Evaluation of real-time data obtained from gravimetric preparation of antineoplastic agents shows medication errors with possible critical therapeutic impact: Results of a large-scale, multicentre, multinational, retrospective study

J Clin Pharm Ther. 2017 Aug;42(4):446-453. doi: 10.1111/jcpt.12529. Epub 2017 Apr 21.

Abstract

What is known and objective: Medication errors are a significant cause of morbidity and mortality especially with antineoplastic drugs, owing to their narrow therapeutic index. Gravimetric workflow software systems have the potential to reduce volumetric errors during intravenous antineoplastic drug preparation which may occur when verification is reliant on visual inspection. Our aim was to detect medication errors with possible critical therapeutic impact as determined by the rate of prevented medication errors in chemotherapy compounding after implementation of gravimetric measurement.

Design: A large-scale, retrospective analysis of data was carried out, related to medication errors identified during preparation of antineoplastic drugs in 10 pharmacy services ("centres") in five European countries following the introduction of an intravenous workflow software gravimetric system. Errors were defined as errors in dose volumes outside tolerance levels, identified during weighing stages of preparation of chemotherapy solutions which would not otherwise have been detected by conventional visual inspection.

Key results: The gravimetric system detected that 7.89% of the 759 060 doses of antineoplastic drugs prepared at participating centres between July 2011 and October 2015 had error levels outside the accepted tolerance range set by individual centres, and prevented these doses from reaching patients. The proportion of antineoplastic preparations with deviations >10% ranged from 0.49% to 5.04% across sites, with a mean of 2.25%. The proportion of preparations with deviations >20% ranged from 0.21% to 1.27% across sites, with a mean of 0.71%. There was considerable variation in error levels for different antineoplastic agents.

What is new and conclusion: Introduction of a gravimetric preparation system for antineoplastic agents detected and prevented dosing errors which would not have been recognized with traditional methods and could have resulted in toxicity or suboptimal therapeutic outcomes for patients undergoing anticancer treatment.

Keywords: antineoplastic agents; gravimetric IV workflow software system; medication errors; preparation; safety.

Publication types

  • Multicenter Study

MeSH terms

  • Administration, Intravenous
  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects
  • Dose-Response Relationship, Drug
  • Drug Compounding / standards*
  • Europe
  • Humans
  • Medication Errors / prevention & control
  • Medication Errors / statistics & numerical data*
  • Pharmacy Service, Hospital / standards
  • Pharmacy Service, Hospital / statistics & numerical data*
  • Retrospective Studies
  • Software
  • Workflow

Substances

  • Antineoplastic Agents