||5U01CA269195-02 Interpret this number
||University Of Notre Dame
||Adapting a Point of Use Test Card, the Chemopad, for Protecting Chemotherapy Drug Quality in Sub-Saharan Africa
Adapting a point of use test card, the chemoPAD, for protecting
chemotherapy drug quality in sub-Saharan Africa
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.