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Prevention of medication errors in NICU patients

Authors

Van der Sijs H, Helder O, Tissières P, Mader S, Thiele N, Perapoch J

© Quirin Leppert

User group

Healthcare professionals, neonatal units, hospitals, and health services

Statement of standard

Medication errors are monitored and evaluated to reduce the exposure of infants to avoidable therapeutic risks.

Rationale

The risk of drug administration errors is high in infants for a range of reasons, including different types of errors and reduced compensatory ability. (1,2) The majority of prescriptions for infants are for off-label and unlicensed medications, which are more often associated with medication errors and potential adverse drug events. (3–5)

There is a high risk of calculation errors because doses are based on bodyweight, which may vary 10-fold (from 0.5-5kg), and changes with growth during the first months. Electronic prescribing reduces the frequency of missing, illegible and incomplete orders. Absence of electronic clinical decision support may result in dose (calculation) errors. (6,7) Errors and inaccuracy in drug preparation occur because use of adult dosage formulations require measurement of small volumes, and/or calculation of dilution steps. (8,9) Patient identification may be problematic, as infants cannot confirm their identity and may be part of a multiple pregnancy with similar names and birth dates. (10) Infants often have both intra-venous and intra-arterial catheters and nasogastric tubes increasing the risk of administration by the wrong route. (11)

Benefits

Short-term benefits

  • Easily understandable information about drug doses, preparation, and administration (12)
  • Reduced risk of calculation errors (7)
  • Reduced risk of administration by incorrect route (13)
  • Reduced risk of illegible and incomplete drug prescriptions (7)

Long-term benefits

  • Evidence-based drug information specific to newborn infants (14)
  • Improved availability of neonatal formulations (14)
  • Improved accuracy of drug doses (9)
  • Improved drug safety alerting (15)

 

Components of the standard

Component Grading of evidence Indicator of meeting the standard
For parents and family    
1. Parents are informed by healthcare professionals about any medication errors. B (High quality) Clinical records
       
2. Parents are encouraged to speak up when they believe a mistake has been made with the prescription, dosage or administration of medicines to their infant. B (Moderate quality) Parent feedback
       
For healthcare professionals    
3. A guideline for compounding, dosage, and administration of all dispensed parenteral and oral drugs in neonatal care is adhered to by all healthcare professionals. B (High quality) Guideline
       
4. Training on medication compounding and in the use of electronic calculation support and electronic prescribing is attended by all responsible healthcare professionals. B (High quality) Training documentation
       
5. Electronic calculation support is used. (1,7,15) A (Moderate quality)
B (Moderate quality)
Guideline
       
6. Healthcare professionals are not interrupted during medication compounding. (1,16) A (Moderate quality)
B (Moderate quality)
Guideline
       
7. Medication is compounded and administered using double checks at each stage. (1) A (Moderate quality)
B (Moderate quality)
Guideline
       
8. Generated drug safety alerts are handled carefully weighing benefits and risks. (1,15) A (Moderate quality)
B (Moderate quality)
Guideline
       
9. Medication errors are recorded in clinical records, explained to parents and reported within the hospital. (1) A (Moderate quality)
B (Moderate quality)
Audit report, guideline
       
10. Adverse drug reactions are reported to the national authorities. (17) A (Moderate quality)
B (Moderate quality)
C (High quality)
Audit report
       
For neonatal unit and hospital    
11. A guideline for compounding, dosage, and administration of all dispensed parenteral and oral drugs in neonatal care is available and regularly updated. B (High quality) Guideline
       
12. Training on medication compounding and in the use of electronic calculation support and electronic prescribing is ensured. B (High quality) Training documentation
       
13. An electronic prescribing system for all medication orders is provided. (1,7) A (Moderate quality)
B (Moderate quality)
Guideline
       
14. Different connecting systems for oral and intravenous administration are available. (11,13,17) A (Moderate quality)
B (Moderate quality)
C (High quality)
Training documentation
       
15. A system for reporting and analysis of medication errors is available. (1,17) A (Moderate quality)
B (Moderate quality)
C (High quality)
Audit report
       
16. A hospital pharmacist trained and experienced in neonatal practice is available. (8) A (Moderate quality)
B (Moderate quality)
Audit report
       
For health service    
17. A national guideline on compounding, dosage, and administration of all dispensed parenteral and oral drugs in neonatal care is available and regularly updated. B (High quality) Guideline
       
18. A national system for analysis of medication errors is available. (17) A (Moderate quality)
B (Low quality)
C (High quality)
Audit report
       

Where to go

Further development Grading of evidence
For parents and family  
N/A  
For healthcare professionals  
N/A  
For neonatal unit  
N/A  
For hospital  
  • Implement an electronic prescribing system with integral clinical decision support (checks for dose, drug-drug interactions, duplicate therapy, allergy and contraindications).
B (Moderate quality)
  • Provide satellite pharmacies or central pharmacy compounding individualised doses for infants.
B (Moderate quality)
  • Implement smart infusion pumps.
A (Low quality
  • Implement bar code assisted medication administration.
B (Moderate quality)
For health service  
  • Provide national neonatal/paediatric drug formulary with evidence based (or expert based) dose recommendations.
B (Moderate quality)
  • Support the development of paediatric investigation plans. (14)
A (Moderate quality)
B (Moderate quality)
C (High quality)

Getting started

Initial steps
For parents and family
  • Parents are verbally informed by healthcare professionals about prescribed medication and medication errors.
For healthcare professionals
  • Attend training on medication compounding and in the use of electronic calculation support and electronic prescribing.
  • Perform double checks for compounding and administration of drugs.
  • Report and document medication errors.
  • Use calculation aids for calculation of doses.
For neonatal unit and hospital
  • Develop and implement a guideline for compounding and administration of drugs.
  • Develop and implement a guideline specifying which handbook/formulary is to be used.
  • Develop information material on drug information and medication errors for parents.
  • Support healthcare professionals to participate in training on medication compounding and in the use of electronic calculation support and electronic prescribing.
  • Ensure a hospital pharmacist is trained and experienced in neonatal practice.
For health service
  • Develop and implement a national guideline on compounding, dosage and administration of all dispensed parenteral and oral drugs in neonatal care.
  • Establish a national service for medication error reporting.
 

Sources

  1. Antonucci R, Porcella A. Preventing medication errors in neonatology: Is it a dream? World J Clin Pediatr. 2014 Aug 8;3(3):37–44.
  2. Gray JE, Goldmann DA. Medication errors in the neonatal intensive care unit: special patients, unique issues. Arch Dis Child Fetal Neonatal Ed. 2004 Nov;89(6):F472-473.
  3. Cuzzolin L, Agostino R. Off-label and unlicensed drug treatments in Neonatal Intensive Care Units: an Italian multicentre study. Eur J Clin Pharmacol. 2016 Jan;72(1):117–23.
  4. Conroy S. Association between licence status and medication errors. Arch Dis Child. 2011 Mar;96(3):305–6.
  5. Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp MD, Federico F, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001 Apr 25;285(16):2114–20.
  6. Poole RL, Carleton BC. Medication errors: neonates, infants and children are the most vulnerable! J Pediatr Pharmacol Ther JPPT Off J PPAG. 2008 Apr;13(2):65–7.
  7. Maat B, Bollen CW, van Vught AJ, Egberts TCG, Rademaker CMA. Impact of computerized physician order entry (CPOE) on PICU prescribing errors. Intensive Care Med. 2014 Mar;40(3):458–9.
  8. Chedoe I, Molendijk H, Hospes W, Van den Heuvel ER, Taxis K. The effect of a multifaceted educational intervention on medication preparation and administration errors in neonatal intensive care. Arch Dis Child Fetal Neonatal Ed. 2012 Nov;97(6):F449-455.
  9. Uppal N, Yasseen B, Seto W, Parshuram CS. Drug formulations that require less than 0.1 mL of stock solution to prepare doses for infants and children. CMAJ Can Med Assoc J J Assoc Medicale Can. 2011 Mar 8;183(4):E246-248.
  10. Adelman JS, Aschner JL, Schechter CB, Angert RM, Weiss JM, Rai A, et al. Evaluating Serial Strategies for Preventing Wrong-Patient Orders in the NICU. Pediatrics. 2017 May;139(5).
  11. The Joint Commision. Sentinel event alert: Tubing misconnections – a perstistent and potentially deadly occurrence [Internet]. 2006. Available from: http://www.premiersafetyinstitute.org/wp-content/uploads/jcaho-sentinel-event-issue-361.pdf
  12. van der Zanden TM, de Wildt SN, Liem Y, Offringa M, de Hoog M, Dutch Paediatric Pharmacotherapy Expertise Network NKFK (Nederlands Kenniscentrum voor Farmacotherapie bij Kinderen). Developing a paediatric drug formulary for the Netherlands. Arch Dis Child. 2017;102(4):357–61.
  13. ISO-norm 80369-3, Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications [Internet]. 2016. Available from: https://www.iso.org/standard/50731.html
  14. European Medicines Agency. Pediatric investigation plan [Internet]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000608.jsp&
  15. Kazemi A, Ellenius J, Pourasghar F, Tofighi S, Salehi A, Amanati A, et al. The effect of Computerized Physician Order Entry and decision support system on medication errors in the neonatal ward: experiences from an Iranian teaching hospital. J Med Syst. 2011 Feb;35(1):25–37.
  16. McDowell SE, Ferner HS, Ferner RE. The pathophysiology of medication errors: how and where they arise. Br J Clin Pharmacol. 2009 Jun;67(6):605–13.
  17. European Medicines Agency. Good practice guide on recording, coding, reporting and assessment of medication errors [Internet]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_
    guideline/2015/11/WC500196979.pdf

November 2018 / 1st edition / next revision: 2023

Recommended citation

EFCNI, Van der Sijs H, Helder O et al., European Standards of Care for Newborn Health: Prevention of medication errors in NICU patients. 2018.

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