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Publishing the evidence for children’s medicines
  1. Imti Choonara1,
  2. Howard Bauchner2
  1. 1
    Academic Division of Child Health, University of Nottingham, Derbyshire Children's Hospital, Derby, UK
  2. 2
    Boston University School of Medicine, Boston, MA, USA
  1. Imti Choonara, Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Derby DE22 3DT, UK; imti.choonara{at}

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The right of children to receive medicines that have been scientifically tested for both efficacy and safety is now becoming widely accepted. Tragedies such as the grey baby syndrome in association with the use of the antibiotic chloramphenicol in neonates could have been avoided if appropriate scientific studies had been performed.1 European legislation has now established that children should have the same rights as adults to receive medicines that have been proven to be of benefit and are unlikely to cause serious toxicity.2 The European legislation follows on from American initiatives and should result in improved drug therapy for children. National networks to coordinate clinical trials of medicines in children have been established in several European countries alongside North American networks.3

On a global scale, the World Health Organization (WHO) has recognised the importance of children’s medicines. It has produced a special report on the problems of ensuring the safety of medicines for children.4 Having published the initial report, which was concerned with problems associated with formulations and medication errors, WHO has now launched a major campaign entitled “Make medicines child size”.5 This campaign, in collaboration with UNICEF, Save the Children, Médecins Sans Frontières and the International Paediatric Association, aims to improve availability and access to safe, child specific medicines for children throughout the world.

The scientific study of medicines in children is known as paediatric clinical pharmacology and this is now recognised as a subspecialty of paediatrics.6 7 Formal training programmes have been set up and there is increasing recognition that paediatric clinical pharmacologists are needed throughout the world (ie, not only in developed countries). Paediatric clinical pharmacologists have been instrumental in emphasising the importance of providing an evidence base for drug therapy in paediatric patients.8 9 They have also played leading roles in both clinical trials and studies of drug toxicity in children.1012

The end point for scientific research is publication in a peer reviewed journal that is accessible to health professionals throughout the world. Archives of Disease in Childhood has a longstanding interest in medicines for children. Its parent organisations, The Royal College of Paediatrics and Child Health and the BMJ Publishing Group, have been instrumental in producing the British National Formulary for Children (BNFC). One of the key partners in helping ensure the production of the BNFC and its predecessor, Medicines for Children, was the Neonatal and Paediatric Pharmacists Group.

We are delighted to announce that Archives, in future, will incorporate Paediatric and Perinatal Drug Therapy (PPDT) within the journal. PPDT was launched in 1997 to fill a gap concerning the scientific evidence of drug therapy in children. PPDT has progressed from an annual review to a quarterly publication containing original articles and is the official journal of both the Neonatal and Paediatric Pharmacists Group and the European Society for Developmental, Paediatric and Perinatal Pharmacology (ESDP). The latter has been instrumental in producing the scientific evidence in relation to unlicensed and off label medicines in children that has resulted in European legislation.9 The ESDP runs training courses and also organises the largest international conference in the area of paediatric drug therapy.

We are confident that this new partnership will benefit both health professionals who are responsible for treating children with medicines and children themselves. Our aim is to publish high quality original research into all aspects of drug therapy in neonates, infants and children alongside reviews that will hopefully ensure children receive medicines safely and effectively. Although initially a section within Archives, the aim is to produce a separate edition as quickly as the submission of original material allows.



  • Competing interests: None.