Learn from the website of the Ministry of Health，The Ministry of Health released the "Administrative Measures for Clinical Application of Antibacterial Drugs" (Ministry of Health Order No. 84)，It will be implemented from August 1, 2012。The content of the full text is as follows:
"Administrative Measures for Clinical Application of Antibacterial Drugs" (Ministry of Health Order No. 84)
Chapter 1 Total
The first article To strengthen the management of the clinical application of antibacterial drugs in medical institutions，Standardize the clinical application behavior of antibacterial drugs，Improve the clinical application level of antibacterial drugs，Promote the reasonable application of antibacterial drugs，Control bacterial resistance，Safe medical quality and medical safety，According to relevant health laws and regulations，Formation of this method。
Two The antibacterial drugs referred to in this method refer to the treatment of bacteria、Icheella、Spiral、Like Body、Spiral、Drugs in the pathogenic disease caused by pathogenic microorganisms such as fungi and other pathogens，excluding the treatment of tuberculosis、Drugs of infectious diseases caused by parasitic diseases and various viruses, as well as Chinese medicine preparations with antibacterial effects。
Article 3 The Ministry of Health is responsible for the supervision and management of the clinical application of antibacterial drugs nationwide in the country。
The local health administrative department at or above the county level is responsible for the supervision and management of the clinical application of antibacterial drugs in medical institutions in the administrative region。
Article 4 This method is applicable to the clinical application management of antibacterial drugs at all levels and various medical institutions at all levels。
Article 5 The clinical application of antibacterial drugs should follow safety、Effective、Principles of Economy。
Article 6 The clinical application of antibacterial drugs is implemented for grading management。According to safety、Efficacy、Bacterial resistance、Price and other factors，Divided antibacterial drugs into three levels: non -restricted use level、Restricted use level and special use level。The specific division standard is as follows:
(1) Non -restricted use of antibacterial drugs refers to the safety of long -term clinical application.、Effective，It has less impact on bacterial resistance，Antibacterial drugs with relatively low prices;
(II) Restriction of use of antibacterial drugs refers to the safety of long -term clinical applications、Effective，It has a greater impact on bacterial resistance，or antibacterial drugs with relatively high price;
(3) Special -used antibacterial drugs refer to antibacterial drugs with one of the following circumstances:
1. Have obvious or serious adverse reactions，Antibacterial drugs that should not be used at will;
2. Need strict control of use，Anti -bacterial antibacterial drugs that avoid excessive bacteria;
3. Efficacy、Antibacterial drugs with less clinical data in safety;
4. Evital antibacterial drugs.
Antibacterial drug grading management directory is formulated by the provincial health administrative departments，Report the Ministry of Health File。
Chapter 2 Organization and responsibilities
Seventh The main person in charge of the medical institution is the first responsible person of the clinical application management of antibacterial drugs in the agency。
Article 8 Medical institutions shall establish a system of antibacterial drug management in this institution。
Article 9 Medical institutions shall set up antibacterial drug management institutions or equipped with specialty (partner) personnel responsible for the management of antibacterial drug management。
Hospitals above level or above、Maternal and Child Health Hospital and specialized disease prevention and control institutions (hereinafter referred to as hospitals above level 2) shall set up antibacterial drug management working groups under the Committee of Pharmaceutical Management and Drug Therapy。Antibacterial Drug Management Working Group is medical、Pharmacy、Infectious diseases、Clinical microorganisms、Nursing、The person in charge of the hospital infection management and other departments and the person with senior technical job qualifications with related majors，Medical Affairs、Pharmacy and other departments are responsible for daily management。
Other medical institutions set up an antibacterial drug management working group or designated specialty (part -time) personnel，Responsible for specific management work。
Article 10 The main responsibilities of a medical institution antibacterial drug management institution or specialty (part -time) personnel are:
(1) Implement laws related to the management of antibacterial drugs、Regulations、Regulations，Formulate the institutional antibacterial drug management system and organize implementation;
(II) Review the Catalog of Antibacterial Drug Supply of the Institution，Developed technical documents for clinical application of antibacterial drugs，Organize implementation;
(3) Monitor the clinical application of antibacterial drugs and bacterial resistance of the agency，Regular analysis、Evaluation、Report the monitoring data above and release relevant information，Put forward intervention and improvement measures;
(4) Antibacterial drug management of medical staff、Regulations、Regulations and technical specifications for training，Organizational propaganda and education on patients with antibacterial drugs reasonably。
Article 11 Hospitals above levels should set up infectious diseases，A professional physician with infectious diseases。
Professional physicians in the Department of Infectious Diseases and Infectious Diseases are responsible for technical guidance to the clinical application of antibacterial drugs in the clinical departments of the institution，Participate in the management of the clinical application of antibacterial drugs。
Article 12 Hospitals above stake sports betting applevels should be equipped with clinical pharmacists from related majors such as antibacterial drugs。
Clinical pharmacist is responsible for providing technical support for clinical application of antibacterial drugs in the agency，Instruct patients to use antibacterial drugs reasonably，Participate in the management of the clinical application of antibacterial drugs。
Article 13 Hospitals above levels should be according to actual needs，Establish a clinical microbiological room that meets the requirements of the biological safety requirements of the laboratory。
Clinical Microbiology Room develops microbes culture、separation、Appraisal and drug sensitive test，Provide pathogenic diagnosis and technical support for bacterial resistance，Participate in the management of the clinical application of antibacterial drugs。
Article 14 Health Administrative Department and Medical Institutions strengthen the construction of related disciplines involving antibacterial drug clinical application management，Establish a professional talent training and assessment system，Give full play to the role of relevant professional and technical personnel in the management of antibacterial drugs in the management of the clinical application of antibacterial drugs。
Chapter 3 The clinical application management of antibacterial drugs
Article 15 Medical institutions shall strictly implement the "Prescription Management Measures"、"Regulations on the Management of Medical Institutions"、"Principles of Antibacterial Drugs Clinical Application Guidance"、"National Prescription Collection" and other relevant regulations and technical specifications，Strengthen the selection of antibacterial drugs、Purchasing、Prescription、Adjustment、Management of clinical application and drug evaluation。
Article 16 Medical institutions shall be in accordance with the antibacterial drug grading management directory formulated by the provincial health administrative department，Formulate the institutional antibacterial drug supply directory，and filed with the health administrative department issued to the "Medical Institutional Practice License"。Antibacterial drug supply directory of medical institutions includes varieties of purchasing antibacterial drugs、Products。Unpacking antibacterial drugs、Products，Medical institutions must not purchase。
Article 17 Medical institutions shall strictly control the number of varieties of the agency's antibacterial drug supply directory。The same universal name antibacterial drug variety，Injection dosage type and oral dosage type must not exceed 2 types。Antibiotics with similar or the same pharmacological characteristics must not be repeatedly included in the supply directory。
Article 18 Medical institutions are indeed due to clinical work，The number of antibacterial drugs and the number of products exceeds the prescribed，The health administrative department shall explain the reasons and reasons in detail to the health administrative department issued by the "Medical Institutional Practice License";，The hygiene administrative department shall not accept the filing of its antibacterial drug varieties and quality regulations。
Article 19 Medical institutions shall regularly adjust antibacterial drug supply directory varieties，And within 15 working days after each adjustment, the health administrative department will be issued to the "Medical Institutional Practice License" for record。The adjustment cycle is in principle 2 years，The shortest must not be less than 1 year。
Article 20 Medical institutions shall purchase antibacterial drugs in accordance with the approved and announced drug name approved and published by the national drug supervision and management department，Prefer to choose "National Basic Drug Catalog"、"National Prescription Collection" and "National Basic Medical Insurance、Antibacterial Drug Variety。
Primary medical and health institutions can only choose antibacterial drugs in basic drugs (including provinces and regions and cities)。
Article 21 Antibacterial drugs for medical institutions shall be uniformly purchased and supplied by the pharmacy department，Other departments or departments shall not engage in the purchase of antibacterial drugs、Adjustment activity。Antibacterial drugs that are not purchased by non -pharmaceutical departments in the clinic。
Article 22 Due to special treatment needs，Medical institutions need to use the institutional institutional antibacterial drug supply directory，You can start a temporary procurement program。Temporary procurement shall apply to the clinical department for application，Explanation of applying for the name of antibacterial drugs、Format、Specification、quantity、Use objects and reasons，After reviewing and agreeing with the Antibacterial Drug Management Working Group of the Institution，Temporary purchase and use from the pharmacy department。
Medical institutions shall strictly control the variety and quantity of temporary procurement of antibacterial drugs，The same universal antibacterial drug variety starts temporary procurement procedures. In principle, it must not exceed 5 cases per year。If more than 5 cases，It should be discussed whether it is included in the institution's antibacterial drug supply directory。Adjusted the total number of antibacterial drug supply directory must not be increased。
Medical institutions shall temporarily procure antibacterial drugs every six months to the health administrative department of the "Medical Institutional Practice License" for the filing of the medical institution。
Article 23 Medical institutions shall establish a system of antibacterial drug selection and regular assessment system。
Selection of medical institutions and the introduction of antibacterial drugs，The application report shall be submitted by the clinical department，After the pharmacy department puts forward opinions，Review of the Antibacterial Drug Management Working Group。
Antibacterial Drug Management Working Group for more than two -thirds of members for review and consent，And more than two -thirds of the members of the Committee of Pharmaceutical Management and Drug Therapy can be included in the purchase and supply directory after reviewing and agreed。
Antibacterial Drug Variety or Pinerial Regulations There are hidden safety hazards、The efficacy is uncertain、High resistance rate、Poor cost -effective or illegal use，Clinical Department、Pharmacy Department、Antibacterial Drug Management Working Group can propose to retreat or replace opinions。Clear opinion opinions after more than one -half of the Antibacterial Drug Management Working Group agree to execute，Reported to the Pharmaceutical Management and Drug Therapy Committee for the record; replaced the opinions of the pharmaceutical management and drug therapy committee for discussion。
Clear or replaced antibacterial drug varieties or regulations In principle, it is not allowed to re -enter the institutional antibacterial drug supply directory。
Article 24 Doctors with senior professional and technical positions，It can be awarded the prescription right of special use of antibacterial drugs; physicians with qualifications for professional and technical positions above the intermediate level，Can be awarded the prescription right to restrict the use of antibacterial drugs; physicians with primary professional and technical positions，Township、My stake betting appNational Township、Town、The village's medical institutions in the village independently engage in practicing assistant physicians and rural doctors，It can be awarded non -restricted use of antibacterial drug prescription rights。After training and assessment of the pharmacist，Fang can get the qualifications of antibacterial drugs。
Hospitals above levels shall regularly conduct the training of antibacterial drug clinical application knowledge and standardized management of doctors and pharmacists。After the physician was trained and passed by the institution, the doctor was qualified，Fang can get the corresponding prescription right。
Other medical institutions who enjoy prescription rights in accordance with the law、Village doctors and pharmacists engaged in prescription agents，Organize related training from local health administrative departments at or above the county level、Assessment。Qualified for assessment，Given the corresponding antibacterial drug prescription right or qualification for antibacterial drugs。
Article 25 Antibacterial drug clinical application knowledge and standardized management training and assessment content shall include:
(1) "Drug Management Law"、"Practicing Physician Law"、"Administrative Measures for Clinical Application of Antibacterial Drugs"、"Prescription Management Measures"、"Regulations on the Management of Medical Institutions"、"Principles of Antibacterial Drugs Clinical Application Guidance"、"National Basic Medicine Prescription Collection"、"National Prescription Collection" and "Standards for Hospital Prescription Review Management (Trial)" and other related laws、Regulations、rules and specification documents;
(2) The clinical application and management system of antibacterial drugs;
(3) Pharmacological characteristics and precautions for commonly used antibacterial drugs;
(4) Drug -resistant trends and control methods of common bacteria;
(V) Prevention and control of adverse antibacterial drugs.
Article 26 Medical institutions and medical personnel shall strictly grasp the testimony of using antibacterial drugs to prevent infection。Prevention、Treatment of mild or local infection should be preferred by non -restricted use of antibacterial drugs; severe infection、Low immune function is low infected or pathogenic bacteria are only sensitive to restricting the use of antibacterial drugs，Fang can choose restricted use of antibacterial drugs。
Article 27 Strictly control the use of special use of antibacterial drugs。Special use -level antibacterial drugs must not be used in the clinic。
Clinical application of special use of antibacterial drugs should strictly grasp the drug use syndrome，After consultation and consent of the professional and technical personnel designated by the Antibacterial Drug Management Working Group，Publication of a prescription with corresponding prescription physicians。
Special use -class antibacterial drug consultants are infectious diseases with experience in the clinical application of antibacterial drugs、Respiratory Department、Severe Medicine Division、Microbiology Examination Department、Pharmaceutical Department and other physicians with senior professional and technical positions、Pharmacist or antibacterial drug professional clinical pharmacist with senior professional and technical positions。
Article 28 Emergency situations such as patients with dying life，Doctors can use antibacterial drugs。Antibacterial drugs should be recorded in detail in detail，and should be supplemented by the necessary procedures for using antibacterial drugs in 24 hours。
Article 29 Medical institutions shall formulate and strictly control the proportion of antibacterial drugs with intravenous infusion of outpatient patients。
Village Clinic、Clinic and community health service stations use antibacterial drugs to carry out intravenous infusion activities，It should be approved by the county -level health administrative department。
Article 30 Medical institutions shall carry out monitoring of clinical application of antibacterial drugs，Analyze the use of antibacterial drugs in the agency and clinical departments，Evaluate the use of antibacterial drugs; analyze the trend of anti -bacterial drugs，Unreasonable use of antibacterial drugs should be taken in time in time。
Article 31 Medical institutions shall reasonably choose antibacterial drugs。The test results of clinical microbial specimens were not issued，Medical institutions can choose antibacterial drugs，Clinical microbial specimen test results are adjusted accordingly after the test results are issued。
Article 32 Medical institutions should carry out bacterial resistance monitoring work，Establish a bacterial and drug -resistant warning mechanism，and take the following corresponding measures:
(1) Antibacterial drugs with the main target bacterial resistance rate of more than 30%，The early warning information is reported to the institutional medical staff in time;
(2) Antibacterial drugs with the main target bacterial resistance rate of more than 40%，Should be carefully experienced medicine;
(3) Antibacterial drugs with the main target bacterial resistance rate of more than 50%，Should be selected by reference to the results of the drug sensitivity test;
(4) Antibacterial drugs with the main target bacterial resistance rate of more than 75%，The clinical application of bacteria for this target should be suspended，According to the monitoring results of tracking bacterial resistance，Determine whether to restore clinical applications。
Article 33 Medical institutions shall establish a ranking of the clinical application of antibacterial drugs in this institution、Internal publicity and reporting system。
Medical institutions shall use antibacterial drugs for clinical departments and medical staff、Use the usage rate and intensity of usage and make internal publicity; criticize and educate physicians who rank after ranking or discover serious problems，The situation is seriously notified。
Medical institutions shall summarize the clinical application of the clinical department and medical staff in accordance with the requirements，Report to the health administrative department issued to the "Medical Institutional Practice License" issued。The clinical application of non -restricted use of antibacterial drugs，Report once a year; restrict the clinical application of the use level and special use of antibacterial drugs，Report once every half a year。
Article 34 Medical institutions should make full use of informationization methods to promote the reasonable application of antibacterial drugs。
Article 35 Medical institutions shall conduct surveys on the abnormal situation of the following clinical application of antibacterial drugs，and deal with it according to different situations:
(1) Antibacterial drugs with abnormally increased amounts of usage;
(2) Antibacterial drugs that have always ranked at the forefront within half a year;
(3) Frequently super indications、Antibacterial drugs used by ultra -dose;
(4) Antibacterial drugs sold by enterprises illegally;
(5) Antibacterial drugs that frequently occurred in severe adverse events。
Article 36 Medical institutions should strengthen the production of antibacterial drugs、Management of the sales behavior of operating enterprises in the institution，Enterprises that exist stake online sports bettingin improper sales，Should take a timely suspension of medicine、Clear retirement and other measures。
Chapter 4 Supervision and Management
Article 37 The health administrative department at or above the county level shall strengthen the supervision and inspection of the clinical application of antibacterial drugs in medical institutions in the administrative region。
Article 38 Staff of the Health Administrative Department supervised and inspected the clinical application of antibacterial drugs in medical institutions in accordance with the law，Delivery should be presented，The medical institution of the inspection should be cooperated，Provide the necessary information，Do not refuse、Obstacles and concealment。
Article 39 Local health administrative departments at or above the county level shall establish a medical institution's antibacterial drug clinical application management evaluation system。
Article 40 Local health administrative departments at or above the county level shall establish the ranking of the clinical application of antibacterial drugs、Announcement and Admissions Talking System。The use of antibacterial drugs in medical institutions in this administrative area、Usage and use intensity is ranked，announced the ranking situation to the medical institution in the administrative area，and report to the higher -level health administrative department for the record;、The person in charge of various medical institutions at all levels of medical quality and safety incident or serious medical quality and safety hazards in the special medical quality and safety hazards conducts admonitions，The situation is seriously notified。
Article 41 The county -level health administrative department is responsible for the township and township hospital of the district、Community Health Service Center (station) use antibacterial drugs、Usage and other situations rank and publicize。
Entrusted by the county -level health administrative department，Township Health Center is responsible for the use of antibacterial drugs in the villages of the villages in the area、Usage and other situations rank and publicize，Report to the county -level health administrative department。
Article 42 The Ministry of Health establishes the national antibacterial drug clinical application monitoring network and the national bacterial resistance monitoring network，Monitor the clinical application and bacterial resistance of antibacterial drugs nationwide; regularly announce the clinical application control indicators of antibacterial drugs according to the monitoring situation，Carry out the quality management and control of the clinical application of antibacterial drugs。
Provincial Health Administrative Department shall establish a clinical application monitoring network and bacterial resistance monitoring network in this administrative area，Monitor the clinical application of antibacterial drugs and bacterial resistance of medical institutions，Carry out the quality management and control of the clinical application of antibacterial drugs。
The clinical application of antibacterial drugs and bacterial resistance monitoring technology solutions will be formulated separately by the Ministry of Health。
Article 43 The health administrative department shall incorporate the clinical application of antibacterial drugs in the medical institution into the evaluation index system of the medical institution;、Judging、Evaluation important indicators，The assessment is not qualified，Downs relegation to medical institutions depending on the situation、Downshop、Evaluation is not qualified to deal with。
Article 44 Antibacterial drug management institutions of medical institutions shall regularly organize relevant professional and technical personnel to counter antibacterial drug prescriptions、Review of the Implementation of the doctor's order，and the results of the review as a regular assessment of the physician、Clinical Department and Medical Personnel Performance Evaluation Basis。
Article 45 Medical institutions shall be warned to physicians who have more than 3 times of antibacterial drugs 3 times and have no proper reasons，Restricting its special use level and restrictions on the prescription right of the use of antibacterial drugs。
Article 46 One of the following situations in the doctor，Medical institutions shall cancel its prescription right:
(1) If the antibacterial drug assessment is not qualified;
(2) After restricting the prescription right，There is still an extraordinary prescription and no proper reasons;
(3) The prescription of antibacterial drugs is not prescribed in accordance with regulations，Caused serious consequences;
(4) No antibacterial drugs are not used in accordance with regulations，Caused serious consequences;
(5) The prescription of antibacterial drugs is prescribed for improper benefits。
Article 47 The pharmacist did not review the prescription of antibacterial drugs and medication in accordance with the regulations，Caused serious consequences，or found that the prescription is not suitable、Ultra -constant prescriptions, etc., have not intervened and have no legitimate reasons，Medical institutions should cancel their drug adjustment qualifications。
Article 48 Physician's prescription rights and pharmacist drug transfer qualifications cancellation，It must not restore its prescription rights and drug adjustment qualifications in six months。
Chapter 5 Legal liability
Article 49 Medical institutions have one of the following situations，from the health administrative department at or above the county level to order correction within a time limit;，Report criticism，and give warning; cause serious consequences，Responsible supervisors and other direct responsible persons，Give punishment:
(1) If the Organization of Antibacterial Drug Management Organization is not established or the professional and technical personnel who have not been designated (partner) are responsible for the specific management work;
(2) If the rules and regulations of antibacterial drugs have not been established;
(3) The clinical application of antibacterial drugs is chaotic;
(4) Failure to implement antibacterial drug classification management in accordance with these Measures、Doctor's antibacterial drug prescription authority management、Pharmacists' antibacterial drug transfer qualification management or is not equipped with relevant professional and technical personnel;
(5) Other violations of acts stipulated in these Measures.
Article 50 Medical institutions have one of the following situations，from the health administrative department at or above the county level to order correction within a time limit，Give warning，And can be fined less than 30,000 yuan according to the seriousness of the circumstances;，You can give a punishment according to the plot:
(1) Doctors who have not obtained the prescription of antibacterial drugs or doctors who have canceled antibacterial drug prescriptions are prescribed by antibacterial drugs;
(2) No antibacterial drug prescription、Appropriate audit of the doctor's order，The plot is serious;
(3) The non -pharmacy department is engaged in the purchase and sale of antibacterial drugs、Adjusting activity;
(4) Purchase antibacterial drugs for sale、The clinical application is linked to the economic interests of the individual or the department;
(5) Purchase of antibacterial drugs、Clinical applications to get improper interests。
Article 51 The person in charge of the medical institution、Drug purchaser、Physician and other relevant personnel to ask for、Receive drug production enterprises、Drug operating enterprises or the property given by its agent or the improper benefits of the antibacterial drugs，The local health administrative department at or above the county level is processed in stake betting appaccordance with relevant national laws and regulations。
Article 52 Doctors have one of the following situations，The health administrative department at or above the county level shall be in accordance with the relevant provisions of Article 37 of the Practicing Physician Law，Give warning or order to suspend the practice activities for more than six months or less;，A revocation of its practice certificate;，Criminal responsibility in accordance with the law:
(1) No antibacterial drug prescription is not prescribed in accordance with the provisions of these Measures，Caused serious consequences;
(2) Use antibacterial drugs that have not been approved by the national drug supervision and management department;
(3) Use the variety other than the supply of antibacterial drug supply directory、Products，Caused serious consequences;
(4) Violation of other provisions of these Measures，Caused serious consequences。
Rural doctors have one of the stipulated situations in the previous paragraph，The county -level health administrative department shall be handled in accordance with Article 38 of the "Regulations on the Management of Rural Physicians"。
Article 53 of the pharmacist has one of the following situations，from the health administrative department at or above the county level to order correction within a time limit，Give warning; constitutes a crime，Criminal responsibility in accordance with the law:
(1) No review in accordance with regulations、Adjusting antibacterial drug prescription，The plot is serious;
(2) If the antibacterial drug varieties or rules are not added in accordance with regulations;
(3) Violation of other provisions of these Measures.
Article 54 Unproocked by the county -level health administrative department，Village Clinic、Clinic、Community Health Service Station uses antibacterial drugs to carry out intravenous infusion activities，from the local health administrative department at or above the county level to order correction within a time limit，Give warning;，You can fined 10,000 yuan under 10,000 yuan according to the plot。
Article 55 Local health administrative departments at or above the county level have not fulfilled supervision responsibilities in accordance with these Measures，Caused serious consequences，The direct responsible supervisor and other directly responsible persons will give a lot of over、Dowager downgrade、Withdrawal、Fleement and other administrative sanctions。
Article 56 Medical institutions and their medical staff violated the Drug Management Law，Handling in accordance with the relevant provisions of the Drug Management Law。
Chapter 6 Attachment
Article 57 State Traditional Chinese Medicine Management Department is responsible for the supervision and management of the clinical application of antibacterial drugs in traditional Chinese medicine medical institutions。
Article 58 Provincial health administrative departments should be within 3 months from the date of the release of these measures，Formulate the hierarchical management directory of antibacterial drugs in this administrative area。
Article 59 This method will be implemented from August 1, 2012.
