Association of outpatient fluoroquinolone prescribing with the National Medical Products Administration announcements of label changes in China

ABSTRACT

Background

In 2017 and 2021, the National Medical Products Administration (NMPA) announced to revise the drug label of fluoroquinolones. We aimed to evaluate the association of fluoroquinolone prescribing with the NMPA announcements of label changes.

Research design and methods

Monthly prevalence of fluoroquinolone prescriptions for uncomplicated urinary tract infections (uUTI), acute exacerbation of chronic bronchitis (AECB), and acute sinusitis (AS) between 2016 and 2022 was calculated, and interrupted time series analysis was applied to assess the impacts of NMPA label changes on fluoroquinolone use.

Results

Prevalence of fluoroquinolone prescriptions decreased by 2.39% (95% CI, −4.72% to −0.07%) for uUTI but increased by 3.02% (95% CI, 1.71% to 4.34%) for AS immediately after the 2017 label change. Moreover, after the 2021 label change, fluoroquinolone use decreased shortly in all the three indications. However, a significant increasing trend was observed in fluoroquinolone use for AECB episodes, and fluoroquinolons were used for 61.4% of treated uUTI, 31.6% of treated AECB, and 5.42% of treated AS at the end of 2022, respectively.

Conclusions

The label changes issued by the NMPA had no substantial impacts on fluoroquinolone prescribing in the study region in China. Fluoroquinolone prescribing was still highly prevalent for uUTI and AECB and thus requiring further antimicrobial stewardship.

KEYWORDS:

• Fluoroquinolones
• label change
• black box warning
• policy evaluation
• outpatient

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

H Zhao conceived of and designed the work. H Lin, P Shen, and Y Sun acquired the data. H Zhao analyzed the data. H Zhao drafted the manuscript. X Yao and S Zhan critically revised the manuscript for important intellectual content. S Zhan, H Lin, and P Shen supervised the study. H Zhao obtained the funding. All authors were responsible for the interpretation of the data, and revised, and gave final approval of the manuscript. H Zhao is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Data availability statement

YRHCD is open for research purposes. Data requests should be sent to the Yinzhou District Center for Disease Control and Prevention, by contacting Mr. Peng Shen at [email protected] or Mr. Yexiang Sun at 19,464,[email protected]. The feasibility, novelty, and scientific rigor of the proposal will be discussed, and the decision whether to share the data will be made by an academic committee. The data that support the findings of this study are available from the corresponding author upon reasonable request.

Ethical approval

The study was approved by the ethical review board of Peking University Health Science Center (approval number: IRB00001052–23125). Informed consent was not required owing to the use of anonymized routine data.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14787210.2024.2368823.

Additional information

Funding

This manuscript was funded by the National Natural Science Foundation of China [Grant No. 82204157] and the China Postdoctoral Science Foundation [grant NO. 2023T160032 and 2022M710251].The funder had no role in the study design, data collection, data analysis, data interpretation, writing of the report, or decision to submit the article for publication. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit the article for publication.