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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

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

• 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

• 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.
• 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.

Documents

Study report

Report

Study, other information

Link to project page on CNODES website