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  • Arrival of the First Digital Medicine System

    Healthcare is in the midst of a technological revolution, with new advances rapidly changing the landscape of digital tools for healthcare providers and patients. One such advancement is a new type of health tool that has the potential to help some patients adhere to specific medication. It is called a digital medicine system (DMS) and is an innovative drug-device combination. It integrates adherence measurement with pharmacologic treatment by embedding an ingestible sensor in a pill, allowing for information sharing via a mobile interface.

    When approved by the FDA in November 2017, Abilify MyCite (aripiprazole tablets with sensor) became the first drug-device combination product with a digital ingestion tracking system developed for patients with serious mental illness. This new DMS is comprised of aripiprazole tablets embedded with an ingestible event marker sensor. It has been approved for several indications, which include acute treatment of manic and mixed episodes associated with bipolar I disorder, the treatment of schizophrenia, and for use as an add-on treatment for depression in adults.

    The ingestible sensor indicates when the tablet dissolves in the stomach by transmitting a signal to a patch worn on the patient's abdomen. The patch then communicates through a smartphone to track adherence. Patients must only apply the wearable sensor when instructed by the app, to the left side of the body above the lower edge of the rib cage. This patch must be replaced every seven days. The MyCite App is the smartphone application available to display the information for the patient. There also is the opportunity to use a web-based portal for healthcare professionals and caregivers, called the MyCite Dashboard.

    Prescribing medication with associated digital technology will introduce novel patient counseling topics. Healthcare providers should refer patients to the app store to ensure compatibility with their chosen smartphone and advise them that they must download the MyCite App and follow all provided instructions. Patients should be advised that initial use of a DMS should be facilitated by a healthcare provider.

    One of the limitations of use of Abilify MyCite is that the ability to improve compliance or assist in modifying dosage has not yet been proven. Additionally, tracking ingestion in real-time or emergency is not recommended because detection by the app and portal may be delayed or may not occur. Although most ingestions are detected within 30 minutes, it is possible for the app and portal to take up to two hours to detect. To gain increased knowledge regarding how a DMS such as this will fit within the lives of patients and caregivers, a limited initial rollout is being orchestrated over the coming months in select regional provider networks.


    DailyMed website. Abilify MyCite prescription drug label. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=e8787c3f-5e41-42d1-8091-44b56346620f&type=display. Accessed September 16, 2018.

    FDA website. FDA News Release. FDA approves pill with sensor that digitally tracks if patients have ingested their medication. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm584933.htm. Updated February 22, 2018. Accessed September 16, 2018.

    Otsuka website. News & Media. Otsuka Announces First Collaboration Agreement to Bring the ABILIFY MYCITE® System to the US Market. https://www.otsuka-us.com/discover/articles-1208. Updated August 30, 2018. Accessed September 16, 2018.