Patient drug compliance remains a major issue in health care delivery.

Drug non-compliance, in which patients neglect to take prescribed medications in accordance with physician instructions, is an ongoing and serious problem. A health economics analysis conducted by the University of Arizona, School of Pharmacy estimated that drug noncompliance results in nearly $77 billion in excess medical care every year. This study found that of all medications prescribed to combat a disease, less than 70% of the recommended drugs are actually even consumed. Conservatively, approximately 40% of patients who receive outpatient drug therapy experience treatment failure or new medical problems as a result of noncompliance of their prescribed (usually oral) treatment regimen [1]. Compliance monitored by patient self-reporting or by healthcare provider questions are poor indicators of actual compliance. In fact, in one study of patients taking medication for heart disease, when compared to electronic monitoring, 67% over-reported their compliance with therapy [2]. A method to directly verify drug ingestion would provide an important tool in the effective and efficient delivery of healthcare. Increased assurance of drug compliance would directly impact the healthcare system by decreasing morbidity and hospitalizations, and lowering associated healthcare costs.

Currently available techniques and methods to assure drug compliance are inadequate, and often inaccurate. Existing products include various devices that use timed alarms to remind patients to take medication, but do not directly verify that medication is actually taken. The Sequella Compliance Monitor (SCM), jointly developed by Sequella and Lenterra, is a novel, cost-effective tool to provide healthcare providers with a means to perform non-invasive monitoring of medication compliance.

Conceptual rendering of a wearable compliance monitor.

The SCM concept is a wristwatch-like device that is worn by the patient, which uses harmless laser light to illuminate blood vessels through the skin. Fluorescing compounds called “fluorophores” are included along with the active ingredients in a medication, and enter the bloodstream. These fluorophores emit light in response to laser illumination. Detection of this fluorescence allows the SCM to reliably and non-invasively record the time of each ingestion. This data is stored on the device and is wirelessly accessible by medical personnel.

A prototype device designed and built by Lenterra has been clinically tested and proven using the indocyanine green (IcG) fluorophore (typically used for angiography of the eye, a common procedure to test for retinal disorders). Development of a fully-realized wearable SCM is underway.

More information can be found at Sequella’s website.