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.

这一早期概念的探索性研究拨款(EARGER)将通过研究如何检测和破坏假药和非法药物的供应网络来促进国家健康、福利和繁荣。假药在发展中国家伤害了数十万患者，当它们渗透到美国的药品供应中时，也伤害了美国人。在美国，阿片类药物等非法药物导致的死亡人数超过了车祸或枪支暴力。使用传统方法分析药品既耗时又昂贵，因此生产商和经销商往往不会被发现。这项研究将利用一种廉价的纸质分析设备(PAD)，其形式为测试卡，可供社区卫生工作者和普通市民部署，能够在5分钟内检测到药丸或粉末中的有效成分和填充物。通过快速识别所用填充物的类型，可以将几个不同地点的假药或非法药物联系起来，研究人员可以开始对供应链进行反向工程，以确定产品的来源及其分销渠道。将制定有效的测试卡部署战略，然后可以提供数据可视化工具，使地方监管机构能够迅速采取行动，追踪和扰乱假药或非法药物的供应商。该项目将涉及研究生和本科生，前者专注于在低资源环境下检测假药和供应链脆弱性，后者专注于非法阿片类药物供应链的检测。这项研究将产生描述产品在供应链中移动的模型，提出可能被用来关闭非法产品分销的夹点或关键路径。通过一名分析化学家和一名业务研究人员之间的伙伴关系，该项目将能够及时收集和分析上市后的药品样本，以发现各种非法做法和有害药品或毒品。PAD通过手机网络提供快速但不完善的数据；从运营工程的角度来看，该系统提供了新的机会，以动态重新定位样本收集，优化验证性分析的后勤和与监管当局的互动，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基本药物的样本，并用PADS进行测试。该项目将整合操作工程的方法，测试检测活性成分和填充剂的方法，确定不同类型样本的增量价值，以了解假药供应链，并审查动态响应早期劣质产品报告的创新抽样方法。这项研究将导致建立描述产品在供应链中移动的模型。参与该项目的学生将在警方毒品实验室测试街头毒品样本，并根据有效成分和填充物含量将其分类，目的是推断有多少生产商活跃在这些非法产品的供应链中。这一奖项反映了NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。

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.

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

Enzyme-based paper test for detection of lactose in illicit drugs

用于检测非法药物中乳糖的酶纸测试

• DOI: 10.1039/c9ay02459j
• 发表时间: 2020
• 期刊: Analytical Methods
• 影响因子: 3.1
• 作者: Zinna, Jessica;Lockwood, Tracy-Lynn E.;Lieberman, Marya
• 通讯作者: Lieberman, Marya

Discrimination of Substandard and Falsified Formulations from Genuine Pharmaceuticals Using NIR Spectra and Machine Learning

• DOI: 10.1021/acs.analchem.2c00998
• 发表时间: 2022-09-06
• 期刊: ANALYTICAL CHEMISTRY
• 影响因子: 7.4
• 作者: Awotunde, Olatunde;Roseboom, Nicholas;Lieberman, Marya
• 通讯作者: Lieberman, Marya