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

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS107333
• Study ID:
  108049
• Official title and acronym:
  The Use of Oral Fluoroquinolones in Canada: Drug Utilization Study Update
• DARWIN EU® study:
  No
• Study countries:
  Canada
• Study description:
  In January 2017, Health Canada issued a risk communication to restrict the use of fluoroquinolone antibiotics due their disabling and potentially persistent side effects. The labelling of all systemic fluoroquinolones available in Canada were updated accordingly. ; There is a need to determine if fluoroquinolone utilization patterns have changed since these regulatory actions were implemented. ; The main objectives 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. ; We will conduct a retrospective cohort study using administrative health databases from 6 provinces (Alberta, British Columbia, Manitoba, Nova Scotia, Ontario, and Saskatchewan) between January 1, 2008 and December 31, 2022. Similar methods to the previous CNODES drug utilization study will be used. ; We will assess utilization patterns and indications of systemic oral fluoroquinolones available in Canada from 2008 to present. In addition, we will assess the impact of the 2017 risk minimization measures (risk communication, updates to the labels) on the use of fluoroquinolones through a time series analysis. ; These findings will provide important insight on the current trends of fluoroquinolones use in Canada. ; The study will only include prescriptions for the oral formulation of fluoroquinolones and will not include fluoroquinolone prescriptions dispensed in hospital.
• Study status:
  Finalised

Research institutions and networks

Institutions

Lady Davis Institute

Networks

Canadian Network for Observational Drug Effect Studies (CNODES)

Canada

Study timelines

Date when funding contract was signed

Actual:06/10/2023

Study start date

Planned:01/02/2024

Actual:23/10/2023

Data analysis start date

Planned:01/02/2024

Actual:01/12/2023

Date of interim report, if expected

Planned:01/03/2024

Actual:01/03/2024

Date of final study report

Planned:30/04/2024

Actual:30/04/2024

Sources of funding

Other

More details on funding

CNODES is a collaborating core network partner of CoLab, which is funded for query-related activity by Canada’s Drug Agency (CDA-AMC, grant number C222 360).

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable