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.

Grant Number: 5R44TR003071-03
NIH Institute/Center: NIH
Principal Investigator: Edward Acworth