Study identification

PURI

https://redirect.ema.europa.eu/resource/108049

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

Contact details

Pierre Ernst

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Other

More details on funding

CADTH (Canadian Agency for Drugs and Technologies in Health)
Study protocol
Study protocol
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable