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Reported medication errors associated with methotrexate.

Thomas J Moore1, Christopher S Walsh, Michael R Cohen

  • 1Drug Safety and Policy, Institute for Safe Medication Practices, Huntingdon Valley, PA 19006, USA. tmoore@ismp.org

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|August 4, 2004
PubMed
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Methotrexate medication errors, often due to dosage confusion, led to serious harm and deaths. These errors occurred across all stages of medication use, highlighting a critical patient safety issue.

Area of Science:

  • Pharmacovigilance
  • Patient Safety
  • Medication Error Analysis

Background:

  • Adverse event reports to the Food and Drug Administration (FDA) are crucial for identifying drug safety issues.
  • Methotrexate is a widely used medication with a narrow therapeutic index, increasing the risk of medication errors.

Purpose of the Study:

  • To investigate medication errors involving methotrexate reported to the FDA.
  • To identify the causes, types, and consequences of methotrexate-related medication errors.

Main Methods:

  • Analysis of adverse event reports submitted to the FDA between November 1997 and December 2001.
  • Categorization of errors by indication for use, error type, and point of occurrence in the medication-use process.

Main Results:

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  • 106 cases of methotrexate medication errors were identified, resulting in 25 deaths (24%) and 48 serious outcomes (45%).
  • Common errors included confusion regarding once-weekly dosing (30%) and other dosage inaccuracies (22%).
  • Rheumatoid arthritis was the most frequent indication (42%), with errors attributed to prescribers (37%), patients (20%), dispensing (19%), and healthcare professionals (17%).

Conclusions:

  • Medication errors involving methotrexate occur throughout the medication-use process.
  • Dosage confusion, particularly with once-weekly schedules, is a significant contributing factor.
  • These errors frequently lead to severe adverse events, including fatalities, underscoring the need for improved safety measures.