The impact of post-market regulatory safety advisories on patients, prescribers, and the healthcare system

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:. The main objective is to assess the impact of post-market regulatory safety advisories on safety outcomes in patients. Other objectives are to assess the impact of safety advisories on drug utilisation, health services utilisation (e.g. hospitalisations, clinical monitoring, or diagnostic testing), patient-health professional interaction (e.g. informed consent), and healthcare professional or patient/carer knowledge, attitudes, beliefs, and intended behaviours. Additional objectives, if feasible, are to identify attributes of prescription drug safety advisories that enhance or jeopardise their effectiveness.