National safety alerts

A historical Medicines and Healthcare products Regulatory Agency (MHRA) safety update highlights the risk of accidental overdose of intravenous paracetamol in neonates, infants and children.

The National Patient Safety Agency (NPSA) raise similar concerns on the risk of harm to infants and children from inadvertent overdose of intravenous paracetamol.

Safety concerns in practice

Healthcare professionals working in neonatology and paediatrics continue to raise concerns on the risk of overdose and there are anecdotal reports of similar errors occurring, in addition to other errors which are addressed on this page.

Intravenous paracetamol is a base analgesic for many clinical procedures and is widely used in paediatric settings.

Prescribing safely

Risk

Paracetamol dosing in paediatrics is weight dependent and usually very small volumes of paracetamol infusion are needed. Calculation errors can easily lead to a 10-fold overdose.

The risk of prescribing the incorrect dose in this patient group is greater as calculation errors with intravenous paracetamol are easy to make. Healthcare professionals will sometimes work out the dose ‘in their head’ and confusion with the zeros can occur e.g., a 3kg neonate requires a dose of 10mg/kg. Intravenous paracetamol products are available in a 10mg/mL strength. A 30mg dose is required, which corresponds to a 3mL volume to be administered.

Incorrect calculations and unclear prescribing, where the dose is prescribed in both milligram (mg) and millilitre (mL) may lead to an inadvertent overdose.

Mitigation

• Ensure that the dose prescribed is appropriate for the age and weight of the infant. For dosing information refer to the BNF for Children.
• Take care to avoid dosing errors due to confusion between milligram (mg) and millilitre (mL) which could result in accidental overdose and death. Ensure a local policy is implemented and subsequently followed.
• Configure paediatric protocols within Electronic Prescribing and Administration (EPMA) systems.

Administering safely

Risk

A 50mL paracetamol vial contains enough paracetamol to provide a dose suitable for all children up to 33kg. This makes it very difficult for practitioners to recognise errors when administering paracetamol to small children, particularly for those not working in a neonatal or paediatric specific environment.

Mitigation

• Use an infusion pump to administer the required dose.
• For doses that require a volume less than the whole vial, withdraw the required dose into a syringe and administer from the syringe to reduce the risk of over infusion.
• Utilise EPMA systems, which may require active intervention to enable paracetamol to be prescribed in mg along with recommendations on the appropriate volume preparation to use.

High risk scenarios

Children weighing less than 10kg

Risk

The risk of overdose in this patient group is greater as a 50mL intravenous paracetamol vial contains up to 10-20 times the dose required for neonates and infants e.g., a 2kg neonate requires a dose of 7.5mg/kg. A 15mg dose requires 1.5mL of the 50mL vial; inadvertent administration of the whole vial would result in a huge overdose.

Mitigation

• The 10mL paracetamol ampoule should be used for term new-born infants (not licensed in pre-term neonates), infants and children weighing up to 10kg.
• B. Braun Ltd and Fresenius Kabi manufacture 10mg/mL ampoules containing a total dose of 100mg (10mL). These ampoules correspond more closely to the small volumes required for neonates, infants, and children. Particular attention will be required to the storage of the product to reduce confusion with other small 10mL vials e.g., sodium chloride 0.9%, water for injection etc. Increased staff awareness and training on the availability of this product is also essential.
• A maximum single intravenous paracetamol dose should never exceed 75mg (7.5mL) in patients weighing 10kg.
• To aid administration consider withdrawing the volume to be administered and further diluting with sodium chloride 0.9% or glucose 5% to a minimum concentration of 1mg in 1mL.
• Take care to ensure the dose is measured and administered accurately.

Overweight children

Risk

Using body weight to calculate dosing in children who are very overweight (obese) may result in much higher doses of intravenous paracetamol being administered than necessary. This could lead to potential overdose.

Body weight

• A child’s height and weight can be used to determine what centile they fall into and therefore determine if they are underweight, healthy weight, overweight or very overweight (obese).
• Use the NHS BMI calculator to determine what centile the child falls in to.

Mitigation

• The Neonatal and Paediatric Pharmacists Group (NPPG) recommends that for obese children i.e., 98^th centile or above, the Adjusted Body Weight (AdjBW) (correction factor 0.35) is used to determine the dose for oral and intravenous paracetamol up to adult maximum dose.
• For children ≥40kg, do not exceed the maximum recommended dose for an adult. Familiarity with adult dosage regimens is needed. In all cases, treatment should not rely purely on calculated dose but be clinically reviewed regularly to ensure that the child is receiving the correct dose for both efficacy and safety.
• Refer to the SPS page on drug dosing in childhood obesity for general information on childhood obesity.

Switching from oral to intravenous paracetamol

Risk

Oral and intravenous paracetamol dosing are not interchangeable. Prescribing paracetamol as oral/intravenous (PO/IV) may lead to confusion and potential overdose.

Mitigation

• Specify a single route of administration.
• Refer to the BNF for Children to prescribe the correct paracetamol dose for the route of administration, using the child’s age and weight.
• Do not administer intravenous paracetamol concomitantly with oral paracetamol, including combination products.

Transfer of care

Risk

A risk of double dosing may occur when a patient has been administered paracetamol in a surgical setting i.e., theatres and then transferred to a ward setting where paracetamol is prescribed on the medication chart.

Mitigation

• Prior to administration, check when the dose was last given. If the child has been transferred from another setting e.g., theatres, check the relevant medication administration charts to establish when the last dose was given.
• Extra vigilance is needed when a request is made to administer paracetamol to a child.

Available products

Available paracetamol 10mg/mL solution for infusion products

The following companies manufacture 10mL ampoules, 50mL bottles and 100mL bottles:

• B Braun Summary of Product Characteristics (SPC)
• Fresenius Kabi SPC

The following companies manufacture 50mL bags and 100mL bags:

• Accord Healthcare Ltd SPC
• Altan Pharma SPC
• Noridem Enterprise Ltd SPC
• B Braun SPC
• Fresenius Kabi SPC

Potential for confusion

Manufacturers often use the same packaging design for a product range, which can lead to confusion and the incorrect paracetamol product being picked.

Risk mitigation

Where purchasing contracts permit, consider using a different manufacturer for each specific volume (10mL, 50mL and 100mL) to avoid picking errors.

This poster provides an example of a resource which organisations can adapt for local use to provide guidance to healthcare professionals involved with prescribing, reviewing and administering intravenous paracetamol.

Note, the poster refers to the Perfalgan product, which has now been discontinued.

Acknowledgments

We are grateful for the input from NHS colleagues working in paediatrics and the Neonatal & Paediatric Pharmacists Group (NPPG).

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