title: Proposed MHRA changes to UK children's paracetamol dosing recommendations: modelling study.
abstract: OBJECTIVE
  Paracetamol is the most commonly administered medicine to children. A recent study highlighted the risk of overdose of paracetamol using British National Formulary for Children (BNFC) age-based dosing guidelines. This current study assesses the safety of changes to the UK paracetamol product dosing system proposed by the Medicines and Healthcare products Regulatory Authority (MHRA) which include a larger number of narrower age bands and a single dose per age band.
  
  
  METHODS
  Theoretical comparison of the proposed MHRA dosing system with the product dosing instructions of a commonly prescribed form of paracetamol in the UK.
  
  
  METHODS
  United Kingdom Participants Proposed MHRA dosing recommendations and current product dosing instructions were compared using a previously validated model.
  
  
  METHODS
  For both dosing recommendations, single and cumulative daily doses of paracetamol for boys and girls at the 9th, 50th and 91st centiles for weight were calculated for 3 month, 1 year, 6 year and 12 year age groups.
  
  
  RESULTS
  With the current product dosing instructions, underweight children are at risk of receiving approximately two times the recommended single and cumulative daily dose of paracetamol, particularly at age 1 year and 6 years. This risk is negligible when the same model is applied to the proposed MHRA dosing system, whereby underweight, average weight and overweight children at all ages receive doses marginally above or within the recommended dose range or limit.
  
  
  CONCLUSIONS
  The proposed MHRA dosing recommendations for paracetamol use in children are effective at reducing the risk of paracetamol overdose in children of all ages, when compared with current product dosing instructions.
authors.affiliation: Medical Research Institute of New Zealand, Wellington 6021, New Zealand.
authors.forename: Sally
authors.initials: S
authors.lastname: Eyers
authors.forename: James
authors.initials: J
authors.lastname: Fingleton
authors.forename: Kyle
authors.initials: K
authors.lastname: Perrin
authors.forename: Richard
authors.initials: R
authors.lastname: Beasley
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage*; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D003695:Delivery of Health Care / Q000331:legislation & jurisprudence / Q000592:standards*; D004334:Drug Administration Schedule; D062787:Drug Overdose / Q000517:prevention & control*; D004335:Drug and Narcotic Control; D005260:Female; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007223:Infant; D008297:Male; D008954:Models, Biological; D006113:United Kingdom
chemical_list: D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen