Paracetamol update for community pharmacies.

Paracetamol has a low risk of toxic effects if taken appropriately, however some patient groups may be at increased risk of toxicity even at therapeutic doses, particularly those with a body weight of 50kg and under.

Health Services Safety Investigations Body (HSSIB) review of oral paracetamol prescriptions for adult inpatients with low body weight (less than 50 kg) identified multiple incidents of overdose, including one death.

To minimise the risk of harm, the HSSIB identified the benefits of electronic prescribing and medication administration systems including an alert for oral paracetamol, that prompts documentation of a patient’s weight and consideration of the risk of liver toxicity when their weight is less than 50kg.

Information is available here:

• Unintentional overdose of paracetamol in adults with low bodyweight
• March 2022, the British Hepatology Pharmacy Group (BHPG) issued a Position Statement for prescribing weight-adjusted oral paracetamol in adults: Paracetamol Position Statement_Mar 2022.pdf
• In August 2023 Humber APC issued guidelines for prescribing oral paracetamol in adults which replicates the BHPG position statement: ORAL PARACETAMOL IN ADULTS Aug 2023.pdf
• BNF monograph for Paracetamol includes the following cautions: Paracetamol | Drugs | BNF | NICE

Cautions

Before administering, check when paracetamol was last administered and the cumulative paracetamol dose over previous 24 hours; body weight under 50 kg; chronic alcohol consumption; chronic dehydration; chronic malnutrition; long-term use (especially in those who are malnourished).

Some patients may be at increased risk of experiencing toxicity at therapeutic doses, particularly those with a body weight under 50 kg and those with risk factors for hepatotoxicity. Clinical judgement should be used to adjust the dose of oral and intravenous paracetamol in these patients.

Co‐administration of enzyme-inducing antiepileptic medications may increase toxicity; doses should be reduced.

Actions in pharmacies: (Cautionary and advisory labels/ Product information leaflets.)

The BNF recommends that Cautionary and advisory labels are added to dispensing labels, however, pharmacies must be mindful of pharmacy labelling systems automatically adding ‘Cautionary and advisory label’ (No 29) to all labels for dispensed paracetamol. This cautionary label does NOT take account of reduced body weight scenarios. Reference should be made to the BNF guidance regarding the use of cautionary and advisory labels: Guidance for cautionary and advisory labels | About | BNFC | NICE

Additionally, patient information leaflets included in dispensed medication (which MUST be provided by the pharmacy), do NOT reference the need for a dose reduction in adult low body weight scenarios.

Please ensure patients are suitable counselled regarding the dose which has been prescribed and is appropriate for them.