Adaptive, Rapid, Parallel-Phase Implementation of the Chemopad to Combat Substandard/Falsified (SF) Chemotherapy Drugs across Sub-Saharan Africa

Background: In low- and middle-income countries (LMICs), a significant proportion of medications, including anticancer agents, are substandard or falsified (SF).¹ These poor-quality medicines do not meet the necessary specifications for standard, appropriate patient care.¹ The prevalence of SF chemotherapy drugs compromises treatment efficacy and patient safety, increasing the risk of morbidity and mortality and loss of rapport in the healthcare system.² To safeguard public health, the ChemoPAD, a low-cost paper analytical device, was developed to detect the presence of active pharmaceutical ingredients (APIs) and identify potential SF chemotherapy medications in LMICs.³

Methods: This study methodology was guided by implementation mapping and consisted of a parallel, adaptive approach of two phases - pre-implementation and clinical implementation.⁴ The pre-implementation involved a collaboration with Tikur Anbessa Specialized Hospital (TASH), Moi Teaching and Referral Hospital (MTRH), and Kamuzu Central Hospital (KCH) - National Cancer Center, to conduct an implementation needs assessment through three virtual informal focus groups. The participants (n = 8) were pharmacists, pharmaceutical coordinators, and the heads of the pharmacy department. The discussion was guided by workflow mapping questions using the CFIR framework. A data trend analysis compared current workflow processes, ChemoPAD feasibility, and barriers and facilitators for implementation. In parallel, a nominal group technique was employed to facilitate discussions on exploring and refining program objectives and implementation strategies with the ChemoPAD research team (n = 14) for the clinical implementation phase.⁵ This iterative approach facilitated consensus and generated ideas, which were further refined through focus groups before reintroduction to the research team for additional feedback and consensus-building.

Results: Both phases discovered ways to promote sustainable workflows. In the pre-implementation phase, participants were receptive to incorporating the ChemoPAD into the workflow, favoring a proactive screening approach for hospital-supplied chemotherapy medicines to ensure drug quality, reduce the risk of adverse events, and prevent supply chain disruptions. Barriers and facilitators have been identified and will be considered for successful ChemoPAD implementation. In the clinical implementation phase, concrete strategies developed include: standard operating procedure, training materials, workflow diagrams, and designating hospital staff and regulatory champions.

Conclusions: This study demonstrated the use of a rapid, adaptive, parallel-phase implementation approach and virtual communication methods to enhance implementation science research in multiple LMIC settings.

Gomes:United Therapeutics: Other: Industry-sponsored fellowship. Muluneh:Servier: Consultancy.