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.     

兽药的合理使用

科学、高效、安全地使用兽药,不但能及时预防和治疗动物疾病,提高养殖效益,而且对控制和减少药物残留、提高动物产品质量具有重要意义。     

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.     

抗生素的安全使用

在兽医临床中使用抗生素类药物应注意以下几点：（1）严格掌握适应症,弄清致病微生物的种类及动物对药物的敏感性。动物对一些抗生素也有过敏反应,也应当进行皮试,有条件时应做药敏试验,为了减少损失,对一些敏感性强的名种畜,宜皮试为好。这样既可对症下药,又可节省用药,减少开支;（2）注意用量及疗程,应根据药物作用和对动物的药动学特点,制定给药方案与剂量。     

Tocolytic drugs for use in veterinary obstetrics

The author presents a literature review of two tocolytic agents used in veterinary obstetrics: isoxsuprine and clenbuterol. The medical background from which these drugs emerged for human use and to which is linked their application in animal medicine is described. Each drug is reviewed according to its pharmacology, basic considerations for its clinical use and the reports on its application in the treatment and management of obstetrical disorders in veterinary medicine.     

兽用合成抗菌药的安全使用

抗菌药物在保障畜禽健康、促进畜禽生长、提高经济效益方面起了积极的作用。然而长期使用,具有危害性。首先,导致细菌产生耐药性;其次,敏感菌得到了控制,不敏感菌或耐药菌乘机大量繁殖,产生新的致病菌,     

兽药使用环节存在的问题及对策

经过对兽药生产厂家和经营企业几年的整治,尤其是新<兽药管理条例>和<兽药标签和说明书管理办法>出台后,又经过GMP认证,兽药生产经营市场秩序和经营行为得到了一定的规范.但兽药使用环节中却存在诸多的问题,如:违法使用人用药品;违法使用禁用兽药;不执行休药期规定;未建立台帐等等.这些问题的存在,直接导致了动物产品的安全性问题.对此,笔者分析了兽药使用环节存在问题的原因,并对解决这些问题提出了个人观点.     

对兽药批发单位异地送货被罚案的感想

2002年,我县一兽药器械批发站将毗邻A县一业务单位订购的兽药送到该单位时,被A县畜牧局以无该县核发的《兽药经营许可证》在其辖区内进行兽药的销售活动为由,将全部兽药扣押。并依据《兽药管理条例》第十六条、第四十三条的规定,欲给予没收全部兽药、罚款8000元的行政处罚。兽药器械批发站不服,其理由为:既已在本县办理了《兽药经营许可证》和《营业执照》,即被允许进行兽药器械的批发业务;在A县既没有设立门市又没有在集贸市场销售,只是送货而已,不该受罚。后经反复交涉,A县畜牧局变相(以会务赞助费)收取了2000元的罚款。对此案笔者…     

北京市已经明令禁止9个兽药品种的生产、经营和使用

继今年农业部发布了《关于发布(食品动物仅用的兽药及其他化合物清单)的通知》，明确对氯霉素等8种原料药物及单、复方制剂在所有食品动物中全面禁用，对林丹等9种杀虫剂在水生食品动物中禁用，对性激素等3种原料药及其制剂限定使用。为此，药政部门对本市的兽药品种进行了核查，废止了兽药地方标准1个，撤消《禁用清单》中所列的兽药及含有这些药物成分的单、复方制剂产品批准文号31个，共涉及兽药生产企业15家，兽药品种9个(乙烯雌酚注射液、氯霉素、氯霉素可溶性粉、氯霉素注射液、呋喃唑酮、呋喃唑酮预混剂、鱼宝、宫得康悬浮剂、鱼泰乐)。