Published: Thu, November 16, 2017
Hi-Tech | By Joan Schultz

Digital pill that tracks when patients take their medication approved in US

Digital pill that tracks when patients take their medication approved in US

In a historic move by the US Food and Drug Administration (FDA), the first ever digital pill has been approved for use. 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. Patients can sign up to have a doctor and up to four people receive alerts.

However, the makers behind it, Japanese company Otsuka Pharmaceutical, developed a new version called Abilify MyCite that comes with a tiny ingestible sensor inside each pill.

The "digital pill" was approved in the U.S. but not in Australia. A spokesperson told the publication the FDA is planning to hire more staff with "deep understanding" of software development in relation to medical devices, and engage with entrepreneurs on new guidelines. It is also not approved for use in pediatric patients, and may increase suicidal thinking and behavior in children, adolescents, and young adults.

"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".

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"It's truth serum time", Arthur Caplan, a medical ethicist at NYU's Langone Medical Centre said.

While the technology may seem useful, many are concerned it will lead to a slippery slope of ethical and privacy issues, including law enforcement and insurance agencies monitoring drug usage and adding legal reprimands or additional copays for missed pills, according to The Verge. "How will that interaction be handled?" Self-reported mood information can also be shared via the app, if the patient chooses.

"Could this type of device be used for real-time surveillance?"

Smart pills are a thing and they've come one step closer to entering the mainstream after the FDA approved a pill packed with a digital sensor for the first time in the US. "The answer is of course it could", Professor Giordano said.

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Drugmakers frequently reformulate their drugs to extend their patent life and to justify raising prices.

Otsuka already sells a long-acting injectable version of Abilify meant to last for one month. The sensor technology and patch are made by Proteus Digital Health.

In Australia, Abilify is used to treat symptoms of schizophrenia and mania in bipolar disorder.

In the same article, Eric Topol, MD, director of Scripps Translational Science Institute, predicted that payers might eventually offer financial incentives to use digital bills, but anxious about the ethical issues that could present themselves if the if the technology was "so much incentivized that it's nearly is like coercion".

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