Analysis of different cytotoxic chemotherapy control methods in 30 french hospitals

2 October 2011

J. Descout, C. Grignon, S. Coulon, A. Dauphin Service de pharmacie, unité centralisée de préparation des cytotoxiques,
groupe hospitalier Cochin-Saint Vincent de Paul,
27 rue Faubourg Saint-Jacques, 75679 Paris, France

Introduction: Control of chemotherapies is variable from one hospital centre to another and there is no consensus as to the methods to be applied. Although not imposed by best preparation practices, analytical control of chemotherapies is considered to be essential by many in-house pharmacies. This study is intended to review the status of the various control methods for currently produced cytotoxic preparations.

Equipment and methods
General and more specific questionnaires on the control method were devised and the in-house pharmacies were questioned by telephone, visit or e-mail. The results were analysed from Excel® files.

The results from 30 hospitals (17 CHU, 10 CH, 2 CLCC, 1 EPSPH) were analysed. 29 in-house pharmacies practice at least one control method. 27 practice a control during manufacturing (26 visual, 4 gravimetric and 2 video inspections) and 12 practice a physiochemical control on the finished product (8 by UV/IR Multispec® spectrophotometry, 4 by HPLC). The analytical controls are mainly conducted in units with a high level of activity (67% of in-house pharmacies ≥ 60 preparations/day vs 13% of in-house pharmacies < 60 preparations/day). 92 % of the in-house pharmacies using an analytical method have a control laboratory. 12 in-house pharmacies are considering changing or adding on one or more methods, 4 conduct physiochemical analysis and 8 controls during manufacturing. The desired techniques are: 5 HPLC, 5 Multispec®, 4 video and 4 gravimetry.

Discussion, conclusion
Analytical control is not made general practice for reasons of available resources (installations, personnel and equipment) and delays in production. Production in advance and dose banding would avoid such backlogs. The complementary nature of controls during manufacturing and analytical controls does however seem to be essential to the in-house pharmacies questioned. Video capture seems to have a promising future.

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