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美国膳食补充剂的监管:倡导合理方法、保护患者安全及护理的作用

The regulation of dietary supplements in the United States: advocating for a reasonable approach, protecting patient safety, and the role of nursing.

作者信息

Vatistas Thomas J, Samuels Joanne G

机构信息

Community hospital, Norway, ME, USA.

出版信息

Policy Polit Nurs Pract. 2012 May;13(2):113-6. doi: 10.1177/1527154412456706.

DOI:10.1177/1527154412456706
PMID:23044485
Abstract

Many Americans report using dietary supplements (DS) and there is evidence that the use of such products is increasing. Under the current regulatory system DS are not tested for safety or effectiveness, as with over the counter and prescription drugs, and the Food and Drug Administration (FDA) has limited authority to protect Americans from potential harm. DS in the United States have become a major public health and patient safety issue with injuries, illnesses, and deaths attributed to their use. Efforts in congress to legislate safer regulations have been met with limited success, in part because of the lobbying efforts of the DS industry. Although there is near consensus in the literature and among stakeholder government agencies that a modified FDA role is needed, resolving the issue requires a multifaceted approach. Along with political and legislative action, effort must be made to increase the American public's knowledge of DS.

摘要

许多美国人报告使用膳食补充剂(DS),并且有证据表明此类产品的使用正在增加。在当前的监管体系下,与非处方药和处方药不同,膳食补充剂无需进行安全性或有效性测试,而且美国食品药品监督管理局(FDA)保护美国人免受潜在危害的权力有限。在美国,膳食补充剂已成为一个重大的公共卫生和患者安全问题,因其使用导致了受伤、患病和死亡。国会为制定更安全法规所做的努力取得的成功有限,部分原因是膳食补充剂行业的游说活动。尽管文献以及利益相关政府机构之间几乎达成共识,即需要调整FDA的角色,但解决这个问题需要采取多方面的方法。除了政治和立法行动外,还必须努力提高美国公众对膳食补充剂的认识。

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