DNA Today Newsletter15

Feb 23
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An Alternative to the Hype of the HIMSS16 Show Floor

By DNA Today Newsletter, Events, News, Pharmacogenetics, Profile, Spring 2016

Dave Garets,

Healthcare IT industry analyst

I know what you’re thinking: “Garets is mouthing off again. Thank goodness he doesn’t do it more than once a year.” Last year about this time I blogged about what you’d see at HIMSS15. Now I’m going to suggest something you ought to check out at HIMSS16 beyond the blather about BI/analytics/big data, population health, patient engagement and next generation revenue.Dave Garets Biog

The industry has been taking a breather after slamming in all the EHRs, and trying to buy some time for the BI/analytics and population health solutions to mature and those markets to shake out. That shake-out most likely hasn’t brought the cream to the top to most CIOs’ satisfaction, and it’s still a risky, hype-imbued proposition to make vendor decisions in those application categories even today. Trust me: You’ll see a gazillion booths at HIMSS16, just like HIMSS15, emblazoned with Donald Trump-like assertions of superiority in these spaces. Be careful!

So when you get tired of hearing about analytics, pop health, patient engagement and rev cycle (i.e., within 15 minutes of going on the floor the first time), what else is worth a look?

Well, another concept is getting its share of hype, and that’s “precision medicine.” You may be tempted to say that it’s too early to really address precision medicine on a broad scale, but I’d argue not if you focus on pragmatic solutions to today’s biggest healthcare problems.

One of the things I’ve been doing in my failed retirement efforts is to sit on the board of Genelex Corporation, a Seattle-based pharmacogenomics firm. They’re not just one of the leading pharmacogenomics testing labs in the country, but what differentiates them from anyone else in the industry is some powerful software that has been under development since 1997. What it does is go beyond today’s leaders in the drug-drug interaction decision support space by adding drug-gene interactions, and more importantly, adding the cumulative impact of multi-drug/gene interactions. These cumulative interactions make up 37% of the most severe drug interactions and are completely missed by other interaction programs. What that means is that the software can inform the physician or pharmacist that the patient is at significant risk for an expensive or deadly adverse drug event (ADE) caused by interactions that the big boys miss completely. If you were running an ACO and were at risk for care quality, cost and patient satisfaction, would you be interested in technology that did that?

Oh, one of the other things it does is ride on top of population health management applications to analyze an entire population of covered lives to predict which patients are at the highest risk for an ADE and predict how much money you’d save by genetically testing them to avoid the ADE altogether. In November of last year, the results of a clinical trial run by the University of Utah was published in the Journal of Medical Economics that said that the tested cohort in the trial experienced declines of 39% of hospital admissions and 71% of ED visits compared to a matched control.

And one more thing – one of Cerner’s largest clients is running a pilot with the Genelex technology, and the company just announced integration into Epic’s workflow for its clients.

This is a real, practical application of precision medicine that saves lives by helping solve the ADE problem. And one that more than pays its way. Check it out at booth 12147. See you there!

 

Aug 25
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Professor spearheads pharmacogenomics learning program for pharmacists

By DNA Today Newsletter, News, Pharmacogenetics, Profile, Summer 2015

Professor David Kisor saw a need for more pharmacogenomic education for pharmacists, and he wanted to fill it.

Dr. Kisor, PharmD, serves as professor and chair of pharmaceutical sciences at Manchester University’s Pharmacy Program, in Fort Wayne, Ind. He’s long been interested in the field of pharmacogenomics, or how individual genetic differences affect drug response, and has written extensively on the topic.

For the past 10 years, Dr. Kisor said, most pharmacist education has included some information on pharmacogenomics, but inconsistently across different program curricula. Some programs do not including the subject matter at all, he added. This will change in 2016 when the Accreditation Council for Pharmacy Education, which accredits programs leading to the doctor of pharmacy degree, will begin requiring pharmacogenomics as a component of all pharmacy program curricula.

“The problem is, though, we have a work force of pharmacists out there that have had relatively little education on pharmacogenomics,” Dr. Kisor said.

He wanted to help change that.

Dr. Kisor envisioned a pharmacogenomics program specifically tailored for pharmacists. As drug-drug interaction experts, pharmacists are well-suited to learn and apply information about drug-gene and drug-drug-gene interactions, he said.

“When pharmacists learn about this information, they view it and approach it in a similar way to drug-drug interactions,” Dr. Kisor said.

“They have a very clear understanding of the pharmacokinetic and pharmacodynamic implications, and they can apply that to patient care.”

Other efforts have been made to this end, Dr. Kisor said, such as a group based at the University of California San Diego that has a program called PharmGenEd. This program offers pharmacy students and practicing pharmacists online courses and curricula in pharmacogenomics.

More Hands-On

Dr. Kisor, though, wanted something more hands on. So he and colleagues at his university and the Indiana Pharmacist Alliance designed their own.

“We felt that a six-week, 20-hour program capped off with a whole day of live interaction with simulated patients would give pharmacists more experience at applying pharmacogenomics,” Dr. Kisor said.

As far as we’re aware, this 20-hour program is the first of its kind.”

The program, which wrapped up in mid-2015, included 13 hours of self-study and seven hours of live sessions where pharmacists interviewed volunteers serving as simulated patients. The pharmacist discussed the patient’s medical “chief complaint” and symptoms. They were then expected to review simulated medication regimens and pharmacogenetic test results to arrive at a diagnosis.

“And, across the board, they were able to take that information and apply it,” Dr. Kisor said.

“When the pharmacists met with the simulated patients, they were able to utilize reference materials and [pharmacogenetic] guidelines to appropriately make recommendations for those patients, so it gave them a lot of confidence.”

Information Vital to Pharmacists

Twenty-four pharmacists or pharmacy students signed up for the course, Dr. Kisor said, and the vast majority had nothing but good things to say about the program. Of the 17 pharmacists that took the after-course survey, all agreed they would apply what they learned in their individual practices.

“It was successful from the standpoint of having a number of different types of practitioners there. We had community pharmacists, we had hospital pharmacists, and we had long term care pharmacists,” Dr. Kisor said.

With this program’s success, Dr. Kisor said there are plans for more. A number of pharmacists had reached out to him after the registration deadline passed asking when the next one would be.

“There are plans through the Indiana Pharmacist Alliance, and even other avenues, to expand and broaden the program to more pharmacists,” Dr. Kisor said.

Dr. Kisor said pharmacogenetic information is vital for pharmacists to learn and apply to the comprehensive medication reviews they already provide patients. Pharmacists also have a role to play in educating both patients and other healthcare providers on the importance of genetic differences on drug response, he added.

“I think pharmacists need to not only be educated about pharmacogenomics, but they also need to be the ones to educate others about pharmacogenomics,” Dr. Kisor said.

“With the increased interest in pharmacogenetic testing, questions are going to be coming from patients. “And because pharmacists are the most accessible healthcare provider, they are the ones that are going to see a lot of these questions.”

Want to hear another pharmacist’s perspective on pharmacogenomics? Check out Genelex’s own Rachel Sass’ take on in the issue at “The Pharmacist’s Corner.”

Jun 17
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Genelex associate lab director follows life-long passion for pharmacogenetics research

By DNA Today Newsletter, Genelex News, News, Pharmacogenetics, Profile, Spring 2015

As a 12 year-old-boy in India, Ranjit Thirumaran, M.Pharm, PhD, saw the toll adverse drug reactions can take firsthand.

Following hospitalization after a minor accident, his uncle suddenly died, likely due to an adverse drug reaction from a recently administered dose of warfarin.

“I was always curious: Could something have been done to save him?” said Dr. Thirumaran, Genelex’s associate lab director.

“Over time when I learned about the pharmacogenetics field, it kind of thrilled me,” he continued. “Using molecular data to tailor drug therapy to the individual patient, in order to maximize therapeutic benefit and to minimize adverse events.”

This interest ultimately brought Dr. Thirumaran into the field of genetics. With a Master’s in Pharmacy from Birla Institute of Technology, one of India’s most prestigious institutes, already under his belt, Dr. Thirumaran received an international PhD program fellowship from Helmholtz International Graduate School for Cancer Research in 2004.

He earned his PhD in molecular genetic epidemiology in 2006 from the German Cancer Research Center, Germany’s largest biomedical research facility. Here his research focused on the genetics of skin cancer and resulted in 13 international publications.

Pharmacogenetics, or the genetic basis of variability in drug responses, was Dr. Thirumaran’s next field of study. He began his post-doctoral fellowship at St. Jude Children’s Research Hospital in Memphis, Tenn, in 2007. He eventually became a staff scientist, where he published pharmacogenetics and drug metabolism research.

A key area of research for Dr. Thirumaran was his work on genetic predictors of human CYP activity (the family of liver enzymes that metabolizes many common medications), including a few original discoveries in this field. His research on vitamin D receptor gene variants as predictors of intestinal CYP3A4 expression, and that CYP3A4 intestinal expression varies seasonally,  won him Best Research Presentation at the 17th International Society for the Study of Xenobiotics conference.

After seven years at St. Jude, Dr. Thirumaran decided it was time for a change of scenery and wanted to continue his passion for pharmacogenetics in Seattle. He had visited the Emerald City twice before and thought now would be a good a time as any to move to a place that had grown on him.

“I just fell in love with this place,” he said of Seattle. “I like the weather (I am a pluviophile – a lover of rain), the mountains, the lakes, the parks, the eclectic neighborhoods, the beaches. I like the energy here.”

With a new home in mind, Dr. Thirumaran now needed a new job. He wanted to venture into the clinical, rather than the research, side of pharmacogenetics and began his search for Seattle-based labs.

“When I looked for pharmacogenetics companies in Washington state, Genelex was kind of the premiere place,” he said, adding that he turned down a research position in Chicago.

Dr. Thirumaran began at Genelex in October as associate lab director, where he works directly under Dr. Tia Aulinskas, the company’s chief science officer and co-founder. He directly supervises laboratory administrative support, clinical trials project groups, the publications committee and assists Dr. Aulinskas with oversight of the technical lab group.

Through it all, Dr. Thirumaran remembers what first made him interested in clinical pharmacogenetics and feels fortunate to be part of the field.

“The thing that’s inspiring, or that I enjoy in this field is getting the right dose of the right drug to the right patient at the right time and seeing the patient’s quality of life improve,” he said.

“When you can actually see significant improvements in a patient’s quality of life;  that makes me feel as if you did something for the patient’s benefit. That’s one thing I always enjoy.”

Jun 17
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Gauging the IMPACT of pharmacogenetic testing

By DNA Today Newsletter, Genelex News, News, Pharmacogenetics, Spring 2015

Update: The results of this research are in! Find out more here.

How can pharmacogenetic testing improve care for elderly patients taking multiple medications?

Genelex is trying to find out.

As a pioneer in the field of personalized medicine, Genelex, the creators of the YouScript Personalized Prescribing System, is continually investigating ways to further research on the benefits of pharmacogenetic testing.

The Seattle-based company is sponsoring the IMPACT study, a prospective, non-interventional, multisite observational study assessing the benefits of pharmacogenetic testing among elderly polypharmacy patients with principal investigator Dr. Diana Brixner, PhD, RPh. Dr. Brixner is Professor and Chair of the Department of Pharmacotherapy at the University of Utah College of Pharmacy. IMPACT stands for Improving Medication Protocols and Abating Cost of Treatment.

Polypharmacy patients are often most at risk from adverse drug events, which the Centers for Disease Control and Prevention estimate cost $3.5 billion annually in extra health care costs. Pharmacogenetic testing helps reduce these side effects by allowing doctors to tailor medication regimens to a patient’s DNA.

The three-phase study seeks to demonstrate the benefits of pharmacogenetic testing via YouScript among elderly polypharmacy patients. The research will also assess the impact of recommendations for medication changes on clinical decision making, patient outcomes, and health care resource utilization to determine which medications, specialties, or patient segments derive the greatest benefit from this intervention.

Click here to find out more about the study on ClinicalTrials.gov.

Jun 17
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NIH panel: Patient-centered approach needed for pain management

By DNA Today Newsletter, News, Personalized Medicine, Spring 2015

Those suffering from chronic pain need individualized care strategies to be best served by their physicians, according to the recent findings of an expert panel convened by the National Institutes of Health (NIH).

“Persons living with chronic pain have often been grouped into a single category, and treatment approaches have been generalized with little evidence to support this practice,” said Dr. David Reuben, panel chair and professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles, said in a NIH news release.

“Chronic pain spans a multitude of conditions, presents in different ways, and requires an individualized, multifaceted approach.”

The eight-member panel reported that chronic pain is most often treated with opioids, though long-term studies supporting the effectiveness of this course of treatment related to pain, functionality or quality of life are lacking. The panel also recommended more research be done on the long-term safety of opioids and as well as multidisciplinary approaches to pain management that do not rely predominantly on opioids.

“We have inadequate knowledge about treating various types of pain and how to balance effectiveness with potential harms,” Dr. Reuben said. “We also have a dysfunctional health care delivery system that promotes the easiest rather than the best approach to addressing pain.”

Chronic pain affects more Americans than diabetes, heart disease and cancer combined, according to the NIH, and is cited as the most common reason Americans access the health care system. Approximately 76.2 million Americans, or one in every four, have suffered from pain that lasts longer than 24 hours.

The panel’s recommendations highlighted several areas of promising research, including using individual patient genetics in tailored pain management. Since most opioids are metabolized by highly variable CYP450 enzymes, response to painkillers can vary greatly from patient to patient.

For example, patients reporting little or no relief from opioid painkillers may seem to a provider to be addicted and simply seeking more. However, in some patients with specific genetic variants, the body’s slower formation of a painkiller’s more active component can lead to tolerance, despite inadequate pain relief, and cause the inappropriate labeling of a patient as a drug seeker.

Learn more at youscript.com about how the YouScript Personalized Prescribing System allows physicians to personalize prescribing for their patients.

Mar 04
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Mixing old and new: House-call doctor uses cutting-edge technology in patient care

By DNA Today Newsletter, News, Winter 2015, YouScript Software

As a physician whose sole business is house calls, Devang Patel, DO, racks up quite a few miles seeing patients in the Plainfield area of Illinois.

Dr. Patel begins every morning with a paper printout of his patient roster for the day, and more than a little technology. With his laptop and medical supplies in his car and the morning’s first patient address punched in to his GPS, Dr. Patel is ready to begin his day as a 21st century house-call doctor.

Dr. Patel’s desire to stick to house calls developed during his residency, when the idea of working in a clinic began to make him feel boxed in. After a stint at a practice that allowed him to do house calls, Dr. Patel said he fell in love with this truly personalized method of patient care.

Dr. Patel is board-certified in family medicine and focuses on geriatric care. His main goal is preventing hospitalizations in a patient population that he says is typically on four or more medications on a chronic basis—exactly the sort of population that would benefit from the YouScript Personalized Prescribing System.

“At first it felt unreal,” Dr. Patel said of the idea of YouScript drug-sensitivity testing.

“Genetic testing? I don’t have time to sit there figuring out, going through basic pharmacology for every single medication out there.”

But Dr. Patel said he soon learned the benefit of the technology, particularly the wallet-sized card his patients get and carry with them to show during a hospital stay or visit to a specialist. The card, included with the patient’s test results, lists variations in that patient’s enzyme-coding genes that will have an impact on drug metabolism.

“If they’re normal metabolizers for everything, we’re fine, and I don’t have to say anything special,” Dr. Patel said.

“But if they’re ultra-rapid or slow metabolizers of any one of the [gene] systems, which are commonly used as metabolic pathways, I tell them, ‘This is very important. Keep it next to your Medicare card. Make sure that wherever you go, if you’re [seen] by another doctor, tell them to look at that.’”

For most of his patients, Dr. Patel said he uses the companion YouScript software to review medications they may have been on for a long time and see if their genetics might put them at risk for any potentially serious drug-gene or drug-drug-gene interactions. Dr. Patel would then use YouScript’s alternative medication feature to see if other similar drugs could reduce that risk.

It’s this extra layer of protection, achieved through the use of technology, that allows Dr. Patel to optimize patient care while practicing the increasingly rare art of house-call medicine.

“Medication-related errors and adverse reactions [are] one of the most common reasons for hospitalization,” Dr. Patel said.

“[That] goes into our core philosophy; we want to prevent [those]. So anything we can do in anticipation is good.”

Mar 03
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2014 concludes with multiple accolades for Genelex

By DNA Today Newsletter, News

The year 2014 ended on a positive note for Genelex, with multiple publications bestowing the company with six awards or accolades for business growth and technological advancement.

In November, Inc. magazine included the Seattle-based company at the number 10 spot in its list of the top-10 fastest-growing private companies in Seattle. Genelex was the only healthcare software and genetic testing company included on the list.

“I could not be prouder of our team at Genelex, who works tirelessly every day to provide patients with the safest and most effective medicine that science can currently give them,” said Genelex Chief Operating Officer Kristine Ashcraft.

“It is gratifying to know that our dedication to our mission is being rewarded with such stellar growth.”

In September, Seattle Business magazine recognized Genelex’s progress toward eliminating adverse drug events with a silver award in the health category of the magazine’s 2014 Tech Impact Awards.

“The company’s effectiveness in tackling [adverse drug events] has made it one of the fastest growing private companies in the Puget Sound region ­– and perhaps one of the most beneficial, Seattle Business editors wrote in their October edition”

In October, the Puget Sound Business Journal ranked Genelex 47th in its 2014 list of the fastest growing Washington companies. It was Genelex’s third inclusion on the prestigious list since 1995, and second consecutive listing.

Earlier in 2014, Genelex was also included on Inc. magazine’s list of the 5,000 fastest growing private companies in the U.S. at number 1,104 and ranked at the 35th spot on Seattle Business magazine’s 2014 list of the best midsize Washington companies to work for.

Mar 03
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The Future: Pharmacogenetics in Primary Care

By DNA Today Newsletter, News, Pharmacogenetics, Winter 2015

primary carePrimary care physicians are in a prime position to advance the continued implementation of pharmacogenetic testing to improve patient care, according to a review article in the journal Primary Care Reports.

The article, which appeared in the October issue of Primary Care Reports, makes the case that primary care physicians are ideally positioned to advise patients in a manner that will make pharmacogenetic, or drug-sensitivity, testing more clinically useful. The authors write that not only are the vast majority of prescriptions written in the primary care setting, but that an estimated 60 percent of adverse drug events (ADEs) take place in the primary care setting. ADEs, defined as any injury resulting from drug use, contributed to an estimated 13.5 million patient visits between 2005 and 2007.

The review article’s authors report that education for primary care physicians on pharmacogenetic testing is an important first step in expanding the use of this technology, citing two published surveys that found a marked lack of self-reported understanding of this testing among primary care physicians. Creating protocols to determine which patients would most benefit from pharmacogenetic testing will also be a key consideration for primary care physicians.

“Despite significant barriers and pitfalls, creating solid protocols for implementation will yield optimal results for physicians and patients as genetic information takes a more prominent place in patient care,” the review article authors conclude.

An online CME course through AHC Media focusing on this Primary Care Reports article is available and costs $33.75 for those who do not subscribe to the journal. Learn about what credits are offered through the course, read the article and take the test via the Genelex resources page here.

The article was co-authored by Genelex regional pharmacist liaison Brian Hocum, PharmD, CGP.

Nov 18
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All that wheezes is not asthma: Doctor uses YouScript to solve puzzling patient case

By Case Studies, DNA Today Newsletter, Fall 2014, News, Personalized Medicine

As cardiopulmonologist Mark Pamer, DO, goes about his day at his South Florida practice, one adage from medical school that sticks in his mind is: “All that wheezes is not asthma.”

“[As doctors], we probably all heard that. Did we understand it? You know, probably not,” said Dr. Pamer. “We understood it later on in residency or fellowship or in life.”

This adage proved itself during Dr. Pamer’s treatment of a puzzling patient case involving a 59-year-old man who came into his practice with all the classic signs of asthma. It was worse in the winter and around animals, and included nasal congestion. The patient also had history of gastroesophageal reflux disease (GERD) also known as acid reflux, hypertension, irritable bowel syndrome and tremors.

The patient was on multiple medications, including fluticasone/ salmeterol (Advair) for asthma, dexlansoprazole (Dexilant) for GERD and primidone (Mysoline) for tremors, in addition to a rescue inhaler.

The patient came to Dr. Pamer complaining of worsening asthma symptoms, so the dose of Advair was increased. A month later, the asthma symptoms had not changed. Pulmonary function tests and chest x-rays simply did not point to asthma.

Dr. Pamer stopped the Advair and had the patient evaluated for asthma-mimicking states, which can include acid reflux. These tests showed the patient’s reflux was not being controlled by the Dexilant, which is metabolized by the highly variable CYP2C19 enzyme pathway.

Fortunately, Dr. Pamer knew the value of the YouScript Personalized Prescribing System in figuring out tough cases. Genotyping and YouScript analysis revealed the patient to be a CYP2C19 rapid metabolizer, which was predicted to decrease the blood levels of Dexilant.

Primidone, being an inducer of both CYP2C19 and CYP3A4, was likely decreasing Dexilant blood levels even more. Together, these factors resulted in a clinically significant increase in Dexilant metabolism and a decrease indrug effectiveness.

This analysis, in combination with a 24-hour pH probe on the patient, revealed his asthma symptoms were actually a result of acid reflux. The reflux, in turn, was the result of both the patient’s genetics and a drug-drug interaction that was drastically reducing the blood levels of Dexilant.

“I wouldn’t have learned any of this from talking to him,” Dr. Pamer explained. “It just seemed that he had horrible asthma.”

After Dr. Pamer consulted with the patient’s neurologist, the 59-year-old was titrated off primidone. Additionally, his Dexilant was replaced with rabeprazole (Aciphex), which is not as dependent on the CYP2C19 pathway for drug metabolism. The patient’s “asthma” was controlled, and his cough went away.

“I’ll tell you that your knowledge base improves exponentially once you start to use this test,” Dr. Pamer said of YouScript.

Nov 18
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Study: Pharmacogenomic knowledge gaps persist among physicians

By DNA Today Newsletter, Fall 2014, News, Pharmacogenetics

More work seems needed to better familiarize physicians with the concept of pharmacogenomic testing, according to the results of a recent study.

The study in the August edition of Pharmacogenomics and Personalized Medicine found that just 12.6 percent of the 300 physicians surveyed strongly or somewhat agreed with the question, “How familiar are you with pharmacogenomics?”

Study authors Johansen Taber and Dickinson report this study gels with past research on physicians’ familiarity with pharmacogenomics, such as a 2012 survey of more than 10,000 physicians that found only 10 percent of respondents felt they were adequately informed about the applicability of genetic testing to drug therapy.

Despite the 12.6 percent figure, Johansen Taber and Dickinson found that, after being presented with a definition of pharmacogenomics, 37 percent of physicians they surveyed reported being confident in their knowledge about the influence of genetics on drug therapy. This suggests that few physicians may be aware of what pharmacogenomics refers to, the study authors write.

“Pharmacogenomics” is often used to describe the broader study of how genes affect drug therapy and response. “Pharmacogenetics” is generally used to describe testing for specific gene variants that could have an impact on drug response.

Johansen Taber and Dickinson surveyed physicians in primary care, cardiology and psychiatry because these specialties collectively care for a wide variety of patients.

Nearly 20 percent of respondents said they had ordered a pharmacogenetic test during the last year, with 49.7 percent responding that they anticipated ordering a pharmacogenetic test in the next year. For those physicians that had not ordered tests and did not plan to, the most common reason for not doing so was not knowing which tests to order.

Though nearly half of respondents anticipated they would order a pharmacogenetic test in the next year, a quarter named a test not related to pharmacogenomics when asked what test they predicted ordering. This underscores the notion, the study authors write, that physicians may not understand the term “pharmacogenomics.”

When asked what should be included in an ideal pharmacogenomic educational resource, almost identical majorities said they would like to learn how to interpret pharmacogenetic results (88.4 percent) and learn recommendations for prescribing (88.1 percent.).

The authors conclude that more educational resources, ideally web-based and integrated into a physician’s daily work flow, are needed. Through the YouScript Personalized Prescribing System, providers have both web-based and live pharmacist support at their fingertips to help interpret pharmacogenetic test results.

Learn more about YouScript here. Genelex has also partnered with accredited institutions to offer continuing education on pharmacogenetics.