{"title":"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","authors":"Jodoin","doi":"10.12788/JCOM.0041","DOIUrl":null,"url":null,"abstract":"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","PeriodicalId":15393,"journal":{"name":"Journal of Clinical Outcomes Management","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2021-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"COVID-19 Monoclonal Antibody Infusions: A Multidisciplinary Initiative to Operationalize EUA Novel Treatment Options\",\"authors\":\"Jodoin\",\"doi\":\"10.12788/JCOM.0041\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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\",\"PeriodicalId\":15393,\"journal\":{\"name\":\"Journal of Clinical Outcomes Management\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2021-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Outcomes Management\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.12788/JCOM.0041\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Outcomes Management","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.12788/JCOM.0041","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Medicine","Score":null,"Total":0}
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