University of South Florida College of Pharmacy, Tampa, FL, USA.
Nova Southeastern University College of Pharmacy, Fort Lauderdale, FL, USA.
Ann Pharmacother. 2019 Dec;53(12):1192-1199. doi: 10.1177/1060028019865224. Epub 2019 Jul 18.
Little is known regarding the impact of the Food and Drug Administration (FDA) boxed warning on prescribing rates of fluoroquinolone (FQ) antibiotics in the outpatient setting. The primary objective of this study was to evaluate the 2016 FDA boxed warning update on FQ prescribing rates for uncomplicated urinary tract infection (uUTI). This was a single-center retrospective cohort study conducted at 6 family medicine practices, including women aged 18 to 65 years with an outpatient visit for uUTI from January 1, 2016, to December 31, 2016. A total of 436 patients met inclusion. FQs were prescribed in 38% of patients before the FDA boxed warning and in 30% of patients after (8% reduction). Non-FQ prescribing had a corresponding 8% increase, comprising 62% of uUTI prescribing before the FDA boxed warning and 70% after ( = 0.08). The likelihood of being prescribed a FQ was not significantly different following release of the FDA boxed warning (adjusted odds ratio = 0.67 [95% CI = 0.41-1.10]). Variables significantly associated with an increase in FQ prescribing based on logistic regression were age ≥58 years and chronic kidney disease. Concordance of antibiotic prescribing with the Infectious Diseases Society of America clinical practice guidelines for uUTI was low, and the incidence of treatment failure was low. The 2016 FDA boxed warning was not significantly associated with decreased FQ prescribing for uUTI across a large academic family medicine practice. Methods to improve education and disseminate FDA warnings in practice are needed.
对于食品和药物管理局（FDA）的盒装警告对氟喹诺酮（FQ）类抗生素在门诊环境下的处方率的影响知之甚少。本研究的主要目的是评估 2016 年 FDA 关于非复杂性尿路感染（uUTI）的 FQ 类抗生素处方更新的盒装警告。这是一项在 6 家家庭医学诊所进行的单中心回顾性队列研究，包括年龄在 18 至 65 岁之间的女性，她们在 2016 年 1 月 1 日至 2016 年 12 月 31 日期间因 uUTI 门诊就诊。共有 436 名患者符合纳入标准。在 FDA 盒装警告之前，38%的患者开了 FQ 类药物，在警告之后，这一比例为 30%（减少了 8%）。非 FQ 类药物的处方相应增加了 8%，在 FDA 盒装警告之前占 uUTI 处方的 62%，在警告之后占 70%（=0.08）。在发布 FDA 盒装警告后，开 FQ 类药物的可能性没有显著差异（调整后的优势比=0.67[95%置信区间=0.41-1.10]）。基于逻辑回归，与 FQ 类药物处方增加显著相关的变量是年龄≥58 岁和慢性肾脏病。根据美国传染病学会临床实践指南，抗生素处方与 uUTI 的一致性较低，治疗失败的发生率较低。2016 年 FDA 盒装警告与 uUTI 中 FQ 类药物处方减少没有显著相关性，在大型学术性家庭医学实践中。需要改进教育和在实践中传播 FDA 警告的方法。
