FDA approves digital pill that alerts doctors when you take your medicine

FDA approves the first pill that can alert your doctor when you swallow it

Regulators in the USA have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, offering a new way of monitoring patients but also raising privacy concerns. The information can be shared with up to four caregivers and doctors, with the consent of the patient.

The medicine is a version of Otsuka Pharmaceutical Co Ltd's established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking device developed by Proteus Digital Health.

In the United States approved a "smart" pill with a sensor inside.

Before a patient uses Abilify MyCite for the first time, clinicians must facilitate use of the medication, patch, and system to ensure the patient is able and willing to use it.

The medicine, however, is not used to treat patients who suffer from psychosis related to dementia. For instance, patients could feel pressured to use the brand-name digital tracking drugs by doctors or insurance companies. "Is the doctor going to start yelling at me? How will that interaction be handled?" They can also indicate through the app which members of their care team have access to information about their medication ingestion, activity and self-reported mood and rest.

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

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The path to FDA approval has not been without problems, and despite each individual element (the drug and the sensor) already being approved by the FDA separately, the approval process for the Abilify MyCite has been delayed by FDA queries about the product's use and safety. If a digestible chip can send the necessary information to a doctor's office, perhaps there might be less need for home-visit nurses-interactions that can be very useful on their own, health professionals say.

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

Otsuka hasn't indicated how much the digitized Abilify pills will cost yet.

But people with schizophrenia and bipolar disorder can also have impaired executive functions, including short-term memory, and may forget to take-or forget if they've taken-their medication for the day.

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".

Now, however, the technology has been integrated directly into a pill and can be marketed-along with a wearable patch and a mobile application-for the treatment of specific health conditions.

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