Description:
It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.
Drugs don’t work in patients who don’t take them.
— C. Everett Koop, M.D, former U.S. Surgeon General
Medication adherence is described as the extent to which patients take medications as prescribed by their health care providers.
A World Health Organization (WHO) report confirms that almost half of patients with chronic illnesses do not take medications as prescribed. Low medication adherence greatly lowers efficacy; and it leads to preventable prolongation of illnesses, re-hospitalizations and sometimes death. Approximately 125,000 Americans die annually (342 people every day) due to poor medication adherence. Every day, prescription non-adherence costs more than $270 million in additional hospitalization and other medical costs. Nine out of every 10 outpatients are taking prescribed medicines improperly, contributing to prolonged or additional illness. Cost of non-adherence to medications is estimated approximately $100 billion a year in the U.S. In addition, other forms of medication non-adherence such as misuse, underuse or overuse (abuse) also have negative consequences in individuals.
Medication non-adherence is especially burdensome to patients with substance use disorders who are prescribed medications for psychiatric and medical conditions. In addition, approximately 50% of patients prescribed Buprenorphine for opioid dependence and NRT/other medications for smoking cessation report taking medications as prescribed.
NIDA seeks to develop and test prototype mobile/tablet technology-based application to provide a low-cost, highly personalized, interactive patient-centric medication adherence tool that improves upon currently available mobile technology-based medication adherence applications.
Background Information
The WHO, Institute of Medicine (IOM), National Institute of Health (NIH), American Heart Association (AHA) and advocacy organizations have all acknowledged that this is both a complex and a difficult issue to solve but the time for action is now.
Barriers to medication adherence are complex, variable and reside at multiple levels: the patient, the provider, the healthcare system and their interactions. Systematic reviews have found that existing medication adherence interventions yield only modest benefits and while simple reminder systems do work, most of the systems were complex, cost-prohibitive and labor-intensive greatly limiting generalizability.
Adherence is an active process but existing low-cost solutions are passive. Examples of commercially available apps for Android and Apple devices: Pillbox Alert, Med Minder, Med Helper - Prescription App, MyMedSchedule, Dosecast, RxmindMe, Intelecare. They are typically simple to use and employ visual aids but are limited by patient input of their medications; sole reliance on reminders; predominant focus on the use of English language; and not always Health Insurance Privacy and Portability Act of 1996 (HIPPA) and Health Information Technology for Economic and Clinical Health (HITECH) Act compliant.
Other solutions use electronic pillboxes which record pill use by the patient and in some cases, provide reminders: MEMS cap, Wisepill device, Med-eMonitor, etc. These products have limited main stream application due to high costs of these stand-alone devices that typically record one medication per container; with limited links to real-time and interactive feedback or education; and most have limited programming capacity.
The newer FDA approved medical devices such as the SIMpill® Medication Adherence System and the PillStation® medication adherence system are more complex and offer adherence reminders and organization solutions but do not provide tailored interventions based on the patient’s baseline, nor do they address adverse effects, other barriers to medication adherence.
Phase I Activities and Expected Deliverables
Develop and test the acceptability and feasibility of a mobile/tablet-based technology application prototype that improves medication adherence by successfully addressing the barriers to medication adherence and contain the following features:
• Allow multiple user input and interaction (i.e. between physician, pharmacy, patient, caregiver/parent) and superiority to existing mobile applications and electronic pillbox/medication monitoring tools; • The core medication adherence enhancement solution is to be a mobile application. However, hybrid solutions that link to external systems will be preferred, e.g. demonstrate capacity to link to external electronic databases, such as pharmacy, laboratory and/or medication information systems; other existing stand alone medication monitoring tools such as electronic pillboxes, etc.;
• Account for low health literacy and visual impairment needs of patient;
• Demonstrate capabilities for GIS, GPS, SMS, phone, Bluetooth, online, video and other platforms of real-time communication;
• Eliminate patient need to enter medication information (i.e. names and doses of medications) through the use of barcodes, photo/camera capabilities and similar technologies;
• Demonstrate capabilities to link to patient’s record in EMR, EHR, pharmacy database and other healthcare systems (e.g. appointment scheduling systems, provider locations, etc.);
• Use computational modeling, branching logic and/or query functions to develop sophisticated adherence solution algorithms for the software;
• Provide a baseline ecological momentary assessment of patient’s status (such psychiatric and/or physical symptoms, mood states, drug cravings/drug use) and its impact on medication adherence, so that customized interventions can be delivered to the patient, based on their ability;
• Offer a menu of customizable adherence strategies, based on each individual’s baseline rate of medication adherence, ranging from simple to complex (and provide some rating mechanism for the strategies offered);
• Offer tailored medication education content suited for adult learning and links to reliable information databases;
• Link to social media sites, email and other communication resources to enable caregiver, parent, significant other person support/monitoring;
• Build in incentives (financial and other positive reinforcements) for meeting medication adherence goals;
• Demonstrate scalability and cost-effectiveness;
• Must be HIPPA and HITECH Act compliant;
• Demonstrate feasibility, acceptability and preliminary efficacy in improving medication adherence: test the application on 9 patients receiving a FDA approved medication to gather preliminary data on the reliability of the system and its ease of use by patients, providers and caregivers;
• Demonstrate that the proposed research activity will likely lead to a marketable product or process, including consideration of the potential barriers to entry and the competitive market landscape. This may include a letter of commitment for additional investment or support from a private sector party or other non-SBIR funding sources.
Phase II Activities and Expected Deliverables
Develop and validate a production model prototype by using the system in substance abusing patients undergoing treatment with an FDA approved medication either for treating addiction such as buprenorphine or a psychiatric disorder such as Major Depressive Disorder.
Provide evidence for commercialization potential, i.e., record of successfully commercializing prior SBIR/STTR or other research projects, commitments of additional investment from private sector or other non-SBIR funding sources, and any other indicators of commercial potential for the proposed research.
