Ms Alice Bhasale

PhD Researcher, Pharmacy School, Faculty of Medicine and Health

Telephone 61-86276122

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Thesis work

Thesis title: International comparison of risk communication using regulatory drug safety advisories: policy and perceptions.

Supervisors: Barbara MINTZES , Lisa BERO , Carmen HUCKEL SCHNEIDER

Thesis abstract:

Aims:
To investigate differences in regulatory policy and practice regarding emerging drug safety issues between Australia, Canada, the UK and the US, in particular for the communication of risk using drug safety advisories. The impact of these risk communications will be considered from the perspective of consumers and health professionals, in a subsequent phase of the study
Methods:
The research will involve an international comparison of regulatory policy for emerging drug safety issues, and qualitative research into the impact of regulatory communications (drug safety advisories), on clinicians and consumers. Regulatory policies from the US, Canada, Australia and Europe will be identified and analysed using content analysis methods with a structured coding instrument. The risk communication goals, policy frameworks, governance structures, communication strategies and policy mechanisms of regulators will be determined. Following this, three case studies of drugs/drug classes for which an advisory was issued between 2005 and 2016 in one or more of the included jurisdictions, will be identified for in-depth analysis using pre-determined criteria.
These case studies will form the basis of a more comprehensive consideration of regulatory activity, before approval, at approval and reimbursement, around the time of the advisory and since the advisory.
For the same case studies, semi-structured interviews with clinicians and consumers will be conducted in two jurisdictions, using these case studies, to assess the effect of regulatory risk communication on awareness and self-reported behavior. Using qualitative research analysis methods, the effective features of risk communications will be determined, taking into account relevant social and environmental factors that influence their impact. The goals of regulatory policy in disseminating the advisory will be considered in the context of the qualitative data.

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