Author: Anna Shajee Edited by: Ruchi Maniar
The U.S. Food and Drug Administration recently approved the first drug of its kind – a pill that includes a digital ingestion tracking system. Currently known as the ‘Abilify MyCite’ (aripiprazole tablets with sensor), it has an ingestible sensor embedded in the pill that records that the medication was taken. This treatment has been approved specifically for patients with mental illness to ensure that they are adhering to their prescriptions. Creators of Abilify MyCite claim it will constitute a new mode of treatment for physicians during the course of “treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults" (1,2).
Abilify MyCite was first approved by the FDA in 2002 to specifically treat schizophrenia (1,3,4). The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012 (1,2,3). The FDA granted the approval of Abilify MyCite to Otsuka Pharmaceutical Co., Ltd. According to Otsuka, this sensor is the "size of a grain of sand, and is made up of ingredients found in food"(3).
Schizophrenia is a psychotic disorder, which includes symptoms of delusions and hallucinations. This chronic and severe mental disorder affects how a person thinks, feels, and behaves, and often schizophrenic patients may feel like they have lost touch with reality. Although schizophrenia is not as common as other mental disorders, the symptoms can be very disabling. Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. There are four basic types of bipolar disorder; all of them involve clear changes in mood, energy, and activity levels. These patients may experience alternating episodes of mania and depression. Patients with bipolar disorder and schizophrenia can also have impaired executive functions, including short-term memory, and may forget to take—or forget if they’ve taken—their medication for the day (8). Hence, the idea behind a sensor-based medication could prove valuable.
Digital Ingestion Tracking
First digital pill approved by the FDA
The Abilify MyCite functions by creating signaling between the pill’s sensor and a patch worn by the patient on his/her skin. The sensor used for this mechanism, developed by Proteus Digital Health, and is activated by stomach fluids to send a signal to a patch worn on the patient’s torso. This in turn transmits the information to a smartphone app (2,4). As soon as the pill comes into contact with fluids in the stomach, the sensor is activated and this is communicated to the MyCite Patch. Finally, the sensor is digested and eliminated from the body. The MyCite patch detects and records the date and time when the tablet was detected in the stomach, in addition to physiological data, such as the patient's activity level. The patch communicates all of this to the MyCite App on a compatible mobile device, such as a smartphone. Self-reported mood information can also be shared via the app, if the patient chooses. The information received can be monitored by the patients as well as their caregivers, if given consent by the patients.
While the majority of the health industry are embracing this new technology, others worry about protecting patient privacy as more data is generated and shared. Patients who are prescribed to the Abilify MyCite have to provide consent so that their physicians can see their data. The patient can also choose whether or not to share information with caregivers, such as family members. Otsuka Pharmaceutical and certain insurers also plan to gather anonymized, aggregated data from patients who consent. A price for the drug has not yet been established (4).
Though the idea behind Abilify MyCite is to improve a patient's compliance with their medication regimen, the drug cannot be used to track ingestion of a medication in real-time and delays may occur in tracking the drug's mechanism (5). Safety and effectiveness has not been established in pediatric patients, and neither is Abilify MyCite approved to treat older patients with dementia-related psychosis.
Although the Abilify MyCite is the first digital pill approved by the FDA, it is not the only connected medical product to the new era of digital medicine (6). Other technologies include devices that can tell if a patient has had an epileptic seizure, monitor blood glucose in diabetics, or allow patients to have a constant communication with their physicians outside of a hospital setting. As more devices monitor patients’ behavior and collect data, experts see the potential for better care, as well as privacy risks.