Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Article
  • Published:

Association between neonatal intensive care unit medication safety practices, adverse events, and death

Journal of Perinatology volume 41, pages 1739–1744 (2021)Cite this article

Subjects

Abstract

Objective

Determine the associations between neonatal intensive care unit (NICU) medication safety practices, laboratory-based adverse events (lab-AEs), and death.

Study design

We combined data from a 2016 survey of Pediatrix NICUs on use of medication safety practices with 2014–2016 infant data. We grouped NICUs based on the number of safety practices used (≤5, 6–7, and 8–10) and evaluated the association between the number of safety practices used and lab-AEs and deaths using logistic regressions.

Results

Of the 94 NICUs included, 17% used ≤5 medication safety practices, 51% used 6–7, and 32% used 8–10. NICUs with more safety practices did not have a difference in lab-AEs or death.

Conclusion

In this cohort, the use of more medication safety practices was not associated with fewer lab-AEs or decreased death.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on Springer Link
  • Instant access to full article PDF
Buy now

Prices may be subject to local taxes which are calculated during checkout

Similar content being viewed by others

References

  1. Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997;277:301–6.

    Article  CAS  PubMed  Google Scholar 

  2. Batel Marques F, Penedones A, Mendes D, Alves C. A systematic review of observational studies evaluating costs of adverse drug reactions. Clinicoecon Outcomes Res. 2016;8:413–26.

    Article  PubMed  PubMed Central  Google Scholar 

  3. Kunac DL, Kennedy J, Austin N, Reith D. Incidence, preventability, and impact of Adverse Drug Events (ADEs) and potential ADEs in hospitalized children in New Zealand: a prospective observational cohort study. Paediatr Drugs. 2009;11:153–60.

    Article  PubMed  Google Scholar 

  4. Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics. 2002;110:e53.

    Article  PubMed  Google Scholar 

  5. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med. 2003;349:1157–67.

    Article  CAS  PubMed  Google Scholar 

  6. Krzyzaniak N, Bajorek B. Medication safety in neonatal care: a review of medication errors among neonates. Ther Adv Drug Saf. 2016;7:102–19.

    Article  PubMed  PubMed Central  Google Scholar 

  7. Stavroudis TA, Shore AD, Morlock L, Hicks RW, Bundy D, Miller MR. NICU medication errors: identifying a risk profile for medication errors in the neonatal intensive care unit. J Perinatol. 2010;30:459–68.

    Article  CAS  PubMed  Google Scholar 

  8. Chedoe I, Molendijk HA, Dittrich ST, Jansman FG, Harting JW, Brouwers JR, et al. Incidence and nature of medication errors in neonatal intensive care with strategies to improve safety: a review of the current literature. Drug Saf. 2007;30:503–13.

    Article  PubMed  Google Scholar 

  9. Suresh G, Horbar JD, Plsek P, Gray J, Edwards WH, Shiono PH, et al. Voluntary anonymous reporting of medical errors for neonatal intensive care. Pediatrics. 2004;113:1609–18.

    Article  PubMed  Google Scholar 

  10. Morriss FH. Adverse medical events in the NICU. Epidemiol Prev. 2008;9:e8–23.

    Google Scholar 

  11. Morriss FH Jr, Abramowitz PW, Nelson SP, Milavetz G, Michael SL, Gordon SN, et al. Effectiveness of a barcode medication administration system in reducing preventable adverse drug events in a neonatal intensive care unit: a prospective cohort study. J Pediatr. 2009;154:363–8, 368. e361.

    Article  PubMed  Google Scholar 

  12. Cordero L, Kuehn L, Kumar RR, Mekhjian HS. Impact of computerized physician order entry on clinical practice in a newborn intensive care unit. J Perinatol. 2004;24:88–93.

    Article  PubMed  Google Scholar 

  13. Morriss FH Jr, Abramowitz PW, Nelson SP, Milavetz G, Michael SL, Gordon SN. Risk of adverse drug events in neonates treated with opioids and the effect of a bar-code-assisted medication administration system. Am J Health Syst Pharm. 2011;68:57–62.

    Article  CAS  PubMed  Google Scholar 

  14. Nguyen MR, Mosel C, Grzeskowiak LE. Interventions to reduce medication errors in neonatal care: a systematic review. Ther Adv Drug Saf. 2018;9:123–55.

    Article  PubMed  Google Scholar 

  15. Greenberg RG, Smith PB, Bose C, Clark RH, Cotten CM, DeRienzo C. National survey of neonatal intensive care unit medication safety practices. Am J Perinatol. 2018;35:1419–22.

    Article  PubMed  Google Scholar 

  16. Matti N, Nguyen MR, Mosel C, Grzeskowiak LE. Utilization of neonatal medication error prevention strategies: a clinical practice survey of Australian and New Zealand neonatal units. Ther Adv Drug Saf. 2018;9:609–17.

    Article  PubMed  PubMed Central  Google Scholar 

  17. Spitzer AR, Ellsbury DL, Handler D, Clark RH. The Pediatrix BabySteps Data Warehouse and the Pediatrix QualitySteps improvement project system-tools for “meaningful use” in continuous quality improvement. Clin Perinatol. 2010;37:49–70.

    Article  PubMed  Google Scholar 

  18. England A, Wade K, Smith PB, Berezny K, Laughon M. Best Pharmaceuticals for Children Act - Pediatric Trials Network Administrative Core C. Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience. Contemp Clin Trials. 2016;47:376–82.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Laughon MM, Chantala K, Aliaga S, Herring AH, Hornik CP, Hughes R, et al. Diuretic exposure in premature infants from 1997 to 2011. Am J Perinatol. 2015;32:49–56.

    PubMed  Google Scholar 

  20. Smith PB, Cotten CM, Hudak ML, Sullivan JE, Poindexter BB, Cohen-Wolkowiez M, et al. Rifampin pharmacokinetics and safety in preterm and term infants. Antimicrob Agents Chemother. 2019;63:e00284–19.

    CAS  PubMed  PubMed Central  Google Scholar 

  21. Hornik CP, Herring AH, Benjamin DK Jr, Capparelli EV, Kearns GL, van den Anker J, et al. Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants. Pediatr Infect Dis J. 2013;32:748–53.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Piper L, Smith PB, Hornik CP, Cheifetz IM, Barrett JS, Moorthy G, et al. Fluconazole loading dose pharmacokinetics and safety in infants. Pediatr Infect Dis J. 2011;30:375–8.

    Article  PubMed  PubMed Central  Google Scholar 

  23. Sampson MR, Bloom BT, Lenfestey RW, Harper B, Kashuba AD, Anand R, et al. Population pharmacokinetics of intravenous acyclovir in preterm and term infants. Pediatr Infect Dis J. 2014;33:42–49.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Ericson JE, Arnold C, Cheeseman J, Cho J, Kaneko S, Wilson E, et al. Use and safety of erythromycin and metoclopramide in hospitalized infants. J Pediatr Gastroenterol Nutr. 2015;61:334–9.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, et al. Clindamycin pharmacokinetics and safety in preterm and term infants. Antimicrob Agents Chemother. 2016;60:2888–94.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  26. Ku LC, Zimmerman K, Benjamin DK, Clark RH, Hornik CP, Smith PB, et al. Safety of enalapril in infants admitted to the neonatal intensive care unit. Pediatr Cardiol. 2017;38:155–61.

    Article  PubMed  Google Scholar 

  27. Cohen-Wolkowiez M, Poindexter B, Bidegain M, Weitkamp JH, Schelonka RL, Randolph DA, et al. Safety and effectiveness of meropenem in infants with suspected or complicated intra-abdominal infections. Clin Infect Dis. 2012;55:1495–502.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  28. Commander SJ, Gao J, Zinkhan EK, Heresi G, Courtney SE, Lavery AP, et al. Safety of metronidazole in late pre-term and term infants with complicated intra-abdominal infections. Pediatr Infect Dis J. 2020;39:e245–8.

    Article  PubMed  Google Scholar 

  29. Buckley MS, Rasmussen JR, Bikin DS, Richards EC, Berry AJ, Culver MA, et al. Trigger alerts associated with laboratory abnormalities on identifying potentially preventable adverse drug events in the intensive care unit and general ward. Ther Adv Drug Saf. 2018;9:207–17.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  30. DiPoto JP, Buckley MS, Kane-Gill SL. Evaluation of an automated surveillance system using trigger alerts to prevent adverse drug events in the intensive care unit and general ward. Drug Saf. 2015;38:311–7.

    Article  CAS  PubMed  Google Scholar 

  31. Fabretti SC, Brassica SC, Cianciarullo MA, Romano-Lieber NS. Triggers for active surveillance of adverse drug events in newborns. Cad Saude Publica. 2018;34:e00069817.

    Article  PubMed  Google Scholar 

  32. Kane-Gill SL, Dasta JF, Schneider PJ, Cook CH. Monitoring abnormal laboratory values as antecedents to drug-induced injury. J Trauma. 2005;59:1457–62.

    Article  PubMed  Google Scholar 

  33. Du W, Lehr VT, Lieh-Lai M, Koo W, Ward RM, Rieder MJ, et al. An algorithm to detect adverse drug reactions in the neonatal intensive care unit. J Clin Pharm. 2013;53:87–95.

    Article  Google Scholar 

  34. Cammack B, Oschman A, Lewis T. Improving Recognition and Reporting of Adverse Drug Reactions in the NICU: A Quality Improvement Project. Pediatr Qual Saf. 2019;4:e203.

    Article  PubMed  PubMed Central  Google Scholar 

  35. Institute for Safe Medication Practices (ISMP). ISMP list of high-alert medications in acute care settings. https://www.ismp.org/tools/institutionalhighAlert.asp.

  36. Pratico AD, Longo L, Mansueto S, Gozzo L, Barberi I, Tiralongo V, et al. Off-label use of drugs and adverse drug reactions in pediatric units: a prospective, multicenter study. Curr Drug Saf. 2018;13:200–7.

    Article  CAS  PubMed  Google Scholar 

  37. Hsieh EM, Hornik CP, Clark RH, Laughon MM, Benjamin DK Jr, Smith PB, et al. Medication use in the neonatal intensive care unit. Am J Perinatol. 2014;31:811–21.

    Article  PubMed  Google Scholar 

  38. Gore R, Chugh PK, Tripathi CD, Lhamo Y, Gautam S. Pediatric off-label and unlicensed drug use and its implications. Curr Clin Pharm. 2017;12:18–25.

    Article  Google Scholar 

  39. Cuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert Opin Drug Saf. 2006;5:703–18.

    Article  PubMed  Google Scholar 

  40. Holdsworth MT, Fichtl RE, Raisch DW, Hewryk A, Behta M, Mendez-Rico E, et al. Impact of computerized prescriber order entry on the incidence of adverse drug events in pediatric inpatients. Pediatrics. 2007;120:1058–66.

    Article  PubMed  Google Scholar 

  41. Manrique-Rodriguez S, Sanchez-Galindo AC, Lopez-Herce J, Calleja-Hernandez MA, Martinez-Martinez F, Iglesias-Peinado I, et al. Impact of implementing smart infusion pumps in a pediatric intensive care unit. Am J Health Syst Pharm. 2013;70:1897–906.

    Article  PubMed  Google Scholar 

  42. Upperman JS, Staley P, Friend K, Neches W, Kazimer D, Benes J, et al. The impact of hospitalwide computerized physician order entry on medical errors in a pediatric hospital. J Pediatr Surg. 2005;40:57–9.

    Article  PubMed  Google Scholar 

  43. Larsen GY, Parker HB, Cash J, O’Connell M, Grant MC. Standard drug concentrations and smart-pump technology reduce continuous-medication-infusion errors in pediatric patients. Pediatrics. 2005;116:e21–5.

    Article  PubMed  Google Scholar 

  44. Hardmeier A, Tsourounis C, Moore M, Abbott WE, Guglielmo BJ. Pediatric medication administration errors and workflow following implementation of a bar code medication administration system. J Health Qual. 2014;36:54–61. quiz 61-53.

    Article  Google Scholar 

  45. Ferranti JM, Horvath MM, Jansen J, Schellenberger P, Brown T, DeRienzo CM, et al. Using a computerized provider order entry system to meet the unique prescribing needs of children: description of an advanced dosing model. BMC Med Inf Decis Mak. 2011;11:14.

    Article  Google Scholar 

Download references

Funding

This study was funded by grant #: NIH-5R21HD080606-02.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA

    Laura E. Miller, P. Brian Smith, C. Michael Cotten, Chi D. Hornik & Rachel G. Greenberg

  2. Department of Medicine, Division of Population Health, Stanford University, Stanford, CA, USA

    Chris DeRienzo

  3. Duke Clinical Research Institute, Durham, NC, USA

    P. Brian Smith, Chi D. Hornik & Rachel G. Greenberg

  4. Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

    Carl Bose

  5. Pediatrix Medical Group Inc, Sunrise, FL, USA

    Reese H. Clark

  6. Clemson University, Clemson, SC, USA

    Daniel K. Benjamin

Authors
  1. Laura E. Miller
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Chris DeRienzo
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. P. Brian Smith
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Carl Bose
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Reese H. Clark
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. C. Michael Cotten
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Daniel K. Benjamin
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Chi D. Hornik
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Rachel G. Greenberg
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

All authors have been involved in the study design, analysis, and manuscript revision. All authors read and approved the final manuscript. LEM is the guarantor who accepts full responsibility for the work and the conduct of the study, had access to the data, and controlled the decision to publish. LEM contributed to the conception and design of the study, the data interpretation, the manuscript drafting, and the critical revision of the manuscript. CDR contributed to the conception and design of the study, and both supervised and contributed to the data acquisition and interpretation, manuscript drafting, and critical revision of the manuscript. PBS contributed to the conception and design of the study, the data interpretation, and the critical revision of the manuscript. CB contributed to the conception and design of the study, the data interpretation and the critical revision of the manuscript. RHC contributed to the conception and design of the study, the data acquisition, the data interpretation, and the critical revision of the manuscript. CMC contributed to the conception and design of the study, the data interpretation, and the critical revision of the manuscript. DKB contributed to the conception and design of the study, the data interpretation, and the critical revision of the manuscript. CDH contributed to the conception and design of the study, the data interpretation, and the critical revision of the manuscript. RGG had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. RGG contributed to the conception and design of the study, the data interpretation, the manuscript drafting, and the critical revision of the manuscript.

Corresponding author

Correspondence to Rachel G. Greenberg.

Ethics declarations

Conflict of interest

RGG has received support from industry for research services (https://dcri.org/about-us/conflict-of-interest/).

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Miller, L.E., DeRienzo, C., Smith, P.B. et al. Association between neonatal intensive care unit medication safety practices, adverse events, and death. J Perinatol 41, 1739–1744 (2021). https://doi.org/10.1038/s41372-020-00857-y

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41372-020-00857-y

Search

Advanced search

Quick links