‘Digital pills’ for mental diseases: an ethical and social analysis of the issues behind the concept

Abstract

Recently, the US Food and Drug Administration has given a landmark approval to the very first digital pill with a sensor embedded in the inside. These are complex systems that include a drug and an electronic tracker that is activated when the patient takes the pill. Accordingly, they might be an excellent tool for monitoring and potentially improving patients’ adherence to prescriptions. This would serve well to avoid unnecessary healthcare costs and reduce the anxiety of patients and their relatives. However, digital pills might also diminish patient autonomy, reduce privacy, or promote inadequate use of pharmaceutical resources. This article is aimed at contributing to adequate use of this new tool by showing the main ethical and social issues they involve and proposing measures meant to address them. Finally, we conclude by defending the idea that these new systems should be seen as means of complementing traditional strategies to promote adherence to treatment, and not as substitutes.

Ethical Issues of Digital Twins for Personalized Health Care Service: Preliminary Mapping Study

“…The growing accessibility of wearables and biosensors offers developers of digital twin systems opportunities to build up a system that can update a person’s digital twin in real time. The pharmaceutical company, Otsuka, has developed a new generation of digital pills (Abilify MyCite) that helps patients track medicine intake by sending signals to the patient’s mobile devices and relevant parties [ 22 , 23 ]. These technologies are usually marketed as innovations that can empower patients by helping them better manage their health conditions (eg, improving adherence).…”

Capillary Microfluidics for Monitoring Medication Adherence

“…studied the issue from the clinicians’ perspective where one of the main challenges was stated as the lack of a method to assess patient's self‐management and the incompatibility of the IT systems for medication management [115] . Ingestible sensors embedded in pills and read by a wearable patch, [116] such as “digital pills” developed by Proteus Digital Health [117] or the MyTMed system, [118] have been developed to confirm exactly when a pill has been taken; however, the readiness of such technologies and whether they reduce patient's autonomy are currently debated [119, 120] …”

“…[115] Ingestible sensors embedded in pills and read by aw earable patch, [116] such as "digital pills" developed by Proteus Digital Health [117] or the MyTMed system, [118] have been developed to confirm exactly when ap ill has been taken;h owever, the readiness of such technologies and whether they reduce patientsa utonomy are currently debated. [119,120] Ideally,adevice developed for medication adherence should not be ab urden for the patient but af acilitator for as afe treatment and effective communication with the healthcare provider. As previously discussed, portable assays using microfluidics devices have proven valuable for drug analysis and therapeutic drug monitoring.…”

Ingestible sensor system for measuring, monitoring and enhancing adherence to antiretroviral therapy: An open-label, usual care-controlled, randomised trial

“…S1). [11][12][13] The system includes sensor pill, an adhesive wearable sensor patch, a mobile app, and a provider web portal, with post-dose text messaging. The sensor contains tiny amounts of silicon, copper, and magnesium that pass through the body naturally, like fiber in food.…”