Regulatory safety advisories on medicines: an international comparison of content and delivery

Abstract

When a medicine is first approved, data on safety is often limited. It is only after the medicine enters general use that less common or longer-term adverse drug reactions may be detected, better understood and quantified. If new evidence emerges of harm, regulators can issue safety advisories to inform clinicians and the public about these risks. Safety advisories are designed to communicate crucial information on these emergent harms and support informed prescribing decisions.This thesis uses a database of regulatory safety advisories from four jurisdictions over a 10-year period to examine how different regulators are using safety advisories to communicate, how the delivery and content of communications on the risks of medicines can affect prescribers’ awareness, knowledge and behaviours, and the links between the content of advisories and effects on prescribing.