title: Reliability of chemotherapy preparation processes: Evaluating independent double-checking and computer-assisted gravimetric control.
abstract: Background and objectives Centralized chemotherapy preparation units have established systematic strategies to avoid errors. Our work aimed to evaluate the accuracy of manual preparations associated with different control methods. Method A simulation study in an operational setting used phenylephrine and lidocaine as markers. Each operator prepared syringes that were controlled using a different method during each of three sessions (no control, visual double-checking, and gravimetric control). Eight reconstitutions and dilutions were prepared in each session, with variable doses and volumes, using different concentrations of stock solutions. Results were analyzed according to qualitative (choice of stock solution) and quantitative criteria (accurate, <5% deviation from the target concentration; weakly accurate, 5%-10%; inaccurate, 10%-30%; wrong, >30% deviation). Results Eleven operators carried out 19 sessions. No final preparation (n = 438) contained a wrong drug. The protocol involving no control failed to detect 1 of 3 dose errors made and double-checking failed to detect 3 of 7 dose errors. The gravimetric control method detected all 5 out of 5 dose errors. The accuracy of the doses measured was equivalent across the control methods ( p = 0.63 Kruskal-Wallis). The final preparations ranged from 58% to 60% accurate, 25% to 27% weakly accurate, 14% to 17% inaccurate and 0.9% wrong. A high variability was observed between operators. Discussion Gravimetric control was the only method able to detect all dose errors, but it did not improve dose accuracy. A dose accuracy with <5% deviation cannot always be guaranteed using manual production. Automation should be considered in the future.
authors.affiliation: 1 Pharmacy Service, Geneva University Hospitals, Geneva, Switzerland.|2 School of Pharmaceutical Science, University of Geneva and University of Lausanne, Geneva, Switzerland.
authors.forename: Laurent
authors.initials: L
authors.lastname: Carrez
authors.affiliation: 1 Pharmacy Service, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Lucie
authors.initials: L
authors.lastname: Bouchoud
authors.affiliation: 1 Pharmacy Service, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Fleury-Souverain
authors.affiliation: 3 Faculty of Medicine, Division of Clinical Epidemiology, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Christophe
authors.initials: C
authors.lastname: Combescure
authors.affiliation: 1 Pharmacy Service, Geneva University Hospitals, Geneva, Switzerland.
authors.forename: Ludivine
authors.initials: L
authors.lastname: Falaschi
authors.affiliation: 2 School of Pharmaceutical Science, University of Geneva and University of Lausanne, Geneva, Switzerland.|4 Pharmacy Service, Lausanne University Hospital, Lausanne, Switzerland.
authors.forename: Farshid
authors.initials: F
authors.lastname: Sadeghipour
authors.affiliation: 1 Pharmacy Service, Geneva University Hospitals, Geneva, Switzerland.|2 School of Pharmaceutical Science, University of Geneva and University of Lausanne, Geneva, Switzerland.
authors.forename: Pascal
authors.initials: P
authors.lastname: Bonnabry
mesh_terms: D004339:Drug Compounding / Q000379:methods* / Q000592:standards; D004360:Drug Therapy, Computer-Assisted; D008012:Lidocaine / Q000008:administration & dosage / Q000737:chemistry; D008508:Medication Errors / Q000517:prevention & control*; D010607:Pharmacy Service, Hospital / Q000592:standards*; D010656:Phenylephrine / Q000008:administration & dosage / Q000737:chemistry; D011786:Quality Control; D015203:Reproducibility of Results; D000066908:Simulation Training / Q000379:methods; D013046:Specific Gravity; D013594:Syringes
chemical_list: D010656:Phenylephrine; D008012:Lidocaine
keywords: Cytotoxic drugs; computer-assisted gravimetric control; preparation errors; simulation study; visual double-checking