FDA Approves First Digital Ingestion Tracking System Med


The Food and Drug Administration has approved the first drug in the United States to come with a digital ingestion tracking system.

In a statement issued in May, when the FDA accepted the submission of the product for review, the company said "with the patient's consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs".

The treatment is called Abilify MyCite, which is meant to treat schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder, and for use as an add-on treatment for depression in adults.

Using Abilify MyCite to track drug use in real time or in the event of an emergency is not ideal, however, as there may be a delay or problem in the detection. The pill is embedded with a tiny sensor about the size of a grain of sand that lets doctors know if and when a patient has taken their medication.

Abilify MyCite could be particularly useful for older patients who may welcome the ability to share their medication information with others, but has also raised concerns about the ability to effectively track patients.

The drug was developed by Otsuka Pharmaceutical co. and the sensor by Proteus Digital Health.

The sensor in the pill activates and communicates to the wearable patch when it comes in contact with stomach fluid, and then is digested and eliminated. It will record the time the pill was taken, the dosage, as well as activity levels and heart rate. Web-based dashboards are provided to healthcare providers and caregivers to view a summary of the information. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest.

Pills with digital tracking systems are said to be under consideration for other conditions.

"The FDA supports the development and use of new technologies in prescription drugs, and is committed to working with companies to understand how technology can benefit patients and prescribers", said Mitchell Mathis of the FDA's Center for FDA Drug Evaluation and Research.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, said the digital pill has the potential to improve public health, but warned it could foster more mistrust if used improperly.

The study found this a "feasible method to measure real-time opioid ingestion patterns in individuals with acute pain and to develop real-time interventions if opioid abuse is detected".