曲马多复方制剂监管现状研究

Research on the Status Quo of the Regulation of Compound Tramadol

目的介绍国际曲马多复方制剂滥用情况,总结各国对曲马多复方制剂的监管经验,以期为中国曲马多复方制剂的监管提供思路。方法通过文献阅读法、对比分析法就各国滥用现状、监管现状、监管手段等方面进行归纳比较。结果对比国际经验,我国曲马多单复方制剂存在管制级别差异;缺乏全面的处方监测;曲马多复方制剂说明书成瘾性表述不完善;医护人员滥用知识培训有限。结论建议调整我国曲马多复方制剂管制级别;完善药物滥用监测系统,建立药品信息化追溯体系;修改药品说明书,增加成瘾性的风险提示;加强药物滥用风险知识的宣传与培训。

Objective To summarize supervision experiences in various countries with an eye to providing ideas for China on basis of introducing current status of compound tramadol abuse worldwide.Methods To Summarize and compare the abuse status,supervision situations and measures,etc.in various countries through literature review.Results In comparison with foreign experiences,China was confronted with the following problems:differentiation of control level for tramadol and its compound preparations,lack of comprehensive surveillance on prescription,inadequate description of addiction in the package insert,limited knowledge of drug abuse of healthcare professionals.Conclusion China should make efforts to uniform control level for all tramadol containing preparations,set up medication tracking system,revise the package insert to emphasis the risk of addiction and strengthen awareness and training on risks of drug abuse.