Hướng dẫn sử dụng thuốc kháng sinh bộ y tế Informational, Transactional

Ban hành tài liệu “Hướng dẫn chung sử dụng kháng sinh” - Cục Quản Lý Khám Chữa Bệnh – Bộ Y Tế

Trong bối cảnh đề kháng kháng sinh đang là mối đe dọa hàng đầu với sức khỏe người bệnh và là thách thức lớn đối với cộng đồng y khoa, Hội đồng các chuyên gia đầu ngành được thành lập dưới sự chỉ đạo của Cục Quản Lý Khám Chữa Bệnh – Bộ Y Tế đã biên soạn tài liệu “Hướng dẫn chung sử dụng kháng sinh”, nhằm mục đích hỗ trợ các bác sĩ, cán bộ y tế trong việc tham khảo nhanh các thông tin quan trọng liên quan đến sử dụng kháng sinh, góp phần thúc đẩy việc kê toa kháng sinh hợp lí, đem lại lợi ích cho người bệnh.

Hội Hồi sức Cấp cứu và Chống độc Việt Nam xin gửi tới Quý đồng nghiệp file mềm của hướng dẫn này như một tài liệu mang tính chất tham khảo, hỗ trợ trong thực hành. Bản pdf của tài liệu xin tải về tại đây.

Tài liệu này cũng sẽ được đăng tải trên ứng dụng điện thoại thông minh mang tên DigitalAMS (sử dụng trên hệ điều hành iOS và Android) trong thời gian sắp tới (sẽ có thông báo cụ thể sau).

Quyết định số 708/QD-BYT của Bộ Y tế về Hướng dẫn sử dụng kháng sinh

Ngày 02/03/2015, Bộ Y tế đã ban hành quyết định số 708/QĐ-BYT về việc ban hành tài liệu chuyên môn "Hướng dẫn sử dụng kháng sinh". Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government on functions, tasks, powers, and organizational structure of the Ministry of Health;

At request of Director General of Vietnam Administration of Medical Services,

HEREBY DECIDES:

Article 1. “Manual for antibiotic stewardship in hospitals” is attached to this Decision.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Article 3. This Decision comes into effect from the date of signing and replaces Decision No. 772/QD-BYT dated March 4, 2016 of Minister of Health on issuance of “Manual for antibiotic stewardship in hospitals”

Article 4. Chief of Ministry Office, Chief Ministry Inspectorate, Director General of Vietnam Administration of Medical Services, Directors General and Directors of Departments affiliated to Ministry of Health, directors of hospitals having hospital beds, Directors of Departments of Health of provinces and central-affiliated cities and heads of medical ministries and relevant ministries are responsible for implementing this Decision./.

PP. MINISTER DEPUTY MINISTER

Nguyen Truong Son

MANUAL

MANAGING USE OF ANTIBIOTICS IN HOSPITALS (Attached to Decision No. 5631 dated December 31, 2020)

  1. TERM INTERPRETATION

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

- Antimicrobial refers to a substance created from different sources (microorganisms, plants, animals, synthetic or semi-synthetic) which affect microorganisms including bacteria (antibacterial), fungi (antifungal), parasites (antiparasitic) and viruses (antiviral). All antibiotics are antimicrobial whereas antimicrobial are not necessarily antibiotics.

- Microorganisms are living creatures that are very small in size and can only be seen through a microscope. Microorganisms include bacteria, fungus and unicellular creatures. Although not being classified as living creatures, viruses are occasionally considered as microorganisms.

- However, for the purposes of the antibiotic stewardship programs, the term “antibiotics” referred to in manual shall include all substances that affect infectious microorganisms (bacteria, viruses and infectious fungi).

  1. OBJECTIVES

1. Improve effectiveness in treating infections

2. Ensure safety and minimize odds against patients.

3. Reduce the likelihood of developing drug resistance of infectious microorganisms

4. Reduce costs without affecting treatment quality

5. Promote policy on using antibiotics appropriately and safely.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

1. Establish Board for antibiotic stewardship and identify roles, functions and tasks of each board member.

2. Develop operation plans on a regular or irregular basis and implement activities to manage the use of antibiotics in hospitals according to developed plans.

3. Examine, assess and conduct interventions.

4. Assess, conclude and reports on use results of antibiotics and level of resistance of infectious microorganisms of the facilities.

  1. CONTENTS FOR IMPLEMENTATION

6 core missions of antibiotic stewardship programs in hospitals, including:

√ Establish Board for antibiotic stewardship in hospitals.

√ Develop regulations on use of antibiotics in hospitals.

√ Supervise use of antibiotics and supervise resistance against antibiotics in hospitals.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

√ Provide training for medical staff in hospitals.

√ Assess implementation, report and provide feedback.

Decentralization of hospitals for operations of Board for antibiotic stewardship is specified under Annex 1.

  1. Establish Board for antibiotic stewardship

1. Heads of hospitals shall issue decisions on establishment of Board for antibiotic stewardship in hospitals, assign each member, regulate roles and cooperation of members of antibiotic stewardship groups.

2. Compositions of Board for antibiotic stewardship

2.1. Primary members: Heads of hospitals (Chairpersons), clinical (intensive care, infectious diseases or doctors experienced in treating infections and using antibiotics), pharmacists (prioritizing pharmacists working in clinical pharmacology), individuals working with microorganisms, controlling bacterial contamination, representatives of Department of General Planning and Department of Quality Control.

2.2. Other members: nursing, information technology staff.

II. Develop regulations on use of antibiotics in hospitals

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Develop general regulations on use of antibiotics in hospitals based on:

√ Disease models of infectious diseases in hospitals;

√ Information on microbial situations and drug resistance of infectious microorganisms in hospitals;

1.2. Develop general regulations on use of antibiotics in hospitals based on:

√ Antibiotic use manual and guidelines on diagnosis, treatment issued by Ministry of Health;

√ Guidelines for diagnosis, treatment of domestic and overseas specialized medical associations;

1.3. Things to be aware of when developing manual:

- Antibiotic selection manual:

√ Position of bacterial contamination, severity of infection;

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

√ Separation of patients based on risks of contracting drug-resistant microorganisms;

√ Pharmacokinetics and pharmacodynamics of antibiotics;

√ Patients’ characteristics (infants, the elderly, pregnant women, nursing moms, patients with liver dysfunctions, kidney dysfunctions, patients with history of antibiotic allergy)

√ Availability of antibiotics in hospitals and ability to replace in case antibiotics are unavailable;

√ If microorganisms and microbial results are empirically suitable for clinical conditions and consistent with antibiotic treatment regimens of patients, consider selecting antibiotics with the highest effectiveness, the lowest toxicity and the narrowest spectrum on detected pathogens;

√ Scale down antibiotics according to antibiotic sensitivity testing results after considering clinical situations;

√ Consider combining antibiotics to expand effective spectrum of infectious microorganisms, improve antimicrobial capacity, reduce and prevent drug resistance mutation during treatment.

- Antibiotic optimization manual:

√ Antibiotic dose depends on: severity of diseases, immune conditions of patients, sensitivity of infectious microorganisms and risks of contracting drug resistant microorganisms (in case microorganism results are not available), changes to physiologies of diseases and interventions made on patients that may affect pharmacokinetics of antibiotics;

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

√ For entities capable of implementing treatment monitor via drug concentration in blood (antibiotics of aminoglycosid, glycopeptid,…), ensure target concentration according to recommendation to achieve treatment effectiveness and reduce toxicity.

2. Develop treatment manuals for common infectious diseases in hospitals

Depending on specialty of medical examination and treatment establishments, infections that should be prioritized in terms of developing treatment manuals and regiments include: septicemia, community-acquired pneumonia, hospital-acquired pneumonia (including ventilator-associated pneumonia), urinary tract infection, skin and soft tissue infection, intra-abdominal infection or other specialized infections of hospitals.

3. Develop surgical antibiotic prophylaxis use manual

3.1. Depending on specific conditions of each specialty in hospitals, develop surgical antibiotic prophylaxis use manual. This manual must rely on patient's characteristics, surgery characteristics, surgery incision infection and antibiotic resistant of infectious microorganisms isolated from surgery incision infection and infection control operations in hospitals.

3.2. Things to be aware of when developing manual:

√ Classify surgeries and risks of surgery incision infection or infections related to surgery: Clean, Clean-Contaminated, Contaminated and Dirty.

√ Choose patients who meet recommended standards for using antibiotic prophylaxis

√ Choose antibiotics, dose, administration, time of use and use duration.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

4. Develop list of antibiotics prioritized for management and regulations on supervision

4.1. Antibiotics to be prioritized for management are antibiotics developed on the basis of:

√ Antibiotics for treating infection caused by drug resistant/multi-drug resistant microorganisms or antibiotics used in case of no response, failure to treat infection using initial antibiotics;

√ Antibiotics with high toxicity that requires supervision of drug concentration in blood or close supervision of unwanted effects and toxicity;

√ Antibiotics facing high risks of being resisted against if used on a large scale;

√ Antibiotics capable of causing collateral damage and potentially raising resistance of infectious microorganisms rapidly;

√ Antibiotics whose prime cost for a day of treatment or a period of treatment is high;

√ Antibiotics recently approved for use worldwide, issued with registration number or expected to be issued with market registration number in Vietnam.

Depending on hospital tier and conditions of each hospital, develop list of antibiotics to be prioritized for management and regulations on managing the use of said antibiotics, such as regulations on medical consultation and approval before use, regulations on automatic prescription suspension, regulations on limiting doctors eligible for prescribing/limiting patients eligible for using, etc.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

- Antibiotics to be prioritized for management – Group 1:

√ Antibiotics to be prioritized for management – Group 1 are preserved antibiotics for any of the following cases: the last antibiotics to be chosen for cases of heavy infections which have failed to respond or poorly responded to previous antibiotic regimens; for cases of bacterial contamination potentially or empirically caused by multi-drug resistant microorganisms; antibiotics for cases of heavy bacterial contamination caused by drug resistant microorganisms facing risks of being highly resisted if used on a large scale and requiring appropriate recommendation; antibiotics with high toxicity requiring monitor of treatment concentration via drug concentration in blood (if capable of implementing at facilities) or close monitor of clinical process and testing to minimize unwanted effects and toxicity.

√ Medical examination and treatment establishments must prepare specific plans and roadmap for developing and issuing guidelines for using Group 1 antibiotics within their competence based on national and international accredited and up-to-date specialized guidelines.

Warnings regarding approval of Group 1 antibiotics:

▪ Depending on specific conditions of each hospital, list of Group 1 antibiotics under Annex 2 may be revised (if necessary); approval procedures shall conform to Annex 3; written request for use of antibiotic shall conform to Annex 4 and treatment guidelines/antibiotic use guidelines of hospitals (if any).

▪ Experience-based treatment shall be applied for Group 1 antibiotics for cases of heavy bacterial contamination or cases potentially caused by drug-resistant germs. Recommend sampling of specimen (if possible) for microorganism testing before using antibiotics and revise treatment regimens (if necessary) after receiving microorganisms and clinical response assessment of patients.

▪ Dose of antibiotics during treatment may vary depending on physiological development of diseases and clinical response of patients rather than staying compliant original dose prescribed on date of approval. Doctors must specify in medical records when revising drug dose.

▪ Deadline for approval: before use or within 24 – 48 hours in case of emergency care/out of office hours.

▪ Period of use of antibiotics must not exceed 14 days for each approval instance; reassessment of patient’s response is required to decide further actions in case period of use of antibiotics exceed 14 days.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

▪ In case opinions of individuals authorized to approve differ from those of doctors in charge, drug use must be discussed and agreed upon on the basis of specific clinical conditions of patients.

- Antibiotics to be supervised during use – Group 2:

Antibiotics to be supervised during use – Group 2 are antibiotics recommended for adopting programs for supervision of use at hospitals including supervising use of antibiotics, supervising probability of resisting antibiotics of germs, and conducting research assessing drug use in order to make appropriate intervention depending on hospital conditions.

5. Develop manual for switch to oral antibiotics from injection/intravenous antibiotics under ideal conditions

Based on clinical response of patients, criteria for identifying patients, diagram for switch to oral antibiotics from injection antibiotics under Annex 5 and list of antibiotics that can be switched from injection to oral administration under Annex 6.

6. Develop technical documents and guidelines on clinical microbiology techniques

6.1. Depending on conditions of each hospital, Microbiology Departments/Microbiology Wards in Laboratory Department, develop, appraise, implement, periodically review and revise Procedures for culturing, isolating, identifying and producing antibiotic sensitivity testing.

6.2. Develop procedures and guidelines on collecting, preserving, transporting and receiving specimen appropriately for clinical and microbiology departments.

7. Develop procedures and regulations on basic bacterial contamination control

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

√ Hand washing procedure;

√ Procedure for processing reused medical equipment (sterilizing and sanitizing);

√ Procedure for processing fabric items (collecting and processing dirty fabric items; distributing clean fabric items);

√ Procedure for hospital surface sanitation (cleaning and sanitizing);

√ Procedure for classifying, collecting, transporting and storing solid medical waste;

√ Procedure for processing specimen.

7.2. Regulations:

√ Regulations on using personal protective gears in: collecting, transporting and processing specimen;

√ Regulations on isolating patients contracted with multi-drug resistant microorganisms;

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

√ Managing fabric items to prevent contagion.

III. Supervise use of antibiotics and supervise resistance against antibiotics in hospitals.

1. Supervise use of antibiotics

Supervise use of antibiotics on a regular and continuous basis

√ Prior to implementing antibiotic stewardship programs: assist in providing important information on model of prescribing antibiotic use in hospitals and on patients/other specific departments. Supervision results will assist identifying risks of inappropriate use of antibiotics thereby direct operations and strategies of the antibiotic stewardship programs accordingly.

√ During implementation of the antibiotic stewardship programs: periodically (usually once every 6 months or once every year) monitor the use of antibiotics in hospitals and effectiveness of operation strategies within the antibiotic stewardship programs.

√ Methods of supervising the use of antibiotics possible include:

. Cost analysis (ABC analysis).

. Use analysis via defined daily dose (DDD) on a hospital scale and/or department, ward scale. DDD must be adjusted for 100 or 1000 (person-day or day-bed) (days of hospitalization).

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

. In-depth analysis of issues related to use of antibiotics (e.g. antibiotics prioritized for management under the programs described under Point 4.2 Part II Section D of this Manual, antibiotics used in large number or observing irregular proliferation in use, antibiotics recorded to increase resistance of infectious microorganisms, antibiotics used against important infections and commonly seen in hospitals). Analysis may be localized in certain clinical departments and units which use many concerned antibiotics. Analysis indicators may include: recommendation, selection, dose, administration, injection - oral switch, scale down antibiotics, adverse events, length of antibiotic therapy.

1.2. Based on supervision results of antibiotic use, Board for antibiotic stewardship may develop policies and regulations on use of antibiotics and orient appropriate operational strategies.

2. Supervise resistance against antibiotics

2.1. Hospitals that have microbiology department must periodically conclude resistance against antibiotics (at least once a year and when necessary) via developing Conclusion of susceptibility (or resistance) of microorganisms in hospitals.

2.2. Conclusion of susceptibility (or resistance) of microorganisms in hospitals must include following information:

√ Distribution of infectious microorganisms, classification by specimen, classification by treatment department (intensive care and non-intensive care), classification by origin of infection (community, hospital) (if possible).

√ Probability of susceptibility and resistance of microorganisms against antibiotics (prioritizing antibiotics tested according to the CLSI and antibiotics used in treatment regimen).

√ Tendency to change probability of susceptibility, resistance and neutral by time.

√ Monitor MIC value (if possible) of some antibiotics against multi-drug resistant microorganism (e.g. MIC of MRSA against vancomycin, Gram-negative multi-drug resistant bacteria against colistin, carbapenem or aminoglycosid).

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

2.4. Board for antibiotic stewardship must guarantee that all medical personnel in hospitals can access microbiology results, conclusion of microbiology results, receive training in interpreting and applying the results in patient care and treatment.

IV. Operational strategies for managing the use of antibiotics in hospitals

Depending on conditions of each hospital, Board for antibiotic stewardship may prepare plans by order of priority to implement following strategies:

1. Strategy 1: Implement prescription approval before use

1.1. Apply to antibiotics prioritized for management under antibiotic stewardship programs developed by hospitals.

1.2. Implement regulations on completing written request for use of antibiotics, regulations and procedures for approval developed by the hospitals.

1.3. May monitor this activity by measuring percentage of prescriptions with antibiotics requiring priority in management before use which may/may not complete written request for use of antibiotics and are approved before use.

2. Strategy 2: Audit and feedback

2.1. Implement after hospitals have issued guidelines, regulations, procedures and lists related to use of antibiotics. These activities assist supervision and ensure compliance with guidelines for each case; detect issues in implementation of guidelines thereby develop appropriate measures.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

2.3. Audit and feedback may be implemented on a prospective manner (performing directly on each patient as they are receiving treatment) or retrospective manner (concluding all patients who have received treatment and later giving feedback to individuals making up prescriptions) depending on local personnel.

2.4. In case of limited personnel, may adopt retrospective measures or feedback supervision for some prioritized antibiotics (for example, antibiotics prioritized for management, antibiotics clinically inappropriate); prioritized infection diseases; clinical departments or sequential feedback supervision in clinical departments.

2.5. Basis for implementation of feedback supervision shall be guidelines, regulations, procedures and list on use of antibiotics developed in hospitals. Each hospital must develop appropriate schedule for feedback supervision. Schedules must be developed based on implementation methods, for example: feedback supervision by departments, feedback supervision by patient (internal medicine patients, external medicine patients, pediatric patients, etc…), feedback supervision by infections (hospital-acquired pneumonia, community-acquired pneumonia, etc.), feedback supervision by antibiotics used, etc.

3. Strategy 3: Implement interventions in Clinical departments

These are interventions performed directly on patients in Clinical departments by specialized groups of Board for antibiotic stewardship. Interventions may be related to all aspects of use of antibiotics. Some prioritized interventions are suggested below:

3.1. Intervention 1: Antibiotic optimization

Antibiotic dose must be optimized based on patient’s characteristics, such as location of infection, pharmacokinetic/pharmacodynamic properties of antibiotics, microorganisms and susceptibility of organisms against antibiotics; supervision results of antibiotic concentration in blood (for certain antibiotics). If possible, pharmacists shall supervise antibiotic dose and intervene/advise individuals who prescribe about optimized dose for specific patients. In case of limited human resources; pharmacists may perform this activity prioritizing certain departments, wards (intensive care, infectious diseases, pediatrics, etc.) or certain antibiotics (e.g. aminoglycosid, carbapenem, colistin, vancomycin,..)

3.2. Intervention 2: Antibiotic scale down

√ Scale down therapy includes: (1) Consider switch from experience-based antibiotic regimen to goal-based antibiotic regimen for infectious microorganisms identified based on isolation, identification and antibiotic sensitivity testing results; (2) Suspend experience-based antibiotic regimen in case of insufficient infection evidence and (3) Suspend antibiotics used simultaneously in antibiotic regimens that are no longer necessary.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

√ Board for antibiotic stewardship may independently review of patients with positive microbiological culturing results (data extracted from Microbiology department), discuss directly with treating doctors to identify cases in which scale down can be adopted and advise scale down for specific patients with consensus of treating doctors.

3.3. Interventions 3: Switch from injection antibiotics to oral antibiotics

√ Board for antibiotic stewardship must ensure that all relevant medical personnel are trained to perform the switch from injection antibiotics to oral antibiotics in clinical practice. Specialized groups (including doctors and/or pharmacists working in clinical pharmacology) shall review all patients who receive prescriptions of injection antibiotics suitable for switch from injection antibiotics to oral antibiotics and conduct daily assessment regarding capacity for meeting switch criteria. If necessary, may intervene with treating doctors to make the switch to oral antibiotics and advise appropriate dose.

√ List of antibiotics for injection – oral switch, criteria for identifying patients eligible for switch from injection antibiotics to oral antibiotics and switch procedures are under Annex 6.

4. Other strategies

Hospitals must prioritize primary strategies above and may implement following strategies if their resources allow:

4.1. Supervision strategy for use of prophylaxis antibiotics.

4.2. Strategy of developing guidelines and procedures to promote appropriate and timely use of antibiotics in sepsis and septic shock.

4.3. Strategy of periodic antibiotic time-outs at certain points in treatment process (48 – 72 hours after antibiotic regimen begins) in combination with clinical properties and microbiology results to issue decisions on suspending, continuing and/or revising antibiotic regimen; after 5 - 7 days or appropriate period of time depending on types of infection to promptly scale down, make the injection/intravenous antibiotic switch or replace/suspend antibiotics.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

4.5. Strategy for managing cooperation of antibiotics with the same effective spectrum on anaerobic bacteria.

  1. Training

Organize continuous training and education for doctors, pharmacists and nurses regarding antibiotic stewardship programs including compliance with guidelines, regulations and working methods to improve effectiveness of antibiotic stewardship activities in hospitals:

1. Update guidelines for diagnosis and treatment, and guidelines for use of antibiotics and antifungal.

2. Train and educate on diagnosis and treatment of bacterial contamination/fungi infection, and reasonable antibiotic prescription.

3. Train, educate and update on basic microbiology, interpreting microbiology, antibiotic sensitivity testing results and applying said results in patient care.

4. Train and educate medical personnel on bacterial contamination control, specimen handling and surgical, operational medical equipment handling, etc.

5. Educate patients and their caregivers on basic principles regarding infection prevention and control, personal hygiene, hand washing, etc.

VI. Assess implementation, report and provide feedback

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

1.1. Antibiotic use supervision indicators:

- Indicators to be implemented:

√ Number and percentage of patients prescribed with antibiotics.

√ Defined daily dose, submit reports in form of DDD/100 or 1000 (person – day or day – bed)

- Indicators recommended for implementation:

√ Average days of therapy (DOT). DOT can be reported further in form of DOT/100 or 1000 (person – day or day – bed) (days of hospitalization).

√ Average length of therapy.

√ Amount and percentage of patients prescribed with 1 antibiotic.

√ Amount and percentage of patients prescribed with multiple antibiotics.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

√ Amount and percentage of surgeries designated with antibiotic prophylaxis.

√ Amount and percentage of switch from injection antibiotics to oral antibiotics.

√ Percentage of prescriptions conforming to antibiotic use manual; clinical guidelines for bacterial contamination or antibiotic prophylaxis use manual.

Note: Supervision indicators may be adopted to an entire hospital or prioritized antibiotics; prioritized bacterial contamination diseases; clinical departments, etc.

1.2. Indicators for bacterial contamination of hospitals

Hospitals shall rely on guidelines of Minister of Health on approving bacterial contamination control manual in medical examination and treatment establishments to identify criteria for bacterial contamination control in hospitals.

1.3. Indicators for level of drug resistance (identified according to EUCAST or CLSI standards):

- Indicators to be implemented:

√ Amount and percentage of positive culture.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

- Indicators recommended for implementation:

√ Amount and percentage of drug resistant microorganisms for each type of antibiotic/specimen/clinical department or ward;

√ Monitor resistance tendency of prominent microorganisms in hospitals (pay attention to

2. Report and provide feedback

2.1. Periodically produce reports on supervision indicators and provide feedback for heads of hospitals.

2.2. Provide feedback for doctors: directly or indirectly via written form stored in clinical departments. Send feedback to heads of clinical departments, treating doctors, heads of pharmaceutical departments, pharmacists working in clinical pharmacology and relevant departments in form of articles or presentation in meetings or seminars of hospitals and report to Councils for medication and treatment of hospitals.

2.3. Hospitals shall assess and prepare time-based plans using Form under Annex 7.

DD. IMPLEMENTATION

  1. Responsibilities of directors of hospitals

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

2. Directing close cooperation between sub-committees for antibiotic stewardship and monitoring of drug resistance of common infectious microorganisms affiliated to Council for Medication and Treatment and antibiotic stewardship groups in hospitals, between Council for Medication and Treatment and Council for Bacterial Contamination Control to develop antibiotic stewardship programs and implement these programs in hospitals.

3. Investing funding, developing incentive policies, encouraging and commending to enable effective implementation of these programs.

4. Directing close cooperation between Council for Medication and Treatment and Council for Bacteria Contamination Control.

II. Responsibilities of heads of clinical departments

1. Complying with specialized applicable guidelines, procedures and regulations.

2. Supervising reasonable and safe antibiotics prescription in the departments.

3. Guiding and cooperating in research to assess effectiveness of implementation of antibiotic stewardship programs.

III. Responsibilities of heads of microbiology departments

1. Complying with specialized applicable guidelines, procedures and regulations.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

3. Providing data on culturing results and susceptibility of microorganisms to antibiotics to optimize antibiotics for patients; monitoring and providing model of antibiotic resistance in the departments.

4. Guiding and cooperating in research to assess effectiveness of implementation of antibiotic stewardship programs.

IV. Responsibilities of heads of pharmaceutical departments

1. Proposing list of antibiotics prioritized for management and procedures for prescribing said antibiotics.

2. Supervising and submitting reports on antibiotic use in departments/wards.

3. Guiding and cooperating in research to assess effectiveness of implementation of antibiotic stewardship programs.

  1. Responsibilities of heads of Departments of Bacteria Contamination Control

1. Developing and implementing regulations on isolating patients infected with multi-drug resistant microorganisms and guiding, supervising implementation of departments.

2. Elaborating basic bacterial contamination control measures such as hand washing, using protective gears, sanitizing equipment, tools and environment.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

4. Assisting in supervising multi-drug resistant microorganisms and cooperating with microbiology departments in determining disease causes in waves of hospital-acquired bacterial contamination (via molecular epidemiology).

VI. Responsibilities of heads of information technology departments/wards

Promoting information technology affairs to optimize antibiotic stewardship affairs: consolidating, analyzing and integrating information regarding electronic medical records; physician orders, microbiology results; kidney, liver functions history of drug allergy reactions of patients; medicine interactions, medicine costs, data extraction and calculation of indicators to be reported, etc.

VII. Responsibilities of other departments and medical personnel

Depending on specific functions and tasks, relevant departments and medical personnel are responsible for implementation./.

ANNEX 1

DECENTRALIZATION FOR ANTIBIOTIC STEWARDSHIP (Attached to Decision No. dated )

Primary factors to be implemented under antibiotic stewardship programs*

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Hospitals for adoption

Special and tier I

Tier II

Other hospital tiers

Commitment of heads of hospitals

1. Antibiotic stewardship is identified to be a priority by heads of hospitals and included in hospital effectiveness assessment indicators.

X

X

X

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

X

X

X

3. Allocate (financial and human) resources for effective implementation of programs.

X

X

X

Assignment of responsibilities

4. Establish multidisciplinary antibiotic stewardship councils/groups (consul Section III.A) and be responsible for establishing and coordinating programs.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

X

X

5. Establish multidisciplinary antibiotic supervisory sub-committees, be responsible for conducting regular antibiotic stewardship affairs and reporting to antibiotic stewardship groups:

▪ Option 1: this includes at least 3 doctors and clinical pharmacists (who are best to be specialized in treating infections and using antibiotics reasonably).

▪ Option 2: this includes more than 1 doctor/pharmacist operating in clinical pharmaceutical affairs.

X

X

X

Antibiotic stewardship activities

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

▪ Option 1: Each hospital must develop/update antibiotic use recommendations based on biological evidence, local microbiology data and disease model in the hospital (consulting international/national manual)

▪ Option 2: Each hospital may develop/update antibiotic use recommendations based on biological evidence, local microbiology data and disease model in the hospital or employ antibiotic use manual issued by Ministry of Health and revise accordingly

▪ Option 3: Each hospital employs antibiotic use manual issued by Ministry of Health and revises accordingly

X

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

X

X

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

X

X

7. Develop list of antibiotics to be supervised when prescribing

X

X

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

8. Develop list of antibiotics prioritized for management and procedures for approving antibiotics prioritized for management

X

X

X

9. Develop assessment criteria and identify issues to be intervened (consult Section D.VI)

X

X

X

10. Provide training and education for medical personnel (consult Section D.V):

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

▪ Option 2: basic training (at least once/year)

X

X

X

X

X

X

X

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

11. Antibiotic supervisory sub-committees regularly assess/inspect antibiotic use. Depending on resources of hospitals, inspection/assess may be performed at prioritized clinical departments or for specific clinical conditions in frequency regulated under annual operation plans for antibiotic stewardship.

X

X

X

12. Antibiotic supervisory sub-committees cooperate with microbiology departments, departments of bacterial contamination control to monitor susceptibility of antibiotics, probability of resistance of primary infectious microorganisms and develop intervention measures if necessary.

X

Feedback and report

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

X

X

X

14. Representatives of antibiotic stewardship groups produce regular reports on implementation of antibiotic stewardship programs and submit to heads of hospitals.

These reports shall be publicized to medical personnel of the entities (consult Section D.VI.2)

▪ Option 1: 3-6 months/time

▪ Option 2: at least 1 time/year

X

X

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

ANNEX 2

LIST OF ANTIBIOTICS PRIORITIZED FOR MANAGEMENT IN HOSPITALS (Attached to Decision No. dated )

No.

Antibacterials/antifungals/antivirals

Administration/

form*

Hospital tier

Note

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

(2)

(3)

Special

(4)

Tier 1

(5)

Tier 2 and lower medical facilities

(7)

1.1

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

1

Ceftolozan-tazobactam

Injection

+

+

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

With roadmap for developing use manual issued in the entities

2

Tigecyclin

Intravenous fusion

+

+

+

With roadmap for developing use manual issued in the entities

3

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Intravenous fusion/aerosol/intrathecal

+

+

+

With roadmap for developing use manual issued in the entities

4

Fosfomycin

Intravenous fusion

+

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

+

With roadmap for developing use manual issued in the entities

5

Linezolid

Intravenous fusion/oral

+

+

+

With roadmap for developing use manual issued in the entities

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Amphotericin B lipid complex

Intravenous fusion

+

+

+

With roadmap for developing use manual issued in the entities

7

Caspofungin

Intravenous fusion

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

+

+

With roadmap for developing use manual issued in the entities

8

Micafungin

Intravenous fusion

+

+

+

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

9

Voriconazol

Intravenous fusion/oral

+

+

+

With roadmap for developing use manual issued in the entities

10

New antibacterials/antifungals** (ceftazidim-avibactam, ceftobiprol, cefiderocol, dalbavancin, dalfopristin- quinupristin, eravacyclin, omadacyclin, oritavancin, plazomicin, tedizolid, telavancin, anidulafundin, isavuconazol, liposomal amphotericin B)

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

+

+

+

With roadmap for developing use manual issued in the entities

11

Carbapenem antibiotics (meropenem, imipenem, doripenem)***

Intravenous fusion

+

+

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Encouraged to develop use manual in the entities

12

Ertapenem

Intravenous fusion

-

-

+

Encouraged to develop use manual in the entities

13

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Intravenous fusion

-

+

+

Encouraged to develop use manual in the entities

14

Teicoplanin

Intravenous injection, intravenous fusion, intramuscular injection

-

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

+

Encouraged to develop use manual in the entities

15

Amphotericin B deoxycholat

Intravenous fusion

-

+

+

Encouraged to develop use manual in the entities

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Aciclovir

Intravenous fusion

-

+

+

Encouraged to develop use manual in the entities

17

Valganciclovir

Oral

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

+

+

Encouraged to develop use manual in the entities

18

Posaconazol

Oral

+

+

+

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

1.2

Antibiotics to be supervised during use – Group 2

1

Aminoglycoside class of antibiotics (amikacin, gentamicin, tobramycin, neltimicin)

Intramuscular injection, intravenous injection, intravenous fusion

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

+

+

2

Fluoroquinolone class of antibiotics (ciprofloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, pefloxacin, sparfloxacin)

Intravenous/oral

+

+

+

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Note:

* Administration/use form of medicine is based on Vietnam National Pharmacopoeia 2015 or produce leaflets approved by European Medicine Agency (EMA) or Food and Drug Administration (FDA) (for new medicines).

** New antibacterials/antifungals are issued with registration number by FDA or EMA. The list maybe updated as soon as the new medicines are approved in Vietnam.

*** Infectious disease departments, emergency departments, intensive care departments and anesthesiology resuscitation of central hospitals (tier 1) according to Article 3 of Circular No. 43/2013/TT-BYT dated December 12, 2013 do not require approval before use.

“+”: Must be implemented

“-“: Not required to be implemented

ANNEX 3

PROCEDURES FOR PRESCRIBING, APPROVING AND DISTRIBUTING ANTIBIOTICS PRIORITIZED FOR MANAGEMENT (Attached to Decision No. dated )

Procedures for prescribing, approving and distributing antibiotics prioritized for management under Annex 1 are as follows:

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

ANNEX 4

REQUEST FOR USE OF ANTIBIOTICS PRIORITIZED FOR MANAGEMENT

Reason for using antibiotics prioritized for management

Antibiotic (active ingredients, concentration)

Dose/time (loading dose if any)

Use interval

Usage

Length of therapy (days)

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

CRITERIA FOR IDENTIFYING PATIENTS AND FLOWCHARTS FOR SWITCH FROM INJECTION ANTIBIOTICS TO ORAL ANTIBIOTICS (Attached to Decision No. dated )

  1. Criteria for encouraging switch from injection antibiotics to oral antibiotics according to clinically assessment

Adult inpatients satisfying following criteria:

  1. Stable vital signs and good progress

□ Systolic pressure remains stable (>90mmHg) and not under vasoactive or rehydration method

  1. Symptoms of infection drastically improved or absent

□ No fever, temperature remains < 38.3oC and antipyretics are not required in at least 24 hours

□ No hypothermia, temperature remains > 36oC in at least 24 hours

  1. Gastrointestinal tract is not damaged and remains stable functionally

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Malasorbtion syndrome, short bowel syndrome, severe inflammatory bowel, ileus, continuous nasogastric aspiration.

  1. Oral tract is not damaged (patient can take medicine orally)

□ No vomit

□ Cooperative patients

  1. Contraindications of oral antibiotics related to type of infection are absent

□ Not reaching appropriate antibiotic concentration in spots of infection when taking orally

□ Not showing following states of infection:

√ Severe septicemia, septicemia due to S.aureus

√ Cellulitis or necrotizing fasciitis

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

√ Infective endocarditis

√ Mediastinitis

√ Cystic fibrosis

√ Bronchiectasis

√ Deep tissue infection, e.g. abscess, empyema

√ Bone marrow edema

√ Necrotizing soft-tissue infection

√ Infectious arthritis

√ Infections related to implanted devices

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

  1. Oral antibiotics with good bioavailability, effective spectrum overlapping or similar to intravenous medicine and available in hospitals.
  1. Flowcharts for switch from injection antibiotics to oral antibiotics according to clinical assessment

B.1. Adult patients:

Hướng dẫn sử dụng thuốc kháng sinh bộ y tế	Informational, Transactional

B.2. Pediatric patients

Pediatric using intravenous antibiotics

Hướng dẫn sử dụng thuốc kháng sinh bộ y tế	Informational, Transactional

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

ANNEX 6

LIST OF ANTIBIOTICS SUBJECT TO SWITCH FROM INJECTION/FUSION TO ORAL (Attached to Decision No. dated )

4 groups of antibiotics subject to switch from injection/fusion to oral

Group

Definition

Antibiotics

Group 1

Antibiotics with high oral bioavailability (>90%); good absorption and consumption with a dose similar to the dose of injection administration

Levofloxacin

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Moxifloxacin

Fluconazol

Metronidazol

Group 2

Antibiotics with lower oral bioavailability (70-80%) which can be offset by increasing the dose of oral antibiotics

Ciprofloxacin

Voriconazol

Group 3

Antibiotics with high oral bioavailability (>90%) but with maximum oral dose lower than maximum injection dose (due to poor digestive absorption)

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Cephalexin

Amoxicillin

Group 4

Antibiotics with oral bioavailability and maximum dose lower than those of injection

Cefuroxim

Note:

Group 1-2 can be used initially in oral form for non-life threatening infections, patients with stable hemodynamics and having no absorption problems; use in switch from injection/intravenous to oral if clinical conditions are satisfied.

Group 3-4 can be used in switch from injection/intravenous to oral according to following principles: after basic infection has been dealt with by initial injection antibiotics and in combination with immune state of patients.

Adopt 3 methods of switching from injection/intravenous antibiotics to oral antibiotics in treatment as follows:

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

2. Switch therapy: transition from injection antibiotics to oral antibiotics of the same group whereas oral antibiotics can contain different active ingredients with the same efficacy and effective spectrum.

3. Scale down therapy: transition from injection antibiotics to other antibiotics which can be the same type, same groups or different groups from injection antibiotics. However, frequency, dose and effective spectrum must not necessarily be similar to injection antibiotics.

Schedule: Some antibiotics recommended for switching in adults

Intravenous antibiotics

Oral antibiotics

Levofloxacin 500 every 12 hours or 750mg every 24 hours

Levofloxacin 500 every 12 hours or 750mg every 24 hours

Moxifloxacin 400mg every 24 hours

Moxifloxacin 400mg every 24 hours

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Linezolid 600mg every 12 hours

Fluconazol 200-400mg every 24 hours

Fluconazol 200-400mg every 24 hours

Metronidazol 500mg every 12 hours

Metronidazol 500mg every 12 hours

Doxycylin 100-200mg every 12 hours

Doxycyclin 100-200mg every 12 hours

Minocyclin 200mg every 12 hours

Minocyclin 200mg every 12 hours

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Clarithromycin 500mg every 12 hours

Azithromycin 500mg every 24 hours

Azithromycin 500mg every 24 hours

Ciprofloxacin 400mg every 12 hours

Ciprofloxacin 500mg every 12 hours

Voriconazol 200mg every 12 hours

Voriconazol 200mg every 12 hours

Ampicillin/sulbactam (ampicillin-based dose) 1-2g every 6 hours

Amoxicillin/acid clavulanic (amoxicillin-based dose) 500-1000mg every 8 hours

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Cephalexin 500mng every 6 hours

Cefotaxim 1g every 12 hours

Ciprofloxacin 500-750mg every 12 hours

Ceftriaxon 1-2g every 24 hours

Ciprofloxacin 500-750mg every 12 hours or amoxicillin/acid clavulanic 875/125mg every 12 hours

Cefuroxim 750mg-1,5g every 8 hours

Cefuroxim axetil 500mg-1g every 12 hours

Cloxacillin 1g every 6 hours

Cloxacillin 500mg every 6 hours

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Clindamycin 300-450mg every 6 hours

Vancomycin (recommended dose)

Linezolid 600mg every 12 hours

Ceftazidim or cefepim (2g every 8 hours)

Ciprofloxacin (750mg every 12 hours) or levofloxacin (500mg every 12 hours or 750mg every 24 hours)

Gentamicin 5mg/kg every 24 hours

Ciprofloxacin 500mg every 12 hours (750mg every 12 hours for cases of infecting P.aeruginosa)

Tobramycin 5mg/kg every 24 hours

Ciprofloxacin 500mg every 12 hours (750mg every 12 hours for cases of infecting P.aeruginosa)

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

ANNEX 7

ANTIBIOTIC STEWARDSHIP EFFECTIVENESS ASSESSMENT (Attached to Decision No. dated )

  1. SUPPORTING ACTIVITIES OF HEADS OF HOSPITALS

Established in hospital where you are working

1. Has director of the hospital where you are working issued official documents to support/promote activities (antibiotic stewardship programs) to improve antibiotic use?

□ Yes

□ No

2. Has your hospital received any budget-based financial assistance for antibiotic stewardship activities? (e.g. funding for salary, personnel training, information technology, etc.)

□ Yes

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

  1. RESPONSIBILITIES

Has your hospital assigned any doctor to assume responsibilities for final results of antibiotic stewardship programs?

□ Yes

□ No

  1. PHARMACEUTICAL SPECIALTY

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

□ Yes

□ No

PRIMARY ASSISTANCE IN ANTIBIOTIC STEWARDSHIP PROGRAMS

Which of the following personnel work with leaders to improve the use of antibiotics?

1. Doctor

□ Yes

□ No

2. Clinical pharmacist

□ Yes

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

3. Microbiology expert

□ Yes

□ No

4. Epidemiology expert

□ Yes

□ No

5. Quality control expert

□ Yes

□ No

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

□ Yes

□ No

7. Information technology technician

□ Yes

□ No

8. Nurse

□ Yes

□ No

  1. ACTIVITIES TAKEN TO ASSIST THE MOST OPTIMAL USE OF ANTIBIOTICS

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

1. Does the hospital develop antibiotic use manual?

2. If yes, is the hospital’s manual based on antibiotic use manual of Ministry of Health and susceptibility of microorganisms in local administrative divisions to assist selection of appropriate antibiotics for common diseases?

□ Yes

□ Yes

□ No

□ No

SPECIFIC INTERVENTIONS MADE TO IMPROVE ANTIBIOTIC USE

Which of the following activities has been done to improve antibiotic prescription?

GENERAL INTERVENTION

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

□ Yes

□ No

2. Do doctors or pharmacists review treatment regimen for specific antibiotics? (e.g. monitor patient’s progress and consider treatment response)

□ Yes

□ No

CHANGES DURING TREATMENT REGIME

Does your hospital conduct following activities?

1. If possible, are antibiotics switched to oral administration from injection administration?

□ Yes

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

2. Is antibiotic dose adjusted in case of dysfunction of some organs (namely liver, kidney, etc.)?

□ Yes

□ No

3. Is dose optimization (based on pharmacokinetics/pharmacodynamics) adopted to optimize infection treatment?

□ Yes

□ No

4. Is automatic warning system available in case treatment regimen observes unnecessary overlapping? (such as overlapping active ingredients during prescription, etc.)

□ Yes

□ No

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

Has your hospital made any specific intervention to guarantee optimal use of antibiotics in treating the following common infections?

1. Community-acquired pneumonia

□ Yes

□ No

2. Urinary infection

□ Yes

□ No

3. Skin and soft tissue infection

□ Yes

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

4. Surgical antibiotic prophylaxis

□ Yes

□ No

5. Invasive infection (e.g. to the blood)

□ Yes

□ No

  1. MONITOR: SUPERVISE PRESCRIPTION, ANTIBIOTIC USE AND ANTIBIOTIC RESISTANCE

PROCEDURES

1. Does antibiotic stewardship program monitor compliance with antibiotic use manual in terms of recommendations, dose, administration, length of therapy and days of therapy?

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

□ No

2. Does antibiotic stewardship program monitor compliance with specific treatment recommendations (susceptibility of microorganisms in the entity, etc.)

□ Yes

□ No

USE OF ANTIBIOTICS AND FINAL RESULT ASSESSMENT

1. Does your hospital monitor percentage of C.difficile infection?

□ Yes

□ No

2. Does your hospital produce reports on drug resistance of infectious microorganisms isolated in the hospital? (monitor any of following indicators: number of microorganisms and resistance of ESBL, MRSA, VRSA, VRE, carbapenem-resistant microorganisms, colistin-resistant microorganisms, drug-resistant C.difficile)

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

□ No

DOES THE HOSPITAL MONITOR THE USE OF ANTIBIOTICS USING FOLLOWING DATA?

1. Number of gam used (defined daily dose)?

□ Yes

□ No

2. Antibiotic purchase cost?

□ Yes

□ No

  1. REPORTS ON IMPROVEMENT OF ANTIBIOTIC USE AND RESISTANCE

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

□ Yes

□ No

2. Does the hospital provide reports on drug resistance of microorganisms isolated in hospitals to prescribing doctors?

□ Yes

□ No

3. Has prescribing doctors received any feedback regarding methods of improving their prescription?

□ Yes

□ No

  1. TRAINING

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

□ Yes

□ No

REFERENCE

1. Australian Commission on Safety and Quality in Health Care (2018), Antimicrobial Stewardship in Australian Health Care, pp. 86

2. Antimicrobial stewardship programmes in health-care facilities in low-and- middle-income countries ", A WHO practical toolkit 2019, pp.

3. Antimicrobial treatment: Early intravenous to oral switch - Paediatric Guideline",2019, Children's Health Queensland Hospital and Health service, version 3.1, pp.

4. Akhlouf H. "Development of operationalized intravenous to oral antibiotic switch criteria", Journal of Antimicrobial Chemotherapy Advance Access published December 20, 2016, pp. 3.

5. British society for Antimicrobial Chemotherapy (2018), Antimicrobial stewardship from principles to practice, pp. 211.

...

...

...

Bạn phải đăng nhập hoặc đăng ký Thành Viên TVPL Pro để sử dụng được đầy đủ các tiện ích gia tăng liên quan đến nội dung TCVN.

Mọi chi tiết xin liên hệ: ĐT: (028) 3930 3279 DĐ: 0906 22 99 66

7. Ministry of Health Malaysia (2019), National Antimicrobial Guideline, pp. Appendix 6: Antimicrobial Stewardship (AMS)

8. (2019), "The Core Elements of Hospital Antibiotic Stewardship Programs", CDC, pp.

9. South Australian expert Advisory Group on Antimicrobial resistance (2017), "IV to Oral switch clinical guideline for adult pateints: can antibiotic STOP", pp.

10.Team NHS Fife Antimicrobial Management (2016), "Antimicrobial Prescribing IV to Oral Switch Therapy (IVOST) Guideline", pp.

11.WHO (2019), "The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use", pp.