Handling of cytotoxic drugs and related waste in low and middle-income countries: A toolkit to promote safe handling practices

Sandrine von Grünigen, Pharmacist MSc, MIH 

PhD Thesis in Global Health, University of Geneva, Switzerland, Presented on June 28th 2022

ISOPP member, Dr. Sandrine von Grünigen obtained a doctoral degree at the University of Geneva (Switzerland) for her thesis on ”Handling of cytotoxic drugs and related waste in low and middle-income countries: A toolkit to promote safe handling practices”. Many ISOPP members contributed to the survey. A summary of her research can be found below.


Cancer is a global burden, including in low- and middle-income countries (LMICs). Cancer prevention and control have been part of the global agenda for some years. Many efforts were made to improve access to chemotherapies. Due to their intrinsic toxicity, cytotoxic drugs must be handled with great caution to ensure the safety of the patients and the personnel handling them. However, safe handling aspects still seem to be neglected in many LMIC cancer programs, where the increasing use of anti-cancer drugs is only recent.  

This PhD focused on the safe handling of chemotherapy drugs in LMICs. The primary objective was to promote the improvement of handling practices, wherever cytotoxic drugs are transported, received, stored, prepared, administered, and disposed of, to ensure the quality of services and the patient and staff safety.  

The first study developed Cyto-SAT, a self-assessment tool designed to help staff at cancer centers in LMICs safely handle cytotoxic drugs. 134 items derived from international guidelines were validated by a strong consensus of international experts through a Delphi survey. The pilot-test of Cyto-SAT by 33 cancer centers from 26 LMICs confirmed its applicability in local settings, its usefulness and usability by healthcare facilities, and its acceptability as a quality improvement tool. 

The second study provided an overview of the level of quality and safety of chemotherapy handling practices in LMICs. The results of the self-assessments with Cyto-SAT revealed wide disparities in practices among the 53 facilities in 34 countries. Many gaps were identified, particularly in the chemotherapy preparation step, especially in cancer centers from low-income countries. Major opportunities for improvement were also identified in key cross-cutting areas such as initial and continuous training of the staff as well as in effective incident management. 

The third study allowed the development and proof of concept of a toolkit to facilitate a comprehensive assessment of chemotherapy handling practices in health facilities in LMICs. In addition to Cyto-SAT, three observation checklists for the prescribing, preparation, and administration of chemotherapy drugs were created. A surface-wipe sampling method was also part of the toolkit to measure cytotoxic contamination of the immediate environment. The toolkit was successfully applied in three African hospitals. It allowed an easy benchmarking of facilities and practices against international standards and the development of an action plan. The toolkit represented a valuable support to implement a continuous quality improvement process, promote best practices and ultimately ensure patient and staff safety. 

In the fourth study, an online training module on safe handling of chemotherapy was developed based on Kern's six-step approach. Evaluation of the 11 asynchronous self-study lessons using a pretest/posttest system showed significant improvements in participants' theoretical knowledge in all but one lesson (which lacked statistical power) and a high degree of participant satisfaction with the content and courseware. 

This PhD resulted in appropriate ready-to-use tools (assessment tools and e-learning) that can be easily used to assess and support the improvement of local practices. It also highlighted gaps and areas where improvements and corrective actions are needed to ensure patient and staff safety. This work represents a first step in the development of a comprehensive safe handling program. As a direct continuation of this thesis, there are three important objectives: (i) the large-scale deployment of these tools, (ii) the sustainability of their use, (iii) the optimization of the training program and its evaluation.

The link to the educational platform is www.Pharm-Ed.net 
The link to the training module on safe handling of chemotherapy drugs (only in French): https://pharmed.datapharma.ch/courses/medicaments-cytostatiques-et-chimiotherapie
The link to the self-assessment tool Cyto-SAT (English version) is https://pharmed.datapharma.ch/cyto-sat_en/