Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857, USA.
Annu Rev Med. 2011;62:1-10. doi: 10.1146/annurev-med-060309-164311.
Contemporary medicine is a large and complex system involving many participants, all of whom play a critical role in managing the risks intrinsic to medical product use. Despite the robust premarket review and approval process of the U.S. Food and Drug Administration (FDA), new information will inevitably be learned in the postmarketing period about the safety of medicines and how they are and should be used. For much of this information, FDA relies on public reports about possible adverse events. In turn, the public depends on FDA to communicate the most up-to-date safety information on medical products to better inform treatment decisions. Expanding the scope and strengthening the capabilities of the drug safety surveillance system are among key FDA projects designed to reduce avoidable injury and death from medication use. Although improving drug safety is our goal and obligation to the public, FDA cannot protect the public adequately without the active involvement of all participants in healthcare.
当代医学是一个庞大而复杂的体系，涉及众多参与者，他们在管理医疗产品使用固有风险方面都发挥着至关重要的作用。尽管美国食品和药物管理局 (FDA) 对药品进行了严格的上市前审查和批准程序，但在上市后阶段，必然会获得有关药品安全性以及其使用方式和应如何使用的新信息。对于这些信息中的大部分，FDA 依赖于关于可能发生的不良事件的公众报告。反过来，公众也依赖于 FDA 将有关医疗产品的最新安全性信息传达给他们，以便更好地做出治疗决策。扩大药物安全监测系统的范围和增强其能力是 FDA 旨在减少因用药而导致的可避免伤害和死亡的关键项目之一。尽管提高药物安全性是我们对公众的目标和义务，但如果没有医疗保健所有参与者的积极参与，FDA 就无法充分保护公众。
