Because adherence to prescribed antipsychotics by patients with serious mental illness such as schizophrenia is so low, new clinical recommendations have been released on when and how to use urine testing procedures to help monitor adherence.
Investigators carried out a literature review of 17 reports, conducted semistructured interviews with clinicians from nine community mental health clinics (CMHCs), and then convened a panel of physician experts to make recommendations on the monitoring of urine to determine adherence to antipsychotic drug regimens.
The panel’s consensus describes six clinical scenarios in which this type of monitoring should be conducted at the first evaluation and five scenarios in which monitoring is recommended following the initial evaluation. The panel recommends that monitoring be conducted at the site where the medication is prescribed, that education be provided before testing, and that feedback be provided afterward.
“There was strong agreement that monitoring can be used to improve assessment and thence clinical care and outcomes,” write the investigators, led by Amy N. Cohen, PhD, Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles (UCLA).
Dr Amy Cohen
“I think the take-home message is that this strategy was very acceptable by patients. And across the board, all of the clinicians we talked to said that it was really helpful and opened up a dialogue with the patient,” Dr Cohen told Medscape Medical News.
She noted, though, that this is an “initial clinical consensus” and that more research is needed, including pilot studies in which the recommendations are compared with other adherence methods.
“That kind of comparison is important before there’s widespread incorporation of these guidelines,” she said. That said, “providers found urine-adherence monitoring to be extremely helpful, and it saves time. I’d recommend that it’s an avenue to be explored in community mental health clinics,” said Dr Cohen.
The full consensus recommendations were published online December 15 in Psychiatric Services.
“Vexing Challenge”
It has been estimated that 50% of patients do not follow their antipsychotic drug regimens, write the investigators. Yet, adherence could lead to substantial savings. For example, $1600 per patient with schizophrenia per year in Medicaid and criminal justice costs could be saved with better adherence, they write.
However, examining adherence “presents a vexing challenge,” they note. Both patient self-reports and clinician estimates have not been reliable, and there is a need for objective measures.
Beginning in 2013, “there have been urine testing technologies that simultaneously detect illicit substances as well as ingested medications and estimate levels of certain antipsychotic medications,” including aripiprazole, quetiapine, and risperidone, the researchers report. “However, there has been no consensus regarding effective implementation of this technology at mental health programs to improve adherence and guide treatment.”
“When we learned a bit about urine monitoring and knew that a variety of community clinics were using it, we wanted to explore how they were using it and if they were using that data to change care treatment plans,” said Dr Cohen.
The researchers used the RAND/UCLA Appropriateness Method in their search for consensus. This method is becoming popular “when there is inadequate evidence from controlled trial research,” they write.
They first reviewed 13 articles published between 2014 and 2017 and four unpublished reports. All of the articles addressed antipsychotic drug adherence, including urine monitoring.
As expected, the review showed that patient self-report and clinician assessment of adherence did not match objective measures, such as electronic or blood plasma monitoring.
The investigators also conducted telephone interviews between January and September 2016 with 13 clinical experts (11 physicians, one nurse, one counselor) from nine CMHCs in six states. All of the CMHCs were already “substantially” using urine-monitoring technology for assessing antipsychotic adherence, although not all used it at initial evaluation.
In light of this, the researchers convened a 1-day in-person meeting in September 2016. Nine individuals were invited to participate, but only four were able to do so. These two men and two women were all physicians and were from four states.
Before the meeting, the researchers created 46 hypothetical clinical scenarios, or “indications,” to be discussed.
“The indications were designed to be comprehensive, homogeneous, and manageable,” write the investigators. For each of the indications, the panel members rated three aspects: appropriateness to the population; impact on patient treatment, symptoms, and functioning; and feasibility in typical community mental health care. Each aspect was rated on a scale of 1 to 9. For appropriateness, a rating of 1 indicated extremely appropriate, and a rating of 9 indicated extremely inappropriate. For impact on patient treatment, 1 indicated highly unlikely, and 9 indicated highly likely. For feasibility, 1 indicated extremely difficulty, and 9 indicated very easy.
15 Top Indications
Results showed that 15 of the scenarios scored at least an average rating of 7.0 on all three aspects, indicating “usually appropriate,” “probably likely,” and “generally easy,” respectively.
The six indications for monitoring at the time of initial evaluation are as follows:
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The patient has an established diagnosis of a serious mental illness.
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The patient presents with new symptoms of a serious mental illness.
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The patient has a serious mental illness and is at risk for poor adherence.
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The patient has a serious mental illness and is homeless.
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The patient has a co-occurring substance use disorder.
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The patient is elderly.
Recommendations for repeated monitoring include the following:
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Patients should undergo repeat monitoring when there is concern about a previous monitoring result.
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Repeat monitoring is recommended when there is a change in the patient’s situation, such as in level of care or living requirement, that may require medication reconciliation.
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Repeat monitoring is recommended when the patient experiences clinical deterioration or does not respond adequately to treatment.
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The panel recommends that periodic testing be conducted, either at set intervals or on random occasions.
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The panel recommends that for stable patients, testing be conducted at least annually.
The panel also made the following recommendations:
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Urine should be collected on site where the medication is prescribed.
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Verbal or written education should be provided on possible costs and the importance of treatment adherence before urine monitoring is conducted.
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After testing, patients should be informed of the results.
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A clinician should be available to address any patient concerns.
“Education and quick feedback of the results came up a lot during the consensus meeting,” said Dr Cohen. She noted that several of the clinics have already developed pamphlets explaining urine monitoring that can be handed out.
“It goes along with the whole idea of patient-centered care, recovery-oriented care in today’s environment.”
She noted that some patients don’t realize that they are noncompliant with their medication regimens because they misunderstand treatment instructions or they do not realize that missing even a few doses here and there makes a difference.
“But if they know that someone is going to check, they think, ‘I better get it together and pay attention.’ The people who used this technology said they really did see differences in their patient population in terms of improved adherence, and they felt that it was very easy to use,” she said.
Obstacles in implementing urine monitoring procedures included “integration with an electronic medical record, use within clinic workflow, and limited staff resources,” write the study authors.
“Future directions should include research studying the comparative effectiveness of urine monitoring and alternative strategies for assessing medication adherence” in these patients, they add.
“Wakes Us Up”
Asked to comment, Thomas N. Wise, MD, professor of psychiatry at Virginia Commonwealth University, the Johns Hopkins University School of Medicine, and the George Washington University School of Medicine, told Medscape Medical News that “this is a good report that wakes us up to better approaches” for measuring adherence.
Dr Thomas Wise
He added that it’s also a good reminder that treatment resistance could be due to patients not taking medication, not because the medication wasn’t effective.
Overall, the new recommendations “make sense,” said Dr Wise. He noted that increased adherence could save a substantial amount for each state. “We’re going to have to look at the costs of doing urine tests; but the more we do them, the unit price should come down,” he said.
“This is actually a pretty big deal. I suspect many people weren’t aware of these urine tests, so this is an important article.”
Dr Wise also said that the investigators’ use of different scenarios was “a clever methodology…. I’m just disappointed that more [clinicians] did not respond, but this certainly looks like a valid adherence measure,” he said.
“There still needs to be more work done and more data” before organizations such as the American Psychiatric Association (APA) adopt the measure or recommendations as part of their guidelines, said Dr Wise.
But he can see this area as something the APA’s Committee on Mental Health Information Technology would delve into.
“The investigators say that this isn’t the final answer, but they do point out a really important area ― and they’re continuing an important conversation.”
The study was funded by Ameritox, Ltd. Dr Cohen has received research support from Ameritox. The original article includes a full list of disclosures for the other study authors. Dr Wise has been a consultant with Asuka.
Psychiatric Services. Published online December 15, 2017. Abstract
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