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Doctors will now be able to prescribe medication that digitally relays the date and time patients take it. In early November, the FDA confirmed that it had approved a digitally-enabled version of Abilify, an antipsychotic pill. The new medication, called Abilify MyCite, was created by pharmaceutical manufacturer Otsuka in conjunction with Proteus Digital Health. It contains a sensor made of digestible materials which, once taken, signals a disposable adhesive patch worn on the ribcage. The patch broadcasts the date and time of ingestion to a cellphone app, from which patients can list their mood and hours slept before the data is sent to doctors.

Approval of Abilify’s digital pill is the latest in a series of innovations designed to remedy the issue of prescription nonadherence. A review in the Annals of International Medicine estimates that patient noncompliance contributes to around 125,000 US deaths annually, and costs the American healthcare system anywhere from $100 to $289 billion per year in treatment for patients whose conditions worsen as a result of breaking medication schedules.  

There are, however, concerns among researchers and medical providers as to whether a pill that monitors its patients can actually improve compliance, especially since the medicine in question is Abilify—a treatment for controlling symptoms like extreme paranoia and hallucinations. A few, such as Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University, wonder if schizophrenic patients would actually be willing to ingest a “tattletale” medication.

“There’s an irony in it being given to people with mental disorders that can include delusions,” Lieberman said. “It’s like a biomedical Big Brother.”

While the monitoring function of Abilify’s new pill cannot be utilized without patient consent, and consent can be rescinded at patients’ behest, Dr. Paul Appelbaum—director of law, ethics and psychiatry at Columbia University’s psychiatry department—said that many suffering from psychosis may already neglect their medication because they don’t believe they are unwell, or are paranoid of doctors’ intents. In response to questions regarding potential breaches of patient privacy, Otsuka representatives noted that the monitoring functions of Abilify MyCite can only work if patients are willing to use the app and patch. Otsuka believes the medication will appeal to patients looking to prove their compliance, or build trust with a psychiatrist.

Proteus’s digital sensor has previously seen limited commercial use since it passed clinical trials in 2016, but it had never been embedded in a pill before Abilify. However, several states have started prescribing the sensor for certain conditions, such as hepatitis C, and it has been found to increase compliance in patients with hypertension. Another successful medicine documentation tool is AICure, which allows patients to record their medication habits via smartphones’ video function. AICure has proved successful in prompting tuberculosis patients to remember their medication, and the product has the potential to provide greater freedom to patients with conditions like schizophrenia, who would otherwise have to be directly observed taking their medication.