Adverse Drug Reactions, Medical Accidents, and Patient Safety

Abstract

The open-ended nature of Medicare and Medicaid funding in the US has made increased governmental oversight of the health sector partly an exercise in fiscal self-preservation. Most EU countries, on the other hand, exert tighter control over total health care spending through budgetary processes, so do not experience as intense fiscal pressures to implement quality improvement measures. On both sides of the Atlantic, however, payor oversight also attempts to improve patient safety and welfare. The regulatory response to medical risks has nonetheless been relatively low-key and cautious everywhere. Apart from a few subject areas - US drug and device regulation, and EU regulation of genetically modified food, for example - the precautionary principle has not found robust expression in regulatory policy focused on health care itself. In both America and the EU the reasons for this range from the difficulty of identifying iatrogenic risk, to the traditional deference accorded to self-regulation in the medical profession, to the paucity of enforcement resources. This chapter compares US & EU approaches to adverse drug reactions, medical accidents and patient safety through the lens of the precautionary principle.

Keywords: Risk Regulation in the U.S., Risk Regulation in Europe, medical risk, adverse drug reactions, patient safety, medical accidents, iatrogenic risk, precautionary principle

JEL Classification: I1, I11, I18, I19, K32, K33