Cremer-Schaeffer Peter, Knöss Werner, Broich Karl
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
Schmerz. 2019 Oct;33(5):378-383. doi: 10.1007/s00482-019-0387-x.
The law on the amendment of the narcotics law and other regulations, which was accepted by consensus by the German Parliament, significantly expanded the options for the use of cannabis-based medicinal products. In individual cases, already approved cannabis-based medicinal products can also be prescribed outside the approved indication at the expense of the statutory health insurance funds (GKV). The cost of treatment with cannabis flowers and extracts as well as dronabinol, which are not approved under the drug law, will also be covered by the GKV upon application. Physicians must advise their patients on the options of treatment with cannabis-based medicinal products and support them in applying for reimbursement. The prescription of unauthorized medical cannabis products poses particular challenges, as there is no summary of product characteristics that is mandatory for authorized finished products. In addition, physicians are obliged to participate in an accompanying survey. To this end, they must send data to the Federal Institute for Drugs and Medical Devices providing information about treatment with cannabis-based medicinal products. When prescribing medical cannabis products as defined in the Act of 6 March 2017 amending the law on narcotic drugs and other regulations, physicians assume a special responsibility that goes far beyond the responsibility for the use of authorized finished medicinal products.
德国议会一致通过的关于麻醉品法及其他法规修正案的法律，显著扩大了基于大麻的药用产品的使用选择。在个别情况下，已获批的基于大麻的药用产品也可在获批适应症以外开具处方，费用由法定医疗保险基金（GKV）承担。根据申请，药品法未批准的大麻花、提取物以及屈大麻酚的治疗费用也将由GKV支付。医生必须就基于大麻的药用产品的治疗选择向患者提供建议，并协助他们申请报销。开具未经授权的医用大麻产品处方带来了特殊挑战，因为对于已获授权的成品药而言，不存在强制要求的产品特性概述。此外，医生有义务参与一项配套调查。为此，他们必须向联邦药品和医疗器械研究所发送数据，提供有关基于大麻的药用产品治疗的信息。在开具2017年3月6日修订麻醉药品法及其他法规的法案中所定义的医用大麻产品时，医生承担着一项特殊责任，这一责任远远超出了对已获授权的成品药用产品使用的责任。
