FDA Approves First Digital Pill to Track Medicine Intake

16 Dec Is Big Brother Here? FDA Approves First Digital Pill to Track Medicine Intake

Doctors will soon be able to address the longstanding and expensive problem of patient adherence to taking medicine as prescribed. The Food and Drug Administration (FDA) approved a digital pill with an embedded ingestible sensor that would tell doctors whether and when a patient has taken his or her medicine. The Abilify MyCite (aripiprazole tablets with sensor) product is approved for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar disorder, and for use for those being treated for depression.

The estimated cost of nonadherence or noncompliance by patients is up to $100 billion a year according to experts. This noncompliance results in health care complications, and a need to have further treatment or hospitalization for these patients.

“When patients don’t adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly,” said Dr. William Shrank, chief medical officer of the health plan division at University of Pittsburgh Medical Center, in a report by the New York Times.

Patients who agree to use the digital pill must sign a consent form to allow their doctors and up to four other people to track their medicine usage by receiving electronic data. A smartphone app will be used to allow the patient to change who they want to receive the electronic data at any time.  There are some concerns about privacy and whether this new technology will be truly voluntary, since most patients are interested in listening to their doctor’s advice. Dr. Peter Kramer, a psychiatrist who wrote the book “Listening to Prozac,” told the New York Times that he was concerned about “packaging a medication with a tattletale.”

Other companies are also developing digital tools to help track when a patient has placed a pill on their tongue and swallowed it.  Not all of these new technologies need regulatory clearance, and some are already being used by patients to treat heart problems, strokes, HIV, diabetes and other health issues.

Insurers may eventually give patients incentives to use digital pills, like discounts on their copayments, said Dr. Eric Topol, Director of Scripps Translational Science Institute. He questioned whether this would raise some ethical issues if the use of this new technology would be “so much incentivized that it almost is like coercion.”

Source: New York Times, “First Digital Pill Approved to Worries About Biomedical ‘Big Brother,’” November 13, 2017.

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