BMJ  2005;331:646-647 (24 September), doi:10.1136/bmj.331.7518.646

Editorial

Safer prescribing for children

Will be boosted by European and US laws and the new British national formulary for children

The first 150 words of the full text of this article appear below.

Paediatric prescribing can be precise, beneficial, and safe. It can also be confusing, based on little or no evidence of effectiveness, and can put children at risk. The nature of marketing authorisations (formerly product licences) for drugs merely enhances the paradox. They were designed as a means of obtaining approval for use by an appropriate regulatory body, usually a government agency; so the decision to apply for authorisation is influenced more by commercial than clinical considerations.¹ One result is that unlicensed and "off label" prescribing is common. Paediatricians, general practitioners, and others are torn between providing treatment which their experience and reason have deemed suitable and denying it because of the lack of research data underpinning indications, dosages, or formulations.

A study in five European hospitals showed that 39% of drugs prescribed for children were off label and a further 7% were unlicensed.² Similar studies in general practice of . . . [Full text of this article]

BMJ (h.marcovitch@btinternet.com)

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This article has been cited by other articles:

• Permanand, G., Mossialos, E., McKee, M. (2007). The EU's new paediatric medicines legislation: serving children's needs?. Arch. Dis. Child. 92: 808-811 [Abstract] [Full text]  

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