Technology Enabled Specialty Pharmacy for Oral Oncology

描述（由申请人提供）：该SBIR I期申请提出了MedicaSafe ChemoCareRx的开发，这是一种基于MedicaSafe专有药物治疗优化（MTO）技术的口腔肿瘤患者的技术支持专业药房服务。口服肿瘤化疗方案使用的增加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，而是可以在家中自行完成治疗。虽然这种新的治疗方案为患者提供了更大的灵活性和控制力，但它也带来了重大的挑战和风险。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关注点。因此，在美国和其他地方，专门专注于口服溶瘤药的专业药店正变得越来越普遍。这些项目的目标是最大限度地坚持治疗，教育患者关于药物耐受性和副作用，并积极监测治疗方案的依从性，持久性和治疗时间，通常通过电话提供治疗咨询服务。尽管专业药房项目已被证明可以提高依从率，并相对于零售同行降低整体医疗保健成本，但仍有很大的改进空间，因为利用这些服务的癌症患者的平均依从率仍然远远低于最低期望的依从门槛。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，因为它需要一群受过专门训练的临床医生投入大量时间进行患者评估、教育和随访。由于这些和其他运营成本，专业药房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遇。该系统的关键组件包括一个基于Android的3g连接电子粘附设备（EAD），带有“类似智能手机”的触摸屏界面，用于跟踪和分配复杂的多药物治疗方案；经经验验证的症状管理指南（SMG）的改编多媒体版本，供患者在EAD触摸屏上使用；一套治疗优化算法，用于在生活方式和安全性方面优化患者的药物方案，以及包含详细药物依从性数据和症状严重程度的实时治疗报告，这些报告能够自动集成到医生和药房的电子医疗记录（emr）中。第一阶段将包括利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的主要意见领袖的活动将包括访谈，以探讨该方法的挑战和要求；任务分析，以识别潜在的使用相关危害并改进任务绩效；低保真原型测试和开发活动，以完善系统的概念设计；高保真度测试和开发，使用“看起来像，工作像”的核心系统组件物理原型来测试系统的稳定性和可用性；一项试验性依从性研究比较了ChemoCareRx在现实临床环境中相对于标准治疗（SC）的表现，另一项接受性研究从患者和提供者的角度测试了该系统的接受程度。

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.