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

采用使用点测试卡 chemoPAD 来保护撒哈拉以南非洲地区的化疗药物质量

• 批准号: 10689048
• 负责人: Marya Lieberman
• 金额: $ 46.15万
• 依托单位: UNIVERSITY OF NOTRE DAME
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-23 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10689048
• 关键词: Address; Africa South of the Sahara; Awareness; Biological Assay; Cameroon; Cancer Etiology; Clinic; Clinical; Clinics and Hospitals; Cold Chains; Country; Data; Development Plans; Drops; Drug Screening; Educational workshop; Ethics; Ethiopia; Goals; Health; High Pressure Liquid Chromatography; Hospitals; Image; Injectable; Kenya; Left; Malawi; Malignant Neoplasms; Manufacturer; Marketing; Medicine; Methods; Modeling; Motivation; Needs Assessment; North Carolina; Nurses; Oncology; Paper; Participant; Patients; Performance; Pharmaceutical Preparations; Pharmacists; Pharmacologic Substance; Phase; Pilot Projects; Play; Privatization; Protocols documentation; Reporting; Research Personnel; Resource-limited setting; Resources; Sampling; Scientist; Screening Result; Site; Surveys; System; Technology; Technology Transfer; Telephone; Testing; Training; Validation; Vertebral column; Vial device; Work; cancer therapy; chemotherapy; cost-effectiveness evaluation; drug quality; empowerment; improved; low and middle-income countries; manufacture; multidisciplinary; neural network; new technology; outreach; post-market; programs; screening; smartphone application; supply chain; symposium; therapy outcome; validation studies

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

采用使用点测试卡，chemoPAD，用于保护