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Journal de Pharmacie Clinique

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New program for quality control of cytotoxics manufactured in centralised unit Volume 21, issue 3, Septembre 2002

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Authors
Pharmacie Logipôle, Laboratoire d'analyses et de contrôle qualité et unité de reconstitution des cytotoxiques, Hôpital Trousseau, route de Loches, 37170 Chambray-lès-Tours cedex.

The Department of Pharmacy Logipôle 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.