[Off label use of analgesics in pediatric perioperative pain

Der Schmerz · Feb 2014

Practice Guideline

[Off label use of analgesics in pediatric perioperative pain therapy from a legal perspective : Austrian interdisciplinary recommendations on pediatric perioperative pain management].

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. ⋯ 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".

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- M Mayrhofer and Österreichischen Gesellschaft für Anästhesiologie, Reanimation und Intensivmedizin (ÖGARI).
- Abteilung für Technikrecht, Institut für Verwaltungsrecht und Verwaltungslehre, Johannes Kepler Universität Linz, Altenbergerstr. 69, 4040, Linz, Österreich, michael.mayrhofer@jku.at.
- Schmerz. 2014 Feb 1;28(1):65-6.
AbstractPharmaceuticals 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".

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[Off label use of analgesics in pediatric perioperative pain therapy from a legal perspective : Austrian interdisciplinary recommendations on pediatric perioperative pain management].

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