title: Patient information on drug therapy. A problem of medical malpractice law: between product safety and user safety.
abstract: Medicinal products are associated with risks as well as potential therapeutic benefits. This is reflected by the legal requirements for patient information on drug therapy which can be differentiated into general product information, regulated by pharmaceutical (i. e. product safety) law, and individual patient information on the treatment with the product, which is subject to medical malpractice law. The physician's duty to inform the patient comprises therapeutic information as well as information required for informed consent. Therapeutic information intends to empower the patient to comply with the requirements of treatment and to protect him/her against preventable danger and risk; it is part of the medical treatment, aimed at the individual patient and his/her personal situation. Information required for informed consent enables the patient to a self-determined decision on the treatment offered; it can be divided into information on the course of treatment and risk information. Product information and treatment information complement each other; the former should be the basis of individual information on the concrete treatment, provided by the physician in a mandatory oral conversation with the patient. Product information cannot replace the physician's individual information about the treatment.
authors.affiliation: Institute for Health Law and Medical Law, University of Bremen.
authors.forename: Dieter
authors.initials: D
authors.lastname: Hart
mesh_terms: D003257:Consumer Product Safety; D004348:Drug Labeling; D004358:Drug Therapy; D005062:European Union; D006801:Humans; D007258:Informed Consent; D008318:Malpractice / Q000331:legislation & jurisprudence*; D010353:Patient Education as Topic