The FDA has approved the first pill to feature a digital sensor, Abilify MyCite, designed to track a patient's medication adherence.

Pill Capsule

The US Food & Drug Administration has approved a new version of Abilify that manufacturer Otsuka Pharmaceuticals says will be able to track whether or not a patient has taken it. Used to treat schizophrenia and bipolar mania, the new pill, dubbed Abilify MyCite, contains a small sensor that communicates with an external patch worn by the patient. From there, data on the drug's ingestion can be sent to an app where patients can input their mood and then, with the patient's permission, a database accessible to their physicians.

New Digital Pill Could Improve Medication Adherence

Around 70% to 80% of people who have schizophrenia can be effectively-treated with antipsychotic medications, like Abilify, The Mighty reports. But maintaining consistent treatment can be difficult. About 50% of patients who are prescribed antipsychotics for long-term therapy do not adhere to their medication regimen, according to researchers in the World Journal of Psychiatry.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients," notes Dr. Mitchell Mathis, who currently serves as director for the FDA's Division of Psychiatry Products. There's still no evidence, however, whether or not the tracking system actually gets people to take their medication more regularly.

Abilify MyCite is the first drug with a digital sensor to gain US approval, the FDA says, making clear that the pill's prescribing information "notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown."

Black Box Warnings

Abilify MyCite will become available in 2018. It's been approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar 1 disorder and as an add-on treatment for depression in adult patients.

The drug is being released with a black box warning, informing care providers that use in elderly patients with dementia-related psychosis increases the risk of death. A second boxed statement warns that use in children and young adults already taking an antidepressant could increase the risk for suicidal ideation or suicidal behavior.

Critics Say Tracking Patient Behavior Is "Coercive"

Beyond these stated risks, a number of mental health advocates have criticized the concept behind MyCite, a trackable pill that warns doctors about missed doses, is overly-coercive. A story in the New York Times suggested that MyCite could turn out to be a "biomedical 'Big Brother.' "

As currently envisioned, patients would be able to sign a consent form and allow their doctors, along with four other people, to receive notifications on the date and time a pill is taken. The phone app that comes along with MyCite will let patients block data transmission at any time. Again, Abilify MyCite is completely elective, but that could actually pose problems for its adoption.

Will Patients Choose To Be Tracked?

Abilify, after all, is used to treat patients with schizophrenia and other disorders with psychotic symptoms. "Many of those patients don't take meds because they don't like side effects, or don't think they have an illness, or because they become paranoid about the doctor or the doctor's intentions," according to Paul Appelbaum, MD, a professor of psychiatry from Columbia University who spoke to the Times.

Under these circumstances, how likely is it that patients struggling with paranoia will choose to take a pill that records their actions and transmits signals to other people?

The Legal Herald

About Laurence Banville

Attorney Contributor:

Laurence P. Banville, Esq. is the managing partner of Banville Law. He is a regular contributor on several topics including negligent security cases, child sexual abuse and Dram Shop and liquor liability cases.

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