title: [Physician versus 'off-label" ordinance].
abstract: Polish physicians are obliged by legislation to prescribe drugs authorized for the sale in the Republic of Poland, based on registration documentation, including the Summaries of Product Characteristics (SPC). So called 'off label' treatment occurs in case of the conflict between prescription and information contained in the SPC, which may be considered as a 'medical experiment'. In case of adverse drug reactions, such classification excludes the responsibility of the marketing authorization holders, and damages are not covered by obligatory third party insurance, which can pose financial and legal consequences to the doctor. Deviations from SPC-compliant prescription may include a different way of drug administration, drug administration compliant with the indications yet in patients for whom there is no specified drug dosage, or in case of an indication not contained in the SPC. Medicinal products with equivalent active component, form and dose can have different registration indications in the SPC, and the actively promoted dispensation of less expensive substitutes by the pharmacists may, against doctor's will, result in the use that is non-compliant with registration of the substitute drug. Pharmacotherapy of 'orphan diseases', for which there are no registered medicinal products, also becomes an essential issue as it forces doctors into 'off-label' prescriptions. Moreover, the reimbursement of drugs in most cases is limited to medicinal products that are prescribed according to the registration indications. The pleas by medical professionals to make ordination and reimbursement of drugs depend on active pharmaceutical ingredient and evidence of efficacy, as well as to introduce Evidence Based Medicine (EBM) standards for the treatment of diseases, did not receive proper attention from the governing bodies. Therefore, a fundamental question remains unanswered as to what should be the principal gauge for physicians' therapeutic decision: the ethics, conscience, recent scientific evidence or legal and administrative regulations?
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Kordus
authors.forename: Radosław
authors.initials: R
authors.lastname: Spiewak
mesh_terms: D011307:Drug Prescriptions / Q000592:standards*; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D007349:Insurance, Health, Reimbursement; D007880:Legislation, Drug; D056687:Off-Label Use / Q000191:economics / Q000331:legislation & jurisprudence*; D010819:Physician's Role; D011044:Poland