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励之后，这项第二阶段的SBIR申请建议开发MedicaSafe阿片类药物--一种用于治疗慢性疼痛患者处方阿片类药物疗法的风险管理系统。由于阿片类止痛药的使用急剧增加，因此需要这一系统。虽然这种形式的药物在治疗疼痛方面可以非常有效，但它也可能被滥用、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，也是处方药中毒最近成为意外死亡的第二大原因的主要原因。为了解决这个问题，该领域的领导人越来越多地呼吁 通过一种“平衡”的阿片类药物风险管理办法，同时减少这些药物的误用和滥用，而不限制有合法医疗需求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”包装重新命名的非专利阿片类止痛药，在一个专门的低成本、防篡改的药物分配设备(DDD)中重新命名，该设备通过有限使用的通行码控制对处方药物的访问，患者用于获取这些通行码和报告治疗状态的网络/电话门户，以及提供者用于设置治疗参数和监测患者进展的基于网络的管理门户。该系统的综合能力使提供者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，并提供有关有效的“安全使用”做法的教育。在一期工程中，高保真“长得像、工程得像”的物理样机对TE核心部件的建议系统进行了研制和测试。只要该系统运行可靠，结果表明，疼痛患者认为这种方法是管理与阿片类药物使用相关的风险的一种可接受和有价值的手段，疼痛提供者认为该系统体现了理想的阿片类药物风险管理解决方案的原则。在第二阶段，继续的努力将集中在生产考虑了第一阶段结果的MedicaSafe系统的完整版；完成一项情景研究，评估Beta版本的MedicaSafe系统在自然临床环境中的表现；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)替代方案在一年期间为慢性疼痛患者提供阿片类药物治疗的有效性；最后，完成一项接受性研究，从患者和提供者的角度全面评估对MedicaSafe系统的接受程度。 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。这项研究将制定一种风险管理办法，通过使用“智能”包装重新命名非专利阿片类药物，以减少处方阿片类药物的滥用，同时促进有效的疼痛管理。

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. 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 approach that involves re-branding generic opioids through the use of "smart" packaging intended to reduce prescription opioid abuse while simultaneously promoting effective pain management.