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

Adapting a point of use test card, the chemoPAD, for protecting chemotherapy drug quality in sub-Saharan Africa Project Narrative Many low- and middle-income countries don’t have the resources to test the quality of chemotherapy drugs, even though bad quality or fake chemotherapy medicines can cause cancer treatments to fail. This project will create inexpensive test cards and a free phone app to detect bad quality chemotherapy medicines at the point of use in hospitals and cancer clinics. Our team of scientists, oncology pharmacists, doctors, supply chain experts, and drug regulators in Ethiopia, Malawi, Kenya, and Cameroon will test the technology to make sure it can detect bad quality chemotherapy drugs before the drugs are given to patients. 1