The FDA approves new technology designed to help ensure patients take their medications as prescribed. Here's how it works.
You have no choice but to trust that your patients are taking their medications as prescribed. But that could be about to change with new technology that remotely keeps track of whether patients really do stick to their healthcare regimens.
The U.S. Food and Drug Administration has cleared as a medical device a sensor by Proteus Digital Health Inc. that is designed to be integrated into a pill or other ingestible pharmaceutical and then swallowed.
“The FDA validation represents a major milestone in digital medicine,” says Eric Topol, MD, professor of genomics at the Scripps Research Institute and author of The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Healthcare. “Directly digitizing pills, for the first time, in conjunction with our wireless infrastructure, may prove to be the new standard for influencing medication adherence and significantly aid chronic disease management,” he says.
The company says the sensor is ideal for use with drugs that help manage diabetes or diseases with time-sensitive regimens such as Parkinson’s, Alzheimer’s, Huntington’s, as well as schizophrenia and multiple sclerosis.
After the patient swallows the sensor, stomach fluid provides the power needed to communicate a signal that determines exactly what the medication is and the precise time the patient took it. This information is transferred through body tissue to a patch worn on the body. The patch detects the signal and records the information. It also can record the patient’s heart rate, body temperature, physical activity, and sleep patterns.
The patch transmits the information to a mobile phone application accessible by caregivers and physicians. The goal is to help patients develop and sustain healthy habits and allow doctors to use the data to provide more effective care.
Proteus Digital Health says the first product using the ingestible and wearable sensors will be available commercially in the United Kingdom later this year. Patients will be able to buy the product directly from select locations of Lloydspharmacy, a large community pharmacy chain. For now, consumers who want to use the sensors must pay for them themselves, although the company believes insurers and government payers eventually will foot the bill.
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