New program for quality control of cytotoxics manufactured in centralised unit

The Department of Pharmacy Logipole Trousseau (Tours, France) recently developed an original quality control of cytotoxics prepared in centralised unit. A study with 40 cytotoxics preparations allowed to validate this programme based on a visual control and the assay by high performance liquid chromatography of only but all the 5-FU preparations. Results of the assay have been analysed after a first six-month control period and allowed us: 1) to determine the mean concentration errors according to the packaging (bags, infusors, cassettes); 2) to identify and rectify manufacturing mistakes (non-respect of hospital manufacturing guidelines; default with control sampling) and 3) to define the pharmacist's action (prescriber information; potential removal and substitution of the preparation) in case of significant dose error (> 10%). This quality control programme allows to ensure daily the conformity of the preparation to prescription of 60% of the chemotherapies and, to validate every day the global process of centralised preparation. The 5-FU was first selected because of its quantitatively major use but now, the control policy will focus on other cytotoxics with narrow therapeutic margin to increase safety of the treatment.