EAGER: ISN: Unraveling Illicit Supply Chains for Falsified Pharmaceuticals with a Citizen Science Approach

EAGER：ISN：以公民科学的方式揭开假药的非法供应链

• 批准号: 1842369
• 负责人: Marya Lieberman
• 金额: $ 30万
• 依托单位: University of Notre Dame
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1842369&HistoricalAwards=false
• 关键词: EAGER; ISN; Unraveling; Illicit; Supply

This EArly-concept Grant for Exploratory Research (EAGER) will advance the national health, welfare, and prosperity by studying ways to detect and disrupt the supply networks for falsified pharmaceuticals and illicit drugs. Falsified pharmaceuticals harm hundreds of thousands of patients in the developing world, as well as injuring Americans when they penetrate the U.S. pharmaceutical supply. Illicit drugs, such as opioids, are the cause of more deaths in the U.S. than automobile accidents or gun violence. Analyzing pharmaceuticals using traditional methods is time-consuming and expensive, so producers and distributors often escape discovery. This research will utilize an inexpensive paper analytic device (PAD) in the form of a test card that can be deployed by community health workers and ordinary citizens, that is capable of detecting active ingredients and fillers in a pill or powder within 5 minutes. By swiftly identifying of the types of fillers used, counterfeit pharmaceuticals or illicit drugs in several different locations can be linked, and researchers can begin to reverse engineer the supply chain to identify the source of the product and its distribution channels. Effective deployment strategies for test cards will be developed, and data visualization tools can then be provided to enable local regulatory agencies to act quickly to trace and disrupt suppliers of falsified medicines or illicit drugs. The project will involve both graduate students, focused on detection of fake medicines and supply chain vulnerabilities in low resource settings, and undergraduates, focused on detection of supply chains for illicit opioid drugs. The research will lead to models that describe the movement of products through the supply chain, suggesting pinch points or critical pathways that could be used to shut down distribution of the illicit products. Through the partnership between an analytical chemist and an operations researcher, this project will allow for timely collection and analysis of post-market pharmaceutical samples to detect a wide range of illegal practices and harmful medicines or drugs drugs. The PAD gives fast but imperfect data via the cell phone network; from an operations engineering perspective, the system offers new opportunities to dynamically retarget sample collection, optimize logistics of confirmatory analysis and interactions with regulatory authorities, and model how illicit products enter the pharmaceutical supply chain. The project will test these strategies in real-world settings. Samples of essential medicines will be collected by covert shoppers in Kenya, Malawi, and Bangladesh, and tested with PADs. Integrating methods from operations engineering, the project will test approaches for detecting active ingredients and fillers, determine the incremental value of different types of samples for understanding the supply chains of falsified medications, and examine innovative sampling methods that respond dynamically to early reports of bad quality products. The research will lead to models that describe the movement of the products through the supply chain. Students involved in this project will test samples of street drugs in a police drug lab and classify them into batches according to active ingredient and filler content, with the goal of deducing how many producers are active in the supply chains for these illegal products.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项对探索性研究的早期概念赠款（急切）将通过研究发现和破坏伪造的药物和非法药物的供应网络的方法来提高国家健康，福利和繁荣。 伪造的药物会伤害发展中国家的数十万患者，并在穿透美国药品供应时会伤害美国人。 非法药物（例如阿片类药物）是美国死亡人数多的原因，而不是汽车事故或枪支暴力。使用传统方法分析药物是耗时且昂贵的，因此生产者和分销商经常逃脱发现。这项研究将以廉价的纸张分析装置（PAD）的形式以测试卡的形式使用，该测试卡可以由社区卫生工作者和普通公民部署，该纸张能够在5分钟内检测到药丸或粉末中的活性成分和填充剂。 通过迅速识别所使用的填充剂类型，可以连接几个不同位置的假药或非法药物，研究人员可以开始反向供应链，以识别产品及其分销渠道的来源。 将开发有效的测试卡部署策略，然后可以提供数据可视化工具，以使当地的监管机构能够迅速采取行动，以追踪和破坏伪造的药物或非法药物的供应商。 该项目将涉及两位研究生，专注于在低资源环境中检测假药和供应链漏洞，以及本科生，重点是检测非法阿片类药物的供应链。 这项研究将导致描述产品通过供应链运动的模型，提示可用于关闭非法产品分布的捏点或关键途径。通过分析化学家和运营研究人员之间的合作关系，该项目将允许及时收集和分析市场后药物样本，以检测广泛的非法实践，有害药物或药物。 垫子通过手机网络提供了快速但不完美的数据；从操作工程的角度来看，该系统为动态重新制定样本收集，优化确认性分析的物流和与监管机构的互动提供了新的机会，并模拟非法产品如何进入药品供应链。该项目将在现实世界中测试这些策略。 肯尼亚，马拉维和孟加拉国的秘密购物者将收集必需药物的样本，并用垫子进行测试。该项目从运营工程中进行集成方法，将测试用于检测活性成分和填充剂的方法，确定不同类型的样品的增量价值，以了解伪造药物的供应链，并研究创新的抽样方法，这些方法对不良质量产品的早期报告动态响应。该研究将导致描述产品通过供应链的运动的模型。 参与该项目的学生将在警察药物实验室中测试街头药物的样本，并根据积极成分和填充含量将其分类为批量，目的是推论有多少生产商活跃于这些非法产品的供应链中。这奖反映了NSF的立法任务，并被认为是通过基金会的智力效果和广泛的评估来评估的，并且值得通过评估。

项目成果

Beyond Wax Printing: The Future of Paper Analytical Device Fabrication

• DOI: 10.1016/j.snb.2023.134059
• 发表时间: 2023-05
• 期刊: Sensors and Actuators B: Chemical
• 作者: Rachel M. Roller;M. Lieberman

Reciprocal innovation: A new approach to equitable and mutually beneficial global health partnerships

• DOI: 10.1080/17441692.2022.2102202
• 发表时间: 2022-07-26
• 期刊: GLOBAL PUBLIC HEALTH
• 影响因子: 3.3
• 作者: Sors, Thomas G.;O'Brien, Rishika Chauhan;Litzelman, Debra K.
• 通讯作者: Litzelman, Debra K.

Considerations for the design and implementation of point-of-care technology for use in low- and middle-income countries

• DOI: 10.1038/s43586-023-00197-z
• 发表时间: 2023-02-09
• 期刊: NATURE REVIEWS METHODS PRIMERS
• 作者: Hayes, Kathleen L. L.;Lieberman, Marya
• 通讯作者: Lieberman, Marya

Inferring sources of substandard and falsified products in pharmaceutical supply chains

• DOI: 10.1080/24725854.2023.2174277
• 发表时间: 2023-02-23
• 期刊: IISE TRANSACTIONS
• 影响因子: 2.6
• 作者: Wickett，Eugene;Plumlee，Matthew;Pribluda，Victor
• 通讯作者: Pribluda，Victor

Substandard Cisplatin Found While Screening the Quality of Anticancer Drugs From Addis Ababa, Ethiopia

• DOI: 10.1200/jgo.19.00365
• 发表时间: 2020-01-01
• 期刊: JCO GLOBAL ONCOLOGY
• 影响因子: 4.5
• 作者: Eberle, Madeline S.;Ashenef, Ayenew;Lieberman, Marya
• 通讯作者: Lieberman, Marya