Sandrine von Grünigen1,2, Antoine Geissbühler3,4, Pascal Bonnabry1,5. 1. Pharmacy, Geneva University Hospitals, Geneva, Switzerland. 2. Faculty of Medicine, Institute of Global Health, Geneva University, Geneva, Switzerland. 3. HI5lab, Department of Radiology and Medical Informatics, Geneva University, Geneva, Switzerland. 4. Division of eHealth and Telemedicine, Geneva University Hospitals, Geneva, Switzerland. 5. Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, Geneva, Switzerland.
Abstract
INTRODUCTION: The handling of cytotoxic medicines is a high-risk process for human and environmental health. Considering the rising burden of cancer in low- and middle-income countries (LMICs), we aimed to develop, validate, and pilot test a self-assessment tool to support the implementation of safe handling practices and promote continuous quality improvement for cytotoxic drug management in LMICs. METHODS: First, the self-assessment tool Cyto-SAT was developed and validated. Key sources on the safe handling of cytotoxic medicines were reviewed to derive items addressing safety and quality aspects at every stage of the process. A two-round online Delphi survey was conducted to validate and prioritize the items. The validation rules in the first and second rounds were defined as ≥65% and ≥75% agreement, respectively. Then, intended users in healthcare facilities in LMICs evaluated the Cyto-SAT tool in a pilot test. They were asked to fill out an online evaluation questionnaire. RESULTS: Twenty-seven experts from 13 high-income countries and LMICs participated in the Delphi survey. Final expert consensus was achieved for 134/137 (97.8%) items. Consensus on priority was achieved for 52 of 134 (38.8%) items. The final Cyto-SAT tool comprises 134 items in 10 domains and 28 subdomains covering the whole cytotoxic drug handling process (https://pharmed.datapharma.ch/cyto-sat_en/). Staff from 34 institutions in 28 LMICs completed the Cyto-SAT evaluation. Almost all of them reported total agreement or agreement with its usefulness (96%), applicability (94%), usability (98%), and acceptability (97%). CONCLUSION: Cyto-SAT is the first self-assessment tool designed to assist professionals in LMICs in the safe handling of cytotoxic drugs. The pilot test revealed that Cyto-SAT is a useful and highly appreciated tool that supports practice improvement in LMICs. Cyto-SAT will be used in an international survey to obtain a global overview of handling practices in various LMIC settings.
INTRODUCTION: The handling of cytotoxic medicines is a high-risk process for human and environmental health. Considering the rising burden of cancer in low- and middle-income countries (LMICs), we aimed to develop, validate, and pilot test a self-assessment tool to support the implementation of safe handling practices and promote continuous quality improvement for cytotoxic drug management in LMICs. METHODS: First, the self-assessment tool Cyto-SAT was developed and validated. Key sources on the safe handling of cytotoxic medicines were reviewed to derive items addressing safety and quality aspects at every stage of the process. A two-round online Delphi survey was conducted to validate and prioritize the items. The validation rules in the first and second rounds were defined as ≥65% and ≥75% agreement, respectively. Then, intended users in healthcare facilities in LMICs evaluated the Cyto-SAT tool in a pilot test. They were asked to fill out an online evaluation questionnaire. RESULTS: Twenty-seven experts from 13 high-income countries and LMICs participated in the Delphi survey. Final expert consensus was achieved for 134/137 (97.8%) items. Consensus on priority was achieved for 52 of 134 (38.8%) items. The final Cyto-SAT tool comprises 134 items in 10 domains and 28 subdomains covering the whole cytotoxic drug handling process (https://pharmed.datapharma.ch/cyto-sat_en/). Staff from 34 institutions in 28 LMICs completed the Cyto-SAT evaluation. Almost all of them reported total agreement or agreement with its usefulness (96%), applicability (94%), usability (98%), and acceptability (97%). CONCLUSION:Cyto-SAT is the first self-assessment tool designed to assist professionals in LMICs in the safe handling of cytotoxic drugs. The pilot test revealed that Cyto-SAT is a useful and highly appreciated tool that supports practice improvement in LMICs. Cyto-SAT will be used in an international survey to obtain a global overview of handling practices in various LMIC settings.