PhD defence: Evaluating and identifying characteristics of effective risk minimisation measures

Medicines can have side effects, so risk minimisation measures are put in place to help protect patients by reducing these risks. This thesis explores how to improve risk minimisation measures to ensure safer use of medicines.

One study investigated the incorrect use of intravenous fluids that can lead to hyponatraemia, a condition that can be dangerous. Surveys of Danish doctors and nurses revealed gaps in knowledge and prescribing practices. For example, only 29 percent of doctors chose the correct treatment for severe hyponatraemia, and many nurses struggled to identify high-risk patients. These findings highlight the need for better education and clearer guidance.

Another study assessed a Danish guide designed to improve intravenous fluid prescribing. While the guide had valuable content, only 22 percent of doctors received it, and unsafe practices persisted. This shows that good tools fail without proper implementation.

Safety communication was also examined. Denmark’s shift to digital communication improved awareness of important medicine safety updates, with 81 percent of doctors now aware of these messages. Doctors preferred digital updates sent by trusted health authorities rather than pharmaceutical companies.

This research emphasises that effective risk minimisation measures depend on clear communication, repeated interventions, and end-user involvement. Regulators collaborate with experts and healthcare professionals. By improving how safety measures are designed and delivered, regulators can better protect patients and ensure medicines are used safely and effectively.