ABSTRACT

CONTENTS 27.1 Introduction ......................................................................................................................483 27.2 Pharmaceutical Care ......................................................................................................484 27.3 Increased Medical Errors ..............................................................................................485 27.4 Patient Education ............................................................................................................485 27.5 FDA Efforts on Patient Education ................................................................................486 27.6 Adverse Event Reporting ..............................................................................................486 27.7 Conclusions ......................................................................................................................487 References ....................................................................................................................................487

Although medical products are required to be safe, safety does not mean zero risk. A safe product is one that has reasonable risks, given the magnitude of the benefit expected and the alternatives available. All participants in the medical product development and delivery system have a role to play in maintaining this benefit-risk balance by making sure that products are developed, tested, manufactured, labeled, prescribed, dispensed, and used in a way that maximizes benefit and minimizes risk.1