Use of unlicensed and off-label medications in paediatric gastroenterology with a review of the commonly used formularies in the UK

Aliment Pharmacol Ther. 2003 Feb 15;17(4):571-5. doi: 10.1046/j.1365-2036.2003.01441.x.


Background: Use of unlicensed and off-label medications is common in hospital based paediatric practice. Whilst inpatient prescription can be closely monitored within the hospital setting, it is subspecialties like paediatric gastroenterology, caring for chronically ill children on an outpatient basis that require administration of regular medications in the community. Local practitioners rely on available paediatric formularies or information provided by the tertiary unit for monitoring and dispensing further prescriptions.

Aim: To assess the proportion of unlicensed and off-label medications prescribed in a paediatric gastroenterology unit to children discharged to the community and assess adequacy of information about these medications in commonly used British formularies.

Methods: All prescriptions prescribed over a six-month period (Jan-Jul 2002) either in the paediatric gastroenterology outpatient department or for children discharged home after an inpatient stay, were retrieved from the pharmacy database. The main outcome measures were to assess the proportion of medications prescribed for unlicensed or off-label use.

Results: 308 patients received 777 prescriptions of which 384 (49%) were for unlicensed or off-label use. Of these 291 (76%) were off-label; 208 in relation to indication and 83 to child's age. 93 of the prescribed medications were unlicensed; 37 were due to manipulation of formulation. Of the commonly used formularies in the UK, only 'Medication for Children(R)' contained dosage information on more than half (9/13) of the most often prescribed off-label/unlicensed medications in paediatric gastroenterology.

Conclusions: Use of unlicensed and off-label medications remains a problem in paediatric practice. Until licensing laws change and more drugs are licensed in children, paediatric gastroenterologists remain responsible for provision of information to families, local practitioners, nurses and pharmacists. Of the commonly used formularies, 'Medicines for Children' is the most detailed and comprehensive, and should be available to all general practitioners and pharmacists in the UK. Clear communication between specialist units and local practitioners is imperative to ensure safe and effective prescribing to children.

MeSH terms

  • Ambulatory Care
  • Child
  • Digestive System Diseases / drug therapy*
  • Drug Information Services
  • Drug Labeling
  • Drug Prescriptions
  • Drugs, Generic / therapeutic use*
  • Formularies, Hospital as Topic
  • Gastrointestinal Agents / therapeutic use
  • Humans
  • Nonprescription Drugs / therapeutic use*
  • United Kingdom


  • Drugs, Generic
  • Gastrointestinal Agents
  • Nonprescription Drugs