Aug 28
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Study Shows Promise for Reducing Unnecessary Procedures

By DNA Today Newsletter, News

An immense medication management trial sponsored by Leumit Health Care Services, an Israeli health fund, and Teva Pharmaceuticals is ending this year. The trial examined the clinical outcomes of using integrated drug and gene interaction alerts in an EHR, something few other studies have done and which has been sorely needed in the industry.

The study involved Leumit integrating a new medication management program, DDI+, into the EHR of half of its prescribers. This is a huge population — Leumit is working with its entire body of 2,000 doctors and 700,000 patients. Additionally, a 1000-patient genetic-testing subarm received Genelex testing for the genes CYP2D6, CYP2C9, CYP2C9 and VKORC1. DDI+ was created with information from First Databank and YouScript® and provides prescribers with graphic alerts for potential adverse effects.

Outcome variables included the number of emergency room referrals, hospitalizations, imaging procedures and the number of medications, as well as the costs associated with these variables. As of now, data collection is complete and preliminary numbers are promising. Initial results also showed a small but significant drop in the number of hospitalizations, drugs used and imaging procedures performed. Additionally, a substantial number of physicianschanged their prescribing patterns when they received warnings.

Final analysis is still underway and is expected to be published early next year.

Aug 28
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Psychiatrist’s Love of Technology Translates into Better Patient Care

By DNA Today Newsletter, News

Something a patient might notice when they’re talking with Dr. Michael Rieser is his computer. It might, for instance, be filling itself with words – the patient’s own words – recorded, transcribed and saved to the patient’s file automatically. Dr. Rieser, a psychiatrist working in Lexington, Kentucky, has always been interested in technology that can help him provide better patient care and it’s evident in his practice. Now he is using it to better manage medications as well.

Dr. Rieser is board-certified in child and adolescent psychiatry, adult psychiatry and emergency medicine. He works as the medical director at the Ridge Behavioral Health System, a 110-bed practice in Lexington that consists of a mix of psychiatrists and internists who perform in-patient, multi-unit services. It can get very busy. “We get patients from all over Kentucky at this hospital,” said Dr. Rieser.

One of the biggest challenges Ridge Behavioral Health deals with is the high number of medications newly admitted patients are taking. “Some of those patients may come in with 25 or 30 medications.” This can be dangerous since a patient’s chance for adverse drug effects rises with each medication they take. Luckily, there are clinical decision support tools to help avoid these problems, like YouScript®. Dr. Rieser’s been one of the hospital’s biggest proponents of these technologies. “They’ve got computers littered all over the hospital so I can go anywhere and run it. People are used to seeing me use it.”

Improving Patient Health

Dr. Rieser started using YouScript in 2011. “When I started using it, I was so overwhelmed with how many drug interactions there were. You pick up some of these toxic antidepressant effects, it’s really common… Now, even the short regimens, just a couple of medications, I check them in YouScript.”

Dr. Rieser’s interest in medication management came to a head with one particular case. A boy, about 12, was admitted as psychotic. His history included ADHD, then later bipolar disorder, both of which came with various medications. As a routine part of his care, Dr. Rieser put the patient’s drug list into YouScript. “When I punched it in, something jumped out at me.” The child had been prescribed both Prozac® and dextroamphetamine concurrently. “The Prozac inhibited the metabolism of the dextroamphetamine and doubled the blood level,” Dr. Rieser explained, “so the kid was basically amphetamine toxic and not sleeping. I’d get psychotic too.” The root cause of the kid’s psychosis was in his drug regimen, not his brain. Dr. Rieser decreased the child’s dose of dextroamphetamine and the patient recovered.

Encouraging Adoption

Patients and other prescribers seem interested in the program, although they’re sometimes hesitant to adopt it themselves. This isn’t uncommon, as implementing new workflow procedures often take time. Nevertheless, Dr. Rieser feels that most prescribers will come around.

“This technology is a little bit like what happened when physicians were being exposed to X-ray reports for the first time. You get to see stuff you’ve never seen before, and you end up seeing stuff you never would have imagined would have been there. It has a big impact on your decision -making.”

Aug 25
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Chronic pain patients’ pocketbooks feel pinch of major drug-drug interactions

By News, Pain, Personalized Medicine

Chronic pain patients already have enough to worry about from adverse drug events, but a new study highlights a possibly overlooked concern – their costs.

According to a recent study published by Pergolizzi et al. in the May 2014 article in the Journal of Managed Care & Specialty Pharmacy, already vulnerable chronic pain patients could end up paying 22 percent more per month in medical costs if exposed to opioid drug interactions.

The economic hardships of adverse drug events caused by drug-drug interactions on chronic pain patients taking opioids have already been well-established, with some studies cited by Pergolizzi et al. indicating overall health care cost increases can vary from $250 to as much as $1,200 over six months. Research indicates that adverse drug events affect millions of patients each year, or roughly 5 percent of hospital admissions.

With this research already on the books, Pergolizzi sought to determine costs of major, potentially-major drug-drug interactions in long-acting opioids. The researchers found that chronic pain patients taking long-acting opioids who had a drug-drug interaction paid $609 per month over a 90-day period than similar patients. Costs were tallied from all payments for covered healthcare services over the 90-day observation period and included inpatient and outpatient medical, ER visits and prescription costs.

The most common drug combination reported among patients in the study was fluconazole and oxycodone, both of which interact via the body’s CYP450 pathway. Drug interactions using this pathway are among the most common and potentially avoidable. A prescription for one of these analgesics does not guarantee the patient will experience a potentially major drug-drug interaction, but patients taking analgesics not metabolized by CYP450 are more likely to avoid a potentially major interaction.

Though only 5.7 percent of the 57,752 patients in this study were exposed to potential major drug-drug interactions, Pergolizzi et al. argue that intervention and management for this relatively small number of patients has the potential to drastically reduce the seemingly out-of-proportion difference in medical costs between those exposed and those not.

With both the health of chronic pain patients’ bodies and pocketbooks on the line, full knowledge of their drug regimen is essential for physicians. Click here to learn more about Genelex’s innovative approach to pharmacogenetic testing.

Aug 22
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People of Note: Dr. David Nash

By News, Personalized Medicine

Physicians will need to start thinking on a higher level, at least according to Dr. David Nash. One of the keynote speakers at this year’s Allscripts Client Experience (ACE), and founder of the Jefferson School of Population Health at Thomas Jefferson University, Dr. Nash is an outspoken proponent for population-focused care. According to Dr. Nash, hospitals need to be using technology to get a better understanding of their population’s socioeconomic, genetic and behavioral aspects. That’s where progress will be made in the healthcare industry.

Genelex agrees that understanding patient populations as a whole is an important step towards improving care in this country. Using technology, such as the Allscripts Touchworks and Professional EHRs and its suite of possible clinical decision support tools, can help providers identify trends and optimize care for their population as a whole. As Dr. Nash said, “We need to learn from everyone’s experiences, have better access to organized information, and overall be better connected.”

We were very excited to see Dr. Nash at ACE this year. Watch an interview with him at the ACE Keynote Speaker’s page and follow Thomas Jefferson University on Twitter at @JeffersonUniv.

Aug 22
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Study links genetics to skin reactions caused by common anti-epileptic drug

By News, Personalized Medicine

A study released this month provides a genetic link between a drug commonly prescribed to combat seizures and severe adverse, potentially fatal skin reactions. The study, which was published by Chung et al. in the August 2014 issue of the Journal of the American Medical Association, associated variants of the CYP2C gene group (which includes CYP2C9 and CYP2C19) with maculopapular rashes, the rare and sometimes-life-threatening toxic epidermal necrolysis, a related condition known as Stevens-Johnson syndrome.

Researchers have known for decades that certain polymorphisms of CYP2C9 and CYP2C19 can decrease the body’s ability to eliminate phenytoin, thereby increasing the potential of patients to be exposed to more of the drug than is needed. In fact, up to 170% increases in phenytoin AUC have been observed in CYP2C9 *3 allele carriers.

This new research by Chung et al. calls out 10 specific polymorphisms. These were rare in the study’s control population, which had not suffered any phenytoin-related adverse skin reactions, but common in the cases that had. Analysis showed that cases studied from Taiwan, China and Japan with the specific variant CYP2C9*3 were 11 times more likely to experience a phenytoin-related adverse skin reaction.

Maculopapular rashes are characterized by flat, red areas of skin covered in small, overlapping bumps. Both toxic epidermal necrolysis and Stevens-Johnson syndrome often produce blisters, which can cover 30 percent of the body or more, and makes the skin look as though it had been scalded. Both conditions commonly start with flu-like symptoms and is followed by painful, red rashes. Both can affect skin and mucous membranes and can be very serious and life-threatening.

This study adds to the growing body of research stressing the importance of a physician’s full understanding of a patient’s overall CYP450 system. Visit the JAMA website for the full text of the article.

 

Aug 08
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FDA Plans New Regulations for More Reliable Diagnostics

By News, Personalized Medicine

FDA logo

On July 31st, 2014, the FDA announced that they would be taking two steps to ensure the reliability of diagnostic tests. First, the FDA has issued guidance on the development of in vitro diagnostic companion devices. These are tests designed to be used in conjunction with a medication to identify patients who may or may not benefit from the treatment. Secondly the FDA is notifying Congress of their intention to publish oversight framework for laboratory developed tests (LDTs).

The reasoning behind these two changes is to help bring diagnostic tests in line with similar FDA-approved products. The FDA has historically exercised discretion about these kinds of devices and tests, but as the technology grows, regulations must keep up. These new guidelines will also hopefully help stimulate early collaborations between laboratories and the FDA, which will help improve development and access of new therapies.

How does this affect Genelex and YouScript?

On the first point, the YouScript Personalized Prescribing software doesn’t count as an IVD companion device according to the FDA’s rules. IVD companion devices are designed to provide “information essential for the safe and effective use of a corresponding therapeutic product.” While YouScript is designed to optimize medication regimens, it is not essential for the use of any medications, nor is it linked to one specific medication.

On the second point, about LDTs, this would eventually affect Genelex DNA testing. Genelex DNA testing would indeed fall under the heading of an LDT (although the YouScript software itself does not). However, this does not mean that immediate changes are needed. The FDA has made it clear that the first five years of the new regulations will be spent regulating Class 3, high risk LDTs, mainly in the oncology sector. Genelex DNA testing would be considered to be lower risk, which means the laboratory has ample time to plan for this transition.

Furthermore, the FDA has made it clear that they will work closely with CLIA so accreditation for both processes can be done at the same time as often as possible. Genelex laboratory testing is CLIA accredited. Additionally, we have more strict documentation and oversight in place than other labs may as we are also CAP and NYSDOH accredited. This would make any additional information sharing requirements the FDA may have more easily done.

These new FDA requirements will not adversely affect Genelex DNA testing or the YouScript Personalized Prescribing System and will hopefully help spur greater reliability and collaboration in the industry.

Aug 08
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Case Report: Misdiagnosis of Adverse Effect Leads to Prescribing Cascade

By Case Studies, Drug Interactions, News

 

A 70-year-old man fell, resulting in subdural hemorrhage and frontal lobe contusions (bleeding in his brain). He was admitted to the ICU, where lab results showed two interesting facts: he had unusually high levels of salicylate in his blood and X-ray imaging showed opaque material in his colon.

He was self-administering donepezil, calcium carbonate, alendronate, pravastatin, ezetimibe, omeprazole and perindopril. His diagnostic history revealed he’d been diagnosed with mild Alzheimer’s two months earlier and had also visited a family physician complaining of abdominal discomfort shortly thereafter.

After talking with friends and family, the physicians learned that the patient had taken large amounts of Pepto-Bismol® (bismuth salicylate) to ease his abdominal discomfort while waiting for a gastroenterologist appointment. This would have been the opaque material in his X-ray. His mental and physical state worsened immediately after taking it, resulting in his fall. Ultimately, he was diagnosed with salicylate toxicity from the Pepto-Bismol.

This case is interesting as it represents a prescription cascade. The adverse effect of one medication (donepezil) was misdiagnosed as a novel medical condition (gastrointestinal distress), which lead to further medication use (Pepto-Bismol). This could have been prevented by correctly identifying the cause and decreasing the donepezil dose. He would have never needed the Pepto-Bismol in the first place.

This particular cascade lead to toxicity from overly-large OTC doses, but all prescription cascades can be problematic as they lead to polypharmacy, which is associated with a higher risk of adverse drug events. In fact, YouScript analysis shows that, even if the Pepto-Bismol had been self-administered at appropriate doses, it could have caused decreased levels of the patient’s alendronate and pravastatin, leading to a potential treatment failure.

Prescribers should keep these possible cascades in mind when prescribing new medications. Sometimes the answer isn’t what new drug the patient needs, but which drugs they’re already taking.

Find the case report in full here.

Aug 08
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Chronic Conditions Affect Quality, Length of Life

By News, Personalized Medicine

Average life expectancy in the United States is actually rising more slowly than in other parts of the developed world and the culprit may be chronic conditions. As people live longer, thanks in part to improvements to acute care, they become more likely to develop chronic conditions such as heart disease or cancer.

This means that further breakthroughs in life expectancy may depend on finding new ways to combat chronic conditions. According to a new report from John Hopkins, each chronic condition costs a person an average of 1.8 years of life and multiple conditions increase that impact.

This problem is widespread. According to the Centers for Disease Control and Prevention about half of all adults are now living with at least one chronic medical condition and one in four have multiple. The CDC also reports that seven of the top ten causes of death in 2010 were from chronic conditions, that the majority of US healthcare costs are for those associated with chronic diseases, and that heart disease and stroke alone cost the United States over $315 billion in 2010.

Multiple disease states, also known as multimorbidity, often results in polypharmacy, the taking of multiple drugs, which increases the chance for drug-drug, drug-gene or cumulative interactions, as well as adverse drug effects and treatment failures.

“The medical advances that have allowed sick people to live longer may not be able to keep up with the growing burden of chronic disease. It is becoming very clear that preventing the development of additional chronic conditions in the elderly could be the only way to continue to improve life expectancy,” said Eva H. DuGoff, a PhD at John Hopkins. “The growing burden of chronic disease could erase decades of progress. We don’t want to turn around and see that life expectancy gains have stopped or reversed.”

Aug 08
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Single Accreditation Standard for MD’s, DO’s

By News

Osteopathic Therapy

Most physicians in the United States hold a Doctor of Medicine degree (MD), however, a second type also exists: the Doctor of Osteopathic Medicine (DO). The differences between the two are slight and mostly focus on how they are trained. Now, however, that difference shrinks even more.

In February 2014, the American Osteopathic Association (AOA), American Association of Colleges of Osteopathic Medicine (AACOM) and Accreditation Council for Graduate Medical Education (ACGME) announced that they would no longer have separate accreditation standards for graduate medical education programs. MD’s and DO’s previously had to go through separate accreditation systems during their training, but no more.This transition to the ACGME providing accreditation for all GME programs is scheduled to start in July 2015 and finish by June, 2020.

It’s hoped that a single accreditation system will help standardize training and reduce administrative burden.