Impact of antimicrobial resistance on regulatory policies in veterinary medicine: status report.

AAPS PharmSci Pub Date : 2002-01-01 DOI:10.1208/ps040437
Linda Tollefson, William T Flynn
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引用次数: 25

Abstract

Increasing resistance to antimicrobial agents is of growing concern to public health officials worldwide. The concern includes infections acquired in hospitals, community infections acquired in outpatient care settings, and resistant foodborne disease associated with drug use in food-producing animals. In the United States, a significant source of antimicrobial-resistant foodborne infections in humans is the acquisition of resistant bacteria originating from animals. The US Food and Drug Administration's (FDA's) goal in resolving the public health impact arising from the use of antimicrobial drugs in food-producing animals is to ensure that significant human antimicrobial therapies are not compromised or lost while providing for the safe use of antimicrobials in food animals. The FDA's approach to the problem is multipronged and innovative. The strategy includes revision of the pre-approval safety assessment for new animal drug applications, use of risk assessment to determine the human health effect resulting from the use of antimicrobials in food animals, robust monitoring for changes in susceptibilities among foodborne pathogens to drugs that are important both in human and veterinary medicine, research, and risk management.

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抗微生物药物耐药性对兽药监管政策的影响:现状报告。
抗菌素耐药性的增加是全世界公共卫生官员日益关注的问题。值得关注的问题包括在医院获得的感染、在门诊护理机构获得的社区感染,以及在食用动物中与用药相关的耐药食源性疾病。在美国,人类耐药食源性感染的一个重要来源是获得来自动物的耐药细菌。美国食品和药物管理局(FDA)解决在食用动物中使用抗菌药物所产生的公共卫生影响的目标是确保重要的人类抗菌疗法不会受到损害或丢失,同时确保在食用动物中安全使用抗菌药物。FDA解决这个问题的方法是多管齐下和创新的。该战略包括修订新动物药物申请的批准前安全评估,利用风险评估来确定在食用动物中使用抗菌素对人类健康的影响,对食源性病原体对药物的敏感性变化进行强有力的监测,这在人类和兽医学、研究和风险管理中都很重要。
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