Use of medicines outside the terms of their marketing authorisation

It is recognised that sometimes medicines are used outside the terms of their marketing authorisation (previously known as product licence). Such use is referred to as off label prescribing and this may be common practice where there is a recognised established body of evidence to support this. Information about appropriate use in mental health conditions and for references relating to their clinical evidence base can be found in the following sources:

• Psychotropic Drug Directory
• The Maudsley Prescribing Guidelines in Psychiatry
• The BNF and BNF for Children
• NICE Technology Appraisals and Clinical Guidelines
• Prescribing in children

As far as possible medicines should be used within the terms of the marketing authorisation, however children often require medicines that are not specifically licensed for paediatric use. Many of the drugs listed in this formulary do not have paediatric licenses and such off label use should be supported by a recognised established body of evidence or informed and guided by a respectable and responsible body of professional opinion. Please see BNF for Children for dosing and licensing status as well as the above references for information on the clinical use of these medicines in children.