title: [Off label use of analgesics in pediatric perioperative pain therapy from a legal perspective: Austrian interdisciplinary recommendations on pediatric perioperative pain management].
abstract: Pharmaceuticals are not always licensed for all medically indicated areas and types of application. The off label use of pharmaceuticals is particularly common in pediatrics. The obligatory licensing of pharmaceuticals according to § 7 AMG (drug registration and administration act) only applies to the dispensing and provision but not for the use in patients, particularly in a perioperative setting. For medical practice there are standards in the form of the medical obligation for welfare and diligence. Pharmaceuticals can only be used after obtaining appropriate informed consent. The off label use of medications is allowed and sometimes necessary under these prerequisites as long as the administration of the medication is medically indicated and shows promise of success. Furthermore, an application can be permissible for"curative intent".
authors.affiliation: Abteilung für Technikrecht, Institut für Verwaltungsrecht und Verwaltungslehre, Johannes Kepler Universität Linz, Altenbergerstr. 69, 4040, Linz, Österreich, michael.mayrhofer@jku.at.
authors.forename: M
authors.initials: M
authors.lastname: Mayrhofer
mesh_terms: D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D001317:Austria; D002648:Child; D003299:Cooperative Behavior; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D033183:Interdisciplinary Communication; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D059408:Pain Management / Q000379:methods*; D010149:Postoperative Pain / Q000188:drug therapy*; D019990:Perioperative Care / Q000331:legislation & jurisprudence* / Q000379:methods*
chemical_list: D000700:Analgesics
vernacular_title: "Off label use" von Analgetika in der perioperativen Kinderschmerztherapie aus rechtlicher Sicht : Österreichische interdisziplinäre Handlungsempfehlungen zum perioperativen Schmerzmanagement bei Kindern.