In September 2015, the Food and Drug Administration accepted the first digital medicine new drug application for a drug-device combination of Otsuka’s Abilify® (aripiprazole) and an ingestible sensor embedded in the tablet that digitally records ingestion. When this digital medicine is taken, it sends a signal to a patch worn by the patient. The information is recorded, time-stamped, and relayed to any Bluetooth-enabled device and, with patients’ consent, to their physicians and/or their caregivers. An encapsulation model in which a tablet is co-encapsulated with the ingestible sensor has been successfully used in the setting of renal transplant, diabetes, hypertension, and hypercholesterolemia.
Au-YeungKYDiCarloL.Cost comparison of wirelessly vs. directly observed therapy for adherence confirmation in anti-tuberculosis treatment. Int J Tuberc Lung Dis. 2012;16:1498-1504.
BelknapRWeisSBrookensA. Feasibility of an ingestible sensor-based system for monitoring adherence to tuberculosis therapy. PLoS One. 2013;8:e53373.
8.
Peters-StricklandTPestreichLHatchA. Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole. Neuropsychiatr Dis Treat. 2016;12:2587-2594.
9.
KaneJMKishimotoTCorrellCU.Non-adherence to medication in patients with psychotic disorders: epidemiology, contributing factors and management strategies. World Psychiatry. 2013;12:216-226.
10.
PrendergastMBGastonRS.Optimizing medication adherence: an ongoing opportunity to improve outcomes after kidney transplantation. Clin J Am Soc Nephrol. 2010;5:1305-1311.
11.
EisenbergerUWüthrichRPBockA. Medication adherence assessment: high accuracy of the new ingestible sensor system in kidney transplants. Transplantation. 2013;96:245-250.
