International comparative study on medicines safety regulation

Summary

To compare national safety warnings on medicines in Australia, Canada, the European Union and the United States over a 12-year period, from 2005-2016.

Supervisor(s)

Dr Barbara Mintzes

Research Location

Sydney Pharmacy School

Program Type

Masters/PHD

Synopsis

Medicines have a key role in improving health and easing symptoms, but can also cause serious harm, and many harmful effects only become known once a medicine is in wide use.

When new safety concerns arise, governments often differ in whether or how they warn clinicians and the public. This is the first international comparison of the effectiveness of different approaches. The aim is to improve safety oversight.

This mixed method study includes a policy analysis, advisory content analysis, key informant interviews, and population-based analyses of prescribing effects. Applicants may focus on either qualitative or quantitative components.

Additional Information

This is a collaborative project with teams from University of British Columbia, Harvard, University of Copenhagen, and University of South Australia. Some travel may be needed for data collection.

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Keywords

medicines, public health, health policy, drug regulation, drug safety, health services and patient safety, Pharmacoepidemiology, Qualitative research, pharmacy, international policy comparison, quality use of medicines, bioethics.

Opportunity ID

The opportunity ID for this research opportunity is: 2182