The Food and Drug Administration has approved a digital pill — a medication implanted with a sensor that can indicate when the medication is taken. This is a significant advancement in the field of digital devices to monitor medicine-taking.  Non-compliance with medications has been estimated to cost $100 billion annually, so this is an expensive problem causing patients to become sicker and often require additional hospitalizations.

Ameet Sarpatwari, an instructor in medicine at Harvard Medical School, “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.

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. Not all will need regulatory clearance, and some are already being used or tested in patients with heart problems, stroke, H.I.V., diabetes and other conditions. 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.

Abilify is an arguably unusual choice for the first sensor-embedded medicine. It is prescribed to people with schizophrenia, bipolar disorder and, in conjunction with an antidepressant, major depressive disorder.

Many patients with these conditions do not take medication regularly, often with severe consequences. But symptoms of schizophrenia and related disorders can include paranoia and delusions, so some doctors and patients wonder how widely digital Abilify will be accepted. “Many of those patients don’t take meds because they don’t like side effects, or don’t think they have an illness, or because they become paranoid about the doctor or the doctor’s intentions,” said Dr. Paul Appelbaum, director of law, ethics and psychiatry at Columbia University’s psychiatry department. 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.”

To read the article in its entirety refer to: https://www.nytimes.com/2017/11/13/health/digital-pill-fda.html?emc=edit_na_20171113&nl=breaking-news&nlid=53732119&ref=cta; http://www.proteus.com/


By Barb Brant, MPA RN CDIP CCDS CCS