新冠肺炎单克隆抗体输注:实施EUA新治疗方案的多学科举措

Jodoin
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引用次数: 1

摘要

目的:利用多学科合作、美国食品和药物管理局(FDA)的指导,为住院风险高的轻度或中度新冠肺炎门诊患者开发和实施COVID-19]单克隆抗体输注的过程,和感染预防标准方法:当单克隆抗体治疗通过紧急使用授权(EUA)可用于轻度或中度新冠肺炎门诊患者时,我们的机构试图为我们的患者提供这种治疗选择,并根据美国食品药品监督管理局的指导和感染预防标准,维持一个成功的新疗法管理计划。我们实施过程的关键组成部分是涉及决策者和利益相关者的多学科规划;在此过程中设定现实的目标;团队沟通;以及定期测量和报告质量改进结果:从2020年11月20日至2021年3月5日,共输注了790支新冠肺炎单克隆抗体。采取了将不良药物反应可能性降至最低的步骤,发生率较低(<;1%)。在此过程中,工作人员没有担心感染,患者提出了与成本相关的担忧,通常是由于输液前关于账单的沟通不完整。患者、家属、护理人员、医生、药房,医院管理部门对该计划表示满意结论:该过程可以为其他医院或医疗保健机构提供模板,以安全有效的方式为轻度或中度新冠肺炎患者提供新的治疗
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COVID-19 Monoclonal Antibody Infusions: A Multidisciplinary Initiative to Operationalize EUA Novel Treatment Options
Objective: To develop and implement a process for administering COVID-19 monoclonal antibody infusions for outpatients with mild or moderate COVID-19 at high risk for hospitalization, using multidisciplinary collaboration, US Food and Drug Administration (FDA) guidance, and infection prevention standards Methods: When monoclonal antibody therapy became available for mild or moderate COVID-19 outpatients via Emergency Use Authorization (EUA), our institution sought to provide this therapy option to our patients We describe the process for planning, implementing, and maintaining a successful program for administering novel therapies based on FDA guidance and infection prevention standards Keys components of our implementation process were multidisciplinary planning involving decision makers and stakeholders;setting realistic goals in the process;team communication;and measuring and reporting quality improvement on a regular basis Results: A total of 790 COVID-19 monoclonal antibody infusions were administered from November 20, 2020 to March 5, 2021 Steps to minimize the likelihood of adverse drug reactions were implemented and a low incidence (< 1%) has occurred There has been no concern from staff regarding infection during the process Rarely, patients have raised cost-related concerns, typically due to incomplete communication regarding billing prior to the infusion Patients, families, nursing staff, physicians, pharmacy, and hospital administration have expressed satisfaction with the program Conclusion: This process can provide a template for other hospitals or health care delivery facilities to provide novel therapies to patients with mild or moderate COVID-19 in a safe and effective manner
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