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The antibacterial drugs for clinical use to manage the way "(health decree no.113)

 

 

Health ministry of China www.moh.gov.cn the 2012-05-08 12:52:56

 

 

No. 84

 

        The antibacterial drugs in clinical application management approach "has been in February 2012 to 13 the nikkei BuWuHui adopted by the health ministry, are hereby promulgated, since 2012 as of August 1,.

 

Department long ChenZhu

 

Two ○ 12 years April 24,

 

 

 

The first chapter is always

 

 

 

        Article 1 in order to strengthen the medical institutions antibacterial drugs for clinical use management and standardize the antibacterial drugs for clinical use behavior, improve the antibacterial drugs for clinical use level and promoting rational clinical application of antimicrobial agents, control bacterial resistance and ensuring medical quality and the safety of medical treatment, according to relevant health laws and regulations.

 

        Article 2 the term "antibacterial drugs is to point to the treatment of bacteria, mycoplasma, chlamydia, rickettsia, helicoid, fungi and pathogens of infectious diseases caused by pathogenic drugs, not including treatment for tuberculosis, parasites, and all kinds of virus of infectious diseases caused by drugs and has antibacterial effect of the Chinese medicine preparations.

 

        Article 3 the ministry of medical institutions shall be responsible for the clinical application of antimicrobial drug supervision and management.

 

        Local public health administrative department at or above the county level shall be responsible for the medical institution in the administrative areas of antimicrobial drugs for clinical use the supervision and management.

 

        Article 4 these measures shall apply to all kinds of medical institutions at various levels antibacterial drugs in clinical application management.

 

        Article 5 the antibacterial drugs for clinical use safe, effective, shall follow the principle of economy.

 

        Article 6 the antibacterial drugs for clinical use grading management. According to safety, efficacy, bacteria resistant, price and other factors, will be divided into three antimicrobial drugs: the level limit the use, limiting the use of class and special use level. The division standard specific as follows:

 

        (a) the level limit the use of antibacterial drugs is to point to the long-term clinical application proved safe, effective, and bacteria resistant to less effect, the price is relatively low antibacterial drugs;

 

        (2) the level limit the use of antibacterial drugs is to point to the long-term clinical application proved safe, effective, and bacteria resistant to greater influence, or the price of relatively high antibacterial drugs;

 

        (3) special use antimicrobial level is to point to has the following circumstances antibacterial drugs:

 

        1. Have obvious or serious adverse reactions, should not be free to use antibacterial drugs;

 

        2. Need to strictly control the use, avoid too resistant bacteria produce antibacterial drugs;

 

        3. Therapeutic effect, safety aspects of the clinical data of less antimicrobial;

 

        4. Expensive antiviral drugs.

 

        Antimicrobial drug classification management by each provincial directory developed by the health authorities, submitted to the ministry of public health for the record.

 

 

 

The second chapter organization and responsibility

 

 

 

        Article 7 main person in charge of the medical institution is antibacterial drugs in clinical application management organization of the first owner.

 

        Article 8 a medical institution shall establish this organization management system antimicrobial drugs.

 

        Article 9 the medical institutions shall establish a management office antimicrobial drugs or have designed (and) job personnel shall be responsible for the management of the agency antimicrobial drugs.

 

        The second class above hospitals, maternity and child care centers for disease control and prevention and the specialized subject institutions (hereinafter referred to as the second class above hospital) ought to be in pharmacy management and drug treatment learning committee set up under the antimicrobial management teams. Antibacterial drugs management by medical, pharmaceutical, the working group to infectious diseases, clinical microbes, nursing, hospital infection such as management director and have relevant professional technical position qualified personnel composition, medical, pharmaceutical and other departments jointly responsible for the daily management work.

 

        Other medical institutions antimicrobial management working group established or designated designed (and) job personnel, responsible for specific management work.

 

        Article 10 medical institutions antibacterial drugs management institution or designed (and) job personnel is the primary responsibility of the:

 

        (a) implement antibacterial drugs management related laws, regulations and rules, the regulations antimicrobial drug agency management system and organize the implementation;

 

        (2) reviewing antimicrobial this institution supply catalogue, formulate the antibacterial drugs for clinical use relevant technical documents, and organize the implementation;

 

        (3) antimicrobial drugs for clinical use this institution and the bacterial drug resistance monitoring, regular analysis, evaluation, report and related information monitoring data released, put forward the intervention and improvement measures;

 

        (4) the medical personnel to antimicrobial management related laws, regulations, and rules and regulations and technical standard training, the organization to patients rational use of antimicrobial agents in the promotion of the education.

 

        Article 11 the second class above shall be set up infectious diseases department hospital, equipped with infectious disease professional doctor.

 

        Infectious diseases department and infectious diseases professional doctor responsible for the clinical departments this institution antimicrobial clinical application technical guidance, and participate in clinical application of antimicrobial management work.

 

        Article 12 the second class above hospital antimicrobial drugs shall be equipped with related professional clinical pharmacist.

 

        The clinical pharmacists this agency responsible for antibacterial drugs in clinical application to provide technical support and guide the rational use of antimicrobial agents patients, participate in clinical application of antimicrobial management work.

 

        Article 13 the second class above hospital should according to actual needs, set up a laboratory biological safety requirements of clinical microbial room.

 

        Clinical microbial room in microorganism training and isolation, identification and drug susceptibility testing, etc, to provide etiologic diagnosis and bacteria resistant technical support and participate in the antibacterial drugs in clinical application management.

 

        Article 14 the administrative department of public health and medical institutions involved strengthening antimicrobial clinical application management related disciplines construction, establishment of professional personnel training and assessment system, give full play to the relevant professional technical personnel in the antibacterial drugs in clinical application management work in the role.

 

 

 

In the third chapter antibacterial drugs in clinical application management

 

 

 

        Article 15 a medical institution shall strictly carry out the prescription management method ", "the medical treatment organization pharmacy management regulation", "the antibacterial drugs for clinical use guiding principle", "the national prescription set", and other relevant regulations and technical standards, strengthen the selection, purchase, antimicrobial prescription, dispensing and clinical application and drug evaluation of management.

 

        Article 16 medical institutions shall, according to the provincial health administrative departments of antimicrobial drug classification management directory, make this institution supply antimicrobial catalogue, and issued to the "practice license of medical institution" health administrative departments for the record. Medical institutions antibacterial drugs supply the directory includes procurement of antibacterial agents varieties, product rules. The record of the antibacterial drugs without the variety, quality rules, a medical institution shall not purchase.

 

        Article 17 a medical institution shall strictly control the organization of antimicrobial supply directory number of varieties. The same generic names antimicrobial drug varieties, preparation and oral dosage form each injection shall not exceed 2 kinds. Has the similar or the same pharmacology characteristics of antimicrobial agents shall not be repeated in supply directory.

 

        Article 18 the medical institution really due to the clinical needs, antimicrobial agents and product variety rules in excess of the prescribed quantity shall be issued to the "practice license of medical institution" the administrative department of health causes and reasons for detailed instructions; How not fully or reason not established, the health administrative departments shall not accept their antimicrobial drug varieties and product the number of rules for the record.

 

        Article 19 a medical institution shall adjust regularly antimicrobial supply directory variety structure, and in every time after adjustment 15 working days of its issued the "practice license of medical institution of the health administrative departments for the record. The adjustment period in principle for 2 years, the shortest shall not be less than 1 year.

 

        Article 20 the medical institutions shall, in accordance with the national drug supervision and administration department for approval and promulgated by the generic name antimicrobial drug purchases, first choose the national basic drugs directory ", "the national prescription set" and "the national basic medical insurance, inductrial injury insurance and maternity insurance directory of drugs included antiviral drugs varieties.

 

        Basic medical and health institutions can only choose basic drugs (including the provincial supplemented varieties) the antibacterial drugs varieties.

 

        Article 21 the medical institutions shall be pharmaceutical department antimicrobial drugs by unified purchase and supply, and other department or agency shall not be engaged in antimicrobial drugs procurement, dispensing activities. The clinical use of pharmacy department shall not purchase and supply of antibiotic drugs.

 

        Article 22 for special treatment need, medical institutions need to use this institution supply directory antimicrobial outside of antibacterial agents, can trigger temporary purchasing program. Temporary purchasing by clinical departments shall apply for buying that antimicrobial names, types, specifications, quantity, use object and use reasons and approved by the agency antibacterial drugs management examination and approval of the working group, the pharmacy department temporary one-time buy used.

 

        A medical institution shall strictly control the temporary purchasing antibacterial drugs category and quantity, the same general antimicrobial varieties of temporary purchasing procedures a year starting in principle shall not exceed 5 cases of times. If more than 5 cases of times, to discuss whether the agency should be included in the directory antimicrobial drug supply. After the adjustment antibacterial drugs supply directory number shall not increase total varieties.

 

        A medical institution shall every half year will antibacterial drugs to the temporary purchasing issued the "practice license of medical institution of the health administrative departments for the record.

 

        Article 23 a medical institution shall establish the selection and antimicrobial drugs regularly evaluation system.

 

        The selection of medical institutions and introduce new varieties of antimicrobial drugs, it shall submit the application report by clinical departments, the pharmacy department put forward advice, antimicrobial management review by the working group.

 

        More than two-thirds of antimicrobial management working group members agreed to review, and after the pharmacy management and drug treatment learn more than two-thirds of the committee members examine and verify agrees rear can included in the purchase and supply directory.

 

        Antibacterial drugs or product variety rules unsafe, curative effect not sure, high resistance, the cost performance or illegal poor use, clinical departments, and pharmacy department, antibacterial drugs management working group can put forward to repel or to replace the opinion. To repel the opinion antimicrobial management working group members agree to more than half the execution, and report to the pharmacy management and drug treatment learning committee for the record; Replace the pharmacy management opinions and drug treatment to learn the committee through before implementation.

 

        To repel or to replace the antiviral drugs varieties or product rules in principle 12 months not to enter this institution supply directory antimicrobial drugs.

 

        Article 24 with senior professional technical position qualified physicians, will be awarded in the special use level ChuFangQuan antimicrobial drugs; With intermediate, the above professional technical position qualified physicians, will be awarded in the level limit the use of antimicrobial ChuFangQuan; Has primary professional technical position qualified physician, in townships, nationality townships, and towns, in the village of medical institutions engaged in general independent assistant practicing doctors practising activities and village doctor, can award the level limit the use of antibacterial drugs ChuFangQuan. By training and passed the examinations of the pharmacist, can receive antimicrobial drug dispensing qualification.

 

        The second class above hospital for doctors and pharmacists shall regularly on antibacterial drugs for clinical use knowledge and standardized management training. By the institutions and physician training after assessment is eligible, will obtain corresponding ChuFangQuan.

 

        Other medical institutions shall enjoy ChuFangQuan physician, rural doctors and engaged in the work of the prescription dispensing medicine guru, by the local public health administrative department at or above the county level shall organize relevant training and performance. The examinations, awarded the corresponding antimicrobial ChuFangQuan antimicrobial drugs or adjust qualification.

 

        Article 25 the antibacterial drugs for clinical use knowledge and standardized management training and assessment contents should include:

 

        (a) "drug administration law and the practice YiShiFa", "the antibacterial drugs in clinical application management method", "prescription management method", "the medical treatment organization pharmacy management regulation", "the antibacterial drugs for clinical use guiding principle", "the national basic drug formularies", "the national prescription set" and "the hospital prescription comment on standard management (try out)", and other relevant laws, regulations, rules, regulations and normative documents;

 

        (2) antimicrobial drugs in clinical application and management system;

 

        (3) commonly used antimicrobial agents of the efficacy of the points for attention and characteristics;

 

        (4) the common bacteria resistant trends and control methods;

 

        (5) antibacterial adverse drug reactions prevention and treatment.

 

        Article 26 the medical institutions and medical personnel should strictly master the use of antimicrobial agents nabbed the prevention of infection. The prevention of infection, treatment mild or local infection should limit the use of the first magnitude antibacterial drugs; Serious infection, immune function is low amalgamative infection or pathogens to limit the use of class only antimicrobial sensitive, can choose limiting the use of antibacterial drugs level.

 

        Article 27 the strict control of special use antimicrobial use level. Special use antimicrobial drugs in outpatient service level shall not be used.

 

        Clinical application of antimicrobial use special level shall strictly grasp nabbed the drug use, and the management of the antimicrobial designated specialized technical personnel after consultation agree with ChuFangQuan corresponding doctor opens a prescription.

 

        Special use antimicrobial consultation level personnel by has antibacterial drugs in clinical application experience of infectious diseases department, HuXiKe, severe all-around-doctors, microbial test branch, pharmacy department etc with senior professional technical position qualified physicians, pharmacists or with senior professional technical position of professional qualifications antimicrobial drugs as clinical pharmacists.

 

        Article 28 for rescue dying patients and emergency, doctors can YueJi use antimicrobial agents. YueJi use antimicrobial agents shall make a detailed record against drug use, and shall, within 24 hours YueJi fill do use antimicrobial agents of the necessary formalities.

 

        Article 29 a medical institution shall formulate and strictly control clinic patients intravenous use antimicrobial agents proportion.

 

        Village clinic, clinics and community health service stations use of antimicrobial agents in intravenous activities, the health administrative departments at the county level shall be subject to approval.

 

        Article 30 medical institutions shall carry out antibacterial drugs for clinical use monitoring work, analyzes the institution and clinical each major department the use of antibacterial agents, evaluate antibacterial drugs use suitability; The trend of antimicrobial use are analyzed, and the antimicrobial not reasonable to use shall timely take effective intervention measures.

 

        Article 31 a medical institution shall, according to the clinical microbial samples result is reasonable to choose antimicrobial agents. Clinical microbial samples before the results were not issue, medical institutions may, according to the local and the agency bacteria resistant monitoring experience to choose antimicrobial agents, clinical microbial samples results according to the test results after issue corresponding adjustment.

 

        Article 32 the medical institutions shall carry out bacteria resistant monitoring work, establish bacteria resistant early warning mechanism, and take the following measures:

 

        (a) the main target resistant bacteria more than 30% of the antibacterial drugs, it shall timely information reporting this agency will warning medical personnel;

 

        (2) the main target resistant bacteria more than 40% of the antibacterial drugs, should be careful drug experience;

 

        (3) the main target resistant bacteria more than 50% of the antibacterial drugs, shall refer to the results of drug sensitive test choose;

 

        (4) the main target resistant bacteria more than 75% of the antibacterial drugs, shall be suspended for the goal of the clinical application of bacteria, according to track bacteria resistant monitoring results, before deciding whether to restore clinical application.

 

        Article 33 a medical institution shall establish this organization antibacterial drugs clinical application rankings, internal public and reporting system.

 

        A medical institution shall clinical departments and medical personnel to antimicrobial usage, utilization rate and use the circumstance such as strength rank and to internal public; Ranking or found on a serious problem of physician criticism education, the severe cases shall be informed.

 

        Medical institutions shall, in accordance with the requirements of clinical departments and medical personnel antibacterial drugs in clinical application summarizing, and issued to the "practice license of medical institution" and report to the administrative department of public health. The level limit the use of antimicrobial clinical application, reports on a year; Limiting the use of level and special use antimicrobial drugs for clinical use level, every half year a report.

 

        Article 34 a medical institution shall make full use of information means to promote the reasonable application of antimicrobial agents.

 

        Article 35 a medical institution shall to the following antibacterial drugs for clinical use the abnormal situation investigation, and make a decision according to different situation:

 

        (a) the usage of abnormal growth antimicrobial;

 

        (2) and a half years in the forefront of always use antimicrobial;

 

        (3) often super indications and exceed dosage of use antimicrobial;

 

        (4) enterprise illegal sales antiviral drugs;

 

        (5) serious adverse events occurred frequently antibacterial drugs.

 

        Article 36 a medical institution shall strengthen antibacterial drugs production, management enterprise in this institution sales behavior management, to the existing unfair sales behavior enterprise, it shall timely take into medicine, such as suspension to repel measures.

 

 

 

The fourth chapter supervision and management

 

 

 

        Article 37 the health administrative department at or above the county level shall strengthen medical institutions within their respective administrative regions antimicrobial clinical application of supervision and inspection.

 

        Article 38 personnel of the administrative department of health medical institutions shall, in accordance with law, antimicrobial clinical application and inspection, and shall produce their certificates, check medical institutions shall cooperate with and provide the necessary materials, and may not refuse or obstruct and hide.

 

        Article 39 the local public health administrative department at or above the county level shall establish medical institutions antibacterial drugs in clinical application management evaluation system.

 

        Article 40 local public health administrative department at or above the county level shall establish antibacterial drugs in clinical application, and announced by the JieMian conversation and ranking system. Within their respective administrative regions antimicrobial usage medical institutions, utilization rate and use the circumstance such as strength rank, will be to the ranking in the administrative areas by medical institutions, and report to the health administration department at a higher level for the record; To produce great, big medical quality security incident or there is serious medical quality safe hidden trouble at various levels and of various kinds of medical institutions JieMian head of conversation, the severe cases shall be informed.

 

        Article 41 the health administrative departments at the county level in the area under its jurisdiction is responsible for rural hospitals and community health service center (station), antimicrobial usage status of utilization rate ranking and announces.

 

        The health administrative departments at the county level by the entrusted, rural hospitals is responsible for the area under its jurisdiction antimicrobial usage village clinic, utilization rate, etc to rank and announces, and to county public health administrative department report.

 

        Article 42 the health ministry to establish a national network, antimicrobial clinical application and the bacteria resistant monitoring network, the clinical application of antimicrobial resistance bacteria and monitor; According to the monitoring results released regularly antimicrobial clinical application control indexes, antibacterial drugs in clinical application quality management and control work.

 

        Provincial administrative departments for public health shall establish the administrative area of antibiotic drugs for clinical use monitoring network and bacteria resistant monitoring network, for medical institutions antibacterial drugs for clinical use and bacteria drug resistance monitoring, antibacterial drugs in clinical application quality management and control work.

 

        Antibacterial drugs for clinical use and bacteria resistant monitoring technology plan shall be separately formulated by the ministry of public health.

 

        Article 43 the public health administrative department shall medical institutions will antimicrobial clinical application into the medical institutions evaluation indicator system; Will antibacterial drugs clinical application for medical institutions and grading, review and evaluation important index, should have not qualified, depending on the situation of medical institutions, to fall, evaluation relegation unqualified processing.

 

        Article 44 the medical institution shall regularly antimicrobial management institution organization related professional technology personnel antimicrobial prescription, the doctor's advice to implement comment on, and will comment on the results as physicians regular check, clinical departments and medical personnel performance assessment basis.

 

        Article 45 a medical institution shall antimicrobial prescription for an extra three times or more without justifiable reasons and doctors warned, limit the special use level and limiting the use of antibacterial drugs ChuFangQuan level.

 

        Article 46 the doctors appear one of following state, a medical institution shall cancel the ChuFangQuan:

 

        (a) antimicrobial agents should have not qualified;

 

        (2) limit ChuFangQuan, still appear unusual prescription and without warrant;

 

        (3) be not according to stipulations antimicrobial prescription, thereby causing serious consequences;

 

        (4) use antimicrobial agents not according to stipulations, thereby causing serious consequences;

 

        (5) antimicrobial prescription issued seek improper interest.

 

        Article 47 the pharmacists not according to stipulations antimicrobial prescription drug review with the doctor's advice, if the consequences are serious, or found prescription is not suitable for, superior prescription not intervene and situation without warrant, the medical institution shall cancel its drug dispensing qualification.

 

        Article 48 ChuFangQuan doctors and pharmacists drug dispensing qualification cancelled, in six months not to resume its ChuFangQuan and drug dispensing qualification.

 

 

 

Chapter 5 legal responsibility

 

 

 

        Article 49 the medical institution has one of following state, the public health administrative department at or above the county level shall be ordered to correct; If do not change, criticized, and give warning; Serious consequences, is responsible to the person in charge and the other persons who are directly responsible, given sanctions:

 

        (a) has not been established antibacterial drugs management structure or not designated designed (and) post technical personnel in charge of specific management;

 

        (2) has not been established antibacterial drugs management rules and regulations;

 

        (3) antimicrobial drugs for clinical use of management confusion;

 

        (4) not in accordance with the provisions of regulations antibacterial drugs, physicians and classification management antimicrobial prescription rights management, pharmacists, and regulate the administration of the qualifications of the antimicrobial drugs or not equipped with relevant professional technology personnel;

 

        (5) other violations of these regulations of behavior.

 

        Article 50 the medical institution has one of following state, the public health administrative department at or above the county level shall be ordered to rectify, and give a warning, and may, according to circumstances, impose a fine of no more than RMB thirty thousand weight; Responsible for the person in charge and the other persons who are directly responsible, but, according to circumstances, given sanctions:

 

        (a) use antimicrobial ChuFangQuan without obtaining the doctors or use was cancelled the antimicrobial ChuFangQuan doctor opens the antimicrobial prescription;

 

        (2) not antimicrobial prescription, the doctor's advice to implement suitability audit, if the circumstances are serious;

 

        (3) the pharmacy department engaged in purchase and sale, adjust antimicrobial activity;

 

        (4) antimicrobial will purchase and sale, clinical application and personal or department of economic benefits received;

 

        (5) in the purchase and sale, antimicrobial drugs in clinical applications seek improper interest.

 

        Article 51 the medical institution the principals, buyers of pharmaceuticals, physicians and other relevant persons demands, or accepts drug-producing enterprises, drug-handling enterprise or its agent to give the property or through the open antibacterial drugs to seek improper interest, by local public health administrative department at or above the county level according to the relevant state laws and regulations for processing.

 

        Article 52 the physician has one of following state, the health administrative department at or above the county level shall, in accordance with the YiShiFa practice of article 37 of the relevant provisions, shall be ordered to suspend a warning or six months of on one the following practice activities; If the circumstances are serious, shall revoke its certificate of practice; Constitute a crime, shall be investigated for criminal responsibility:

 

        (a) not issued in accordance with these measures antimicrobial prescription, thereby causing serious consequences;

 

        (2) use without the approval of the pharmaceutical supervisory and administrative departments of antimicrobial agents;

 

        (3) use this institution supply directory antimicrobial outside the varieties, product rules, thereby causing serious consequences;

 

        (4) violates these measures other regulations, thereby causing serious consequences.

 

        Rural doctors in one of the circumstances prescribed in the preceding clause, the administrative department of public health at the county level in accordance with the regulations on the administration of rural doctors from article 38 of the relevant regulations.

 

        Article 53 the pharmacists has one of following state, the public health administrative department at or above the county level shall be ordered to rectify, give warning; Constitute a crime, shall be investigated for criminal responsibility:

        (a) not according to stipulations audit, antimicrobial prescription dispensing, and if the circumstances are serious;

        (2) prescribed antibacterial drugs or who increase variety rules of the product;

 

        (3) violates these measures of the other provisions.

 

        Article 54 the health administrative departments at the county level without approval, the village clinic, clinic, community health service station unauthorized use of the antimicrobial agents intravenous infusion of carry out activities, the public health administrative departments at the county level or above to make corrections within a time limit and be given a disciplinary warning; Fails to change, according to the seriousness of the case can be fined ten thousand yuan shall be imposed.

 

        Article 55 local public health administrative department at or above the county level shall not according to the provisions of these measures to perform supervisory duties, thereby causing serious consequences, the persons who are directly in charge and the other persons who are directly responsible shall be given JiDaGuo, degradation, removed, discharge, administrative sanctions.

 

        Article 56 medical institutions and their staff in violation of the pharmaceutical administration law, in accordance with the pharmaceutical administration law "concerned regulation processing.

 

 

 

The sixth chapter is attached

 

 

 

        Article 57 national Chinese medicine management department in the areas of responsibility of traditional Chinese medical treatment antimicrobial drug agency responsible for the supervision and administration of clinical application.

 

        Article 58 the provincial public health administrative department shall, in this way the date of publication 3 months, the administrative region formulated antimicrobial classification management directory.

 

        Article 59 the measures since 2012 as of August 1,.