Contents of the Management Measures for Clinical Application of Antimicrobial Drugs
Article 1 Antimicrobial drugs as mentioned in these Measures refer to drugs used to treat infectious diseases caused by pathogenic microorganisms such as bacteria, mycoplasma, chlamydia, rickettsiae, spirochetes, fungi, etc., excluding the treatment of tuberculosis, parasitic diseases, and infections caused by various viruses. Disease drugs and traditional Chinese medicine preparations with antibacterial effects.
Article 2 The Ministry of Health is responsible for the supervision and management of the clinical application of antimicrobial drugs in medical institutions nationwide.
Local health administrative departments at or above the county level are responsible for the supervision and management of the clinical application of antimicrobial drugs in medical institutions within their respective administrative regions.
Article 3 These measures apply to the clinical application management of antimicrobial drugs in all types of medical institutions at all levels.
Article 4 The clinical application of antibacterial drugs should follow the principles of safety, effectiveness and economy.
Article 5 The clinical application of antibacterial drugs is subject to hierarchical management. According to safety, efficacy, bacterial resistance, price and other factors, antibacterial drugs are divided into three levels: unrestricted use level, restricted use level and special use level. The specific classification criteria are as follows:
(1) Non-restricted-use antibacterial drugs refer to antibacterial drugs that have been proven to be safe and effective through long-term clinical use, have little impact on bacterial resistance, and are relatively low-priced;
(2) Restricted-use antibacterial drugs refer to antibacterial drugs that have been proven safe and effective through long-term clinical use, have a greater impact on bacterial resistance, or are relatively expensive;
Responsibilities of the Management Measures for Clinical Application of Antimicrobial Drugs
The main responsibilities of the antimicrobial drug management organization or full-time (part-time) personnel in medical institutions are:
(1) Implement laws, regulations and rules related to antimicrobial drug management, formulate the institution’s antimicrobial drug management system and organize its implementation
(2) Review the institution’s antimicrobial drug supply catalog, formulate technical documents related to the clinical application of antimicrobial drugs, and organize implementation
(3) Monitor the clinical application of antimicrobial drugs and bacterial resistance in the institution, regularly analyze, evaluate, and report monitoring data and release relevant information, and propose intervention and improvement measures
(4) Provide training to medical staff on laws, regulations, rules and technical standards related to antimicrobial drug management, and organize publicity and education on the rational use of antimicrobial drugs for patients.
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