FDA Approves First Digital Tracking Pill In The US

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet.                  Proteus Digital Health

The sensor embedded in the pill sends information to the wearable patch that can be accessed on a phone or tablet. Proteus Digital Health

Patients are given the option to sign a consent form allowing their doctor and up to four family members or care-givers to receive information about when the pills were taken.

But adherence to prescribed dosing is a big problem, one that some drugmakers have tried to battle for years; patients who don't take their medications don't refill their prescriptions. This is then transmitted to a mobile phone app, allowing patients to track their own compliance and share this data with caregivers and doctors.

USA regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology. The signal is detected by a plaster-like patch worn on the left hand side of the patient's rib cage which must be replaced every seven days, Andrew Wright, the drug maker's parent company Otsuka America's vice president for digital medicine told the New York Times.

It was Otsuka and Proteus' second try at the FDA for the digital version of Abilify.

While a patient can block transmissions via a smartphone app, the technology is still likely to prompt questions about privacy.

Applying technology directly into the medicines themselves is a more cutting-edge approach, but one that is clearly gaining traction, as evidenced by the FDA's approval of Abilify MyCite (aripiprazole tablets with sensor).

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In combination though, the Abilify MyCite system was rejected by the FDA in April a year ago due to concerns over the possible impact of "human factors" on safety.

The company notes that Abilify MyCite is meant to track drug ingestion, pointing out, "The ability of Abilify MyCite to improve patient compliance or modify aripiprazole dosage has not been established". Web-based dashboards are provided to healthcare providers and caregivers to view a summary of the information.

"Being able to track ingestion of medications prescribed for illness may be useful for some patients", Dr. Mitchell Mathis of the FDA said in statement.

There's good reasons as to why tracking whether people living with schizophrenia take their medication could be helpful. Patients should be monitored for worsening and emergence of suicidal thoughts and actions.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions. "FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers".

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".

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