Epidemiology of head injury

Abstract

metabolism of chloramphenicol is impaired in neonates and therefore significantly lower doses are required to prevent toxicity. 14Drug toxicity is not restricted to the fetus and the newborn infant; sodium valproate hepatotoxicity is thought to be related to enhanced omega oxidation. 15This pathway is enhanced by polypharmacy and certain metabolic diseases, it also appears to be enhanced in children younger than 3 years.These examples illustrate the importance of increasing our knowledge of drug metabolism in children to minimise toxicity while ensuring eYcacy. InitiativesMedicines for adults are evaluated to ensure that they meet acceptable standards of safety, quality, and eYcacy, whereas in children they are often not evaluated.This unsatisfactory situation resulted in the setting up of a joint working party between the (then) British Paediatric Association and the Association of the British Pharmaceutical Industry, and the publication of a joint report on the licensing of medicines for children in May 1996. 16At the same time there was discussion in the Europe Community regarding the guidance on clinical investigation of medicinal products in children.After consultation involving health professionals throughout the European Community a new guidance has been issued (March 1997), which came into force in September 1997. 17The new guidance is a major step forward because of its emphasis on the need for product testing in children.It divides medicinal products into four categories with the following recommendations:(1) Diseases aVecting children exclusively-trials of medicinal products in children may start before any adult human exposure (2) Diseases that mainly aVect children, are of particular gravity in children, or have a diVerent natural history in children-clinical trials in children are needed at an early stage in clinical development following demonstration of safety and reasonable (phase I and II) evidence of eYcacy in adults (3) Diseases occurring in adults and children for which there is currently no treatment-as point 2 (4) Diseases occurring in adults and children for which treatment exists-clinical trials in children should usually follow completion of adult phase III trials.This is a sensible approach that should encourage the pharmaceutical industry to concentrate on clinical trials for conditions in children where there is either no or inadequate treatment at present. ResponseThe new guidance also encourages pharmaceutical companies to carry out trials in children where the product is likely to be used in children.In the past there was no pres-sure on the pharmaceutical company to carry out trials in children.The recent report by the House of Commons health committee on the specific health needs of children and young people confirmed that the present system was unacceptable. 6 The Royal College of Paediatrics and Child Health through its medicines committee has shown that it is keen to cooperate with both the pharmaceutical industry and the regulatory authorities.The Medicines Control Agency in the UK has played a leading role in the development of the new guidance for Europe.We hope that pharmaceutical companies respond to the challenge of ensuring that medicines used in children are evaluated scientifically.