Quyết định 5631/QĐ-BYT Hướng dẫn quản lý sử dụng kháng sinh trong bệnh viện

DECISION

On promulgating the “Guidance on management of the antibiotic use in hospitals”

_______________

THE MINISTER OF HEALTH

Pursuant to the 2009 Law on Medical Examination and Treatment;

Pursuant to the Government’s Decree No. 75/2017/ND-CP dated June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of the Director of the Medical Services Administration,

DECIDES:

Article 1. To promulgate together with this Decision the “Guidance on management of the antibiotic use in hospitals”.

Article 2. The “Guidance on management of the antibiotic use in hospitals” promulgated together with this Decision shall be applied to hospitals. Based on this Guidance and the actual conditions, the Director of each hospital shall organize the implementation accordingly.

Article 3. This Decision takes effect on the date of its signing and replaces the Minister of Health’s Decision No. 772/QD-BYT dated March 04, 2016 on issuing the “Instructions on management of the antibiotic use in hospitals”.

Article 4. Mr. /Ms.: Chief of the Ministry Office, Chief of the Ministry's Inspectorate, Directors of the Medical Services Administration and Departments and Agencies of the Ministry of Health, Directors of hospitals and institutes with sick-beds under the Ministry of Health, Directors of Departments of Health of provinces and centrally-run cities, Medical heads of ministries, branches and Heads of relevant units shall responsible for the implementation of this Decision./.

GUIDANCE

ON MANAGEMENT OF THE ANTIBIOTIC USE IN HOSPITALS
(Attached to the Decision 5631/QD-BYT dated December 31, 2020)

A. INTERPRETATION OF TERMS

- Antibiotics mean substances produced by microorganisms that destroy or inhibit the growth of other living microorganisms. Antibiotics are not a synthetic substances, semisynthetic substances or derivatives from plants or animals.

- Antimicrobial means a substance produced from different sources (microorganisms, plants, animals, synthetic or semi-synthetic that act against all types of microorganisms including bacteria (antibacterial), viruses (antiviral), fungi (antifungal) and protozoa (antiprotozoal). All antibiotics are antimicrobials, but not all antimicrobials are antibiotics.

- Microorganisms are so small organisms that they usually require a microscope to see. Microorganisms including bacteria, fungi and protozoa. Although virus is not considered a living organism but sometimes, it might also be classified as microorganism.

- However with the purpose of the program on management of the antibiotic use, the term “antibiotics” mentioned in this Guidance including all substances that act against pathogenic microorganisms (such as bacteria, viruses and fungi).

B. OBJECTIVES

1. To improve the effectiveness of infectious disease treatment.

2. To ensure safety and reduce adverse events for the patient.

3. To reduce the resistance of pathogenic microorganisms.

4. To reduce cost without affecting to the treatment quality.

5. To promote the policy on rational and safe use of antibiotics.

C. REQUIREMENTS (For implementers)

1. To establish an antibiotic use management board and define the role, functions and tasks of each member.

2. To develop a periodic or extraordinary work plan and carry out activities related to the management of antibiotic use in hospitals according to such plan.

3. To inspect and supervise and implement interventions.

4. To evaluate, summarize and report on the use of antibiotics and resistance level of pathogenic microorganisms in the hospital.

D. IMPLEMENTATION

The program on management of antibiotic use in hospitals stipulates 06 core tasks, including:

√ Establishment of the antibiotic management board in the hospital.

√ Formulation of regulations on management of the use of antibiotics in the hospital.

√ Supervising the use of antibiotics and monitoring the antibiotic resistance in the hospital.

√ Implementation of interventions to improve quality of the use of antibiotics in the hospital.

√ Training and retraining for healthcare workers in the hospital.

√ Assessment of the implementation, report and feedback.

Regarding the division of hospitals for the operation of the antibiotic management board, refer Appendix 1.

I. Establishment of the antibiotic management board

1. The head of the hospital shall issue a decision on the establishment of the antibiotic management board in the hospital and on the missions assigned to each of its members, whose roles and coordination must be defined.

2. The constituents of the antibiotic management board

2.1. Main members: Leader of the hospital (head of the board), clinical doctors (intensive care, infection or doctors with experiences in providing treatment for infectious diseases requiring antibiotics), pharmacists (priority is given to clinical pharmacists), persons doing microbiological or infectious control works; representatives of the General Planning Department and Quality Management Department.

2.2. Other members: nurses and information technology staff.

II. Formulation of regulations on management of the use of antibiotics in the hospital

1. Formulation of the general guidance on the use of antibiotics in the hospital

1.1. Formulation of general guidance on the use of antibiotics in the hospital based on the following contents:

√ Pathogenic model of hospital-acquired infectious diseases;

√ Information on microorganisms and the drug resistance of pathogenic microorganisms in the hospital;

1.2. Formulation of general guidance on the use of antibiotics in the hospital with the reference from the following documents:

√ Guidance on the use of antibiotics and Guidance on diagnosis and treatment promulgated by the Ministry of Health;

√ Guidance on diagnosis and treatment provided by domestic and foreign specialized and professional associations;

1.3. Contents to be paid attention when formulating the Guidance:

- Guidance on selection of antibiotics:

√ Depending on the position of infections and the severe level of the infectious disease.

√ Characteristics of pathogenic microorganisms and the resistance level;

√ Stratification of patients who are related to the risk of infection with drug-resistant microorganisms;

√ Pharmacokinetic and pharmacodynamic properties of antibiotics;

√ The patient characteristics (pediatric patients; elderly patients, pregnant women; breastfeeding women, patients with impaired liver or kidney functions and patients with a history of antibiotic allergy)

√ The availability of drugs in the hospital and the possibility of replacing the unavailable drugs;

√ If there is a clear evidence that the microorganism and the microbiological results are consistent with the clinical status and response to the patient's antibiotic regimen, the best effective and least virulent antibiotic that has the narrowest spectrum on the identified pathogens should be considered;

√ Antibiotic de-escalation according to antibiotic susceptibility tests after taking the clinical course into account;

√ Considering antibiotic combinations with the aim of expanding the spectrum of effects on pathogenic microorganisms, synergistically enhancing bactericidal effects, minimizing and preventing the emergence of resistance mutations during the treatment.

- Instructions to optimize the dose regimen of antibiotics:

√ Dosage of antibiotics is subject to the severity of disease, patient's immune status, susceptibility of pathogenic microorganisms and risk of infection with drug-resistant microorganisms (in the absence of microbiological results), physiological changes of the disease and interventions performed in the patient that may affect the pharmacokinetics of the antibiotics;

√ Optimizing the dose according to the pharmacokinetic/pharmacodynamic properties of the drugs;

√ For units that have conditions to monitor treatment through quantitative drug concentration in the blood (e.g. aminoglycoside, glycopeptides, etc.), the level of drug in the blood must be maintained as per recommendations in order to achieve treatment effectiveness and minimize toxicity.

2. Formulation of the guidance on treatment against infectious diseases commonly found in the hospital

Depending on the professional characteristics of each medical examination and treatment establishments, infections should be prioritized to develop treatment guidelines or regimens, including:  Sepsis, community-acquired pneumonia, hospital-acquired pneumonia (including ventilator-associated pneumonia), urinary tract infection, skin and soft tissue infections, intra-abdominal infection, or specialized hospital-acquired infections.

3. Formulation of the guidance on the use of antibiotics in surgical prophylaxis

3.1. Depending on the specific conditions of each faculty at the hospital, the guidance on the use of surgical prophylaxis shall be developed. This guidance should be developed on the basis of the characteristics of the patient, surgical features, the situation of wound infection and the antibiotic resistance of the pathogenic microorganism isolated from the wound infection and the status of infection control at the hospital.

3.2. Contents to be paid attention when formulating the Guidance:

√ Surgical classification and classification of the risk of wound infection or surgical-related infections: Clean, Clean - Contaminated, Contaminated and Dirty.

√ Selection of qualified patients to recommend prophylactic antibiotics.

√ Selection of the types of antibiotics, dose, route, duration and time of use.

√ Monitoring and evaluation of the patient during the use of prophylactic antibiotics.

4. Formulation of the list of antibiotics to be given priority in management and regulations on monitoring

4.1. Antibiotics that need to be prioritized to be managed and used in hospitals are antibiotics chosen based on the following principles:

√ Antibiotics to treat infections caused by drug-resistant microorganisms, multidrug-resistant microorganisms or used in case of non-response or treatment failure with first-line antibiotics;

√ Antibiotics with high toxicity that require monitoring the drug concentration in blood or strict measures to monitor and manage adverse effects and toxicity;

√ Antibiotics with the high risk of resistance if being used widely;

√ Antibiotics that are capable of damaging the neighborhood and rapidly increase the resistance rate of pathogenic microorganisms;

√ Antibiotics have a high cost per day of treatment or one course of treatment;

√ New antibiotics have been approved for use in the world, have just been granted a registration number or expected to be issued a registration number for circulation in Vietnam.

Depending on the hospital class and the conditions of each hospital, the development of a list of antibiotics that need to be prioritized for management as well as regulations to help manage the use of these antibiotics, such as regulations on consultation, approval before use, regulations on automatic prescription discontinuation, regulations to limit the doctors eligible to prescribe/restrict the use of patients, etc.

4.2. The List on antibiotics requiring medical consultation and approval before use[1]:

- Antibiotics requiring priority management - Class 1:

√ Antibiotics requiring priority management - Class 1 is reserve antibiotics, in one of the following cases: last-line antibiotics in treatment of serious infections when it has failed or is poorly responsive to previous antibiotic regimens; selection of treatment for infections with suspicion or with definable microbiological evidence caused by multidrug-resistant microorganisms;  antibiotics used to treat serious infections caused by drug-resistant microorganisms, with a high risk of resistance if widely used, appropriate indications should be considered; high toxicity antibiotics requiring monitoring of therapeutic concentrations through drug concentrations in the blood (if implementation is available at the facility) or close clinical and laboratory monitoring to minimize adverse effects and toxicity.

√ Medical examination and treatment establishments should make a specific plan and roadmap to formulate and promulgate Guidance on the use of class-1 antibiotics for their establishments, on the basis of domestic and foreign professional, prestigious and up-to-date instructions.

Attention to be paid when approving class-1 antibiotics requiring priority management

▪ Depending on specific conditions of each hospital, the list of class-1 antibiotics requiring priority management provided in Appendix 2 may be supplemented (in case of necessary); refer the approval process in Appendix 3; the written request for using antibiotics in Appendix 4 and adjust them according to the hospital’s instruction on treatment/use of antibiotics (if any).

▪ The empirical treatment is applied to class-1 antibiotics for cases of serious infections with suspicion caused by resistant bacteria. It is recommended to (if conditions permit) collect specimens for microbiological testing before using antibiotics and to adjust the regimen (if necessary) after receiving the microbiological results in combination with the assessment of the clinical response of patient.

▪ The dose of antibiotics during the treatment may be changed according to the patient’s pathophysiological developments and clinical responses, such dose is not fixed by the time of approval. The doctor should clearly state in the medical records when adjust the antibiotic dose.

▪ Regulations on the time of approval: Before using or within 24 - 48 hours in case of emergency/out of office hours.

▪ The time for using antibiotics should not exceed 14 days for each time of approval, it is required to re-assess the patient’s response to decide on the next treatment when exceeding this time.

▪ Persons authorized to approve are healthcare workers assigned in the antibiotic management board’s decisions, priority is given to clinical pharmacists/doctors specialized in intensive care or doctors with experiences in treatment of infectious diseases and rational use of antibiotics;

▪ In case where the authorized persons have different opinions from the doctors in charge of treatment, the use of antibiotics should be discussed and agreed by both parties based on the specific clinical conditions of the patient.

- Antibiotics requiring supervision and monitoring when use - Class 2:

Antibiotics requiring supervision and monitoring when use - Class 2 mean antibiotics encouraged to be put in the use monitoring program in the hospital, including monitoring the consumption of antibiotics, supervising the antibiotic resistance rate of bacteria, studying and evaluating the use of antibiotics so as having appropriate interventions depending on the hospital’s conditions.

5. Formulation of the Guidance on switching antibiotics from intravenous to oral administration when permissible

Based on clinical responses of the patient, the establishment may refer the norms for determination of patient’s eligibility to switch from intravenous to oral administration of antibiotics and the outline to switch antibiotics from intravenous to oral administration in Appendix 5; the List of antibiotics switched from intravenous to oral administration in Appendix 6.

6. Preparation of documents and guidance on clinical microbiology techniques

6.1. Depending on each hospital’s conditions, Microbiology Faculty or units in the Laboratory Faculty shall prepare, appraise, implement, review and adjust periodically the Procedures for culture, isolation, identification and carrying out antibiotic susceptibility test.

6.2. Establishment of procedures and guidance on proper extraction, storage, transport and acquisition of clinical specimens by the clinical faculty and microbial faculty.

7. Establishment of procedures and regulations on basic bacterial infection control

7.1. Procedures:

√ Hand hygiene procedures;

√ Procedures for handling reusable medical equipment (disinfection and sterilization);

√ Procedures for handling linens (collection and handling of dirty linens; distribution of clean linens);

√ Procedures for cleaning of the surface of the hospital (cleaning and disinfection);

√ Procedures for separating, collecting, transporting and storing solid medical wastes;

√ Procedures for processing specimens.

7.2. Regulations:

√ Regulations on using personal protective equipment in: taking specimens, transporting and processing specimens;

√ Regulations on isolation of patients infected with multidrug-resistant microorganisms;

√ Environmental cleaning for healthcare;

√ Management of linens for prevention of infection.

III. Supervising the use of antibiotics and monitoring the antibiotic resistance in the hospital

1. Supervising the use of antibiotics

1.1. The supervision of the use of antibiotics should be carried out periodically and continuously;

√ Before implementing the program on management of the use of antibiotics: providing important information on the model of prescribing antibiotics inside the hospital so as on groups of patients/groups of different faculties. The supervising results shall help the hospital to identify the potential risks of inappropriate use of antibiotics, thereby aligning activities and strategies of the antibiotic use management program accordingly.

√ Periodically, during the implementation of the program on management of the use of antibiotics (regularly once every 06 months or once a year): monitoring the use of antibiotics in the hospital and the effectiveness of activities and strategies of the program on management of the use of antibiotics.

√ Forms of monitoring the use of antibiotics in reality may include:

• Analysis of costs (ABC analysis).

• Analysis of consumption via the defined daily dose of the whole hospital and/or according to each faculty. The defined daily dose shall be adjusted for 100 or 1,000 (person - day or day - bed) (days in hospital).

• Analysis of consumption via the days of therapy, length of therapy. The days of therapy and length of therapy shall be adjusted according 100 or 1,000 (person - day or day - bed) (or days in hospital).

• In-depth analysis of issues related to antibiotic use (for example: antibiotics requiring management priority in the program described at Point 4.2, Part II, Section D of this Guidance, antibiotic heavy use or there is a sudden increase in use, antibiotics have been shown to increase resistance to pathogenic microorganisms, antibiotics used in important and common infections in hospitals). Localized analysis may be carried out in a number of clinical faculties and units using many concerned antibiotics. Analysis criteria may include: Indication, selection, dose, use, switching from intravenous to oral administration, antibiotic de-escalation, adverse events and duration of antibiotic use.

1.2. From the results or monitoring the use of antibiotics, the antibiotic management board may formulate policies and regulations on use of antibiotics, orient appropriate strategies.

2. Monitoring the antibiotic resistance

2.1. In a hospital where the microbiological faculty is available, it is required to carry out periodic summarization on antibiotic resistance (at least once a year and when necessary) through developing a summarization on the level of susceptibility (or resistance) of microorganisms in the hospital.

2.2. The summarization on the level of susceptibility (or resistance) of microorganisms in the hospital should contain the following contents:

√ The distribution of pathogenic microorganism strains, classification according to the type of specimens, classification according to the treatment faculty (intensive care and others), classification according to the origin of infection (community and hospital) (if possible).

√ The ratio of susceptibility and resistance against antibiotics of microorganism strains (priority is given to antibiotics requiring trial under the Clinical and Laboratory Standards Institute’s regulations and antibiotics permitted to be used in the treatment regimen).

√ Trends in susceptibility, resistance, and intermediate ratios change over time.

Monitoring the MIC value (minimum inhibitory concentration) (if permissible) of a number of antibiotics and multidrug-resistant microorganisms (for example: MIC of MRSA and vancomycin, gram-negative bacteria with resistance to colistin, carbapenem or aminoglycoside).

2.3. Data about pathogenic microorganism strains and the susceptibility level should be used to develop an empirical antibiotic therapy regimen in the establishment.

2.4. The antibiotic management board must ensure that all healthcare workers in the hospital can access the microbiological results and the summarization on microbiological results as well as have been trained on interpretation and be able to apply these results when providing care and treatment to patients.

IV. Strategies and activities to manage the use of antibiotics in the hospital. Depending on each hospital's conditions the antibiotic management board may make a priority plan to implement a number of strategies as follows:

1. Strategy 1: Implementing the approval of prescription before use

1.1. Applying to the list of antibiotics requiring priority management in the program on management of the use of antibiotics issued by the hospital.

1.2. Implementing regulations on fulfillment of the written request for using antibiotics, procedures/regulations on approval issued by the hospital.

1.3. These activities can be monitored by measuring the proportion of prescriptions with antibiotics requiring priority management before use whose written requests for using antibiotics are fulfilled or not and pre-approved or not.

2. Strategy 2: Audit and feedback

2.1. The audit and feedback strategy shall be implemented after instructions, regulations, procedures and lists related to the use of antibiotics are issued by the hospital. This activity helps to monitor and ensure that instructions are followed on each case; detect barriers in implementing and following the instructions, and then take appropriate solutions.

2.2. The antibiotic management board must assign dedicated groups (one group usually consists a doctor and a pharmacist in charge of clinical work, a microbiological doctor may cooperate) to monitor the use of antibiotics and giving feedback.

2.3. The audit and feedback may be carried out concurrently (monitoring and giving feedback directly on each case) or carried out retrospectively (summarizing cases had been treated, then giving feedback to the prescribers) depending on the human resources at the establishment.

2.4. If the human resources are limited, it is possible to apply retrospective method or audit and feedback with some preferred antibiotics (for example, antibiotics requiring priority management, antibiotic use is not clinically appropriate); a number of priority bacterial pathologies; some clinical departments or implement rotational feedback and audit in clinical departments.

2.5. Grounds for the implementation of audit and feedback are instructions, regulations, procedures and lists on the use of antibiotics which have been developed at the hospital. Each hospital should develop an appropriate audit and feedback form. The form shall be made depending on the method of implementation. For example: Monitoring and giving feedback according to departments or faculties; monitoring and giving feedback according to patients (internal medicine, surgical and pediatric patients, etc.) monitoring and giving feedback according to used antibiotics, etc.

3. Strategy 3: Implementing interventions at clinical departments

These are direct interventions on patients at the clinical department, performed by the dedicated team of the antibiotic management board. Such interventions may be related to all aspects of the use of antibiotics. Here are some preferred interventions:

3.1. Intervention 1: Optimizing dose

The antibiotic dose should be optimized on the basic of the individual characteristics of the patient, the position of infections, PK/PD properties of antibiotics, microorganisms and the susceptibility of microorganisms to antibiotics; the result of monitoring the drug concentration in the blood (for some drugs). If possible, the pharmacist may supervise the antibiotic dose and intervene/consult the prescribers to select the optimal dose on some special patients. If the human resources are limited, the pharmacists may carry out these activities focusing on a number of departments (such as intensive care, infectious and pediatric departments, etc.) or with a number of antibiotics (for example: aminoglycoside, carbapenem, colistin, vancomycin, etc.)

3.2. Intervention 2: Antibiotic de-escalation

√ De-escalation therapy including: (1) Consider adjusting empirical antibiotic regimens to target-oriented treatment regimens on pathogenic microorganisms identified through isolation, identification and antibiotic susceptibility test results; (2) Discontinue an empirical antibiotic regimen when there is insufficient evidence of infection and (3) Discontinue concomitant antibiotic use in antibiotic regimen when no longer needed.

√ If permissible, microbiological specimens should be collected and undergone susceptibility test before staring the use of antibiotics. Doctors providing treatment and pharmacists in charge of clinical work need to review and monitor the patient within 48 - 72 hours after the treatment begins or when having the microbiological result to evaluate and apply the de-escalation therapy (if the clinical conditions are available).

√ The antibiotic management board may independently review all patients with positive microbiological culture results (data extracted from the microbiological faculty), directly discuss with the doctor providing treatment for each patient to identify cases can be applied the de-escalation therapy and advice the appropriate de-escalation on each individual as agreed with the doctor providing treatment.

3.3. Intervention 3: Switching antibiotics from intravenous to oral administration

√ The antibiotic management board must ensure that all related healthcare workers shall be trained and re-trained to switch antibiotics from intravenous to oral administration in clinical practice. The dedicated group (including doctors and/or pharmacists in charge of clinical pharmacy) shall review patients who are prescribed an appropriate intravenous antibiotic to switch from intravenous to oral administration, and then assess the ability to meet switching criteria on a daily basis. In case of necessity, it is possible to intervene consistently with the treating doctor to switch to oral antibiotics and advise the appropriate switching dose.

√ The list of antibiotics switched between intravenous and oral administration, norms for determination of patient’s eligibility to switch from intravenous to oral administration of antibiotics and the switching process can be found in Appendix 6.

4. Other strategies

Hospitals need to focus their human resources on core strategies as mentioned above, and depending on conditions and human resources, hospitals can also refer to the following strategies:

4.1. Strategy on monitoring the use of prophylactic antibiotics.

4.2. Strategy on formulating guidance and procedures to promote and ensure the appropriate and timely use of antibiotics in sepsis and septic shock.

4.3. Strategy on monitoring of antibiotic time-outs at some points in the treatment process (48 - 72 hours after the initiation of antibiotic regimen) in combination with clinical features and microbiological results in order to make the decision to discontinue, continue and/or change the antibiotic regimen; after 5 - 7 days or the appropriate time depending on the type of infection to ensure timely de-escalation, switching antibiotics intravenous to oral administration, replacing/stopping antibiotics.

4.4. Strategy on managing (evaluating and advising to select the appropriate antibiotics) in case the patient is allergic to penicillin.

4.5. Strategy on managing the combination of antibiotics with similar spectrum effects on anaerobic bacteria.

V. Training and drills

Organizing the continuous training and drills on the antibiotic management program including the compliance to guidance, regulations and working methods to enhance the efficiency of the management of antibiotic use in the hospital for doctors, pharmacists and nurses:

1. Guidance on diagnosis and treatment and antibiotic and antifungal use shall be updated.

2. Training and drills on diagnosis and treatment of bacterial/fungal diseases and rational prescription of antibiotics shall be carried out.

3. Training, updating and drills on basic microbiology, interpreting microbiological results, antibiotic susceptibility tests, applying these results in patient care.

4. Healthcare workers shall be trained and drilled in methods for bacterial infection control, handling of specimens and medical instruments for surgery and procedures etc.

5. Education of patients and caregivers on basic principles of infection prevention and control, personal hygiene, hand washing, etc.

VI. Performance evaluation, reporting and feedback

1. Evaluation made through indexes

1.1. Monitoring index of antibiotic use:

- Indexes to be taken:

√ Quantity, percentage of patients prescribed with antibiotics.

√ Antibiotic consumption per day dose (DDD - Defined Daily Dose), reported as DDD/100 or 1,000 (person - day or day - bed).

- Indexes encouraged to be taken:

√ Average days of therapy (DOT). DOT may be reported as DOT/100 or 1,000 (person - day or day - bed) (days in hospital).

√ Average length of therapy (LOT).

√ Quantity, percentage of patients prescribed with one antibiotic.

√ Quantity, percentage of patients prescribed with a combination of antibiotics.

√ Quantity, percentage of patients prescribed with intravenous antibiotics.

√ Quantity, percentage of surgical operations prescribed with prophylactic antibiotics.

√ Quantity, percentage of antibiotics switched from intravenous to oral administration.

√ The rate of appropriate prescription according to antibiotic instructions; instructions for treatment of infections or instructions for the use of prophylactic antibiotics.

Note: Monitoring indexes can be performed across the entire hospital or some preferred antibiotics; some preferred infectious diseases; some clinical faculties, etc.

1.2. Indexes of hospital-acquired bacterial infection

Hospitals shall, based on the Minister of Health’s Guidance on approving instructions to control infections in medical examination and treatment establishments, identify criteria to control hospital-acquired bacterial infection.

1.3. Indexes of drug resistance level (in conformity to EUCAST or CLSI standard):

- Indexes to be taken:

√ Quantity, percentage of positive culture.

√ Quantity, percentage of important multidrug-resistant microorganisms isolated from total positive cultures.

- Indexes encouraged to be taken:

√ Quantity and percentage of microorganisms resistant to each antibiotic/each specimen/faculty or in the clinical sector;

√ Monitoring the resistant trend of popular microorganisms in hospitals (attention should be paid to microorganism strains such as extended spectrum beta-lactamase (ESBL), methicillin- resistant staphylococcus aureus (MRSA), vancomycin-resistant staphylococcus aureus (VRSA), vancomycin-resistant enterococcus (VRE), carbapenem- and colistin- resistant microorganism strains, etc.)

2. Report and feedback

2.1. Reports on monitoring indicators and feedback to leaders of the hospital shall be sent periodically.

2.2. Providing feedbacks to doctors: directly or via documents retained in the clinical faculty. Information shall be sent to leaders of the clinical faculty and treating doctors and leaders of the pharmacy faculty and related functional faculties and departments, in the form of news or presentation at the pre-shift meetings and seminars in the hospital, and reported to the Medicine and Treatment Council.

2.3. The hospital shall self-evaluate and make an operating plan according to the time provided in the form in Appendix 7.

DD. IMPLEMENTATION ORGANIZATION

I. Responsibilities of the Director of the hospital

1. To ensure organizational structure and assign officers to implement the program on management of the use of antibiotics in his/her unit.

2. To direct the close coordination between Subcommittee for supervision of antibiotic use and surveillance of antibiotic resistance in common pathogenic microorganisms under the Medicine and Treatment Council, the team for management of antibiotic use in the hospital and the Council of bacterial infection control in order to develop the program on management of the use of antibiotics and organize the implementation of this program in the hospital.

3. To make investments, give supporting policies, encouragement and commendation to have the program executed in an effective manner.

4. To direct the close coordination between the Medicine and Treatment Council and the Council of bacterial infection control.

II. Responsibilities of heads of clinical faculties

1. To comply with issued professional guidance, procedures and regulations.

2. To monitor the safe and rational prescription of antibiotics in the faculty.

3. To provide guidance and coordinate in studying to evaluate the effectiveness of the program on management of the use of antibiotics.

III. Responsibilities of the Head of the Faculty of microorganism

1. To comply with issued professional guidance, procedures and regulations.

2. To direct the formulation of documents and guidance on clinical microbiology techniques and implementation in the unit.

3. To provide data on the results of the culture and susceptibility of microorganisms to antibiotics to optimize the use of antibiotics for each patient; to monitor and provide information on the antibiotic resistance model in the unit.

4. To provide guidance and coordinate in studying to evaluate the effectiveness of the program on management of the use of antibiotics.

IV. Responsibilities of the Head of the Faculty of pharmacy

1. To propose the list of antibiotics requiring priority management and the prescribing procedures for these antibiotics.

2. To monitor and report the use of antibiotics at faculties/departments.

3. To provide guidance and coordinate in studying to evaluate the effectiveness of the program on management of the use of antibiotics.

V. Responsibilities of the Head of the Faculty of bacterial infection control

1. To establish and implement regulations on the isolation of patients infected by multidrug-resistant microorganisms while guiding and supervising the faculties’ compliance.

2. To regulate details of methods for basic bacterial infection control, such as hand hygiene, use of protective equipment, sterilization of instruments, equipment and ambiance.

3. To regulate details of sectors/faculties/areas given priority and tighten the supervision and control of bacterial infections in operating theaters, procedure rooms, recovery rooms; cleaned hands of surgeons, doctors and nurses; surgical instruments, breathing tube, oxygen breathing apparatus, endoscopic tools, linens, etc. after sterilization, hospital's daily water, distilled water for rinsing tools and in oxygen warming containers, etc.

4. To facilitate the supervision of multidrug-resistant microorganisms and coordinate with the Faculty of microorganism to find causes and sources of outbreaks of hospital-acquired infections (through molecular epidemiology).

VI. Responsibilities of the Head of Information technology faculty/department

To promote the information technology activities in order to optimize the management of antibiotic use: such as compiling, analysis and integration of information in electronic medical records; doctors’ medical orders, microorganism-related findings; patients’ kidney function, liver function and history for drug allergies; drug interaction, drug costs, support in extracting data and calculating indicators to be reported, etc.

VII. Responsibilities of heads of other faculties/departments and medical officials

Concerned faculties/departments and medical officials shall be responsible for performing tasks subject to their functions and tasks.

APPENDIX 1

DIVISION OF HOSPITALS FOR THE MANAGEMENT OF THE ANTIBIOTIC USE
(Attached to the Decision 5631/QD-BYT dated December 31, 2020)

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Core elements to be implemented in the Program on management of the use of antibiotics*

APPENDIX 2

LIST OF ANTIBIOTICS REQUIRING PRIORITY MANAGEMENT IN HOSPITALS
(Attached to the Decision No. 5631/QD-BYT dated December 31, 2020)

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Note:

* Administration route/administration form of drugs is based on 2015 Vietnamese National Drug Formulary or product information sheet approved by European Medicines Agency (EMA) or Food and Drug Administration (FDA) (for new medicine).

** New antibacterial/antifungal medicine with circulation registration numbers issued by FDA or EMA. The list may be updated after new drugs are approved in Vietnam.

*** Departments of infectious diseases, emergency departments, intensive care units and anesthesiology-recovery departments of central hospitals (Line 1) prescribed in Article 3 of the Circular No. 43/2013/TT-BYT dated December 11, 2013 must not an approval before use.

“+”:  Compulsory

“-”: Voluntary

APPENDIX 3

PROCEDURES FOR PRESCRIPTION, APPROVAL AND DISTRIBUTION OF ANTIBIOTICS REQUIRING PRIORITY MANAGEMENT
(Attached to the Decision No. 5631/QD-BYT dated December 31, 2020)

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Procedures for prescription, approval and distribution of antibiotics requiring priority management in Appendix 1: to refer to the following procedures:

APPENDIX 4

FORM OF WRITTEN REQUEST FOR USING ANTIBIOTICS REQUIRING PRIORITY MANAGEMENT

AUM: Antibiotic use management; PM Priority management

APPENDIX 5

NORMS FOR DETERMINATION OF PATIENT’S ELIGIBILITY TO SWITCH FROM INTRAVENOUS TO ORAL ADMINISTRATION OF ANTIBIOTICS AND THE OUTLINE TO SWITCH ANTIBIOTICS FROM INTRAVENOUS TO ORAL ADMINISTRATION

(Attached to the Decision No. 5631/QD-BYT dated December 31, 2020)

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A. Criteria to encourage the switch of intravenous to oral antibiotics according to clinical judgment

Adult inpatients must meet the following criteria:

B. Outline to switch antibiotics from intravenous to oral administration according to clinical judgment

B.1. For adult patients:

B.2. For pediatric patients

Pediatric patients use intravenous antibiotics

APPENDIX 6

LIST OF ANTIBIOTICS SWITCHED FROM INTRAVENOUS TO ORAL THERAPY (IV/PO)
(Attached to the Decision No. 5631/QD-BYT dated December 31, 2020)

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Four classes of antibiotics applicable for switch from from intravenous to oral therapy

To apply the three types of intravenous to oral conversion as follows:

1. Sequential therapy: It refers to the act of replacing a parenteral version of a medication with its oral counterpart of the same active ingredients.

2. Switch therapy: It describes the conversion of an IV medication to a PO equivalent; within the same class and has the same level of potency and the same spectrum of activity, but of a different active ingredient.

3. Scale down therapy: It refers to the conversion from an injectable medication to an oral agent in another class or to a different medication within the same class. The frequency, dose, and the spectrum of activity may not be exactly the same.

Table: A number of recommended switched antibiotics for adults: