FDA Approves First Pill With Digital Tracking System

FDA Approves First Pill With Digital Tracking System

FDA Approves First Pill With Digital Tracking System

The Abilify pill was first approved by thee Food and Drugs Administration (FDA) back in 2002, to treat schizophrenia and the sensor technology was approved for marketing in 2012.

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the USA each year in "caring for health conditions that are attributable to nonadherence".

"It is important to note that Abilify MyCite's prescribing information (labeling) notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown", the FDA said in the November 13 statement.

"The 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", he added.

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The tracking system provides a way for doctors to objectively measure if patients are sticking to their medication schedules, opening doors for monitoring medicine intake methods in other areas of medicine and health care.

Although the sensor can alert caregivers, the makers of Abilify, Japan-based Otsuka Pharmaceutical, said it is unclear whether the tracking device will actually help improve patients' ability to take their medication daily as prescribed.

Whatever way you look at it, this is a major breakthrough for digital health and we're sure now that the FDA has approved one smart pill, we'll soon be flooded by more of them over the coming years.

"H$3 aving fewer people using the system initially means their prescribers, health plans, and Otsuka can focus on learning from these patients' experiences", the company said in its announcement.

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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.

The system has three main components: the pill itself, a patch that detects and records the time and date the pill was ingested and tracks other physiological data, and a smartphone app that allows gathered data to be viewed. In the drug's label, for instance, the FDA noted the wearable patch detects the IEM signal usually within 30 minutes following ingestion. Patients can also grant healthcare providers access to the information through an online portal. "If the MYCITE APP does not indicate that the ABILIFY MYCITE tablet was taken, do not repeat the dose". Patients should be monitored for worsening and emergence of suicidal thoughts and actions.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", Mitchell Mathis, M.D., director of the division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

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