[Are children getting the right drugs?].
In recent years there has been increased attention to the fact that pharmacotherapy in children does not have the same evidence based platform as in adults. This is mainly due to the fact that most drugs being developed are only studied in adults before they are approved, both because of practical and technical difficulties in doing research on (small) children as well as ethical considerations on the inclusion of children in the testing of a new drug. Furthermore, the pharmaceutical industry has also not been very interested in developing drugs specifically for children. In 1998 the American Food and Drug Administration (FDA) established that studies in children should also be included in the development of new drugs. This was legally formalised by Congress in the Best Pharmaceuticals for Children Act (BPCA) in 2002. This has resulted in a re-evaluation of several drugs primarily developed for adults but frequently used in children. So far the FDA has changed the product information for 87 drugs, 17 drugs have been given new dosage recommendations for children, for 21 drugs the description of side effects have been changed, and 11 drugs are no longer recommended for use in children because of lack of any demonstrable effect. There has also been increased focus on better drug formulations for children. Also in Europe the need for better and safer drugs for children is given attention. The European Commission has submitted a proposal for a legal approach to the problem similar to the BPCA legislation in USA, which will probably be approved by the EU parliament and take effect in 2006. Furthermore, there is a strong commitment to establish co-operation between the pharmaceutical industry and paediatric and pharmacological networks in order to increase and facilitate drug studies in children. The European Medicines Agency will have a central role in this work by developing lists of drugs for which paediatric studies are needed and prevent unnecessary competition and duplication of studies.
Bratlid
Dag
D
Institutt for laboratoriemedisin, barne- og kvinnesykdommer, Norges teknisk-naturvitenskapelige universitet, og Avdeling for barn og ungdom, St. Olavs Hospital, 7006 Trondheim. dag.bratlid@medisin.ntnu.no
D000328:Adult; D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000331:legislation & jurisprudence; D004358:Drug Therapy / Q000592:standards*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D064420:Drug-Related Side Effects and Adverse Reactions; D032984:Ethics, Research; D005060:Europe; D019317:Evidence-Based Medicine; D006801:Humans; D007231:Infant, Newborn; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D011786:Quality Control; D014481:United States
D004364:Pharmaceutical Preparations