Quantitative and qualitative control of antineoplastic preparations: Gravimetry versus HPLC

Abstract

This article compares gravimetry vs. high-performance liquid chromatography (HPLC) as quality control (QC) methods for paclitaxel, docetaxel and oxaliplatin preparations. We aimed at assessing the preparation method reliability in our hospital, evaluating compounding accuracy and estimating the influence of personnel training and standardized homogenization on compounding accuracy. Agreement, correlation, concordance, accuracy and precision between methods were evaluated for each drug. Conforming preparation percentages (CPs) at different tolerance limits (TLs) and compounding accuracy were calculated for each method and drug. Compounding accuracy was compared before and after personnel training and standardized homogenization implantation. SPSS v 20.0 and Ene v 2.0 were used. A total of 222 samples (58 docetaxel, 95 paclitaxel and 69 oxaliplatin) were analyzed. Gravimetry and HPLC are comparable methods. Overall CP was 81% for gravimetry at 10% TL and 85% for HPLC at 15% TL. Compounding accuracy is shown to be good for all methods and drugs. Homogenization optimization and personnel training make measurements more accurate for docetaxel and paclitaxel HPLC, but seem to worsen accuracy for docetaxel gravimetry. Gravimetry has shown to be a good alternative to HPLC for routine QC. Coupling with electronic methods should be considered in the future.

Keywords

Cytostatic agents drug compounding gravimetry high-performance liquid chromatography quality control

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References

Institute for Safe Medication Practices (ISMP). List of high-alert medications in acute care settings. ISMP. 2014, www.ismp.org/Tools/institutionalhighAlert.asp (accessed 23 December 2017).

Choi

et al.

Successful treatment of cisplatin overdose with plasma exchange. Yonsei Med J 2002; 43: 128–132.

Hofmann

et al.

Plasmapheresis reverses all side-effects of a cisplatin overdose. A case report and treatment recommendation. BMC Cancer 2006; 6: 1.

Chu

et al.

Massive cisplatin overdose by accidental substitution for carboplatin. Toxicity and management. Cancer 1993; 72: 3707–3714.

Sheich-Hamad

et al.

Cisplatin-induced renal toxicity: possible reversal by N-acetylcysteine treatment. J Am Soc Nephrol 1997; 8: 1640–1644.

Vila-Torres

et al.

Cisplatin preparation error; patient management and morbidity. JOPP 2009; 15: 249–253.

Pongudom

Chinthammitr

. Inadvertent intrathecal vincristine administration: report of fatal case despite cerebrospinal fluid lavage and a review of the literature. J Med Assoc Thai 2011; 94: S258–S263.

Serrano-Fabiá

et al.

Multidisciplinary system for detecting medication errors in antineoplastic chemotherapy. JOPP 2010; 16: 105–112.

León Villar

et al.

Errores asociados con la prescripción, validación, preparación y administración de medicamentos citostáticos. Farm Hosp 2008; 32: 163–169.

10.

Jiménez Torres NV, Almenar Cubells N, de Asís Silla F, et al. Seguridad del paciente oncológico. Visión interdisciplinar. Real academia nacional de Farmacia. Madrid: Fundación José Casares Gil, 2010.

11.

Neuss

Polovich

Mc Niff

et al.

2013 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards Including Standards for the Safe Administration and Management of Oral Chemotherapy. J Oncol Pract 2013; 9: 5s–13s.

12.

ISOPP Standards of Practice. Safe handling of cytotoxics. J Oncol Pharm Pract 2007; 13: 1–81. Suppl).

13.

Goldspiel

Hoffman

Griffith

et al.

ASHP guidelines on preventing medication errors with chemotherapy and biotherapy. Am J HealthSyst Pharm 2015; 72: e6–35.

14.

United States Pharmacopeia 31. General Chapter 797: Pharmaceutical compounding – sterile preparations. Rockville: United States Pharmacopeial Convention, 2008.

15.

EudraLex. Volume 4 Good manufacturing practice (GMP) Guidelines. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 1. Manufacture of Sterile Medicinal Products. Brussels: European commission enterprise and industry directorate-general-consumer goods Pharmaceuticals; 2008, https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf (accessed 23 December 2017).

16.

Documento de consenso para la prevención de errores de medicación en quimioterapia. GEDEFO. February 2001. Rev 0; 1–17, http://gruposdetrabajo.sefh.es/gedefo/images/stories/documentos/Web_Doc_Con_errores.pdf (accessed 23 December 2017).

17.

Pérez Huertas

Cueto Sola

Escobar Cava

et al.

Applying dose banding to the production of antineoplastic drugs: a narrative review of the literatura. Farm Hosp 2015; 39: 210–216.

18.

Mayor

. National Health Service England introduces dose banding. Lancet Oncol 2016; 17: e271.

19.

National Institute for health and Care Excellence. Chemotherapy dose standardisation. Key therapeutic topic [KTT22], www.nice.org.uk/advice/ktt22 (2018, accessed 6 December 2018).

20.

Lecordier

Heluin

Plivard

et al.

Safety in the preparation of cytotoxic drugs: how to integrate gravimetric control in the quality assurance policy?. Biomed Pharmacother 2011; 65: 17–21.

21.

Reece

Lozano

Roux

et al.

Implementation and evaluation of a gravimetric i.v. Workflow software system in an oncology ambulatory care pharmacy. Am J Health Sys Pharm 2016; 73: 165–173.

22.

Carrez

Bouchoud

Fleury-Souverain

et al.

Reliability of chemotherapy preparation processes: evaluating independent double-checking and computer-assisted gravimetric control. J Oncol Pharm Pract 2017; 23: 83–92.

23.

Poppe

Savage

Eckel

. Assessment of final product dosing accuracy when using volumetric technique in the preparation of chemotherapy. J Oncol Pharm Pract 2016; 22: 3–9.

24.

Watt

Antier

Jacques

et al.

New program for quality control of cytotoxics manufactured in centralised unit. J Pharm Clin 2002; 21: 179–182.

25.

Castagne

Habert

Abbara

et al.

Cytotoxics compounded sterile preparation control by HPLC during a 16-month assessment in a French university hospital: importance of the mixing bags step. J Oncol Pharm Pract 2010; 17: 191–196.

26.

Delmas

Gordien

Bernadou

et al.

Quantitative and qualitative control of cytotoxic preparations by HPLC-UV in a centralized parenteral preparations unit. J Pharm Biomed Anal 2009; 49: 1213–1220.

27.

Bourget

Paci

Rey

et al.

Contribution of high-performance thin-layer liquid chromatography to a pharmaceutical quality assurance programme in a hospital chemotherapy unit. Eur J Pharm Biopharm 2003; 56: 445–451.

28.

Bourget

Laville

Paci

et al.

Application of an acceptance sampling plan for post-production quality control of chemotherapeutic batches in a hospital pharmacy. Eur J Pharm Biopharm 2006; 64: 92–98.

29.

Paci

Borget

Mercier

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.

30.

Lelièvre

Devys

Daouphars

et al.

Qualitative and quantitative analysis of chemotherapy preparations. Eur J Hosp Pharm Sci Pract 2010; 16: 33–38.

31.

Dziopa

Galy

Bauler

et al.

A quantitative and qualitative method to control chemotherapeutic preparations by Fourier transform infrared-ultraviolet spectrophotometry. J Oncol Pharm Pract 2013; 19: 121–129.

32.

ISO 9001:2015, www.iso.org/iso/home/standards/management-standards/iso_9000.htm (accessed 23 December 2017).

33.

Martínez Gómez MA, Sendra García A, Ruiz Millo O, et al. Optimización de la homogeneización de prepa raciones de antineoplásicos parenterales para el control de calidad cuantitativo. At: 56 SEFH National Congress. Santiago de Compostela; 2011. Personal Communication.

34.

ICH Harmonised Tripartite Guideline on Validation of analytical procedures: text and methodology. ICH Q2(R1). 2005, www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__Guideline.pdf (accessed 23 December 2017).

35.

International Conference Harmonization (ICH). Note for guidance on validation of analytical methods: methodology. In: International conference on harmonization, Yokohama, Japan, 1995.

36.

International Union of Pure Applied Chemistry (IUPAC). Selectivity in analytical chemistry. Pure Appl Chem 2001; 73: 1381–1386.

37.

Walker

Charbonneau

Law

. Stability of docetaxel solution after dilution in ethanol and storage in vials and after dilution in normal saline and storage in bags. Can J Hosp Pharm 2007; 60(4): 231–237.

38.

MacLeod

Sewell

. Physical and chemical stability of docetaxel infusions. EJHP 2011; 17: 39–43.

39.

Hart

Ahmed

. Taxotere 1-vial (docetaxel 20 mg/ml) physical and chemical stability over 28 days in infusion bags containing 0.9% saline solution and 5% glucose solution. EJOP 2011; 5: 24–27.

40.

Trissel

Martinez

. Stability of paclitaxel in 5% dextrose injection or 0.9% sodium chloride injection at 4, 22, or 32℃. Am J Hosp Pharm 1994; 51: 3058–3060.

41.

Pourroy

Botta

Solas

et al.

Seventy-two-hour stability of Taxol® in 5% dextrose or 0.9% sodium chloride in Viaflo®, Freeflex®, Ecoflac® and Macoflex N® non PVC bags. J Clin Pharm Ther 2005; 30: 455–458.

42.

Eiden

Philibert

Bekhtari

et al.

Physicochemical stability of oxaliplatin in 5% dextrose injection stored in polyvinyl chloride, polyethylene, and polypropylene infusion bags. Am J Health Syst Pharm 2009; 66(21): 1929–1933.

43.

Dancey CP and Reidy J. Statistics without maths for psychology: using SPSS for Windows. Upper Saddle River: London Prentice Hall, 2004.

44.

Fleiss

. The design and analysis of clinical experiments, New York: John Wiley & Sons, 1986.

45.

McBride GB. A proposal for strength-of-agreement criteria for Lin's Concordance Correlation Coefficient. NIWA Client Report: HAM2005-062. National Institute of Water and Atmospheric Research Ltd, 2005, www.medcalc.org/download/pdf/McBride2005.pdf (accessed 23 December 2017).

46.

Erstad

Nix

. Accuracy and reproducibility of small-volume injections from various-sized syringes. Am J Health Syst Pharm 2006; 63: 748–750.

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