Chemotherapy products in hospitals include a reconstitution step of manufactured drugs providing an adapted dosage to each patient. The administration of highly iatrogenic drugs raises the question of patients’ safety and treatment efficiency. In order to reduce administration errors due to faulty preparations, we introduced a new qualitative and quantitative routine control based on Fourier Transform Infrared (FTIR) and UV-Visible spectrophotometry. This automated method enabled fast and specific control for 14 anticancer drugs. A 1.2 mL sample was used to assay and identify each preparation in less than 90 sec. Over a two-year period, 9370 controlled infusion bags showed a 1.49% nonconformity rate, under 15% tolerance from the theoretical concentration and 96% minimum identification matching factor. This study evaluated the reliability of the control process, as well as its accordance to chemotherapy deliverance requirements. Thus, corrective measures were defined to improve the control process.
GallelliJ. Issues and risks associated with handling antineoplastic drugs. J Pharm Pract1991; 4: 72–76.
2.
LegatCLimatSCoutetJ. Impact économique de la préparation centralisée des médicaments anticancéreux. J Pharm Clin2003; 22: 181–185.
3.
SessinkPJWittenhorstBCAnzionRB. Exposure of pharmacy technicians to antineoplastic agents: reevaluation after additional protective measures. Arch Environ Health1997; 52: 240–244.
4.
EscomsMCCabanasMJOliverasM. Errors evolution and analysis in antineoplastic drug preparation during one year. Pharm World Sci1996; 18: 178–181.
5.
BasuyauFBrunelleP. Comparaison de deux mesures physiques rapides pour le contrôle de la dose des préparations injectables de médicaments anticancéreux avant administration: application au 5-fluorouracile. J Pharm Clin2000; 19: 5–9.
6.
BonanBMartelliNBerhouneM. The application of hazard analysis and critical control points and risk management in the preparation of anti-cancer drugs. Int J Qual Health Care2009; 21: 44–50.
7.
FlynnEAPearsonREBarkerKN. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health Syst Pharm1997; 54: 904–912.
8.
RitterHTrisselLAAndersonRW. Electronic balance as quality assurance for cytotoxic drug admixtures. Am J Health Syst Pharm1996; 53: 2318–2320.
9.
BazinCVieillardVAstierA. Reliable real-time analytical control of monoclonal antibodies chemotherapies preparations on Multispec automaton. Ann Pharm Fr2010; 68: 163–177.
10.
HavardLBonanBHuenJM. Quality control in centralized cytotoxic reconstitution unit: dream or reality?STP Pharma Pratiques2005; 15: 148–160.
11.
DelmasAGordienJBBernadouJM. Quantitative and qualitative control of cytotoxic preparations by HPLC-UV in a centralized parenteral preparations unit. J Pharm Biomed Anal2009; 49: 1213–1220.
12.
RenzulloCPailletCPivotC. Analyse comparative des méthodes analytiques de dosage des préparations d'anticancéreux en unité de reconstitution centralisée. Société Française de Pharmacie Oncologique, Nice, France, 2007, General poster session2007.
13.
ICH Harmonised Tripartite Guideline. Validation of analytical procedures: text and methodology, Q2(R1), Current step 4 version, Parent guideline on methodology, 6 November 1996. Incorporated in: International conference on harmonisation, November 2005. Available from http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf.
14.
Project de Guide de Bonnes Pratiques de PréparationsProjet. Agence Française de Sécurité Sanitaire des Produits de Santé (A.F.S.S.A.P.S.)Paris: Bonnes Pratiques de Préparation, 2007.
15.
BourgetPPaciAReyJB. Contribution of high-performance thin-layer chromatography to a pharmaceutical quality assurance programme in a hospital chemotherapy manufacturing unit. Eur J Pharm Biopharm2003; 56: 445–451.
16.
GravelEBourgetPMercierL. Fluorescence detection combined with either HPLC or HPTLC for pharmaceutical quality control in a hospital chemotherapy production unit: application to camptothecin derivatives. J Pharm Biomed Anal2005; 39: 581–586.
17.
BourgetPPerelloLDemirdjianS. Place et spectre fonctionnel de l'HPTLC dans un programme d'assurance qualité pharmaceutique hospitalier. Pathol Biol2001; 49: 86–95.
18.
Joseph-CharlesJBertucatMLevillainP. Intérêt de la spectrophotométrie dérivée pour l'identification d'une substance. Bull Soc Pharm Bordeaux1997; 136: 56–76.
19.
BorgetILavilleIPaciA. Application of an acceptance sampling plan for post-production quality control of chemotherapeutic batches in an hospital pharmacy. Eur J Pharm Biopharm2006; 64: 92–98.
20.
WattSAntierDJacquesV. Validation et mise en place d'un nouveau programme de contrôle-qualité des cytotoxiques reconstitués en unité centralisée. J Pharm Clin2002; 21: 179–182.
21.
GalyGBaulerSBuchiM. Cost of functioning of a centralised pharmaceutical unit: evaluation of mean costs of chemotherapy preparations according to the level of production of the unit. Bull Cancer2011; 98: 1153–1163.
22.
Paci A, Borget I, Mercier L, et al. Safety and quality assurance of chemotherapeutic preparations in a hospital production unit: Acceptance sampling plan and economic impact. J Oncol Pharm Pract 2012; 18: 163–170.
