Second Edition 2022
Second Edition 2022
Second Edition 2022
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ISBN: 978-967-2854-18-0
FOREWORD FROM
DIRECTOR-GENERAL OF HEALTH MALAYSIA
MESSAGE FROM
SENIOR DIRECTOR OF PHARMACEUTICAL SERVICES
MESSAGE FROM
HEAD OF CLINICAL SERVICES (INFECTIOUS DISEASES)
Foreword
TAN SRI DATO’ SERI DR. NOOR HISHAM ABDULLAH
Director-General of Health Malaysia
Antimicrobial resistance poses a significant threat to human health around the world.
It adversely impacts infectious diseases, deaths, hospital length of stay, and healthcare
costs. Containment of antimicrobial resistance is critical in ensuring the continuity
of successful treatment with antimicrobials and preventing the emergence of
infections of multidrug-resistant organisms. In the Global Action Plan on
Antimicrobial Resistance, the World Health Organization (WHO) Member States are
called to provide stewardship programmes that monitor and promote optimisation
of antimicrobial use at national and local levels in accordance with international
standards.
Thank you.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 5
Message
NORHALIZA A HALIM
Senior Director of Pharmaceutical Services
Last but not least, I would like to thank the secretariat, contributors and
reviewers for their hard work in reviewing and updating this protocol.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 7
Message
DATO’ DR. MAHIRAN MUSTAFA
Senior Consultant Infectious Diseases Physician
Head of Infectious Diseases Services
Ministry of Health, Malaysia
The first edition of this protocol marked an important step at the national level for
nationwide implementation of antimicrobial stewardship programme especially at
Ministry of Health facilities. Since then, antimicrobial stewardship has been given
more priority and implementation has expanded to include many other facilities
including the private hospitals. This revised edition has taken into consideration the
latest available guidelines, recommendations and toolkits from established sources
to ensure it remains relevant. It also incorporates more detailed guides on how to
initiate an antimicrobial stewardship programme and manage antimicrobial
stewardship interventions, as well as tips to run antimicrobial stewardship activities
for small hospitals and hospitals with limited resources.
Finally, I would like to take this opportunity to thank all contributors from
multidisciplinary healthcare professions, Pharmaceutical Services Programme as the
secretariat for this protocol, Medical Development Division and Family Health
Development Division for their joint effort in reviewing and updating this protocol.
Notably, I am looking forward positively for all practitioners from various levels to
make full use of this protocol to improve antimicrobial utilisation in the healthcare
facilities.
“Antimicrobial stewardship is a team game with the patient at the centre and it’s our
teamwork that makes the dream work.”
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 9
ADVISORS
YBhg. Datuk Dr. Noor Hisham Abdullah
Director General of Health
10 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Dr. Benedict Sim Lim Heng Dr. Tuan Suhaila Tuan Soh
Consultant Infectious Diseases Physician Microbiologist
Hospital Sungai Buloh Hospital Sungai Buloh
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 11
Dr. Jemah Sajari Mdm. Nur Syellawaty Ahmad
Consultant Family Medicine Specialist Pharmacist
Serendah Health Clinic, Hulu Selangor Klang District Health Office, Klang
Dr. Wan Noor Azlin Wan Idris Mdm. Kueh Mei Yen
Family Medicine Specialist Principal Assistant Director (Pharmacy)
Precint 9 Health Clinic, Putrajaya Family Health Development Division
EXTERNAL REVIEWERS
SECRETARIAT
Pharmaceutical Services Programme, MOH
“The Secretariat would like to thank all parties who have directly or indirectly
involved in reviewing and updating this protocol”
12 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
CONTENTS
ADVISORS 10
EXTERNAL REVIEWERS 12
INTRODUCTION 15
OBJECTIVES 16
Antimicrobial Stewardship Implementation 16
Governance 16
General Policies 18
Specific Policies 19
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 13
Step 1 - Identify areas for improvement based on available data 29
1.1 Surveillance data 29
1.2 Audit 30
Step 2 - Develop and implement targeted AMS interventions 32
based on the identified areas of concern in Step 1
Step 3 - Assess the effectiveness of interventions 38
REFERENCES 50
APPENDICES 53
14 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
INTRODUCTION
The introduction of antimicrobial agents has contributed to the reduction of infectious diseases
as the major cause of premature death. Treatment with antimicrobial agents seems so effective
and safe that they are sometimes prescribed for dubious indications and for longer than
necessary, with little concern for adverse effects and the development of resistance.
The emergence of AMR can cause the resistance to first-line medicines and leads to the use
of second or third-line drugs which is less effective, more toxic and costlier. As more resistance
is acquired, we are eventually left without any effective antimicrobial therapies. Hence, AMR
can negatively impact patient outcomes, become a major threat to patient safety, increase
healthcare expenditure, and limit treatment options for common infections.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 15
OBJECTIVES
3. To improve patient outcomes (e.g. reduce morbidity and mortality from infection).
Introduction
At the healthcare facility level, different contexts and types of facilities will face different
challenges. The essential healthcare facility core elements in the WHO toolkit: Antimicrobial
Stewardship Programmes in Healthcare Facilities in Low- and Middle-income Countries
(Appendix 2) have been stratified into basic core elements requiring fewer resources and more
advanced core elements requiring more resources. However, this differentiation may vary from
facility to facility based on size, needs, priorities, resources and context. (Refer Table 2).
Governance
Hospital
The Antimicrobial Stewardship Programme in hospitals is under the purview of the Hospital
Infection and Antibiotic Control Committee and is supported by the:
a. Hospital Director
b. Head of various clinical departments
c. Head of Pharmacy Department
d. Head of Medical Microbiology
16 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Implementing and maintaining an effective AMS requires a dedicated multidisciplinary team
and involves ongoing communication and collaboration among multiple disciplines and
departments. The AMS team should be appointed by the Hospital Director.
The role of the Hospital Director is critical in ensuring the success of the Antimicrobial
Stewardship Program initiatives by:
• ensuring AMS becomes strategic goal of the organisation
• communicating on why change is needed to staff and other leaders of
Departments
• allocating adequate resources in terms of manpower and time for dedicated
AMS team activities
• reviewing progress by the team, identifying barriers and providing advice
• assigning high-performing staff to the team and resourcing them adequately
• endorsing the AMS team and the activities
Primary Care
The Antimicrobial Stewardship Programme (AMS) in Primary Care shall be implemented at
both District and Health Clinic levels and is within the purview of the District Infection and
Antibiotic Control Committee (DIACC). The committee at the district level should be appointed
by the District Health Officer.
All Health Clinics with Family Medicine Specialists (FMS) or Medical Officers In Charge
(MOIC) and pharmacists shall have an AMS team at the clinic level. Members of the AMS
team at the clinic level shall be appointed by FMS/ MOIC. Implementing and maintaining an
effective AMS requires a dedicated multidisciplinary team and involves ongoing
communication and collaboration among team members.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 17
General Policies
1. Formulation of AMS team in each hospital, Health District Office and Health Clinics
The core members of AMS team should be multidisciplinary and appointed by Hospital
Director/ District Health Officer/ FMS/ Medical Officer In Charge.
Every healthcare facility shall develop and document their local antimicrobial policy.
The policy should be endorsed by the Drugs and Therapeutics Committee (JKUT) and
ultimately the Hospital Director/ District Health Officer/ FMS/ Medical Officer In Charge
and publicized to the whole health care facility.
Provide regular updates on antimicrobial prescribing, practice and usage for healthcare
professionals.
18 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Specific Policies
***for primary care without FMS, AMS team from the main clinic shall conduct a
minimal AMS activity such as clinical audit
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 19
SECTION A:
ANTIMICROBIAL
STEWARDSHIP
PROGRAMME
IN HOSPITAL
The judicious use of antibiotics is an important strategy to preserving
efficacy in the treatment of infectious diseases. Thus, this protocol was
developed to provide practical recommendations to healthcare
professionals in the hospitals in implementing antimicrobial
stewardship programme to improve the quality of antibiotic usage and
prescribing as well as improve patient clinical outcomes. The
recommendations in this protocol are based on reviews of several
published guidelines such as IDSA Guidelines, CDC – Core Elements
Antimicrobial Stewardship in Hospitals, WHO Practical Guide to
Antimicrobial Stewardship in Hospital and other guidelines from other
countries where appropriate.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 21
4. Evaluates compliance to clinical guidelines and reports on process measures, outcomes
measures (e.g. clinical and financial) and antimicrobial resistance patterns to Hospital
Infection and Antibiotic Control Committee (HIACC) and Hospital Director.
Infectious Disease(ID)
Other Members Physician / Senior Physician
or Clinician
Clinical Microbiologist or
Microbiologist
Optional:
• Information Technology
Officer
• Hospital Epidemiologist
• Interested Clinicians
• Quality Officer
Every AMS team member shall meet regularly to discuss about any plan for AMS activities, to
review current activities, to measure the outcome of intervention that has been done and to
deliberate any problem that arise.
22 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Roles and Responsibilities
Represents the AMS team in the Hospital Infection and Antibiotic Control
Committee (HIACC) and gives feedback on AMS programme.
Proposes annual AMS activities with the Hospital Director and various
departments.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 23
Pharmacist
Clinical Microbiologist
24 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Ensures selective reporting of antimicrobial susceptibilities and
interpretative reporting of microbiology results.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 25
A.2 ANTIMICROBIAL STEWARDSHIP ACTIVITIES
i. General Overview
The core elements below need to be in place prior to start antimicrobial stewardship activities:
CORE ELEMENTS
1 Governance structure
26 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
ii. Getting Started
Before starting the AMS initiatives, a facility should analyse its local current situation and
identify areas of concern. The AMS programme must be individualized to the facility’s financial,
structural, organizational and human resources and to the patient mix case. A large tertiary
facility with various specialties will need more comprehensive AMS plans and actions
compared to a district hospital. Therefore, it is important for the AMS team to analyse, discuss
and decide what are the antimicrobial issues that require intervention and the best strategies
to implement.
The checklist below can be used to analyse the facility current situation and navigate the AMS
activities:
1. Governance
Conduct regular (yearly) situational analysis of the AMS programme
requirement to identify gaps to implementation of an AMS
programme (e.g. surveillance programme, human & financial
resources etc.)
2. Antimicrobial policy
The healthcare facility has a written policy that requires prescribers
to clearly document the antibiotics prescribed and its indication in
the prescription chart and medical record.
3. Hospital-endorsed guideline
Note: Strategies to achieve the missing elements needs to be documented for future AMS planning.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 27
iii. AMS Actions/ Interventions
Introduction
AMS interventions should begin in a stepwise build on existing systems and available data
and encourage participation of clinical staff and prescribers. Start with a simple intervention
on a small scale and keep it doable.
Below are the steps for AMS actions. It involves monitoring, surveillance and audit of antibiotic
utilisation.
Step 2 Develop and implement targeted AMS interventions based on the identified
areas of concern in step 1. Choose specific location (e.g. wards or unit) or
disease condition or specific antibiotic where it is feasible to intervene.
Determine the outcome and process measures that will be used to monitor
effectiveness of the intervention.
(Refer to section A.3)
Step 3 Assess the effectiveness of interventions and decide if further action needs
to be taken based on the target set.
28 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Step 1 - Identify areas for improvement based on available data
Surveillance of antimicrobial use can show us how and why antimicrobials are being used by
healthcare providers. Situation analysis via monitoring of antimicrobial prescription and
consumption with comparison to national data provides insights and helps determine the area
(ward/service/discipline) or antibiotic to be targeted for intervention. Access to information on
antimicrobial consumption is an important source for healthcare professionals and policy
makers and is the first step in increasing awareness of the importance of careful antibiotic use.
Routine measurement and display of consumption information to healthcare professionals and
policy makers can help monitor progress in our effort towards a more prudent use of
antimicrobials. Prescribers should be made aware of their own prescribing practices. Thus,
feedback to prescribers is one potential form of intervention.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 29
1.2 Audit
The audit measures utilisation patterns such as the choice of antibiotic, dose,
frequency and duration, against local or national antimicrobial guidelines.
Additional criteria such as empirical or definitive therapy (with cultures and
antimicrobial susceptibility results) can also be included. Deviations from
accepted standards will be documented.
30 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
PPS audit allows the hospital to measure changes in practice and determine the
impact of interventions.
Example of Point Prevalence Survey Forms & Work Process (Appendix 4).
Example of Point Prevalence Survey User Manual & Assessment Tool – Google
Drive link:
https://drive.google.com/drive/folders/1rRhsRQKW8XHNATDKrispuxekWwCUaLo9?usp=sharing
Overprescribing Antibiotics are prescribed when not needed, e.g. fever without
evidence of infection, asymptomatic urinary tract
colonization, viral infections, malaria, and inflammatory
conditions.
Wrong dose Antibiotics are prescribed with the wrong dose (overdosing or
underdosing).
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 31
Wrong dose interval Antibiotics are prescribed with the wrong dose interval (too
much time between doses).
Wrong route Antibiotics are prescribed by the wrong route (e.g. IV instead
of oral).
Example of Surgical Antibiotic Prophylaxis Forms & Work Process (Appendix 5).
Example of Surgical Antibiotic Prophylaxis Audit Data Collection Protocol – Google Drive
link: https://drive.google.com/drive/folders/1rRhsRQKW8XHNATDKrispuxekWwCUaLo9?usp=sharing
After areas of intervention has been identified through audits (i.e. specific location, e.g. ward
or unit or disease condition or antibiotic with high usage), the AMS team should discuss on
the interventions that can be applied. If the intervention involves a unit/discipline, the AMS
team should meet up with the respective unit/ discipline, select a champion from the
unit/discipline that can give commitment to make changes, set goals of what to achieve in
changing the antimicrobial practice and discuss on possible strategies and interventions that
can be implemented tailored to the local settings.
AMS interventions should be implemented in a stepwise approach. Start with strategies that
are simple and doable, building on the existing structures, maximizing teamwork and
encouraging champions among clinical staff including prescribers in developing the
intervention. AMS interventions should align with local needs.
32 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Determine the outcome and process measures that will be used to monitor the effectiveness
of the intervention. Outcomes of the interventions must be measurable. (Refer to section A.3)
Below is the example of AMS activities or interventions for improving antimicrobial prescribing
practice:
b) Antimicrobial Selection
Empirical antimicrobial selection is determined by the indication, suspected
causative organism and site of infection as per antimicrobial guidelines. A review of
a patient’s antimicrobial therapy after microbiology results are available is important
to avoid polypharmacy e.g. duplication of treatment, overlapping bacterial coverage
(e.g. metronidazole added on top of another antibiotic with anaerobic cover). Co-
administered medications should also be reviewed to prevent interactions with other
medicines.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 33
Antimicrobial order tools can be an effective measure to decrease antimicrobial
consumption by implementing automatic stop orders and/or requiring clinicians to
justify antimicrobial use.
e) Dose Optimization
Dose optimization will tailor therapy to the patient’s clinical characteristics, causative
organism, site of infection, and pharmacokinetic and pharmacodynamic
characteristics of the antimicrobial agent.
f) De-escalation/ Streamlining
Antimicrobial streamlining or de-escalation is a process which converts broad-
spectrum antimicrobial therapy to a narrower-spectrum antimicrobial treatment that
targets a more specific organism once culture reports are available. Unnecessary
exposure to a broad-spectrum empirical antimicrobial treatment will increase the
risk of developing subsequent antimicrobial resistance.
34 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
• When cultures and sensitivity results become available, antibiotic treatment
should be streamlined accordingly; choose susceptible antibiotic with the least
toxicity, narrowest spectrum and lowest cost.
• Discontinue empiric antimicrobial therapy if sensitivity testing or clinical
correlation subsequently does not support the presence of infection.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 35
iii. Infected implant or prostheses
iv. Necrotising soft tissue infection
v. Melioidosis (at least 10 to 14 days of IV therapy)
vi. Deep-seated infection e.g. abscesses/empyema
vii. Complicated orbital cellulitis (abscess or other complication)
h) AMS Round
Audit and feedback can also be done in a real-time manner during AMS rounds or
normal everyday ward rounds. Appropriateness of a prescribed antimicrobial can
be assessed during the round and immediate oral or written feedback can be
delivered. Issues that can be assessed include compliance to guidelines, streamlining
after microbiology test results are released, dose optimization, IV to oral switch,
duration of the treatment and any further investigation required.
The frequency of the AMS round shall depend on the facility’s resources and the
urgency of interventions. For example:
36 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
i) Education
AMS team should prepare a formal or informal teaching and training to engage
prescribers and other healthcare workers i.e. pharmacists and nurses in improving
antibiotic prescribing, dispensing and administration practices. By engaging them,
it will help to enhance and increase the acceptance of AMS strategies. This program
shall be included in the induction training for all newly reporting medical, nursing
and pharmacy staff.
• Using local key opinion leaders (champions) to advocate for key messages
• Prescribing aids
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 37
Step 3 - Assess the effectiveness of interventions
Once AMS interventions have been implemented or performed, analyse and present changes
made (with the respective unit, if applicable). Discuss whether the interventions should be
continued or changed and follow up with a continuous improvement cycle i.e. Plan-Do-Study-
Act.
Tips to run AMS activities for small hospital and limited resources
Studies have demonstrated a number of interventions to improve antibiotic use for each of
these three disease conditions; community- acquired pneumonia (CAP), urinary tract infection
(UTI) and skin and soft tissue infection (SSTI). Hence, these are often high-yield targets for
improvement.
Assess duration of
Diagnostic Guide empiric
therapy including
considerations therapy
discharge prescription
38 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
SSTI Develop diagnostic Avoid empiric use of Uncomplicated
criteria to distinguish antipseudomonal beta- bacterial cellulitis can
purulent and non- lactams and/or anti- be treated for 5 days if
purulent infections and anaerobic agents unless there is a timely clinical
severity of illness (i.e., clinically indicated. response.
mild, moderate and
severe) to ensure
infections can be
treated appropriately
according to guidelines.
AMS also can be done by focusing on certain broad-spectrum antibiotic, especially reviewing
when it was started as empirical therapy. Three important questions can be used when
reviewing are:
• Is the antibiotic still needed?
• If so, is the antibiotic tailored to the culture results (e.g. is the narrowest spectrum agent
being used?)
• How long the antibiotic should be used?
Daily activities done by pharmacists are also a part of AMS, such as:
• Monitor response to antibiotic therapy with feedback to the treating clinician.
• Review unnecessary polypharmacy of the same antimicrobial coverage.
• Opportunities for IV to PO switch.
• Monitor safety of antimicrobial therapy (e.g. renal dose adjustment and drug-drug
interaction).
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 39
A.3 ANTIMICROBIAL STEWARDSHIP PROGRAMME MEASUREMENT
Successful AMS programme includes all the elements of successful quality improvement
programmes and measuring the effectiveness of their activities is a key component. Monitoring
and analysis of antimicrobial usage is critical to measure the effects of stewardship
interventions in order to reduce antimicrobial resistance and to support appropriate
antimicrobial prescribing. Structural, process and outcome measures should be incorporated
into the AMS plan. All the program measurement should be reported to the local, state and
national level.
Structural Measures
1. AMS team members a. Does your hospital have a dedicated AMS team?
b. Number of AMS Doctors/ number of beds in your
hospital?
c. Number of AMS Pharmacists/ number of beds in your
hospital?
2. AMS committee meeting a. Does your hospital have regular AMS committee
meeting?
b. How frequent is the meeting?
40 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
6. Education a. How many trained personnel in your AMS team?
• Number of AMS personnel trained under MOH AMS
training module.
• Number of AMS personnel trained under other
certified organization besides MOH. Please specify
the name of organization and date.
• Number of AMS personnel attended any AMS short
courses. Please specify the name of the course and
date.
Note: Not all of the examples listed may be necessary and/or feasible in all hospitals.
Process Measures
Documented indication for Number of patients with a written indication for antibiotic
antibiotic use treatment/ Total number of patients treated with
antibiotic(s).
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 41
De-escalation Number of patients where a de-escalation from the initial
therapy is performed/ Total number of indicated empirical
treatments.
Surgical prophylaxis stopped Surgeries with prophylaxis stopped within 24 hours after
within 24 hours after surgery surgery/ Total number of surgeries that require
prophylaxis.
• Microbiology outcomes
Clostridium difficile / MDR organisms:
Number of healthcare-associated infections in a period of time/ Total number
of patient days within that period x 100 000.
42 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
SECTION B:
ANTIMICROBIAL
STEWARDSHIP
PROGRAMME IN
PRIMARY CARE
Inappropriate use of antimicrobials, primarily involving therapeutic
agents used to treat infections, is considered one of the world’s most
significant public health problems. In addition to diminishing the
therapeutic benefit of essential medications, inappropriate use of
antimicrobials also facilitates the development and spread of
multidrug-resistant organisms.
1. Implement the National Antimicrobial Guideline, clinical guidelines and pathways for
common infections.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 43
2. Report the surveillance and clinical audit findings and ensure the necessary actions are
taken.
3. Establish formulary restrictions and approval systems, especially for broad-spectrum
antimicrobials.
4. Select and optimize the antimicrobial dose tailored to patient characteristics.
5. Educate prescribers, pharmacists, and paramedics on good antimicrobial prescribing
practices and antimicrobial resistance.
44 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
2. Pharmacist
• AMS teams frequently take opportunities to tighten infection control practices during
their course of work. Having an Infection Control/ Link Nurse within the team
complements the efforts of the AMS team in bringing down resistance rates.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 45
conducted at least twice a year. Access to information on antimicrobial utilisation can be an
important source for healthcare professionals and policy makers to monitor progress towards
a more prudent use of antibiotics. The results of antimicrobial use should be discussed with
prescribers and necessary action should be taken based on relevant findings.
Process Audits generally are carried out annually to ensure adherence to clinical guidelines
and pathways and to evaluate the antibiotic prescribing practices. The AMS Process Audits
include Clinical Audit (Appendix 11) and Point Prevalence Survey (Appendix 12).
In addition, Structure Audit evaluates the implementation of AMS core elements and reviews
the progress of stewardship activities once a year. (Appendix 13).
Reports/
Type of Audit Frequency Responsibility Indicator
Data to
46 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Point Once a year in Clinic AMS 1. Percentage 1. PKD
Prevalence a selected Team of clinics 2. State
Survey (PPS) clinic. implementing 3. National
PPS
2. Percentage
of appropriate
antibiotic
prescription for
URTI
2. Percentage
of clinics with
score of > 80%
Reports of the AMS audit shall be presented in Infection and Antibiotic Control Committee
Meeting at the District, State and National level. Remedial actions on the shortfall in quality
shall be discussed and communicated to the implementation level.
In order to ensure the success of the program, two-way system communication has to be
established within the institution. Any feedback may be disseminated via:
a) Email/letter to heads of units
b) Email/letter to individual prescribers
c) Newsletter or bulletin
d) Presentation at unit or district meetings
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 47
4. Formulary Restriction
Formulary restriction is one of the pillars of AMS Programme. MOH drug formulary implements
restrictions based on category of prescribers; however, these restrictions may not be adequate
to guide the local prescribers about judicious use of antibiotic. Therefore, each district is
required to formulate their own district’s formulary with consideration of specific MOH
program such as Integrated Management of Childhood Illnesses and Modified Syndromic
Approach.
All prescribers should comply with formulary restriction either from local or national formulary
which can be implemented through pre-approval (can only be started after getting a specific
approval) either written or verbally.
6. Education
Antimicrobial Stewardship team should provide continuous education for prescribers,
pharmacists and paramedics to enhance knowledge and promote good prescribing behavior
especially to new staffs. Educational Key Points (Appendix 10) must be highlighted during
these sessions to instill appropriate use of antimicrobial.
48 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
3. Prescribing aids
• Educational aids to guide prescribers at the point of prescribing. These may include
clinical algorithms for the diagnosis of infection, or methods to standardize the
documentation of treatment decisions, such as infection stamps or stickers to be
included in the clinical notes.
• Information technology support to provide guidance for prudent antimicrobial use.
• Electronic patient record which is able to highlight potential antibiotics interaction
and allergy.
Public awareness activities should be planned and carried out with the aim of creating
awareness towards the judicious use of antibiotics and challenges of antimicrobial resistance.
A. Process indicators
• Percentage of clinics implementing structure audits.
• Percentage of clinics implementing clinical audits.
• Percentage of clinics implementing antibiotic PPS.
B. Outcome indicators
• Percentage of clinics with structure audit score of > 80%.
• Percentage of good practices in antibiotic prescription (clinical audit score > 80 %).
• Percentage of appropriate antibiotic prescription for URTI from PPS (based on
National Antimicrobial Guideline/ clinical guidelines/ pathways for URTI patients).
• Pattern of selected antibiotics utilisation using DDDs.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 49
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10. Kuti,J.L., Shore, E., Palter, M., Nicolau,D.P. 2009. Tackling empirical antibiotic therapy for VAP in
your ICU. SeminRespirCrit Care Med;30(1):102-115.
11. Masterton, R.G. 2011. Antibiotic de-escalation. Critical Care Clin;27(1):149-62.
12. Joung, M.K., Lee, J., Moon, S. et al. 2011. Impact of de-escalation therapy on clinical outcome for
intensive care unit—acquired pneumonia. Critical Care, 15:R79
13. Ramirez JA, Srinath L, Ahkee S, et al. Early switch from intravenous to oral cephalosporins in the
treatment of hospitalized patients with community-acquired pneumonia. Arch Intern Med.
1995;155: 1273-1276.
14. Weingarten SR, Riedinger MS. Varis G, et al. Identification of low-risk hospitalized patients with
pneumonia: implications for early conversion to oral antimicrobial therapy. Chest. 1994;105:1109-
1115.
15. Ahkee S, Smith S, Newman D, et al. Early switch from intravenous to oral antibiotics in hospitalized
patients with infections: a 6-month prospective study. Pharmacotherapy. 1997;17:569-575.
16. Przybylski KG, Rybak MJ, Martin PR, et al. A pharmacist-initiated program of intravenous to oral
antibiotic conversion. Pharmacotherapy. 1997;17:271-276.
17. Rimmer D. Third generation cephalosporins in the parenteral to oral switch. Pharmacoeconomics.
1994;5 (suppl 2):27-33.
50 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
18. Chan R, Hemeryck L, O'Regan M, et al. Oral versus intravenous antibiotics for community acquired
lower respiratory tract infection in a general hospital: open, randomised controlled trial. Br Med J.
1995; 310:1360-1362.
19. Ehrenkranz NJ, Nerenberg DE, Shultz JM, et al. Intervention to discontinue parenteral antimicrobial
therapy in patients hospitalized with pulmonary infections: effect on shortening patient stay. Infect
Control HospEpidemiol. 1992;13:21-32.
20. Hendrickson JR, North DS. Pharmacoeconomic benefit of antibiotic step-down therapy: converting
patients from intravenous ceftriaxone to oral cefpodoximeproxetil. Ann Pharmacother.
1995;29:561- 565.
21. Paladino JA, Sperry HE, Backes JM, et al. Clinical and economic evaluation of oral ciprofloxacin
after an abbreviated course of intravenous antibiotics. Am J Med. 1991; 91:462-470.
22. Specialist Advisory Committee on Antimicrobial Resistance (SACAR) Antimicrobial Framework. J
AntimicrobChemother 2007; 60 ; Suppl 1: i87-i90
23. Timothy H. D, Robert C. O, John E. McG, Dale N. G, Robert A. W et al; Guidelines for Developing
an Institutional Program to Enhance Antimicrobial Stewardship; Antimicrobial Stewardship
Guidelines • CID 2007:44 (15 January)
24. Guidelines for Antimicrobial Stewardship in Hospitals in Ireland; SARI Hospital Antimicrobial
Stewardship Working Group December 2009
25. Richard H. Drew ; Antimicrobial Stewardship Programs:How to Start and Steer a Successful Program
J Manag Care Pharm. 2009;15(2)(Suppl):S18-S23
26. Mohd. Fozi K, Kamaliah MN. The effect of profiling report on antibiotic prescription for upper
respiratory tract infection. Malaysian Family Physician 2013;8(2):26-31.
27. J. Moody et al. APIC-SHEA Position Paper: American Journal Of Infection Control 40(2012): 94-95
28. https://www.cdc.gov/antibiotic-use/healthcare/implementation/core-elements-small-critical.html
29. World Health Organization. ( 2019) . Antimicrobial stewardship programmes in health-care
facilities in low- and middle-income countries: a WHO practical toolkit. World Health
Organization. https://apps.who.int/iris/handle/10665/329404.
30. Hutchinson, J. M., Patrick, D. M., Marra, F., Ng, H., Bowie, W. R., Heule, L., Muscat, M., & Monnet,
D. L. (2004). Measurement of antibiotic consumption: A practical guide to the use of the Anatomical
Thgerapeutic Chemical classification and Definied Daily Dose system methodology in Canada.
The Canadian journal of infectious diseases = Journal canadien des maladies infectieuses, 15(1),
29–35. https://doi.org/10.1155/2004/389092
31. Core Elements of Hospital Antibiotic Stewardship Programs. Atlanta, GA: US Department of Health
and Human Services, CDC; 2014. http://www.cdc.gov/getsmart/healthcare/ implementation/core-
elements.html
32. Antimicrobial Stewardship Toolkit. Best Practices from the GNYHA/UHF Antimicrobial Stewardship
Collaborative. https://www.uhfnyc.org/assets/1042
33. A Practical Guide to Antimicrobial Stewardships in Hospital. bsac.org.uk/practical-guide-to-
antimicrobial-stewardship-in-hospitals/
34. Barlam, T. F., Cosgrove, S. E., Abbo, L. M., MacDougall, C., Schuetz, A. N., Septimus, E. J., ... &
Hamilton, C. W. (2016). Implementing an antibiotic stewardship program: guidelines by the
Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America.
Clinical Infectious Diseases, 62(10), e51-e77
35. National Antimicrobial Guideline 2019
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 51
APPENDICES
APPENDIX 1: District Infection and Antibiotic Control Committee (DIACC)
a) Composition of District Infection and Antibiotic Control Committee. The following will
be members of the DIACC:
1. Medical Officer of Health- chairman
2. Appointed District Pharmacist - (Secretariat)
3. Public Health Specialist (Primary Care) - (Infection Control Coordinator)
4. Public Health Specialist (Epidemiology)
5. Public Health Specialist (KPAS)
6. Appointed Family Medicine Specialist (AMS Coordinator)
7. District Matron
8. District Assistant Medical Officer
9. Appointed Infection Control Nurse/Personnel
10. Appointed District Medical Laboratory Technologist
11. Information and Communication Technology Officer (ICT)
12. Three (3) Representatives of Pharmacist from Health Clinic
13. Three (3) Representatives of Link Nurse/Personnel from Health Clinic
b) Chairman
The committee will be chaired by the District Health Officer and the chairman:
• Leads facilitation and coordination of district public health efforts in promoting good
infection control practice and judicious use of antimicrobial.
• Provides a platform for programme planning and implementation.
• Leads DIACC meetings.
• Reviews and approves DIACC output.
• In the absence of the Chairman, the meeting will be chaired by a delegate assigned
by the chairman.
54 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
• Acts as head of the secretariat for DIACC
- Schedule and prepare the agenda of bi-annual DIACC
- Draft minutes for DIACC meetings
- Maintain a spreadsheet to track progress on recommendations
- Facilitate DIACC correspondence
- Draft and maintain DIACC documents, reports and meeting minutes as
appropriate
i) Frequency of meetings
• Meetings shall be held at least twice a year.
• Members of the committee shall be notified of the date and agenda of the
meeting at least two weeks prior to the meeting.
• Minutes should be kept and ratified.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 55
iii) Members of the meeting
• The quorum of meeting shall consist of at least 2/3 of the committee members.
56 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Appendix 2: Antimicrobial Stewardship Programmes in Healthcare Facilities in Low- and
Middle-income Countries
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 57
58 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 59
Example of Terms of Reference:
60 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 61
Appendix 3: How to Perform an Audit
No
Source of data
1. Antibiotic consumption
(DDD)
Intervention
2. Antibiotic prescription
3. Culture & Susceptibility
data
AUDITT
Feedback
62 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
EXAMPLE OF AUDIT USING DDD DATA
NO
E.g. Baseline = DDD Increases beyond the upper limit END
• Average DDD previous (e.g.>30% from baseline)
year
1 week
NO
Require intervention?
YES 1 week
1 month
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 63
64
EXAMPLE OF ANTIBIOTIC AUDIT FORM
ANTIBIOTIC:
If Definitive/
Empiric If Empiric
Empiric/ to Definitive
Indication Definitive/ Compliance
Month Ward Dose & Patient MRN of Treatment Prescriber Remarks
Empiric to Duration
Frequency Antibiotic to Reason for
guideline (Days)
Start Date
cont.
Stop Date
Definitive Culture Source
beyond
72 hours
Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Appendix 4: How to Perform Antibiotic Point Prevalence Survey (PPS)
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 65
EXAMPLE OF PPS FORM
66 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Appendix 5: How to Perform Surgical Antibiotic Prophylaxis Audit
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 67
68 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
SURGICAL PROPHYLAXIS AUDIT WORK PROCESS (Continuous Improvement Cycles)
Form!"#$%&%'(&))*)+%,-&$
a planning team
Audit briefing
./0*,%1#*-2*)+
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audit finding to AMS Team
Implement>$'(-$-),%,8-%*),-#?-),*"):D48&)+-:%'(&))-0
the interventions/changes planned
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 69
Appendix 6: Example of Formulary Restriction
Antimicrobials are divided into 3 categories – the first being antimicrobials that require
preauthorization before it can be prescribed. Authorization is issued by the relevant consultant
of the department and in accordance with preapproved indications. The second category
involves antimicrobials that can be prescribed for certain indications which will be subject to
a review by the stewardship team within 3 working days and justification for its continuation
is required. The last category is other antimicrobials that do not require pre-approvals.
Example:
70 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Appendix 7: Example of Antibiotic Order Form
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Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 71
72 HOURS ANTIBIOTIC REVIEW FORM
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K*!+%?,1,8,L%!>9%3#/6!! ! ! ! !! !!
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72 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Appendix 8: Example of IV to PO Therapy Conversion
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 73
Example of Anmicrobials That Can Be Included in IV to PO Therapy Conversion
(Not all IV Antimicrobial are available in Oral formulation)
=Sequential therapy with direct conversion (same medication but different IV to oral dose)
=Sequential therapy without direct conversion (same medication but different IV to oral dose)
> =Switch or step-down therapy (same or different class of medication with same/similar spectrum of
activity)
74 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Appendix 9: The WHO EML AWaRe classification of commonly used antibiotics
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 75
Appendix 10: Educational Key Points
• Antimicrobials should be used after a treatable infection has been recognized or there is a
high degree of suspicion of infection. In general, colonization or contamination should not
be treated. Antimicrobials should be used for the prevention of infection where research
has demonstrated that the potential benefits outweigh the risks. Long-term prophylaxis
should be avoided unless there is a clear clinical indication (for example, rheumatic fever
and post-splenectomy).
• The timing, regimen, dose, route of administration and duration of antimicrobial therapy
should be optimized and documented. The indication for which the patient is being
prescribed the antimicrobials should be documented in the drug chart and case notes by
the prescriber.
• Wherever possible, antimicrobials should be given orally rather than intravenously. Clear
criteria should be defined for when intravenous therapy is appropriate. As soon as possible
the prescription should be switched to an oral equivalent. The intravenous prescription
should be reviewed after 48 hours as a minimum.
• Antimicrobial treatment should be stopped as soon as possible. A stop date or review date
should be recorded by the prescriber on the drug chart. In general, antimicrobial courses
should be reviewed within five days.
To ensure rapid treatment and infection control, mechanisms should be in place to ensure that
patients receive antimicrobial drugs in a timely manner.
76 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Appendix 11: Clinical Audit Guidelines in Health Clinic
Introduction:
Clinical audit for AMS is a tool that looks into details in clinical practice by individual health care
provider that prescribed antibiotic and overall trend of prescription by health clinic. This can be
further used for quality improvement cycle that involves assessment of the effectiveness of clinical
services against agreed standards of best practice.
Stage of implementation:
STAGE 1 - PREPARATION:
• Done annually by random sampling of minimal 30 case notes as samples or as needed
whenever there are issues in the trend of antibiotic prescription.
• Identify available resources, e.g. audit team headed by FMS in charge of health clinic.
• Existing guidelines defining desired standards as reference, such as NAG and clinical
pathways.
• Define criteria: All antibiotic prescription on any health care provider to be randomly selected
with minimum of 30 record within the past 1 month.
Any adhoc audit for individual prescriber or health clinic performance in AMS prescription
performance can be done when necessary throughout the year. Data can be used for self-
monitoring audit that does not require any report submission.
Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 77
Excel format for clinical audit:
78 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Appendix 12: Workflow of PPS in Health clinic
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Second Edition 2022 | Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities 79
Structure Audit Checklist for AMS
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80 Protocol on Antimicrobial Stewardship (AMS) Programme in Healthcare Facilities | Second Edition 2022
Pharmaceutical Services Programme
Medical Development Division
Family Health Development Division
Ministry of Health Malaysia