Use of unlabelled and off licence drugs in children

doi:10.1136/bmj.320.7243.1210

BMJ 2000;320:1210 ( 29 April )

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Use of unlabelled and off licence drugs in children

Use of unlicensed drugs may be recommended in guidelines

A European paediatric rule is needed to protect children

Use of unlicensed drugs may be recommended in guidelines

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EDITOR $---$ Conroy et al report the widespread use of drugs that are either not licensed for use in children or are prescribedoutside the terms of their product licence (off label prescribing)in children admitted to hospital.¹ Although it is not illegalto use medicines in this way, the responsibility for any adverseevents becomes the clinician's or the pharmacist's rather thanthe manufacturer's. However, much unlicensed use may be recommendedin local or nationalguidelines.

As part of our trust's response to the use of unlicensed drugs in children, I reviewed all drugs recommended in our localpaediatric medical guidelines. These contained 69 guidelines foracute management and elective investigation of children. The guidelinesrecommended 86 drugs, but only 47 (55%) were licensed for usein children. A further 14 drugs were licensed only for childrenabove a certain age or weight, 24 were unlicensed or off label,and the status of one . . . [Full text of this article]

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Survey of unlicensed and off label drug use in paediatric wards in European countries: Sharon Conroy, Imti Choonara, Piero Impicciatore, Angelika Mohn, Henrik Arnell, Anders Rane, Carmen Knoeppel, Hannsjoerg Seyberth, Chiara Pandolfini, Maria Pia Raffaelli, Francesca Rocchi, Maurizio Bonati, Geert `t Jong, Matthijs de Hoog, and John van den Anker
BMJ 2000 320: 79-82. [Abstract] [Full Text] [PDF]

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