目的 探索与分析美国药品信息追溯与安全保障体系。方法 通过查阅国内外文献,分析美国《药品供应链安全法案》的出台背景,药品信息追溯与安全保障体系的关键要素,特点与优势以及面临的问题与挑战。结果 美国建立以产品识别码为核心的全程追溯信息链,并以此为基础建立供应链参与方信息传递、可疑产品确认与调查、非法产品处理的责任链,设计长达10年的过渡期。FDA在药品供应链中对行业给予指导和协助,通过召回等措施控制供应链安全,监督参与方履行职责,以此保障药品安全,保护和促进公众健康。结论 美国建立的药品信息追溯与安全保障体系能够使合法产品进入供应链后全程留痕,随着药品所有权的转移,供应链参与方在各环节承担相应责任。FDA作为保障药品供应链安全的监督者,能够根据责任链采取风险控制措施,追究各个参与方的责任。美国的药品供应链责任明晰,各参与方分工合作,在FDA的协助与指导下,避免非法产品的流通使用,这种做法值得我国借鉴与学习。
Abstract
OBJECTIVE To explore and analyze the U.S drug traceability and security system. METHODS By researching domestic and foreign literature,this study analyzed the background of the U.S Drug Supply Chain Security Act,the key elements, characteristics and advantages of the drug traceability and security system, as well as problems and challenges. RESULTS Based on the complete information chain, whose core element is the product identifier, the U. S established a responsibility chain among trade parties for information transmission, verification and investigation of suspect product and disposition of illegitimate products. The system also designed a transition period of 10 years. To ensure drug safety, as well as protect and promote public health, FDA provides guidance and assistance to the industry, controls supply chain security through recalls and other measures, and supervises the trade parties. CONCLUSION The U.S drug traceability and security system can make legal products in the supply chain leave a trace during the whole process. With the transfer of drug ownership, the supply chain participants should take corresponding responsibilities. As a supervisor, FDA can take risk control measures according to the responsibility chain and take the blame. The responsibility of the U.S pharmaceutical supply chain is clear, and the participants work together to avoid the circulation of illegal products under the assistance and guidance of the FDA. The U.S drug traceability and security system is worth being referenced and learned in China.
关键词
药品供应链安全法案 /
药品信息化追溯 /
可疑产品 /
产品标识码
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中图分类号：
R954
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参考文献
[1] MACKEY T K, LIANG B A, YORK P, et al. Counterfeit Drug Penetration into Global Legitimate Medicine Supply Chains: A Global Assessment[J]. Am J Tropical Med Hygiene, 2015, 92(6):59-67.
[2] MACKEY T K, LIANG B A, YORK P, et al. Counterfeit Drug Penetration into Global Legitimate Medicine Supply Chains: A Global Assessment[J]. Am J Tropical Med Hygiene, 2015, 92(6):59-67.
[3] National Association of Boards of Pharmacy. Wholesale Drug Distribution: Protecting the Integrity of the Nation’s Prescription Drug Supply[EB/OL]. (2019-01-14)[2013-08]. https://nabp. pharmacy/wp-content/uploads/2016/07/wholesale-drug-distribution-protecting-the-integrity-of-the-nations-prescription-drug-supply. pdf.
[4] Keith Goldberg. Diversion Scheme Faked Origin Of $440M In Drugs, US Says[EB/OL]. (2019-01-15)[2012-12-14]. https://www. law360. com/articles/401661.
[5] ELIZABETH A. GALLENAGH, LORI F. Hirsch. Title II – Licensure of Wholesale Distributors and 3PL’s[EB/OL]. (2019-01-14)[2017-11]. https://www. fdli. org/wp-content/uploads/2017/11/DQSA-Hrisch-B. pdf.
[6] Dirk Rodgers. Does the DSCSA Have A ‘Spirit’[EB/OL]. (2019-09-10)[2019-01-15]. https://www. rxtrace. com/2018/09/does-the-dscsa-have-a-spirit. html/.
[7] Heather Goodman. How DSCSA Changes the Licensing Landscape[EB/OL]. (2018-09-21)[2019-02-06]. www. pharmexec. com/heather-goodman
[8] TANG W C, WANG Y L, ZHANG X. Research on Drug TracingScheme and Information Architecture in China[J]. Chin Pharm Aff(中国药事), 2018, 32(7):30-34.
[9] FDA. Instruction For Completion Of Form FDA 2 3911-DRUG NOTIFICATION[EB/OL]. [2019-01-18]. https://www. fda. gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM513942. pdf
[10] FDA. Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance for Industry[EB/OL]. (2018-10)[2019-02-05]. https://www. fda. gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm624205. pdf.
[11] DSCSA FAQs - Frequently Asked Questions[EB/OL]. [2019-01-27]. https://www. rxscanmatrix. com/Public/RxScan%20DSCSA%20FAQs. pdf.
[12] FDA. Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy[EB/OL]. (2018-09)[2019-01-17]. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM565272.pdf.
[13] FDA, Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier[EB/OL]. (2018-09)[2019-01-18]. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM586509.pdf.
[14] FDA. DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information Draft Guidance[EB/OL]. (2014-11)[2019-01-18]. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM424895.pdf.
[15] OIG. Drug supply chain Security:Dsipensers received most tracing information[EB/OL]. (2018-03)[2019-01-19]. https://oig.hhs.gov/oei/reports/oei-05-16-00550.pdf.
[16] Tracelink.Serialization in 2019:Industrypriorties and business outlook[EB/OL]. (2019-01-14)[2019-01-19]. https://www.tracelink.com/insights/serialization-in-2019-industry-priorities-and-business-outlook.
[17] Brian Daleiden,Is the market now DSCSA ready?[EB/OL]. [2019-01-19]. http://www.worldpharmatoday.com/Articles/is-the-market-now-dscsa-ready.
[18] Federal Register. Pilot Project Program Under the Drug Supply Chain Security Act; Request for Comments[EB/OL]. (2017-07-20) [2019-01-19]. https://s3.amazonaws.com/public-inspection. federalregister. gov/2017-15203.pdf
[19] GEYNISMAN D M, WONG Y N. Drug Supply Chain Security Act and Oral Anticancer Medications[J]. JAMA Oncol, 2016, 2(3), 295.
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脚注
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基金
国家食品药品监督管理总局药化注册司项目资助(20170012)
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