美国FDA对公共卫生紧急事件的防范和应对措施

美国FDA是医疗产品监管部门,在保护美国公众免于生物、化学、放射性/核威胁和新发流行性传染病威胁中起了至关重要的作用。美国FDA负责评审应对上述威胁的医疗应对产品包括药品、治疗用生物制剂、疫苗和器械的安全性和有效性,使用法律机制加快医疗应对产品的紧急使用,监控医疗应对产品的不良反应,与政府其他部门协同防范公共卫生威胁并作出反应。简介美国FDA的医疗应对产品评审政策、紧急使用以及FDA对公共卫生紧急事件的防范和应对措施。     

Pharmacists’ roles in emergency and disasters: COVID-19 as an example

BackgroundEmergencies and disasters are major threats to health care systems. Coronavirus Disease 2019 (COVID-19) is at the center of a recent emergency situation that requires increased attention from health care professionals, including pharmacists. This study was aimed at providing an overview of pharmacists’ roles in disasters and formulating a definition of expected roles and tasks through which they can perform these roles properly.MethodsA systematic review was conducted utilizing a literature search performed on the Medline, EMBASE and PubMed databases. The last search occurred on 14 July 2020. Data were extracted and recorded on a data extraction sheet by the reviewers, then categorized using the prevention, preparedness, response, and recovery (PPRR) model. Study quality was evaluated using the Critical Appraisal Skills Program (CASP) checklist.ResultsFifteen articles addressing pharmacists’ roles in disasters were included. Of these, three addressed pharmacists’ roles during the COVID-19 pandemic. Pharmacists’ roles in the prevention of emergencies, including COVID-19, are focused on chronic disease medication supply and education. Regarding pharmacists’ preparedness to perform their roles in disasters, they were more focused on health policy and population health planning, especially regarding the COVID-19 pandemic. Direct patient care continues to support patients through medication availability, and pharmacists’ clinical roles are examples of their response to disasters. In addition, pharmacists have an important role in disaster recovery that involves several activities, such as restocking emergency kits and reestablishing normal stock. Studies were generally of a reasonable quality. However, some limitations were noted among studies, and higher quality studies that contribute to existing knowledge are needed.ConclusionHealth care systems’ utilization of pharmacists’ new roles can result in a well-prepared disaster response, as observed during the COVID-19 pandemic. Pharmacists’ engagement in decision-making processes and adequate demonstration of pharmacists’ nontraditional roles in the literature can facilitate the health care community’s acceptance of such roles.     

Strengthening pandemic preparedness through pharmacy and public health collaborations: Findings from a facilitated discussion exercise

BackgroundCommunity pharmacists are key partners to public health agencies during pandemics and other emergencies. Community pharmacy and public health agencies can establish memoranda of understanding (MOUs) for dispensing and administering medical countermeasures and providing related services to affected population(s) during a public health incident.ObjectiveThe objective of this facilitated discussion exercise was to identify the strengths and opportunities associated with the activation of a statewide pharmacy–public health agencies MOU with community pharmacists on the basis of a simulated pandemic influenza event.MethodsA facilitated discussion exercise was held in the Puget Sound region of the State of Washington in May 2017. The participants included pharmacists from 2 community pharmacy organizations, emergency preparedness officials from 2 local health departments and the state health department, staff of the state pharmacy association, and faculty from a school of pharmacy. The evaluators recorded the discussions and observations, augmented by a postexercise telephone call with participants from each of the participating community pharmacy organizations. Key themes from the exercise are reported.ResultsFive themes were identified during the facilitated discussion exercise. Two themes described the strengths of the MOU and its operational plan: (1) collaboration strengthens preparedness and response planning, and (2) an MOU provides a framework for effective collaboration. Three themes acknowledged the opportunities to optimize activation of the existing MOU: (1) early and active engagement between health department personnel and community pharmacists, (2) establishing pharmacy policies and procedures to support readiness and response, and (3) addressing the training or other educational needs of community pharmacists.ConclusionThis exercise provided community pharmacists and public health agency personnel an opportunity to better plan for responding to a pandemic. The open dialogue in this facilitated discussion allowed the exercise participants to identify the strengths, priorities, and perspectives as well as the gaps in the MOU operational plan. The lessons learned in this exercise can inform the community pharmacy and public health response to the coronavirus disease pandemic.     

公共卫生事件中医疗机构中药制剂应急管理探讨

目的 回顾与总结新型冠状病毒肺炎疫情下医疗机构中药制剂应急管理措施,为进一步改进和完善我国应对突发公共卫生事件中药品应急管理体系建设提供参考。方法 结合本次新型冠状病毒肺炎疫情中各省医疗机构中药制剂应急管理工作实践,梳理开展医疗机构中药制剂应急管理工作流程,探讨突发公共卫生事件中医疗机构中药制剂管理策略及措施。结果 目前,19个省份发布新型冠状病毒肺炎防控用医疗机构中药制剂应急管理文件,25个省份完成百余种医疗机构中药制剂备案审批并投入临床使用。结论 建立完善的药品应急管理体系,可以提高监管效率,协调指导相关工作有序进行,进一步提高突发公共卫生事件应对能力。     

建立我国突发事件应急状态下的医疗产品紧急使用授权机制探讨

目的： 通过对美国FDA的紧急使用授权（Emergency Use Authorization,EUA）制度进行研究,结合我国国情,探讨在我国建立医疗产品紧急使用授权机制。方法： 文献研究、专题访谈。结果与结论： 紧急使用授权制度有别于我国现有的特别审评程序,对于应对突发事件应急状态下所需药物的评估和使用授权,提高药物使用的安全性、时效性、可及性及合规性具有重要意义。本研究初步提出了在我国建立医疗产品紧急使用授权机制的考虑要点,包括建立紧急使用授权制度的必要性、制度的基本定位、上位法的支持、制度构建的关键要素、配套的技术指南及其他需要关注的问题。     

美国国家药品应急体系构建与运作研究

目的借鉴美国应急药品国家战略储备体系运作模式,提出建设我国国家药品应急体系的建议。方法从储备形式、供应体制、训练与演习3个方面,对美国国家药品应急体系进行分析。结果与结论我国国家药品应急体系应借鉴美国的模式,实现储备形式多样化、供应方式体系化和训练演习制度化。     

突发公共卫生事件相关的药品审评审批政策思考

2019年的新型冠状病毒肺炎疫情对中国应对突发公共卫生事件的应急反应是一个严峻的考验。研究了美国食品药品监督管理局（FDA）医疗对策、紧急使用授权,以及药品审评审批加急程序的相关政策,为重大威胁相关的药品审评审批政策的制定提供参考,并为应对突发公共卫生事件的药品的战略性研制和储备提供思路。     

Medical countermeasures for unwanted CBRN exposures: part II radiological and nuclear threats with review of recent countermeasure patents

Introduction: The global threat of a chemical, biological, radiological, or nuclear (CBRN) disaster is an important priority for all government agencies involved in domestic security and public health preparedness. Radiological/nuclear (RN) attacks or accidents have become a larger focus of the United States Food and Drug administration (US FDA) over time because of their increased likeliness. Clinical signs and symptoms of a developing acute radiation syndrome (ARS) are grouped into three sub-syndromes named for the dominant organ system affected, namely the hematopoietic (H-ARS), gastrointestinal (GI-ARS), and neurovascular systems. The availability of safe and effective countermeasures against radiological/nuclear threats currently represents a significant unmet medical need.

Areas covered: This article reviews the development of RN threat medical countermeasures and highlights those specific countermeasures that have been recently patented and approved following the FDA Animal Rule. Patents for such agents from 2015 have been presented.

Expert opinion: Two granulocyte colony-stimulating factor (G-CSF)-based radiation countermeasures (Neupogen® (Amgen, Thousand Oaks, CA) and Neulasta® (Amgen, Thousand Oaks, CA)) have recently been approved by the FDA for treatment of H-ARS and both these agents are radiomitigators, used after radiation exposure. To date, there are no FDA-approved radioprotectors for ARS.     

运用品管圈活动降低急诊不合理处方发生率的实践

目的：运用品管圈活动降低我院急诊不合理处方发生率,促进急诊合理用药,保障患者用药安全。方法：按照品管圈十大步骤及七大手法开展活动,分别调取我院2016年8月至9月（活动前）和2016年12月至2017年1月（活动后）的急诊处方,对处方进行点评,通过所得数据对此次活动进行效果确认。结果：急诊不合理处方发生率由活动前的46.28%降低至改善后的15.17%。结论：通过开展此次活动,再次印证了品管圈是推动医疗质量持续改进的有效管理工具,在降低急诊不合理处方发生率方面效果显著,提升了药学服务质量,体现了药师的价值。     

Medical countermeasures for unwanted CBRN exposures: Part I chemical and biological threats with review of recent countermeasure patents

Introduction: The threat of chemical, biological, radiological, and nuclear (CBRN) warfare has been addressed as the uppermost risk to national security since the terrorist attacks on 11 September 2001. Despite significant scientific advances over the past several decades toward the development of safe, non-toxic and effective countermeasures to combat CBRN threats, relatively few countermeasures have been approved by the US Food and Drug Administration (US FDA). Therefore, countermeasures capable of protecting the population from the effects of CBRN attack remain a significant unmet medical need. Chemical and biological (CB) threat agents can be particularly hazardous due to their effectiveness in small quantities and ease of distribution.

Area covered: This article reviews the development of countermeasures for CB threats and highlights specific threats for which at least one countermeasure has been approved following the FDA Animal Rule. Patents of CB countermeasures since 2010 have been included.

Expert opinion: Nine CB countermeasures have received FDA approval for use in humans following the Animal Rule, and a number of promising CB countermeasures are currently under development. In the next few years, we should expect to have multiple countermeasures approved by the FDA for each indication allowing for more flexible and effective treatment options.     

“Vital in today's time”: Evaluation of a disaster table-top exercise for pharmacists and pharmacy staff

BackgroundWhile the importance of pharmacists’ involvement in disaster management is becoming increasingly recognised in the literature, there remains little research on methods for preparing pharmacists and pharmacy staff for disasters.Objective(s): To investigate the use of a table-top disaster exercise to improve disaster awareness and preparedness for pharmacists and pharmacy staff attending The Society of Hospital Pharmacists of Australia (SHPA) Medicine Management conference 2019.MethodsA table-top disaster exercise was developed by the research team and presented as a workshop at the SHPA's annual conference in 2019. The workshop presented attendees with the hypothetical ‘Cyclone Oma’ that was tracking across the fictional state of ‘New Cardiff’. Each workshop table was assigned a different hospital and was required to respond to Cyclone Oma as the scenario evolved. Workshop attendees were invited to complete a pre- and post-survey assessing their perceptions of disaster management and preparedness for pharmacists and pharmacy staff.ResultsThe pre- and post-workshop survey was completed by 41 out of the 47 attendees. Participants’ assessments of their understanding of disaster management activities increased after attending the workshop (p< 0.001). Most participants felt the workshop improved their understanding of their role in a disaster (87.8%, 36/41) and allowed them to identify their strengths and weaknesses in disaster management (90.2%, 37/41). The workshop was well received with 92.7% (38/41) of participants stating they would like further continuing professional development opportunities in disaster management.ConclusionsThis is the first disaster table-top exercise in Australia targeted specifically at the pharmacy workforce to be conducted and evaluated. The exercise improved understanding of disaster management and was well received by the participants. This research calls for further education and training opportunities in disaster management targeted at the pharmacy workforce.     

北京协和医院静脉药物配置中心实时审核干预不合理医嘱分析及对策

目的：分析北京协和医院静脉药物配置中心实时干预的不合理医嘱,并探讨解决对策。方法：回顾性统计2018年我院静脉药物配置中心审方药师根据《临床药物治疗学》、药品说明书、MICROMEDEX及Up To Date等相关资料对长期医嘱和临时医嘱进行实时前置审核所发现的不合格医嘱类型与数量,计算干预率。结果：从实时审核医嘱中共发现不合理医嘱174份,主要涉及药物用法用量不适宜、录入错误、溶媒不适宜及药物浓度不适宜等,干预率达100%。结论：通过静脉药物配制中心药师对医嘱的实时审核和干预,能有效地降低和避免不合理用药的产生,促进临床合理用药。     

State‐of‐the‐art therapeutic medical countermeasures for bacterial threat agents

In the event of another bioterrorism attack with a bacterial agent, antibiotics will be critical medical countermeasures to have in the US Strategic National Stockpile. Conventional antibiotics such as ciprofloxacin, doxycycline, and streptomycin are generally considered a first line of defense against organisms such as Bacillus anthracis and Yersinia pestis. However, antibiotic resistance is a growing public health threat, especially among potentially life‐threatening pathogens; it is possible that threat agent bacteria could naturally evolve, or be engineered to express, antibiotic resistance against commonly used antibiotics. At the same time that the need for novel or improved antibiotics is becoming urgent, the antibiotic development pipeline has slowed, with only two completely new classes of antibiotics having been introduced over the past 40 years. In the present work, we review the current antibiotic pipeline, including novel, innovative approaches being considered to target bacteria or virulence, with a focus on those compounds that have been tested for activity against threat agent bacteria. We opine on the benefits and challenges inherent in certain mechanisms of action and stress that regulatory, policy, and technical strategies need to be revisited in order to incentivize industry to continue antibiotic development. Drug Dev Res 72: 361–378, 2011.© 2011 Wiley‐Liss, Inc.