title: Safety in the preparation of cytotoxic drugs: How to integrate gravimetric control in the quality assurance policy?
abstract: OBJECTIVE
  We present the way to integrate gravimetric control (GC) in a centralized preparation of cytotoxic drugs unit. Two different modalities are described. In the first strategy, the balance is located inside the isolator, whereas in the second, it is located outside in order to remove many technical and ergonomic constraints. These two modalities are compared in terms of benefits and limits.
  
  
  METHODS
  GC consists in comparing the observed weight variation with the expected weight variation using a precision balance. According to the B-in strategy, this variation is directly attributable to the weight of the cytotoxic solution injected, whereas with the B-out strategy, the weight of various additional components must be taken into account.
  
  
  RESULTS
  Five hundred and seventy-seven preparations have been weighed. For "B-in" strategy, the 95% confidence interval is [1.02-1.14%] and every preparation is below the threshold of 5%. For "B-out" strategy, the 95% confidence interval is [2.34-2.63%] and 94% of preparations are below the threshold of 5%. B-in strategy is distinctly more precise than B-out strategy and can be applied to all preparations. However, B-out strategy is a feasible option in practice and enables the detection of an important mistake. All in all, results obtained from B-out strategy can be considered as a quality indicator in the production line.
  
  
  CONCLUSIONS
  Results of GC are helpful in the final step of release, which the pharmacist is responsible for. Many contributions in the quality assurance policy could justify using of GC in every unit.
authors.affiliation: Department of Pharmacy, Jean-Monnet Hospital, 3, avenue R.-Schuman, 88000 Épinal, France. lecordier.julien@gmail.com
authors.forename: J
authors.initials: J
authors.lastname: Lecordier
authors.forename: Y
authors.initials: Y
authors.lastname: Heluin
authors.forename: C
authors.initials: C
authors.lastname: Plivard
authors.forename: A
authors.initials: A
authors.lastname: Bureau
authors.forename: C
authors.initials: C
authors.lastname: Mouawad
authors.forename: B
authors.initials: B
authors.lastname: Chaillot
authors.forename: J-J
authors.initials: JJ
authors.lastname: Lahet
mesh_terms: D000970:Antineoplastic Agents; D004339:Drug Compounding; D004780:Environment, Controlled; D016273:Occupational Exposure / Q000517:prevention & control*; D010607:Pharmacy Service, Hospital / Q000592:standards*; D011786:Quality Control; D012449:Safety
chemical_list: D000970:Antineoplastic Agents