FDA Approves First Digital Pill to Track Medication Adherence

The US Food and Drug Administration (FDA) has approved a pill equipped with a sensor that is capable of digitally tracking whether or not patients are adhering to their medications; this is the first drug in the United States with a digital ingestion tracking system.

According to the FDA, patients do not take their medications as prescribed in about 50% cases. In fact, 20% to 30% of new prescriptions are never even filled at the pharmacy. These actions have consequences; the Centers for Disease Control and Prevention estimates that non-adherence to prescribed medication results in 30% to 50% of chronic disease treatment failures as well as a staggering 125,000 deaths each year in the United States.

The repercussions of not adhering to prescribed treatment regimens do not stop there—according to experts who recently spoke with the New York Times, noncompliance to medication can result in $100 billion a year, mainly due to patients growing sicker and requiring additional treatment or even hospitalization.

“When patients don’t adhere to the lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly,” William Shrank, MD, chief medical officer of the Health Plan Division at the University of Pittsburgh Medical Center told the news outlet.

As of right now, approved use of Otsuka and Proteus’ product, Abilify Mycite, pertains mostly for the treatment of a variety of mental disorders, such as schizophrenia, bipolar I disorder-associated manic and mixed episodes, as well as an add-on treatment for adults who have depression, according to the official FDA news release.

“Being able to track ingestion of medications prescribed for mental illness may be useful for some patients,” Mitchell Mathis, MD, director of the FDA’s Center for Drug Evaluation and Research’s Division of Psychiatry Products said in the news release.

So, how does it work? The pill, equipped with a sensor, sends messages to a wearable patch, which then passes the message to a mobile application that allows patients to “track the ingestion of their medication” via their cell phones. The information is also accessible—per the patient’s permission—via a web-based portal for physicians and caregivers to access as well. Patients have the option to change their mind and block recipients at any time.

Other digital devices developed to monitor if patients are taking their medicine are in the works, and not all will require regulatory clearance. These devices include ingestible sensors, like Abilify Mycite, as well as technology capable of “confirming whether a patient has placed a pill on the tongue and swallowed it,” according to the article in the New York Times. Some of these devices are already being tested in patients suffering from heart problems, diabetes, or HIV.

For those with HIV, it can be particularly difficult to adhere to their treatment regimens for several reasons, including busy schedules with a lot of traveling, unstable living conditions, other illness or depression, and lack of health insurance. Therefore, a device that includes a patch or uses a phone app, could help these individuals remember to take their medication.

Another technology, AiCure, has proven beneficial to patients with tuberculosis. AiCure is an artificial intelligence platform that uses HIPAA-compliant facial recognition to confirm ingestion of prescribed medications in real-time, and has already proven successful in tuberculosis patients who had been treated by the Los Angeles County Health Department.

According to the news outlet, the choice to begin with Abilify is unusual, as many patients with the mental disorders that the device was approved for often do not take medications regularly. In addition, because those with schizophrenia often experience delusions or paranoia, doctors are wondering if a device with tracking capabilities will be accepted in this population.

Nonetheless, Abilify Mycite will be available to a limited number of health plans next year, Otsuka’s vice president for digital medicine Andrew Wright, told the news source. As of right now, little is known regarding if the device will work to improve adherence, a factor that will likely dictate if this technology will receive widespread pickup.