• children;
  • off label;
  • overdose;
  • paracetamol;
  • underdose


• Paracetamol is the most frequently prescribed analgesic and antipyretic in children.

• The adherence to paracetamol dosage recommendation in children is poor, with paracetamol prescriptions alone accounting for 30% of off label prescribing as a result of dose violation.


• Our study has identified that approximately a fifth of paracetamol prescriptions issued to children by their GP are off label, with the most common reason being either too small or too high a dose.

• Both overdosing in young children and underdosing in older children together with their associated risks of toxicity or under treatment occur relatively frequently.

AIMS To assess the level of paracetamol off label prescribing in the community and the potential for paracetamol under or overdosing.

METHODS The Scottish Practice Team Information (PTI) database containing prescribing data for approximately 35 839 children aged (0–12 years) was analysed for paracetamol prescriptions for the year 2006. Off label prescribing was defined as prescribing outside the BNFc age and dose recommendations.

RESULTS Two thousand seven hundred and sixty-one children aged 0–12 years were issued with 4423 prescriptions for paracetamol. (1446 males). Children 1–5 years (1329, 42.2%) accounted for 48.9% (2164) of all paracetamol prescriptions. Eighteen per cent (793) of individual prescriptions were off label and after accounting for repeat prescriptions 625 (22.75%) individuals were exposed to off label prescriptions. A further 15% (668) of prescriptions contained insufficient dosage data to determine their status, 13.3% (368) being underdosed and 4.4% (121) overdosed at least once during the study year. In total 11.3% (502) of all prescriptions were classified as underdose, 2.9% (127) as overdose and 15% (667) had no dosage instructions. Age was significantly related to non recommended dosage (χ2 test, P < 0.001). Children 1–3 months old were at highest risk of being overdosed; 27% of prescriptions recommended actual or potential overdosage and 25% (354) of children aged 6–12 years were prescribed an actual or potential underdose. Overall 57.2% of all prescriptions failed to comply with current BNFc recommendations.

CONCLUSION Paracetamol off label prescribing is common in primary care, with relatively high levels of potential overdosing in the youngest children and potential underdosing in the oldest children.