Kordus Katarzyna, Spiewak Radosław
Przegl Lek. 2015;72(1):38-41.
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?
波兰医生受法律约束，必须根据注册文件，包括产品特性摘要（SPC），开具有波兰共和国销售授权的药物。所谓的“超说明书”治疗发生在处方与SPC中包含的信息冲突的情况下，这可能被视为一种“医学实验”。在发生药物不良反应的情况下，这种分类排除了上市许可持有人的责任，损害赔偿也不在强制性第三方保险范围内，这可能给医生带来财务和法律后果。与符合SPC的处方的偏差可能包括不同的给药方式、在没有规定药物剂量的患者中符合适应症的给药，或者在SPC中未包含的适应症的情况下给药。具有等效活性成分、剂型和剂量的药品在SPC中可能有不同的注册适应症，药剂师积极推广使用较便宜的替代品，可能会违背医生的意愿，导致使用不符合替代药物注册规定的药物。对于没有注册药品的“罕见病”的药物治疗，也成为一个重要问题，因为这迫使医生进行“超说明书”处方。此外，在大多数情况下，药品报销仅限于根据注册适应症开具的药品。医疗专业人员关于使药物处方和报销取决于活性药物成分和疗效证据，以及引入疾病治疗的循证医学（EBM）标准的请求，没有得到管理机构的适当关注。因此，一个基本问题仍然没有答案：医生治疗决策的主要依据应该是什么：伦理、良知、最新科学证据还是法律和行政法规？
