Le Phuong, Grund Laurie, Marwa John, Ojo Wuraola, Otts John, Arab Farhia
College of Pharmacy, University of Minnesota, Minneapolis, MN.
Innov Pharm. 2018 Jul 16;9(2):1-11. doi: 10.24926/iip.v9i2.966. eCollection 2018.
On November 27, 2013, President Obama signed into law the Drug Quality Security Act (DQSA). Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), replaces all existing or future state-wide drug track or trace systems with a new federal drug tracing program that uses pedigrees and product identifiers for verification of the drugs being accepted by the buyer. While the full implementation of the DSCSA is projected to take about ten years from its enactment, both the implementation framework and milestones of the new federal tracing program have been carefully laid out. In this essay, we will explore the current state of the U.S. pharmaceutical supply chain and the imperatives behind the DSCSA. At the crux of this essay is an analysis of the DSCSA implementation plan, its challenges according to feedback from stakeholders, and its potential effectiveness against the entrance of substandard and counterfeit drugs into the U.S. pharmaceutical supply chain.
2013年11月27日，奥巴马总统签署了《药品质量安全法案》（DQSA）使其成为法律。《药品质量安全法案》的第二章，即《药品供应链安全法案》（DSCSA），用一个新的联邦药品追踪计划取代了所有现有的或未来的全州范围的药品追踪或追溯系统，该计划使用谱系和产品标识符来验证买方所接受药品的真实性。虽然预计《药品供应链安全法案》从颁布起全面实施需要大约十年时间，但新联邦追踪计划的实施框架和里程碑都已精心制定。在本文中，我们将探讨美国药品供应链的现状以及《药品供应链安全法案》背后的必要性。本文的关键在于对《药品供应链安全法案》实施计划的分析、根据利益相关者反馈所面临的挑战，以及其在防止不合格药品和假冒药品进入美国药品供应链方面的潜在有效性。
