title: [Off-label prescription of drugs in the statutory health insurance].
abstract: Prescribing a medication for a condition not described in the label approved by national and international regulatory bodies (in Europe the EMEA, European Medicines Agency) is a medical necessity recognised by law. In many clinical fields, studies allowing approval of drugs are lacking. Nonetheless doctors are obliged to prescribe off-label medication in certain situations. In this tension of conflicting interests, knowledge of the applicable standards is essential. Due to the various aspects concerning social and drug law, civil and even criminal law on the one hand and requirements for therapy and diagnostic guidelines and criteria set by evidence-based medicine on the other, the subject matter becomes complex and intricate. The legal and medical facts are described and practical advice is presented for dealing with the issue in hospital and general practice.
authors.affiliation: Medizinischer Dienst der Krankenversicherung Bayern, BZ Nürnberg. harald.niederauer@mdk-bayern.de
authors.forename: H H
authors.initials: HH
authors.lastname: Niederauer
mesh_terms: D005060:Europe; D006801:Humans; D009313:National Health Programs / Q000331:legislation & jurisprudence*; D056687:Off-Label Use / Q000331:legislation & jurisprudence*; D010817:Physician-Patient Relations; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence*