Impact of drug warning system on prescriptions

Abstract

The emergence of a serious adverse effect from a recently marketed drug is a great concern. The earlier we can detect and evaluate those unwanted effects, the better we can prevent them. Regulatory authorities play an important role in detecting, assessing and informing healthcare professionals and consumers on drug safety issues. Regulatory authorities use drug safety warnings as a communication tool for notifying prescribers about the risk and providing the recommendation for their practices. Expected outcomes of drug safety warnings are prescribers' awareness of these risks and a change in their prescribing according to the safety information. However, effectiveness of these safety warnings on clinical practice had been reviewed and led to recommendation for reform in These results suggest that changes in patterns of concerned drugs were associated with international warnings, which may get through to Australian prescribers via NPS MedicineWise or other medical associations. In summary, the impact on drug use depends on the intensity and clarity of warnings as well as the certainty, severity and prevalence of adverse effects. This thesis expands the current understanding of the impact of regulatory iii safety warnings on prescriptions and also provides the scope for possible improvement to the warning system in Australia.iv