title: [Patient education responsibility, specialty and administration information from the internal medicine viewpoint].
abstract: Drug therapy requires both the thorough education of the patient by the physician and the patient's consent. The contents of the patient education should be based on the urgency of drug therapy, the patient's educational background, and his level of knowledge. Besides the instructions and explanations given to medicine users by physicians or pharmacists, the written patient information leaflet represents the main source of information. The objectives of the written information concerning a pharmaceutical product are to provide patients with clear information about the drug and, thus, to improve the drug compliance. Guidelines of the European Community (EC) for the writing of drug information leaflets (guideline 92/27) will hopefully lead to a more consumer-oriented drug information. The data sheet should give medical specialists the detailed information needed to safely use the drug. The note for guidance "Summary of Product Characteristics", recently proposed by the CPMP (Committee for Proprietary Medicinal Products) of the EC, provides detailed instructions on how to present drug information.
authors.affiliation: Robert-Rössle-Klinik, Abteilung für Hämatologie, Medizinische Fakultät Charité, Humboldt-Universität zu Berlin.
authors.forename: W D
authors.initials: WD
authors.lastname: Ludwig
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000331:legislation & jurisprudence; D004346:Drug Information Services / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D004358:Drug Therapy; D064420:Drug-Related Side Effects and Adverse Reactions; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007388:Internal Medicine; D010353:Patient Education as Topic / Q000331:legislation & jurisprudence*; D017410:Practice Guidelines as Topic
vernacular_title: Aufklärungspflicht, Fach- und Gebrauchsinformationen aus ärztlich-internistischer Sicht.