnerable population: disabled Americans on Social Security disability insurance.

The article, published in the September edition of the journal Medical Care, found the percentage of Social Security disability insurance (SSDI) recipients younger than 65 receiving any amount of opioid prescriptions rose from 43.9 percent in 2007 to 44.7 percent in 2010, with that figure dipping in 2011 to 43.7 percent.

Study authors Morden et al. reported a steadier rise in what they defined as “chronic use” of opioids (six or more prescriptions filled per year): 21.4 percent in 2007 increased to 23.1 percent in 2011.The authors called the chronic use trend “…worrisome, in light of established and growing evidence that intense opioid use to treat nonmalignant pain may not be effective and may confer important risks.”

The study’s findings are consistent with growing evidence of what some have called an “opioid epidemic” in the U.S. The Centers for Disease Control and Prevention report that 46 people die per day from an overdose of prescription painkillers. Of 22,810 deaths related to pharmaceutical overdose in 2011, 74 percent involved opioid painkillers.

Morden et al. focused on SSDI recipients because growing numbers of Americans are applying for – and receiving – these benefits. The authors report that musculoskeletal conditions, such as back pain, are often treated with opioid pain relievers. In 2011, these conditions were the most common SSDI-qualifying diagnoses, accounting for 33.8 percent of program participants (up from 20 percent in 1996).

The authors write that this shift in the makeup of disabling conditions, combined with increasing national trends in prescription opioid use and overdose deaths, “suggests the potential for substantial opioid use in the SSDI population and raises concern for the overall health and safety of these injured and ill workers.

“Although the best approach to pain management and opioid analgesic prescribing, in particular, are debated,” Modren et al. write, “intense chronic opioid use for non-malignant pain is increasingly recognized as ineffective and potentially hazardous to individuals and to the public.”

In addition to the figures on overall prevalence, the study showed that median daily morphine equivalent doses (MEDs) amongst SSDI recipients per recipient increased overall from 9.8 mg in 2007 to 11 mg in 2010, dropping down slightly in 2011 to 9.9 mg.

Average daily doses remained intense in the growing population of chronic users, with 20 percent of chronic users getting 100 mg of MEDs or more and 10 percent reaching or exceeding 200 mg of MEDs. Studies cited by Morden et al. show that opioid use of this intensity has been associated with risk of overdose death in the general U.S. population.

The study’s authors call for Medicare administrators and clinicians to develop pain management strategies for addressing opioid painkiller use in disabled Medicare recipients, individuals who often already suffer a high burden of illness, injury and low incomes.

When it comes to pain management, prescriber knowledge of DNA sensitivity testing’s role in predicting opioid effectiveness is crucial. An understanding of potential drug-drug interactions is also key, as the study found that about 38 percent of SSDI recipients defined as chronic opioid users also suffered from depression. This raises the possibility of pain medications and anti-depression drugs interacting and decreasing drug effectiveness, causing potentially harmful adverse drug events, or both.

YouScript Personalized Prescribing software can help take some of the uncertainty out of prescribing by identifying drug interactions in a patient’s regimen and suggesting alternatives. YouScript can also identify potential drug-gene and drug-drug-gene interactions when teamed with testing of the body’s highly variable cytochrome P450 pathways. Learn more about how these tools can help here.

Sep 11
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Meaningful Use requirements linked to fewer adverse drug events

By Drug Interactions, News

The use of health information technology enhancements, such as clinical decision support tools, can help reduce adverse drug events (ADEs) in hospitals by between 27.3 and 69.2 percent, according to a recently released study of Florida hospitals.

The research scrutinizes what impact Meaningful Use (MU) requirements for implementing electronic health records (EHR) systems had on patient care, and the results seem to be promising for supporters of health information technology improvements.

In addition to a reduction in ADEs, the study found a perhaps more telling trend: hospitals with physicians who resisted the introduction of the MU requirements examined in the study saw a 14.3 percent increase in ADEs. By comparison, hospitals with no physician resistance saw a 51.7 percent decrease in ADEs.

In the study, Encinosa and Bae looked at 2.4 million Florida hospitalizations from all hospitals in the state in 2010 to determine the impact of five MU requirements related to medication management. These requirements are part of a larger Medicare and Medicaid EHR incentive program that offers payments to providers and hospitals that show they’re using EHRs to improve patient care.

This research joins earlier work of Encinosa and Bae on the costs of ADEs that estimated 55,700 ADEs would have been averted at a savings of $267 million per year if all Florida hospitals had adopted these five MU requirements.

The new study, appearing in the August issue of the Journal Healthcare, considered the following first-stage Meaningful Use core measures that pertain to medication management:

  • Use of computerized ordered entry for medication orders.
  • Implementation of decision support systems for drug-drug and drug-allergy interaction checks.
  • Capability to exchange key clinical information, such as diagnostic test results, among providers electronically.
  • Maintain active medication list.
  • Maintain active medication allergy list.

The study broke hospitals into eight categories that included high and low quality hospitals, facilities with physician resistance, and those that reported the five medication MU measures as major challenges to implementing the larger set of MU requirements.

Those that saw these five requirements as challenging started with the greatest percentage of ADEs before the five measures were implemented. Once the requirements were put in place, these hospitals saw the greatest percentage decrease in their rate of ADEs at 69.2 percent.

At the other end of the spectrum, hospitals described as high quality started with the lowest percentage of ADEs before introducing the five requirements. These hospitals, in turn, saw the lowest percentage decrease in their ADE rate at 27.3 percent.

A key factor of the push to improve health information technology is through the use of clinical decisions support tools, such as YouScript Personal Prescribing software. When used with cytochrome P450 genetic testing, YouScript has the potential to improve patient outcomes and reduce adverse drug events. Learn more about the software here.

Sep 11
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Study: Elderly patients at greater risk of kidney injury if on antipsychotic drugs

By Cytochrome P450, Drug Interactions, News, Pharmacogenetics

New research into the risks of three common antipsychotic drugs for the elderly suggests older patients are 73 percent more likely to experience acute kidney injury (AKI) while on any of the three medications.

The research, published in the August 19 issue of the Annals of Internal Medicine, examined the medical records of nearly 100,000 adults 65 and older who were taking any of three common atypical antipsychotic medications: quetiapine, risperidone and olanzapine.

Authors Hwang et al. report that these three drugs are prescribed to millions of older adults per year worldwide. These medications are frequently used to manage behavioral symptoms associated with dementia, the authors write, though the FDA has advisories issued for each drug warning that such use is associated with increased mortality.

Hwang et al. found that patients who had received a prescription for any one of these three medications in the previous 90 days where 73 percent more likely to be hospitalized for AKI, defined as sudden reduction or loss of kidney function. The drugs were also associated with an increased risk of hypotension, acute urinary retention and death. Hypotension and acute urinary retention (the inability to empty one’s bladder) have both been associated with AKI, the researchers report.

Specifically, patients prescribed these drugs were nearly twice as likely to suffer from hypotension and acute urinary retention (91 percent more likely and 98 percent, respectively) and more than twice as likely to die. With this data behind them, the researchers conclude that their findings support the existing safety concerns about the use of these drugs in older adults.

The research also has broader implications regarding the importance of fully understanding an elderly patient’s genetic makeup. All three of the antipsychotic drugs studied are processed through the body’s CYP450 pathway, making them subject to drug-drug and drug-gene interactions. Genetic variations along these lines could drastically affect how a patient metabolizes these medications and could lead to additional adverse drug events.

For example, a large clinical study in 2005 found that CYP2D6 poor metabolizers had 75 percent higher levels of risperidone in their systems compared to CYP2D6 normal metabolizers. Additionally, the study showed a roughly three-fold increase in adverse drug effects and a six-fold increase in discontinuing risperidone because of an adverse effect in CYP2D6 poor metabolizers compared to normal metabolizers.

Pharmacogenetic testing allows prescribers to discover variations in CYP2D6 and other members of the CYP50 pathway family. Such tests, teamed with YouScript, can help physicians prescribe with confidence once they have a complete understanding of their patients’ genetic proclivities in their charts.

Sep 11
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TCAPP and Genelex: Partners in battling pediatric pain

By News

It’s tragic when a young life is haunted by the specter of a disease that causes chronic pain. Such afflictions affect child and family both, making the availability of caregiver resources all the more vital.

Since 2011, The Coalition Against Pediatric Pain (TCAPP) has been supporting families of children affected by chronic pain from rare diseases and has brought many together to share information and resources. The national nonprofit also raises money to fund research focused on pediatric pain conditions and brings together esteemed medical experts from across the country to share ideas. Advocating for children affected by chronic-pain-causing diseases and educating the public at large about the long-term consequences of pediatric pain are also key goals of TCAPP.

The nonprofit was founded by families of children living with chronic neuropathic pain diseases, such as Reflex Sympathetic Dystrophy/Complex Regional Pain Syndrome (RSD/CRPS), Ehlers Danlos Syndrome, muscle spasms, migraines, abdominal migraines and painful gastrointestinal conditions. All of the founding members’ children have RSD/CRPS, in which high levels of nerve impulses are sent to an affected site on the body, and many suffer from multiple conditions.

TCAPP began working with Genelex in 2012, says Aurora Richards-Stipnieks, DVM, treasurer and board member of the nonprofit. The relationship began after Barbara Granoff, a founding board member of the nonprofit, used the DNA drug sensitivity testing Genelex provides to better map a drug regimen for her daughter, Shira, who is living with multiple chronic pain-causing diseases.

More information about Shira’s genetic makeup allowed her physicians to help ensure that medications she took did not accumulate in her body, possibly leading to adverse drug reactions, and helped them choose pain medications that work more effectively. This led to Shira having more trust in her medication routine, and ultimately, improved medication outcomes. Learn more about Shira’s story here.

Since then, Genelex has helped TCAPP raise almost $2,000 in donations for TCAPP through demonstrations of the YouScript Personal Prescribing System at two major medical specialty conferences, Richards-Stipnieks says. This is in addition to other Genelex contributions, such as working with TCAPP on their annual Think Tank events. These bring pediatric and adult medical experts together to share information and brainstorm ways to offer better treatment to children suffering from chronic pain.

Learn more about the Think Tanks here, and find out more about TCAPP’s mission and how to donate here.

Sep 11
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Participating in life again: A patient story of pediatric pain

By Case Studies, News, Personalized Medicine, Pharmacogenetics

 

Barbara Granoff, Founding Member of The Coalition Against Pediatric Pain (TCAPP), says her 15-year-old daughter’s life was changed by the DNA drug sensitivity testing Genelex offers.

Shira is living with Ehlers Danlos Syndrome as well as dysautonomia, gastroparesis, Mast Cell Activation Disorder and more. “The amount of medications we tried in hopes of controlling the pain is mind boggling,” mother Barbara said. “But even more alarming were the horrible side effects some of the medications produced.”

“There were many times when I felt we had to pick our poison, as the disease was sometimes easier to live with than the side effects. Eventually, I had to say ‘NO MORE’. I wasn’t willing to put her through any new medications, no matter how ‘safe’ they were, until I could figure out why she was having such unusual reactions.”

“Luckily, I came across Genelex and read about their DNA drug sensitivity testing. It’s been a life changer for Shira. Armed with her genetic information, we were able to make educated choices in medications. My daughter has gone from being too sick to attend school to being an honor roll student. We are not without hurdles, but I truly believe that knowing the correct medications to treat her with has helped her to be able to participate in life again.”

The YouScript Personalized Prescribing software integrates pharmacogenetic testing with comprehensive drug-gene and drug-drug interaction information to assess the cumulative impact of a patient’s genetics and drug regimen.  Information, alerts and recommended alternatives are presented in an easy-to-understand, clinically actionable format to assist physicians in personalized pain management for their patients.

Aug 28
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Can the Marriage of Pharmacogenetics and EHRs Solve Adoption Problems?

By DNA Today Newsletter, News

Don’t be intimidated by the idea of starting to use pharmacogenetics in your clinic – the tools you need may already be at your disposal.

The New England Healthcare Institute states that medication management tools such as pharmacogenetic testing can help reduce readmissions and prevent costly adverse drug events. After all, a 2010 study by Davies et al. found that 20% of hospital readmissions were due to adverse drug reactions. However, Stanek et al. found in 2012 that a lack of information, especially about when and how to use pharmacogenetics, was a major barrier to adoption.

But the key to implementation may already exist in your practice.

Are you making the most of your EHR?

Medication management tools can be integrated into existing EHRs and a number of different products are available on the market today. One of the main benefits of integrating pharmacogenetic analysis is the software can evaluate all patient medication regimens and provide the prescriber with notifications of who may benefit from pharmacogenetic testing. Doctors don’t have to become experts in the science of pharmacogenetics, but can rely upon evidence-based analysis and alerts instead.

Medication management programs may also come with other benefits as well. For instance, other benefits of using the YouScript® Personalized Prescribing software can include:

  • Active Analysis: Regular, automatic analysis highlights which patients are at risk for adverse drug events and which patients have known interactions in their drug regimen. Medications sync to YouScript from the patient’s chart in real-time.
  • Automatic Notifications and Recommendations: YouScript looks at scheduled patient appointments and automatically sends a report of high risk patients. Providers are notified when genetic test results are ready for review.
  • Customizable Integration: Each integration is customized to the practice’s workflow to make it easy to incorporate testing and analysis. Options include a configurable requisition form which merges patient information from their chart; adding YouScript to the launch menu; and single-sign on allowing the prescriber to explore and audition new medications before making prescription changes in the EHR.

YouScript is already a certified Allscripts™ EHR Application and is working with several other EHR vendors to incorporate pharmacogenetic analysis into their workflows. If you are interested in integrating YouScript into your EHR, make your request at http://info.youscript.com/integrate.

Aug 28
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Opioid Overdose Continues to Rise

By DNA Today Newsletter, News

A worrisome trend continues. Despite medical and government efforts, opioid-related deaths continue to rise across the country. According to the CDC, drug overdose death rates have more than doubled in the past 15 years and now take more lives than automobile accidents among 25 to 64-year-olds.

Rates of abuse seem highest in white, middle-aged males and translate to a financial burden for the United States of over $50 billion per year. Over half of the deaths the CDC reported were related to prescription medications.

Opioid prescriptions rates vary by state. According to the CDC’s Morbidity and Mortality Weekly Report, the highest numbers seem to be concentrated in the southeast parts of the country, with Alabama, Tennessee and Kentucky topping the charts. Twelve states had more than one prescription per person. Alabama, for instance, had 143 opioid prescriptions for every 100 people.

Opioids are widely used painkillers, but dosing must be carefully monitored due to their addictive qualities. Many patients become addicted to opioids while in the hospital and resort to illicit means to get painkillers once their prescription runs out. Government and private institutions are pushing for changes in opioid prescribing to help combat this trend, including greater access to substance abuse treatment and prescription drug monitoring programs.

Prescribers can also potentially help curb trends by being aware of the pharmacogenetic considerations surrounding opioid medications. Precisely dosing opioid medications can be difficult because many are processed by the highly variable CYP450 family of enzymes, which means other drugs within a patient’s regimen and the patient’s own genetics may influence the opioid’s efficacy, which can, in turn, lead to accidental overdosing.

To learn more about genetically-caused opioid interactions, visit http://genelex.com/clinical-guidance/pain/.

Aug 28
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St. Jude Implements PG4KDS Pharmacogenetic Testing

By DNA Today Newsletter, News

 

One of the biggest barriers to the adoption of pharmacogenetics is uncertainty about implementation, but major institutions are already pursing pharmacogenetics. For instance, St. Jude Children’s Research Hospital just published their pediatric pharmacogenetics program model.

St. Jude Children’s Research Hospital is a pediatric treatment facility located in Memphis, Tennessee that’s famous for its dedication to patient care and its embrace of innovative strategies. They’ve always been interested in personalizing medicine—now they’re implementing a new pharmacogenetics testing program as well.

This implementation is timelier than ever. Mary Relling, PharmD, the St. Jude Pharmaceutical Sciences chair, says in an article, “There are now several medications strongly affected by genetic variation; if we can test patients before they are treated with those medications, we have an opportunity to choose a better drug or a better dose of the drug right from the start.”

St. Jude’s program involves testing CYP2D6, CYP2C19, TMPT and SLCO1B1 and tying those genotypes to twelve high-risk drugs in the EHR. Testing results showed that 78% of children tested had at least one high-risk genotype.

This program is buoyed by a strong support structure, including a Family Advisory Council and Ethics Committee, a Pharmacogenetic Oversight Committee, a clinical pharmacogenetics coordinator and an accredited residency training program. Plans are in place to eventually implement more complex testing processes and at least eight new genes. St. Jude credits their institution-wide support and education programs for their success.

Other well-known institutions that are pursing pharmacogenetics include the Mayo Clinic, Johns Hopkins University, the Cleveland Clinic and Baylor College of Medicine.