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article imageFDA Approves Pill With Digital Tracking System

By Karen Graham     Nov 14, 2017 in Health
The Food and Drug Administration (FDA) has approved the first digital pill for the US which tracks if patients have taken their medication. The pill called Abilify MyCite is fitted with a tiny indigestible sensor.
Abilify MyCite was developed by Otsuka Pharmaceutical Co., Ltd. Abilify was first approved by the FDA in 2002 to treat schizophrenia, and the ingestible sensor, made by Proteus Digital Health, was initially approved for marketing in 2012.
Abilify MyCite is a Digital Medicine System that includes Otsuka's oral aripiprazole tablets embedded with an Indigestible Event Marker (IEM) sensor, a wearable patch worn by the patient, and the Mycite app (a smartphone application); and web-based portals for healthcare providers and caregivers.
The system is meant to ensure compliance in patients with certain serious mental health disorders. The tracking system tracks ingestion of the medication, activity levels, and sleep patterns, as well as self-reported rest and mood which, with patient consent, can be shared with the healthcare provider and selected members of the family and care team.
The sensor is no bigger than a grain of sand and is made of silicon, copper, and magnesium. An electrical signal is activated when the sensor comes in contact with stomach acid. It will then pass through the body naturally. The patch is worn on the left rib cage and receives the signal from the sensor several minutes after the pill is ingested.
Information from the patch is then sent to a smartphone app over Bluetooth. It will record the time the pill was taken, the dosage, as well as activity levels and heart rate. The patient’s doctor and up to four other people chosen by the patient, including family members, can access the information. The patient can revoke access at any time.
Concerns over invasion of privacy
Some experts are concerned that digitally tracking patient compliance in taking medications could lead to punishing patients who don't comply and is akin to an invasion of patient privacy. Ameet Sarpatwari, an instructor in medicine at Harvard Medical School told The New York Times the digital pill “has the potential to improve public health. [But] if used improperly, it could foster more mistrust instead of trust.”
Despite the concerns, the FDA is already anticipating a surge in approval requests for other digital pill systems. An FDA spokesperson said the agency is planning on hiring more staff with a "deep understanding" of software development in relation to medical devices, as well as engage with entrepreneurs on new guidelines.
Otsuka has not indicated how much the new digital pill system will cost. They first want to work with insurers in covering the digitized pills. The company will only ramp up production if it can find willing insurers.
More about digital pill, FDA approval, Proteus Digital Health, Smartphone, spoftware
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