Desirability and feasibility of wireless electronic monitoring of medications in clinical trials

Abstract

Medication nonadherence is a vexing problem in health care necessitating patients and health professionals' efforts to prevent, minimize, or reverse it. Research participants' inconsistent medication taking obscures treatment efficacy and adds costs to biomedical research. Electronic monitoring devices (EMDs), like the Medication Event Monitoring System (MEMS), have grown in sophistication, providing precise, timely insights into individuals' medication-taking patterns across clinical populations. This article reports on the desirability and feasibility study of using a wireless EMD in clinical research to promote adherence to clinical regimens and research protocols. Nonadherence in transplant patients has been linked to late acute rejection and graft loss. High levels of adherence (97.7 %) were documented for six renal transplant recipients for a mean of 6 months (M=196.1±71.2 days) who indicated acceptance of the technology. MEMS data confirmed the feasibility of using wireless EMDs to monitor medication use. Monitoring provides greater assurance that research studies reflect the biological impact of medications and provide a basis for targeting adherence enhancement efforts within research investigations.

Technologies for Medication Adherence Monitoring and Technology Assessment Criteria: Narrative Review

“…Some newer versions of electronic pill bottle technologies, such as the GlowCap and AdhereTech devices, possess the ability to wirelessly transmit patient medication adherence data, providing opportunities to assess and monitor patient medication adherence in real time [ 1 , 15 , 18 , 29 - 31 ]. Electronic pill bottle technologies are commonly reported to have advantages including their discrete design and small size [ 10 , 16 , 32 , 33 ], objective medication adherence monitoring ability [ 1 , 8 , 11 , 14 , 34 , 35 ], and acceptance among patients [ 1 , 30 , 31 ]. However, as the pill bottle design is only capable of storing 1 type of medication at a time, these devices are not suitable for patients with complex multidrug regimens [ 1 , 4 , 8 , 9 , 18 , 30 , 32 ].…”

Mitigating the Effects of Nonadherence in Clinical Trials

“…However, both direct and indirect methods have proven to overestimate adherence . A third category, comprised of electronic monitoring systems (such as MEMS, a conventional medicine bottle fitted with an electronic cap that date stamps each opening and closing) are more accurate than indirect measures but lack the ability to confirm ingestion . As a result, partial adherence and “drug holidays” frequently go undetected …”

“…11,26,33 A third category, comprised of electronic monitoring systems (such as MEMS, a conventional medicine bottle fitted with an electronic cap that date stamps each opening and closing) are more accurate than indirect measures but lack the ability to confirm ingestion. 12,26,33,35,36 As a result, partial adherence and "drug holidays" frequently go undetected. 11,33 Three newer technologies are addressing the problem of directly confirming medication ingestion 11 : (1) Proteus Digital Health and e-Tect are developing ingestible sensors that are embedded into each dose.…”

Strategies to Improve Patient Engagement in Young Kidney Transplant Recipients: A Review

“…To complement the prevention techniques discussed, we should also monitor for early signs of MNA and then initiate treatment as needed. Electronic monitoring devices, such as the wireless pill bottles discussed, are quickly becoming the gold standard in monitoring patients’ medication adherence, particularly in a research setting [ 29 ].…”