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Standard operating procedure (SOP) · NEO-SOP-002 · Version 0.1 · Draft for local review

Supports: 37.1

At a glance

  • Every medicine for a neonate or infant is dosed on a measured, current weight, in mg/kg, using an approved neonatal reference.
  • Every calculation is checked by a second person before the medicine is given. Infusions and high-alert medicines are also verified by a pharmacist.
  • Dose limits, prematurity and organ function are checked before each new prescription and each change of dose.
  • Every dose, calculation check and administration is recorded on the same chart, with the weight used.
  • Stop and get help straight away if: no measured weight is available, the calculated dose is above the maximum, or the two calculations do not match.

1. Purpose

To make sure every medicine given to a neonate or infant is dosed for the child's current weight and age, that the calculation is correct and independently checked, and that every dose is recorded. The aim is to prevent dosing errors, which are among the most frequent causes of serious harm in neonatal care (37.1).

2. Scope

Item Coverage
Applies to All prescribers, pharmacists, nurses and doctors who prescribe, prepare, check or give medicines to neonates and infants
Patients Neonates (birth to 28 days of postnatal age, including preterm infants by corrected age) and infants (28 days to 12 months)
Locations Neonatal units, special care baby units, maternity wards and any ward caring for neonates or infants, including neonatal transfer teams
Medicines All medicines, including those given by mouth, by tube, by injection, by infusion, on the skin and in the eye

3. Definitions

Term Meaning in this SOP
Measured weight A weight taken on a calibrated scale, recorded with the date, time and scale used. Used for dosing only if it is no more than 24 hours old, or if the infant's weight is known to be stable.
Dose per kilogram The dose in mg/kg (or microgram/kg) stated in the approved reference, multiplied by the measured weight in kg.
Concentration The amount of active medicine in each millilitre of the preparation as supplied or prepared (for example 10 mg/mL).
Postnatal age Days or weeks since birth.
Postmenstrual age Gestational age at birth plus postnatal age. Used to adjust doses in preterm infants.
High-alert medicine A medicine with a high risk of serious harm when used in error, listed in Section 11.
Independent double check A second registered professional recalculates the dose from the prescription and the weight, without seeing the first result, and confirms it matches.

4. Background

Neonates and infants differ from adults and older children in how they absorb, distribute, break down and excrete medicines. Liver enzymes and kidney function are immature, particularly in preterm infants, and body water and protein binding change in the first weeks of life. Many medicines have no licensed neonatal dose, so prescribers use reference sources that give doses by weight and postmenstrual or postnatal age.

Weight changes quickly in the first days of life, so a birth weight may not be the right weight for dosing. Errors most often come from using an old weight, mis-placing a decimal point, confusing units, or misreading a concentration.

5. Responsibilities

Role Responsibility
Prescriber (doctor or prescribing nurse practitioner) Records the current measured weight, calculates the dose in mg/kg and mg, states the volume and concentration, checks the maximum dose and any adjustment for prematurity or organ function.
Pharmacist Verifies the prescription for high-alert medicines, all infusions, and any dose outside the approved reference. Advises on preparation and stability.
Registered nurse preparing the medicine Calculates the volume independently, prepares and labels the medicine, and starts the second check.
Second registered nurse or doctor Carries out the independent double check for high-alert medicines and infusions, and signs the chart.
Registered nurse giving the medicine Confirms the patient, medicine, dose, route and time before giving it, and records the administration.
Unit manager Makes sure staff are trained and assessed, that scales are calibrated, and that audits take place.
Medical director or chief executive Approves this SOP and its neonatal reference sources, and receives audit results and incidents.

6. Materials and equipment

7. Safety

Write numbers so that the risk of misreading is removed:

Dose errors in neonates are often a factor of ten. Before giving any dose, ask yourself whether the number is plausible for this infant's weight.

8. Before you start

  1. Check the patient's identity using two identifiers (for example hospital number and date of birth).
  2. Check that a measured weight is available and no more than 24 hours old. If not, weigh the infant before calculating.
  3. Record gestational age at birth and current postnatal age, and calculate postmenstrual age.
  4. Check allergies, feed status, current medicines and the most recent renal and liver results where relevant.
  5. Check the reference for the medicine, the dose per kg, the maximum single dose and the maximum daily dose for this age.

9. Procedure

9.1 Prescribing

  1. Weigh the infant on the calibrated scale and record the weight in kg to two decimal places, with date, time and scale.
  2. Write the prescription in mg/kg and in mg, state the volume and concentration, and state the frequency and duration.
  3. Check the dose against the reference for postmenstrual and postnatal age. Adjust for prematurity, kidney or liver impairment, and interacting medicines.
  4. Confirm the dose is within the maximum single and daily dose. If it is above a maximum, do not prescribe it without discussion with the pharmacist and the consultant.

9.2 Verification and preparation

  1. For high-alert medicines and all infusions, the pharmacist verifies the prescription before the first dose and after any change.
  2. The nurse preparing the medicine calculates the volume independently and compares it with the prescription.
  3. A second registered professional repeats the calculation without seeing the first result. Both results must match before the medicine is given.
  4. Label the prepared medicine with all the information in Section 7 and the patient identifier. Do not give a medicine that has no label or an unclear label.
  5. If the two calculations do not match, stop. Recalculate with the prescriber and pharmacist, and record the outcome.

9.3 Administration

  1. Use the five checks at the bedside: right patient, right medicine, right dose, right route, right time.
  2. For pump infusions, check the programmed rate, the concentration and the dose per hour against the prescription, with the second person.
  3. Record the dose given, the time, the route, the nurse's name and the checks completed on the chart.
  4. If a dose is not given, record the reason and inform the prescriber.

9.4 After the dose

  1. Monitor the infant's response and any adverse effects as set in the drug's protocol.
  2. Report any dosing error, near miss or unexpected effect under the incident reporting policy within 24 hours.

10. Decision points

Situation Action
No measured weight within 24 hours Weigh the infant before calculating. Do not calculate from a previous weight unless the infant is in an emergency (see Section 12).
Calculated dose is above the maximum single or daily dose Do not give. Discuss with the pharmacist and the prescriber, and document the decision.
Two calculations do not match Stop, recalculate with a third check if needed, and do not give until resolved.
Medicine not in the unit's reference Ask the pharmacist before use. Record the source of the dose used.
Kidney or liver impairment Ask the pharmacist for an adjustment and record the reason for the change.
Infant is unwell or deteriorating Discuss the dose with the senior clinician before giving. Do not delay treatment in an emergency.

11. High-alert medicines in the neonatal unit

The following always need a pharmacist verification and an independent double check before the first dose and before each change of dose: infusions and concentrated preparations; opioids; anticoagulants; insulin; concentrated potassium and electrolytes; neuromuscular blocking agents; antiseizure medicines given intravenously; and any medicine on the unit's local high-alert list.

12. Special situations

13. Escalation

14. Monitoring

The unit manager carries out a monthly audit of 20 randomly selected neonatal prescriptions, or all if fewer, and reports results to the neonatal governance meeting each quarter.

Measure Target
Prescriptions with a weight measured within 24 hours 100 percent
High-alert medicines with a pharmacist verification and an independent double check 100 percent
Calculations correct on audit 100 percent for high-alert medicines, at least 98 percent for all other medicines
Dosing incidents reported and reviewed within 7 days 100 percent

15. Records

16. Training

All staff who prescribe, prepare, check or give medicines to neonates or infants complete a dose calculation assessment at induction and every year. The assessment includes at least ten calculations from realistic neonatal scenarios. A score of 100 percent is required on the calculation section. Staff who do not pass receive supervised practice and are reassessed within four weeks.

17. Related documents

Code Document
NEO-POL-001 Neonatal level of care
NEO-FRM-001 Neonatal level of care assessment record
NEO-REG-001 Neonatal staffing against level of care register
PHM-SOP-001 Medicine storage and temperature monitoring
INC-SOP-001 Root cause analysis of serious incidents

18. Evidence

This SOP is based on the reference sources listed below and on the requirement of criterion 37.1 of the ASF standards. The local neonatal dosing guide must be checked against these sources at each review, and the review date recorded in the change history.

E-learning for this document

References

  1. British Medical Association and Royal Pharmaceutical Society. British National Formulary for Children (BNFc). Current edition.
  2. Institute for Safe Medication Practices (ISMP). List of Error-Prone Abbreviations, Symbols, and Dose Designations. Current edition.
  3. The Joint Commission. National Patient Safety Goal NPSG.03.06.01: Maintain and communicate accurate patient medication information. Current edition.
  4. Local neonatal dosing guide and national neonatal formulary (to be inserted by the unit at adoption).

Change history

Version Date Change
0.1 2026-10-26 First draft for review. Not yet approved by the ASF Expert Committee.
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