Real-time Adherence & Risk Management of Opioid Therapies

描述（由申请人提供）：在获得非常成功的第一阶段奖项后，该第二阶段SBIR申请提出了MedicaSafe阿片类药物的开发-一种用于治疗慢性疼痛患者处方阿片类药物治疗的风险管理系统。对这一系统的需求源于阿片类止痛药使用的急剧增加。虽然这种形式的药物可以非常有效地治疗疼痛，但它也可能被误用，滥用，并涉及严重的风险。处方阿片类药物现在是美国第二大滥用药物，处方药中毒最近成为意外死亡的第二大原因。 为了解决这个问题，该领域的领导人越来越多地呼吁 对类阿片风险管理采取“平衡”办法，同时减少这些药物的误用和滥用，而不限制有合法医疗需要的患者获得这些药物。MedicaSafe阿片类药物旨在实现这一目标。该解决方案包括通过“智能”包装重新命名的通用阿片类止痛药，在一个专门的低成本，防篡改的药物分配设备（DDD）中，通过有限使用的密码控制处方药的访问，患者使用网络/电话门户网站来获取这些密码并报告治疗状态，以及基于网络的管理门户网站提供商用于设置治疗参数并监控患者进展。该系统的综合能力使供应商能够远程监测和控制患者获得阿片类止痛药，同时评估其实时临床状态并提供有关有效“安全使用”做法的教育。 在第一阶段，一个高保真的“看起来像，像”的物理原型的核心组件的拟议系统的开发和测试。只要该系统可靠地执行，结果表明，疼痛患者将该方法视为管理与使用阿片类药物相关的风险的可接受和有价值的手段，并且疼痛提供者将该系统视为体现理想的阿片类药物风险管理解决方案的原则。 在第二阶段，继续努力的重点是制作一个完整版的MedicaSafe系统，其中考虑到第一阶段的调查结果;完成一项情况研究，评估MedicaSafe系统Beta版在自然临床环境中的性能;完成一项随机对照临床试验，比较MedicaSafe与最新的电子依从性监测（EAM）的疗效在一年的时间里，为慢性疼痛患者提供阿片类药物治疗的替代方案;最后，完成了一项接受研究，从患者和提供者的角度全面评估了MedicaSafe系统的接受程度。

DESCRIPTION (provided by applicant): Following a highly successful Phase I award, this Phase II SBIR application proposes development of MedicaSafe Opioids - a risk management system for the treatment of chronic pain patients prescribed opioid therapies. The need for this system arises from the dramatic increase in the use of opiod painkillers. Although this form of medication can be highly effective in the treatment of pain, it can also be misused, abused, and involve serious risks. Prescription opioids are now the second most abused drugs in the US, and a primary reason prescription drug poisoning has recently become the second-leading cause of unintentional death. To address this issue, leaders in the field have increasingly called for the adoption of a "balanced" approach to opioid risk management that simultaneously reduces the misuse and abuse of these drugs without limiting their availability to patients with legitimate medical needs. MedicaSafe Opioids is intended to achieve this objective. The solution consists of generic opioid painkillers re-branded via "smart" packaging in a specialized low-cost, tamper-resistant drug dispensing device (DDD) that controls access to prescribed medications via limited-use pass codes, a web/phone portal patients use to obtain these pass codes and report on treatment status, and a web-based administrative portal providers use to setup treatment parameters and monitor patient progress. The combined capacities of the system makes it possible for providers to remotely monitor and control patient access to opioid pain killers, while assessing their real-time clinical status and providing education about effective "safe use" practices. In Phase I, a high fidelity "looks like, works like" physical prototype of te core components of the proposed system was developed and tested. As long as the system performs reliably, results suggest that pain patients view the approach as an acceptable and valuable means of managing the risks associated with the use of opioids, and that pain providers view the system as embodying the principles of an ideal opioid risk management solution. In Phase II, continued efforts will focus on the production of a full version of the MedicaSafe system that takes into account Phase I findings; completion of a situational study that assesses performance of the Beta version of the MedicaSafe system in a naturalistic clinical environment; completion of a randomized controlled clinical trial that compares the efficacy of MedicaSafe vs. the latest electronic adherence monitoring (EAM) alternative in the delivery of opioid therapies for chronic pain patients over the course of a year; and, finally, completion of an acceptance study that comprehensively evaluates acceptance of the MedicaSafe system from both the patient and provider point of view.