Published: Tue, November 14, 2017
Science | By Hubert Green

FDA approves first 'digital pill' to track patients

FDA approves first 'digital pill' to track patients

United States regulators have approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology. The FDA said in a statement Monday that the digitally-enhanced medication "works by sending a message from the pill's sensor to a wearable patch". The pill and its companion smartphone app allow doctors-and anyone else the patient designates, for that matter-to track their dosing. Labeling information stresses that it has not been proven if tracking such information improves treatment regimens.

Always forget if you've taken your medication?

Choudhry, whose work includes developing predictive analytics initiatives to spot patients who don't take their meds, estimates that almost $300 billion is spent in the USA each year in "caring for health conditions that are attributable to nonadherence".

The Abilify pill was first approved by thee Food and Drugs Administration (FDA) back in 2002, to treat schizophrenia and the sensor technology was approved for marketing in 2012.

But until now, the FDA had not approved a sensor-pill combination.

Should prescribes take to Abilify MyCite, the new formulation could help Abilify's maker Otsuka Pharmaceutical Co. Ltd. According to the California-based digital medicine company, the sensor is made of elements "found in a typical diet".

In prescribing Abilify MyCite, physicians must make sure patients download the corresponding mobile application on their smartphones and are comfortable using it, since that is how they will ultimately view the information provided from the drug-device combo.

The drug is the size of a grain of salt, the sensor has no battery or antenna and is activated when wet from stomach fluid. Patients can also grant healthcare providers access to the information through an online portal. The system is meant to integrate into individuals' lives, and individuals indicate through the app which member (s) of their care team can access information about their medication ingestion, activity, and self-reported mood and rest. If the MyCite app is unable to show if the pill was ingested, a repeat dose is not advised.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.

"The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers", added Mitchell Mathis, M.D. Psychiatric Products Division director for the Center for Drug Evaluation and Research at the FDA.

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