Drug-Response Testing Program Growing at Chicago Suburb Hospital System

May 10, 2016 by Turna Ray
Originally published on GenomeWeb

NEW YORK – The pharmacogenomics program at NorthShore University HealthSystem will begin testing patients in house this summer and implement decision support tools within its electronic medical records system to help doctors incorporate this information in patient care.

The four-hospital system, which operates in the Chicago area, last year made a substantial commitment to integrate genetic testing and counseling into various aspects of care. One of the key pieces of NorthShore's precision medicine efforts is its PGx clinic, where patients are screened for a number of genes known to impact their ability to respond to various drugs.

Since opening more than a year ago, NorthShore's PGx clinic has had 218 patient visits, 187 of which have taken place in the nine months from September. The PGx program has tested 122 patients in total.

Approximately half of these patients came to the clinic on their own, having learned about the Precision Medicine Initiative or the National Cancer Moonshot Initiative in the popular press. The other half come in through referrals — between 35 percent and 40 percent from psychiatrists, and the rest from primary care physicians, pain specialists, and oncologists.

Before patients can get PGx testing, they have to attend an in-person education session to set their expectations about the process, and they have to come in again to receive and discuss test results. NorthShore has been using a test from PGXL Laboratories to assess patients for variations in 15 genes. Doctors can also order Assurex Health's GeneSight test, which detects variations that can impact patients' response to psychiatric, pain, and attention deficit/hyperactivity disorder medications, as well as their ability to convert folic acid into its active form.

However, in mid-June, NorthShore will launch in-house PGx testing using a custom microarray panel, which will enable doctors to assess more genes than they are currently able to through PGXL and Assurex. Around that time, decision support tools provided by ActX will also be turned on within their EMR workflow. NorthShore uses Epic Systems' EMRs.

Despite the growing interest from doctors and patients, PGx testing "is still in this early-adopter period," Mark Dunnenberger, director of the pharmacogenomics program at NorthShore, told GenomeWeb.

Doctors are already accustomed to factoring in clinical information in order to optimize treatments for patients. So, the idea that genetics is another piece of information that can get patients to the right drug, "resonates really well with the clinicians," Dunnenberger said.

Although physicians are increasingly aware of PGx through peer-reviewed literature and medical conferences, when it comes to actually integrating genomic information into the care of their patients, they find it difficult. "There are a lot of nuances to consider when genotyping somebody," he said, adding that there are a number of PGx testing options on the market, but doctors don't always know which one to order or when.

Through the PGx clinic and interactions with physicians, Dunnenberger and his colleagues believe that doctors still need a lot of education about what PGx can and cannot do. "We've spent the last nine months doing targeted physician education where over a lunch we talk to them about … the benefits and limitations of testing," he said. "We want to empower the [physician] to order the test themselves and be comfortable doing that without having the two hours of visits we have in our clinic."

At the end of April, NorthShore decided to implement ActX's genomic decision support tools, through which doctors receive interruptive EMR alerts that inform them that they're about to prescribe a drug that a patient is unlikely to respond well to based on his or her genotype information. The alerts, depending on the clinical scenario and drugs involved, could suggest, for example, that the doctor prescribe an alternative treatment or change dosing.

ActX's tools also allow doctors to view a patient's genomic profile, indicating which drugs may be a problem and why. This feature is "the cool piece for us," Dunnenberger said. Instead of presenting PGx information in terms of the genes, ActX's program presents this information in the context of the drugs.

Through interactions with physicians, it became clear to Dunnenberger and his colleagues that clinicians are far more familiar with the drugs for the conditions they treat than they are with the genetic markers influencing drug response. "In fact, an argument can be made that they need not know very much about the genes, but just try to avoid or alter the medications that might be high risk for that patient," he said.

NorthShore decided to use EMR decision support from a third party after trying its hand at internally developing alerts. For some time, NorthShore doctors were receiving pop-up alerts for TPMT variants involved in metabolizing thiopurines; HLA-B*5701 for predicting hypersensitivity to abacavir; and HLA-B*1502 for predicting dangerous skin reactions to carbamazepine. But scaling this proved to be a difficult task, since the rules engines within EMRs aren't built with genetics-based rules in mind.

"Just doing those three alerts, it took us 35 individual rules to get the appropriate alerting," Dunnenberger said. "To be able to do that on a sustained level [to keep up with] where pharmacogenomics is going to go, we were going to have to hire a lot of people to just manage that rule set."

To make things more complicated, the testing lab changed the way it reported TPMT results, which in turn threw off the rules that triggered alerts within the EMR. "So … it's not only about keeping up with the pharmacogenomics data, but also having to keep up with things like [whether] your lab has changed how it's reporting the results."

A number of healthcare systems have implemented pre-emptive PGx testing programs, in which patients are assessed for variants that might impact their ability to respond to drugs they will likely receive in the future. These data are stored in the EMR, so when doctors go to prescribe the drugs in the future, they are alerted of the PGx information that will influence patient responses.

But patients often don't have a linear path through the healthcare system. They see multiple providers for a single healthcare issue, all of whom could potentially act on PGx information, and they move in and out of healthcare systems using different EMRs. A survey at Vanderbilt University, which for several years has been running a preemptive PGx testing program, found that healthcare providers believe this information is useful, but they also could not agree on who should be responsible for acting on the results to guide patient care.

The Clinical Pharmacogenetics Implementation Consortium's Informatics Workgroup in March published a set of principles for integrating PGx information in EMRs with clinical decision support so healthcare providers can make better use of this information at the point of care.

Recognizing the complexity of this work, NorthShore decided to adopt ActX's genomics decision support tools, which are customizable so the alerts can be adjusted to physician and patient needs. "Just because we're into their system, doesn't mean we're going to turn their whole system on right away," Dunnenberger explained. NorthShore will still work with doctors to figure out the types of alerts they want, how often they want to be alerted, and which specific gene-drug pairs should be included, he said.

In mid-June, when the ActX decision support goes live in the EMR and NorthShore begins to test patients using an in-house platform, physicians will be able to receive alerts for four additional drug-gene pairs. "We're just at the tip of the iceberg in terms of what we can do with clinical decision support," he said.