Medication Adherence Assessment

Abstract

BackgroundThis open-label single-arm exploratory study evaluated the accuracy of the Ingestible Sensor System (ISS), a novel technology for directly assessing the ingestion of oral medications and treatment adherence.MethodsISS consists of an ingestible event marker (IEM), a microsensor that becomes activated in gastric fluid, and an adhesive personal monitor (APM) that detects IEM activation. In this study, the IEM was combined to enteric-coated mycophenolate sodium (ECMPS). Twenty stable adult kidney transplants received IEM-ECMPS for a mean of 9.2 weeks totaling 1227 cumulative days.ResultsEight patients prematurely discontinued treatment due to ECMPS gastrointestinal symptoms (n=2), skin intolerance to APM (n=2), and insufficient system usability (n=4). Rash or erythema due to APM was reported in 7 (37%) patients, all during the first month of use. No serious or severe adverse events and no rejection episode were reported. IEM detection accuracy was 100% over 34 directly observed ingestions; Taking Adherence was 99.4% over a total of 2824 prescribed IEM-ECMPS ingestions. ISS could detect accurately the ingestion of two IEM-ECMPS capsules taken at the same time (detection rate of 99.3%, n=2376).ConclusionsISS is a promising new technology that provides highly reliable measurements of intake and timing of intake of drugs that are combined with the IEM.

Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co‐encapsulation

“…Subsequently, all of the data on the paired device are uploaded to a secured, centralized data storage location21 ( Figure 1 b ). These data are available in near‐real‐time to the patient user on their mobile device and, with patient permission, to healthcare personnel and other significant persons, who can access these data from a secure web portal 22, 23, 24, 25…”

“…From a total of almost 30,000 sensor ingestions, no serious adverse events were observed in clinical studies 21. Early versions of the patch were associated with self‐limited, localized skin rashes in ∼10% of users 21, 22. The Proteus Digital Health Feedback Device (DHFD) was issued CE Mark approval in 2010 to market its ingestible sensor and personal physiologic monitor system in the European Union and was approved for marketing as a medical device by the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) in 2012.…”

Advancing Transplantation

“…244 This system has already been introduced in Europe and the United States. 244 The ISS consists of an ingestible event marker (IEM), the microsensor that becomes activated after ingestion, and an adhesive personal monitor patch to detect the IEM once activated.…”

“…244 This system has already been introduced in Europe and the United States. 244 The ISS consists of an ingestible event marker (IEM), the microsensor that becomes activated after ingestion, and an adhesive personal monitor patch to detect the IEM once activated. Using wireless Bluetooth-based technology, the adhesive personal monitor can relay information to a smartphone, which in turn sends the data to a secured, centralized data storage and processing location.…”

“…Using wireless Bluetooth-based technology, the adhesive personal monitor can relay information to a smartphone, which in turn sends the data to a secured, centralized data storage and processing location. Although this "Big Brother" style approach may seem daunting, the system has been associated with high (99.4%) adherence to mycophenolate in kidney transplantation, 244 and similar innovations are already being used in various fields of medicine. As adherence to treatment is particularly important in transplantation, these innovative techniques could help improve long-term outcomes for our patients.…”