Van der Sijs H, Helder O, Tissières P, Mader S, Thiele N, Perapoch J
Target group
Infants and parents
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
Parents are informed by healthcare professionals about any medication errors.
B (High quality)
Clinical records
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
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
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
Electronic calculation support is used. (1,7,15)
A (Moderate quality) B (Moderate quality)
Guideline
Healthcare professionals are not interrupted during medication compounding. (1,16)
A (Moderate quality) B (Moderate quality)
Guideline
Medication is compounded and administered using double checks at each stage. (1)
A (Moderate quality) B (Moderate quality)
Guideline
Generated drug safety alerts are handled carefully weighing benefits and risks. (1,15)
A (Moderate quality) B (Moderate quality)
Guideline
Medication errors are recorded in clinical records, explained to parents and reported within the hospital. (1)
A (Moderate quality) B (Moderate quality)
Audit report1, guideline
Adverse drug reactions are reported to the national authorities. (17)
A (Moderate quality) B (Moderate quality) C (High quality)
Audit report1
For neonatal unit and hospital
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
Training on medication compounding and in the use of electronic calculation support and electronic prescribing is ensured.
B (High quality)
Training documentation
An electronic prescribing system for all medication orders is provided. (1,7)
A (Moderate quality) B (Moderate quality)
Guideline
Different connecting systems for oral and intravenous administration are available. (11,13,17)
A (Moderate quality) B (Moderate quality) C (High quality)
Training documentation
A system for reporting and analysis of medication errors is available. (1,17)
A (Moderate quality) B (Moderate quality) C (High quality)
Audit report1
A hospital pharmacist trained and experienced in neonatal practice is available. (8)
A (Moderate quality) B (Moderate quality)
Audit report1
For health service
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
A national system for analysis of medication errors is available. (17)
A (Moderate quality) B (Low quality) C (High quality)
Audit report1
1The indicator “audit report” can also be defined as a benchmarking 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.
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