Identification of priorities for medication safety in neonatal intensive care

Drug Saf. 2005;28(3):251-61. doi: 10.2165/00002018-200528030-00006.


Background: Although neonates are reported to be at greater risk of medication error than infants and older children, little is known about the causes and characteristics of error in this patient group. Failure mode and effects analysis (FMEA) is a technique used in industry to evaluate system safety and identify potential hazards in advance. The aim of this study was to identify and prioritize potential failures in the neonatal intensive care unit (NICU) medication use process through application of FMEA.

Methods: Using the FMEA framework and a systems-based approach, an eight-member multidisciplinary panel worked as a team to create a flow diagram of the neonatal unit medication use process. Then by brainstorming, the panel identified all potential failures, their causes and their effects at each step in the process. Each panel member independently rated failures based on occurrence, severity and likelihood of detection to allow calculation of a risk priority score (RPS).

Results: The panel identified 72 failures, with 193 associated causes and effects. Vulnerabilities were found to be distributed across the entire process, but multiple failures and associated causes were possible when prescribing the medication and when preparing the drug for administration. The top ranking issue was a perceived lack of awareness of medication safety issues (RPS score 273), due to a lack of medication safety training. The next highest ranking issues were found to occur at the administration stage. Common potential failures related to errors in the dose, timing of administration, infusion pump settings and route of administration. Perceived causes were multiple, but were largely associated with unsafe systems for medication preparation and storage in the unit, variable staff skill level and lack of computerised technology.

Conclusion: Interventions to decrease medication-related adverse events in the NICU should aim to increase staff awareness of medication safety issues and focus on medication administration processes.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Competence / standards
  • Clinical Competence / statistics & numerical data
  • Computers
  • Culture
  • Decision Trees
  • Delivery of Health Care / methods
  • Dose-Response Relationship, Drug
  • Drug Administration Routes
  • Drug Administration Schedule
  • Drug Compounding / adverse effects
  • Drug Compounding / statistics & numerical data
  • Equipment Failure / statistics & numerical data
  • Health Knowledge, Attitudes, Practice
  • Health Priorities*
  • Health Services Research / methods
  • Humans
  • Infant, Newborn
  • Infusion Pumps / adverse effects
  • Infusion Pumps / standards
  • Infusion Pumps / statistics & numerical data
  • Intensive Care Units, Neonatal / standards*
  • Medical Errors / classification
  • Medical Errors / statistics & numerical data
  • Medication Errors / classification
  • Medication Errors / prevention & control*
  • Quality Assurance, Health Care / methods
  • Risk Management / methods
  • Time Factors
  • Total Quality Management / methods