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Peer-reviewedCC BY 4.0Italian Journal of Pediatrics

Medical error in neonatal units: an Italian survey on national frequency and types of error

  • Luca Massenzi1
  • Roberta Parladori2
  • Luigi Gagliardi3
  • Massimiliano Ciantelli4
  • Gloria Brigiari5
  • Francesco Crispino6
  • Camilla Gizz7
  • Nunzia Decembrino8
  • Elena Sorrentino9
  • Genny Raffaeli10,11
  • Sabrina Palamides12
  • Rocco Agostino1
12 affiliations
  1. 1Neonatology and NICU, Ospedale Provinciale, Bozen, Italy
  2. 2NICU, IRCCS S. Orsola, Bologna, Italy
  3. 3Neonatology and Pediatric, Ospedale Versilia, Viareggio, Italy
  4. 4Neonatology, Azienda Ospedaliera Universitaria, Pisa, Italy
  5. 5Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy
  6. 6NICU and Pediatry, ASReM, Ospedale A. Cardarelli, Campobasso, Italy
  7. 7Neonatology and NICU, Ospedale S. Eugenio, Rome, Italy
  8. 8NICU, Policlinico G. Rodolico S. Marco, Catania, Italy
  9. 9Neonatology and NICU, Ospedale S. Pietro Fatebenefratelli, Rome, Italy
  10. 10NICU, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
  11. 11Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milan, Italy
  12. 12Neonatology and NICU, Ospedale S. Giovanni Addolorata, Rome, Italy
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Abstract

Background: Neonatal Units (NUs) are high-risk environments for medication errors (MEs), mainly due to complex weight/gestational age-based dosing and frequent off-label drug use. Although the incidence of serious harm is low, medication errors remain a major safety concern. The aim of this study was to have a snapshot of MEs errors within Italian NUs.

Methods: The Neonatal Pharmacotherapy Study Group and the Risk Management and Simulation Study Group of the Italian Society of Neonatology (SIN) conducted a national cross-sectional web-based survey between 2022 and 2023. Responding NUs were stratified into two groups: those reporting fewer than five MEs per year (< 5 MEs/y )and those with five or more (≥ 5 MEs/y). Descriptive and inferential statistics were applied.

Results: Prescription (33%) and drug preparation (29%) were the most frequently reported error types. The use of digital prescribing tools was higher in centers reporting fewer errors. Double-checking procedures limited to high-alert drugs was associated with higher error rates. 80% of NUs did not have a structured annual error report, and 55% failed to re-evaluate or implement corrective actions after identifying errors. Only 21% of NUs systematically informed families of therapeutic errors; as reasons for non-disclosure many centers citing the absence of harm or fear of legal/professional consequences.

Conclusions: While some centers adopt proactive safety strategies, others use incomplete protocols or outdated tools. The lack of systematic error reporting underscores the need for a cultural shift toward a constant analysis of this problem and a more continuous surveillance and evaluation of implemented safety strategies. A unified, anonymous digital reporting system could support error monitoring and targeted interventions at the local and national levels.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13052-026-02306-6.

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Cite

BibTeXRIS
BibTeX
@article{massenzi2026medical,
  title = {{Medical error in neonatal units: an Italian survey on national frequency and types of error}},
  author = {Luca Massenzi and Roberta Parladori and Luigi Gagliardi and Massimiliano Ciantelli and Gloria Brigiari and Francesco Crispino and Camilla Gizz and Nunzia Decembrino and Elena Sorrentino and Genny Raffaeli and Sabrina Palamides and Rocco Agostino},
  journal = {Italian Journal of Pediatrics},
  year = {2026},
  month = aug,
  doi = {10.1186/s13052-026-02306-6},
  url = {https://doi.org/10.1186/s13052-026-02306-6},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Medical error in neonatal units: an Italian survey on national frequency and types of error
AU  - Luca Massenzi
AU  - Roberta Parladori
AU  - Luigi Gagliardi
AU  - Massimiliano Ciantelli
AU  - Gloria Brigiari
AU  - Francesco Crispino
AU  - Camilla Gizz
AU  - Nunzia Decembrino
AU  - Elena Sorrentino
AU  - Genny Raffaeli
AU  - Sabrina Palamides
AU  - Rocco Agostino
PY  - 2026
DA  - 2026/08/11
JO  - Italian Journal of Pediatrics
DO  - 10.1186/s13052-026-02306-6
UR  - https://doi.org/10.1186/s13052-026-02306-6
AB  - Background: Neonatal Units (NUs) are high-risk environments for medication errors (MEs), mainly due to complex weight/gestational age-based dosing and frequent off-label drug use. Although the incidence of serious harm is low, medication errors remain a major safety concern. The aim of this study was to have a snapshot of MEs errors within Italian NUs.  Methods: The Neonatal Pharmacotherapy Study Group and the Risk Management and Simulation Study Group of the Italian Society of Neonatology (SIN) conducted a national cross-sectional web-based survey between 2022 and 2023. Responding NUs were stratified into two groups: those reporting fewer than five MEs per year (< 5 MEs/y )and those with five or more (≥ 5 MEs/y). Descriptive and inferential statistics were applied.  Results: Prescription (33%) and drug preparation (29%) were the most frequently reported error types. The use of digital prescribing tools was higher in centers reporting fewer errors. Double-checking procedures limited to high-alert drugs was associated with higher error rates. 80% of NUs did not have a structured annual error report, and 55% failed to re-evaluate or implement corrective actions after identifying errors. Only 21% of NUs systematically informed families of therapeutic errors; as reasons for non-disclosure many centers citing the absence of harm or fear of legal/professional consequences.  Conclusions: While some centers adopt proactive safety strategies, others use incomplete protocols or outdated tools. The lack of systematic error reporting underscores the need for a cultural shift toward a constant analysis of this problem and a more continuous surveillance and evaluation of implemented safety strategies. A unified, anonymous digital reporting system could support error monitoring and targeted interventions at the local and national levels.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13052-026-02306-6.
SN  - 1824-7288
ER  -