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。     

An Assessment of State Board of Pharmacy Legal Documents for Public Health Emergency Preparedness

Objective. To estimate pharmaceutical emergency preparedness of US states and commonwealth territories.Methods. A quantitative content analysis was performed to evaluate board of pharmacy legal documents (ie, statutes, rules, and regulations) for the presence of the 2006 Rules for Public Health Emergencies (RPHE) from the National Association of Boards of Pharmacy’s (NABP) Model Pharmacy Practice Act.Results. The median number of state-adopted RPHE was one, which was significantly less than the hypothesized value of four. Rule Two, which recommended policies and procedures for reporting disasters, was adopted significantly more than other RPHE. Ten states incorporated language specific to public health emergency refill dispensing, and among these, only six allowed 30-day refill quantities.Conclusion. Based on the 2006 NABP model rules, it does not appear that states are prepared to expedite an effective pharmaceutical response during a public health emergency. Boards of pharmacy should consider adding the eight RPHE to their state pharmacy practice acts.     

Project Integrate: Translating Screening and Brief Interventions for Alcohol Problems to a Community Hospital Emergency Department

ABSTRACT

Screening and brief intervention (SBI) for alcohol problems in the emergency department (ED) is effective. The objective of this study was to examine the translation of SBI into a busy community ED environment. The authors assessed key stakeholders views of SBI delivery model, then utilized feedback to adapt model. Adoption of SBI was recorded, with data collected on use of screening tool, and referral for a BI. Model was modified due to physicians' and nursing resistance; physicians only screened and a research assistant (RA) delivered the BI. When the RA was present, screening by ED staff increased from 50% to 71% but returned to 50% after the RA left. An identified opportunity was increased nursing interest after observation of SBI, with 15 nurses trained in SBI after ED intervention concluded. Important barriers to translating SBI to community ED clinical practice exist. However, with additional staff present, high levels of SBI can occur.