Department of Pharmacy Practice, Chicago State University College of Pharmacy, Chicago, IL, USA.
Int J Clin Pharm. 2011 Jun;33(3):537-42. doi: 10.1007/s11096-011-9503-4. Epub 2011 Mar 29.
In September 2007, the FDA issued an alert recommending that ceftriaxone and calcium-containing solutions should not be administered to any patient within 48 h of each other. Due to the widespread use of ceftriaxone, significant concern was expressed by the greater healthcare community about the warning, which the FDA eventually retracted in April of 2009. We sought to quantify the impact of the warning on healthcare institutions.
A survey was administered to the membership of the Society of Infectious Diseases Pharmacists to quantify perceived changes in ceftriaxone use among healthcare institutions across the United States.
A survey of Infectious Diseases experts was conducted. Participants were queried for hospital policies/drug use statistics during two times: immediately after the FDA warning and approximately 13 months post warning (preceding the FDA retraction).
Related changes in formulary, drug-use policy, and the number of employee hours that were devoted to addressing the FDA warning were assessed.
Ninety-four surveys representing 94 hospital systems were included in the analysis. Approximately half (n = 49, 52%) of respondent institutions enacted at least one drug-use policy change based on the warning; one institution removed ceftriaxone from a clinical protocol. Institutions' final interpretations of the warning differed slightly from initial understanding of the warning, and there was an overall minor decrease in the perceived use of ceftriaxone. The majority of those surveyed (n = 70, 74%) estimated that their respective institutions devoted between 1 and 49 employee hours to address the warning.
Hospitals with ID pharmacists had minimal changes to ceftriaxone use after the 2007 FDA warning. Specialized pharmacists may be uniquely situated to help hospitals interpret global recommendations locally.
2007 年 9 月，FDA 发布警告称，头孢曲松和含钙溶液不应在彼此 48 小时内用于任何患者。由于头孢曲松的广泛使用，更广泛的医疗保健界对该警告表示了极大的关注，FDA 最终于 2009 年 4 月撤回了该警告。我们试图量化该警告对医疗机构的影响。
向感染病药师协会的会员进行了一项调查，以量化全美医疗机构对头孢曲松使用的看法变化。
对感染病专家进行了调查。在两次调查中询问了参与者医院政策/药物使用统计数据：FDA 警告后立即和警告后约 13 个月（在 FDA 撤回之前）。
评估与处方、药物使用政策相关的变化，以及用于解决 FDA 警告的员工时间。
共有 94 份代表 94 家医院系统的调查参与了分析。大约一半（n = 49，52%）的调查机构根据警告采取了至少一项药物使用政策变化；一家机构从临床方案中删除了头孢曲松。机构对警告的最终解释与最初对警告的理解略有不同，并且总体上认为头孢曲松的使用略有减少。大多数接受调查的人（n = 70，74%）估计，他们各自的机构花费了 1 到 49 个员工小时来解决该警告。
在 2007 年 FDA 警告后，具有感染病药师的医院对头孢曲松的使用几乎没有变化。专门的药师可能特别适合帮助医院在本地解释全球建议。
