Analysis of veterinary drug residue monitoring results for commercial livestock products in Taiwan between 2011 and 2015

Antibiotics have been widely used in the treatment of livestock diseases. However, the emergence of issues related to drug resistance prompted governments to enact a series of laws regulating the use of antibiotics in livestock. Following control of the problem of drug resistant bacteria, public attention has shifted to the recurring incidence of human health and safety issues caused by residual veterinary drugs in livestock products. To guarantee the safety and hygiene of meat, milk, and eggs from food-producing animals, governments and relevant agencies established laws and regulations for the use of veterinary drugs. It is, therefore, necessary to monitor the content of residual drugs in livestock products at regular intervals to assess whether the regulations have resulted in the effective management of food product safety, and to prevent and manage sudden problems related to this issue. A 2011–2015 livestock product post-marketing monitoring program launched by the Taiwan Food and Drug Administration (TFDA) inspected 1487 livestock products. Over the past 5 years, there were 34 samples identified that did not conform to the regulations; these samples included residue drugs such as β-agonists, chloramphenicols, β-lactam antibiotics, sulfa drugs, enrofloxacin, and lincomycin. Inspections of commercial livestock products with the consistent cooperation of agricultural authorities did not detect the drugs that were banned by the government, whereas the detection of other drugs decreased annually with an increase in the post-market monitoring sample size. In the future, the TFDA will continue to monitor the status of residual veterinary drugs in commercial livestock products, adjust the sampling of food products annually according to monitoring results, and closely cooperate with agricultural authorities on source management.     

A refined approach to estimate exposure for use in calculating the Maximum Residue Limit of veterinary drugs

Maximum Residue Limits (MRLs) are standards that represent the maximum residue concentration expected to be found if a veterinary drug is administered according to good practice in the use of veterinary drugs (GVP). MRLs are established only where the exposure to residues in food resulting from particular use patterns of the veterinary drug pass a public health risk assessment. The current model diet as used by major regulators overstates mean consumption of food for populations when compared to results from food surveys of actual consumption. Exposure to residues is overestimated when calculating long-term (chronic) exposure using the model diet leading to the risk to consumers being overstated. Additionally the model diet underestimates the size of large portions eaten by the group of consumers that eat large quantities of a particular food in a single meal potentially leading to understating of risks associated with exposure to residues of drugs that produce an adverse effect after a single exposure. A revision of dietary consumption figures is proposed that will better match the consumption figures used in point-estimates of dietary exposure to the timeframe for consumption that is relevant to the reference dose.     

2013年攀枝花市动物食品中兽药残留检测及结果分析

目的：根据食品风险监测的要求检测全市几类动物食品的兽药残留情况。方法运用酶联免疫试剂盒对食品中的兽药残留情况进行筛查,将筛查结果为阳性的样品送省疾病预防控制中心理化检验室用GC-MS或LC-MS进一步复核。结果382份样品初筛结果为阳性检品22份。送省疾病预防控制中心复核,结果均为阴性。对酶联免疫法筛查结果进行评估,假阳性率为5．8％。 ELISA法初筛攀枝花市兽药残留9个项目,其中6个项目出现假阳性检品。抗生素类呋喃类均有假阳性结果出现,其余未出现假阳性;运用ELISA法初筛时,除鸡肉、鸡蛋未出现假阳性,其余均出现假阳性。其中,肝脏最高,依次是虾、鲜活淡水鱼、猪肉、牛肉。结论酶联免疫法运用于食品检测,方法简单,所需仪器简单,可快速地出具检测结果;及时为后续运用GC-MS和LC-MS对初筛阳性样品进行复核提供重要的参考价值;从而缩短了检测时间,提高了工作效率,节约了成本;结果表明攀枝花市动物食品中兽药残留含量低于限量标准,可安全食用。     

Implications of ABC transporters on the disposition of typical veterinary medicinal products

The ATP-Binding Cassette (ABC) transporters ABCB1, ABCC2 and ABCG2 are efflux transporters that facilitate the excretion of drugs, contribute to the function of biological barriers and maintain low cytoplasmic substrate concentrations in cells. ABC transporters modulate drug absorption, distribution and elimination according to the level of expression in the intestine, liver, kidney, and at biological barriers such as the blood-brain barrier. Moreover individual transporters are known to convey multi-drug resistance to tumour cells. While these diverse functions have been described in laboratory animal studies and in humans, the available information is very limited in animal species that are typical veterinary patients. This brief review summarizes the available data on organ distribution and expression levels in animals, genetic defects in dogs resulting in a non-functional P-gp expression, and describes examples of kinetic investigations directed to assess the clinical relevance of species differences in ABC-transporter expression.     

头孢菌素类药物在环境中的行为及残留研究进展

Cephalosporins have a wide spectrum of antibacterial activity and low toxicity. They are widely used in animals. When the cephalosporins are discharged into the soil and sewage through the discharge of sewage from industrial production or by the discharge of feces after animal administration, the abundance of environmental microbial resistance genes (ARGs) and bacteria resistance in the environment will be increased. Thus, it will reduce the success of antibiotic treatment of bacterial infections. In this article, the adsorption, migration, degradation and other behaviors of cephalosporin antibiotics in the environment (soil, manure, and water), current residues and effects on environmental micro-ecology are reviewed, to attracted people’s attention to the residual harm of cephalosporin antibiotics in the     

Opportunities and obstacles in veterinary dental drug delivery

Dentistry is a relatively new field in veterinary medicine, despite the fact that dental disease is common in dogs and cats. Obstacles to the development of dental treatments in animals include the diversity of the dentition among the species, the difficulty in administration of oral treatments, the different presentations of oral disease, and the cost of regulatory approval for each species. Mechanical removal of plaque and calculus has been the mainstay of periodontal disease treatment in animals and humans. New adjunctive therapies, as well as new applications for older drugs, are being introduced for periodontal therapy.     

头孢菌素类药物在环境中的行为及残留研究进展

头孢菌素类药物抗菌谱广、毒性小，在畜禽养殖业中使用十分广泛。当头孢菌素类药物通过工业生产中污水的排放，或经动物给药后的粪便排放等方式排入土壤、污水中时，会使得环境微生物的耐药基因(ARGs)丰度增加，增加环境中细菌的耐药性，从而威胁到抗生素对细菌感染的治疗。本文对头孢菌素类抗生素在环境(土壤、粪肥、水体)中的吸附、迁移、降解等行为、目前的残留情况以及对环境微生态的影响进行综述，引起人们对头孢菌素类抗生素在环境中的残留危害的重视。     

The role of pharmacokinetics in veterinary drug residues

This review provides a summary of those pharmacokinetic properties of veterinary drugs relevant to marker residues, marker tissues, and residue depletion rates. The scientific literature in this field is very extensive and there is also a wealth of data available on the websites of various regulatory jurisdictions. Therefore, this review is limited to selected examples, cited to illustrate general principles. The areas considered are: (1) the relationship of dose to plasma concentration through the pharmacokinetic properties, area under plasma concentration-time curve, bioavailability, and clearance; (2) the critical dependence of drug pharmacokinetics and residue depletion on product formulation; (3) disease state and population pharmacokinetics; and (4) the requirement for residue depletion studies for generic products shown to be bioequivalent to pioneer products.     

临床药物评价的意义和方法

近年来不断有新药及改变剂型或用途的老药投入临床使用.为了达到临床用药符合安全、有效、经济之目的,临床医生重视并学习临床药物评价的意义及方法是很有必要的.本文简要介绍了有关临床药物评价的概念和药物安全性、有效性、药物经济学、药剂学评价的基本方法.儿科临床药物评价的特点主要在于重视药物在小儿不同发育阶段的疗效与不良反应的差异,以及开展用无痛苦或最小痛苦手段对临床药物进行监测.     

药物不良反应及其监测工作现状

本研究分析了引起药物不良反应的相关因素及建议措施,强调加强药物不良反应监测工作的重要性,旨在提高医务人员合理使用药物的水平,从而降低药物不良反应的发生率。     

加强药品不良反应认识

护理安全是防范和减少医疗事故与纠纷的重要工作，从患者入院到出院，护理人员监护患者的药物治疗全过程，认识、发现和上报药物不良反应（ADR），对配合救治ADR病例和减少同类事件的发生有着举足轻重的意义和作用。     

医院药品库的科学化管理

医院药品库是医院工作的重要组成部分,是医院采购药品、供应药品、合理管理药品、保证药品质量安全有效的部门。加强药品库管理,确保药品质量,是保障患者用药安全的重要环节。如何管理好药品库,笔者仅提出一些看法与同行们进行探讨,希望把药品库管理提高到更高更新的水平,也是为了更好地为患者服务,为社会服务。     

244例药品不良反应报告分析

目的了解我院药品不良反应（ADR）发生的特点及规律。方法收集我院2009年1月1日至2009年12月31日上报至全国药品不良反应监测网络的244例ADR报告,进行回顾性统计分析。结果 244例ADR中女性多于男性,61岁以上的老年人组发生率为最高,其次为21～30岁年龄组;最易引发ADR的给药途径是静脉滴注;引发ADR最多的药物种类为抗微生物类,占63.93%;主要累及器官或系统为皮肤及其附件。结论应加强ADR知识的培训,对抗微生物药和中药注射剂使用时应重点监测,合理应用抗菌药物,减少ADR的发生。     

抗高血压药物不良反应118例报告

目的：总结分析抗高血压药物不良反应,探讨基层高血压管理中的要求,以提高患者的治疗依从性。方法回顾性总结118例高血压药物不良反应患者临床资料,将有关数据进行分类统计分析。结果118例患者中,男性43例,占36．4％;女性75例,占63．6％;女性多于男性,比例为1瞷1．74;其中50～69岁的患者明显多于其他年龄段,占62．2％;药物不良的发生率以钙离子拮抗剂（ CCB）为主,占54．1％;其次为血管紧张素Ⅱ受体拮抗剂（ ARB）占21.2％,ACEI占13．6％,复方制剂占9．3％,利尿剂占0．9％,β受体阻滞剂占0．9％;临床主要的不良反应为下肢水肿、面部潮红、头痛、乏力、咳嗽等症状。结论高血压的患病率女性高于男性,50～69岁患者高于其他年龄段;抗高血压药物的不良反应与患者的性别、年龄、药物种类有关,在抗高血压治疗时应合理选用。     

574例药物不良反应情况分析

目的：了解本院药物不良反应（ADRs）的发生情况。方法：对本院5年来收到的ADRs病例进行回顾性分析。结果：ADRs共涉及药物10余类74种，其中以抗感染药物比例最高；静脉滴注比例较其他给药途径多；临床表现以致皮肤及其附件损害比例最高。其次为消化系统。结论：ADRs可发生在任何年龄段人群，应加强合理用药的宣传及ADRs监测，以保证用药安全。     

西洛他唑致药物热1例

1例78岁老年男性,既往有糖尿病病史20余年,因双下肢麻木四月余入院。B超与cT检查结果均提示下肢动脉重度闭塞,予盐酸沙格雷酯片0．1gtid联合西洛他唑片100mgbid治疗。联合用药1d后,患者出现发热,体温升高至37．9℃。采用冰袋物理降温及予甲磺酸左氧氟沙星片抗感染治疗5d,体温波动于36．8～37．7℃。期间查血常规、胸片,结果提示感染可能性不大,考虑可能与药品相关。第六天停用与出现发热有时间关系的盐酸沙格雷酯片与西洛他唑片,第七天患者体温恢复至36．0～36．5℃,第八天患者再次服用西洛他唑片50mg后,体温再次升高至37．3℃,16h后体温降至正常。     

我国药品风险管理与药品不良反应监测

结合中国药品不良反应监测的现状,阐述了药品风险管理的具体内容,表明药品不良反应监测贯穿于药品风险管理的全过程,为加强中国药品风险管理研究提供参考。     

95例艾滋病患者药物不良反应的分析

目的:分析95例艾滋病(AIDS)患者的药物不良反应发生情况及特点。方法:采用回顾性分析方法,对95例药物不良反应报告涉及的患者年龄、性别、用药情况以及不良反应事件等进行分类统计。结果:95例药物不良反应中男性79例,女性16例,20⁴9岁之间82例;高效抗逆转录病毒治疗(HAART)药物不良反应发生率最高,占46.60%;临床表现以皮疹为主,其次为肝损伤;平均合并用药种类达15.46种。结论:AIDS患者个体情况特殊,易发生药物不良反应的因素较多,开展和加强药物不良反应监测,对保障此类患者的用药安全有重要意义。     

药品合理分类及药品监管制度在医院西药房管理中应用的意义

目的 探讨药品合理分类及药品监管制度在医院西药房管理中的应用价值.方法 以相关规定和药品说明书等为参考,对本院西药房的药品进行合理分类,并且加强药品监管制度.观察比较药品合理分类和加强药品监管制度改进前后各12个月（分别为2011、2012年全年）的药房差错率和患者满意度.结果 2011年1～12月的药房差错率为1.64％,患者满意度为80.31％;2012年1～12月的药房差错率为0.49％,患者满意率为97.83％;两个时间段的药房差错率和患者满意度比较,差异有统计学意义（P＜0.05）.结论 西药房管理中对药品进行分类,加强监督管理,可降低药房差错率,提高患者满意度.     

我国药品安全风险交流现状研究

目的探讨我国药品风险交流的现状,促进药品风险交流工作的开展,为下一步制定药品安全风险交流工作指南提供依据。方法通过查阅文献,检索我国相关法律法规,浏览官方网站等方式,分析我国目前药品风险交流的主要方式与途径,揭示目前存在的问题并提出完善我国药品安全信息交流的建议。结果与结论我国的药品风险沟通制度尚不完善,缺乏与之相配套的法律、法规。建议制定我国药品风险交流指南性文件;积极开展主管部门与医疗机构之间的交流研究;建立药品安全信息交流咨询委员会;实行多种形式的风险信息发布等。