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1.
A risk assessment of the food safety implications of drugs used in food-producing animals is an essential component of the regulatory approval process for products containing these drugs. This ensures that there is negligible risk to human health if these drugs are used according to the instructions that appear on the approved label. A relative paucity of approved products for veterinary species; however, forces veterinarians worldwide to use drugs in an extralabel manner to treat disease and alleviate suffering in animals. In food-producing animals, this may result in residues that are potentially harmful to the human consumer. This review describes how risk assessment principles can be extended to evaluate the risks posed by different classes of extralabel drug use. Risk management practices in the United States and Europe are summarized and contrasted to illustrate the application of these principles. 相似文献
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S C Fitzpatrick 《Journal of animal science》1990,68(3):870-873
Concern over the presence of veterinary drug residues in food has been increasing world wide. Because of this concern the Food and Drug Administration's Center for Veterinary Medicine (CVM) has been involved on an international basis in efforts to develop food safety standards for veterinary drugs. The major thrust of the Codex Committee on Residues of Veterinary Drugs in Foods (CC/RVDF) has been to achieve international agreement on veterinary drugs issues. CVM is an active participant on this committee. The CC/RVDF has established a list of priority veterinary drugs that are, or that have the potential to cause trade problems as the result of public health concerns. Included in this list are anabolic hormones, chloramphenicol, sulfonamides, nitrofurans, nitroimidazoles, somatotropins, benzimidazoles and trypanocides. In the upcoming years, the CC/RVDF will work toward developing international maximum residue levels for these compounds. The evaluation of the toxicity of veterinary drug-bound residues is another area of international concern. In conjunction with the Bureau of Veterinary Medicine, Health and Welfare Canada, CVM is developing guidelines on biological models to demonstrate the safety of veterinary drug-bound residues. In working with veterinary drug regulators from other countries, CVM has new solutions to human food safety problems. 相似文献
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A D Watson 《Journal of veterinary pharmacology and therapeutics》1992,15(2):151-159
Differences in bioavailability of many drugs from their various dosage forms have been shown to be relatively common in human medicine. Although comparable bioavailability ('bioequivalence') is though to ensure comparable clinical effectiveness and safety ('therapeutic equivalence'), the relationship between bioinequivalence and therapeutic inequivalence is less clear. Thus the prevalence of clinically important differences in bioavailability is unknown. While similar concerns have arisen about drug products used in small animal practice, there have been few investigations and some earlier reports are incomplete. However, there are indications of bioinequivalence with enteral formulations of ampicillin, aspirin, chloramphenicol, digoxin, mitotane, oxytetracycline, penicillin V and theophylline. Other studies have suggested bioequivalence with enteral formulations of chloramphenicol, digoxin, phenytoin, oxytetracycline and thyroxine. Limited data for injectable preparations showed bioinequivalence with chloramphenicol and possibly oxytetracycline. There is no reason to expect formulation-related bioinequivalence to be less prevalent in veterinary than in human medicine. Indeed, it may be more common in veterinary practice because other potential influences on bioavailability (food, diseases, other drugs, etc.) are frequently ignored, and cheaper generic products are often favoured for economic reasons. 相似文献
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Bergh MS Budsberg SC 《Journal of veterinary internal medicine / American College of Veterinary Internal Medicine》2005,19(5):633-643
Nonsteroidal anti-inflammatory drugs (NSAIDs) are used to control acute and chronic pain as well as to manage oncologic and neurologic diseases in human and veterinary patients. Despite ongoing research and efforts to improve the safety and efficacy of existing drugs, adverse effects such as gastrointestinal irritation, renal and hepatic toxicity, interference with hemostasis, and reproductive problems persist. The true incidence of NSAID-induced adverse effects in animals is unknown, but is likely underestimated, because cats and dogs may be more sensitive than humans to NSAIDs due to alterations in drug metabolism, absorption, and enterohepatic recirculation. NSAIDs produce both analgesia and toxic adverse effects primarily by inhibiting cyclooxygenase (COX), thereby decreasing the production of prostaglandins that signal inflammation and pain as well as mediate physiologic functions such as platelet aggregation, gastric protection, and electrolyte balance in the kidney. The presence of at least 2 COX isoforms may account for variability in NSAID efficacy and toxicity both within and among species. This paper reviews and evaluates the published literature on the safety, pharmacology, uses, and complications of a subclass of COX-1-sparing drugs, the coxibs, in veterinary medicine. Coxibs and other COX-1-sparing drugs provide a clinically useful improvement over traditional NSAIDs, but data are incomplete and more in vivo species-specific, target-tissue, and clinical studies are needed. 相似文献
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Potential interactions between non-steroidal anti-inflammatory drugs and other drugs 总被引：1，自引：1，他引：0
Lauren A. Trepanier DVM PhD Diplomate DACVIM Diplomate DACVP 《Journal of Veterinary Emergency and Critical Care》2005,15(4):248-253
Objective: The objective of this review is to summarize what is known in human and veterinary patients regarding the potential interactions of non‐steroidal anti‐inflammatory drugs (NSAIDs) with clinically important drugs. Data sources: Relevant articles as identified through searches of Medline, 1985 to present. Human data synthesis: Hemodynamic drug interactions are most likely to cause clinically relevant problems in humans, in which NSAIDs blunt the response to anti‐hypertensive agents and diuretics in patients with cardiovascular disease, or cause renal decompensation in patients with hypovolemia. In addition, NSAIDs enhance the ulcerogenic effects of glucocorticoids or other recently administered NSAIDs, and can increase bleeding from anti‐coagulant drugs or from herbs with platelet inhibitory activities. Veterinary data synthesis: Although there are numerous studies examining the safety and efficacy of various NSAIDs in healthy or arthritic dogs, there are very few studies that address the safety of these agents in veterinary patients receiving medication for other acute or chronic conditions. Conclusions: Based upon what is known in humans, more studies are needed in veterinary patients to assess the safety of NSAIDs in those animals being treated with anti‐hypertensive, diuretic or anti‐coagulant drugs. 相似文献
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Prescott JF 《Animal health research reviews / Conference of Research Workers in Animal Diseases》2008,9(2):127-133
The vast literature on antimicrobial drug use in animals has expanded considerably recently as the antimicrobial resistance (AMR) crisis in human medicine leads to questions about all usage of antimicrobial drugs, including long-term usage in intensively managed food animals for growth promotion and disease prevention. Attention is also increasingly focusing on antimicrobial use and on bacterial resistance in companion animals, which are in intimate contact with the human population. They may share resistant bacteria with their owners, amplify resistant bacteria acquired from their owners, and act as a reservoir for human infection. Considerable effort is being made to describe the basis of AMR in bacterial pathogens of animals. Documentation of many aspects of use of antimicrobials in animals is, however, generally less developed and only a few countries can describe quantities of drugs used in animals to kg levels annually. In recent years, many national veterinary associations have produced 'prudent use guidelines' to try to improve antimicrobial drug use and decrease resistance, but the impact of guidelines is unknown. Within the evolving global movement for 'antimicrobial stewardship', there is considerable scope to improve many aspects of antimicrobial use in animals, including infection control and reduction of use, with a view to reducing resistance and its spread, and to preserving antimicrobial drugs for the future. 相似文献
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Lynn M. Pezzanite Dean A. Hendrickson Steven Dow Jason Stoneback Lyndah Chow Danielle Krause Laurie Goodrich 《Equine veterinary journal》2022,54(1):24-38
Antibiotics have been injected intra-articularly by equine veterinarians for decades, either prophylactically when other drugs are administered for osteoarthritis or therapeutically to treat septic arthritis. This route of administration has also more recently gained attention in human orthopaedic clinical practice, particularly as an alternative to systemic antibiotic administration to treat infections following prosthetic arthroplasty. While the rationale for injecting antibiotics intra-articularly has been largely focused on achieving high local drug concentrations, there has been relatively little focus on pharmacokinetic parameters of antibiotics administered by this route, or on the potential for local toxicity. The increasing incidence of antibiotic resistance in veterinary and human medicine prompts reconsideration of off-label antibiotic usage and evaluation of evidence-based dosing strategies. The purpose of this review was to summarise the current literature describing intra-articular antibiotic usage, including specific studies where pharmacokinetics, potential safety and toxicity have been evaluated. This review will advance practitioners’ understanding of the use of intra-articularly administered antibiotics, including the overall pros and cons of the approach. 相似文献
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Population pharmacokinetics in veterinary medicine: Potential use for therapeutic drug monitoring and prediction of tissue residues 总被引：1，自引：0，他引：1
T. MARTÍN-JIMÉNEZ & J.E. RIVIERE 《Journal of veterinary pharmacology and therapeutics》1998,21(3):167-189
Population pharmacokinetics can be defined as a study of the basic features of drug disposition in a population, accounting for the influence of diverse pathophysiological factors on pharmacokinetics, and explicitly estimating the magnitude of the interindividual and intraindividual variability. It is used to identify subpopulations of individuals that may present with differences in drug kinetics or in kinetic/dynamic responses. Rooted in procedures used in engineering systems, population pharmacokinetics methods were conceived as a means to determine the pharmacokinetic profile in populations in which a sparse number of samples were obtained per individual, such as those in late stage human clinical trials. This is the situation commonly encountered in all aspects of veterinary medicine. The exploratory nature of this technique allows one to probe relationships between clinical factors (such as age, gender, renal function, etc.) and drug disposition and/or effect. Similarly, the utilization of these techniques in the clinical research phases of drug development optimize the determination of efficacy and safety of drugs. Given the observational nature of most studies published so far, statistical methods to validate the population models are necessary. Simulation studies may be conducted to explore data collection designs that maximize information yield with a minimum expenditure of resources. The breadth of this approach has allowed population studies to be more commonly employed in all areas of drug therapy and clinical research. Finally, in veterinary medicine, there is an additional field in which population studies are potentially ideally suited: the application of this methodology to the study of tissue drug depletion and drug residues in production animals, and the establishment of withdrawal times tailored to the clinical or production conditions of populations or individuals. Such application would provide a major step toward assuring a safe food supply under a wide variety of dose and off-label clinical uses. Population pharmacokinetics is an ideal method for generating data in support of the implementation of flexible labelling policies and extralabel drug use recently approved under AMDUCA (Animal Medicinal Drug Use Clarification Act. 21 CFR Part 530). 相似文献
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The hazard of using chloramphenicol in food animals 总被引：3，自引：0，他引：3
J A Settepani 《Journal of the American Veterinary Medical Association》1984,184(8):930-931
To summarize, concern has developed over the extra-label use of chloramphenicol in food-producing animals because a type of blood dyscrasia that is usually fatal to a significant subgroup of the population with an apparent predisposed sensitivity to chloramphenicol has been associated with extremely low levels of exposure to the drug. In a monitoring program, using a method of analysis that is limited as to the type of residues it can detect, USDA has found 4 to 8 animals a year that were slaughtered for use as human food that contained residue levels of chloramphenicol that approach or exceed those concentrations associated in a causal relationship with aplastic anemia in man. Given the preponderance of evidence presented above, the FDA must consider--under its mandate to protect the human health by assuring safe and effective veterinary drugs--a course of action that will preclude the availability and the use of chloramphenicol in food animals. 相似文献
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Moreno-López J 《Polish journal of veterinary sciences》2002,5(2):123-125
Outbreaks of Bovine Spongiform Encephalopathy (BSE) and food borne microbial infections, dioxin contaminated animal products, the presence of veterinary drug residues, microbial resistance to antibiotics, mycotoxins, agricultural and industrial chemicals, etc. are serious concerns for the food industry in many countries. Since the direct links between feed safety and safety of foods of animal origin are obvious, feed production and manufacture should be considered as an integral part of the food production chain. Industry is responsible for the quality and safety of food and feed that is produced. This paper is a brief review of some microorganisms as source of infections for farm animals that could result in human illnesses. These include Salmonella enterica, Bacillus anthracis, Toxoplasma gondii, Trichinella spiralis, prions, Listeria monocytogenes, EHEC, Campylobacter, Clostridium botulinum, Hog Cholera virus, Foot and Mouth Disease virus, etc. as well as other contaminants associated with animal feed such as mycotoxins, veterinary drugs, dioxins and PCB and Genetically Modified Organisms. 相似文献
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K. L. Hepworth-Warren 《Equine Veterinary Education》2021,33(8):436-443
The last decade has led to major shifts in opinions on the use of hydroxyethyl starch (HES) solutions in fluid therapy, specifically in human patients with sepsis. The majority of evidence documenting adverse effects of HES solutions on coagulation and renal health come from studies in people. However, these findings have led to investigation into the safety of HES solutions in veterinary species. While there are now studies investigating the effects of HES solutions on coagulation and renal health in dogs, cats and horses, information regarding long-term follow-up, clinical significance of these changes and use of these solutions in critically ill animals is still lacking. The information presented here serves to review the physiology of oncotic pressure and the rationale behind colloid use, specifically HES solutions. Additionally, the foundation of arguments against the use of HES and the available literature regarding HES use in animals will be summarised. 相似文献
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Approaches in the safety evaluations of veterinary antimicrobial agents in food to determine the effects on the human intestinal microflora 总被引：1，自引：0，他引：1
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. 相似文献
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In the last decade, the organic agriculture in Switzerland has been substantially increased due to the interest of consumer and financial incentives of the federation. Ruminants take directly or indirectly the largest part from grassland used within the organic managed surfaces. As the contacts between veterinary practice and organic agriculture has increased, the potential for veterinary activity in this area has developed considerably. The organic agriculture guidelines stipulate that all the preventive measures should be taken in feeding, keeping and breeding to insure animal health safety. This requires veterinary services for herd management. The organic status of a farm affects veterinary practice also in the form of alternative therapy/drugs administration and measures like dehorning and tail-docking. An important point in organic managed herds requests that treatment of animals should depend on alternative medical preparations or procedures based on veterinarian's experience and also on the therapeutic effect on the animal species concerned as well as on the disease. However, there are no restrictions on the veterinarian to use registered drugs as long as no alternative therapy, according to experience and possible success, is available to treat the animals. The prophylactic administration of allopathic veterinary drugs is not permissible. Further features in organic farms regarding the use of drugs are the keeping of withholding/withdrawal time, the documentation and the treatment frequency tolerated by organic marketing. Despite the above measures, the animal health has a priority regardless of its organic status. Although management of organic farms represent a unique responsibility, there are still obvious deficits in the education of veterinary practitioners for this new situation. However, in the future the extension of veterinary activity to include the alternative medical therapy should be regarded for the practitioner as a challenge and an opportunity at the same time. 相似文献
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Stärk KD 《Schweizer Archiv für Tierheilkunde》2000,142(12):673-678
Most animal-derived food products originate from production chains consisting of a series of well-defined, separate production steps. Undesired events affecting food safety can principally occur at any point within the production chain. The principle of integrated food safety assurance from stable to table has therefore been established. The livestock holding has thus to be understood as a fix element of the production chain, and the producer has to accept a part of the responsibility for food safety. On a farm, food safety can be negatively affected by animal feed (microbiological or toxicological contamination), management (hygiene, stocking density, cleaning and disinfecting), veterinary treatments (use of antibiotics) and recycling of slurry. Most relevant practices can be summarised under the standard of "good farming practice". HACCP programmes as they are applied in the processing industries could in principle also be used at the farm level. Influential management steps would need to be identified and controlled. This approach is, however, still in its infancy at present. Using the current monitoring systems, microbiological and toxicological problems in food are difficult to be identified before the end of the production chain. As the cause of a problem can be found at the farm level, traceability of products through the production chain is essential. In Switzerland, traceability of animals is realised using compulsory animal identification and the animal movement database. Using this link, information on the health status of a herd could be made available to the slaughterhouse in order to classify animals into food-safety risk categories. This principle is a key element in the ongoing discussion about visual meat inspection in Europe and elsewhere. 相似文献
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Antimicrobial drug use in veterinary medicine 总被引：1，自引：0，他引：1
Morley PS Apley MD Besser TE Burney DP Fedorka-Cray PJ Papich MG Traub-Dargatz JL Weese JS;American College of Veterinary Internal Medicine 《Journal of veterinary internal medicine / American College of Veterinary Internal Medicine》2005,19(4):617-629
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. 相似文献
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A literature review of reports of the stability and storage of common injectable chemotherapy agents used in veterinary patients 
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下载免费PDF全文 Many chemotherapy drugs used in human patients are discarded after single use or within 24 h of reconstitution, as per the manufacturer's product label recommendations. This can be wasteful and costly to veterinary clients. This report reviews the published stability and storage data for 19 injectable chemotherapy drugs commonly used in veterinary medicine. Based on these data, storage procedures are presented, assuming aseptic technique and a closed system drug transfer device (CSDTD) are used for drug preparation and handling. Further studies on the risk of microbiological contamination of chemotherapeutics using a CSDTD, and validated high quality drug assays such as stability‐indicating high‐performance liquid chromatography, are required. The authors' intent is not to supersede product label recommendations, but to suggest that longer storage without significant loss of drug efficacy may be possible, thus reducing the costs of chemotherapeutics to some veterinary clients. 相似文献