Department of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, Maryland, USA
Department of Practice, Sciences, and Health Outcomes Research, University of Maryland School of Pharmacy, Baltimore, Maryland, USA.
BMJ Open Qual. 2024 Jul 24;13(3):e002925. doi: 10.1136/bmjoq-2024-002925.
The US Food and Drug Administration (FDA) issued a warning in December 2018 regarding an increased risk of aortic aneurysms and aortic dissections associated with fluoroquinolone (FQ) use. This warning specifically targeted older adults and patients with conditions such as hypertension, Marfan syndrome, Ehlers-Danlos syndrome, atherosclerosis, peripheral vascular disease and history of aneurysms.
To evaluate the impact of the safety warning on prescribing trends of FQs in the targeted population.
This cross-sectional study with an interrupted time series (ITS) analysis (January 2018-December 2019) used a 25% random sample of IQVIA PharMetrics Plus for Academics health plan claims database. The impact of the warning on FQ utilisation was quantified among the targeted population and a non-targeted population.
From 2018 to 2019, both study populations saw a decrease in the year-over-year percent change of FQ prescriptions per 100 000 beneficiaries (-11%, from 14 227 to 12 662, targeted; -15%, from 5227 to 4446, non-targeted) and proportion of FQ use versus other antibiotics (from 15.6% to 13.8%, targeted; from 9.4% to 8%, non-targeted). In the targeted population, the ITS analysis did not show a significant trend change, a change in level or postwarning trend in the monthly rate of FQ prescriptions per 1000 beneficiaries. A positive trend change was observed in the non-targeted population (0.07, <0.01-0.13), but there were no significant changes in level or post-warning trend.
We did not find a change in FQ prescription rates after the warning. The utility of safety advisories as a primary tool for mitigating FQ use in high-risk populations should be revisited.
美国食品和药物管理局（FDA）于 2018 年 12 月发布警告称，氟喹诺酮类药物（FQ）的使用与主动脉瘤和主动脉夹层的风险增加有关。该警告特别针对老年人和患有高血压、马凡综合征、埃勒斯-当洛斯综合征、动脉粥样硬化、外周血管疾病和动脉瘤病史等疾病的患者。
评估安全警告对目标人群中 FQ 处方趋势的影响。
这项横断面研究采用了中断时间序列（ITS）分析（2018 年 1 月至 2019 年 12 月），使用了 IQVIA PharMetrics Plus for Academics 健康计划索赔数据库的 25%随机样本。该研究在目标人群和非目标人群中定量评估了该警告对 FQ 使用的影响。
从 2018 年到 2019 年，两个研究人群中，FQ 处方的年增长率都有所下降，每 10 万受益人的 FQ 处方（目标人群为-11%，从 14227 降至 12662；非目标人群为-15%，从 5227 降至 4446）和 FQ 与其他抗生素的使用比例（目标人群为-15%，从 15.6%降至 13.8%；非目标人群为-15%，从 9.4%降至 8%）。在目标人群中，ITS 分析未显示出显著的趋势变化，也未显示出每月每千名受益人的 FQ 处方率的水平变化或警告后趋势。在非目标人群中观察到一个正趋势变化（0.07，<0.01-0.13），但在水平或警告后趋势方面没有显著变化。
我们没有发现警告后 FQ 处方率的变化。应重新审视安全警报作为降低高危人群 FQ 使用的主要工具的效用。
