"Smart Pill" Sensors Monitor Medication Adherence

November 20, 2014

The first FDA-approved "smart pill" documents medication adherence and physiologic response.

Every evening, Laura calls her aging mother, Mary, who lives an hour away, to see if she remembered to take her medications and find out how she’s feeling. Laura wishes she could be there to do more for her mother. If only her mother lived closer, she could make sure she’s taking her meds, as well as assist in her care.

This is a common problem for many families, in which elderly parents live just far enough away that their adult children can’t help them with their day-to-day care.

Mary would like to remain independent, but her family worries she might be forgetting to take her medications, and they would like to be able to check on her more often.

Enter the “smart pill” with e

dible sensors to monitor adherence.

Laura’s pharmacist tells her about a new FDA-approved medical device that may be helpful in this situation. It is an ingestible sensor in a “smart pill” or digital medicine her mother can take alongside her oral prescription medicines that will communicate to Laura and Mary’s doctor that her dose was taken. It will also send information about Mary’s activity levels and rest.

The FDA-approved ingestible sensor measures 1 mm square and is comprised mostly of silicon and food materials.

The company that makes the technology, Proteus Digital Health, has created an ingestible sensor delivered inside small, inactive tablets that gather information and communicate it to a disposable, battery-operated patch worn on the torso.

The ingestible sensor tablet is taken at the same time as the patient’s prescribed oral medications, and it becomes activated when in contact with fluids within the stomach. The wearable patch receives information from the ingestible sensor and sends the digital health information to a mobile application via Bluetooth.

The system is designed to detect dose timing and associated physiologic response including heart rate, activity, rest, and skin temperature. Only those who have permission, such as family and health care providers, will be able to see the confidential health information via a password-protected website.

Depending on the pharmacy’s capabilities and the physician’s prescription, the ingestible sensor is dispensed in 1 of 3 ways:

  • Using stand-alone packaging, where the patient ingests 1 sensor-enabled inactive tablet each time they take their prescribed active medication.
  • Packaged in specialty blister packets or sachets, where 1 sensor-enabled inactive tablet is dispensed in the same compartment as 1 dose of the prescribed active medication.
  • Inside capsules that co-encapsulate a sensor-enabled inactive tablet and the active medication of interest.

For now, the Proteus tablet that contains the ingestible sensor is marketed as a medical device. Proteus Digital Health is working to create a new category of products called Digital Medicines, and has partnered with Novartis and Otsuka Pharmaceuticals to do so. These products will integrate the sensor with the active pharmaceuticals, though additional regulatory approvals are required.

The Proteus tablet and similar products with further enhancements have the potential to greatly improve medication adherence, measure the effects of those medications in real time, and save lives and billions of dollars in unnecessary hospitalizations and medical bills.