Vaikų gydimo vaistais teisinio reglamentavimo aspektai.
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The paper discusses the present-day practical and legal situation in children’s treatment with medicines, highlights the historical preconditions of treating children with drugs which have not been clinically tried by pediatric population are highlighted, and reviews the legal acts that regulate the development of medicines for children’s treatment. Most drugs being developed are only tried on adults before they are approved, both because of practical and technical difficulties in doing research on children as weIl as ethical considerations on inclusion of children in the trial of new drugs. Recently more attention has been drawn to the fact that pharmacotherapy in children does not have the same evidence-based platform as in adults: pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In US, approximately 75% of all medications on the market do not have approved pediatric labeling. Children have been described as "therapeutic orphans" because of the deficit of appropriate studies in their age group. Many differences exist in physiology, pathology, pharmacokinetics, and pharmacodynamics between children of different age. The participation of minors in clinicaI triaIs is essential to provide a safe and effective treatment of children. In 1989, the United Nations General Assembly approved the Convention on the Rights of the Child. The prineipIe articulated in this convention is of fundamental importance: children have the right to the highest attainable level of health. Later on, detailed guidelines for clinicaI investigations of medicinaI products in the pediatrie population are provided by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), although encouraging efforts have been made to address these issues in the United States and later in Europe. In 1998, the American Food and Drug Administration established that studies in children should include in the development of new drugs. This was le gaIly formalized in the Best Pharmaceuticals for Children Act in 2002, which resulted in re-evaluation of severaI drugs primarily developed for adults but frequently used by children. In Europe, there is a strong commitment to establish cooperation between the pharmaceutical industry and pediatrie networks in order to increase and facilitate drug studies with children. The European Medieines Agency (EMEA) plays the central role in this work by developing lists of drugs for which pediatrie studies are needed and thus prevent unnecessary duplication. The European Regulation on medieines for pediatrie use entered into force on 26 January 2007. As a reward or incentive for conducting pediatric studies, companies will be entitled to extensions of patent protection and market exclusivity. The Regulation establishes the European network of pediatric clinicaI triaIs for off patent medicines. The Pediatric Committee at the EMEA will be responsible for the pediatric investigation plans (PIPs) of all medicines. The European pediatric clinicaI triaIs database, partly accessible to the public, will hold the details and the results of all pediatric triaIs conducted in line with these PIPs. The article also elucidates the legal requirements for pediatric clinicaI triaIs in Lithuania.
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