Pharmacy World and Science

, Volume 23, Issue 3, pp 102–106 | Cite as

Incidence and risk factors of preparation errors in a centralized cytotoxic preparation unit

  • S. Limat
  • J.P. Drouhin
  • K. Demesmay
  • E. Tissot
  • M. Jacquet
  • M.C. Woronofl‐lemsi


Objective: A major objective of centralized preparation is to improve the quality of the final product, and thus their safety for the patient. Few data are available concerning errors occurring during preparation and the risk factors associated with the errors. To assess risk factors associated with preparation errors in a centralized cytotoxic preparation unit. Design: Medication errors were detected during preparation (self‐education by technicians) or at the time of control (qualitative and semi‐quantitative). For each preparation, several potential risk factors were studied. Univariate analysis was carried out using Chi‐2 or Fisher exact tests. Variables with p<0.15 associated in univariate analysis were entered in a stepwise regression model. In an overall analysis, all types of error were considered. In a second analysis, only major errors (errors associated with drug, dose or major incompatibility) were studied. Results: Analysis included 30,819 preparations. Overall and major error rates were respectively 0.45% and 0.19%. The number of bottles (more than one), the volume of active solution (more than 50 ml) and the daily workload were the major risk factors identified by successive univariate and multivariate analysis. Conclusion: Low rates of medication errors compared to previous studies were reported. Major preparation errors were principally related to drug labeling (dose/bottle and concentration) and workload. Preparation mistakes appeared to have many causes. These results could be used to revise the general organization and determine a suitable purchasing policy.

Cytotoxic drugs Centralized preparation Drug product characteristics Medication error Purchasing policy Quality control Workload 


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  1. 1.
    Power L, Anderson R, Cortopassi R, Gera J, Lewis R. Update of safe handling of hazardous drugs: the advice of experts. Am J Hosp Pharm 1990;47:1050-60.Google Scholar
  2. 2.
    Gallelli J. Issues and risks associated with handling antineoplastic drugs. J Pharm Practice 1991,4(1):72-6.Google Scholar
  3. 3.
    Valanis B, Vollmer W, Labuhn K, Glass A. Association of antineoplastic drug handling with acute adverse effects in pharmacy personnel. Am J Hosp Pharm 1993,50:455-62.Google Scholar
  4. 4.
    Tilleul P, Prugnaud JL, Ponsar P. Dispensation des médicaments anticancéreux. Etude économique d'un système decentralize. J Pharm Clin 1987,6:211-24.Google Scholar
  5. 5.
    Husson C, Harnycheff F, Becker A. Centralisation des préparations de médicaments anticancéreux injectables: mise en place et bilan dans le service pharmaceutique d'un hôpital parisien. J Pharm Clin 1989,8:153-60.Google Scholar
  6. 6.
    Pinguet F, Canal P, Favre G. Expérience de préparation centalisée des anticancéreux: conséquences économiques. J Pharm Clin 1989,9:55-60.Google Scholar
  7. 7.
    Augry F, Iltis A, Letellier D. Evaluation de l'économie réalisée au sein d'une unité centralisée de fabrication des médicaments cytotoxiques destinés à la voie parentérale. J Pharm Clin 1996;15:12-4.Google Scholar
  8. 8.
    Favier M, Fliche E, Bressolle F. Economic benefit of a centralized reconstitution unit of cytotoxic drugs in isolator. J Oncol Pharm Practice 1996,2:182-5.Google Scholar
  9. 9.
    Cazin JL, Gosselin P. Implementing a multiple-isolator unit for centralizes preparation of cytotoxic drugs in a cancer center pharmacy. Pharm World Sci 1999,21(4):177-83.Google Scholar
  10. 10.
    Wernli M, Bögli F, Mühlebach S, Conen D. Centralized preparation of cytotoxic drugs for improved quality control. Schweiz Med Wochenschr 1994,124:1962-5.Google Scholar
  11. 11.
    American Society Hospital Pharmacy. ASHP guidelines on quality assurance for pharmacy prepared sterile products. Am J Health Syst Pharm 2000,57:1150-69.Google Scholar
  12. 12.
    Crane V. New perspectives on preventing medication errors and adverse drug events. Am J Health Syst Pharm 2000,57:690-7.Google Scholar
  13. 13.
    Van der Bemt P, Egberts T, De Jong-Van den Berg L, Brouwers J. Drug-related problems in hospitalised patients. Drug Saf 2000,22(4):321-33.Google Scholar
  14. 14.
    Escoms M, Cabanas M, Oliveras M, Hidalgo E, Barroso C. Errors evolution and analysis in antineoplastic drug preparation during one year. Pharm World Sci 1996,18(5):178-81.Google Scholar
  15. 15.
    Flynn E, Pearson R, Barker K. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health Syst Pharm 1997,54:904-12.Google Scholar
  16. 16.
    Quach V, Hernando V, Combeau D, Brion F. Control evaluation of cytotoxic infusion preparations in isolator. Proc Eur Assos Hosp Pharm 2000:24 (abstract 55).Google Scholar
  17. 17.
    Cauchetier E, Fernandes E, Sedrati N, Avril J, Corbri V. Evaluation d'un système qualité en pharmacotechnie. Proc SNPHPU 2000 (abstract 06).Google Scholar
  18. 18.
    Bordet F, Crauste-Manciet S, Brossard D. Analyse des préparations non conformes d'une unité de préparation de cytotoxiques. Proc HOPIPHARM 2000:61 (abstract 69).Google Scholar
  19. 19.
    Larroutourou P, Huchet J, Taugourdeau MC. Centralized preparation of hazardous drugs. A choice between isolator and laminar airflow. Pharm Weekbl Sci 1992,14(3):88-92.Google Scholar
  20. 20.
    Favier M, Hansel S, Bressolle F. Preparing cytotoxic agents in an isolator. Am J Hosp Pharm 1993,50(11):2335-9.Google Scholar
  21. 21.
    Tillett L. Barrier isolators as an alternative to a cleanroom. Am J Health Syst Pharm 1999,56(14):1433-6.Google Scholar
  22. 22.
    Leach R, Wintmarsh S, Partridge C, Potter S. New cytotoxic production unit. Hosp Pharm 2000,7:109-10.Google Scholar
  23. 23.
    Milliken D, Gervais A. The impact of computerization on medication discrepancies in a centralized unit dose drug distribution system. Hosp Pharm 1990,25(7):650-2.Google Scholar
  24. 24.
    Favier M, De Cazanove F, Saint-Martin F. Preventing medication errors in antineoplastic therapy. Am J Hosp Pharm 1994,51:832-3.Google Scholar
  25. 25.
    Bontemps H, Fauconnier J, Bosson JL, Brilloit C, François P, Calop J. Evaluation de la qualité de la prescription des médicaments dans un CHU. J Pharm Clin 1997,16:49-53.Google Scholar
  26. 26.
    Augry F, Ravaud P, Lopez I, Letellier D, Iltis A, Bouscary D et al. Erreurs de prescription des médicaments cytotoxiques: étude prospective de 5000 ordonnances. J Pharm Clin 1998,17:20-4.Google Scholar
  27. 27.
    Bates D, Leape L, Cullen D, Laird N, Petersen L, Teich J et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA 1998,280(15):1311-6.Google Scholar
  28. 28.
    Bates D, Teich J, Lee J, Seger D, Kuperman G, Ma'Luf N et al. The impact of computerized physician order entry on medication error prevention. J Am Med Inform Assoc 1999,6(4):131-21.Google Scholar
  29. 29.
    Cohen M. Drug product characteristics that foster drug-usesystem errors. Am J Health Syst Pharm 1995,52:395-9.Google Scholar
  30. 30.
    Cohen M, Anderson R, Atillio R, Green L, Muller R, Pruemer J. Preventing medication errors in cancer chemotherapy. Am J Health Syst Pharm 1996,53:737-46.Google Scholar
  31. 31.
    Woller T, Stuart J, Vrabel R, Senst B. Checking of unit dose cassettes by pharmacy technicians at three Minnesota hospitals. Am J Hosp Pharm 1991,48(9):1952-6.Google Scholar
  32. 32.
    Fernandez C. Can we prevent cytotoxic disasters? Br J Haematol 2000,108:464-9.Google Scholar
  33. 33.
    Ritter H, Trissel L, Anderson R, Moyer L, Morales J. Electronic balance as quality assurance for cytotoxic drug admixtures. Am J Health Syst Pharm 1996,53(19):2318-20.Google Scholar
  34. 34.
    Pelus E, Dellanegra M, Charlety D, Magnin N, Petit N, Meylan I. Unité de préparation centralisée des cytotoxiques: de la mise en place à l'assurance qualité. J Pharm Clin 1998,17:97-102.Google Scholar

Copyright information

© Kluwer Academic Publishers 2001

Authors and Affiliations

  • S. Limat
    • 1
  • J.P. Drouhin
    • 1
  • K. Demesmay
    • 1
  • E. Tissot
    • 1
  • M. Jacquet
    • 1
  • M.C. Woronofl‐lemsi
    • 2
  1. 1.Pharmacy DepartmentBesançon University HospitalFrance
  2. 2.Department of PharmacyBesançon University HospitalFrance

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