The first drug with a sensor embedded in a pill that alerts doctors when patients have taken their medications was approved by the Food and Drug Administration, raiding issues involving privacy, cost, and whether patients really want caregivers looking over their shoulders.
Japan's Otsuka Pharmaceutical Co. will insert a tiny chip -- the size of a grain of sand -- inside the psychiatric medication Abilify used to treat schizophrenia and other serious mental illness.
The technology is a breakthrough in allowing others to see whether patients are taking their medicines as prescribed, but also raises privacy concerns. Forty percent to 45 percent of people with common cardiovascular and other chronic diseases such as diabetes do not take their medications as prescribed.
"That's a big deal because medication non-adherence is a huge public-health challenge in the United States," said Kevin Volpp, a physician and director of the University of Pennsylvania's Center for Health Incentives and Behavioral Economics.
The tablet, Abilify MyCite, contains a digital sensor that is activated by stomach fluids, sending a signal to a patch worn by the patient, which, in turn, notifies a smartphone app that the medication has been taken. The information can be shared with physicians and others with the goal of keeping doctors more informed in making treatment decisions.
But the pill is not magic. People still have to take it, and the skin patch has to be replaced every seven days.
The technology is likely to be controversial. "There's an open question of how paternalistic do we want our health care providers to be," Volpp said. "Many patients, for whatever reasons, may decide, 'I don't want to take the medicine.' Having their provider, or health plan, monitor closely whether they are taking the medicines on a daily basis may be uncomfortable to some patients."
Niteesh Choudhry, a physician at Brigham & Women's Hospital in Boston and a professor at Harvard Medical School, said: "This is a technological feat. There's a lot to be celebrated here from a purely technological perspective. That said, there are a ton of unknowns."
First, will the technological monitoring be reliable, and will the data improve patients' taking their medications? "We really don't know anything about that yet," Choudhry said.
Will patients feel better, be hospitalized less often, and function better? "Those clinical outcomes, some of which are very patient-centric, need to ultimately be established," Choudhry said.