Study identification

EU PAS number

EUPAS30098

Study ID

41058

Official title and acronym

Influence of safety advisories on drug utilization: an international interrupted time series study

DARWIN EU® study

No

Study countries

Australia
Canada
Denmark
Netherlands

Study description

While medicines have a key role in health care to ease symptoms, treat disease and prevent future ill health, many harmful effects of medicines only become known once a medicine is in widespread use. When new safety concerns emerge, national regulatory agencies issue advisories to warn professionals and the public, however, there are disparities and variations amongst national regulatory agencies in how they respond to emergent drug safety concerns. Without effective warnings and communication of medication risks, prescribers may continue to prescribe and patients may continue to use medicines in ways that lead to unnecessary harm. While regulatory warnings differ from country to country, there has been no research thus far that has compared the effectiveness of differing approaches. Using an interrupted-time series design, our study intends to examine and compare the impact of drug safety advisories on drug utilization in Australia, Canada, Denmark, the United Kingdom, and the United States. Through a selection of approximately 30 advisories from each country, we will estimate the impact of drug advisories on drug utilization in comparison to a control country without similar advisories. Additionally, we will evaluate and estimate the impact of each advisory on drug utilization relative to one or more control countries with a similar advisory. Results from this study will inform best practices in regulatory risk communication on medicines, in terms of the effects on medicine prescribing and use. This project is one component of the larger Safety Advisories Framework for Effective Risk-communication (SAFER) project, which is funded by the Canadian Institutes of Health Research (CIHR) in Canada and the National Health and Medical Research Council (NHMRC) in Australia.

Study status

Ongoing
Research institutions and networks

Institutions

Therapeutics Initiative

Contact details

Colin Dormuth

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Canadian Institute for Health Research
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable