It is estimated that nearly 75% of adults do not adhere to a prescribed pharmacologic regimen, including failure to fill new prescriptions, taking less than the prescribed dose, or discontinuing drug therapy without prior discussion with their physician.1 Long-term treatments for chronic illnesses often require strict patient medication adherence, yet only 51% of patients in the United States who are prescribed antihypertensive drugs adhere to the prescribed treatment. This number varies from 40–70% for patients taking antidepressants and greatly increases the risk of relapse.2 Patient nonadherence to a prescribed pharmacologic treatment can not only harm the patient, but also carries a significant financial burden. The total economic burden of medication nonadherence is estimated to be $100–300 billion annually1 including the cost of hospitalizations and emergency department visits that could have been prevented with proper adherence. In one study, the number of hospitalizations and emergency department visits related to chronic vascular diseases declined with increased adherence and the uptick in pharmacy costs were offset by the healthcare savings.3
In addition to contributing to suboptimal treatment outcomes, medication nonadherence can also impact safety and efficacy data in clinical trials for investigational drugs. If a large trial with an outpatient population has variable adherence, the protocol-specified dose may be too low for efficacy or too high and toxic.4 In 2012, the Food and Drug Administration (FDA) guidance on clinical trials for human drugs and biological products encouraged the use of adherence prompts, alert systems, and counting pills or smart bottles to monitor medication adherence and encourage patient compliance.5 New technology in the form of smart pills and bottles could help in reducing nonadherence in both clinical trials and individual patient pharmacologic treatment plans.
Dispensing Information with Medication
Pill boxes are an inexpensive tool for improving patient adherence, but visual acuity6 and cognitive impairment7 are potential barriers in correctly filling the pill boxes or taking the daily required medications without reminders (particularly in the elderly). Real-time measurement is now possible with pill dispensers containing sensors to monitor adherence, provide reminders, and transmit data to patients, caretakers, and clinicians. One such smart pill bottle was invented by researchers at the University of Alabama in Huntsville and licensed to AdhereTech; it uses a sensor in the bottle to detect if the bottle has been opened and calculates the number of pills or liquid remaining in real-time. This data is then transmitted wirelessly from the bottle to computer servers and is analyzed for any missed doses or errors. If a patient skips a dose, the bottle notifies the patient or other approved individuals via on-bottle lights and chimes and an automated phone call or text message.8 The use of real-time data analysis can detect lengthy nonadherence and follow-up via a phone call or text message for information on the missed dose or doses. Their responses can be sent directly to live case managers for immediate interventions such as changing the dose or switching the patient to an alternate medication. The bottles are FDA-registered Class I medical devices and the AdhereTech data collection system is HIPAA-compliant. A pilot test is underway at the Walter Reed National Military Medical Center and will be tested in a 12-week randomized trial at Weill Cornell Medical College involving 70 HIV-positive patients with sub-optimal medication adherence.9