Improving the Food and Drug Administration's mandate to ensure postmarketing drug safety.

摘要

These risk mitigation strategies are laudable, but there are several reasons for concern. First, nearly half of these strategies have used Medication Guides alone as a tool to improve drug safety. Although some patients may receive, read, and synthesize the information contained in Medication Guides, there are a variety of reasons that many do not, and Medication Guides remain part of a fragmented and disorganized system of consumer medication information that leaves many patients inadequately informed.6 The ability of Medication Guides alone to substantially improve the safe use of drugs remains doubtful and unproven, at best.