Real-time Adherence and Risk Management of Opioid Therapies

DESCRIPTION (provided by applicant): This application proposes the development of the Adherence and Risk Management of Opioids with Realtime Electronic Data (ARMORED) drug system. The system uses a low-cost, abuse-resistant drug dispensing device that cont rols access to opioid medications with limited-use passcodes. These passcodes can be obtained using several commonly available server-based technologies, including interactive voice response, short message service, email, or web-based applications. The sys tem represents a balanced approach to opioid risk management by reducing the abuse and misuse of the drugs through diversion-deterrence technology, while simultaneously providing resources to enhance patient medication management. Phase I will involve empi rical development and initial feasibility testing of the system. Development will follow a user- centered design approach based on FDA guidelines. Activities with pain management experts and pain patients will include: user-interviews to explore challenges and requirements of the system; a conceptual design to identify features of an ideal opioid risk management system; low fidelity prototypes to test user interfaces; high fidelity prototypes of core components subjected to usability and benchmark testing; a situational study of the system's use by patients in a naturalistic environment; an assessment of the system's abuse-deterrence potential by experts in regulatory drug control, and an competitive analysis that compares the merits of the ARMORED drug syst em approach with existing alternatives. Phase II will involve development of a beta version of the system, and will include testing of the system's ability to reduce prescription opioid misuse, as well as increase patient medication adherence and quality o f life. PUBLIC HEALTH RELEVANCE: Chronic pain is a serious and undertreated public health problem. However, the increased use of prescription opioids for pain management has been associated with escalating abuse that healthcare providers are ill- equipped to address. This research will develop a risk management system designed to reduce prescription opioid abuse and simultaneously promote effective pain management.