Published: 5 September 2019

Publications

Paracetamol – Dangerous when not used correctly

Prescriber Update 40(3): 46-47
September 2019

In December 2018, the Medicines Adverse Reactions Committee (MARC) discussed a report of acute hepatic failure in a child given a suspected paracetamol overdose¹.

The Committee considered that this important event required further discussion and that a holistic response across different healthcare agencies was needed. At the MARC’s request, a number of organisations met to discuss cases of paediatric paracetamol dosing-related adverse events reported in New Zealand.

Review of the New Zealand cases did not clearly implicate use of non-prescription paracetamol, although the source was not clear in some cases. However, medication errors associated with prescribing, dispensing and communication to caregivers were reported.

For example, one case report described a young child who was prescribed an excessive dose of paracetamol (34.5 mg/kg/dose). As a result, the child developed acute liver failure. Another case report described a young child who was inappropriately dosed with a tablespoon. The child also developed acute liver failure from the overdose.

Following review of the cases, the group recommended that healthcare professionals could take a number of actions to avoid these errors. These actions are summarised in Table 1.

Table 1: Actions to take when prescribing and dispensing paracetamol liquid for children

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Only recommend paracetamol for an appropriate condition

Only use paracetamol for approved indications (ie, pain and/or fever).

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Calculate the correct dose^a

Use weight-based dosing.

Use actual body weight, not ideal body weight.

Never exceed the recommended adult dose.

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Prescribe precisely

Specify the dose, the concentration of paracetamol liquid to be dispensed (ie, 120 mg/5mL or 250 mg/5mL), the mL volume to be administered and the maximum daily dose on the prescription. Including the child’s current weight on the prescription can provide a valuable cross check at dispensing.

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Dispense diligently

Check that the prescribed dose is appropriate/safe, that the correct strength of paracetamol liquid (120 mg/5mL or 250 mg/5mL) has been selected for dispensing and ensure that the dosing instructions are clearly written on the medicine label.

Ensure that the caregiver has access to an appropriate measuring device, suitable to administer the dose prescribed, and that they know how to measure the correct dose.

Check to see if the caregiver requires additional written information eg, Paracetamol for babies and children^b

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Communicate to the caregiver

Warn the caregiver that there are potential hazards associated with the use of paracetamol in children.

Ensure that the caregiver knows the dosing interval and the maximum number of doses per day.

Ensure that for families with more than one child, the caregiver is aware of the different doses required for each child and that there are two different strengths of paracetamol liquid available (120 mg/5mL and 250 mg/5mL).

Advise the caregiver to seek medical advice if they are unsure about the dose or if they think they have made a mistake.

Advise the caregiver to keep all medicine, including paracetamol liquid, out of reach and sight of children.

Advise the caregiver to shake the bottle before administering paracetamol liquid.

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Notes

1. See the paracetamol dosing regimen in the New Zealand Formulary for Children, available at: https://www.nzfchildren.org.nz/nzf_2439
2. Health Navigator + PHARMAC. 2018. Paracetamol for babies and children. URL: www.healthnavigator.org.nz/media/5078/paracetamol-safe-use-of-paracetamol-for-children-july-2018.pdf

Medsafe has also reviewed the package labelling of over-the-counter (OTC) paracetamol liquid products. We will be seeking feedback on proposed changes to the Label Statements Database (LSD) for paracetamol in the coming weeks. Have your say by participating in the consultation.

References

1. Medsafe. 2018. Minutes of the 176^th Medicines Adverse Reaction Committee Meeting. URL: www.medsafe.govt.nz/profs/adverse/Minutes176.htm (accessed 24 July 2019).