(Draft)
Chapter I General Provisions
Article 1 In order to strengthen the management of the clinical application of antimicrobial drugs in medical institutions, standardize the behavior of the clinical application of antimicrobial drugs, control bacterial resistance, and safeguard the quality of medical care and medical safety, these measures have been formulated in accordance with the "People's Republic of China*** and the State of China Drug Administration Law", the "People's Republic of China*** and the State of China Practicing Physicians Law", "Regulations on the Administration of Medical Institutions" and "Measures for the Administration of Prescriptions" and other laws, rules and regulations, the formulation of these measures.
Second Article The antimicrobial drugs referred to in these measures refers to the treatment of bacteria, mycoplasma, chlamydia, rickettsiae, spirochetes, fungi and other pathogenic microorganisms caused by infectious diseases of the drug, excluding a variety of viruses caused by infectious diseases and parasitic diseases of the treatment of drugs.
Article 3 The Ministry of Health is responsible for the supervision and management of the clinical application of antimicrobial drugs in medical institutions across the country.
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 administrative regions.
Article IV These measures are applicable to all levels and types of medical institutions clinical application of antibacterial drugs management.
Article 5 The clinical application of antimicrobial drugs should follow the principle of safe, effective and economical.
Sixth, the clinical application of antimicrobial drugs graded management.
Article VII of the medical institutions should be based on relevant laws, regulations, rules and regulations of the relevant provisions of the development of the institution of the clinical application of antibacterial drugs and implementation details, the establishment of clinical application of antibacterial drugs assessment and continuous improvement system.
Chapter II organization and responsibilities
Article VIII of the medical institutions is the head of the institution of the clinical application of antimicrobial drugs management of the first responsible person.
Article IX medical institutions should establish a system of antibacterial drug management and supervision and management mechanism, the medical department is responsible for the daily supervision and management work.
Article X above the second level hospitals should be set up under the Pharmacy Management and Pharmacotherapeutics Committee of antimicrobial drug management working group, by the medical, pharmacy, infectious diseases, clinical microbiology, nursing, hospital infection management and other departments responsible for the person with senior professional and technical qualifications. Other medical institutions to set up antimicrobial drug management work group or designate a full-time technical staff, responsible for the specific management.
Article XI of the Working Group on Antimicrobial Drug Management in Medical Institutions:
(1) Implementation of antimicrobial drug management related laws, rules and regulations. It shall formulate the antimicrobial drug management system of the institution and supervise its implementation;
(2) formulate the supply catalog of antimicrobial drugs and technical documents related to the clinical application of antimicrobial drugs in the institution and supervise its implementation;
(3) monitor the clinical application of antimicrobial drugs and bacterial drug resistance in the institution, regularly analyze and evaluate the monitoring data and release relevant information, and put forward intervention and improvement measures;
(4) Article 11: Responsibilities of the Working Group on Antibacterial Drug Management in Medical Institutions p>
(D) the medical staff on antibacterial drug management related laws, regulations, rules and technical specifications for training; organization of the public knowledge of the rational use of antibacterial drugs publicity and education.
Article XII above the second level hospitals should be set up infectious diseases, with a corresponding number of infectious diseases physicians, is responsible for the clinical application of antimicrobial drugs in the clinical departments of this institution for technical guidance, to participate in the clinical application of antimicrobial drugs in the management of the organization.
Article XIII of the second-level hospitals should be equipped with infectious clinical pharmacists, the clinical application of antimicrobial drugs to provide technical support to guide patients to the rational use of antimicrobial drugs, antimicrobial drugs to participate in the clinical application of the management of the organization.
Article XIV above the second level hospitals should establish clinical microbiology room, microbial culture, separation, identification and drug sensitivity testing, etc., to provide technical support for the diagnosis of pathogenicity, is responsible for the organization of the distribution of common pathogens and drug-resistant bacteria monitoring, to participate in the organization of the management of the clinical application of antimicrobial drugs.
Article XV of the health administrative departments and medical institutions should strengthen the clinical application of antibacterial drugs related disciplines, the establishment of professional training and assessment system, give full play to the role of relevant professional and technical personnel in the clinical application of antibacterial drugs management.
Chapter III Antibacterial Drugs Clinical Application Management
Article XVI of the medical institutions shall strictly implement the "prescription management measures", "provisions of the pharmaceutical management of medical institutions", "Antibacterial Drugs Clinical Application Guiding Principles", "National Formulary", etc., and to strengthen the selection of antibacterial drugs, procurement, prescription, transfer, clinical application and drug evaluation management.
Article 17: Antibacterial drugs in medical institutions shall be purchased and supplied by the pharmacy department, and other departments or divisions shall not engage in the procurement and dispensing of antibacterial drugs, and shall not use antibacterial drugs that are not purchased and supplied by the pharmacy department in the clinic.
Article 18 Medical institutions shall purchase antimicrobial drugs in accordance with the common names of drugs approved and announced by the drug regulatory authorities, and give priority to the use of antimicrobial drugs included in the National Formulary, the National Essential Drugs Catalogue, and the National Drugs Catalogue for Basic Medical Insurance, Workers' Compensation Insurance and Maternity Insurance.
Article 19 of the third-level hospitals shall not purchase more than 50 varieties of antibacterial drugs, second-level hospitals shall not purchase more than 35 varieties of antibacterial drugs; antibacterial drug varieties of the same common name, injection and oral dosage form shall not exceed 2, the prescription composition of similar compound preparations of 1-2 kinds. Antibacterial drugs with similar or identical pharmacological characteristics shall not be duplicated procurement.
Three-generation and four-generation cephalosporins (including compound preparations) class of antimicrobial drugs shall not exceed five oral dosage forms and eight injectable dosage forms; carbapenems class of antimicrobial drugs injectable dosage forms shall not exceed three dosage forms; fluoroquinolones class of antimicrobial drugs oral dosage forms and injectable dosage forms shall not exceed four dosage forms each; and the deep anti-fungal class of antimicrobial drugs shall not exceed five dosage forms.
Article 20 of the medical institutions antibacterial drug procurement directory (including the purchase of antibacterial drugs, including varieties, dosage forms and specifications) shall be issued to the health administrative department of its "license to practice in medical institutions" for the record.
Article 21 of the medical institutions really because of the clinical needs of the work, the need to purchase antibacterial drugs varieties, specifications more than the above provisions, should be to the municipal level above the municipal level of the health administrative department to submit an application, and explain the reasons in detail. By the municipal level above the municipal health administrative department to approve its application for antibacterial drugs, the number and type of varieties, specifications.
Article 22 Medical institutions shall establish a system for the selection and periodic evaluation of antibacterial drugs.
The new introduction of antimicrobial drug varieties in medical institutions, shall be submitted by the clinical department of the application report, after the pharmacy department to put forward comments, reported to the antimicrobial drug management working group for consideration. After consideration and agreement by more than 2/3 of the members of the Antimicrobial Drug Management Working Group, it can be included in the procurement and supply catalog only after review and agreement by more than 2/3 of the members of the Pharmaceutical Management and Therapeutics Committee.
Clinical departments, pharmacy departments, the Antimicrobial Drug Management Working Group and the Pharmaceutical Affairs Management and Therapeutics Committee may propose the withdrawal or replacement of antimicrobial drug varieties with safety risks, uncertain efficacy, serious drug resistance, poor cost-effectiveness, or illegal promotional use. The withdrawal or replacement shall be carried out with the consent of at least 1/2 of the members of the Antimicrobial Drug Management Working Group and reported to the Pharmacy Management and Therapeutics Committee for the record. In principle, the retired or replaced antimicrobial drug varieties shall not be allowed to enter the drug procurement and supply catalog of the organization within 6 months.
Article 23 Due to the therapeutic needs of patients with special infections, antimicrobial drugs that are not listed in the drug prescription set and basic drug supply catalog of the institution, the medical institution may start the temporary procurement procedure, and the temporary procurement shall be submitted by the clinical department with an application report stating the name, specification, dosage form, quantity, target of use, and reason for use of the drugs applied for, and then reviewed and approved by the working group of antimicrobial drug management by the Pharmacy department one-time purchase and use.
Medical institutions should strictly control the temporary procurement of antibacterial drugs and the number of varieties, the same generic name of antibacterial drug varieties to start the temporary procurement process shall not exceed five times, if more than five times, the antibacterial drug management working group should be investigated to decide whether to agree to continue the temporary procurement or included in the regular drug procurement process.
Article 24 Medical institutions shall implement a graded management system for antimicrobial drugs. Antibacterial drugs are divided into non-restricted use, restricted use and special use of three levels.
(A) non-restricted use of antibacterial drugs. Proven safe and effective by long-term clinical application, less impact on bacterial resistance, the price is relatively low antibacterial drugs.
(ii) Restricted-use antimicrobial drugs. Compared with non-restricted-use antibacterial drugs, there are limitations in efficacy, safety, impact on bacterial resistance, drug prices, etc., and it is not suitable for use as a non-restricted-use drug;
(c) special-use antibacterial drugs. With obvious or serious adverse reactions, should not be arbitrarily used antimicrobial drugs; need to strictly control the use of antimicrobial drugs to avoid the rapid emergence of bacterial resistance; new listing less than five years of antimicrobial drugs, efficacy or safety of less clinical information, not better than the current use of drugs of antimicrobial drugs; expensive antimicrobial drugs.
Antimicrobial drugs graded management catalog is separately formulated by the Ministry of Health.
Article 25 The prevention of infection, treatment of mild or local infections should be the first choice of non-restricted use of antibacterial drugs; serious infections, immunocompromised combined infections, or pathogenic bacteria are sensitive only to the restricted use of class antibacterial drugs, you can choose to restrict the use of antibacterial drugs; strict control of special use of antibacterial drugs use.
Article 26 above the second level of hospitals should be the institution of physicians and pharmacists for the clinical application of antimicrobial drugs and standardized management of knowledge and training. Physicians qualified after examination to obtain antimicrobial drug prescription, pharmacists qualified after examination to obtain antimicrobial drug dispensing qualifications.
Other medical institutions, physicians, pharmacists by the municipal level above the municipal health administrative department to organize relevant training, assessment, after passing the assessment, the granting of antibacterial drugs prescription right or transfer qualifications.
Article 27 The clinical application of antimicrobial drugs for physicians and pharmacists knowledge and standardized management of training and assessment should at least include:
(a) "Drug Administration Law", "Practicing Physicians Law", "Antimicrobial Drugs Clinical Application Management Measures", "Prescription Management Measures", "Provisions for Pharmaceutical Management of Healthcare Institutions", "Antimicrobial Drugs Clinical Application Guiding Principles", "National Prescription Collection" and other relevant laws, regulations, rules and normative documents;
(ii) clinical application of antibacterial drugs and management system;
(iii) bacterial resistance and antibacterial drug interactions;
(iv) prevention and treatment of antibacterial drug adverse reactions.
Article 28 Physicians with qualifications of intermediate or above professional and technical positions shall be granted the right to prescribe restricted-use antimicrobial drugs only after they have been trained and passed the examination. With senior professional and technical qualifications of physicians, after training and assessment of qualified, before granting the right to prescribe antibacterial drugs for special use level.
Article 29 The clinical application of special use-level antibacterial drugs should be strictly controlled by the indications for the use of antibacterial drugs by the antibacterial drug management working group designated personnel consultation agreed to by a physician with the corresponding prescription right to issue prescriptions. Outpatient physicians are not allowed to prescribe special use-grade antimicrobial drugs.
Special-use antimicrobial drug consultation personnel with experience in the clinical application of antimicrobial drugs, infectious diseases, respiratory medicine, critical care medicine, etc. with senior professional and technical qualifications of physicians and infectious clinical pharmacists.
Article 30 In case of emergencies, physicians can use antibacterial drugs in a transgressive manner, and the amount of prescription should be limited to 1 day's dosage.
Article 31 The medical institutions shall strictly control the proportion of outpatients using antibacterial drugs by intravenous infusion.
Article 32 The Ministry of Health to establish a national antimicrobial drug clinical application monitoring network and the national bacterial drug resistance monitoring network, the national antimicrobial drug clinical application and bacterial drug resistance monitoring, to carry out antimicrobial drug clinical application of quality management and control work.
Provincial health administrative departments should establish provincial antimicrobial drug clinical application monitoring network and bacterial drug resistance monitoring network, the clinical application of antimicrobial drugs and bacterial drug resistance in medical institutions under their jurisdiction to monitor, carry out the clinical application of antimicrobial drugs quality management and control work.
Article 33 of the medical institutions shall carry out clinical application of antibacterial drugs monitoring work, analysis of the institution and clinical departments of antibacterial drugs, assess the appropriateness of the use of antibacterial drugs; analysis of trends in the use of antibacterial drugs, antibacterial drugs should be taken in a timely manner to take effective interventions for the irrational use of antibacterial drugs.
Article 34 Surgical prophylaxis of antimicrobial drugs should be used 30 minutes to 2 hours before surgery, clean surgery medication time shall not exceed 24 hours.
Article 35 of the medical institutions should carry out bacterial drug resistance monitoring, regularly release information on bacterial drug resistance, the establishment of bacterial drug resistance early warning mechanism, to take appropriate measures. For patients receiving antimicrobial drug therapy, microbiological test sample delivery rate shall not be less than 30%.
(a) The main target bacteria resistance rate of more than 30% of the antimicrobial drugs, the early warning information should be timely notified to the institution's medical staff.
(ii) For antimicrobial drugs with a major target bacterial resistance rate of more than 40%, the drug should be used with caution and experience.
(3) Antimicrobial drugs with a resistance rate of more than 50% to the main target bacteria should be selected with reference to the results of drug sensitivity tests.
(4) For the main target bacteria resistance rate of more than 75% of the antimicrobial drugs, should be suspended from clinical application, according to tracking the results of bacterial drug resistance monitoring, and then decide whether to resume its clinical application.
Article 36 Medical institutions shall use information management tools to promote the rational application of antibacterial drugs.
Article XX prescription review and abnormal warning Medical institutions should be in accordance with the "prescription management measures" and "hospital prescription review management specification (for trial implementation)" of the relevant provisions of the organization of pharmacy and other relevant professional and technical personnel of antibacterial drugs for prescription, medical review, and review the results of the review of the hospital assessment evaluation index system, and the relevant departments and their staff performance appraisal
Chapter IV Supervision and Management
Article 37 The health administrative departments at or above the county level shall strengthen the supervision and inspection of the clinical application of antimicrobial drugs in medical institutions within the administrative region.
Article 38 The staff of the administrative department of health shall, in accordance with the law on the supervision and inspection of the clinical application of antibacterial drugs in medical institutions, shall show their credentials, and the inspected medical institutions shall cooperate, provide the necessary information, and shall not be refused, impeded or concealed.
Article 39 The health administrative departments and medical institutions at or above the provincial level shall establish a ranking of the clinical application of antimicrobial drugs, publicity and admonition system. The administrative regions, medical institutions, clinical departments and medical personnel of antibacterial drug use, use rate and intensity of use, etc., ranking, the ranking of the public; rankings or find serious problems in the health administrative department in charge of the head, the head of the medical institution and the physician to conduct a cautionary talk, the situation is serious to be notified.
Article 40 The administrative department of health shall incorporate the clinical application of antimicrobial drugs in medical institutions into the appointment of medical institutions in charge of the appraisal of the index system; the clinical application of antimicrobial drugs as a medical institution grading, assessment, evaluation of the important indicators, assessment of the unqualified, as appropriate, to the medical institutions to make the downgrade, downgrade, evaluation of the unqualified treatment.
Article 41 of the medical institutions have one of the following circumstances, by the local health administrative department at or above the county level and ordered to make corrections within a certain period of time:
(a) not establish the antimicrobial drug management organization and the corresponding rules and regulations, the clinical application of antimicrobial drugs in health care institutions and the management of chaos;
(b) not in accordance with the provisions of this Measures for the implementation of the antimicrobial drug hierarchy management, the physician antimicrobial drug prescription authority management, not equipped with antimicrobial drugs, and the management of the antimicrobial drug prescription authority management. Antibacterial drug prescription authority management, not equipped with relevant professional and technical personnel;
(C) the purchase and sale of antimicrobial drugs, clinical application and personal or departmental economic interests or bonus allocation linked, or in the purchase and sale of antimicrobial drugs, clinical application of improper profits;
(D) violation of the relevant provisions of the Measures resulting in serious consequences.
Article 42 of the medical institutions shall organize relevant professional and technical personnel of antibacterial drug prescriptions, doctor's orders for the implementation of the review, and the results of the review as a clinical department and medical personnel performance will be based on the assessment.
Article 43 of the medical institutions shall have antimicrobial drugs more than 3 times and no justifiable reason for the prescription of antibacterial drugs, physician warning, limited to the special use of level and restricted use of antibacterial drugs prescription; limited prescription rights, there are still more than 2 consecutive prescription without justifiable reason, the cancellation of its antimicrobial drugs prescription rights.
Article 44 of the physician in one of the following circumstances, the medical institution shall cancel its right to prescribe antimicrobial drugs:
(a) antimicrobial drug training assessment failed;
(b) failure to comply with the provisions of the antimicrobial drug prescription resulting in serious consequences;
(c) failure to comply with the provisions of the use of antimicrobial drugs resulting in serious consequences;
(D) prescribing antimicrobial drugs for personal gain.
Article 45 If the pharmacist fails to review the prescription of antimicrobial drugs in accordance with the regulations for more than three consecutive times, or finds that the prescription is inappropriate, or fails to intervene without justifiable reasons, the pharmacist shall be disqualified from dispensing antimicrobial drugs.
Article 46 Medical institutions shall investigate the following abnormalities in the clinical application of antimicrobial drugs and deal with them according to different situations:
(1) the use of antimicrobial drugs that have increased abnormally;
(2) the use of antimicrobial drugs that have always been at the forefront of the six-month period;
(3) the use of antimicrobial drugs that have often been over-indicated and over-dosed;
(4) the use of antimicrobial drugs that are often overdosed and over-prescribed. /p>
(4) enterprises in violation of the sale of antibacterial drugs;
(5) frequent occurrence of serious adverse reactions to antibacterial drugs;
Article 47 Medical institutions shall strengthen the supervision of antibacterial drug production and operation of the enterprise in the institution of the promotional activities of the promotion of the illegal promotion of the enterprise and the antibacterial drugs, should be promptly taken to warn the enterprises and antibacterial drugs, suspension of the purchase of drugs, withdrawal and other measures.
Chapter V Legal Liability
Article 48 If a medical institution has one of the following circumstances, the health administrative department at or above the county level shall, in accordance with the provisions of Article 48 of the "Regulations on the Administration of Medical Institutions", order a period of time to make corrections and impose a fine of not more than 5,000 yuan; if the circumstances are serious, the "license to practice in a medical institution" shall be revoked:
(a) the use of antimicrobial drugs without obtaining the prescriptive authority of the physician or by a physician who has not obtained the right to prescribe antimicrobial drugs. Prescription of antimicrobial drugs by a physician who has not obtained the right to prescribe antimicrobial drugs or by a physician whose right to prescribe antimicrobial drugs has been revoked;
(b) In violation of the provisions of Article 34 of the Drug Administration Law, purchasing antimicrobial drugs from a production or business enterprise that has not been approved by the relevant state departments;
(c) In violation of the provisions of Article 14 and Article 23 of the Drug Administration Law, a non-pharmacy department engaging in the Antibacterial drug purchase and sale, transfer activities;
(4) violation of the provisions of Article 27 of the "Drug Administration Law", the failure to implement the suitability of antimicrobial drug prescriptions, doctor's orders for review, causing serious damage to patients.
Article 49 A physician in one of the following circumstances, by the health administrative department at or above the county level in accordance with the provisions of Article 37 of the "Practicing Physician Law" shall be given a warning or ordered to suspend the practice of more than six months or less than one year; if the situation is serious, the revocation of its certificate of practice; constitutes a crime, shall be held criminally liable according to the law:
(1) did not obtain the antimicrobial prescribing right or be canceled Antibacterial drug prescription right is still issued after the prescription of antibacterial drugs;
(2) not in accordance with the provisions of this approach to prescribe antibacterial drugs causing serious consequences;
(3) the use of unapproved antibacterial drugs;
(4) soliciting and accepting the drug production, management enterprises, or through the prescribing of antibacterial drugs to make undue profits;
(5) Violation of other provisions of these measures.
Article 50 If one of the following circumstances occurs in a pharmacist, the health administrative department at or above the county level shall, in accordance with the relevant provisions of the Drug Administration Law, give a warning or order the suspension of practice for six months or less than one year; if the circumstances are serious, the pharmacist shall be given a demotion, dismissal, or expulsion according to the law; if the case constitutes a crime, the pharmacist shall be held criminally liable according to the law:
(1) Violation of Articles 26, 34, and 26 of the Drug Administration Law. Article 26, Article 34 of the provisions of the law, illegal purchase of unapproved antimicrobial drugs;
(2) violation of the provisions of Article 27 of the Drug Administration Law, failure to transfer the review of prescriptions and medical instructions, resulting in serious damage to patients;
(3) failure to follow the provisions of this method, privately increase the varieties and specifications of antimicrobial drugs;
(4) violation of the Drug Administration Law Article 90 of the provisions of the Drug Administration Law, in the purchase and sale of drugs, clinical application of improper profits;
(e) violation of other provisions of these Measures.
Article 51 If a health administrative department at or above the county level fails to fulfill its duties in accordance with the provisions of these Measures, it shall be ordered by the higher-level health administrative department to make corrections.
Chapter VI Supplementary Provisions
Article 52 The medical institutions referred to in these Measures refer to the hospitals, community health service centers (stations), maternity and child health centers, health centers, sanatoriums, outpatient clinics, clinics, health centers (stations), first aid centers (stations), specialized disease prevention and treatment hospitals (stations) and other institutions which are approved for registration in accordance with the "Regulations for the Administration of Medical Institutions" and are engaged in the diagnosis of diseases and treatment of diseases. nursing homes (stations) and other institutions.
Article 53 These Measures shall come into force on July 1, 2011 .
These measures shall come into force on July 1, 2011.