FDA Approves Pill That Can Track If Patients Swallow It

Although now approved, Abilify MyCite will carry a warning in its labelling stating that the system has not been shown to improve patient compliance and that it "should not be used to track drug ingestion in "real-time" or during an emergency because detection may be delayed or may not occur".

The newly approved pill is called Abilify MyCite, and it's created to sense when patients have taken their dose of Abilify, an antipsychotic that is commonly used to treat mental disorders such as schizophrenia and bipolar disorder. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Furthermore, doctors and health care providers can get permission from their patients to access the drug tracking data through an online portal.

"Being able to track ingestion of medications prescribed for mental illness may be useful for some patients", said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. For instance, patients could feel pressured to use the brand-name digital tracking drugs by doctors or insurance companies.

The FDA approved usage of sensors in oral medication back in 2012, and some capsules have added sensors, but Abilify is the first where the sensor has been embedded directly in the pill.

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 US healthcare system an estimated $200 billion per year.

The wearable patch was developed by California-based Proteus Digital Health.

Proteus isn't the only firm working on such a digital drug system-they have a lot of company.

The digital pill
Digital Health

In 2014, the World Health Organisation (WHO) reported that around 50 percent of patients on prescription medications do not take their drugs as directed.

This sensor is the "size of a grain of sand, and is made up of ingredients found in food", according to Otsuka. And as with most technological steps forward, it also raises questions about privacy, bioethics, and the use of big data from inside your body.

"Technology will revolutionize behavioral healthcare and this advancement is simply the beginning of the digital transformation", said Birnbaum, who was not involved in the development or approval of the new medication system.

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

The Wall Street Journal reports that the FDA is anticipating a potential raft of approval requests for other digital pills.

The landmark approval is the latest in an expansive rethinking of what constitutes a treatment.

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