Guidance for Industry FDA's Safe Use Initiative Collaborating to Reduce Preventable Harm from Medications

摘要

Today, tens of millions of people in the United States depend on prescription and over-the-counter (OTC) medications to sustain their health—as many as 3 billion prescriptions are written annually. Too many people, however, suffer unnecessary injuries, even death, as a result of preventable medication errors or misuse. The approaches used today for managing medication risks in the United States were put in place over the last century, often in a piecemeal fashion and usually in response to various crises and specific needs. Although FDA and many other stakeholders have been working to improve how the healthcare system manages medication risks in the United States, it is widely recognized that more needs to be done to protect the public from preventable harm from medication use. All participants in the healthcare community at large—patients, consumers, caretakers, healthcare practitioners, pharmacists, healthcare systems, health insurers, drug manufacturers, FDA, and other Federal agencies—have arole to play in managing medication risks and reducing preventable harm from medication. We believe that much preventable harm from medications results from problems that can be addressed best in a more coordinated, systematic manner, with interventionsacross all sectors of the medication distribution and use system.