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1.
Woodward KN 《Journal of veterinary pharmacology and therapeutics》2005,28(2):203-211
In the European Union and elsewhere there is a requirement to ascribe causality to adverse drug reactions which occur in treated animals. In the EU, the ABON system of causality assessment is used but the assignment of causality assigned is not always self evident, and it may be complicated for a variety of reasons. In this paper, the approaches to causality assessment, based on a number of key criteria which examine the administration of the drug in relation to the sequence of ensuing events and the presence of biological plausibility are examined, along with the utility of using algorithms to facilitate this process. Unexpected adverse drug reactions usually require expedited reporting, depending on national or regional regulatory requirements. Again, deciding on what might constitute an expected (or unexpected) adverse reaction, particularly when a product may be intended for use in a number of species, and when within any one species a number of breeds may be treated, is not necessarily a straightforward issue. However, an approach to facilitate the decision- making process, based on a similar approach used in the pharmacovigilance of human medicinal products is discussed. 相似文献
2.
Woodward KN 《Journal of veterinary pharmacology and therapeutics》2005,28(2):185-201
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. 相似文献
3.
Woodward KN 《Journal of veterinary pharmacology and therapeutics》2005,28(2):171-184
Like humans, animals may experience adverse effects when treated with medicinal products. These effects may be related to the pharmacological or toxicological properties of the substances used or they may arise because of hypersensitivity. Veterinary medicinal products may also possess the ability to harm the environment. This paper reviews the potential of veterinary medicinal products to cause adverse effects in animals and on the environment. 相似文献
4.
This paper considers the different approaches to post-authorisation safety monitoring of veterinary medicinal products that is essential to ensure confidence in their safety. Most safety testing is undertaken prior to granting of a marketing authorisation and is generally on a small scale. Field trials are usually much larger, but still involve relatively low numbers of animals compared to the number to which authorised products are administered. Safety testing is generally aimed at detecting common events; the numbers of animals used in the tests are too small for detection of all but the most common reactions. The efficiency of the tests depends on the frequency and severity of the adverse reaction and the ability to associate the adverse event with the product. The latter is affected by the period of time between administration and the event, as well as by its underlying frequency. Adverse reaction surveillance is critical in monitoring the safety of a marketed product. Most is entirely passive and so reporting rates are likely to underestimate true incidence. It is relatively efficient for rare, serious adverse effects and for those with a low underlying frequency in the population, but it is less useful when there is long period between administration and the event, or where the event has a relatively high underlying frequency. Greater emphasis should be placed on active surveillance after production registration. Detailed epidemiological investigations, including cohort, case control and cross-sectional designs, offer the only approaches that provide more information on the association between a product and events that have a high underlying frequency in the population or where there is a long period between administration and the adverse event. The relative merits of different approaches are discussed, with particular reference to our recently published study of the temporal association between canine vaccination and non-specific signs of ill health and plans to undertake studies of associations with feline injection site sarcoma. Emphasis is placed on the need for clearly stated hypotheses and the consideration of equivalence, rather than significance testing when considering safety studies. 相似文献
5.
Müntener CR Bruckner L Stürer A Althaus FR Caduff-Janosa P 《Schweizer Archiv für Tierheilkunde》2012,154(2):57-65
In 2010, we observed again an increase in the number of declarations reported to the vigilance system for veterinary medicinal products up to a total of 160. The species and drug classes reported remained the same as in previous years: the majority of adverse drug reactions (ADRs) concerned either dogs or cats and the most frequently involved drugs were either antiparasitic products or antiinfectives. Adverse reactions following reconversions and 8 cases of suspected allergic reactions following the use of amoxicillin-clavulanic acid combinations in dogs were reported. Additional enquiries were processed by the Swiss Toxicological Information Centre and transmitted to Swiss medic. 11 of these reported accidental ingestions of flavoured tablets in overdose by dogs and some cats. The vaccino vigilance program received 179 declarations following immunization against blue tongue disease as well as 82 declarations following the application of other vaccines. The vigilance system increases the chance to identify rare reactions or interactions and thereby contributes to the security of veterinary medicinal products. 相似文献
6.
R H Poppenga 《Veterinary Clinics of North America: Equine Practice》2001,17(3):455-77, vi-vii
The use of dietary supplements (herbs, vitamins, minerals, amino acids, enzymes, and other compounds) is common in horses. They are heavily marketed in retail stores, magazines, and on the Internet. There is the perception that since these compounds are "natural" they are devoid of toxicity, and, therefore, they are safe to use. Some of the active compounds in supplements, however, have inherent toxicity, and using them may cause adverse effects. Even relatively non-toxic ingredients may be toxic if used over-zealously or for a long period of time. By and large, these compounds have not been tested for safety or efficacy when used as marketed, and, unfortunately, there is little regulatory oversight for such products. Other deleterious consequences of dietary supplement use include interaction of compounds in the products with conventional drugs, resulting in unexpected adverse effects, or the occurrence of violative residues in urine samples collected from show or performance horses. This article provides a brief overview of potential problems associated with dietary supplements, primarily focusing on products containing herbs and essential oils. 相似文献
7.
Magnusson U 《Domestic animal endocrinology》2005,29(2):430-435
The phenomenon of endocrine disruption can be regarded as part of the disciplines of toxicology and environmental toxicology. These two disciplines have generated guideline protocols on how various effects of chemicals should be tested as a basis for regulatory decisions. These protocols almost exclusively involve laboratory rodents and the data obtained are then used for human risk assessment. Would it be justifiable, then, to introduce or promote the use of other species in these test protocols? There are, at any rate rationales for studying effects in species other than laboratory rodents: (1) other species may better mimic the human system; (2) they may in some cases be more useful for studying a certain mechanism or phenomenon; (3) they may highlight the diversity of effects or sensitivity between species. However, there are at least two basic criteria that must be met for a species before it can be introduced in this context: (a) we must have a good understanding of the physiological system to be studied; and (b) we must have a number of tools to study effects on this system. When it comes to the reproductive system – regarding which most endocrine disruption has been reported – farm animals are second only, or in some respects superior, to laboratory rodents with respect to these criteria. This review gives examples of how farm animals can be of use in the study of endocrine disruption with a focus on the author's own data from studies in the pig. 相似文献
8.
Charlotte Means 《Veterinary Clinics of North America: Small Animal Practice》2002,32(2):367-382
One of the most important considerations in treating herbal ingestions is product quality assurance. Although most herbal companies are reputable, there are numerous reports of adulterated products (addition of substances not noted on the label). This has been particularly true of Chinese herbal products, which frequently contain pharmaceutical agents. Plant identification errors occur, and entire batches of product have been mixed using the wrong herb. In some cases, labels are written in a foreign language or only contain directions for mixing, making interpretation difficult. In cases where a known ingestion produces unexpected clinical signs, the potential for adulteration or other errors should be considered. When a product is not standardized, a consumer cannot be sure what dose of active constituents has been used or how bioavailable the product may be. Standardization also provides assurance that the actual herb is in the product [26]. Clients who use herbal products should be advised to treat them as a medication and to keep them away from pets. Specifically, ask clients if they take or use any natural or herbal products. Many people do not consider these substances drugs or assume, "If natural, it is harmless." Clients should be encouraged to learn about the herbal and neutraceutical products they are taking or giving their pets. Owners need to discuss the proper use of herbal products in pets with their veterinarian. Clients can be encouraged to discuss alternative therapies by discussing a pet's diagnosis and suggested treatments thoroughly. Discuss the client's expectations and opinions of alternative and conventional medicine. Issues of safety and efficacy must be fully explained to clients. Clients should be encouraged to report potential adverse reactions or to discuss different routes of therapy if a pet's medical condition is not improving. Clients who want to use alternative medical treatments should obtain a thorough medical workup so as to make a correct diagnosis and be referred to a veterinarian trained in alternative medicine. In choosing an alternative medicine practitioner, the same criteria would be used as for any other specialist: education, training, and professionalism [14]. 相似文献
9.
Lloyd Reeve-Johnson 《中国兽药杂志》2009,43(1):43-48
投资研发一种新型兽药的成功与失败,最终取决于管理者、兽医医师和畜主是否认同药品的安全性和有效性。药品研发成本最高、费时最长的阶段是注册前的临床药效试验阶段,研发者使用动物疾病模型技术来缩短研发时间和降低研发成本。虽然使用动物疾病模型技术获得的数据是极有价值,但这些数据并不能完全说明药品真实的临床功效。本文使用模型分析方法研究了兽医保健体系中参与者的决策顺序,以便更好的理解决定药物选择的参与者、决定药物是否准入市场的政府管理者以及制药公司之间的相互影响及影响的相对水平。因此,了解药品研发和注册如何影响治疗时药品的选用非常重要,也有助于确保药品在市场中获得最大的经济效益。 相似文献
10.
Müntener CR Bruckner L Stürer A Althaus FR Caduff-Janosa P 《Schweizer Archiv für Tierheilkunde》2010,152(12):575-583
During the year 2009, 134 reports of suspected adverse drug reactions (ADRs) to veterinary medicinal products (VMPs) were received (106 in the year 2008). The distribution according to species and drug classes remained in line with previous years. Companion animals were involved in most of the reports (46 % dogs, 19 % cats), followed by cattle or calves (22 %). Antiparasitic drugs made the biggest part with 30 % of the reports, followed by antiinfectives (19 %) and hormones (13 %). Some reactions following their use are specifically discussed. 95 additional enquiries about ADRs of VMPs were received by the Swiss Toxicological Information Centre in Zürich. Most of them concerned dogs or cats and antiparasitics or anti-inflammatory drugs. In the vaccinovigilance program, a total of 1020 reports were received, of which 1000 were related to the vaccination against blue tongue disease. The most frequently reported adverse reactions were aborts, mastitis or alterations of milk quality and they are specifically discussed. 相似文献
11.
S.C. FITZPATRICK S.D. BRYNES† G.B. GUEST‡ 《Journal of veterinary pharmacology and therapeutics》1995,18(5):325-327
The harmonization of standards and procedures for establishing tolerances or maximum residue levels (MRLs) for veterinary drug residues in edible animal products is a major goal of the international veterinary drug community. Such harmonization would contribute to easing trade barriers. This paper proposes use of the toxicologically determined acceptable daily intake (ADI) for the drug as the safety standard for reaching conclusions on the acceptability of residues in meat for human consumption. Specifically, the 'equivalence' of different MRLs for the same veterinary drug would be determined by considering whether they are likely to result in dietary residues that exceed another country's ADI for the drug. Two methods of estimating dietary intake are described, and estimates are made for the veterinary drugs albendazole and ivermectin. Based on these estimates, the US and JECFA MRLs for each drug would be considered 'equivalent' for trade purposes. 相似文献
12.
Scott A Brown 《Veterinary Clinics of North America: Small Animal Practice》2004,34(1):173-85, vi-vii
There is no universally accepted definition of a commonly used term for a functional food: nutraceutical. For the purposes of this article, a nutraceutical is any ingredient found in foods that has a demonstrated (or proposed) physiologic benefit. Although a nutraceutical is generally taken to be an ingredient that can be isolated or purified from food, plants, or marine products and made available in medicinal form, this article also considers claims of benefit to the urinary tract for foods or food supplements in which the active ingredient has not yet been characterized or isolated. 相似文献
13.
OBJECTIVE: To determine the incidence and nature of adverse reactions of dogs and cats to tick antitoxin serum and to re-evaluate the role of atropine in the treatment of tick paralysis. DESIGN: A retrospective questionnaire of veterinarians. PROCEDURE: Questionnaires were posted to 320 veterinarians in tick-endemic regions of Australia. Questions referred to dogs and cats treated for tick paralysis over a period of three years: the number treated, treatment protocols and adverse systemic reactions to tick antitoxin serum. Ninety completed questionnaires were returned and responses analysed. RESULTS: Veterinarians reported that approximately 3% of dogs exhibited adverse reactions immediately following treatment with tick antitoxin serum. Eighteen percent of these reactions were described as anaphylaxis, with the remaining 82% attributed to the Bezold-Jarisch reflex. Six percent of cats treated with tick antitoxin serum reacted adversely and the majority of reactions (63%) were ascribed to the Bezold-Jarisch reflex. Atropine was used routinely by 10% of responding veterinarians in the treatment of dogs and cats with tick paralysis. A similar number of veterinarians used atropine only in selected cases. Most veterinarians (76%) reported that they never used atropine in the treatment of tick paralysis in either dogs or cats. Within the survey population, premedication with atropine reduced the number of Bezold-Jarisch reactions following tick antitoxin administration approximately five-fold in dogs and four-fold in cats. CONCLUSIONS: Data from this pilot survey indicate that more cats than dogs have adverse systemic reactions to tick antitoxin serum and that the majority of these reactions in both dogs and cats could be related to the Bezold-Jarisch reflex. The number of reactions to tick antitoxin serum in dogs and cats could be significantly reduced by the routine use of atropine prior to administration of tick antitoxin serum. 相似文献
14.
The safety of a non-adjuvanted inactivated fungal vaccine for the treatment of dermatophytosis in cats was investigated in two studies: a controlled laboratory study, and a placebo-controlled double-blind field study with a cross-over design in Europe. In the laboratory study, two groups of 10 cats each were administered an intramuscular twofold overdose, followed by five single 1 ml doses, of either vaccine or control product at 14-day intervals. In the field study, cats were treated with three intramuscular injections of 1 ml vaccine administered at 14-day intervals, as recommended by the manufacturer. A total of 89 cats were enrolled in the field study and divided into two groups to receive either vaccine or placebo for the first three treatments, followed by the opposite product for the final three treatments. The cats enrolled in the two studies were 12 weeks of age or older, as recommended by the manufacturer. All the cats were monitored closely for possible injection site reactions, systemic reactions (including changes in rectal body temperature) and adverse events. The results from both studies showed no significant differences between the vaccinated cats and the control or placebo-treated cats with regard to local or systemic reactions. A few mild to moderate local reactions were noted, but these were evenly distributed between the vaccinated and placebo-treated cats and resolved within a few days. No severe or serious adverse events related to the vaccinations were observed. 相似文献
15.
WOODWARD 《Journal of veterinary pharmacology and therapeutics》1998,21(1):47-53
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. 相似文献
16.
Kleiminger E 《Tier?rztliche Praxis. Ausgabe G, Grosstiere/Nutztiere》2012,40(2):119-125
Claw diseases pose a major problem for dairy and sheep farms. As well as systemic treatments of these illnesses by means of drug injection, veterinarians discuss the application of footbaths for the local treatment of dermatitis digitalis or foot rot. On farms footbaths are used with different substances and for various purposes. The author presents the requirements for veterinary medicinal products (marketing authorization and manufacturing authorization) and demonstrates the operation of the "cascade in case of a treatment crisis". In addition, the distinction between veterinary hygiene biocidal products and veterinary medicinal products and substances to care for claws is explained. 相似文献
17.
18.
The Veterinary Pharmacovigilance and Medicines Information Centre is responsible for the monitoring of veterinary adverse drug reactions in South Africa. An overview of reports of suspected adverse drug reactions received by the centre during the period March 2004 to February 2006 is presented. A total of 21 reports was received in the 2-year period, continuing the decline in the number of reports to a lower figure than in any previous year. This is surprising considering the legal obligation of the veterinary professionals to report all adverse drug reactions. Once again the majority of reports involved suspected adverse reactions that occurred in dogs and cats. Most of the products implicated were stock remedies. Veterinarians predominantly administered these products. 相似文献
19.
C Jungb?ck 《Berliner und Münchener tier?rztliche Wochenschrift》1990,103(3):81-83
The definition of saprophytic and non pathogenic germs according to the DAB 9 (German Pharmacopeia) will be explained as follows. Germs should be seen as saprophytic and non pathogenic when they are either classified as a pathogen by biochemical methods or when the safety test in chickens shows no adverse local or clinical reactions. The reason for the different test results in testing the species and the amount of contaminating germs at the laboratories of vaccine producers and state laboratories are explained by the unequal dissemination of germs in each batch and by the discontinuity in cooling the vaccine samples. 相似文献