Cytotoxics compounded sterile preparation control by HPLC during a 16-month assessment in a French university hospital: importance of the mixing bags step

Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners
Vincent CastagneLaurence Bonhomme-Faivre

Abstract

The Centralized Chemotherapy Reconstitution Unit (CCRU) of Paul Brousse Hospital Pharmacy Department assessed the reliability of its Cytotoxics Compounded Sterile Products (CCSP) preparation method in order to improve its CCSP quality assurance system. Five cytotoxic drugs - gemcitabine, 5-fluorouracil, docetaxel, paclitaxel, and oxaliplatin - were assayed by high performance liquid chromatography (HPLC) to determine CCSP concentration. During the observation period, 23,892 CCSP were prepared. Overall, 12,964 preparations contained one of the five analyzed drugs; 7382 (56.9%) out of 12,964 CCSP were analyzed by HPLC; 646 (8.8%) out of 7382 concentrations were outside ± 20% of the prescribed dose; 544 (84.2%) out of 646 were post-administration results and could not be verified. Out of 102 (15.8%) pre-administration results that were re-tested after re-shaking, 94 (92.2%) were found to be acceptable upon re-testing, and 8 (7.8%) were confirmed to be unacceptable and needed to be re-compounded. The 8.8% of tested CCSP were outside ± 20% of the prescribed dose, but extrapolating the results on re-tested CCSP, we can say that our CCSP preparation is reliable with an estimation of only 0.7% of 7382 CCSP analyzed, confirmed as being ...Continue Reading

References

Dec 23, 2003·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·UNKNOWN Agence Française de Sécurité Sanitaire des Produits de Santé
Jun 6, 2006·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Isabelle BorgetPhilippe Bourget

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Citations

Aug 25, 2015·International Journal of Pharmaceutics·Christophe BazinLaurent Havard
Mar 1, 2016·International Journal of Pharmaceutics·Frédéric BenizriBenoit Le Franc
Oct 4, 2011·Talanta·Susanne NussbaumerSandrine Fleury-Souverain
Jun 1, 2017·The Analyst·Nicolas GuichardSandrine Fleury-Souverain
Oct 5, 2018·Arhiv za higijenu rada i toksikologiju·Susana ViegasMário Pádua
Mar 22, 2019·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·Ana Sendra-GarcíaMónica Climente-Martí

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