Adapting a point of use test card, the chemoPAD, for protecting chemotherapy drug quality in sub-Saharan Africa

适配使用点测试卡ChemPAD，用于保护 撒哈拉以南非洲地区的化疗药物质量 项目摘要/摘要 目标：验证一种在使用时检测劣质化疗产品的新技术。 动机：化疗药物是中低位癌症患者负担得起的癌症治疗的支柱 收入国家(LMIC)，但LMIC往往缺乏技术和监管能力，无法评估 化疗产品。目前还没有商业技术来筛查质量不佳的化疗 在LMIC环境中使用的产品，以及埃塞俄比亚、马拉维、肯尼亚和 喀麦隆不对化疗产品进行上市后监测测试。 活动：将被验证的技术称为SpotCheck，由一项廉价的纸质测试组成 卡片(ChemPAD)和一款手机应用程序。我们将首先调整ChemPAD以筛选八种类型的 注射化疗药物。这款手机应用程序的神经网络将经过训练，以识别 伪造或包含的API含量低于所述API含量的65%。临床、学术和供应链合作伙伴 埃塞俄比亚、马拉维、喀麦隆和肯尼亚将每年进行320项形势意识和质量调查 每年的化疗产品；这一结果将使北卡罗来纳大学的一组研究人员能够 调查化疗产品的市场，并评估SpotCheck系统的成本效益。在.之后 技术性能里程碑已过，我们将量身定做SpotCheck的临床验证以适应当地 每个站点的需求、临床工作流程和监管能力。SpotCheck系统的验证将 继续进行规划和道德审批里程碑(埃塞俄比亚和马拉维的Y3和肯尼亚的Y4和 喀麦隆)和三个临床阶段：熟练程度研究、临床验证和实施试点。 能力测试将证明肿瘤科药剂师和护士可以准确地使用SpotCheck &gt；85%以检测SF产品。临床验证将确定SpotCheck在临床上是否正确工作 设置在正品上，而不是熟练的样品上。实施试点研究将探讨 SpotCheck能够测试在患者治疗准备好后残留在产品瓶中的液滴 医院；这种使用方法将允许在许多医院和 在低资源环境下的诊所。技术转让努力将使LMIC合作伙伴能够生产 在当地部署ChemPAD，并将手机应用程序整合到监管报告系统中。 影响：这个项目将有助于填补关于LMIC中化疗药物质量的巨大证据空白， 使制造商和分销商更难销售劣质产品，并提高 用于治疗LMICs中的患者。 1

Adapting a point of use test card, the chemoPAD, for protecting chemotherapy drug quality in sub-Saharan Africa Project Summary/Abstract Goal: validate a new technology for detecting bad quality chemotherapy products at the point of use. Motivation: Chemotherapy medicines form the backbone of affordable cancer treatment in low- and middle- income countries (LMICs), yet LMICs often lack technical and regulatory capacity to evaluate the quality of chemotherapy products. There is currently no commercial technology to screen for bad quality chemotherapy products at the point of use in LMIC settings, and the drug regulators in Ethiopia, Malawi, Kenya, and Cameroon do not conduct post-market surveillance testing on chemotherapy products. Activities: The technology that will be validated, called SpotCheck, consists of an inexpensive paper test card (the chemoPAD) and a cell phone app. We will first adapt the chemoPAD to screen eight types of injectable chemotherapy drugs. The phone app’s neural network will be trained to identify products that are falsified or contain less than 65% of the stated API content. Clinical, academic, and supply chain partners in Ethiopia, Malawi, Cameroon, and Kenya will conduct annual situation awareness and quality surveys of 320 chemotherapy products per year; the results will enable a team of researchers at U. North Carolina to model the markets for chemotherapy products and evaluate the cost-effectiveness of the SpotCheck system. After a technical performance milestone is passed, we will tailor the clinical validation of SpotCheck to suit the local needs, clinical workflows, and regulatory capacity in each site. The validation of the SpotCheck system will proceed through a planning and ethical approval milestone (Y3 in Ethiopia and Malawi and Y4 in Kenya and Cameroon) and three clinical phases: proficiency study, clinical validation, and implementation pilot. Proficiency testing will demonstrate that oncology pharmacists and nurses can use SpotCheck with accuracy >85% to detect SF products. Clinical validation will establish whether SpotCheck works correctly in a clinical setting on authentic products, rather than proficiency samples. The implementation pilot study will probe SpotCheck’s ability to test the drops left over in product vials after patient treatments are prepared in the hospital; this method of use would allow sustainable implementation of SpotCheck in many hospitals and clinics in low-resource settings. Technology transfer efforts will empower LMIC partners to produce the chemoPAD locally and integrate the cell phone app into regulatory reporting systems. Impact: This project will help to fill the huge evidence gap about the quality of chemo drugs in LMICs, make it harder for manufacturers and distributors to sell bad quality products, and improve the quality of products that are used to treat patients in LMICs. 1