Two thirds of children in European hospitals receive unlicensed drugs

Two thirds of children admitted to paediatric wards in five European hospitals were prescribed drugs that were unlicensed or off label, a survey has found. Clinical trials of drugs are often not performed in children, which means there are limited data on their safety and many are unlicensed for children. The European Network for Drug Investigation in Children looked at prescribing for 624 children admitted to paediatric units over four weeks in the United Kingdom, Sweden, Germany, Italy, and the Netherlands (p 79). They found that 39% of the drugs were prescribed outside the terms of the product licence.


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Relevant Article

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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