ScanCap Reminder System in Partnership with Pharmacy Practice

描述(由申请人提供)：Concorance Health Solutions(CHS)是印第安纳州的一家公司，其使命是与药剂师和其他医疗保健提供者合作，提高患者的服药依从性。有了这笔SBIR拨款，CHS将开发和测试一种创新产品ScanCap，这是一种电子提醒帽，可以在药房无缝编程，并整合到处方药的原始包装中。该设备还将具有记录服用剂量的时间并将信息报告给护理人员和医疗保健合作伙伴的能力，以提高患者的用药依从性。研究的具体目标是：目标1)开发ScanCap(产品+数据收集系统)的原型；目标2)在实验室/模拟药房环境中测试零售药房配药系统中的25个ScanCaps；以及目标3)记录两个患者和一个药剂师焦点小组的反应和评论。在第一阶段结束时，CHS将拥有ScanCap电子提醒系统的工作原型，演示与用于自动编程的药房系统的集成，开发记录盖子何时打开并传输数据的能力，并收集定性的客户可行性数据。在第二阶段，CHS将制造该设备，开发用于报告收集的数据的软件界面，并与普渡药学院一起对患者服药依从性的影响进行严格研究。研究表明，坚持服用处方药可以改善许多疾病的整体健康结果，并可以降低许多患者的医疗成本。改善服药依从性是几个NIH研究所目前的重点领域，符合NIH延长健康寿命和减少疾病和残疾负担的使命。然而，典型的服药依从率不到50%，原因有很多，既有刻意的，也有无意的，如健忘和困惑。市场上的提醒设备现在不能作为原始处方套餐的一部分提供，让患者自己挑选和实施柜台提醒产品。一个易于使用的提醒盖，适合标准的处方药瓶，将为药剂师提供一个工具，以帮助他们的患者的药物剂量计划。将提醒设备集成到药房系统中将创建患者对其使用的信心，最终将导致更高的依从性，导致更好的健康结果。拟议的项目将与Rose Hulman Ventures和一家零售药店合作设计和测试ScanCap产品。Scan Cap的功能将包括一个无线接口，可以自动对盖子进行编程，以匹配药物标签说明；当剂量到期时，可以进行视觉和音频提醒；能够与PDA或智能手机连接以进行短信提醒；记录所用剂量，并将患者的用药记录无线传输到电子数据库；价格低廉，一次性使用；体积小，易于携带；以及可适应标准处方瓶、邮购瓶子和安全帽功能的设计。 公共卫生相关性：服药依从性差被描述为一个重大的公共卫生问题。人们普遍认为，不遵守给药时间表对治疗结果产生负面影响，增加住院和疗养院入院人数，并每年增加患者和付款人的护理成本超过1770亿美元。以前商业化的电子提醒设备通常昂贵、复杂，并与原始处方分开销售，这限制了药剂师帮助患者使用该设备的作用，并使医疗保险覆盖机会复杂化。该项目将设计和制造ScanCap，这是一种简单、廉价的药物提醒设备，可以轻松地整合到零售药房实践中，并可以作为原始处方包装的一部分分发，以提高患者的用药依从性。

DESCRIPTION (provided by applicant): Concordance Health Solutions (CHS) is an Indiana company with a mission to improve patient medication adherence in partnership with pharmacists and other healthcare providers. With this SBIR grant, CHS will develop and test an innovative product, the ScanCap, an electronic reminder cap that is seamlessly programmed at the pharmacy and incorporated into original packaging for prescription medications. This device will also have the capability of recording when doses are taken and reporting that information back to caregivers and healthcare partners to improve patient medication adherence. The specific aims of the study are: Aim 1) Develop the prototype of ScanCap (product + data collection system); Aim 2) Test 25 ScanCaps in a retail pharmacy dispensing system in a laboratory/mock pharmacy setting; and, Aim 3) Record reactions and comments from two patient and one pharmacist focus groups. At the conclusion of Phase I, CHS will have a working prototype of the ScanCap electronic reminder system, demonstrated the integration into a pharmacy system for automatic programming, developed the capability to record when the cap is opened and transmit the data, and collected qualitative customer feasibility data. In Phase II, CHS will manufacture the device, develop the software interface for reporting data collected, and conduct a rigorous study of the effect on patient medication adherence with the Purdue School of Pharmacy. Prescription medication adherence is shown to improve overall health outcomes in many diseases and can reduce healthcare costs for many patients. Improving medication adherence is a current focus area of several NIH institutes and in line with the NIH mission to extend healthy life and reduce the burdens of illness and disability. However, typical medication adherence rates are less than 50 percent for a host of reasons that are both intentional in nature and unintentional, such as forgetfulness and confusion. Reminder devices on the market now are not available as part of the original prescription package, leaving the patient to sort through and implement over the counter reminder products on their own. An easy-to-use reminder cap that fits standard prescription vials will give pharmacists a tool to help their patients with medication dosing schedules. Integrating the reminder device into the pharmacy system will create patient confidence in its use and will ultimately result in increased adherence, leading to better health outcomes. The proposed project will partner with Rose Hulman Ventures and a retail pharmacy to design and test the ScanCap product. Features of the Scan Cap will include a wireless interface to automatically program the cap to match the medication label instructions; visual and audible reminders when a dose is due; ability to connect with a PDA or smart phone for text message reminder; recording of doses taken and wireless transmission of patient medication record to an electronic database; inexpensive and disposable; small and easily portable; and a design adaptable to standard prescription vials, mail order bottles, and safety cap features. PUBLIC HEALTH RELEVANCE: Poor medication adherence has been described as a significant public health concern. It is widely recognized that non-compliance with medication dosing schedules negatively impacts treatment outcomes, increases hospitalizations and nursing home admissions, and adds over $177 billion annually to the cost of care for patients and payors. Previously commercialized electronic reminder devices have typically been expensive, complicated, and sold apart from the original prescription, which limits pharmacist's role to help patients with the device and complicates healthcare insurance coverage opportunities. This project will design and manufacture the ScanCap, a simple, inexpensive medication reminder device that incorporates easily into retail pharmacy practice and can be dispensed as part of the original prescription packaging to improve patient medication adherence.