Improving Recognition and Reporting of Adverse Drug Reactions in the NICU: A Quality Improvement Project

Betsy Cammack1, Alexandra Oschman2, Tamorah Lewis1,3

  • 1Children's Mercy Hospital, Department of Pediatrics, Division of Neonatology, Kansas City, MO.

Pediatric Quality & Safety
|November 21, 2019
PubMed

Insights

Adverse drug reactions (ADRs) in the Neonatal Intensive Care Unit (NICU) are often missed. A bedside tool improved ADR detection and the Du score better characterized neonatal ADRs compared to the Naranjo score.

Area of Science:

  • Neonatal Intensive Care Unit (NICU) research
  • Pharmacovigilance
  • Quality Improvement in Healthcare

Background:

  • Adverse drug reactions (ADRs) are significantly under-recognized and under-reported in Neonatal Intensive Care Units (NICUs).
  • Pediatric patients face a higher risk of ADRs compared to non-elderly adults, highlighting a critical need for improved monitoring.
  • The Children's Mercy NICU reported a 0.29% ADR rate in 2015, indicating substantial room for improvement in detection and characterization.

Purpose of the Study:

  • To implement a quality improvement project to increase the daily assessment of patients for ADRs.
  • To evaluate the effectiveness of a bedside monitoring tool in improving ADR recognition and reporting in the NICU.
  • To compare the utility of the Naranjo score versus the neonatal-specific Du score for characterizing ADRs in neonates.

Main Methods:

  • A quality improvement project focused on daily ADR assessment for patients receiving specific high-risk medications (indomethacin, dexmedetomidine, fentanyl, lorazepam, dexamethasone, hydrocortisone).
  • Utilized Plan-Do-Study-Act (PDSA) cycles over one year to implement and refine a bedside monitoring tool.
  • Calculated Naranjo and Du scores for recognized ADRs to compare their effectiveness in characterizing events.

Main Results:

  • The bedside monitoring tool was used 83% of the time, significantly increasing the identification of potential ADRs (28 events).
  • Three PDSA cycles were completed within one year, demonstrating iterative improvement in the process.
  • The Du score showed greater appropriateness for characterizing neonatal ADRs compared to the Naranjo score.

Conclusions:

  • A bedside monitoring tool effectively enhances ADR detection rates in the NICU setting.
  • Challenges were encountered in consistently identifying target patients and ensuring tool accessibility at the bedside.
  • The Du score is a more suitable tool for classifying ADRs in neonates than the Naranjo score.

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