US 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.
Otsuka said that the pairing of the sensor with the antipsychotic Ability was created to allow patients with schizophrenia, bipolar I disorder or major depressive disorder to better track their daily medication intake and share that with their care team - which they can control through the linked app. The new pill, called Abilify MyCite, contains an ingestible sensor that can help patients (and their doctors and caregivers) keep track of whether they are taking their medication as directed. At first techno-blush, concerns about Big Brother tapping one's body fall to the wayside; patients can voluntarily give access to the information gathered by the sensor to their doctor and designated family members or caretakers.
"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", Mitchell Mathis added.
But, so far, there's no evidence that Abilify MyCite improves drug adherence, the FDA emphasizes. The FDA noted that product is not for use in emergency or real-time situations, as detection could be delayed or not occur.
The technology is the product of research between Japanese pharmaceutical company Otsuka and Proteus Digital Health, and is created to solve the problem of people missing medicine doses, which costs the USA healthcare system an estimated $200 billion per year. Proteus Digital Health, based in Redwood City California, makes the sensor.
Here's how the system works: The ingestible sensor inside of the pill is activated by stomach fluids.
The FDA hopes the new pill will help ensure patients with mental disorders will take their medication.
The technology carries risks for patient privacy too if there are breaches of medical data or unauthorised use as a surveillance tool, according to James Giordano, a professor of neurology at Georgetown University Medical Centre. A person who suffers from this mental disorder appears to be out of touch with reality. However, Abilify MyCite is the only version now approved with the digital tracking system.
The landmark approval is the latest in an expansive rethinking of what constitutes a treatment. The pill is one way to address the prevalent problem of patients not taking their medication correctly, with the IMS Institute estimating that the improper and unnecessary use of medicine cost the U.S. healthcare sector over $200 billion in 2012.