Technology Enabled Specialty Pharmacy for Oral Oncology

描述(由申请人提供)：这份SBIR第一阶段申请建议开发MedicaSafe ChemoCareRx，这是一种基于MedicaSafe专有药物治疗优化(MTO)技术为口腔肿瘤患者提供的技术支持的专业药房服务。越来越多的口腔肿瘤化疗方案的使用导致了癌症治疗的范式转变。患者不再需要在输液中心接受治疗，而是可以在家里自己完成治疗。尽管这一新的治疗方案为患者提供了更好的灵活性和可控性，但它也带来了巨大的挑战和风险。随着患者责任的增加和临床监督的减少，治疗依从性和副作用管理已成为这一患者群体的主要担忧。因此，专门专注于口腔肿瘤溶解的专业药店在美国和其他地方正变得越来越常见。这些计划的目标是最大限度地坚持治疗，教育患者有关药物耐受性和不良反应，并积极监测方案的依从性、持久性和治疗时间，通常通过电话提供的治疗咨询服务。尽管与零售同行相比，专业药房计划已被证明可以提高遵从率并降低总体医疗成本，但仍有很大的改进空间，因为使用这些服务的癌症患者的平均遵从率仍然显著低于最低希望的遵从率阈值。此外，专业药学项目通常采用的“高接触”方法也非常耗费时间和资源，因为它需要经过专门培训的临床医生小组将大量时间投入到患者评估、教育和随访上。由于这些和其他运营成本，专业药店在当前市场上保持盈利是极其困难的。ChemoCareRx的开发将直接解决这一市场机会。该系统的关键组件包括一个连接3G的、基于Android的电子依从性设备(EAD)，它具有“类似智能手机”的触摸屏界面，设计用于跟踪和分配复杂的多种药物治疗方案；一个经过调整的多媒体版本的经验性症状管理指南(SMG)，供患者在EAD触摸屏上使用；一套针对生活方式和安全性优化患者用药方案的治疗优化算法，以及能够自动整合到医生和药房电子医疗记录(EMRS)中的实时治疗报告，其中包含详细的用药依从性数据和症状严重程度。第一阶段将使用以用户为中心的设计方法进行ChemoCareRx的经验开发和概念验证测试。与患者、肿瘤学家、临床药剂师、依从性研究人员和医疗保健行业主要意见领袖的活动将包括访谈，以探索该方法的挑战和要求；任务分析，以确定潜在的与使用相关的危险，并改善任务绩效；低保真原型测试和开发活动，以完善系统的概念设计；高保真测试和开发，核心系统组件的物理原型，以测试系统的稳定性和可用性；试验性依从性研究，以比较ChemoCareRx在现实世界临床环境中相对于标准护理(SC)的性能；以及接受性研究，以从患者和提供者的角度测试对系统的接受程度。

DESCRIPTION (provided by applicant): This SBIR Phase I application proposes development of the MedicaSafe ChemoCareRx, a technology- enabled specialty pharmacy service for oral oncology patients built around MedicaSafe's proprietary Medication Therapy Optimization (MTO) technology. The increased use of oral oncology chemotherapy regimens has led to a paradigm shift in the treatment of cancer. Patients are no longer required to receive treatment at infusion centers, but instead can complete treatments at home on their own. Although this new treatment option provides patients with increased flexibility and control, it also poses significan challenges and risks. With increased patient responsibility and reduced clinical oversight, treatment adherence and side-effect management have become major concerns for this patient population. As a result, specialty pharmacies focused specifically on oral oncolytics are becoming increasingly more common place in the U.S. and elsewhere. The goal of these programs are to maximize adherence to therapy, educate patients about medication tolerance and adverse effects, and actively monitor regimen adherence, persistency, and length of therapy, usually through treatment counseling services delivered via the phone. Although specialty pharmacy programs have been shown to increase adherence rates and reduce overall healthcare costs relative to their retail counterparts, there is significant room for improvement, as the average adherence rates of cancer patients who utilize these services still remain significantly below the minimally desirable adherence threshold. Moreover, the "high-touch" approach usually employed by specialty pharmacy programs is also extremely time and resource intensive, as it requires groups of specially trained clinicians to devote extensive amounts of time to patient assessments, education, and follow-up. As a result of these and other operational costs, it is extremely hard for specialty pharmacies to remain profitable in the current marketplace. Development of ChemoCareRx will directly address this marketplace opportunity. Key components of the system include a 3G-connected, Android based Electronic Adherence Device (EAD) with a "smartphone like" touchscreen interface designed for tracking and dispensing complex, multi-drug treatment regimens; an adapted multimedia version of an empirically-validated Symptom Management Guide (SMG) for use by patients on the EAD touchscreen; a set of Treatment Optimization Algorithms for optimizing patient medication regimens with respect to lifestyle and safety, and real-time Treatment Reports with detailed medication adherence data and symptom severity levels able to be automatically integrated into physician and pharmacy Electronic Medical Records (EMRs). Phase I will involve empirical development and proof of concept testing of ChemoCareRx utilizing a user- centered design approach. Activities with patients, oncologists, clinical pharmacists, adherence researchers and key opinion leaders in the healthcare industry will include interviews to explore challenges and requirements of the approach; a task analysis to identify potential use-related hazards and improve task performance; low fidelity prototype testing and development activities to refine the conceptual design of the system; high-fidelity testing and development with "looks like, work likes" physical prototypes of core system components to test system stability and usability; a pilot adherence study to compare performance of the ChemoCareRx relative to standard care (SC) in real-world clinical environment, and an acceptance study to test acceptance of the system from the patient and provider point of view.