Anatomy of a recall

Pet foods on the market that are contaminated or otherwise present a health risk to humans or animals may be subject to a recall under US Food and Drug Administration (FDA) regulations. Legally, all recalls are "voluntary," but there is little incentive for companies to refuse a request by FDA to conduct a recall. While the firm does the bulk of the work, FDA oversees all aspects of a recall to help ensure that violative product is swiftly removed from the market. A recent new federal law will require FDA to improve its abilities to detect outbreaks of pet food-borne illness, respond to a contamination incident, and communicate with industry and the public on the matter of recalls. Veterinarians play a key role in detecting and reporting pet food-borne illness.     

Antimicrobial drug use in veterinary medicine

Recognizing the importance of antimicrobial resistance and the need for veterinarians to aid in efforts for maintaining the usefulness of antimicrobial drugs in animals and humans, the Board of Regents of the American College of Veterinary Internal Medicine charged a special committee with responsibility for drafting this position statement regarding antimicrobial drug use in veterinary medicine. The Committee believes that veterinarians are obligated to balance the well-being of animals under their care with the protection of other animals and public health. Therefore, if an animal's medical condition can be reasonably expected to improve as a result of treatment with antimicrobial drugs, and the animal is under a veterinarian's care with an appropriate veterinarian-client-patient relationship, veterinarians have an obligation to offer antimicrobial treatment as a therapeutic option. Veterinarians also have an obligation to actively promote disease prevention efforts, to treat as conservatively as possible, and to explain the potential consequences associated with antimicrobial treatment to animal owners and managers, including the possibility of promoting selection of resistant bacteria. However, the consequences of losing usefulness of an antimicrobial drug that is used as a last resort in humans or animals with resistant bacterial infections might be unacceptable from a public or population health perspective. Veterinarians could therefore face the difficult choice of treating animals with a drug that is less likely to be successful, possibly resulting in prolonged or exacerbated morbidity, to protect the good of society. The Committee recommends that voluntary actions be taken by the veterinary profession to promote conservative use of antimicrobial drugs to minimize the potential adverse effects on animal or human health. The veterinary profession must work to educate all veterinarians about issues related to conservative antimicrobial drug use and antimicrobial resistance so that each individual is better able to balance ethical obligations regarding the perceived benefit to their patients versus the perceived risk to public health. Specific means by which the veterinary profession can promote stewardship of this valuable resource are presented and discussed in this document.     

Spread of resistant bacteria and resistance genes from animals to humans--the public health consequences

The paper reviews the lines of evidence which link the use of antimicrobial drugs for food animals with the emergence of antimicrobial drug resistance in bacteria pathogenic to humans, with a particular focus on the public health aspects. Deductions from the epidemiology of food-borne infections, ecological studies, outbreak investigations, typing studies and direct epidemiological observations show that resistant bacteria are transferred from food animals to man. In addition to transfer in the food chain, exchange of mobile genetic elements among commensal and pathogenic bacteria contributes to the emergence of drug resistance. There is growing evidence that this has measurable consequences for human public health. One consequence is increased transmission supported by unrelated use of anti-microbials in humans. Other consequences are related to reduced efficacy of early empirical treatment, limitations in the choices for treatment after confirmed microbiological diagnosis, and finally a possible coselection of virulence traits. Recent epidemiological studies have measured these consequences in terms of excess mortality associated with resistance, increased duration of illness, and increased risk of invasive illness or hospitalization following infections with resistant Salmonella.     

The management of risk arising from the use of antimicrobial agents in veterinary medicine in EU/EEA countries – a review

Antimicrobials are essential medicines for the treatment of many microbial infections in humans and animals. Only a small number of antimicrobial agents with new mechanisms of action have been authorized in recent years for use in either humans or animals. Antimicrobial resistance (AMR) arising from the use of antimicrobial agents in veterinary medicine is a concern for public health due to the detection of increasing levels of resistance in foodborne zoonotic bacteria, particularly gram‐negative bacteria, and due to the detection of determinants of resistance such as Extended‐spectrum beta‐lactamases (ESBL) in bacteria from animals and in foodstuffs of animal origin. The importance and the extent of the emergence and spread of AMR from animals to humans has yet to be quantified. Likewise, the relative contribution that the use of antimicrobial agents in animals makes to the overall risk to human from AMR is currently a subject of debate that can only be resolved through further research. Nevertheless, risk managers have agreed that the impact on public health of the use of antimicrobials in animals should be minimized as far as possible and a variety of measures have been introduced by different authorities in the EU to achieve this objective. This article reviews a range of measures that have been implemented within European countries to reduce the occurrence and the risk of transmission of AMR to humans following the use of antimicrobial agents in animals and briefly describes some of the alternatives to the use of antimicrobial agents that are being developed.     

"抗菌新兽药对与人类健康相关细菌微生物学影响的安全性评价"指导原则简介

在食品动物使用抗菌药,可能导致耐药菌产生,耐药菌在人畜间的传递导致产生交叉耐药性.FDA对此制定了安全性评价指导原则.本文简要介绍了抗菌新兽药对与人类健康相关细菌微生物学影响的安全性评价指导原则.该指导原则主要内容包括:释放评价、暴露评价、后果评价、危险评估及危险管理措施制定等.毫无疑问,这一指导原则对我国抗菌新兽药管理和食品安全管理会有所启迪.     

欧盟兽用抗菌药耐药性管理概述

介绍负责管理欧盟兽用抗菌药耐药性的欧洲药品局下设的兽用药品委员会、健康与消费者保护司和食品安全局等相关管理机构以及成立耐药性管理工作组、进行耐药性风险分析、制定相关文件和实施耐药性监测等的管理措施,为我国兽药耐药性相关政策的制定和措施的实行提供参考.     

Legal implications of the extra-label use of drugs in food animals

Although the Food and Drug Administration has never sanctioned the extra-label use of drugs in animals, it has not, until recently, objected when veterinarians deviated from label instructions as long as such use did not result in violative residues in food products derived from treated animals. However, because of the potential human health hazards associated with abuse of this position, the FDA has developed a less lenient policy toward the extra-label use of drugs in food animals. A brief review of the legislated responsibility and authority of the FDA with particular reference to the extra-label use of drugs in food animals is provided. Emphasis is placed on how anesthetics and anesthesia adjuncts in food animals can pose human health hazards.     

我国动物源细菌耐药状况、存在问题和对策

动物源细菌耐药性问题不仅关系到动物的用药安全,也与公共卫生安全密切相关,日益引起各国的关注。中国兽医药品监察所从事动物源细菌耐药性检测工作10余年,对我国动物源细菌的耐药性状况进行了系统的调查。本文从动物源细菌耐药性监测工作的重要性、我国动物源细菌的耐药性状况、存在的问题以及应对策略四个方面进行了综述,以期对我国的动物源细菌耐药性监测工作起一定的参考作用。     

Health council report: "Antimicrobial growth promoters"

The Health Council of the Netherlands has issued a report on the risk of development of resistance among bacteria as result of the use of antibiotics as growth promotors in livestock farming. The committee appointed by the Health Council conclude that the use of antimicrobial growth promotors contributes to the problem of resistance among human pathogens. The conclusions are based on evidence regarding the development of resistance in livestock as the result of the use of antimicrobial growth promotors, the possibility of colonisation/infection of humans with resistant bacteria from the intestinal flora of productive livestock, and the transfer of resistance genes from livestock bacteria to human pathogenic microorganisms. Effective measures for the limitation of the public health risk should focus on termination of the use of antimicrobial growth promotors that confer resistance to (related) antibiotics currently used (or which will be available) to treat patients suffering from bacterial infections. In addition, the committee advised ending the use of antimicrobial growth promotors in 3 years.     

Public health and policy

Antimicrobial agent usage data are essential for focusing efforts to reduce misuse and overuse of antimicrobial agents in food producing animals because these practices may select for resistance in bacteria of animals. Transfer of resistant bacteria from animals to humans can lead to human infection caused by resistant pathogens. Resistant infections can lead to treatment failures, resulting in prolonged or more severe illness. Multiple World Health Organization (WHO) reports have concluded that both antimicrobial resistance and antimicrobial usage should be monitored on the national level. The system for collecting antimicrobial usage data should be clear and transparent to facilitate trend analysis and comparison within and among countries. Therapeutic, prophylactic and growth promotion use should be recorded, along with route of administration and animal species and/or production class treated. The usage data should be compared to resistance data, and the comparison should be made available in a timely manner. In the United States, surveillance of antimicrobial resistance in foodborne bacteria is performed by the National Antimicrobial Resistance Monitoring System (NARMS) for enteric bacteria, however, the United States still lacks a mechanism for collecting antimicrobial usage data. Combined with antimicrobial resistance information from NARMS, antimicrobial usage data will help to direct education efforts and policy decisions, minimizing the risk that people will develop antimicrobial resistant infections as a result of eating food of animal origin. Ultimately mitigation strategies guided by usage data will be more effective in maintaining antimicrobial drugs for appropriate veterinary use and in protecting human health.     

Monitoring of antimicrobial resistance among food animals: principles and limitations

Large amounts of antimicrobial agents are in the production of food animals used for therapy and prophylactics of bacterial infections and in feed to promote growth. The use of antimicrobial agents causes problems in the therapy of infections through the selection for resistance among bacteria pathogenic for animals or humans. Current knowledge regarding the occurrence of antimicrobial resistance in food animals, the quantitative impact of the use of different antimicrobial agents on selection for resistance and the most appropriate treatment regimes to limit the development of resistance is incomplete. Programmes monitoring the occurrence and development of resistance are essential to determine the most important areas for intervention and to monitor the effects of interventions. When designing a monitoring programme it is important to decide on the purpose of the programme. Thus, there are major differences between programmes designed to detect changes in a national population, individual herds or groups of animals. In addition, programmes have to be designed differently according to whether the aim is to determine changes in resistance for all antimicrobial agents or only the antimicrobial agents considered most important in relation to treatment of humans. In 1995 a continuous surveillance for antimicrobial resistance among bacteria isolated from food animals was established in Denmark. Three categories of bacteria, indicator bacteria, zoonotic bacteria and animal pathogens are continuously isolated from broilers, cattle and pigs and tested for susceptibility to antimicrobial agents used for therapy and growth promotion by disc diffusion or minimal inhibitory concentration determinations. This programme will only detect changes on a national level. However, isolating the bacteria and testing for several antimicrobial agents will enable us to determine the effect of linkage of resistance. Since 1995 major differences in the consumption pattern of different antimicrobial agents have occurred in Denmark. The Danish monitoring programme has enabled us to determine the effect of these changes on the occurrence of resistance. The Danish monitoring is, however, not suited to determine changes on a herd level or to detect emergence of new types of resistance only occurring at a low level.     

ACVIM Consensus Statement on Therapeutic Antimicrobial Use in Animals and Antimicrobial Resistance

The epidemic of antimicrobial resistant infections continues to challenge, compromising animal care, complicating food animal production and posing zoonotic disease risks. While the overall role of therapeutic antimicrobial use in animals in the development AMR in animal and human pathogens is poorly defined, veterinarians must consider the impacts of antimicrobial use in animal and take steps to optimize antimicrobial use, so as to maximize the health benefits to animals while minimizing the likelihood of antimicrobial resistance and other adverse effects. This consensus statement aims to provide guidance on the therapeutic use of antimicrobials in animals, balancing the need for effective therapy with minimizing development of antimicrobial resistance in bacteria from animals and humans.     

Responsibilities of animal scientists and drug sponsors when conducting research with investigational new animal drugs

The Center for Veterinary Medicine of the Food and Drug Administration (FDA) is charged with implementing the Federal Food, Drug and Cosmetic Act as it pertains to animal drugs and food additives. Title 21 of the Code of Federal Register Part 500 contains the regulations promogulated by the FDA as it implements this Act. Investigational New Animal Drug (INAD) applications provide for the shipment of experimental drugs and provide for the establishment of reconditioning procedures so edible products from research animals may be used for food. The record-keeping requirements for holders of INAD and for researchers are described. Protocol development and importation of investigational new animal drugs are discussed.     

产气荚膜梭菌及其公共卫生危害

产气荚膜梭菌(C. perfringens)在自然界广泛分布,在鸡、鸭、猪、牛等食源动物中均普遍流行。生肉及其制品在加工过程中可能被产气荚膜梭菌污染而引起人的食源性腹泻,而且越来越多的证据表明产气荚膜梭菌出现了多种耐药性,因此控制产气荚膜梭菌污染具有重要的公共卫生意义。本文从该病流行、毒素、耐药基因、屠宰零售及食品污染风险等各环节进行梳理,分析该病引起的公共卫生危害,并提出了相关的控制建议。     

Antimicrobial resistance in bacteria from food-producing animals. risk management tools and strategies

The application of antimicrobial agents has proved to be the main risk factor for development, selection and spread of antimicrobial resistance. This link applies to the use of antimicrobial agents in human and in veterinary medicine. Furthermore, antimicrobial-resistant bacteria and resistant genes can be transmitted from animals to humans either by direct contact or via the food chain. In this context, risk management has to be discussed regarding prevention and control of the already existing antimicrobial resistance. One of the primary risk management measures in order to control the development and spread of antimicrobial resistances is by regulating the use of antimicrobial agents and subjecting their use to guidelines. Thereby, the occurrence of antimicrobial resistant bacteria in the human and veterinary habitat can be controlled to a certain degree. There is little information about past attempts to prevent the development of resistances or to control them, and even less is known about the effectiveness or the cost intensiveness of such efforts. Most of the strategies focus on preventing and controlling antimicrobial resistance by means of the reduction or limitation of the use of antimicrobial agents in food-producing animals.     

细菌的获得性耐药机制研究进展

抗菌药物的广泛使用,导致细菌耐药性日益严重,耐药菌所致的感染给人类健康及畜禽生产带来巨大威胁。细菌耐药可由多种机制所介导,研究细菌的耐药机制对防止或延缓耐药性的产生具有重要意义。近年来,影响药物与作用靶位结合及作用靶位结构变化等机制介导的耐药受到人们的关注。论文将对作用靶位变化导致细菌耐药问题的最新研究进展进行综述,以期为防止和延缓细菌耐药性的产生提供理论依据。     

OIE抗菌药耐药性国际标准

兽用抗菌药耐药性已经成为一个全球普遍关注的公共健康问题,各国际组织都积极采取相应的措施控制耐药性的产生和蔓延。介绍了国际组织世界动物卫生组织OIE制定的五个国际标准,包括协调抗菌药耐药性监督和检测程序指南、畜牧业抗菌药消耗量监测指南、兽用抗菌药慎用指南、抗菌药敏感性检测的实验室方法指南、动物源抗菌药耐药性对公共健康潜在影响的风险分析方法指南,以期为我国政策制定者和决策者参照国际标准制定出符合我国国情的耐药性相关指南。     

Stakeholder position paper: companion animal veterinarian

The total quantity of use in companion animals is generally believed to be relatively small in comparison with antimicrobial use in food animals. Use in companion animals is principally for treatment, whereas the greater proportion of use in food animals is for prophylaxis, metaphylaxis and growth promotion. Therefore, it is important to collect data on end use in companion animals so that overall estimates of use in companion animals can be generated and separated from estimates for food animals. However, data from antimicrobial use in companion animals are extremely limited and no serious attempts to collect such data have ever been made in the United States. The lack of usage data in is concomitant with the dearth of information on antimicrobial resistance in companion animals. Companion animals have been involved in the transmission to humans of, or become infected with, foodborne zoonotic bacteria such as Salmonella and Campylobacter. Companion animals are an integral part of the ecology of antimicrobial resistance through their contact with food animals and exposure to antimicrobials for disease treatment and through contact with humans and the environment. In the practice of companion animal medicine, antimicrobial use data are important for understanding the potential impact on companion animal heath posed by antimicrobial resistance transferred from food animals, humans and the environment, and the threat to humans and other companion animals posed by antimicrobial use in companion animals. Basic information on the patterns and quantities of antimicrobial use in combination with resistance surveillance data, could help companion animal veterinarians understand the potential for development, or evidence of, an antimicrobial resistance problem in their practices, the role of companion animals in the overall epidemiology of antimicrobial resistance, and for comparison with local, regional, or national data. The combination of data from either a sentinel site system of clinics or a use survey with national data from the pharmaceutical industry should provide sufficient data to credibly estimate the total volume and patterns of antimicrobial use in companion animal medicine. The time and effort for use monitoring or to complete a survey would likely become burdensome. Practice management software now utilized at most companion animal clinics could be used to generate antimicrobial use data as well as patient population data as surrogate for the true population at risk for patient encounters in a companion animal practice.     

Importance of prudent antibiotic use on dairy farms in South Carolina: a pilot project on farmers' knowledge, attitudes and practices

Inappropriate use of antibiotics in humans and animals contributes to decreased antimicrobial susceptibility in bacteria of medical importance. Resistant bacteria being transferred from animals to humans are causing public health concern. In-person interviews were conducted with 20 dairy farmers in rural counties of South Carolina to determine farmers' knowledge and attitudes about prudent antibiotic use among livestock. Four focus groups (n = 22) were also conducted to ascertain farmers' specific information needs about proper antibiotic use. Survey results showed that participants (100%) typically determined a need for antibiotic treatment using symptom assessment and reported following some form of operating procedures regarding administration of antibiotics. Few farmers (32%) had actual written antibiotic protocols. Preferred information sources about antibiotics were veterinarians (100%) and other dairy farmers (50%). Most farmers (86%) were not concerned that overuse of antibiotics in animals could result in antibiotic resistance among farm workers. Qualitative analysis of focus groups revealed significant barriers to following proper antibiotic procedures including limited finances and lack of time. The need for bilingual educational resources for Hispanic/Latino dairy workers was expressed. Desired formats for educational materials were posters, flowcharts, videos, and seminars. Education of South Carolina dairy farmers by veterinarians and public health professionals on the appropriate use of antibiotics in dairy cattle is needed to ensure antibiotic effectiveness in both animals and humans.