No. 84
The Measures for the Administration of Clinical Application of Antimicrobial Drugs was deliberated and passed by the Ministerial Council of the Ministry of Health on February 13, 2012, and is hereby promulgated to come into effect from August 1, 2012 onwards.
Minister Chen Zhu
April 24, 2012
Methods for the Administration of Clinical Application of Antimicrobial Drugs
Chapter 1: General Provisions
Article 1: In order to strengthen the management of clinical application of antimicrobial drugs in healthcare institutions, to standardize the behavior of clinical application of antimicrobial drugs, to improve the level of clinical application of antimicrobial drugs, to promote the rational application of antimicrobial drugs, to control bacterial resistance, to ensure medical quality, and to protect healthcare quality and safety, the Measures on the Management of Clinical Application of Antimicrobial Drugs are hereby promulgated. Bacterial resistance, to protect the quality of medical care and medical safety, according to relevant health laws 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, excluding the treatment of tuberculosis, parasitic diseases and various viruses caused by infectious diseases, as well as antibacterial effect of Chinese medicinal preparations.
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 antibacterial drugs should follow the principle of safe, effective and economical.
Sixth, the clinical application of antimicrobial drugs graded management. According to the safety, efficacy, bacterial resistance, price and other factors, antibacterial drugs are divided into three levels: unrestricted use level, restricted use level and special use level. The specific criteria are as follows:
(1) Non-restricted-use antimicrobial drugs refer to those antimicrobial drugs that have been proved to be safe and effective by long-term clinical application, have less impact on bacterial resistance, and are relatively low in price;
(2) Restricted-use antimicrobial drugs refer to those antimicrobial drugs that have been proved to be safe and effective by long-term clinical application, have a greater impact on bacterial resistance, or are relatively high in price;
(C) special use class antibacterial drugs refers to antibacterial drugs with one of the following circumstances:
1. with obvious or serious adverse reactions, should not be used at random antibacterial drugs;
2. need to strictly control the use of antibacterial drugs to avoid the rapid development of bacterial drug resistance;
3. efficacy, safety of antibacterial drugs in the clinical data is relatively small;
4. the use of antibacterial drugs, antibacterial drugs, antibacterial drugs, antibacterial drugs, antibacterial drugs, antibacterial drugs, antibacterial drugs, antibacterial drugs, and other antibacterial drugs.
4. Expensive antibacterial drugs.
Antibacterial drugs graded management catalog by the provincial health administrative departments, reported to the Ministry of Health for the record.
Chapter II: Organization and Responsibilities
Article 7: The principal person in charge of a medical institution is the first person responsible for the management of the clinical application of antimicrobial drugs in the institution.
Article VIII of the medical institutions should be established in the institution of antimicrobial drug management system.
Article IX of the medical institutions should be set up to manage antimicrobial drug management organization or a full-time (part-time) personnel responsible for the management of antimicrobial drugs in the institution.
Hospitals above the second level, maternal and child health centers and specialized disease control institutions (hereinafter referred to as hospitals above the second level) should be set up under the Pharmacy Management and Pharmacotherapeutics Committee of the antimicrobial drug management working group. Antimicrobial drug management working group by the medical, pharmacy, infectious diseases, clinical microbiology, nursing, hospital infection management and other department heads and senior technical qualifications of the relevant professional staff, medical, pharmacy and other departments **** with the responsible for the day-to-day management.
Other medical institutions to set up antimicrobial drug management team or designate a full-time (part-time) staff, responsible for specific management.
Article X. The main responsibilities of the management of antimicrobial drugs in medical institutions or full-time (part-time) personnel are:
(1) to implement the laws, rules and regulations related to the management of antimicrobial drugs, the development of antimicrobial drug management system and organization of the implementation of the institution;
(2) consideration of the supply of antimicrobial drugs in this institution directory, the development of antimicrobial drugs, clinical application of technical documents, and organization and implementation;
(2) consideration of the supply of antimicrobial drugs catalog, the development of antimicrobial drugs clinical application
(c) monitoring the clinical application of antimicrobial drugs and bacterial drug resistance in the institution, regularly analyzing, evaluating and reporting the monitoring data and releasing relevant information, and proposing interventions and improvement measures;
(d) training the medical staff in the laws, rules, regulations and technical specifications related to the management of antimicrobial drugs, and organizing publicity and education on the rational use of antimicrobial drugs by the patients. Publicity and education on the rational use of antimicrobial drugs for patients.
Article XI above the second level hospitals shall set up infectious diseases, infectious diseases with specialized physicians.
Infectious diseases and infectious diseases physicians are responsible for the clinical application of antibacterial drugs in the clinical departments of the institution for technical guidance, participate in the clinical application of antibacterial drugs management.
Article XII above the second level hospitals should be equipped with antimicrobial drugs and other related professional clinical pharmacists.
Clinical pharmacists are responsible for the clinical application of antimicrobial drugs to provide technical support, guide patients to the rational use of antimicrobial drugs, antimicrobial drugs involved in the clinical application of management.
Article XIII of the second level hospitals should be based on actual needs, the establishment of clinical microbiology room in line with laboratory biosafety requirements.
Clinical microbiology room to carry out microbial culture, isolation, identification and drug sensitivity tests, provide pathogenic diagnosis and bacterial drug resistance technical support, and participate in the management of the clinical application of antimicrobial drugs.
Article XIV of the administrative departments of health and medical institutions to strengthen the management of the clinical application of antimicrobial drugs involved in the construction of relevant disciplines, the establishment of professional training and assessment system, give full play to the role of relevant professional and technical personnel in the management of the clinical application of antimicrobial drugs.
Chapter III Clinical Application Management of Antibacterial Drugs
Article XV of the medical institutions shall strictly implement the "prescription management measures", "provisions of the Pharmacy Management of Medical Institutions", "Antibacterial Drugs Clinical Application Guiding Principles", "National Formulary" and other relevant provisions and technical specifications, to strengthen the management of antibacterial drug selection, procurement, prescription, dispensing, clinical application and evaluation of the drug.
Article XVI of the medical institutions should be in accordance with the provincial health administrative department of antibacterial drugs developed in accordance with the hierarchical management of antibacterial drugs directory, the development of antibacterial drugs supply directory of the institution, and to the issuance of its "license to practice in the medical institutions" of the administrative department of health for the record. Medical institutions antibacterial drug supply catalog, including the purchase of antibacterial drugs, varieties, specifications. Without the record of antibacterial drug varieties, specification, medical institutions shall not be procured.
Article XVII of the medical institutions should strictly control the number of varieties of antibacterial drugs supply directory of the institution. The same generic name antimicrobial drug varieties, injectable and oral dosage form shall not exceed two. With similar or the same pharmacological characteristics of antibacterial drugs shall not be repeated in the supply catalog.
Article XVIII of the clinical work of medical institutions, antibacterial drugs varieties and specification of the number of more than the provisions of the health administrative department shall issue its "license for the practice of medical institutions" of the health department to explain in detail the reasons and justifications; description of the reasons are not sufficient or are not established, the administrative department of health shall not be accepted by the number of varieties of antibacterial drugs and the number of specification of the filing.
Article 19 of the medical institutions shall regularly adjust the antibacterial drug supply directory varieties structure, and each adjustment within 15 working days after the issuance of its "license to practice in medical institutions" of the administrative department of health for the record. Adjustment cycle in principle for two years, the minimum shall not be less than one year.
Article 20 Medical institutions shall purchase antimicrobial drugs in accordance with the generic names of drugs approved and published by the State Drug Administration, and give priority to the use of antimicrobial drug varieties included in the "National Essential Drugs Catalog", the "National Formulary", and the "National Catalog of Drugs for Basic Medical Insurance, Workers' Compensation Insurance and Maternity Insurance".
Primary medical and health care institutions can only use antibacterial drug varieties in the basic drugs (including the additional varieties in each province, region and city).
Article 21: Antibacterial drugs in medical institutions shall be purchased and supplied uniformly by the pharmacy department, and other departments or divisions shall not be engaged in the purchasing and dispensing of antibacterial drugs. Clinical use of non-pharmacy department procurement and supply of antibacterial drugs shall not be used.
Article 22 Due to special therapeutic needs, medical institutions need to use the institution's supply of antibacterial drugs outside the directory of antibacterial drugs, you can start the temporary procurement process. Temporary procurement shall be applied for by the clinical department, explaining the name of the antimicrobial drugs applied for purchase, dosage form, specifications, quantity, use of the object and the reason for use, by the organization's antimicrobial drug management working group review and approval by the pharmacy department of the temporary one-time purchase and use.
Medical institutions should strictly control the temporary procurement of antimicrobial varieties and quantities of the same generic name of antimicrobial varieties to start the temporary procurement process in principle shall not be more than five cases per year. If more than 5 cases, should discuss whether to include the organization's antibacterial drug supply catalog. The total number of varieties in the adjusted antimicrobial drug supply catalog shall not be increased.
Medical institutions should be half-yearly temporary procurement of antimicrobial drugs to the issuance of its "license to practice in medical institutions" of the health administrative department for the record.
Article 23 of the medical institutions shall establish antibacterial drug selection and regular assessment system.
Medical institutions selection and new introduction of antimicrobial drug varieties, should be submitted by the clinical department of the application report, after the pharmacy department to put forward the views of the antimicrobial drug management working group to consider.
Antimicrobial drug management working group of more than two-thirds of the members of the consideration and agreement, and by the Pharmaceutical Management and Pharmacotherapeutics Committee of more than two-thirds of the members of the review and approval before being included in the procurement and supply catalog.
If there are safety risks, uncertain efficacy, high resistance rate, poor cost-effectiveness, or illegal use of antimicrobial drug varieties or specifications, clinical departments, pharmacy departments, and the Antimicrobial Drug Management Working Group can put forward opinions on the withdrawal or replacement of the antimicrobial drug. The opinion of withdrawal shall be implemented after the agreement of more than one half of the members of the antimicrobial drug management working group and reported to the Pharmaceutical Affairs Management and Pharmacotherapy Committee for the record; the opinion of replacement shall be implemented after the discussion and approval of the Pharmaceutical Affairs Management and Pharmacotherapy Committee.
The antimicrobial drug varieties or products that have been withdrawn or replaced shall not be re-entered into the antimicrobial drug supply catalog of the organization within 12 months in principle.
Article 24 Physicians with qualifications for senior professional and technical positions may be granted the right to prescribe special-use antimicrobial drugs; physicians with qualifications for intermediate or higher professional and technical positions may be granted the right to prescribe restricted-use antimicrobial drugs; physicians with qualifications for junior professional and technical positions, practicing assistants engaged in general practice independently in the medical institutions of townships, townships, townships and villages, and rural physicians, may be granted the right to prescribe non-sterile antimicrobial drugs. Physicians with the qualification of junior professional and technical positions, practicing assistants independently engaging in general practice in medical institutions in townships, ethnic townships, towns and villages, as well as rural doctors, can be granted the right to prescribe non-restricted-use antimicrobial drugs. Pharmacists can be qualified to dispense antimicrobial drugs only after they have been trained and passed the examination.
Hospitals above the second level shall regularly train physicians and pharmacists in the clinical application of antimicrobial drugs knowledge and standardized management. Physicians can obtain the corresponding prescribing rights only after they have been trained and passed the examination by the organization.
Other medical institutions in accordance with the law to enjoy the right to prescribe physicians, rural doctors and pharmacists engaged in prescription dispensing work, by the local health administrative departments above the county level to organize relevant training, assessment. Qualified by the examination, the corresponding antimicrobial drug prescription or antimicrobial drug dispensing qualifications.
Article 25 The clinical application of antimicrobial drugs knowledge and standardized management training and assessment shall include:
(1) "Drug Administration Law", "Practicing Physicians Law", "Antimicrobial Drugs Clinical Application Management Measures", "Prescription Management Measures", "Provisions on Pharmacy Management of Healthcare Institutions", "Guiding Principles for the Clinical Application of Antimicrobial Drugs" and "The National Prescription Collection of Essential Drugs", National Formulary" and "Hospital Prescription Review Management Code (for Trial Implementation)" and other relevant laws, regulations, rules and normative documents;
(ii) Clinical application of antimicrobial drugs and management system;
(iii) Pharmacological characteristics and precautions of commonly used antimicrobial drugs;
(iv) Trends of drug resistance of common bacteria and control methods;
(v) Prevention and treatment of adverse reactions to antimicrobial drugs.
Article 26 Medical institutions and medical personnel shall strictly grasp the indications for the use of antimicrobial drugs for the prevention of infection. Prevention of infection, treatment of mild or localized infections should be preferred to non-restricted use of antimicrobial drugs; serious infections, immunocompromised combined infections, or pathogenic bacteria are only sensitive to restricted use of antimicrobial drugs, before selecting restricted use of antimicrobial drugs.
Article 27 Strictly control the use of special-grade antibacterial drugs. Special use class antibacterial drugs shall not be used in outpatient clinics.
Clinical application of special use-grade antimicrobial drugs should be strictly controlled by the indications for the use of medication, by the antimicrobial drug management working group designated by the professional and technical personnel agreed to the consultation, by the corresponding prescription right of the physician to issue prescriptions.
Special use-level antimicrobial drug consultation personnel with experience in the clinical application of antimicrobial drugs, infectious diseases, respiratory medicine, intensive care medicine, microbiology, pharmacy, etc., with senior professional and technical qualifications of physicians, pharmacists, or with senior professional and technical qualifications of antimicrobial drugs, specialized clinical pharmacists as.
Article 28 of the rescue of life-threatening patients and other emergencies, physicians can use antimicrobial drugs over the level. The use of antimicrobial drugs should be recorded in detail to indicate the use of drugs, and should be made up within 24 hours of the necessary procedures for the use of antimicrobial drugs.
Article 29 of the medical institutions shall develop and strictly control the proportion of outpatients intravenous infusion of antibacterial drugs.
Village health centers, clinics and community health service stations using antimicrobial drugs to carry out intravenous infusion activities, shall be approved by the county-level health administrative department.
Article 30 of the medical institutions shall carry out clinical application of antimicrobial drugs to monitor the work of the analysis of the institution and the clinical departments of the use of antimicrobial drugs, assessment of antimicrobial drug suitability; analysis of trends in the use of antimicrobial drugs, antimicrobial drugs should be taken in a timely manner to take effective interventions in the case of irrational use.
Article 31 of the medical institutions should be based on clinical microbiology specimen test results of antibacterial drugs reasonably selected. Clinical microbiology specimen test results are not issued before the medical institutions can be based on local and the institution of bacterial drug resistance monitoring experience in the selection of antimicrobial drugs, clinical microbiology specimen test results are issued according to the results of the corresponding adjustments.
Article 32 The medical institutions shall carry out bacterial resistance monitoring, establish bacterial resistance early warning mechanism, and take the following corresponding measures:
(a) the main target bacteria resistance rate of more than 30% of the antimicrobial drugs, the early warning information should be timely notification of the institution's medical staff;
(b) the main target bacteria resistance rate of more than 40% of the antimicrobial drugs. Should be careful empirical use;
(C) the main target bacteria resistance rate of more than 50% of the antibacterial drugs, should refer to the results of the drug sensitivity test selection;
(D) the main target bacteria resistance rate of more than 75% of the antibacterial drugs, should be suspended for the target bacteria clinical application, according to tracking the results of the monitoring of bacterial resistance, and then decide whether to resume clinical application.
Article 33 Medical institutions shall establish their own clinical application of antibacterial drugs ranking, internal publicity and reporting system.
Medical institutions should be ranked on the clinical departments and medical staff of antibacterial drug use, use rate and intensity of use and internal publicity; the ranking of the latter or the discovery of serious problems in the physician to criticize and educate the situation is serious to be notified.
Medical institutions should be in accordance with the requirements of the clinical departments and medical staff of the clinical application of antimicrobial drugs to summarize, and to the issuance of its "medical practice license" of the health administrative department report. The clinical application of non-restricted use level antibacterial drugs, reported annually; restricted use level and special use level antibacterial drugs clinical application, reported every six months.
Article 34 Medical institutions shall make full use of information technology to promote the rational application of antibacterial drugs.
Article 35 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 has increased abnormally;
(2) antimicrobial drugs have always been in the forefront of the use of antimicrobial drugs within half a year;
(3) antimicrobial drugs are often over-indicated and over-dosed;
(d) Antibacterial drugs that are illegally marketed by enterprises;
(e) Antibacterial drugs that have frequent serious adverse events.
Article 36 The medical institutions shall strengthen the management of antibacterial drug production and operation of enterprises in the institution's sales behavior, the existence of improper sales behavior of the enterprise, should be taken in a timely manner to suspend the purchase of drugs, withdrawal and other measures.
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 law, supervise and inspect the clinical application of antimicrobial drugs in medical institutions, shall show their documents, and the inspected medical institutions shall cooperate, provide the necessary information, and shall not refuse, obstruct or conceal.
Article 39 The local health administrative departments at or above the county level shall establish a system for evaluating the management of the clinical application of antimicrobial drugs in medical institutions.
Article 40 The local health administrative departments at or above the county level shall establish a system for ranking, publicizing and admonishing the clinical application of antibacterial drugs. Medical institutions in the administrative region of the use of antibacterial drugs, the use rate and intensity of use of ranking, the ranking of medical institutions in the administrative region announced, and reported to the higher level of the health administrative department for the record; the occurrence of major, major medical quality and safety incidents or the existence of serious health care quality and safety hazards at all levels of all types of health care institutions in charge of the admonishment, the situation is serious shall be notified.
Article 41 The county-level health administrative departments are responsible for the township health centers, community health service centers (stations) within the jurisdiction of the use of antimicrobial drugs, such as the use of rankings and will be announced.
Commissioned by the county-level health administrative departments, township health centers are responsible for the village health center within the jurisdiction of the antimicrobial drug use, utilization rate and so on to be ranked and publicized, and report to the county-level health administrative departments.
Article 42 The Ministry of Health to establish a national antimicrobial clinical application monitoring network and the national bacterial drug resistance monitoring network, the national antimicrobial clinical application and bacterial drug resistance monitoring; according to the monitoring of the situation of the clinical application of antimicrobial drugs regularly announced the control indicators, to carry out the quality of clinical application of antimicrobial drugs management and control work.
Provincial health administrative departments should establish the administrative region of the clinical application of antimicrobial drugs and bacterial drug resistance monitoring network, the clinical application of antimicrobial drugs and bacterial drug resistance in medical institutions to monitor the situation, to carry out the clinical application of antimicrobial drugs and quality management and control work.
The technical program for monitoring the clinical application of antimicrobial drugs and bacterial drug resistance is formulated separately by the Ministry of Health.
Article 43 The administrative department of health shall include the clinical application of antimicrobial drugs in medical institutions assessment index system; the clinical application of antimicrobial drugs as a medical institution grading, assessment, evaluation of important indicators, assessment of unqualified, as appropriate, the medical institutions to make the downgrade, downgrade, evaluation of unqualified treatment.
Article 44 of the medical institutions antimicrobial drug management agency shall regularly organize relevant professional and technical personnel on antimicrobial prescriptions, the implementation of the review, and review the results of the regular assessment of physicians, clinical departments and medical personnel performance appraisal basis.
Article 45 of the medical institutions shall appear on the antibacterial drugs more than three times and no justifiable reason for the prescription of antibacterial drugs to warn the physician, to limit the special use of the level of antibacterial drugs and limit the use of the level of antibacterial drug prescribing rights.
Article 46 The medical institution shall cancel the prescribing right of the physician in one of the following cases:
(1) Failure of antimicrobial drug examination;
(2) After restricting the right of prescribing, there is still an over-prescribing without a justifiable reason;
(3) Failure to prescribe antimicrobial drugs according to the regulations, resulting in serious consequences;
(4) Failure to use antimicrobial drugs according to the regulations, resulting in serious consequences;
(4) Failure to use the special use level and restricted use level of the antimicrobial drugs. (D) not in accordance with the provisions of the use of antimicrobial drugs, resulting in serious consequences;
(E) prescribing antimicrobial drugs for undue profit.
Article 47 The pharmacist fails to review the prescription of antimicrobial drugs in accordance with the provisions of the prescription and medication orders, resulting in serious consequences, or found that the prescription is inappropriate, over-prescription and other cases without intervention and without justifiable reasons, the medical institution shall cancel its drug dispensing qualifications.
Article 48 After the cancellation of a physician's prescribing right and a pharmacist's drug dispensing qualification, his prescribing right and drug dispensing qualification shall not be restored within six months.
Chapter V Legal Liability
Article 49 If a medical institution has one of the following circumstances, the health administrative department at or above the county level shall order rectification within a certain period of time; if it fails to do so, it shall be notified of the criticisms and be given a warning; if it results in serious consequences, the supervisory personnel in charge of the responsible persons and other directly responsible persons shall be given disciplinary actions:
(1) Failure to establish the organization of the antimicrobial drug management (A) failed to establish the organization of antimicrobial drug management or failed to designate a full-time (part-time) technical personnel responsible for the specific management;
(B) failed to establish antimicrobial drug management rules and regulations;
(C) antimicrobial drug clinical application management chaos;
(D) failed to carry out the antimicrobial drug hierarchical management in accordance with the provisions of this approach, the management of antibacterial drug prescribing authority of the physician, the qualification of the pharmacist antimicrobial drug dispensing management Or not equipped with relevant professional and technical personnel;
(E) other violations of the provisions of these measures.
Article 50 of the medical institutions in one of the following circumstances, by the health administrative department above the county level shall order rectification within a certain period of time, and give a warning, and according to the severity of the circumstances of the fine of up to 30,000 yuan; on the supervisory personnel responsible for and other personnel directly responsible for the circumstances of the disciplinary action to be taken:
(a) the use of antimicrobial prescribing rights of the physician who did not obtain the antibacterial drug prescription authority or the use of the physician who was canceled the right to prescribe antimicrobial drugs. Antibacterial drug prescription by physicians who have not obtained the right to prescribe antimicrobial drugs or by physicians whose right to prescribe antimicrobial drugs has been revoked;
(2) Failure to carry out appropriateness audits of antimicrobial drug prescriptions and instructions, which is a serious matter;
(3) Engagement in antimicrobial drug purchasing, selling and dispensing by non-pharmacy departments;
(4) Linking the purchase and sale of antimicrobial drugs and clinical application with the personal financial interests of an individual or department;
(5) Engagement in antimicrobial drug purchasing, selling and dispensing in non-pharmacy departments; and (E) in the purchase and sale of antimicrobial drugs, clinical application of improper profits.
Article 51 The person in charge of medical institutions, drug purchasers, physicians and other relevant personnel to solicit and accept drug manufacturers, drug companies or their agents to give the property or by prescribing antibacterial drugs to make improper profits, by the local health administrative departments at or above the county level in accordance with relevant state laws and regulations to deal with.
Article 52 If a physician has one of the following circumstances, the health administrative department above the county level shall, in accordance with the provisions of Article 37 of the Practicing Physicians Law, give a warning or order the suspension of practice for six months or less than one year; if the circumstances are serious, revoke his or her practicing certificate; if a crime is constituted, be held criminally liable according to the law:
(1) Failure to issue antibacterial drug prescriptions in accordance with the provisions of this Measures, resulting in serious consequences. (a) Failure to prescribe antibacterial drugs in accordance with the provisions of these Measures, resulting in serious consequences;
(b) Use of antibacterial drugs not approved by the State Drug Administration;
(c) Use of antibacterial drugs outside the supply directory of the institution's varieties, specimens, resulting in serious consequences;
(d) Violation of other provisions of these Measures, resulting in serious consequences.
Rural doctors who have one of the cases stipulated in the preceding paragraph shall be dealt with by the county-level health administrative departments in accordance with the relevant provisions of Article 38 of the Regulations on the Administration of Rural Physician Practices.
Article 53 If the pharmacist has one of the following circumstances, the health administrative department at or above the county level shall order rectification within a certain period of time, and give a warning; if the case constitutes a crime, the criminal responsibility shall be investigated according to law:
(1) Failure to follow the provisions of the audit, transfer of antibacterial drug prescriptions, the circumstances are serious;
(2) Failure to follow the provisions of the private increase in antibacterial drug varieties or gauges;
(3) Violation of the provisions of this Measures. p>(C) violation of other provisions of these measures.
Article 54 Without the approval of the county-level health administrative department, the village health office, clinic, community health service station unauthorized use of antimicrobial drugs to carry out intravenous infusion activities, by the local health administrative department at or above the county level and ordered to make corrections within a specified period of time, and be given a warning; overdue, may be fined 10,000 yuan according to the severity of the case.
Article 55 If the local health administrative department at or above the county level fails to fulfill its supervisory duties in accordance with the provisions of these Measures, and serious consequences are caused, the directly responsible supervisory personnel and other directly responsible personnel shall be given administrative sanctions such as demerit, demotion, dismissal and expulsion in accordance with the law.
Article 56 Medical institutions and their medical personnel in violation of the Drug Administration Law, in accordance with the relevant provisions of the Drug Administration Law.
Chapter VI Supplementary Provisions
Article 57 The State Administration of Traditional Chinese Medicine shall be responsible for the supervision and management of the clinical application of antimicrobial drugs in traditional Chinese medical institutions within its scope of responsibilities.
Article 58 The provincial health administrative departments shall, within three months from the date of publication of these Measures, formulate a hierarchical management catalog of antimicrobial drugs in their respective administrative regions.
Article 59 These Measures shall come into force on August 1, 2012.