Interviewer: Managing medications through genetic testing, up next on The Scope.
Announcer: Examining the latest research, and telling you about the latest breakthroughs, The Science and Research Show is on The Scope.
Interviewer: I'm talking with Dr. Diana Brixner, Professor of Pharmacotherapy and Director of the Outcomes Research Center, and Director of Outcomes for the Programs and Personalized Health at the University of Utah. I wanted to talk today about a study that you led recently looking at the elderly who, amazingly, on average take at least 14 prescribed drugs each year. What are some of the concerns about that?
Dr. Brixner: All of us have different variants of drug metabolizing enzymes, and this will have an impact on how many drugs are, in fact, metabolized. So as you can imagine, in individuals where you are not aware of what the drug metabolizing enzymes can do, you may likely under-dose or overdose an individual. It could lead to adverse drug events. It could also lead to increased drug interactions where two drugs may be overactive where you did not anticipate that.
With the elderly, they do, in fact, take many more drugs, and because they're on more drugs, then the risk of drug-drug interactions or drug-gene interactions between the drugs that are on is much higher. And therefore, using a test to determine their variants in drug metabolizing enzymes can be very valuable.
Interviewer: So what kind of test did you perform on them? I mean, it was more than just a test.
Dr. Brixner: Yes, and that's what makes this product really very interesting. It's a combination of the test, which is done via a buccal swab, and then the gene analysis is done in a certified laboratory. But the results of that test then are run through a clinical decision support tool, and the combination of the test and the support tool is called YouScript, produced by Genelex Corporation in Seattle.
And what the clinical decision support tool does is it takes in account not only the drugs susceptible to these enzymes, but in fact, all the drugs the patient is on. And therefore you get a very complete picture of drug-drug interactions, drug-gene interactions and drug-drug-gene interactions. Let me give you an example, if a patient is on a drug that has an interaction, and then has a drug metabolizing enzyme that affects another drug, it's very likely that that could lead to a drug-drug interaction you would not have ordinarily expected without knowing the genetic information from the patient.
Interviewer: And so, by taking together the results of the test with the results of this clinical support tool, you can modify somebody's drug regimen based on what you think will be least likely to have adverse reactions for that patient?
Dr. Brixner: Yes, that is ultimately the idea, and that, again, comes back to the idea of the clinical pharmacist, and the role that the clinical pharmacist can play in actually interpreting the results of the clinical decisions support tool with the provider and the patient, to then make the appropriate modifications in their therapy regimens so that the patient gets the best benefit with the least exposure to adverse events.
Interviewer: So you got some really striking results from this study.
Dr. Brixner: What we found was that, in the group that was tested, there were significantly lower emergency department visits and hospitalizations than in the group that was matched and not tested. What's interesting is that we also saw actually an increase of outpatient visits in the patients that were tested, which was counterintuitive at the outset. However, when you think about it, in fact, these results make a lot of sense. If patients are tested upfront, it's likely that patients would come in to the provider and have additional outpatient visits then, not only to review the results, but make any appropriate changes to their therapeutic regimens.
Interviewer: And the decrease in hospitalizations and emergency department visits that you saw actually took place over a pretty short follow-up period, right?
Dr. Brixner: Yeah, that's a very interesting point to bring up. Our study looked at a four-month follow-up. And, in fact, we are now currently looking at extended data out to nine months, and we would anticipate that the impact of the savings would be even greater at nine months out to a year, granted there is a point where there are no additional savings. But the other interesting point is that you only need to be tested once, and this information then can be put into the elderly patients file, and then as they bring on new drugs, or change drugs going forward through the rest of their life, this information can be used to guide appropriate treatment.
Interviewer: And you talked about savings. You mean costs savings?
Dr. Brixner: The savings was, in fact, there is the cost of the test and the clinical decisions support, but there is also then cost savings by the emergency department visits and hospitalizations avoided. So what we did using some national costing data is demonstrate that, in fact, the majority of the cost of the test is offset by the savings and fewer emergency department visits and hospitalizations.
Interviewer: So this is a test that, at this point, probably is not covered by most insurance policies, or at least by Medicare, who most of these patients would be with.
Dr. Brixner: And that was exactly why we set out to do this study in the first place. It is a very dynamic environment right now with when looking at how data should be considered for making reimbursement decisions around diagnostic tests. And that includes the test that we're talking about today, preemptive pharmacogenetic testing, as well as the gene testing for targeting drug therapy. It's a different process to look at reimbursement for diagnostic test than it is for drugs. And Medicare and other insurance companies are struggling with how this evidence should be evaluated.
Our hope was to generate enough evidence that would look potentially favorably at the inclusion of this type of a test and clinic decision support tool in managing elderly patients on several drugs or polypharmacy, that we would then go ahead and validate our findings in a larger prospective randomized trial design. It's exactly that type of study that we're working on now, based on our preliminary results to demonstrate the validity of our results in a unified population within one health care system.
Interviewer: What's your hope for where this type of work is going?
Dr. Brixner: Well, that's great question. What I would love to see is that when we do the validation study that we see trends along the same line as what we saw with our preliminary results. I then think it would really be worth considering that when the elderly come in for their annual well visit, as they enter into the Medicare health system, that they should, in fact, have this test done once, so that it's in their file to guide their future treatment regimens. To me this would be a great step forward in improving care for the elderly, and greater involving clinical pharmacists in the role of medication management.
Announcer: Interesting, informative, and all the name of better health. This is The Scope Health Sciences Radio.
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