Department Veterinary Drugs, Federal Office of Consumer Protection and Food Safety (BVL), Berlin, Germany.
PLoS One. 2020 Aug 10;15(8):e0237459. doi: 10.1371/journal.pone.0237459. eCollection 2020.
A surveillance system for sales volumes of antimicrobial agents for veterinary use was established in Germany in 2011. Since then, pharmaceutical companies and wholesalers have been legally obliged to report annual volumes of veterinary antimicrobial products sold to veterinary practices or clinics located in Germany. The evaluation of sales volumes for eight consecutive years resulted in a considerable total decrease by 58% from 1706 tons to 722 tons. During the investigation period, two legally binding measures to control the risk of antimicrobial resistance resulting from the veterinary use of antimicrobials were introduced, a) the German treatment frequencies benchmarking in 2014 and b) the obligation to conduct susceptibility testing for the use of cephalosporins of the 3rd and 4th generation and of fluoroquinolones in 2018. Both had a marked impact on sales volumes. Nonetheless, the category of Critically Important Antimicrobials as defined by the World Health Organization kept accounting for the highest share on sales volumes in Germany in 2018 with 403 tons, despite an overall reduction by 53%. Sales surveillance is considered essential for data retrieval on a global scale and inter-country comparison. However, the usability of a surveillance system based on sales data for risk management of antimicrobial resistance has limitations. The German system does not include off-label use of antimicrobial products authorized for human medicine and does not allow for identification of areas of high risk according to animal species, farm and production types and indications for treatment. For further reduction and enhanced promotion of a prudent use of antimicrobials, targeted measures would be required that could only be deducted from use data collected at farm or veterinary practice level. A surveillance system based on use data is currently lacking in Germany but will be established according to Regulation (EU) 2019/6 on veterinary medicinal products.
德国于 2011 年建立了兽用抗菌药物销售数量监测系统。自此，制药公司和批发商依法有义务报告每年向位于德国的兽医诊所或兽医医院销售的兽用抗菌产品数量。连续八年对销售量进行评估，结果显示总销售量从 1706 吨大幅下降 58%，至 722 吨。在此期间，德国引入了两项具有法律约束力的控制兽用抗菌药物使用产生抗药性风险的措施，a）2014 年德国治疗频率基准测试，b）2018 年规定必须对第三代和第四代头孢菌素和氟喹诺酮类药物的使用进行药敏试验。这两项措施都对销售量产生了显著影响。尽管如此，世界卫生组织定义的“关键抗菌药物”类别在 2018 年仍占德国销售量的最高份额，为 403 吨，尽管总体减少了 53%。销售监测被认为是全球范围内检索数据和国家间比较的必要手段。然而，基于销售数据的抗药性风险管理监测系统的可用性存在局限性。德国系统不包括人用抗菌药物的标签外使用，也无法根据动物种类、农场和生产类型以及治疗适应症识别高风险领域。为了进一步减少并加强促进审慎使用抗菌药物，需要采取有针对性的措施，这些措施只能从农场或兽医诊所层面收集的使用数据中推断出来。德国目前缺乏基于使用数据的监测系统，但根据关于兽用药品的法规（EU）2019/6 将建立该系统。
