PillHarmonics: An Orchestrated Medication Clinical Decision Support Service

PillHarmonics：精心策划的药物临床决策支持服务

• 批准号: 10382886
• 负责人: James Shalaby
• 金额: $ 27.46万
• 依托单位: ELIMU INFORMATICS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2023-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10382886
• 关键词: Address; Adverse drug event; Adverse event; Affect; Algorithms; Automobile Driving; Clinical; Clinical Data; Clinical Research; Complete Blood Count; Conflict (Psychology); Data; Data Element; Disease; Dose; Drug Hypersensitivity; Electronic Health Record; Environment; Evaluation; Exposure to; FDA approved; Failure; Fast Healthcare Interoperability Resources; Fatigue; Genes; Genomics; Growth; Guidelines; Individual; Knowledge; Lead; Length of Stay; Logic; Mainstreaming; Medical Genetics; Medication Management; Modeling; Motivation; National Human Genome Research Institute; Office Visits; Output; Patient Care; Patients; Pharmaceutical Preparations; Pharmacogenomics; Phase; Policies; Primary Health Care; Privatization; Questionnaires; Recommendation; Regimen; Renal function; Reporting; Risk; Services; Source; Specific qualifier value; Specificity; Strategic vision; Structure; Surface; Tacrolimus; Technology; Testing; Time; Translating; United States; Vendor; actionable mutation; base; clinical decision support; clinically relevant; clinically significant; clopidogrel; cloud based; data repository; drug efficacy; drug structure; electronic structure; experimental study; gene interaction; genetic testing; genomic data; holistic approach; improved; instrument; medication safety; novel; patient safety; prototype; response; success; testing services; usability

Project Summary Medication related adverse events account for over 2 million hospital stays and 3.5 million physician office visits per year. Medication decision support, when implemented correctly, can have a significant impact on these numbers, enhancing patient safety and improving drug efficacy. But while drug decision support is now commonplace in Electronic Health Records (EHRs), many issues remain, and clinicians are generally unsatisfied with the lack of patient specificity and inappropriate context of medication alerts. Add to this the fact that drug-gene alerts are becoming increasingly important. Studies show that over half of all primary care patients are exposed to pharmacogenomics (PGx) relevant drugs; that 7% of FDA- approved medications and 18% of the 4 billion prescriptions written in the United States per year are affected by PGx interactions; and that nearly 98% of individuals have at least one actionable variant by current guidelines. PGx findings are most commonly integrated into the EHR as non-actionable PDF reports. Structured EHR-specific solutions are emerging, and several groups are experimenting with HL7 FHIR and CDS Hooks standards. A common theme across these efforts is that PGx is implemented apart from other types of medication decision support, leading to disjointedness of alerts. For many years, groups have suggested the need to integrate PGx with other types of identified medication interactions. Evidence suggests that such a holistic approach can address patient safety issues (e.g., by juxtaposing conflicting drug recommendations) and alert fatigue (e.g., through greater alert precision). However, merging PGx into an environment that already has many usability challenges risks obscuring the benefits of such alerts. In response, this project aims to develop a medication decision support service, ‘PillHarmonics’, that seamlessly integrates drug-gene interaction checking with other types of medication alerting (such as drug-drug, drug-allergy, and drug-condition), thereby enhancing patient safety through minimization of adverse drug events and decreasing alert fatigue via more precise surfacing of relevant alerts. In the planned prototype, PillHarmonics will gather FHIR-formatted clinical data from an EHR, simulated by a HAPI FHIR server; FHIR-formatted genomic data, in this case from Elimu’s genomic data server; and drug knowledge, in this case from First DataBank and PharmGKB. The service translates identified interactions into normalized data elements which are exposed as structured FHIR DetectedIssues, one DetectedIssue per interaction. The PillHarmonics service will be demonstrated via a CDS Hooks application that generates integrated alerts in response to the addition of tacrolimus or clopidogrel to a patient's existing medication regimen. AIM 2 evaluation will entail a ‘perceived usefulness’ assessment of the PillHarmonics algorithm using an established evaluation instrument.

项目概要 药物相关不良事件导致超过 200 万人住院和 350 万名医生 每年就诊一次的药物决策支持如果实施得当，可以产生重大影响。 根据这些数字，增强患者安全并提高药物疗效，但同时药物决策支持也是如此。 现在电子健康记录 (EHR) 中已司空见惯，但仍然存在许多问题，反对者通常 对缺乏患者特异性和药物警报背景不恰当感到不满意。 除此之外，药物基因警报变得越来越重要。研究表明这一点已经结束。 一半的初级保健患者接触药物基因组学 (PGx) 相关药物；7% 的 FDA- 已批准的药物以及美国每年 40 亿张处方中的 18% 受到影响 通过 PGx 相互作用，近 98% 的人至少有一种可操作的变体 指导方针。 PGx 调查结果通常作为不可操作的 PDF 结构化报告集成到 EHR 中。 EHR 特定解决方案不断涌现，多个小组正在试验 HL7 FHIR 和 CDS Hooks 这些努力的一个共同主题是 PGx 的实施与其他类型不同。 药物决策支持，导致警报脱节 多年来，团体一直建议这样做。 需要将 PGx 与其他类型已确定的药物相互作用结合起来。 整体方法可以解决患者安全问题（例如，通过并列相互冲突的药物建议） 和警报疲劳（例如，通过更高的警报精度）。 然而，将 PGx 合并到一个已经存在许多可用性挑战和风险的环境中 作为回应，该项目旨在开发药物决策支持服务， “PillHarmonics”，将药物基因相互作用检查与其他类型的药物无缝集成 警报（例如药物间、药物过敏和药物状况），从而通过以下方式增强患者安全： 通过更精确地显示相关警报，最大限度地减少药物不良事件并减少警报疲劳。 在计划的原型中，PillHarmonics 将从 EHR 收集 FHIR 格式的临床数据，模拟 通过 HAPI FHIR 服务器；在本例中来自 Elimu 的基因组数据服务器和药物； 知识，在本例中来自 First DataBank 和 PharmGKB，该服务将识别的交互转换为知识。 规范化数据元素，作为结构化 FHIR DetectedIssues 公开，每个 DetectedIssue 一个 PillHarmonics 服务将通过生成的 CDS Hooks 应用程序进行演示。 针对在患者现有药物中添加他克莫司或氯吡格雷而发出的综合警报 AIM 2 评估将需要使用 PillHarmonics 算法进行“感知有用性”评估。 既定的评估工具。