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The FDA Approved a Digital Pill That Keeps Tabs on Patients

The FDA Approved a Digital Pill That Keeps Tabs on Patients

But some experts are concerned about how it’ll affect patient privacy.

The Food and Drug Administration (FDA) has approved the first drug with an ingestion-safe sensor in the United States. The sensor records when the medication is taken and can send the information to a smartphone app that can be shared with a patient's doctor.

The system, called Abilify MyCite (aripiprazole tablets with sensor), is approved for the treatment of schizophrenia, for the add-on treatment of depression in adults when other medicines don't give enough relief, and for certain cases of bipolar I disorder.

Medication compliance is an ongoing issue across many health conditions, and taking drugs on schedule can be particularly crucial for treatment success. In one survey, up to 75 percent of patients admitted they didn't always take medicine as directed. However, some experts have expressed concerns about patient privacy with the approval of the pill with a sensor.

How this digital pill works
In Abilify MyCite, the sensor in the pill sends a message to a wearable patch, and the patch then transmits the information to a mobile app. Patients can then track their medication schedule on their smart phone, and can allow their doctors to access the information via a web-based dashboard.

In more detail, here is how it works. The patch detects and records the date and time when the medicine was taken, as well as other information like the person’s activity level. This information is sent to the Abilify MyCite app on a mobile device. The user can review their medication schedule and their activity level, and enter how they are feeling at the time. They can then choose to share the data with other people like their doctors or caregivers.

Before using the system, the FDA suggests that patients have a session with their doctor or other health professional to be sure they know how to use the system. Otsuka Pharmaceutical makes Abilify MyCite, and Proteus Digital Health makes the sensor technology and the wearable patch.

Health conditions helped by Abilify
The mechanism of action is unknown, but Abilify, or aripiprazole, may work through dopamine and serotonin receptors to improve mood, thinking and behavior. In clinical trials, side effects included nausea, vomiting, constipation, dizziness, anxiety, insomnia, restlessness and headache. Less often, serious side effects can occur, including uncontrollable limb and body movements, seizures and high blood sugar.

Schizophrenia affects about 1 percent of the U.S. population. Those affected often have hallucinations or delusions, disorganized thinking or a lack of emotion. Bipolar disorder, also called manic-depressive illness, causes unusual shifts in mood, activity and energy, and those affected find it difficult to carry out typical daily tasks.

So, what are the drawbacks of the new system?
Some experts expressed concerns about the ''big brother'' aspects of such a digital system. In a New York Times piece covering the approval, Peter Kramer, MD, a psychiatrist and author of Listening to Prozac, is quoted as raising concerns about ''packaging a medication with a tattletale" and about the potential coercive aspects of the system.

In the same NYT piece, Ameet Sarpatwari, JD, PhD, an instructor in medicine at Harvard Medical School, said the pill “has the potential to improve public health” especially for people who have trouble following a medication schedule. However, Dr. Sarpatwari added, “if used improperly, it could foster more mistrust instead of trust.” According to Otsuka Pharmaceutical, the consent to use the system and to share information is voluntary and can be withdrawn at any time.

The FDA also cautions that it has not been proven that the product will improve medication compliance in patients. And it warns that the system should not be used to track medication taking during an emergency mental illness episode.

Before you decide to use the system, you should really give it a lot of thought, have a discussion with your health care provider, and make sure you’re comfortable with your decision. The system is expected to hit the market some time next year, with a price to be determined.

Medically reviewed in January 2020.

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