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FDA approves first digital pill

Written by Diane Archer

The New York Times reports that the FDA has approved the first digital pill, a pill that allows doctors to know whether you took your medicines and when. This latest health technology embeds a sensor in a prescription drug that captures and transmits data. The digital pill is designed to help with ensuring that people comply with their medication regimens.

Digital pills will be especially helpful to older people and others who might otherwise forget to take their medications. Researchers have found that patients typically take only half of the doses of their prescribed medications. People who do not take their medications as prescribed may jeopardize their health.  They may end up hospitalized and in need of otherwise avoidable health care. The health care spending implications of medication noncompliance in the US is estimated by one population health management company at between $100 billion and $289 billion a year.

The first digital pill, Abilify MyCite, is a new version of Abilify, an antipsychotic medicine. Patients must sign a written document consenting to give their doctors, and up to four other caregivers, access to the digital data. Abilify MyCite’s sensor is no bigger than a grain of salt. It is made of magnesium, copper and silicon. Once ingested, stomach acid activates the sensor.

The data from the pill’s sensor is transmitted through a patch that patients wear. It indicates whether they took their medicine and when.  Patients can protect their privacy through a digital app that allows them to control who has access to their data.

The FDA requires Abilify MyCite to have a warning that older patients with dementia-related psychosis, who are treated with antipsychotic drugs, are at increased risk of death. “Abilify MyCite is not approved to treat patients with dementia-related psychosis.” The drug poses serious risks of harm, including nausea, vomiting, anxiety, and uncontrollable limb and body movements.

It may not be long before all medicines will be embedded with sensors to allow doctors and caregivers to monitor patients and help ensure medication compliance. At a minimum, sensors will be able to indicate whether a patient has taken a medicine. The public health benefits are significant.

But, we also need to protect people from the big risks posed by this new health technology. Privacy and security issues abound. The data could be used by insurers against patients who fail to comply with their medication regimens. And, if the data is not stored securely or it is hacked, patients may have no control over the people who can access it.

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