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预防与监测:德国联邦州的任务

Prevention and monitoring: tasks of the federal states in Germany.

作者信息

Bottermann Heinrich

机构信息

Ministry of the Environment, Conservation, Agriculture, and Consumer Protection of North Rhine-Westphalia (MUNLV), Düsseldorf, Germany.

出版信息

Int J Med Microbiol. 2006 Jun;296 Suppl 41:25-8. doi: 10.1016/j.ijmm.2006.01.057.

Abstract

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.

摘要

畜牧业中使用抗菌药物并非仅用于治疗目的,还用于掩盖畜牧养殖和管理方面的不足。抗生素药物的使用应受到特定法规的限制,因为一些兽医似乎热衷于通过治疗疾病而非进行健康管理来增加收入。德国《药品法》第56 a (2)条满足了上述要求,该条款根据当前兽医学标准对药品的使用和配药进行规范。这些当前的兽医学标准由共同的科学立场和某些相关委员会的特定意见来描述。目前没有单一的机构委员会。因此,德国联邦兽医协会成员以及负责遵守法规和法案的德国联邦各州委员会成员,在联邦各州兽药工作组(前身为ArgeVet,现为AG TAM)中就兽医学当前标准,特别是关于抗生素药物的正确治疗,确定了一个共同立场,即所谓的“抗生素指南”。这些抗生素指南应帮助兽医从业者仅使用那些在抗生素类别、用量和使用时长方面对所诊断疾病的治疗准确有效的药物。主管当局必须在其监管范围内证明抗生素药物的谨慎和正确使用。当局的监管很复杂,因为抗菌药物不当使用的举证责任在于当局。预防主要可以通过告知负责的兽医正确的治疗方式以及严格规范药理活性物质的注册来进行。每一项额外的标签使用以及现有旧注册的使用都可能破坏对家畜药理活性物质不当使用的监管。德国联邦各州的主管当局,其组织形式在各州可能有所不同,必须履行以下职责:(1) 对药品生产和分销的监管。(2) 对药品正确使用的检查和控制。因此,与人类药品监管相比,兽药分销监管有更广泛的要求。有必要记录和控制所用药物的数量及其分销方式,以进行充分的监管。法律授权是由德国《药品法》第11次修订创建的,但这些规定仍不够精确,无法支持当前流程中的监管。因此,实际的监管过程更多地集中在药品的使用和配药上,而较少关注生产和分销。所以,目前旨在根据现行立法限制药理活性物质不必要使用的监管是有限的。有必要在药品分销控制以及将家畜所有者的自我控制纳入方面修改立法,以实现监管效力的可持续提高。

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