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制药行业能通过全面采用射频识别(RFID)技术和新法规而受益吗?

Could the Pharmaceutical Industry Benefit from Full-Scale Adoption of Radio-Frequency Identification (RFID) Technology with New Regulations?

作者信息

Coustasse Alberto, Kimble Craig A, Stanton Robert B, Naylor Mariah

机构信息

Healthcare administration at Marshall University in South Charleston, WV.

Pharmacy practice at Marshall University School of Pharmacy in Huntington, WV.

出版信息

Perspect Health Inf Manag. 2016 Oct 1;13(Fall):1b. eCollection 2016 fall.

Abstract

Healthcare regulators are directing attention to the pharmaceutical supply chain with the passage of the Drug Quality and Security Act (DQSA) and the Drug Supply Chain Security Act (DSCSA). Adoption of Radio-Frequency Identification (RFID) technology has the ability to improve compliance, reduce costs, and improve safety in the supply chain but its implementation has been limited; primarily because of hardware and tag costs. The purpose of this research study was to analyze the benefits to the pharmaceutical industry and healthcare system of the adoption of RFID technology as a result of newly implemented supply chain regulations. The methodology was a review following the steps of a systematic review with a total of 96 sources used. With the DSCSA, pharmaceutical companies must track and trace prescription drugs across the supply chain, and RFID can resolve many track-and-trace issues with manufacturer control of data. The practical implication of this study is that pharmaceutical companies must continue to have the potential to increase revenues, decrease associated costs, and increase compliance with new FDA regulations with RFID. Still, challenges related to regulatory statute wording, implementation of two-dimensional barcode technology, and the variety of interfaces within the pharmaceutical supply chain have delayed adoption and its full implementation.

摘要

随着《药品质量与安全法案》(DQSA)和《药品供应链安全法案》(DSCSA)的通过,医疗保健监管机构正将注意力转向药品供应链。采用射频识别(RFID)技术有能力提高合规性、降低成本并改善供应链安全,但该技术的实施一直有限,主要原因是硬件和标签成本。本研究的目的是分析由于新实施的供应链法规而采用RFID技术给制药行业和医疗保健系统带来的益处。研究方法是按照系统评价的步骤进行综述,共使用了96个来源。根据DSCSA,制药公司必须在整个供应链中跟踪和追溯处方药,而RFID可以通过制造商对数据的控制解决许多跟踪和追溯问题。本研究的实际意义在于,制药公司仍有潜力通过RFID增加收入、降低相关成本并提高对美国食品药品监督管理局(FDA)新法规的合规性。尽管如此,与监管法规措辞、二维条形码技术的实施以及药品供应链内各种接口相关的挑战,延迟了RFID技术的采用及其全面实施。

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