The Order of the Ministry of Health of the People's Republic of China No. 84 “Administrative Measures for Clinical Application of Antimicrobial Agents†was reviewed and approved by the Ministry of Health at the Ministerial Meeting on February 13, 2012. It is hereby promulgated and will come into effect on August 1, 2012.
Minister Chen Jun April 24, 2012 Regulations for the Administration of Clinical Application of Antibacterial Drugs Chapter I General Provisions Article 1 To strengthen the clinical application and management of antibiotics in medical institutions, regulate the clinical application of antibiotics and improve the clinical application of antibiotics. Promote the rational use of antimicrobial drugs in the clinic, control bacterial resistance, ensure medical quality and medical safety, and formulate these measures in accordance with relevant health laws and regulations.
Article 2 The term "antibacterial drugs" as used in these Measures refers to drugs used to treat the pathogens of infectious diseases caused by pathogenic microorganisms such as bacteria, mycoplasma, chlamydia, rickettsia, spirochetes, and fungi, excluding the treatment of tuberculosis, parasitic diseases, and various viruses. Drugs that cause infectious diseases and traditional Chinese medicine preparations that have antibacterial effects.
Article 3 The Ministry of Health shall be responsible for the supervision and administration of the clinical application of antibacterial drugs in medical institutions throughout the country.
Local health administrative departments at or above the county level shall be responsible for the supervision and administration of the clinical application of antibacterial drugs in medical institutions within their own administrative regions.
Article 4 This method is applicable to the clinical application and management of antibacterial drugs in various types of medical institutions at all levels.
Article 5 The clinical application of antimicrobial drugs should follow the principles of safety, efficiency and economy.
Article 6 The clinical application of antibacterial drugs shall be subject to hierarchical management. According to safety, efficacy, bacterial drug resistance, price and other factors, the antibacterial drugs are divided into three levels: non-restricted use, restricted use and special use. The specific division criteria are as follows:
(1) Non-restricted use of antibacterial drugs refers to antibacterial drugs that have proven to be safe and effective over a long period of time, have little effect on bacterial resistance, and are relatively inexpensive;
(2) Restriction of use of antibacterial drugs refers to antibacterial drugs that have been proved to be safe and effective by long-term clinical application, have a greater impact on bacterial drug resistance, or have relatively high prices;
(C) Special use grade antibacterial drugs refer to one of the following situations:
1. With obvious or serious adverse reactions, antibacterial drugs that should not be used arbitrarily;
2. Need to strictly control the use of bacteria to avoid the emergence of antimicrobial drug resistance too quickly;
3. Antibacterial drugs with less clinical data on efficacy and safety;
4. Expensive antibacterial drugs.
The directory of classified management of antibacterial drugs shall be formulated by the provincial health administrative departments and reported to the Ministry of Health for the record.
Chapter II Organization Structure and Responsibilities Article 7 The principal person in charge of a medical institution is the first person responsible for the clinical application and management of antibacterial drugs in this institution.
Article 8 A medical institution shall establish its own system for the management of antibacterial drugs.
Article 9 A medical institution shall establish an antibacterial drug administration institution or be equipped with special (part-time) personnel to take charge of its antibacterial drug administration work.
Hospitals above Grade 2 and above, Maternal and Child Health Hospitals, and specialist disease prevention and treatment institutions (hereinafter referred to as Grade 2 and above) shall establish antibacterial drug management working groups under the Pharmaceutical Affairs Management and Drug Therapeutics Committee. The antibacterial drug management working group consists of persons in charge of medical treatment, pharmacy, infectious diseases, clinical microbiology, nursing, and hospital infection management, and personnel with relevant professional and high-level technical qualifications. The medical and pharmaceutical departments are responsible for daily management.
Other medical institutions set up an antibacterial drug management working group or designated full-time (part-time) personnel to take charge of specific management tasks.
Article 10 The main responsibilities of a medical institution's antibacterial drug administration agency or specialized (part-time) personnel are:
(1) Implement the relevant laws, regulations and rules for the administration of antibacterial drugs, formulate the institutional antibacterial drug management system, and organize the implementation;
(2) To review the list of antibacterial drug suppliers in this agency, formulate relevant technical documents for the clinical application of antibacterial drugs, and organize the implementation;
(3) To monitor the clinical application of antibacterial drugs and bacterial drug resistance in this institution, regularly analyze, evaluate, report monitoring data and publish relevant information, and propose interventions and improvement measures;
(4) Training of medical personnel on relevant laws, regulations, rules and regulations and technical specifications for antibacterial drug administration, and organizing publicity and education on the rational use of antibacterial drugs by patients.
Article 11 The above-mentioned hospitals at Grade 2 or above shall be provided with Infectious Diseases Division and equipped with professional physicians for infectious diseases.
The Department of Infectious Diseases and Infectious Diseases are responsible for technical guidance on the clinical application of antibacterial drugs in clinical departments of this institution and participate in the clinical application and management of antibacterials.
Article 12 Hospitals above Grade 2 shall be equipped with clinical pharmacists of relevant specialties such as antibiotics.
The clinical pharmacist is responsible for providing technical support for the clinical application of antibiotics in this institution, guiding patients to use antibiotics rationally, and participating in the clinical application and management of antibacterials.
Article 13 Hospitals above Class 2 or above shall, according to actual needs, establish a clinical microbiology room that meets the laboratory biosafety requirements.
The Clinical Microbiology Laboratory conducts work on microbial culture, isolation, identification, and drug susceptibility testing, provides etiological diagnosis and bacterial drug resistance technical support, and participates in the clinical application and management of antimicrobial drugs.
Article 14 Health administrative departments and medical institutions shall strengthen the construction of relevant disciplines involving the clinical application and management of antibacterial drugs, establish professional personnel training and assessment systems, and give full play to the role of relevant professional and technical personnel in the clinical application and management of antimicrobial drugs.
Chapter III Management of Clinical Application of Antimicrobial Agents Article 15 Medical institutions shall strictly implement the “Prescription Management Measuresâ€, “Administrative Regulations for Medical Affairs of Medical Institutionsâ€, “Guiding Principles for Clinical Application of Antibacterial Drugs†and “National Formulary†and other related regulations. Technical specifications to strengthen the management of antimicrobial drug selection, procurement, prescription, adjustment, clinical application and drug evaluation.
Article 16 A medical institution shall, in accordance with the directory of classified administration of antibacterial drugs formulated by the provincial administrative department of health, formulate its own list of antibacterial drug suppliers and file with the health administrative department that issues its "Practice License for Medical Institutions." The antibacterial drug supply directory of medical institutions includes the types and specifications of antibacterial drugs purchased. Unregistered antibacterial drug types and specifications may not be purchased by medical institutions.
Article 17 A medical institution shall strictly control the number of varieties of its antibacterial drug supply catalogue. The same generic name of antibacterial drugs, injection dosage forms and oral dosage forms shall not exceed two kinds. Antibiotics with similar or identical pharmacological characteristics must not be duplicated in the supply catalogue.
Article 18 If a medical institution really needs the needs of clinical work, if the number of antibiotics and the number of antibacterial drugs exceed the stipulations, it shall explain to the health administrative department that issued its "Practice License for Medical Institutions" in detail the reasons and reasons; the explanation is not sufficient or the reasons are not established. The health administrative department shall not accept the record of the number of antibacterial drugs and the number of its regulations.
Article 19 Medical institutions shall periodically adjust the structure of varieties of antibacterial drug supply catalogues, and file with the health administrative department that issued the "Practice Permit for Medical Institutions" within 15 working days after each adjustment. The adjustment period is, in principle, 2 years, and the minimum period is not less than 1 year.
Article 20 Medical institutions shall purchase antibiotics in accordance with the generic name of the drugs approved and announced by the State Drug Administration and Administration Department. The National Essential Drug List, the National Formulary, and the National Basic Medical Insurance, Industrial Injury Insurance and Fertility shall be preferentially selected. List of antibiotics included in the Catalogue of Insurance Drugs.
Grass-roots medical and health institutions can only use antimicrobial drugs in basic medicines (including supplementary varieties in all provinces, municipalities, and municipalities).
Article 21 The antibacterial drugs of medical institutions shall be uniformly purchased and supplied by the pharmaceutical department, and other departments or departments may not engage in the procurement or adjustment of antimicrobial drugs. Clinically, antibiotics purchased and supplied by non-pharmaceutical departments must not be used.
Article 22 If a medical institution needs to use antibacterial drugs other than the antibacterial drug supply catalogue of its own institution for special treatment needs, it may initiate temporary purchasing procedures. Temporary procurement should be submitted by the clinical department, stating that the name, dosage form, specification, quantity, object of use, and reason for use of the purchased antibacterial drug shall be temporarily purchased by the pharmacy department after being reviewed and approved by the antibacterial drug management working group of this institution. .
Medical institutions should strictly control the types and quantities of antibacterial drugs temporarily purchased, and the initiation of temporary procurement procedures for the same generic antibacterial drugs can in principle not exceed five cases per year. If there are more than 5 cases, it should be discussed whether it should be included in the list of antibacterial drugs in this agency. The total number of varieties in the adjusted antibacterial drug supply catalogue must not increase.
Medical institutions shall record the temporary procurement of antibiotics to the health administrative department that has issued their "Practice License for Medical Institutions" for record.
Article 23 Medical institutions shall establish systems for the selection and periodic evaluation of antimicrobial drugs.
Medical institutions selecting and newly introducing antibacterial drug types shall submit an application report from the clinical department, and shall be considered by the antibacterial drug management working group after receiving opinions from the pharmaceutical department.
More than two-thirds of the members of the Antimicrobial Drugs Management Working Group shall consider and agree, and shall be listed in the procurement and supply catalogue after being reviewed and approved by more than two-thirds of the members of the Pharmaceutical Affairs Management and Pharmaceutical Therapeutics Committee.
Where there are potential safety hazards, uncertain therapeutic effects, high drug resistance rates, poor cost-effectiveness, or illegal use of antibacterial drug products or product regulations, clinical departments, pharmaceutical departments, and antibacterial drug administration teams may propose retiring or replacing opinions. The retired opinions were agreed upon by more than one-half of the members of the Antimicrobial Drug Administration Working Group, and reported to the Pharmaceutical Affairs Management and Drug Therapeutics Committee for record. The replacement opinions were implemented after discussion and approval by the Pharmaceutical Affairs Management Committee and the Pharmaceutical Therapeutics Committee.
The retired or replaced antibacterial drug product or product specification may not, in principle, reenter the agency's antibacterial drug supply catalogue within 12 months.
Article 24 Physicians with qualifications for senior professional and technical positions may be granted prescribing rights for special use grade antibiotics; physicians with professional qualifications for intermediate and higher professional titles may be granted prescriptions for restricting the use of prescribing antibacterial drugs; Physicians with qualifications for appointment in the profession, practicing assistant doctors and rural doctors who are engaged in general practice activities independently in medical institutions in townships, nationality townships, towns, and villages may grant non-restricted use of antibacterial drug prescriptions. After the pharmacists have been trained and passed the assessment, they will be eligible for antibacterial drug dispensing.
Hospitals above Grade 2 should regularly train physicians and pharmacists on the clinical application of antibacterial drugs and standardized management. After the doctors have been trained by this institution and passed the examination, they can obtain the corresponding prescription rights.
Doctors, rural doctors, and pharmacists engaged in prescription adjustment work of other medical institutions that enjoy prescription rights according to law organize relevant training and assessment by local health administrative departments at or above the county level. Upon passing the assessment, the corresponding antibacterial drug prescription rights or antibacterial drug dispensing qualifications shall be granted.
Article 25 The clinical application knowledge and standardized management training and assessment content of antimicrobial drugs shall include:
(1) "Drug Administration Law", "Practicing Doctors Law", "Administrative Measures for Clinical Application of Antibacterial Drugs", "Administrative Measures for Prescriptions", "Administrative Regulations for Pharmaceutical Affairs of Medical Institutions", "Guiding Principles for Clinical Application of Antibacterial Drugs," and "National "Basic Pharmaceutical Formulation Set", "National Formulary" and "Hospital Prescription Review Management Specification (Trial)" and other relevant laws, regulations, rules, and regulatory documents;
(2) Clinical application and management system of antimicrobial drugs;
(c) the pharmacological characteristics and precautions of commonly used antimicrobial agents;
(4) The trend of resistance and control methods for common bacteria;
(e) The prevention and treatment of adverse drug reactions.
Article 26 Medical institutions and medical personnel shall strictly control the use of antibacterial drugs to prevent infection. Infection prevention, treatment of mild or local infection should be the first choice of non-restricted use of antibacterial drugs; serious infections, low immune function combined infections or pathogens only sensitive to restricted use of antibiotics, can only be limited to the use of antibacterial drugs.
Article 27 Strictly control the use of antibacterial drugs for special use grades. Special use grade antibiotics should not be used in outpatient clinics.
Clinical use of special use-grade antibacterial drugs should strictly control the indications for the use of drugs. After the consent of the professional and technical personnel designated by the Antimicrobial Drug Administration Working Group, the doctors with the corresponding prescription rights shall issue prescriptions.
The special-use antibacterial drug consultation staff is composed of physicians, pharmacists or senior professional technicians with senior professional and technical qualifications such as Infectious Diseases, Respiratory Medicine, Critical Care Medicine, Microbiology Laboratory, and Pharmacy with experience in the clinical application of antimicrobial drugs. Professional clinical chemist of antibacterial drugs who hold post qualifications.
Article 28 Physicians may use antibacterials at levels as they rescue emergencies such as dying patients. The use of antibacterial drugs in leapfrogging should record the indications for the use of drugs in detail, and the necessary procedures for the use of antibacterial drugs for leapfrogging should be completed within 24 hours.
Article 29 Medical institutions shall formulate and strictly control the proportion of antibiotics used for intravenous infusion in outpatients.
The use of antibacterial drugs in village clinics, clinics and community health service stations to carry out intravenous infusion activities should be approved by the county health administrative department.
Article 30 Medical institutions shall carry out monitoring of the clinical application of antibacterial drugs, analyze the use of antibacterials in their own institutions and clinics, assess the suitability of antibacterial drugs, analyze the trends in the use of antibacterials, and analyze the unreasonable use of antibiotics. Effective interventions should be taken promptly.
Article 31 Medical institutions shall rationally use antimicrobial drugs according to the test results of clinical microbiological specimens. Before the clinical microbiological specimen test results are available, the medical institution may use antibacterial drugs according to the experience of the local and the institution's bacterial resistance monitoring. After the clinical microbiological specimen test results are issued, they are adjusted accordingly.
Article 32 Medical institutions shall carry out monitoring of bacterial resistance and establish an early warning mechanism for bacterial resistance, and take the following measures:
(1) The antibacterial drugs whose main target bacterial resistance rate exceeds 30% should promptly notify the medical personnel of the institution with early warning information;
(2) Antibacterial drugs whose main target bacterial resistance rate is more than 40% should be used with caution;
(3) Antibacterial drugs whose main target bacterial resistance rate exceeds 50% should be selected according to the drug sensitivity test results;
(4) Antibacterial drugs whose main target bacterial resistance rate exceeds 75% should suspend the clinical application of this target bacteria, and follow the tracking results of bacterial drug resistance before deciding whether to resume clinical application.
Article 33 A medical institution shall establish a ranking, internal publicity and reporting system for the clinical application of antibacterial drugs in this institution.
Medical institutions shall rank and publicize the use of antibacterial drugs, usage rates, and intensity of use of the clinical departments and medical personnel; they shall criticize and educate physicians who are ranked lower or who have found serious problems, and shall be notified of serious cases.
The medical institution shall, according to the requirements, summarize the clinical application of antibiotics in clinical departments and medical personnel, and report to the health administrative department that issued its "Practice License for Medical Institutions." The clinical application of non-restricted-use antibacterial drugs is reported once a year; clinical use of antibacterial drugs with restricted use-level and special-use levels is restricted and reported once every six months.
Article 34 Medical institutions shall make full use of informational means to promote the rational application of antimicrobial drugs.
Article 35 Medical institutions shall investigate the abnormalities of the clinical application of the following antibacterial drugs and deal with them according to different circumstances:
(I) Antibacterial drugs with abnormally increased use;
(2) antibacterial drugs that have been used for the first time in half a year;
(3) Antibacterial drugs that are often used for superindividualization and overdose;
(4) antibacterial drugs sold illegally by the company;
(5) Antibiotics that have serious adverse events.
Article 36 A medical institution shall strengthen the management of the sales activities of its antibacterial drug production and sales enterprises in its own institutions, and shall promptly adopt measures such as suspending drug intake, retiring, etc., for enterprises that have improper sales practices.
Chapter IV Supervision and Administration Article 37 The health administrative department at or above the county level shall strengthen the supervision and inspection of the clinical application of antibiotics in the medical institutions within its own administrative region.
Article 38 When working personnel of the administrative department of public health supervise and inspect the clinical application of antibiotics in medical institutions according to law, they shall produce certificates, and the medical institutions to be inspected shall cooperate and provide the necessary materials, and may not refuse, obstruct or conceal.
Article 39 Local health administrative departments at or above the county level shall establish a clinical application management evaluation system for antibacterial drugs in medical institutions.
Article 40 Local health administrative departments at or above the county level shall establish a system for ranking, publicizing and hearing talks about the clinical application of antimicrobial drugs. To rank the use, use and intensity of antibacterial drugs in medical institutions in the administrative region, publish the rankings in the medical institutions within the administrative area, and report them to the health administrative department at the higher level for the record; the occurrence of major and extraordinarily serious medical quality and safety incidents Or the person in charge of various types of medical institutions with serious hidden dangers in medical quality will engage in conversations and the situation will be seriously reported.
Article 41 The county-level health administrative department shall be responsible for ranking and publicizing the use of antibacterial drugs and the utilization rate of township health centers and community health service centers (stations) in the area under their jurisdiction.
Entrusted by the county-level health administrative department, the township health center shall be responsible for ranking and publicizing the use of antibacterial drugs and usage rates in village clinics in the area under its jurisdiction, and report it to the county-level health administrative department.
Article 42 The Ministry of Health shall establish a national antibacterial drug clinical application monitoring network and a nationwide bacterial drug resistance monitoring network to monitor the clinical application of antibacterial drugs and bacterial drug resistance in the country; and regularly publish antibacterial drug clinical application control indicators according to monitoring conditions. Clinical application of antimicrobials for quality management and control.
The provincial health administrative department shall establish a clinical application monitoring network of antibacterial drugs and a bacterial drug resistance monitoring network in the administrative area, monitor the clinical application of antibacterial drugs and bacterial drug resistance in medical institutions, and conduct quality management and control of clinical application of antibacterial drugs.
The clinical application of antibacterial drugs and the technical monitoring program for bacterial resistance are formulated separately by the Ministry of Health.
Article 43. The administrative department of public health shall incorporate the clinical application of antibiotics in medical institutions into the evaluation index system of medical institutions; consider the clinical application of antibiotics as an important indicator for the rating, evaluation and evaluation of medical institutions, and if the assessment fails, depending on the circumstances Medical institutions made downgrades, downgrades, and unqualified evaluations.
Article 44 The antibacterial drug administration agencies of medical institutions shall regularly organize relevant professional and technical personnel to review the prescriptions and orders of antibacterial drugs, and use the results of the reviews as a basis for the regular assessment of doctors, clinical departments and medical personnel.
Article 45: Medical institutions shall warn physicians who have presented antibiotics beyond their usual prescriptions for more than three times and have no justifiable reasons, limiting their special use levels and restricting the use of antibacterial drug prescriptions.
Article 46 If a physician has one of the following circumstances, the medical institution shall cancel its prescription right:
(1) Failed to pass the examination of antibacterial drugs;
(2) After restricting the right to prescribing, an extraordinary prescription still exists and there is no justification;
(3) Failure to prescribe antibiotics in accordance with the regulations has caused serious consequences;
(4) Failing to use antibiotics as prescribed, causing serious consequences;
(5) Prescribing antibiotic drugs to obtain improper benefits.
Article 47 If a pharmacist fails to comply with regulations to review antibiotic prescriptions and prescriptions for medical use and cause serious consequences, or if he finds that the prescription is not appropriate or the supernormal prescription has not been interfered with and there is no justification, the medical institution shall cancel its drug dispensing qualification.
Article 48 After the physician's prescription rights and pharmacist's drug distribution qualifications are cancelled, they must not resume their prescription rights and drug dispensing qualifications within six months.
Chapter V Legal Liabilities Article 49 If a medical institution has any of the following circumstances, the health administrative department at or above the county level shall order it to make corrections within a time limit; if the medical institution fails to make any change within the specified period, it shall make a public criticism and give a warning; if it causes serious consequences, it shall be held Responsible supervisors and other directly responsible personnel are given disciplinary actions:
(1) Failure to establish an antibacterial drug administration organization or designate a special (part-time) technical person to take charge of the specific management work;
(2) Failure to establish rules and regulations for the management of antibacterial drugs;
(3) The management of clinical application of antibiotics is confusing;
(4) failing to implement the grading management of antibacterial drugs, the authority management of prescriptions for antibacterial drugs, the qualification management of pharmacists for antibacterial drugs adjustment, or failing to equip relevant professional and technical personnel in accordance with the provisions of these Measures;
(5) Other acts that violate the provisions of these Measures.
Article 50 If a medical institution has any of the following circumstances, the health administrative department at or above the county level shall order it to make corrections within a time limit, give a warning, and impose a fine of up to 30,000 yuan, depending on the seriousness of the circumstances; the responsible person in charge and other direct responsibilities Personnel may be given sanctions according to the circumstances:
(1) using a doctor who has not obtained the right to prescribe antibacterial drugs or a physician who has used the right to prescribe antibacterial drugs to prescribe antibiotics;
(2) Failure to review the suitability of antimicrobial prescriptions and doctor's orders and the circumstances are serious;
(3) The non-pharmaceutical department engages in the purchase, sale and adjustment of antibacterial drugs;
(4) linking the purchase and sale of antibacterial drugs and clinical application with the economic benefits of individuals or departments;
(5) Obtaining improper interests in the purchase, sale and clinical application of antimicrobial drugs.
Article 51: Persons in charge of medical institutions, drug purchasers, doctors, and other relevant persons who obtain and receive property granted by drug production enterprises, drug trading enterprises, or their agents, or obtain anti- The above-mentioned local administrative departments of health shall be dealt with in accordance with relevant national laws and regulations.
Article 52 If a physician has any of the following circumstances, the health administrative department at or above the county level shall, in accordance with the relevant provisions of Article 37 of the "Law on the Practice of Doctors of Practitioners", give a warning or order a suspension of practice activities of more than six months and less than one year; If the circumstances are serious, his practice certificate shall be revoked; if a crime is constituted, criminal responsibility shall be investigated according to law:
(1) Failure to prescribe antibiotics in accordance with the provisions of these Measures has caused serious consequences;
(2) Use of antibacterial drugs that have not been approved by the State Drug Administration;
(3) The use of varieties and regulations other than the list of antibacterial drugs supplied by this agency has caused serious consequences;
(4) Violating other provisions of these Measures and causing serious consequences.
If a rural doctor has any of the conditions specified in the preceding paragraph, the health administrative department at the county level shall handle it in accordance with the relevant provisions of Article 38 of the Regulations on the Administration of Rural Doctors.
Article 53 Where a pharmacist has one of the following circumstances, the health administrative department at or above the county level shall order it to make corrections within a time limit and give a warning; if a crime is constituted, the criminal liability shall be investigated according to law:
(1) failing to review and adjust prescriptions for antibiotics in accordance with regulations, and the circumstances are serious;
(2) failing to increase the varieties or regulations of antibiotics in accordance with regulations;
(3) Violating other provisions of these Measures.
Article 54 Without the approval of the county-level health administrative department, the village clinics, clinics, and community health service stations that use antibacterial drugs without authorization to carry out intravenous infusion activities shall be ordered by the local administrative department of health at or above the county level to make correction within a specified period and a warning shall be given; If it does not change within the time limit, it may impose a fine of less than 10,000 yuan depending on the severity of the circumstances.
Article 55 If the local health administrative department at or above the county level fails to perform its supervisory duties in accordance with the provisions of these Measures, resulting in serious consequences, the person directly in charge and other directly responsible personnel shall be given administrative overdue, downgraded, dismissed, and fired in accordance with the law. Disposition.
Article 56 If a medical institution or its medical staff violates the "Drug Administration Law," it shall be dealt with 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 administration of the clinical application of antibacterial drugs in Chinese medical institutions within the scope of their duties.
Article 58 Each provincial health administrative department shall, within three months from the date of promulgation of these Measures, formulate a catalogue of classified administration of antibacterial drugs in its own administrative region.
Article 59 These Measures shall come into force on August 1, 2012.
Minister Chen Jun April 24, 2012 Regulations for the Administration of Clinical Application of Antibacterial Drugs Chapter I General Provisions Article 1 To strengthen the clinical application and management of antibiotics in medical institutions, regulate the clinical application of antibiotics and improve the clinical application of antibiotics. Promote the rational use of antimicrobial drugs in the clinic, control bacterial resistance, ensure medical quality and medical safety, and formulate these measures in accordance with relevant health laws and regulations.
Article 2 The term "antibacterial drugs" as used in these Measures refers to drugs used to treat the pathogens of infectious diseases caused by pathogenic microorganisms such as bacteria, mycoplasma, chlamydia, rickettsia, spirochetes, and fungi, excluding the treatment of tuberculosis, parasitic diseases, and various viruses. Drugs that cause infectious diseases and traditional Chinese medicine preparations that have antibacterial effects.
Article 3 The Ministry of Health shall be responsible for the supervision and administration of the clinical application of antibacterial drugs in medical institutions throughout the country.
Local health administrative departments at or above the county level shall be responsible for the supervision and administration of the clinical application of antibacterial drugs in medical institutions within their own administrative regions.
Article 4 This method is applicable to the clinical application and management of antibacterial drugs in various types of medical institutions at all levels.
Article 5 The clinical application of antimicrobial drugs should follow the principles of safety, efficiency and economy.
Article 6 The clinical application of antibacterial drugs shall be subject to hierarchical management. According to safety, efficacy, bacterial drug resistance, price and other factors, the antibacterial drugs are divided into three levels: non-restricted use, restricted use and special use. The specific division criteria are as follows:
(1) Non-restricted use of antibacterial drugs refers to antibacterial drugs that have proven to be safe and effective over a long period of time, have little effect on bacterial resistance, and are relatively inexpensive;
(2) Restriction of use of antibacterial drugs refers to antibacterial drugs that have been proved to be safe and effective by long-term clinical application, have a greater impact on bacterial drug resistance, or have relatively high prices;
(C) Special use grade antibacterial drugs refer to one of the following situations:
1. With obvious or serious adverse reactions, antibacterial drugs that should not be used arbitrarily;
2. Need to strictly control the use of bacteria to avoid the emergence of antimicrobial drug resistance too quickly;
3. Antibacterial drugs with less clinical data on efficacy and safety;
4. Expensive antibacterial drugs.
The directory of classified management of antibacterial drugs shall be formulated by the provincial health administrative departments and reported to the Ministry of Health for the record.
Chapter II Organization Structure and Responsibilities Article 7 The principal person in charge of a medical institution is the first person responsible for the clinical application and management of antibacterial drugs in this institution.
Article 8 A medical institution shall establish its own system for the management of antibacterial drugs.
Article 9 A medical institution shall establish an antibacterial drug administration institution or be equipped with special (part-time) personnel to take charge of its antibacterial drug administration work.
Hospitals above Grade 2 and above, Maternal and Child Health Hospitals, and specialist disease prevention and treatment institutions (hereinafter referred to as Grade 2 and above) shall establish antibacterial drug management working groups under the Pharmaceutical Affairs Management and Drug Therapeutics Committee. The antibacterial drug management working group consists of persons in charge of medical treatment, pharmacy, infectious diseases, clinical microbiology, nursing, and hospital infection management, and personnel with relevant professional and high-level technical qualifications. The medical and pharmaceutical departments are responsible for daily management.
Other medical institutions set up an antibacterial drug management working group or designated full-time (part-time) personnel to take charge of specific management tasks.
Article 10 The main responsibilities of a medical institution's antibacterial drug administration agency or specialized (part-time) personnel are:
(1) Implement the relevant laws, regulations and rules for the administration of antibacterial drugs, formulate the institutional antibacterial drug management system, and organize the implementation;
(2) To review the list of antibacterial drug suppliers in this agency, formulate relevant technical documents for the clinical application of antibacterial drugs, and organize the implementation;
(3) To monitor the clinical application of antibacterial drugs and bacterial drug resistance in this institution, regularly analyze, evaluate, report monitoring data and publish relevant information, and propose interventions and improvement measures;
(4) Training of medical personnel on relevant laws, regulations, rules and regulations and technical specifications for antibacterial drug administration, and organizing publicity and education on the rational use of antibacterial drugs by patients.
Article 11 The above-mentioned hospitals at Grade 2 or above shall be provided with Infectious Diseases Division and equipped with professional physicians for infectious diseases.
The Department of Infectious Diseases and Infectious Diseases are responsible for technical guidance on the clinical application of antibacterial drugs in clinical departments of this institution and participate in the clinical application and management of antibacterials.
Article 12 Hospitals above Grade 2 shall be equipped with clinical pharmacists of relevant specialties such as antibiotics.
The clinical pharmacist is responsible for providing technical support for the clinical application of antibiotics in this institution, guiding patients to use antibiotics rationally, and participating in the clinical application and management of antibacterials.
Article 13 Hospitals above Class 2 or above shall, according to actual needs, establish a clinical microbiology room that meets the laboratory biosafety requirements.
The Clinical Microbiology Laboratory conducts work on microbial culture, isolation, identification, and drug susceptibility testing, provides etiological diagnosis and bacterial drug resistance technical support, and participates in the clinical application and management of antimicrobial drugs.
Article 14 Health administrative departments and medical institutions shall strengthen the construction of relevant disciplines involving the clinical application and management of antibacterial drugs, establish professional personnel training and assessment systems, and give full play to the role of relevant professional and technical personnel in the clinical application and management of antimicrobial drugs.
Chapter III Management of Clinical Application of Antimicrobial Agents Article 15 Medical institutions shall strictly implement the “Prescription Management Measuresâ€, “Administrative Regulations for Medical Affairs of Medical Institutionsâ€, “Guiding Principles for Clinical Application of Antibacterial Drugs†and “National Formulary†and other related regulations. Technical specifications to strengthen the management of antimicrobial drug selection, procurement, prescription, adjustment, clinical application and drug evaluation.
Article 16 A medical institution shall, in accordance with the directory of classified administration of antibacterial drugs formulated by the provincial administrative department of health, formulate its own list of antibacterial drug suppliers and file with the health administrative department that issues its "Practice License for Medical Institutions." The antibacterial drug supply directory of medical institutions includes the types and specifications of antibacterial drugs purchased. Unregistered antibacterial drug types and specifications may not be purchased by medical institutions.
Article 17 A medical institution shall strictly control the number of varieties of its antibacterial drug supply catalogue. The same generic name of antibacterial drugs, injection dosage forms and oral dosage forms shall not exceed two kinds. Antibiotics with similar or identical pharmacological characteristics must not be duplicated in the supply catalogue.
Article 18 If a medical institution really needs the needs of clinical work, if the number of antibiotics and the number of antibacterial drugs exceed the stipulations, it shall explain to the health administrative department that issued its "Practice License for Medical Institutions" in detail the reasons and reasons; the explanation is not sufficient or the reasons are not established. The health administrative department shall not accept the record of the number of antibacterial drugs and the number of its regulations.
Article 19 Medical institutions shall periodically adjust the structure of varieties of antibacterial drug supply catalogues, and file with the health administrative department that issued the "Practice Permit for Medical Institutions" within 15 working days after each adjustment. The adjustment period is, in principle, 2 years, and the minimum period is not less than 1 year.
Article 20 Medical institutions shall purchase antibiotics in accordance with the generic name of the drugs approved and announced by the State Drug Administration and Administration Department. The National Essential Drug List, the National Formulary, and the National Basic Medical Insurance, Industrial Injury Insurance and Fertility shall be preferentially selected. List of antibiotics included in the Catalogue of Insurance Drugs.
Grass-roots medical and health institutions can only use antimicrobial drugs in basic medicines (including supplementary varieties in all provinces, municipalities, and municipalities).
Article 21 The antibacterial drugs of medical institutions shall be uniformly purchased and supplied by the pharmaceutical department, and other departments or departments may not engage in the procurement or adjustment of antimicrobial drugs. Clinically, antibiotics purchased and supplied by non-pharmaceutical departments must not be used.
Article 22 If a medical institution needs to use antibacterial drugs other than the antibacterial drug supply catalogue of its own institution for special treatment needs, it may initiate temporary purchasing procedures. Temporary procurement should be submitted by the clinical department, stating that the name, dosage form, specification, quantity, object of use, and reason for use of the purchased antibacterial drug shall be temporarily purchased by the pharmacy department after being reviewed and approved by the antibacterial drug management working group of this institution. .
Medical institutions should strictly control the types and quantities of antibacterial drugs temporarily purchased, and the initiation of temporary procurement procedures for the same generic antibacterial drugs can in principle not exceed five cases per year. If there are more than 5 cases, it should be discussed whether it should be included in the list of antibacterial drugs in this agency. The total number of varieties in the adjusted antibacterial drug supply catalogue must not increase.
Medical institutions shall record the temporary procurement of antibiotics to the health administrative department that has issued their "Practice License for Medical Institutions" for record.
Article 23 Medical institutions shall establish systems for the selection and periodic evaluation of antimicrobial drugs.
Medical institutions selecting and newly introducing antibacterial drug types shall submit an application report from the clinical department, and shall be considered by the antibacterial drug management working group after receiving opinions from the pharmaceutical department.
More than two-thirds of the members of the Antimicrobial Drugs Management Working Group shall consider and agree, and shall be listed in the procurement and supply catalogue after being reviewed and approved by more than two-thirds of the members of the Pharmaceutical Affairs Management and Pharmaceutical Therapeutics Committee.
Where there are potential safety hazards, uncertain therapeutic effects, high drug resistance rates, poor cost-effectiveness, or illegal use of antibacterial drug products or product regulations, clinical departments, pharmaceutical departments, and antibacterial drug administration teams may propose retiring or replacing opinions. The retired opinions were agreed upon by more than one-half of the members of the Antimicrobial Drug Administration Working Group, and reported to the Pharmaceutical Affairs Management and Drug Therapeutics Committee for record. The replacement opinions were implemented after discussion and approval by the Pharmaceutical Affairs Management Committee and the Pharmaceutical Therapeutics Committee.
The retired or replaced antibacterial drug product or product specification may not, in principle, reenter the agency's antibacterial drug supply catalogue within 12 months.
Article 24 Physicians with qualifications for senior professional and technical positions may be granted prescribing rights for special use grade antibiotics; physicians with professional qualifications for intermediate and higher professional titles may be granted prescriptions for restricting the use of prescribing antibacterial drugs; Physicians with qualifications for appointment in the profession, practicing assistant doctors and rural doctors who are engaged in general practice activities independently in medical institutions in townships, nationality townships, towns, and villages may grant non-restricted use of antibacterial drug prescriptions. After the pharmacists have been trained and passed the assessment, they will be eligible for antibacterial drug dispensing.
Hospitals above Grade 2 should regularly train physicians and pharmacists on the clinical application of antibacterial drugs and standardized management. After the doctors have been trained by this institution and passed the examination, they can obtain the corresponding prescription rights.
Doctors, rural doctors, and pharmacists engaged in prescription adjustment work of other medical institutions that enjoy prescription rights according to law organize relevant training and assessment by local health administrative departments at or above the county level. Upon passing the assessment, the corresponding antibacterial drug prescription rights or antibacterial drug dispensing qualifications shall be granted.
Article 25 The clinical application knowledge and standardized management training and assessment content of antimicrobial drugs shall include:
(1) "Drug Administration Law", "Practicing Doctors Law", "Administrative Measures for Clinical Application of Antibacterial Drugs", "Administrative Measures for Prescriptions", "Administrative Regulations for Pharmaceutical Affairs of Medical Institutions", "Guiding Principles for Clinical Application of Antibacterial Drugs," and "National "Basic Pharmaceutical Formulation Set", "National Formulary" and "Hospital Prescription Review Management Specification (Trial)" and other relevant laws, regulations, rules, and regulatory documents;
(2) Clinical application and management system of antimicrobial drugs;
(c) the pharmacological characteristics and precautions of commonly used antimicrobial agents;
(4) The trend of resistance and control methods for common bacteria;
(e) The prevention and treatment of adverse drug reactions.
Article 26 Medical institutions and medical personnel shall strictly control the use of antibacterial drugs to prevent infection. Infection prevention, treatment of mild or local infection should be the first choice of non-restricted use of antibacterial drugs; serious infections, low immune function combined infections or pathogens only sensitive to restricted use of antibiotics, can only be limited to the use of antibacterial drugs.
Article 27 Strictly control the use of antibacterial drugs for special use grades. Special use grade antibiotics should not be used in outpatient clinics.
Clinical use of special use-grade antibacterial drugs should strictly control the indications for the use of drugs. After the consent of the professional and technical personnel designated by the Antimicrobial Drug Administration Working Group, the doctors with the corresponding prescription rights shall issue prescriptions.
The special-use antibacterial drug consultation staff is composed of physicians, pharmacists or senior professional technicians with senior professional and technical qualifications such as Infectious Diseases, Respiratory Medicine, Critical Care Medicine, Microbiology Laboratory, and Pharmacy with experience in the clinical application of antimicrobial drugs. Professional clinical chemist of antibacterial drugs who hold post qualifications.
Article 28 Physicians may use antibacterials at levels as they rescue emergencies such as dying patients. The use of antibacterial drugs in leapfrogging should record the indications for the use of drugs in detail, and the necessary procedures for the use of antibacterial drugs for leapfrogging should be completed within 24 hours.
Article 29 Medical institutions shall formulate and strictly control the proportion of antibiotics used for intravenous infusion in outpatients.
The use of antibacterial drugs in village clinics, clinics and community health service stations to carry out intravenous infusion activities should be approved by the county health administrative department.
Article 30 Medical institutions shall carry out monitoring of the clinical application of antibacterial drugs, analyze the use of antibacterials in their own institutions and clinics, assess the suitability of antibacterial drugs, analyze the trends in the use of antibacterials, and analyze the unreasonable use of antibiotics. Effective interventions should be taken promptly.
Article 31 Medical institutions shall rationally use antimicrobial drugs according to the test results of clinical microbiological specimens. Before the clinical microbiological specimen test results are available, the medical institution may use antibacterial drugs according to the experience of the local and the institution's bacterial resistance monitoring. After the clinical microbiological specimen test results are issued, they are adjusted accordingly.
Article 32 Medical institutions shall carry out monitoring of bacterial resistance and establish an early warning mechanism for bacterial resistance, and take the following measures:
(1) The antibacterial drugs whose main target bacterial resistance rate exceeds 30% should promptly notify the medical personnel of the institution with early warning information;
(2) Antibacterial drugs whose main target bacterial resistance rate is more than 40% should be used with caution;
(3) Antibacterial drugs whose main target bacterial resistance rate exceeds 50% should be selected according to the drug sensitivity test results;
(4) Antibacterial drugs whose main target bacterial resistance rate exceeds 75% should suspend the clinical application of this target bacteria, and follow the tracking results of bacterial drug resistance before deciding whether to resume clinical application.
Article 33 A medical institution shall establish a ranking, internal publicity and reporting system for the clinical application of antibacterial drugs in this institution.
Medical institutions shall rank and publicize the use of antibacterial drugs, usage rates, and intensity of use of the clinical departments and medical personnel; they shall criticize and educate physicians who are ranked lower or who have found serious problems, and shall be notified of serious cases.
The medical institution shall, according to the requirements, summarize the clinical application of antibiotics in clinical departments and medical personnel, and report to the health administrative department that issued its "Practice License for Medical Institutions." The clinical application of non-restricted-use antibacterial drugs is reported once a year; clinical use of antibacterial drugs with restricted use-level and special-use levels is restricted and reported once every six months.
Article 34 Medical institutions shall make full use of informational means to promote the rational application of antimicrobial drugs.
Article 35 Medical institutions shall investigate the abnormalities of the clinical application of the following antibacterial drugs and deal with them according to different circumstances:
(I) Antibacterial drugs with abnormally increased use;
(2) antibacterial drugs that have been used for the first time in half a year;
(3) Antibacterial drugs that are often used for superindividualization and overdose;
(4) antibacterial drugs sold illegally by the company;
(5) Antibiotics that have serious adverse events.
Article 36 A medical institution shall strengthen the management of the sales activities of its antibacterial drug production and sales enterprises in its own institutions, and shall promptly adopt measures such as suspending drug intake, retiring, etc., for enterprises that have improper sales practices.
Chapter IV Supervision and Administration Article 37 The health administrative department at or above the county level shall strengthen the supervision and inspection of the clinical application of antibiotics in the medical institutions within its own administrative region.
Article 38 When working personnel of the administrative department of public health supervise and inspect the clinical application of antibiotics in medical institutions according to law, they shall produce certificates, and the medical institutions to be inspected shall cooperate and provide the necessary materials, and may not refuse, obstruct or conceal.
Article 39 Local health administrative departments at or above the county level shall establish a clinical application management evaluation system for antibacterial drugs in medical institutions.
Article 40 Local health administrative departments at or above the county level shall establish a system for ranking, publicizing and hearing talks about the clinical application of antimicrobial drugs. To rank the use, use and intensity of antibacterial drugs in medical institutions in the administrative region, publish the rankings in the medical institutions within the administrative area, and report them to the health administrative department at the higher level for the record; the occurrence of major and extraordinarily serious medical quality and safety incidents Or the person in charge of various types of medical institutions with serious hidden dangers in medical quality will engage in conversations and the situation will be seriously reported.
Article 41 The county-level health administrative department shall be responsible for ranking and publicizing the use of antibacterial drugs and the utilization rate of township health centers and community health service centers (stations) in the area under their jurisdiction.
Entrusted by the county-level health administrative department, the township health center shall be responsible for ranking and publicizing the use of antibacterial drugs and usage rates in village clinics in the area under its jurisdiction, and report it to the county-level health administrative department.
Article 42 The Ministry of Health shall establish a national antibacterial drug clinical application monitoring network and a nationwide bacterial drug resistance monitoring network to monitor the clinical application of antibacterial drugs and bacterial drug resistance in the country; and regularly publish antibacterial drug clinical application control indicators according to monitoring conditions. Clinical application of antimicrobials for quality management and control.
The provincial health administrative department shall establish a clinical application monitoring network of antibacterial drugs and a bacterial drug resistance monitoring network in the administrative area, monitor the clinical application of antibacterial drugs and bacterial drug resistance in medical institutions, and conduct quality management and control of clinical application of antibacterial drugs.
The clinical application of antibacterial drugs and the technical monitoring program for bacterial resistance are formulated separately by the Ministry of Health.
Article 43. The administrative department of public health shall incorporate the clinical application of antibiotics in medical institutions into the evaluation index system of medical institutions; consider the clinical application of antibiotics as an important indicator for the rating, evaluation and evaluation of medical institutions, and if the assessment fails, depending on the circumstances Medical institutions made downgrades, downgrades, and unqualified evaluations.
Article 44 The antibacterial drug administration agencies of medical institutions shall regularly organize relevant professional and technical personnel to review the prescriptions and orders of antibacterial drugs, and use the results of the reviews as a basis for the regular assessment of doctors, clinical departments and medical personnel.
Article 45: Medical institutions shall warn physicians who have presented antibiotics beyond their usual prescriptions for more than three times and have no justifiable reasons, limiting their special use levels and restricting the use of antibacterial drug prescriptions.
Article 46 If a physician has one of the following circumstances, the medical institution shall cancel its prescription right:
(1) Failed to pass the examination of antibacterial drugs;
(2) After restricting the right to prescribing, an extraordinary prescription still exists and there is no justification;
(3) Failure to prescribe antibiotics in accordance with the regulations has caused serious consequences;
(4) Failing to use antibiotics as prescribed, causing serious consequences;
(5) Prescribing antibiotic drugs to obtain improper benefits.
Article 47 If a pharmacist fails to comply with regulations to review antibiotic prescriptions and prescriptions for medical use and cause serious consequences, or if he finds that the prescription is not appropriate or the supernormal prescription has not been interfered with and there is no justification, the medical institution shall cancel its drug dispensing qualification.
Article 48 After the physician's prescription rights and pharmacist's drug distribution qualifications are cancelled, they must not resume their prescription rights and drug dispensing qualifications within six months.
Chapter V Legal Liabilities Article 49 If a medical institution has any of the following circumstances, the health administrative department at or above the county level shall order it to make corrections within a time limit; if the medical institution fails to make any change within the specified period, it shall make a public criticism and give a warning; if it causes serious consequences, it shall be held Responsible supervisors and other directly responsible personnel are given disciplinary actions:
(1) Failure to establish an antibacterial drug administration organization or designate a special (part-time) technical person to take charge of the specific management work;
(2) Failure to establish rules and regulations for the management of antibacterial drugs;
(3) The management of clinical application of antibiotics is confusing;
(4) failing to implement the grading management of antibacterial drugs, the authority management of prescriptions for antibacterial drugs, the qualification management of pharmacists for antibacterial drugs adjustment, or failing to equip relevant professional and technical personnel in accordance with the provisions of these Measures;
(5) Other acts that violate the provisions of these Measures.
Article 50 If a medical institution has any of the following circumstances, the health administrative department at or above the county level shall order it to make corrections within a time limit, give a warning, and impose a fine of up to 30,000 yuan, depending on the seriousness of the circumstances; the responsible person in charge and other direct responsibilities Personnel may be given sanctions according to the circumstances:
(1) using a doctor who has not obtained the right to prescribe antibacterial drugs or a physician who has used the right to prescribe antibacterial drugs to prescribe antibiotics;
(2) Failure to review the suitability of antimicrobial prescriptions and doctor's orders and the circumstances are serious;
(3) The non-pharmaceutical department engages in the purchase, sale and adjustment of antibacterial drugs;
(4) linking the purchase and sale of antibacterial drugs and clinical application with the economic benefits of individuals or departments;
(5) Obtaining improper interests in the purchase, sale and clinical application of antimicrobial drugs.
Article 51: Persons in charge of medical institutions, drug purchasers, doctors, and other relevant persons who obtain and receive property granted by drug production enterprises, drug trading enterprises, or their agents, or obtain anti- The above-mentioned local administrative departments of health shall be dealt with in accordance with relevant national laws and regulations.
Article 52 If a physician has any of the following circumstances, the health administrative department at or above the county level shall, in accordance with the relevant provisions of Article 37 of the "Law on the Practice of Doctors of Practitioners", give a warning or order a suspension of practice activities of more than six months and less than one year; If the circumstances are serious, his practice certificate shall be revoked; if a crime is constituted, criminal responsibility shall be investigated according to law:
(1) Failure to prescribe antibiotics in accordance with the provisions of these Measures has caused serious consequences;
(2) Use of antibacterial drugs that have not been approved by the State Drug Administration;
(3) The use of varieties and regulations other than the list of antibacterial drugs supplied by this agency has caused serious consequences;
(4) Violating other provisions of these Measures and causing serious consequences.
If a rural doctor has any of the conditions specified in the preceding paragraph, the health administrative department at the county level shall handle it in accordance with the relevant provisions of Article 38 of the Regulations on the Administration of Rural Doctors.
Article 53 Where a pharmacist has one of the following circumstances, the health administrative department at or above the county level shall order it to make corrections within a time limit and give a warning; if a crime is constituted, the criminal liability shall be investigated according to law:
(1) failing to review and adjust prescriptions for antibiotics in accordance with regulations, and the circumstances are serious;
(2) failing to increase the varieties or regulations of antibiotics in accordance with regulations;
(3) Violating other provisions of these Measures.
Article 54 Without the approval of the county-level health administrative department, the village clinics, clinics, and community health service stations that use antibacterial drugs without authorization to carry out intravenous infusion activities shall be ordered by the local administrative department of health at or above the county level to make correction within a specified period and a warning shall be given; If it does not change within the time limit, it may impose a fine of less than 10,000 yuan depending on the severity of the circumstances.
Article 55 If the local health administrative department at or above the county level fails to perform its supervisory duties in accordance with the provisions of these Measures, resulting in serious consequences, the person directly in charge and other directly responsible personnel shall be given administrative overdue, downgraded, dismissed, and fired in accordance with the law. Disposition.
Article 56 If a medical institution or its medical staff violates the "Drug Administration Law," it shall be dealt with 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 administration of the clinical application of antibacterial drugs in Chinese medical institutions within the scope of their duties.
Article 58 Each provincial health administrative department shall, within three months from the date of promulgation of these Measures, formulate a catalogue of classified administration of antibacterial drugs in its own administrative region.
Article 59 These Measures shall come into force on August 1, 2012.
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