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For pain care and more, PGx testing at Avera Health

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Elizabeth Silverman

July 2018—Putting pharmacogenetic testing into play at Avera Health was years in the making. It took time to operationalize it at an affordable cost. Today, it has wide physician acceptance and is seen as a strong benefit for patients. “Pharmacogenetics is what will differentiate Avera in a new era of ACOs and personalized medicine, and will ultimately lead to a model for transforming health care,” says Trisha Lauterbach, MS, MLS(ASCP)CM, laboratory operations manager at Avera Institute for Human Genetics (AIHG), Sioux Falls, SD.

Genetics and molecular testing are the paths down which laboratories are heading, notes Mike Black, MBA, MT(ASCP), DLM, Avera Health’s laboratory service line administrator. “Traditional testing—hematology, coagulation, urinalysis, microbiology, and the blood bank—is always going to be a part of the patient testing platform. But, as an added value, if research and the clinical side work together, pharmacogenetic tests will be of great benefit to physicians,” Black says, in their ability to reduce the number of medication-related office visits and see more patients.

Avera’s physicians knew the era of genetics had arrived with the sequencing of the human genome and that pharmacogenetics was important, says Erik Ehli, PhD, scientific director of the AIHG, the laboratory that performs the testing. They wanted a laboratory on the cutting edge of it. “In conjunction with our pharmacists,” Dr. Ehli says, “the [AIHG] laboratory took the ball and started running with it.” The AIHG isn’t aiming to do the basic research, he adds, but instead to leverage the existing knowledge and apply it to improving outcomes.

Avera is a nonprofit integrated health care system based in Sioux Falls and operates in more than 300 locations across South Dakota, Minnesota, Iowa, Nebraska, and North Dakota. Its pharmacogenetics program had its origin in 2006 with the building of Avera’s Behavioral Health Center. Timothy Soundy, MD, ​chair of the Department of Psychiatry at the University of South Dakota School of Medicine and a psychiatrist at the Avera Behavioral Health Center, proposed that a genetics laboratory be established to use pharmacogenomics to improve behavioral health outcomes. The laboratory, now called Avera Institute for Human Genetics, principally studied two genes, CYP2D6 and CYP2C19, and their use in guiding prescribing decisions.

‘In pharmacy schools and medical schools there’s going to have to be an increasing emphasis on pharmacogenetics.’ Erik Ehli, PhD

In 2010, a real-world pharmacogenetics opportunity presented itself in the form of the South Dakota Developmental Center in Redfield, whose developmentally disabled patients with co-occurring psychiatric disorders were typically taking a large number of medications. “At that time,” Dr. Ehli says, “Dr. Soundy proposed a research study to answer the question whether an analysis of the genes involved in medication metabolism could decrease the burden of the number of medications these patients were taking.” The state of South Dakota funded the pilot project, and a first-generation microarray platform was used. “Based on the results,” Dr. Ehli says, “we were able to reduce the medication burden for some patients.”

The AIHG’s success in the behavioral health setting led to a study of clopidogrel in 2012 in conjunction with the cardiologists at Avera Heart Hospital, and in 2013 to the clinical use of pharmacogenetics for pain management in Avera’s surgical population. Lauterbach says 65 percent of the surgical patients had medication adjustment recommendations based on a genetic variant. The pain panel soon caught the attention of the then-president and CEO of Avera McKennan Hos­pital and University Health Center after a personal experience, and he became a source of high-level buy-in. “The buy-in has to start from the top,” Lauterbach notes.

Physician champions arose out of the pilots conducted throughout the Avera Health system. “What we found,” Lauterbach says, “was that if a physician had a positive outcome with a patient, they would begin to order the test consistently, and as they shared their experiences and spread the word, their colleagues would try it on a few patients as well. It has been a kind of snowball effect. After we were featured on ‘NBC Nightly News,’ we had patients from all over the world calling to have testing done.”

But the Avera team had hurdles to overcome before pharmacogenomics could be integrated into the Avera Health system, including preanalytic hurdles. “How do we operationalize the preanalytic side across a five-state, six-region health care system?” Lauterbach asks. “How do we get the test there? How do we ensure the providers know about it and know how to order it?” At first the physicians were apprehensive. “It became clear we needed to make pharmacogenetic testing orderable in the same way as a CBC,” she says.

Also important was a clear reporting format. “Pharmacogenetic testing has to fit into the existing physician workflow, and if it’s exceptionally difficult to find the order, to order the test, or to find and interpret the results, you’re not going to have a product that succeeds,” Lauterbach says. “We started working with our electronic medical record and laboratory information system experts to look at how do we order this test, how do we report results, and how do we treat this like any other laboratory test that we offer in our health system.”

In the end, the most efficient use of resources was to tap the expertise of the pharmacists, nurses, and laboratory personnel and to use them as the link in order entry and result reporting. Now, physicians from all over the health system order pharmacogenomic testing in Avera’s EMR, and the sample is electronically tracked and processed like all other laboratory samples. Once the sample has arrived at the AIHG, laboratory personnel enter the genetic variants as structured laboratory results in the EMR’s laboratory module, and the pharmacist pulls the results and the patient’s medications and demographics from the EMR to create a personalized report. For the final report, the pharmacists evaluate the patient’s genetics and current medications and offer recommendations in an easy-to-interpret stoplight format: A medication with a yellow or red indicator signals a moderate to significant drug-drug-gene interaction, and a medication with a green indicator signals minimal interaction. Even for physicians who had been reluctant, Lauterbach says, it was powerful to be able to offer tangible data demonstrating their drug of choice may not have the desired effect.

Which tests to offer was driven by Avera’s physicians and what they were requesting. “Based on our research and our studies,” Dr. Ehli says, “we started to see patterns with genes and SNPs and what medications our primary care and psychiatric physicians were ordering. So working hand in hand with the pharmacists, we were able to look at which ones were going to provide the maximum benefit to our patient population.”

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