The Use of Oral Fluoroquinolones in Canada: Drug Utilization Study Update

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J01MA02) ciprofloxacin

  ciprofloxacin

  (J01MA06) norfloxacin

  norfloxacin

  (J01MA12) levofloxacin

  levofloxacin

  (J01MA14) moxifloxacin

  moxifloxacin

Population studied

• Short description of the study population:
  The study population consisted of individuals registered in the provincial administrative databases in 6 provinces (Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, and Saskatchewan) between January 1, 2008, and December 31, 2022 (last year of data available).
• Age groups:
  • Preterm newborn infants (0 – 27 days)
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  4850000

Study design details

• Study design:
  This is a multicentre retrospective cohort study describing fluoroquinolone utilization trends from 2008 to 2022 and assessing the impact of the risk minimization measures introduced by Health Canada in 2017
• Main study objective:
  The main objective of this study are to update our previous study to describe fluoroquinolone utilization trends from 2008 to 20022 and to assess the impact of the risk minimization measures introduced in 2017.
• Setting:
  Administrative health databases from the provinces of Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, and Saskatchewan.
• Data analysis plan:
  We will first assess utilization patterns and indications for oral fluroquinolones available in Canada from 2008 to 2022. We will estimate the yearly fluoroquinolone dispensation rates (per 1,000 population) overall and by molecule. We will describe fluoroquinolone use by dosage and duration of use, by prescriber group or specialty, and frequent indications associated with their use. For 3 indications of interest (see section 7), we will determine the rate and percentage of prescriptions for fluoroquinolones vs. other antibiotics, for adults with uncomplicated disease. In addition, we will assess the impact of the regulatory actions on fluoroquinolone use over time. A segmented regression model will be used to compare the rate of fluoroquinolone dispensations before and after 2017, and the rates of fluoroquinolone vs. other antibiotics for the 3 indications of interest. Results will be reported by provinces, pooled, and by age group and sex.
• Summary results:
  Fluoroquinolone Utilization; Main Take-Aways; • Overall dispensation rates of the 4 oral fluoroquinolones of interest decreased by approximately 50% across provinces, sexes, and age groups between 2008 and 2022 (from 107 to 45 dispensations per 1,000 population).; • Fluoroquinolone use decreased for the treatment of adults with acute bacterial sinusitis, acute exacerbations of COPD (patients aged ≥ 66 years only), and uncomplicated UTIs (females only).; • Interprovincial variation in the use of fluoroquinolones was noted.; ; Impact Assessment Analysis; Main Take-Aways; • The reduction in the rates of fluoroquinolone dispensations was 50% from January 1, 2017, to February 29, 2020 (segment 2) and 62% from March 1, 2020, to December 31, 2022 (segment 3) relative to segment 1 (January 1, 2008, to December 31, 2016; before introduction of risk minimization measures).; • Similarly, reductions in the percentages of antibiotic dispensations for fluoroquinolones were observed for the 3 selected conditions: uncomplicated UTIs (females only), acute exacerbations of COPD (patients aged ≥ 66 years only), and acute bacterial sinusitis.; • There were variations across provinces in the magnitude of the reductions in the rates of fluoroquinolone dispensations and the percentage of antibiotic dispensations that were fluoroquinolones