title: A quantitative and qualitative method to control chemotherapeutic preparations by Fourier transform infrared-ultraviolet spectrophotometry.
abstract: Chemotherapy products in hospitals include a reconstitution step of manufactured drugs providing an adapted dosage to each patient. The administration of highly iatrogenic drugs raises the question of patients' safety and treatment efficiency. In order to reduce administration errors due to faulty preparations, we introduced a new qualitative and quantitative routine control based on Fourier Transform Infrared (FTIR) and UV-Visible spectrophotometry. This automated method enabled fast and specific control for 14 anticancer drugs. A 1.2 mL sample was used to assay and identify each preparation in less than 90 sec. Over a two-year period, 9370 controlled infusion bags showed a 1.49% nonconformity rate, under 15% tolerance from the theoretical concentration and 96% minimum identification matching factor. This study evaluated the reliability of the control process, as well as its accordance to chemotherapy deliverance requirements. Thus, corrective measures were defined to improve the control process.
authors.affiliation: Hospices Civils de Lyon, Hôpital Edouard Herriot, Lyon, France.
authors.forename: Florian
authors.initials: F
authors.lastname: Dziopa
authors.forename: Guillaume
authors.initials: G
authors.lastname: Galy
authors.forename: Stephanie
authors.initials: S
authors.lastname: Bauler
authors.forename: Benoit
authors.initials: B
authors.lastname: Vincent
authors.forename: Sarah
authors.initials: S
authors.lastname: Crochon
authors.forename: Mamadou Lamine
authors.initials: ML
authors.lastname: Tall
authors.forename: Fabrice
authors.initials: F
authors.lastname: Pirot
authors.forename: Christine
authors.initials: C
authors.lastname: Pivot
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000032:analysis*; D004339:Drug Compounding / Q000379:methods*; D006801:Humans; D008508:Medication Errors / Q000517:prevention & control*; D011786:Quality Control; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D017550:Spectroscopy, Fourier Transform Infrared / Q000379:methods*; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents