This article is more than 5 years old. Information may no longer be current.

Digital sensor in antipsychotic may improve medication adherence

Jeffery A. Lieberman

In November 2017, the FDA approved Abilify MyCite, aripiprazole tablets with an ingestible sensor that digitally tracks whether patients have taken their medication, for the treatment of schizophrenia, manic and mixed episodes associated with bipolar I disorder and as an add-on treatment for depression.

Intended to enhance medication compliance in these patients, the tracking system works by sending a message from the pill's sensor to a wearable patch that transmits the information to a mobile app patients can access from their smartphone. If the patient gives their permission, caregivers and physicians can also access the information via a web-based portal.

To discuss the potential benefits and shortcomings of treating patients with psychiatric disorders with Abilify MyCite, Healio Psychiatry spoke with top experts in the field.

Medication adherence vital for schizophrenia, bipolar disorder

“For some persons with severe mental illness, being adherent to medications means the difference between being institutionalized or receiving outpatient care, so there are some important opportunities for this new formulation,” Dolores Malaspina, MD, director of the psychosis program, department of psychiatry, Ichan School of Medicine at Mount Sinai, told Healio Psychiatry. “An important cause of noncompliance is also executive brain dysfunction that causes persons to forget the medication and a pill with a sensor will be helpful.”

Because medication nonadherence is common among patients with schizophrenia, interventions are needed to avoid exacerbation of symptoms, relapse, functional decline and increased risk for death in these patients, according to a 2016 study published in the International Journal of Psychiatry in Medicine. However, whether Abilify MyCite can improve patient compliance with their treatment regimen remains unconfirmed.

“The question of what added value it brings and at what cost, is an unanswered question,” Jeffery A. Lieberman, MD, of Columbia University and New York Presbyterian Hospital, said in an interview with Healio Psychiatry.

“People with schizophrenia and related psychotic disorders should be taking their medicine as appropriately prescribed. Nobody would question the fact that rates of nonadherence to treat schizophrenia are high — especially in some subpopulations of people with schizophrenia,” Lieberman continued. “So, the rationale for wanting to use such technologies is clear. However, there’s no evidence yet that this technology actually improves compliance — just a hope or expectation.”

In addition, the cost-effectiveness of using this technology is unknown, as the incremental cost, and whether this expense is justified by the added value, remains to be seen, according to Lieberman.

“For too many patients it is the cost of the medication that limits their treatment, so a fancy new pill will not help these individuals,” Malaspina said.

‘Big Brother ’ and paranoid ideation

Another concern may be whether patients with schizophrenia, who may be dealing with symptoms of delusions, paranoia and fear, will be wary of taking a medication that monitors their intake.

“The Abilify MyCite formulation is intended to be able to enhance compliance, so the idea that it’s somewhat invasive and has a biosensor tracking mechanism, may play into individuals who have paranoid ideation, excessive suspicion, or other types of delusional thinking, and therefore, aggravating their delusion-driven concerns is a possibility,” Lieberman told Healio Psychiatry. “But, while a possible deterrent for such specific individuals, it shouldn’t be a reason why physicians would not use the medication for treating people who have psychotic disorders.”

Even if some patients — regardless of whether they have mental illness — are hesitant to broadcast their treatment compliance with their doctors, knowing this information seems more helpful than detrimental, Lieberman said.

“I don’t see any serious downside, but at the same time there are people, who will feel that it’s too much of a ‘Big Brother’ thing, ingesting foreign bodies to monitor their behavior, and would be uncomfortable with that,” Lieberman said. “Having said that, I, personally, would have no hesitation recommending it if I thought it was useful.”

Aripiprazole may not be the best fit

Furthermore, using this tracking technology in aripiprazole particularly may not be ideal because of its (parent drug and metabolites) long half-life of about 96 hours and its duration of action, according to Lieberman. Using this compliance technology with clozapine or quetiapine, which both have very short half-lives, may be more beneficial.

“If you think about what medications this technology would be best combined with, it’s mainly medications that have a short duration of action so that if you missed a dose or stopped taking the medicine, the effects of the drug would dissipate very quickly,” Lieberman said. “If you’re taking [aripiprazole] on a regular basis, you’re accumulating a reservoir of medication that will take several weeks to wash out even if you stopped cold turkey.”

It should be noted that the FDA has issued Abilify MyCite a Black Box warning for its association with compulsive behavior. According to the FDA, the Boxed warning also warns about an increased risk for death among elderly patients with dementia-related psychosis treated with antipsychotics and risk for suicidal thinking and behavior in children, adolescents and young adults taking antidepressants.

Individualized treatment needed

A review published in Neuropsychiatric Disease and Treatment examined 22 clinical articles to determine the role of support services in promoting medication adherence in patients with schizophrenia. According to the findings, support-service intervention strategies, such as electronic reminders via text messages, need to be tailored to the specific needs of these patients.

Malaspina agrees, noting patients with mental illness require a treatment approach that is individually tailored to them, which can only be achieved when they trust their clinician. Abilify MyCite is “just another tool,” she said.

“It’s something that some patients with their symptoms or their sensitivity may object to, and it just happens the technology is combined with a drug that probably doesn’t need it as much as other drugs,” Lieberman said. “I think the symbolic value is notable. As for the practical value, I really can’t say because it depends on the price and how well it actually works to improve compliance. But, at the same time, I think it’s worth trying, particularly in people who are unreliable in taking their medicines.” – by Savannah Demko

References:

El-Mallakh P, Findlay J. Neuropsychiatr Dis Treat. 2015;doi:10.2147/NDT.S56107.

Phan SV. Int J Psychiatry Med. 2016;doi:10.1177/0091217416636601.

Disclosures: Lieberman reports no relevant financial disclosures. Healio Psychiatry was unable to confirm any relevant financial disclosures at the time of publication.