Real-time Adherence and Risk Management of Opioid Therapies

说明(申请人提供)：本申请建议开发具有实时电子数据(装甲)药物系统的阿片类药物依从性和风险管理。该系统使用低成本、抗滥用的配药设备，控制使用有限使用密码的阿片类药物的访问。这些密码可以使用几种常用的基于服务器的技术来获取，包括交互式语音响应、短消息服务、电子邮件或基于Web的应用程序。该系统代表了一种平衡的阿片类药物风险管理方法，通过分流-威慑技术减少药物的滥用和误用，同时提供资源加强患者用药管理。第一阶段将涉及该系统的经验开发和初步可行性测试。开发将遵循以用户为中心的设计方法，基于FDA的指导方针。与疼痛管理专家和疼痛患者进行的活动将包括：用户访谈，以探索该系统的挑战和要求；概念设计，以确定理想的阿片类药物风险管理系统的特点；低保真原型，以测试用户界面；接受可用性和基准测试的核心组件的高保真原型；患者在自然环境中使用该系统的情况研究；管制药物管制专家对该系统滥用威慑潜力的评估，以及将装甲药物系统办法的优点与现有替代办法进行比较的竞争分析。第二阶段将涉及开发该系统的测试版，并将包括测试该系统减少处方阿片类药物滥用以及提高患者用药依从性和生活质量的能力。公共卫生相关性：慢性疼痛是一个严重且未得到充分治疗的公共卫生问题。然而，越来越多的处方阿片类药物用于疼痛控制与不断升级的滥用有关，而医疗保健提供者没有能力解决这一问题。这项研究将开发一种风险管理系统，旨在减少处方阿片类药物滥用，同时促进有效的疼痛管理。

DESCRIPTION (provided by applicant): This application proposes the development of the Adherence & Risk Management of Opioids with Realtime Electronic Data (ARMORED) drug system. The system uses a low-cost, abuse-resistant drug dispensing device that controls 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 system 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 empirical 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 system 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 of 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.