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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC
OF VIETNAM
Independence – Freedom – Happiness
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No. 5631/QD-BYT
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Hanoi, December 31,
2020
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DECISION
ISSUANCE OF “MANUAL FOR ANTIBIOTIC
STEWARDSHIP IN HOSPITALS”
MINISTER
OF HEALTH
Pursuant to Law on
Medical Examination and Treatment in 2009;
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.
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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)
A.
TERM INTERPRETATION
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- 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).
B.
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.
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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.
D.
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.
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√ 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.
I.
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
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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;
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√ 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;
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√ 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.
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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.
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- 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.
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▪ 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
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√ 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;
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√ 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).
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. 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).
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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.
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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.
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√ 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.
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4.5. Strategy for
managing cooperation of antibiotics with the same effective spectrum on
anaerobic bacteria.
V.
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
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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.
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√ 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.
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- 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
I.
Responsibilities of directors of hospitals
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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.
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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.
V.
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.
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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*
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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
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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.
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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
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▪ 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
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X
X
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X
X
7. Develop list of
antibiotics to be supervised when prescribing
X
X
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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):
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▪ Option 2: basic
training (at least once/year)
X
X
X
X
X
X
X
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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
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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
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ANNEX
2
LIST OF ANTIBIOTICS PRIORITIZED FOR
MANAGEMENT IN HOSPITALS
(Attached to Decision No. dated )
No.
Antibacterials/antifungals/antivirals
Administration/
form*
Hospital
tier
Note
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(2)
(3)
Special
(4)
Tier
1
(5)
Tier
2 and lower medical facilities
(7)
1.1
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1
Ceftolozan-tazobactam
Injection
+
+
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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
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Intravenous fusion/aerosol/intrathecal
+
+
+
With roadmap for
developing use manual issued in the entities
4
Fosfomycin
Intravenous fusion
+
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+
With roadmap for
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5
Linezolid
Intravenous fusion/oral
+
+
+
With roadmap for
developing use manual issued in the entities
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Amphotericin B lipid
complex
Intravenous fusion
+
+
+
With roadmap for
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7
Caspofungin
Intravenous fusion
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+
+
With roadmap for
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8
Micafungin
Intravenous fusion
+
+
+
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9
Voriconazol
Intravenous fusion/oral
+
+
+
With roadmap for
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10
New
antibacterials/antifungals** (ceftazidim-avibactam, ceftobiprol, cefiderocol,
dalbavancin, dalfopristin- quinupristin, eravacyclin, omadacyclin, oritavancin,
plazomicin, tedizolid, telavancin, anidulafundin, isavuconazol, liposomal amphotericin
B)
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+
+
+
With roadmap for
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11
Carbapenem
antibiotics (meropenem, imipenem, doripenem)***
Intravenous fusion
+
+
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Encouraged to
develop use manual in the entities
12
Ertapenem
Intravenous fusion
-
-
+
Encouraged to
develop use manual in the entities
13
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Intravenous fusion
-
+
+
Encouraged to
develop use manual in the entities
14
Teicoplanin
Intravenous
injection, intravenous fusion, intramuscular injection
-
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+
Encouraged to
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15
Amphotericin B
deoxycholat
Intravenous fusion
-
+
+
Encouraged to
develop use manual in the entities
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Aciclovir
Intravenous fusion
-
+
+
Encouraged to
develop use manual in the entities
17
Valganciclovir
Oral
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+
+
Encouraged to
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18
Posaconazol
Oral
+
+
+
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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
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+
+
2
Fluoroquinolone
class of antibiotics (ciprofloxacin, levofloxacin, lomefloxacin,
moxifloxacin, norfloxacin, ofloxacin, pefloxacin, sparfloxacin)
Intravenous/oral
+
+
+
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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:
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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)
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CRITERIA FOR IDENTIFYING PATIENTS AND
FLOWCHARTS FOR SWITCH FROM INJECTION ANTIBIOTICS TO ORAL ANTIBIOTICS
(Attached to Decision No. dated )
A. Criteria for
encouraging switch from injection antibiotics to oral antibiotics according to
clinically assessment
Adult inpatients
satisfying following criteria:
A. Stable vital
signs and good progress
□ Systolic pressure
remains stable (>90mmHg) and not under vasoactive or rehydration method
B. 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
C. Gastrointestinal
tract is not damaged and remains stable functionally
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Malasorbtion
syndrome, short bowel syndrome, severe inflammatory bowel, ileus, continuous
nasogastric aspiration.
D. Oral tract is
not damaged (patient can take medicine orally)
□ No vomit
□ Cooperative
patients
E.
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
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√ 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
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F. Oral antibiotics
with good bioavailability, effective spectrum overlapping or similar to
intravenous medicine and available in hospitals.
B. Flowcharts for switch
from injection antibiotics to oral antibiotics according to clinical assessment
B.1. Adult patients:
B.2. Pediatric
patients
Pediatric using
intravenous antibiotics
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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
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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)
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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:
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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
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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
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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
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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
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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)
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ANNEX
7
ANTIBIOTIC STEWARDSHIP EFFECTIVENESS
ASSESSMENT
(Attached to Decision No. dated )
A. 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
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B. RESPONSIBILITIES
Has your hospital
assigned any doctor to assume responsibilities for final results of antibiotic
stewardship programs?
□ Yes
□ No
C. PHARMACEUTICAL
SPECIALTY
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□ 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
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3. Microbiology
expert
□ Yes
□ No
4. Epidemiology
expert
□ Yes
□ No
5. Quality control
expert
□ Yes
□ No
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□ Yes
□ No
7. Information
technology technician
□ Yes
□ No
8. Nurse
□ Yes
□ No
D. ACTIVITIES TAKEN
TO ASSIST THE MOST OPTIMAL USE OF ANTIBIOTICS
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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
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□ 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
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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
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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
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4. Surgical
antibiotic prophylaxis
□ Yes
□ No
5. Invasive
infection (e.g. to the blood)
□ Yes
□ No
E. 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?
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□ 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)
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□ 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
F. REPORTS ON
IMPROVEMENT OF ANTIBIOTIC USE AND RESISTANCE
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□ 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
G. TRAINING
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□ 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.
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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.