Quantitative and qualitative control of cytotoxic preparations by HPLC-UV in a centralized parenteral preparations unit

Delmas, A.F.; Gordien, Jean-Baptiste; Bernadou, Jean-Marc; Roudaut, M.F.; Gresser, A.; Malki, L.; Saux, Marie-Claude; Breilh, Dominique

doi:10.1016/j.jpba.2009.03.007

Cited by 34 publications

(42 citation statements)

References 12 publications

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“…The overall conformity rate was 94.4% or 5.6% of NC. This result, corresponding to an implementation of the [11,22].…”

Section: Discussionmentioning

confidence: 93%

“…We have set, as many units and authors [11,16,21], the validation criteria to ± 15%. Yet, the majority of controls matched the ± 10% range (Figure 4).…”

Section: Discussionmentioning

confidence: 99%

“…The French Society of Oncology Pharmacy (SFPO) recommends, keeping account of technological advances, to establish, as a priority, this method in the quality assurance policy [10]. The main advantages of analytical control are the information delivered: the identification of the drug and solvent and the quantification of the drug are provided [11]. Analytical controls of chemotherapies have few specificities.…”

Section: Introductionmentioning

confidence: 99%

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Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Chouquet

Benoît

Morand

2017

Pharmaceutical Technology in Hospital Pharmacy

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AbstractBackgroundIn France, control of chemotherapy preparations is highly recommended. Analytical control is a method of choice for identifying and quantifying drugs. Pediatric preparations, which often contain small quantities of drugs and are made in low final volumes were until then not analytically controlled. After the development and validation of a new sampling and assaying method for low volume chemotherapy preparations with an UV/Raman automaton (QCPrep +), the quality control results of the preparations intended for the patients were analyzed over a period of eighteen monthsMethodsThe results were studied by type of preparation (low and high volume), per molecule, manipulator, and conformity rates dispersion.ResultsOver the period, 7,548 controls were carried out, representing 87.7% of our production. 75.5% of these controls concerned low-volume preparations (<50mL). The overall conformity rate was 94.4%. The lowest conformity rates were found for vinca alkaloids, methotrexate and some rarely manipulated drugs (cisplatin, decitabine, epirubicin). The study of the results dispersion showed non-conformities increasing with low concentrations, specific to pediatrics. These results show the limits of analytical control for pediatric preparations. The low analytical sensitivity encountered for certain concentrations and drugs requires a complementary quality control tool, like camera or video. However this new analytical method allows us to improve the safety of the injectable chemotherapy circuit.ConclusionYoung patients can benefit from the same level of safety and quality as adult patients. Some critical points could be highlighted: the homogenization of the preparations, the analytical sensitivity of some drugs and human factors. This data allow us to focus our work on staff training, improving our calibration ranges and on the development of complementary control tools.

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“…The overall conformity rate was 94.4% or 5.6% of NC. This result, corresponding to an implementation of the [11,22].…”

Section: Discussionmentioning

confidence: 93%

“…We have set, as many units and authors [11,16,21], the validation criteria to ± 15%. Yet, the majority of controls matched the ± 10% range (Figure 4).…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Chouquet

Benoît

Morand

2017

Pharmaceutical Technology in Hospital Pharmacy

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“…D'autres méthodes analytiques existent et peuvent suppléer le manque de certitude concernant l'identification des analytes. L'utilisation de méthodes de chromatographie liquide à polarité de phases inversée a été proposée par plusieurs auteurs pour séparer les vinca-alcaloïdes [12], les taxanes [13] et les oxazaphosphorines [14]. Cette approche permet une analyse rapide pour ces molécules, mais pour d'autres, comme l'expliquent Delmas et al [14], le temps nécessaire à l'identification est trop long pour une activité de routine notamment pour le couple doxorubicine/daunorubicine où l'analyse dépasse 5 minutes.…”

Section: Retrait De Lotunclassified

Contrôle analytique des préparations cytotoxiques : bilan de 7ans d’activité et perspectives

Delis

Vigneron

Sobalak

et al. 2015

Le Pharmacien Hospitalier et Clinicien

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“…Ultraviolet spectrometry can be performed alone (Druglog ® distributed by Pharmed) or associated to Fourrier Transformed Infrared Spectrometry (FTIR) which was called Multispec ® or to Raman spectrometry (QC Prep + ® , Icônes Services, France) [7]. Ultraviolet detection was also used in quality controls by High Pressure Liquid Chromatography (HPLC) coupled to a diode array detector (DAD) [8]. Raman spectrometry has also been proposed alone and has the major advantage to determine the analyte without destruction through its container and thus limiting chemical contaminations [9,10].…”

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confidence: 99%

Centrally Prepared Cytotoxic Drugs: What Is the Purpose of Their Quality Control?

Lagarce

2017

Pharmaceutical Technology in Hospital Pharmacy

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AbstractTo assess the quality of centrally prepared cytotoxics a global approach is being implemented by pharmacists. A risk analysis is performed, and then many in-process controls are proposed. The aseptic process and the material are also fully validated. Moreover the skills of pharmacy technicians are being checked and monitored over time. This short opinion paper discusses the place of in-process quality control within the quality system applied to cytotoxic preparations. It also discusses the pros and cons of analytical control of the final product versus continuous control of each preparation step by eye witness or an electronic device such as a camcorder. Finally the relevancy of controls is discussed in function of different cases and of the human and material resources available in the pharmaceutical technology cytotoxic unit.

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Quantitative and qualitative control of cytotoxic preparations by HPLC-UV in a centralized parenteral preparations unit

Cited by 34 publications

References 12 publications

Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Analytical Control of Pediatric Chemotherapy Preparations with a UV-Raman Automaton: Results After 18 Months of Implementation and Development of A Suitable Method for Low Volume Preparations

Contrôle analytique des préparations cytotoxiques : bilan de 7ans d’activité et perspectives

Centrally Prepared Cytotoxic Drugs: What Is the Purpose of Their Quality Control?

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