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.

Nov 17
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Smart medication management key to fall prevention

By Fall 2014, News, Personalized Medicine

Falls among the elderly are nothing to take lightly.

The Centers for Disease Control and Prevention (CDC) cite falls as the leading cause of both fatal and nonfatal injuries among Americans 65 and older. In 2012, 2.4 million nonfatal falls among this age group were treated in emergency departments, and more than 722,000 of these patients were hospitalized. In 2011, about 22,900 members of this demographic died from unintentional fall injuries.

Multiple government and nonprofit agencies, such as the CDC and National Council on Aging, say effective medication management is an important way to prevent falls and associated injuries. Many people aged 65 and older take multiple medications, thus raising the specter of drug interactions and adverse side effects, such as dizziness, that could lead to falls.

A 2013 case study in the journal Canadian Family Physician told of an 83-year-old woman taking 17 medications who had a history of falling about once per month. A review of her drug regimen and medical history allowed her doctor to slowly titrate her off two of her three cardiac medications.

Adjustments to her pain medications were also made, all of which resulted in a substantial increase in balance, mobility and a reduction in dizziness. Additionally, the patient had no further falls after 10 weeks.

“By assessing each medication for indication, effectiveness, safety, and compliance, we were able to gradually taper and discontinue cardiovascular medications in order to improve balance and reduce fall risk,” the case study authors write.

In a collection of research complied for the National Council on Aging’s 2005 Falls Free National Action Plan, Kathleen Cameron, R.Ph, MPH, lists a bevy of medications classes that can increase fall risk. These include antidepressants, benzodiazepines and cardiac medications, just to name a few.

Cameron writes that changes in cognitive or physical function such as dizziness, lightheadedness or confusion in seniors provide red flags that may signal the need for a complete assessment by a medical professional.

“Medication use may cause these changes and require interventions aimed at medication modification, such as a dosage reduction, drug replacement or drug elimination, to reduce the risk of falls,” Cameron says.

For more information on fall prevention, visit the National Council on Aging’s website or consult the information available on the CDC website.

Nov 14
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YouScript cumulative interactions feature: Unique in healthcare software

By Fall 2014, News, Personalized Medicine, YouScript Software

Drug interaction checkers are common to most EHRs and e-prescribing solutions, but while other types of drug-interaction software will alert you about how two medications could potentially interact, they don’t take into account the effects multiple medications combined could have on each other.

These cumulative interactions are more likely to be problematic than a single drug-drug interaction because they are more complex and often additive. In these scenarios, the magnitude of the increase or decrease in drug levels is greater than that of a single drug-drug interaction.

For example, a patient who metabolizes medications normally through the CYP2C19 pathway may not notice effects of the drug-drug interaction between citalopram (Celexa), used to treat depression, and omeprazole (Prilosec), used to treat acid reflux disease. However, if that patient were a CYP2C19 intermediate metabolizer, he or she may experience adverse effects from citalopram as a result of this cumulative drugdrug- gene interaction.

The YouScript Personalized Prescribing software can detect interactions between three or more medications through its cumulative interactions feature, then suggest alternatives with a lower risk of interactions. YouScript is the only software able to do so.

The cumulative interactions feature is the foundation for every drug and phenotype interaction analysis performed in the YouScript software. YouScript combines pharmacodynamic and pharmacokinetic interactions documented in clinical literature with a patented algorithm that mimics how the human body would metabolize multiple medications to predict changes in drug-levels and clinical effects. This allows YouScript to evaluate the combined effect of a patient’s genetics and their entire drug regimen.

The software then ranks all identified interactions in order of potential harm to the patient and color codes them for quicker review. The closer to red an interaction is, the more potentially serious it could be. Cumulative interactions are often more significant, and this is reflected in the ranking. With a simple click on the medication name in the YouScript interaction report, providers can review detailed information on how two or more drugs will likely interact and the evidence behind each determination.

By providing clear, actionable guidance, YouScript helps clinicians address the complexities of drug interactions and reduce trial-and-error prescribing. Visit the YouScript website for a free trial.

Nov 12
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FDA warns supplements, meds can be dangerous blend

By Drug Interactions, News, Pharmacogenetics

Mixing medications with dietary supplements, such as vitamins and herbal products, can be dangerous, the U.S. Food and Drug Administration (FDA) has cautioned.

Certain dietary supplements can boost the effects of other medications as well as change how the human body processes medications, according to the FDA, thereby changing the blood levels of that medication.

“[Patients] may be getting either too much or too little of a medication [they] need,” FDA Medical Officer Robert Mozersky says in a recent FDA news release.

“Some dietary supplements may increase the effect of your medication, and other dietary supplements may decrease it.”

For example, birth control pills and drugs designed to treat HIV/AIDS, heart disease and depression are less effective when taken with St. John’s wort, an herbal supplement, according to the FDA. Reduced or increased efficacy of certain medications could result in potentially harmful adverse drug events or treatment failures.

A 2008 review study in the journal American Family Physician lists St. John’s wort as the supplement with the most documented interactions with drugs. The paper by Gardiner et al. advises physicians to ask what dietary supplements their patients are taking and document this information in their patient record.

FDA officials also warn against combining supplements that thin the blood, such as ginkgo biloba and vitamin E, with warfarin, a common medication prescribed for cardiovascular disease or blood clots. Taking any of these products together may increase the risk for internal bleeding or stroke, the FDA warns.

Use of supplements in the U.S. appears to be on the rise. According to the Centers for Disease Control and Prevention (CDC), more than 40 percent of the U.S population used supplements between 1988 and 1994, while more than one-half used them between 2003 and 2006. Multivitamins and multiminerals are the most commonly used dietary supplements, the CDC reports, with approximately 40 percent of men and women reporting use between 2003 and 2006.

The YouScript Personalized Prescribing software database contains hundreds of dietary supplements currently on the market and can detect potential interactions with hundreds of other medications, both prescription and over the counter. Unique among drug interaction software, YouScript can detect interactions between three or more medications and then offer alternatives with a lower risk of interactions.

Find more information on dietary supplements on the FDA’s website.

Nov 07
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Genelex named top-10 fastest-growing business in Seattle

By Drug Interactions, News, Pharmacogenetics

A national business magazine has named Genelex the 10th fastest-growing private company in Seattle.

In the fifth such listing for Genelex this year, Inc. magazine has included the Seattle-based company at the number 10 spot in its list of the top-10 fastest-growing private companies in Seattle. Genelex is the only healthcare software and genetic testing company included on the list.

“[Genelex], which is ranked at number 1,104 on the Inc. 5000, concentrates its efforts on pharmacogenetic testing and offers clinical decision support software to evaluate a patient’s potentially adverse drug interactions,” Inc. staffer Will Yakowicz writes in the top-10 fastest-growing Seattle companies article.

“The goal? To avoid overdose, death and negative reactions. With a 404 percent three-year growth rate, Genelex reeled in $11.5 million in revenue in 2013.”

Yakowicz writes that the magazine’s Inc. 5,000 list tracked company performance, including the three-year revenue growth rate, between fiscal years 2010 and 2013. Check out the entire list here.

“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.”

The recognition joins four other honors for Genelex this year. 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.

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 this year, 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.

Oct 22
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Study: 32 percent of people with cancer have anxiety or other mental health disorder

By Cytochrome P450, News, Personalized Medicine, Pharmacogenetics

A recent study has found that just more than 30 percent of people with cancer in Germany also experienced some form of clinically relevant mental health disorder.

The article, published earlier this month in the Journal of Clinical Oncology, found that 32 percent of people with cancer, or about one in three, had also experienced a clinically meaningful level of mental or emotional distress that met the strict criteria of one or more mental health disorders, such as anxiety, depressive or adjustment disorders. Study authors Mehnert et al. report that 42 percent of study participants with breast cancer had some sort of mental disorder. This was the highest prevalence among the 13 main types of cancer studied.

The article sheds new light on an area of study the authors say has had a considerable amount of research attention paid to it already. While past work has reported elevated levels of distress among people with cancer, Mehnert et al. write these studies vary in quality due to small sample sizes, different diagnostic criteria and assessment standards, and women with breast cancer being over-represented.

The authors write that the study results stress the need for psychological support for people with cancer, which could include psychotherapy, relaxation therapy and imagery. The American Cancer Society offers numerous resources for this kind of support.

Among the 2,100 study participants from cancer centers across Germany, the researchers found that 11 percent of patients had anxiety disorders, which was the most common type of disorder among study participants. The overall prevalence of mental health disorders was higher in those individuals with cancer (32 percent) than in the general population (20 percent) of Germany.

In general, the highest mental health disorder prevalence rates in study participants with cancer were found among those with breast cancer, head and neck cancer, and malignant melanoma. The lowest rates were found in patients with pancreatic cancer, stomach or esophageal cancer, and prostate cancer.

The work also brings to mind the importance of DNA sensitivity, or pharmacogenetic, testing for people with cancer. Certain cancer medications, such as the breast cancer treatment drug tamoxifen (Nolvadex), are metabolized by the body’s genetically variable CYP450 enzymes.

What’s more, many antidepressant and antipsychotic medications are processed by two CYP enzymes that demonstrate genetic variations: CYP2D6 and CYP2C19. Taking these medications in combination with cancer medications can lead to reduced effectiveness. But when there is genetic variation, the cumulative risk of problems may increase.

Learn more about pharmacogenetic testing here, and read more about the German study here.

 

Oct 22
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The Pharmacist’s Corner: What roles can pharmacists play in pharmacogenetics?

By News, Personalized Medicine, Pharmacist's Corner, Pharmacogenetics

By Rachel Sass, PharmD

What is your perception of a pharmacist? Someone in a white coat at the local pharmacy who fills your prescriptions, answers your questions and helps you pick out the right over-the-counter medicine? This is how pharmacists have historically been remembered, and while this area of pharmacy is still critical to the field, the pharmacist’s role has expanded widely.

Thanks to extensive training in pharmacokinetics, pharmacology and therapeutics, pharmacists have the opportunity to play a unique role in interdisciplinary teams and work with physicians, dietitians and other medical professionals to enhance patient care. Pharmacists have already been integrated as critical players in such teams and have even taken the lead in specialty areas, such as anticoagulation, critical care and antibiotic dosing, among many others. These pharmacist-driven programs have become standard of care in many of these specialty areas.

But what about pharmacogenetics?

Clinical pharmacogenomics programs utilizing pharmacogenetic information have been implemented at multiple sites across the country. In a recent article in the journal Pharmacotherapy, Owusu-Obeng et al. discussed the successful implementation of a translational clinical practice initiative using CYP2C19 genotypes to guide clopidogrel therapy.

This pharmacist-led effort in the University of Florida Health Personalized Medicine Program used genetics to tailor antiplatelet therapies for patients undergoing percutaneous coronary intervention and stent placement.  In the first two years of the program, 14 different pharmacists were directly or indirectly involved and were identified by the study authors as being essential to the success of the program.

Additionally, the article identified essential skills that a pharmacist must have prior to initiating a new clinical pharmacogenomics program. These included knowledge about clinical applications of genotype-guided therapy, relevant drug-gene pairs and pharmacogenetic laboratory testing.

“Clinical pharmacists are well positioned to implement clinical pharmacogenomics programs, with expertise in pharmacokinetics, pharmacogenomics, informatics, and patient care,” Owusu-Obeng et al. write.

“Education, training, and practice-based resources are needed to support these roles and to facilitate the development of financially sustainable pharmacist-led clinical pharmacogenomics practice models.”

As a broader understanding of pharmacogenetics gains importance for many healthcare providers, multiple efforts are being made to implement pharmacogenomics in every day practice. Pharmacogenomic competencies are included in pharmacy school accrediting standards, and some professional organizations have adopted professional pharmacogenomics competencies for pharmacists.

Additionally, experts in the field, such as the Clinical Pharmacogenomics Implementation Consortium and the Dutch Pharmacogenetics Working Group, are continuously curating the literature and providing health care providers with clinically actionable guidance.

Pharmacists are well positioned to play a role in implementing pharmacogenetic information. Possible roles include using such information as part of comprehensive medication therapy management programs and involvement in specialty areas that commonly use medications affected by pharmacogenetic variations, such as pain or psychiatry.

These examples represent only a few of the multiple possibilities of how pharmacists can assist with implementation of pharmacogenomics. The American Society of Health System Pharmacists released a statement of the Pharmacist’s Role in Clinical Pharmacogenomics in June of 2014, which provides some additional examples of how pharmacists can implement pharmacogenomics into every day practice. Overall, using pharmacogenetic information has the potential to improve medication-related outcomes and patient safety.

Genelex’s team of highly skilled pharmacists plays a crucial role in helping advance the use of pharmacogenetics to personalize prescribing and medication management through the YouScript Personalized Prescribing System. Learn more about the team here.

Rachel Sass, PharmD, is a board-certified pharmacotherapy specialist who has worked at a Genelex as a personalized prescribing clinical pharmacist for one year.

This is the inaugural post in a guest blogger series PGx in Practice is launching that will feature subject matter experts from within Genelex discussing issues pertaining to pharmacogenetics and the healthcare industry

Oct 10
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Genelex named to top 100 fastest-growing businesses list for 2014

By News

For the third time since Genelex was founded, the Seattle-based company leading the way in DNA sensitivity testing to help combat adverse drug events has been named one of Washington’s 100 fastest-growing private companies.

The Puget Sound Business Journal has released its list of the state’s fastest-growing companies, and Genelex is included for the second year in a row. The rankings, revealed at an Oct. 9 awards banquet at the Sheraton Hotel Seattle, put Genelex at number 47.

Genelex was the ninth fastest-growing company on the Business Journal’’s prestigious list last year and saw its first inclusion on the list in 1995. Howard Coleman, Genelex CEO and chairman of the Board of Directors, says the recognition is due in no small part to healthcare practitioners’ increasing recognition of the value of personalized medicine.

“We were in business for 20-plus years before we started to grow,” says Coleman, who founded Genelex as a paternity-testing laboratory in 1987 with wife Dr. Tia Aulinskas.

“The shift to 100 percent pharmacogenetic testing in 2012 has given the company the focus necessary to fuel this kind of growth,” says Coleman, who accepted the award at the Oct. 9 event.

A complete list of the fastest-growing companies can be found here. To make the Business Journal’s list, companies must have recorded revenue of at least $500,000 in 2011 and demonstrated revenue growth through 2013. The companies must also be privately held, cannot be subsidiaries of other companies and must have the company CEO submit revenues in writing for the past three years.

“Together, the companies that made this year’s list recorded more than $2.08 billion in revenue in 2013 and employ more than 8,805 people, fueling the state’s economy and propelling this region’s rapid growth,” writes Becky Monk, Business Journal assistant managing editor.

This recognition comes within a month of Genelex being honored with the silver award in the health category of Seattle Business magazine’s 2014 Tech Impact Awards.

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. Genelex began focusing solely on developing medication management tools and services in 2012.

Oct 08
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Celebrate pharmacists during the month of October

By News
pharmacist

Genelex’s Pharmacy Team from left to right: Jennifer Jepsen, PharmD; Derry McDonald; John Hodges; Tyler Mamiya, PharmD; Richard Newman; Valerie Fishbeck, PharmD; and Rachel Sass, PharmD. Not pictured are PharmDs Brian Hocum and Meghan King-Moreno and PharmD interns Kaitlin Kiter and Ichiko Petrie

From maintaining a near-encyclopedic knowledge of potentially harmful drug interactions to easing the worries of first-time medication takers, pharmacists play a vital role in modern medical care.

In honor of the many contributions pharmacists make to communities nationwide, the American Pharmacists Association has dubbed October American Pharmacists Month. The goal of American Pharmacists Month is to recognize the commitment that doctors of pharmacy, or PharmD’s, have to comprehensive patient care and personalized medication management.

At Genelex, our team of highly skilled pharmacists plays a crucial role in helping advance the use of pharmacogenetics to personalize prescribing and medication management.

Officially started in 2012 by Dr. Jessica Oesterheld, MD, Genelex’s director of pharmacologics, the pharmacy department has since grown to include five pharmacists and several other researchers, interns and support staff. Dr. Oesterheld has decades of experience as a child psychiatrist and a drug interactions expert, and has written a number of books and papers on cytochromes and their development and interactions.

Now led by Dr. Oesterheld and Tyler Mamiya, PharmD, the pharmacy department is responsible for providing customized personalized prescribing reports for all patients with clinically significant interactions, conducting clinical research and cultivating the YouScript interaction and clinical evidence database. Genelex focuses on the pharmacogenetic testing of the highly variable cytochrome system and clinical decision support tools like YouScript that identify potentially harmful drug interactions caused by genetics or cumulative drug interactions.

“Genelex is one of the most exciting companies to work for,” says Pharmacologics Manager Tyler Mamiya.

“Working at the leading edge of pharmacogenetics is what drives me every day.”

Each pharmacy department staff member brings a unique perspective to their work:

  • Brian Hocum, a certified geriatrics pharmacist who has worked with providers at various hospitals and clinics to help integrate pharmacogenetics into their work flows.
  • Meghan King-Moreno, a certified smoking cessation counselor who has been with Genelex since 2011.
  • Rachel Sass, a board-certified pharmacotherapy specialist who did her residency at the Veterans Affairs Puget Sound Health Care System.
  • Valerie Fishbeck, a certified geriatric pharmacist who previously worked as an ambulatory clinical pharmacist specialist.
  • Jennifer Jepsen, a board-certified pharmacotherapy specialist who worked for seven years at Western State Hospital in Lakewood, Washington.
  • PharmD interns Kaitlin Kiter, who participated in a Medical Brigade in Honduras to provide comprehensive medical services to a rural community with limited healthcare.
  • PharmD intern Ichiko Petrie, who has participated in studies involving the risk assessment of medication use in assisted-living facilities and Vitamin A intake in chronic kidney disease patients.
  • Clinical Trial Manager Richard Newman, who holds a Master’s of Public Health degree and previously led research projects for Seattle’s esteemed Fred Hutchinson Cancer Research Institute.
  • Drug research, support and database management is provided by Pharmacy support specialists John Hodges and Derry McDonald.

Together, the Genelex Pharmacy Team works at the forefront of personalized medicine, advancing the use of pharmacogenetics and sophisticated drug and gene interaction software to improve the management of complex medication regimens.

Be sure to visit the Genelex and YouScript Facebook pages throughout October, as we’ll be posting brief biographies and photos of most of our Pharmacy Team.

Oct 08
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DEA reschedules hydrocodone medications

By Drug Interactions, News

The federal government has placed new restrictions on the prescribing of medications containing the opioid hydrocodone.

Effective Oct. 6, the U.S. Drug Enforcement Agency (DEA) has published a final rule reclassifying hydrocodone combination products (HCPs), defined as medications combining hydrocodone and another drug, from Schedule III to the more restrictive Schedule II. The proposed rule follows the recommendation of a Food and Drug Administration (FDA) Public Advisory Committee meeting held in January last year. ThDEA Logo Hydrocodone Reschedulee FDA  also cited its duty to protect the health and safety of the public as a motivating factor. The change comes after months of public comment and a physician’s petition originally submitted in 1999, according to the DEA.

“Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” DEA Administrator Michele Leonhart said in a news release. “[The rule change] recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”

The change means patients taking HCP painkillers like Vicodin, Lortab or Norco will be limited to an initial 90-day supply and then will have to call or visit their doctor for a new prescription each time they need a refill. Although the Controlled Substances Act prohibits refills of prescriptions for Schedule II controlled substances, a practitioner may issue multiple Schedule II prescriptions in order to provide up to a 90-day supply of medication.

Additionally, the new rule means patients generally must provide a written prescription to a pharmacist to receive the drug. In most instances, prescribers will no longer be able to call in a new prescription or a refill, unless criteria for an emergency situation are met.

Notably, DEA stated in its final rule that prescriptions for HCPs issued before October 6 with legitimate refills may be dispensed before April 8, 2015, however some pharmacies may not be refilling them due to software issues and confusion around conflicting state laws.

Hydrocodone, metabolized by the body’s highly genetically variable CYP2D6 enzyme, is an ingredient in dozens of combination medications, from painkillers to cough suppressants.  The American Academy of Family Physicians (AAFP) reports that HCPs are the most prescribed medications in the U.S., with 135 million prescriptions filled in 2012.

The DEA had been accepting public input on the change since February and had received nearly 600 comments. NationalPainReport.com writes that more than half of the comments (52 percent) supported the rescheduling while 41 percent opposed it.

Multiple news sources have reported concern from pain management experts over the rule change, citing fears that patients may have more difficulty getting medications they rely upon. In a comment letter to the DEA, the American Academy of Pain Medicine (AAPM) wrote that the schedule change may be beneficial in that it might encourage doctors to look more critically at their prescribing practices.

“On the other hand,” the AAPM letter says, “current patients with legitimate medical need may have problems obtaining their medication, particularly if they live in rural or other underserved areas. Their costs may increase through more co-pays, more clinic visits, and the higher price of a Schedule II medication.”

More details on the new DEA rule can be found here. The AAFP has also produced a helpful guide to how the rescheduling affects physicians and their patients.