title: ["Off label" use of some medicinal products. Part I].
abstract: The review is devoted to the complex drug administrating process and the process of making decisions, both affected by the country official regulations, the established guidelines for good clinical practice and last but not least--the knowledge and discretion of the individual physician prescribing a medicine. The publication gives emphasis on the "off label use"--the practice of prescribing pharmaceuticals for an unapproved by official drug institutions indications or in an unapproved age group, unapproved dose or unapproved form of administration. Numerous cases of widespread and even routine practice of "off label use" made for the benefit of the patients are presented. Details of current drug regulations in Bulgaria are provided. Examples of drug prescriptions are drawn for indications other than those specified in the marketing authorization certificate, showing the gap between the established practices, the professionals opinions and the regulators delayed reactions, influenced by the policies of the pharmaceutical industry.
authors.forename: M
authors.initials: M
authors.lastname: Sirakov
mesh_terms: D002031:Bulgaria; D004363:Drug Utilization / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence; D006801:Humans; D040541:Marketing; D056687:Off-Label Use / Q000331:legislation & jurisprudence