Unlicensed and off label analgesic use in paediatric pain management


Unlicensed and off label analgesic use in paediatric pain management


Conroy S; Peden V


Paediatric Anaesthesia




Child; Humans; Great Britain; Drug Utilization; Prospective Studies; Hospitals; Pediatric; Pain/drug therapy; Analgesics/therapeutic use; Drug Approval


BACKGROUND: The management of pain in children has advanced enormously in recent years. Pharmacological treatment of pain is complicated however, by the widespread use of unlicensed and off label medicines in the paediatric population, leading to everyday practical problems. This study aimed to document the incidence and nature of unlicensed and off label analgesic agents in children. METHODS: Data regarding analgesic use were collected prospectively over a 4-week period from two wards. The data were analysed to determine whether the drug use was licensed, unlicensed or off label. RESULTS: Seven hundred and fifteen prescription episodes were analysed. Some 480 of these (67%) were licensed; 235 were licensed medicines used in an off label manner (33%). No medicines were unlicensed. Paracetamol was the most common analgesic used. CONCLUSION: Issues regarding the use of off label drugs in children at risk of pain are discussed. Suggestions are made regarding the way forward for the future.


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Conroy S; Peden V, “Unlicensed and off label analgesic use in paediatric pain management,” Pediatric Palliative Care Library, accessed December 4, 2023, https://pedpalascnetlibrary.omeka.net/items/show/12136.