Personalized multi-medication packaging with integrated real-time instrumentation to improve adherence

Abstract – Medication non-adherence is a persistent public health problem that impacts many patient populations and causes all stakeholders—patients, families, pharmacies, pharmaceutical developers, doctors, and insurers—to lose. It contributes to 45% of treatment failures, 700,000 annual hospitalizations, and one death every 19 minutes, making it responsible for $100B in preventable medical costs per year. Medication non- adherence occurs across diverse care settings, including in increasingly utilized (Covid and post-Covid) home- based acute care and post-acute care programs. For example, a study of 50 patients at a Hospital at-Home program found nine potential adverse drug events related to unintentional medication non-adherence. Similarly, therapeutics have been kept off the market due to non-adherence during clinical trials, resulting in erroneous conclusions. Many device- and app-based technologies have repeatedly failed due to the high cost and high level of interaction required on the part of the patient or caregiver. To address the need for a cost-effective, usable/deployable/scalable, and highly versatile solution for real-time adherence detection at the point of care, Insightfil is developing a novel disease and medication-form agnostic technology platform using Near-Field-Communication (NFC) tags to measure medication adherence and reduce non-adherence in home-based settings with minimal need for technological interaction. Low-cost, disposable NFC tags are attached to a variety of medication packages for automatic detection of the package opening, allowing the moment of pill-taking to be captured via an accompanying smartphone application and entered into the patient record without the need to optically capture information. In addition, the app delivers real-time, personalized, context-sensitive notifications to encourage medication adherence to the patient’s care plan. Our Phase I pilot study of an early prototype demonstrated that medication adherence improved from 64% to >95% with the use of Insightfil technology which was maintained over 18 months. In Phase II, Insightfil will collaborate with UMass Chan Medical School’s innovative Program in Digital Medicine to develop an NFC-enabled native app (Aim 1), optimize the app based on iterative user-testing (Aim 2), and rigorously demonstrate acceptability and fidelity (Aim 3) of the technology in home-based acute care, post-acute care, and outpatient settings The proposed aims will advance Insightfil’s technology toward commercialization and adoption by demonstrating its utility to increase adherence and improve patient outcomes across a variety of care settings and empirically and quantitatively demonstrate the usability and accessibility of the platform. These key technical demonstrations will be leveraged to fund a type-2 hybrid effectiveness-implementation trial, evaluating the technologies’ efficacy and implementation within clinical workflow in preparation for commercial launch.