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.