The medication is embedded with a sensor that can tell doctors whether, and when, patients take their medicine.
For the first time, the Food and Drug Administration (FDA) has approved a digital pill — a medication embedded with a sensor that can tell doctors whether, and when, patients take their medicine.
The approval, announced late Monday, marks a significant advance in the growing field of digital devices designed to monitor medicine-taking and to address the expensive, long-standing problem that millions of patients do not take drugs as prescribed.
Experts estimate that so-called nonadherence or noncompliance to medication costs about $100 billion a year, much of it because patients get sicker and need additional treatment or hospitalization.
Ameet Sarpatwari, who teaches at Harvard Medical School, said the digital pill “has the potential to improve public health,” especially for patients who want to take their medication but forget.
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But, he added, “if used improperly, it could foster more mistrust instead of trust.”
Patients who agree to take the digital medication, a version of the antipsychotic Abilify, can sign consent forms allowing their doctors and up to four other people, including family members, to receive electronic data showing the date and time pills are ingested. A smartphone app will let them block recipients anytime they change their mind. Although voluntary, the technology is still likely to prompt questions about privacy and whether patients might feel pressure to take medication in a form their doctors can monitor.
Dr. Peter Kramer, a psychiatrist and the author of “Listening to Prozac,” raised concerns about “packaging a medication with a tattletale.”
While ethical for “a fully competent patient who wants to lash him or herself to the mast,” he said, “ ‘digital drug’ sounds like a potentially coercive tool.”
Some experts said digital medications might be most welcomed by older people who want help remembering to take pills and by people taking finite courses of medication, especially for illnesses like tuberculosis, in which nurses often observe patients taking medicine.
The technology could potentially be used to monitor whether post-surgical patients took too much opioid medication or clinical-trial participants correctly took drugs being tested.
Insurers might eventually give patients incentives to use the digital technologies, like discounts on co-payments, said Dr. Eric Topol, director of Scripps Translational Science Institute, adding that ethical issues could arise if the technology was “so much incentivized that it almost is like coercion.”
The newly approved pill, called Abilify MyCite, is a collaboration between Abilify’s manufacturer, Otsuka, and Proteus Digital Health, a California company that created the sensor. Abilify is prescribed to people with schizophrenia, bipolar disorder and, in conjunction with an antidepressant, major depressive disorder.
The sensor, containing copper, magnesium and silicon (safe ingredients found in foods), generates an electrical signal when splashed by stomach fluid, like a potato battery, said Andrew Thompson, Proteus’ president and chief executive. After several minutes, the signal is detected by a Band-Aid-like patch that must be worn on the left rib cage and replaced after seven days, said Andrew Wright, Otsuka America’s vice president for digital medicine.
The patch sends the date and time of pill ingestion and the patient’s activity level via Bluetooth to a cellphone app. The app allows patients to add their mood and the hours they have rested, then transmits the information to a database that physicians and others who have patients’ permission can access.
Otsuka has not determined a price for Abilify MyCite, which will be rolled out next year, first to a limited number of health plans, Wright said. The price, and whether digital pills improve adherence, will greatly affect how widely they are used.
Dr. Jeffrey Lieberman, chairman of psychiatry at Columbia University and NewYork-Presbyterian Hospital, said many psychiatrists would likely want to try digital Abilify, especially for patients who just experienced their first psychotic episode and are at risk of stopping medication after feeling better.
But he added, “There’s an irony in it being given to people with mental disorders that can include delusions. It’s like a biomedical Big Brother.”