兽药使用期间稳定性研究的思考与建议

介绍了兽药使用期间稳定性试验的概念,阐述了对使用前需要重新配制和多剂量包装的制剂进行使用期间稳定性试验的重要意义,结合国外有关指导文件对药物使用期间稳定性要求及使用期间稳定性试验研究的技术要求进行了探讨,为使用期间稳定性试验的开展提供参考.     

提高我国兽用生物制品批签发管理的几点思考

简要介绍了我国兽用生物制品批签发的管理现状,就目前我国兽用生物制品批签发管理工作中存在的问题进行了分析,并从健全规章、完善管理机制、加大执法力度以及加大从业人员的培训力度等四个方面提出了提高兽用生物制品批签发管理工作水平的建议和措施。     

国家兽药产品的追踪溯源系统的建设与思考

从畜产品追溯现状和国家药品电子监管着手,分析了国家兽药产品追溯信息系统建设的必要性,介绍了追溯系统的建设目标、策略和框架,重点就兽药产品监管码的选择、赋码技术以及追踪溯源系统的业务流程进行了说明,并对国家兽药产品追溯信息系统的建设原则以及面临的机遇和挑战进行了思考,以期为兽药产品追溯体系建设提供参考。     

我国兽药产品批准文号工作中存在的问题及对策

分析了目前兽药产品批准文号工作存在的申报门槛低,企业申报数量多,兽药标准体系不完善,兽药产品标签、说明书监管困难等方面的问题及产生的原因,并提出了改进兽药产品批准文号审批工作和加强兽药监管的对策,以期为规范和加强我国兽药产品批准文号的监督管理、保证兽药质量、规范兽药市场提供参考。     

平凉市畜产品质量安全监管中的问题与对策

畜产品质量安全关系人民群众身体健康和生命安全,是重要的民生问题,也是备受关注的社会热点。我国历来高度重视畜产品质量安全监管工作,进行了一系列的探索和改革,明确提出实施食品安全战略,通过建立最严的标准、实施最严格的管理、实行最严厉的处罚,坚持最严肃的问责,保障畜产品质量安全,让人民吃得放心。畜牧兽医工作者肩负着养殖、调运、屠宰环节食用畜产品质量安全监管的重任,通过投入品监管、产地检疫、屠宰检疫以及兽药残留抽检,确保畜产品的质量安全。做为一名基层畜牧兽医工作者,通过多年的实际工作,笔者就目前市、县两级畜产品安全监管工作中存在的问题进行了分析,提出了相应的对策建议,望与各位同行共同探讨。     

Veterinary pharmacovigilance. Part 1. The legal basis in the European Union

Pharmacovigilance is a growing discipline and nowhere is this more true than in the context of the legislative requirements for veterinary pharmacovigilance within the European Union (EU), or more specifically, within the European Economic Area. Since 1995, the legislation governing the authorization of veterinary medicinal products in the EU has resulted in the older national procedures being replaced by the mutual recognition procedure and the centralized procedure. Also since 1995, the regulatory requirements for pharmacovigilance have developed and grown, as have the associated guidelines. The recent review of European veterinary medicines legislation, which concluded with the publication of an amending directive and a new regulation in March 2004, has introduced refinements to the pharmacovigilance system. This paper examines the EU legislation governing the authorization of veterinary medicinal products, including the elaboration of maximum residue limits, and the way in which this relates to the requirements of pharmacovigilance.     

Detection of bacterial contamination and DNA quantification in stored blood units in 2 veterinary hospital blood banks

Blood transfusions in veterinary medicine have become increasingly more common and are now an integral part of lifesaving and advanced treatment in small and large animals. Important risks associated with transfusion of blood products include the transmission of various infectious diseases. Several guidelines suggest what infectious agents to screen for in canine and feline transfusion medicine. However, while the risk of bacterial contamination of blood products during storage and administration has not been documented in veterinary medicine, it has emerged as a cause of morbidity and mortality in human transfusion medicine. Clinical experience shows that the majority of blood component bacterial contaminations are caused by only a few species. Unlike other types of bacteria, psychrotolerant species like Pseudomonas spp. and Serratia spp. can proliferate during the storage of blood units at 4°C from a very low titer at the time of blood collection to a clinically significant level (> 10⁵ CFU/mL) causing clinical sepsis resulting from red blood cell concentrate transfusions in human medicine. The purpose of this report was to describe the detection and quantification procedures applied in 4 cases of bacterial contamination of canine and feline blood units, which suggest the need for further investigations to optimize patients’ safety in veterinary transfusion medicine.     

The use of microbiological end-points in the safety evaluation and elaboration of maximum residue limits for veterinary drugs intended for use in food producing animals

The safety evaluation of veterinary drugs intended for use in food producing animals relies heavily on the results of toxicity studies in laboratory animals, supported where possible by any data resulting from human exposure. The general approach involves the calculation of an acceptable daily intake which in turn can be used to elaborate maximum residue limits. It is an approach used in the European Union, in other countries and at the international level. In recent years, concern has been expressed over the presence of microbiologically active residues of veterinary drugs in food and their possible effects on the human gastrointestinal microflora. Methodologies for conducting microbiological safety studies have been investigated and approaches to microbiological safety assessments have been debated. The whole approach has proved to be controversial, partly because there are considerable doubts over the ability of low concentrations of antibiotic substances to produce adverse effects on the human gut flora and partly because there are no validated methods for testing for these attributes. This paper reviews the problems in some detail and discusses the regulatory consequences.     

Statistical principles of "good clinical practice" in veterinary medicine--a position paper for planning, implementation and evaluation of empirical studies

The complexity of the design, conduct, analysis and evaluation of empirical studies necessitates a high degree of interdisciplinary collaboration in all areas of research. In order to make sure that no essential harmonisation is missed among the plenitude of processes, it has become common to provide direction on the essential operating procedures in so called "Good ... Practice" guidelines in recent years. In pharmaceutical research on human medicinal products guidelines on Good Clinical Practice have been an integral part of research and development in industry, academia, and the regulatory authorities for a long time. On the other hand, in the development and registration of pharmaceuticals for veterinary use such procedures are not yet established to this extent in Germany. Notwithstanding there being a lot of regulations on specialised subjects. This paper tries to summarise the current state of the discussion and to give an overview on the important points in the design, conduct, analysis and reporting of veterinary clinical studies mainly from an biometrical point of view.     

International harmonisation of anthelmintic efficacy guidelines (Part 2).

The "International Co-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)" is an international programme of co-operation between regulatory authorities and the animal health industries of the European Union, Japan and the United States of America which aims to harmonise the technical requirements for the registration of veterinary medicinal products. Australia and New Zealand participate as active observers. The objective of this second paper is to present additional guidelines established by the Working Group on anthelmintic guidelines: (1) efficacy of anthelmintics: specific recommendations for equine (VICH GL15), (2) efficacy of anthelmintics: specific recommendations for porcine (VICH GL16), (3) efficacy of anthelmintics: specific recommendations for canine (VICH GL19), (4) efficacy of anthelmintics: specific recommendations for feline (VICH GL20) and (5) efficacy of anthelmintics: specific recommendations for poultry (VICH GL21). These guidelines do not consist of rigid stipulations, but make clear recommendations on the minimal standards needed. To the veterinary profession, livestock producers and animal owners, harmonisation should mean quicker access to safer and more effective veterinary anthelmintics. In general, products should be relatively more affordable because of the reduction in registration costs and efficient use of resources by the regulatory authorities.     

湖北省蛋鸡养殖用药现状、存在问题与建议

为了解湖北省蛋鸡养殖情况,更好地响应和推广兽药减量化行动,对湖北省9个地市内的蛋鸡养殖场基本信息和用药情况进行调研。结果表明：近几年本省蛋鸡养殖场在饲养管理和药物使用方面有一定进步,同时也存在缺乏科学的疫病防治体系、药物使用存在风险隐患等不足,会导致产品质量安全问题。本文分析了产生原因,并提出相关建议,以促进湖北省蛋鸡养殖的科学健康发展,提升本省畜禽产品质量安全水平.     

康乐县畜产品质量安全监管中存在的问题及对策

近几年来,畜产品质量安全问题一直是社会关注的焦点,动物疫病的流行,畜产品投入品的不当使用,是造成动物源性食品安全的重要因素。因此,加强畜产品质量安全监管,对于确保畜产品消费安全,促进畜牧业和农村经济的健康发展具有十分重要的意义,本文结合康乐县畜牧兽医工作的情况,从防疫监督,疫病防控,动物检疫监督等方面分析了本县的畜产品质量安全现状,指出了影响畜产品质量安全工作的主要因素,并指出了针对性的对策及建议。     

Recommendations on vaccination for Latin American small animal practitioners: a report of the WSAVA Vaccination Guidelines Group

The World Small Animal Veterinary Association Vaccination Guidelines Group has produced global guidelines for small companion animal practitioners on best practice in canine and feline vaccination. Recognising that there are unique aspects of veterinary practice in certain geographical regions of the world, the Vaccination Guidelines Group undertook a regional project in Latin America between 2016 and 2019, culminating in the present document. The Vaccination Guidelines Group gathered scientific and demographic data during visits to Argentina, Brazil and Mexico, by discussion with national key opinion leaders, visiting veterinary practices and review of the scientific literature. A questionnaire survey was completed by 1390 veterinarians in five Latin American countries and the Vaccination Guidelines Group delivered continuing education at seven events attended by over 3500 veterinarians. The Vaccination Guidelines Group recognised numerous challenges in Latin America, for example: (1) lack of national oversight of the veterinary profession, (2) extraordinary growth in private veterinary schools of undetermined quality, (3) socioeconomic constraints on client engagement with preventive health care, (4) high regional prevalence of some key infectious diseases (e.g. feline leukaemia virus infection, canine visceral leishmaniosis), (5) almost complete lack of minimal antigen vaccine products as available in other markets, (6) relative lack of vaccine products with extended duration of immunity as available in other markets, (7) availability of vaccine products withdrawn from other markets (e.g. Giardia vaccine) or unique to Latin America (e.g. some Leishmania vaccines), (8) accessibility of vaccines directly by pet owners or breeders such that vaccination is not delivered under veterinary supervision, (9) limited availability of continuing education in veterinary vaccinology and lack of compulsion for continuing professional development and (10) limited peer-reviewed published scientific data on small companion animal infectious diseases (with the exception of leishmaniosis) and lack of support for such academic research. In this document, the Vaccination Guidelines Group summarises the findings of this project and assesses in evidence-based fashion the scientific literature pertaining to companion animal vaccine-preventable diseases in Latin America. The Vaccination Guidelines Group makes some recommendations on undergraduate and postgraduate education and academic research. Recognising that current product availability in Latin America does not permit veterinarians in these countries to vaccinate according to the global World Small Animal Veterinary Association guidelines, the Vaccination Guidelines Group makes a series of “pragmatic” recommendations as to what might be currently achievable, and a series of “aspirational” recommendations as to what might be desirable for the future. The concept of “vaccine husbandry” is addressed via some simple guidelines for the management of vaccine products in the practice. Finally, the Vaccination Guidelines Group emphasises the global trend towards delivery of vaccination as one part of an “annual health check” or “health care plan” that reviews holistically the preventive health care needs of the individual pet animal. Latin American practitioners should transition towards these important new practices that are now well embedded in more developed veterinary markets. The document also includes 70 frequently asked questions and their answers; these were posed to the Vaccination Guidelines Group during our continuing education events and small group discussions and should address many of the issues surrounding delivery of vaccination in the Latin American countries. Spanish and Portuguese translations of this document will be made freely available from the on-line resource pages of the Vaccination Guidelines Group.     

Veterinary pharmacovigilance. Part 4. Adverse reactions in humans to veterinary medicinal products

Although seemingly rare, adverse reactions to veterinary products do occur. These may arise from inadvertent exposure during use or as a result of occupational accidents. They are often mild in nature and include adverse effects such as minor skin reactions. However, more serious reactions may occur, and they are not restricted to the effects of the veterinary medicines themselves. For example, high-pressure injection injuries may occur as a result of accidents occurring during animal vaccination operations. This paper reviews some of these events, mentions where appropriate the regulatory actions taken, and describes some of the measures used to minimise such effects in the future, and serves to bring the issues discussed here to the attention of pharmacologists, pharmacoepidemiologists and others who train those who use veterinary medicinal products.     

畜产品中兽药残留原因及危害

在畜禽饲养管理过程中使用违禁药物或滥用药物,使用饲料添加剂或超量用药,不遵守休药期规定等均可引起畜产品兽药残留。同时饲养环境遭到污染也能致使药物残留,并且我国关于食品安全的法律法规不健全、监管力度不够等,致使畜产品中药物残留问题更加严重。人体摄入存在药物残留的食品后,不仅会引起急性、慢性或蓄积性中毒,还会致使机体细菌产生耐药性,甚至污染整个生活环境等。     

核酸适体在乳及乳制品检测中的应用

核酸适体技术是新型检测技术，因其特异性、高亲和性、快速、低成本等众多优点被广泛应用于乳及乳制品等动物源食品安全检测领域。本文对核酸适体筛选技术的原理和类别进行介绍，并对其在乳及乳制品中添加剂、激素、抗生素残留、真菌毒素、病原微生物污染检测等方面的应用和研究进展进行综述。     

标准物质在兽医生物制品质量控制中的应用状况分析

探讨了兽医生物制品标准物质的概念及其在生物制品质量控制中的应用状况,分析了我国现阶段兽医生物制品标准物质供应和使用中存在的问题。建议进一步明确有关概念,形成共识,建立科学的兽医生物制品标准体系,分清各有关单位在标准物质供应工作中的责任,努力形成合力共同推进我国兽医生物制品标准物质工作进步。     

Approaches in the safety evaluations of veterinary antimicrobial agents in food to determine the effects on the human intestinal microflora

The administration of antimicrobial agents to livestock creates potential for antibiotic residues to enter the food supply and be consumed by humans. Therefore, as a process of food animal drug registration, national regulatory agencies and international committees evaluate data regarding the chemical, microbiologic, pharmacokinetic, pharmacodynamic, pharmacologic, toxicologic, and antimicrobial properties of veterinary drugs to assess the safety of ingested antimicrobial residues to consumers. Currently, European, Australian and United States guidelines for veterinary drug registration require a safety assessment of microbiologic hazards from consumption of antimicrobial residues taking into account the potentially adverse effects on human intestinal microflora. The main concerns addressed are selection of resistant bacteria in the gastrointestinal tract and disruption of the colonization barrier of the resident intestinal microflora. Current requirements differ among national agencies. Efforts are ongoing internationally to review and harmonize approaches and test methods and protocols for application to these microbiologic safety evaluations of antimicrobial drug residues in food. This review describes the background to current regulatory approaches used in applying in vitro and in vivo methods to set a microbiologic acceptable daily intake for residues in food derived from animals treated with an antimicrobial agent. This paper also examines the current research needs to support these evaluations.     

科学规避兽药残留风险的对策措施

笔者对2013?2020年实施的畜产品质量安全监测项目进行多环节系统分析,揭示了主要短板和风险,建议因势利导科学规避兽药残留风险,多策发力提高区域性畜产品质量安全的总体水平。     

畜产品质量安全问题及对策

畜产品是十分重要的营养来源,是人类生存的物质基础。近年来,在世界范围内出现了许多畜产品质量安全问题,威胁到人类的安全。从药物残留、农药及重金属残留、加工运输过程污染及质量监督体系不健全4个方面总结了我国畜产品品质安全存在的问题,并提出提高畜产品质量安全的对策。