At AMIA, clinical decision support is seen as the key to wider use of PGx and greater efficacy

At AMIA, clinical decision support is seen as the key to wider use of PGx and greater efficacy

WASHINGTON — Molecular labs, health systems, electronic health record providers, and clinical decision support content creators seem to agree that pharmacogenomics is one of many necessary components of precision medicine, but the promise cannot be realized until it becomes an inconspicuous part of clinicians’ workflow.

That was the main message of a lively panel discussion and question-and-answer session at the American Medical Informatics Association’s (AMIA) annual symposium here this week.

Marsha Fearing, a pediatrician, biochemical geneticist, and clinical geneticist who is a medical specialist at EHR provider Meditech, discussed the slow adoption of clinical pharmacogenomics.

“Why don’t we do this? Fear asked. “The reason is that it is difficult. If it was easy, we would have done it a long time ago.”

Fearful lamented the lack of discrete genetic data from labs and said primary care physicians in particular don’t have time to read multi-page reports in PDF files, which are simply digital images rather than calculable data.

“You can’t make a decision on a PDF. You can’t do that if you can’t find the data,” she said. Results should arrive as discrete data without the need for manual entry, ideally as a direct application programming interface to the reference laboratory.

Meditech, based in Westwood, Massachusetts, offers a genomics module called Extended genomics, which is designed to provide clinicians with actionable results based on genetic testing as part of standard clinical workflows. However, it has limited utility in pharmacogenomics without the kind of standardization that exists in medical imaging and non-molecular laboratory testing.

“The problem here is determining which genes should be on a panel if you’re going to do pharmacogenomics,” said Ray Lorenz, director of medical science liaisons in neurology and pharmacogenomics for Quest Diagnostics. He said this information should come from the clinical literature on the usefulness of genetic markers and gene-drug interactions.

This is where clinical decision support systems should come in.

“Every week new mutations are discovered, so it’s an impossible science to follow. It’s not an area of ​​comfort, familiarity for most practicing physicians,” Fearing said. “You can see what an incredible cycle of doom it is to put it all together.”

Anna Dover, pharmacist and product manager at First Databank, a developer of clinical decision support content, said pharmacogenomics decision support is not yet present in many EHR facilities, especially for doctors who mainly prescribe common drugs. “Clinicians are unaware of the information [in genetic reports] or what to do with it,” she said.

“Ideally, we are able to leverage the patient’s test result or lack thereof to promote the test, suggest alternative therapies where appropriate, and even consider changing doses, and provide helpful information. to the clinician,” Dover said. “That’s one of the biggest challenges in business intelligence, getting it to the right place in the workflow, at the right time, and in the right format so they can actually use it.”

Patricia Rice, clinical director of precision medicine and genetics at Frederick Health, a health system in Frederick, Maryland, which adopted Expanse Genomics this year, said the organization’s legal department told her to create a separate consent form for somatic and germline care. test. Additional consent forms complicate life for primary care physicians. “That’s another thing the PCP needs to do,” she said.

The healthcare system expects Meditech to fully support an organization-wide precision medicine program within a few years, although the rollout will be in phases. Rice said Frederick Health is working with the provider to integrate the consent process into the EHR when genetic testing alerts arise.

Not everything applies to a doctor’s specialty either, creating conditions to overload them with information about drugs they don’t actually handle and exacerbating the ongoing problem of alert fatigue.

Lorenz said during the presentation that Quest looked at more than 3,700 patient results for five genetic markers for pharmacogenomics and found that 99.7% had variants that could potentially impact the metabolism and efficacy of medications. He also noted that a 2019 paper the pharmacogenomics study at the US Department of Veterans Affairs suggested that more than 99% of patients had at least one pharmacogenomically actionable variant.

According to Quest’s internal research, people with psychiatric diagnoses were more likely to have clinically significant changes than those without a diagnosis of psychiatric illness. “Maybe these are the types of patients we should test more often” to reduce the need for trial and error, Lorenz mused.

One problem is that many drugs are metabolized by multiple enzymes. Clinical decision support helps untangle some of the complexity and empowers pharmacists and frontline clinicians to deliver better care, Lorenz said.

However, the sources of information do not always agree. Genetic panels vary from lab to lab and vocabulary standards are lacking in pharmacogenomics, according to Dover, making it difficult to share relevant information between EHRs.

Even if the terminology issue is resolved, Lorenz said pharmacogenomics should not replace a physician’s judgment, Lorenz said. For example, genetics may suggest that a patient would respond well to GlaxoSmithKline’s antidepressant Wellbutrin (bupropion), but this does not take into account that the drug is contraindicated for people with seizure disorders.

“While we can automate a lot of this genetic information and the combination of all these genomic factors, it still needs to be looked at by a real person,” Lorenz said.

“It’s a very esoteric science,” said Fearing, who is responsible for engaging and educating clinicians on Expanse Genomics. “We need to agree on genetic markers” to include genetic panels. Information should also be organized to separate somatic and germline variants in laboratory reports.

Another problem, according to Lorenz, is that the US Food and Drug Administration in 2018 advised that companies stop putting drug advice in reports.

This makes the reports less useful for clinicians, according to Lorenz. He said it’s likely that lab reporting and clinical decision support will remain separate in the future, although this creates an opportunity for software vendors to partner with labs to build reporting systems. decision support to send actionable reports to clinicians.

During the Q&A portion of the 90-minute session, physician and audience member Thomas Payne, medical director of information technology services at the University of Washington’s UW branch of medicine, said that it was not the right time to add new alerts to frontline practitioners, who are already suffering from alert fatigue.

Dover responded that the purpose of decision support is to educate providers and that companies like FDB are looking for ways to reduce alert fatigue. “This is designed as a fail-safe, preventing harm when it matters,” she said.

“Pharmacogenomics is not a silver bullet. Pharmacogenomics won’t help you find a needle in a haystack, but it does remove some of the hay,” Dover said.

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