Beyond Pillboxes: Medminding for Universal Drug Delivery

描述（由申请人提供）：用药错误现在是意外死亡的主要原因。智能电子设备正在出现，以帮助药物依从性，组织，提醒，监测和传达药物使用。大多数集中在散装药丸，并被构造为分发药丸，在药丸时间提醒，监测何时服用药丸，或向护理人员传达药丸历史。随着近年来药品包装和递送形式的发展，散装药丸正在失去药物形式中的主导地位。例如，在欧洲，它们仅占口服药物销售的10-15%，其中85-90%包装在泡罩包装或多丸给药包中的单单位剂量中。此外，随着生物技术引入许多注射用生物制剂，注射剂的市场份额正在增加，预计销量将超过口服药物。它们现在占世界市场上推出的新药的五分之一，预计不久这一份额将上升到生物技术衍生药物的一半。这些生物制剂可能不稳定，需要冷藏，有时在给药计划中时间紧迫。这些引领潮流的药物都不适合传统的干预模式。五个主要的药物使用者群体与目前的模式服务不足。然而，他们不遵守的模式同样令人关切，他们的安全风险同样令人震惊。这是这五个主要的药物形式，这个项目的地址：“泡罩包装的药丸。 “预充式和注射器/小瓶形式的注射剂“冷藏药物“立即向护理人员报告的时间紧迫的药物。 “液体和局部药物分配器和过大的药丸。我们提出了一种新颖的，多用途的分配器，执行关键功能，以提高药物依从性。该产品将填补目前市场上针对五种目标形式的药物使用者的巨大空白，他们的护理团队需要立即意识到他们的风险，并且没有其他辅助设备可以满足这些需求。该项目将利用我们团队十年的经验和现有的产品组合和知识产权，开发和商业化一个开创性的电子medminder。 公共卫生相关性：一个关键的公共卫生问题是药物管理不善，这往往会加剧疾病并增加合并症。这是NIH的使命的一部分，以促进创新，在打击疾病。我们提出了一种新颖的多用途分配器，用于改善目前没有技术援助的新兴药物形式、包装和输送系统的药物依从性。

DESCRIPTION (provided by applicant): Medication errors are now the leading cause of accidental death. Smart electronic devices are emerging to aid medication adherence with organizing, reminding, monitoring, and communicating medication use. Most are focused on bulk pills and are structured to dispense pills, remind at pill-time, monitor when pills are taken, or communicate pill histories to caregivers. As pharmaceutical packaging and delivery forms have evolved in recent years, bulk pills are losing dominance among medication forms. For example, in Europe, they represent only 10-15% of oral medication sales, with 85-90% packed in single- unit doses in blister packs or multi-pill dosing packets. Moreover, injections are gaining market share and are expected to outsell oral meds, as biotech introduces many biologics that are injected. They now account for one fifth of new drugs launched on the world market, and soon that share is expected to rise to one-half that are biotechnology-derived. These biologics can be unstable, require refrigeration, and sometimes are time-critical in their dosing schedules. None of these trend-setting drugs fit into traditional medminding models. Five major medication user groups are underserved with the present models. Yet, their patterns of nonadherence are equally as concerning and the risks to their safety are just as alarming. It is these five major drug forms that this project addresses: " Blister packed pills. " Injectables in both prefilled and syringe/vial forms " Refrigerated medications " Time-critical medications with immediate reports to caregivers. " Liquid and topical medication dispensers and over-sized pills. We propose a novel, multi-purpose dispenser that performs critical functions to improve medication adherence. The product will fill a large gap in the market now for medication users of the five targeted forms, whose care teams need instant awareness of their risk, and for whom there are no other assistive devices that serve these needs. This project will leverage our team's decade of experience and existing portfolio of products and intellectual property in developing and commercializing a pioneering electronic medminder. PUBLIC HEALTH RELEVANCE: A critical public health concern is mismanagement of medications, which all-too-often exacerbates diseases and multiplies comorbidities. It is part of NIH's mission to promote innovation in combating diseases. We propose a novel, multi-purpose dispenser that serves to improve medication adherence for emerging medication forms, packaging, and delivery systems for which there is no technological aid currently.