Antimicrobial drugs in livestock farming are not used for therapeutic purposes, only, but also to conceal deficiencies in animal husbandry and management. Use of antibiotic drugs should be restricted by specific regulations, since some veterinarians seem to have an interest in increasing their income by treatment of diseases instead of performing health management. The above-mentioned requirements have been fulfilled by section 56 a (2) of German Pharmaceuticals Act, which regulates the usage and dispensary of pharmaceuticals according to the current standards of veterinary science. These current standards of veterinary science are described by common scientific positions and specific opinions of certain relevant committees. There is no single institutional committee available at present. Therefore, members of the German Federal Chamber of Veterinarians and members of the Committees of the German Federal States, which are responsible for the compliance with regulations and acts, defined a common position on current standards of veterinary science, concerning correct treatment with antibiotic drugs within a Working Group of the Federal States for Veterinary Pharmaceuticals (former ArgeVet, now AG TAM), the so-called "antibiotic guidelines". These antibiotic guidelines should help veterinary practitioners to use and prescribe those substances only, which are accurate for treatment of the diagnosed disease concerning the used class of antibiotic, amount, and duration of usage. The responsible authorities have to proof the prudent and proper use of antibiotic drugs in the range of their surveillance. The surveillance by the authorities is complicated, since the burden of proof of improper usage of antimicrobial drugs lies within the responsibility of the authorities. Prevention can primarily be conducted by informing the responsible veterinarians of the proper forms of treatment and by strict regulations for registration of pharmacologically active substances. Every additional label use and the usage of existing old registrations may undermine the surveillance of improper usage of pharmacologically active substances in livestock animals. The responsible authorities of the German Federal States, which may vary in their organization among the states, have to administrate the following duties: (1) Surveillance of manufacture and distribution of pharmaceuticals. (2) Inspection and control of proper usage of pharmaceuticals. Thus, the surveillance of distribution of veterinary pharmaceuticals has a broader range of requirements in comparison to surveillance of human pharmaceuticals. It is necessary to record and to control the amount of used drugs as well as their ways of distribution to perform a sufficient surveillance. The legal authorization was created by the 11th Amendment of the German Pharmaceuticals Act, but these specifications are still too imprecise to support the surveillance in the current process. Hence, the actual surveillance process is more focussed on usage and dispensary of pharmaceuticals and less focussed on manufacture and distribution. Therefore, the current surveillance with the aim to limit unnecessary usage of pharmacologically active substances according to the current legislation is limited. It is necessary to change legislation with regard to control of distribution of pharmaceuticals as well as integration of self-control of livestock owners for a sustainable increase of efficacy.

译文

:畜牧业中使用的抗菌药物不仅用于治疗目的,而且还可以掩盖畜牧业和管理方面的不足。抗生素的使用应受到特定法规的限制,因为一些兽医似乎有兴趣通过治疗疾病而不是进行健康管理来增加收入。上述要求已通过《德国药品法》第56a(2)节得到满足,该节根据当前的兽医科学标准对药品的使用和分配进行了规范。这些现行的兽医科学标准由共同的科学立场和某些相关委员会的特定见解来描述。目前没有单一的机构委员会。因此,负责遵守法规和行为的德国联邦兽医商会成员和德国联邦国家委员会的成员,在当前兽医科学标准中就使用正确的抗生素治疗产生了共同的立场。联邦兽药国家工作小组(前ArgeVet,现为AG TAM),即所谓的“抗生素指南”。这些抗生素指南应帮助兽医从业人员仅使用和开处方那些对于所诊断疾病的治疗准确无误的物质,涉及所使用的抗生素种类,用量和使用期限。主管当局必须在其监视范围内证明对抗生素药物的审慎和正确使用。当局的监督十分复杂,因为证明不当使用抗菌药物的举证责任在当局的责任之内。预防主要可以通过向负责的兽医告知适当的治疗方式以及严格的药理活性物质注册规定来进行。每增加一次标签使用和使用现有的旧注册信息,可能会破坏对家畜动物药理活性物质使用不当的监视。德国联邦各州的主管当局(在各州之间的组织可能有所不同)必须执行以下职责:(1)药品生产和分销的监督。 (2)检查和控制药品的合理使用。因此,与对人类药品的监视相比,对兽药分布的监视具有更广泛的要求。有必要记录和控制使用过的药物的数量及其分配方式,以进行充分的监视。法律授权是由《德国药品法》第11条修正案创建的,但是这些规范仍然不够精确,无法支持当前流程中的监视。因此,实际的监视过程更多地侧重于药品的使用和分配,而较少侧重于制造和分销。因此,旨在限制根据现行法规不必要地使用药理活性物质的当前监视受到限制。有必要改变有关药物分配控制以及牲畜所有者自我控制整合的立法,以实现效力的可持续增长。

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