title: [Off-label therapy: current problems from the perspective of the Pharmaceutical Commission of the German Medical Profession].
abstract: The off-label use of approved pharmaceuticals outside the authorized status is implemented in pharmacotherapy of many diseases, especially for rare diseases and in cases of therapy resistance. The German regulations are presented and analyzed and the relative literature is discussed.
authors.affiliation: info@rwcjanzen.de
authors.forename: R W C
authors.initials: RW
authors.lastname: Janzen
authors.forename: W D
authors.initials: WD
authors.lastname: Ludwig
mesh_terms: D000328:Adult; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D000068258:Bevacizumab; D002648:Child; D003362:Cost-Benefit Analysis / Q000191:economics / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004351:Drug Resistance; D019317:Evidence-Based Medicine / Q000191:economics / Q000331:legislation & jurisprudence; D005858:Germany; D019983:Guideline Adherence / Q000191:economics / Q000331:legislation & jurisprudence; D006801:Humans; D007356:Insurance, Pharmaceutical Services / Q000191:economics* / Q000331:legislation & jurisprudence*; D009313:National Health Programs / Q000191:economics* / Q000331:legislation & jurisprudence*; D056687:Off-Label Use / Q000191:economics* / Q000331:legislation & jurisprudence*; D009965:Orphan Drug Production / Q000191:economics / Q000331:legislation & jurisprudence; D010819:Physician's Role; D000069579:Ranibizumab; D035583:Rare Diseases / Q000188:drug therapy* / Q000191:economics; D012051:Reimbursement Mechanisms / Q000191:economics* / Q000331:legislation & jurisprudence*; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D000069579:Ranibizumab