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FDA approves first digital pill to monitor if patient is taking medicine

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…

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