[Ethical problems of clinical pharmacology in pediatrics]

There is no rational and safe treatment without knowledge of clinical pharmacology. Clinical pharmacology is based on data found in the human. Since results of animals trials cannot be used directly Absorption, Distribution, Metabolism and Elimination rates of drugs in children differ from those known in adults. Therefore pharmacological data in children have to be studied specifically. There are always some questions for the pediatrician whether he is allowed to administer a drug prescribed in adult medicine to children, whether he is allowed to obtain data for therapeutical control purposes and whether he may or even must publish these results for the sake of ill infants. Due to the facts that it is difficult to receive these informations, we do not find dosage schemes, for example in the Physicians Desk Reference or Rote Liste for more than 70% of all registered drugs. A new drug without governmental licence must not be employed in pediatric medicine. After its official approval we may use this new pharmaceutical agent in some circumstances this might be even a must. Especially in Pediatrics there is no strict borderline between the clinical trial of a new drug in a group of patients or its application to a single ill child. Whenever a pediatrician is convinced of the high value of a new drug he will certainly get the parent's permission to apply it for the sake of their child as well as to perform a close therapy control. This attitude and produce is medically, ethically and legally correct.