对《抗菌药物临床应用管理办法(征求意见稿)》第2稿有关问题的探讨

Discussion on the Second Draft of Control Measure for Clinical Application of Antimicrobial Drugs(Consultative Paper)

目的:为《抗菌药物临床应用管理办法(征求意见稿)》第2稿(下简称《办法》第2稿)的修订及后续正式规定的顺利实施和指导临床合理用药提供参考依据。方法:依据国家现有的法律法规以及抗菌药物临床使用现状和基本国情,研究影响《办法》第2稿相关要求执行的难点和问题,并提出建议。结果与结论:《办法》第2稿主要问题包括对品种数限定作用存在不确定性、削弱药师对抗菌药物合理使用的监管力度、对于执业医师抗菌药物处方权的限制缺乏法律依据、以"造成严重后果"为条件的行政处罚规定缺乏可行性、组织体系设置疏漏影响《办法》第2稿的落实、抗菌药物调整时间过长易加重细菌耐药、基础项目设置用词欠严密且个别规定欠合理。建议规章制定机关依据国家《规章制定程序条例》,适当进行修订,尽快使其个别相应内容的逻辑严密、用语准确,条文概念内容规范合理、具体,具有可操作性,以促进其后续正式规定的实施和执行。

OBJECTIVE： To provide reference for smooth implementation of the second draft of Control Measure for Clinical Application of Antimicrobial Drugs （Consultative Paper ） （called Control Measure for short） and rational use of drugs in the clinic. METHODS： Based on relevant state laws, regulations and the clinical application of antimicrobial drugs and basic national condi- tions, the difficulties and problems of the implementation requirement of the second draft of Control Measure were studied and sug- gestions were put forward. RESULTS ＆ CONCLUSIONS： Main problems of the second draft of Control Measure are as follows： the limit effect of Control Measure on drug quantities is uncertain; the supervision of pharmacists on rational use of antimicrobial drugs is weakened; the limits on antimicrobial drugs prescription right of licensed physicians lack of legal basis; administrative pen- alty on the basis of ＂resulting in serious result＂ is not feasible; the leak of organization and system influences the implementation of the second draft of Control Measure; the adjustment of antimicrobial drugs lasts for too long time, which could result in the gen- eration of tolerant bacterial strains; inexact item of primary project and individual inappropriate regulations. It suggests that authori- ties revise rules and regulations probably according to Procedures for Regulation Formulation, promote the strict logic of individual corresponding contents as soon as possible, accurate and reasonable language, reasonable and specific concept of provisions with maneuverability to improve the implementation of following official regulation.