© 2003 BMJ Publishing Group & Royal College of Paediatrics and Child Health
LEADING ARTICLE
Licensing of medicines
Making medicines that children can take
Department of Pharmacy, Alder Hey Children’s Hospital, Liverpool, UK
Correspondence to:
Correspondence to:
Mr A J Nunn, Director of Pharmacy, Alder Hey Children’s Hospital, Eaton Road, Liverpool L12 2AP, UK;
Tony.Nunn@rlch-tr.nwest.nhs.uk
The role of the pharmacist
Keywords: formulation; extemporaneous dispensing; compounding; licensing of medicines; risk management
| The first 150 words of the full text of this article appear below. |
The Medicines Act of 1968 and subsequent UK and European legislation established the process of licensing (now authorisation) to assure the safety, efficacy, and quality of medicines. While the majority of medicines for adults are licensed, many medicines used for children are not licensed for purpose (they are used "off-label") or have not been licensed at all (unlicensed).
Suitable licensed medicines are usually available for common problems such as infections but there are few, if any, available for less common conditions such as hypertension. The success of financial incentives to encourage pharmaceutical companies to licence medicines for children in the USA would suggest that the main reason for the dearth of licensed children’s medicines is profit related. There may also be other reasons related to perceived and actual difficulties in conducting clinical trials, such as recruitment and consent and the cost of developing paediatric formulations. There is
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