A digital pill is a capsule or tablet with embedded sensors that communicate data about when the medication is taken to a mobile app for access by the user and external parties. The system is designed to help improve patient compliance.
The United States Food and Drug Administration (FDA) approved the first digital pill in November 2017. The approved implementation is a version of Abilify (Abilify MyCite), an antipsychotic medication. Patients may supply written consent for their doctors and up to four other people, such as friends or family members, to receive messages with the date and time that the digital pill was taken.
That data can help users keep track of their medications and enable others to monitor that data as well. That information can be helpful when users forget to take their medications or are unsure about whether or not they have taken them. Nudges from external parties can help with compliance when the user intentionally stops taking their medications before completing the full course, which is common. The patient can rescind permission for any of the recipients, at any time, through the associated smartphone app.
Proteus Digital Health makes Abilify MyCite's ingestible sensor as part of the company's Proteus Discover system. Discover consists of a sensor about the size of a grain of sand, a wearable patch, a mobile app and a provider portal. The sensor is powered by an electrochemical reaction that is created when thin layers of magnesium, copper, and gold inside the circuit react with gastric fluid. Sensor data transmitted includes the type of medication, the dosage and the date and time that the pill was ingested. That data is transmitted to the user's wearable patch and correlated with the biometric and activity data that the patch sensors gather, which might include sleep/wake details, activity levels, heart rate and respiration, among other possibilities. This data is correlated with other biometric information measured separately by the patch, such as heart rate, respiration, and sleep activity. The patch communicates with the associated app through a Bluetooth connection, and the data is sent on to a user portal from the app.
According to IQVIA (formerly IMS Health) user non-compliance with prescribed medications causes losses of hundreds of billions of dollars in healthcare annually within the United States. The reporting element of digital pills could help prevent some of those costs by helping ensure, for example, that a patient taking an antibiotic completes the course of medication -- and, as a result, does not require hospitalization. Nevertheless, many within the industry have raised concerns about the potential for coercion in a system where external parties have access to the user's data.