Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials

Perceptions and attitudes of Jordanian paediatricians towards off-label paediatric prescribing

“…The most common reason given for off-label prescribing by respondents was prescribing for a different indication. This contrasts with previous surveys of actual practice, that took place in the UK (Scotland and Northern Ireland), and reported that the most common pattern observed for offlabel prescribing was prescribing at lower or higher than the recommended dose (the dose that had been adjusted/ calculated from an adult dose) [5,12].…”

“…Previous studies have sought to elicit the attitudes and experiences of different healthcare professionals (paediatricians, pharmacists, nurses, and GPs) [5,6,12,13] regarding off-label prescribing to children. The latter studies have reported moderate knowledge of healthcare professionals regarding off-label medicine prescribing to children.…”

Use of off-label and unlicenced drugs in hospitalised paediatric patients: a systematic review

“…According to the EMA, the proportion of paediatric trials which form part of an agreed Paediatric Investigation Plan rose to 23 % in 2012 [64]. Despite statutory and regulatory changes, there is still a lack of alternative drugs with marketing authorisation for use in paediatric populations, meaning that off-label and unlicenced drugs continue to be prescribed in medical practice [65] and that new studies are thus called for to ascertain the current extent of off-label and/or unlicenced prescriptions.…”

Extent and nature of unlicensed and off-label medicine use in hospitalised children in Palestine

“…tablets crushed and reformulated as a suspension. There is a concern because adverse drug reactions in children may be more common during unlicensed and off-label treatment, and the practice may result in either over-or underdosing of medicines in different age groups [7][8][9][10].…”