Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (1)

Improving Inhaler Adherence in a Clinical Trial Through the Use of the Nebulizer Chronolog (1)Nonadherence to prescribed medication regimens is a major concern in clinical trials, as well as in clinical practice. Nonadherence rates are estimated to range from 20 to 80 percent depending on a variety of factors, including the complexity of the regimen, the severity of symptoms, side effects, and the health beliefs of the patient. Inadequate adherence, particularly when undetected, can result in potentially effective medications being deemed ineffective.
A recent innovation, the electronic medication monitor (EMM), which utilizes a microprocessor to record the exact time and date of medication usage, has made it possible to record actual patterns of medication adherence. Currently available for pill dispensers, metered-dose inhalers (MDIs), and eyedroppers, the EMM is the only measure of adherence that can accurately determine the frequency and timing of medication use over time. Studies using EMMs have documented several patterns of medication usage, including decreasing adherence over time and patient-initiated “drug holidays” in which use is suspended for three or more days. Additionally, EMM studies have shown that the traditional methods of measuring compliance, including self-report, pill counts, MDI weights, and serum levels of medication, metabolites or biochemical markers, consistently overestimate actual adherence. With non-mon-itored approaches, one is usually unable to detect deception on the part of the patient or subject. For example, discarding pills or emptying MDIs shortly before follow-up visits results in overestimates of adherence. Subjects have been shown to adhere more closely to the prescribed regimen shortly before the follow-up visit, which may lead to an overestimation when biochemical measures of adherence are used.
We hypothesized that the EMM has potential as a tool not only for accurately assessing compliance, but also for enhancing adherence to prescribed medication. The current study was designed to test whether the use of an EMM could increase adherence to prescribed MDI use in a sample of participants in a clinical trial of early intervention in COPD. Specifically, we tested whether providing participants with feedback from an EMM would improve adherence to the prescribed regimen of inhaler use as well as the validity of self-reported use.