This document outlines an Antibiotic Stewardship Program (ASP) and provides guidance on its implementation. It discusses the rising threat of antimicrobial resistance globally and in India. The goals of an ASP are to combat resistance, improve patient outcomes, safety and reduce costs. Key elements include establishing a multidisciplinary team, conducting surveillance of antibiotic use and resistance patterns, implementing guidelines and formulary restrictions, and optimizing antibiotic use through interventions like automatic substitution and de-escalation of therapy. Barriers to ASP include lack of infrastructure, data and clinician knowledge. Laboratories play an important role through rapid diagnostics and susceptibility testing to guide appropriate empirical therapy.

1. Antibiotic Stewardship Program

2. CONTENTS
1) Introduction
2) Trend of AMR in India
3) Definition of antimicrobial stewardship
4) WHY DO WE NEED AMSP?
5) Goals of antimicrobial stewardship program
6) Antimicrobial stewardship team
7) Implementation of antimicrobial Stewardship Programs
8) Role of microbiology laboratory
9) Conclusion
10)References

3. Introduction
 Antimicrobial resistance (AMR) has emerged as a major public health problem all
over the world.
Infections caused by resistant microbes fail to respond to treatment
because of limited therapeutic options resulting in prolonged illness and greater
risk of death.
Treatment failures also lead to longer periods of infectivity, with increased
numbers of infected people in the community.
This in turn exposes the general population to the risk of contracting a resistant
strain of microorganisms. As they become resistant to first-line antimicrobials, the
forbidding high cost of the second-line drugs may result in failure to treat these
diseases.
Most alarming of all are the diseases caused by multidrug-resistant microbes,
which are virtually non-treatable and thereby contributes to a “post-antibiotic era”.

4. Trend of AMR in India
lndia is among the nations with the highest burden of bacterial infections.
 Mortality: It is estimated 410,000 children ( <5 years) die from pneumonia annually.
 The crude mortality from infectious diseases in India is about 417 per 100,000 persons.
 Consequently, the impact of AMR is likely to be higher in the Indian setting. Increase
in AMR in India has been contributed by injudicious use of antibiotics in humans and
also use in animals.
Largest consumer of antibiotics: In 2010, 12.9 x 109 units of antibiotics consumed,
India was the largest consumer of antibiotics for human health. However, the per capita
consumption of antibiotics in India (10.7 units per capita) was lower than that seen in
many other countries

5. Definition of antimicrobial stewardship
Antimicrobial Stewardship (or Antibiotic Stewardship) Programs (ASPs) have become
the mechanism to optimize antimicrobial therapy within hospitals.
Coordinated intervention is designed to improve and measure the appropriate use of
antimicrobial agents, by promoting the selection of optimal antimicrobial drug regimen
including dosing, duration of therapy and route of administration.
Appropriate initial antibiotic –
usually empirical
Unnecessary antibiotic (broad
spectrum) and increased
resistance and cost
Antimicrobial
stewardship
A Balancing ACT

6. WHY DO WE NEED AMSP?
Antimicrobial stewardship program (AMSP) in a hospital is required for the following reasons.
Antimicrobial Resistance (AMR):AMR is a rising threat across the globe. The multidrug
resistance organisms (MDROs) are prevalent in every country though the extent and the severity
of the problem vary. Extensive misuse of antibiotics is the single most important factor for the
bacteria to undergo mutation to become resistant, which further flourishes exponentially in the
presence of selective pressure of antibiotics.
Misuse and Overuse of Antibiotics:Though last seven decades since the discovery of penicillin,
witnessed that the antibiotics were highly effective and have saved millions of lives, at the same
time, this has also led to their misuse through various ways such as:
Over the counter sale without a prescription
❖ Overuse for self-limiting infections, nonbacteria1 infections, and treatment of colonizer or
contaminant
❖ Use of antibiotic with overlapping spectra of activity (redundant antibiotics)
❖ Inappropriate administrative errors ( wrong dose, wrong frequency, wrong infusion time,
missed dose, etc.)

7. Antimicrobial prescribing facts: The 30% Rule
• 30% of all hospitalised in-patient at any given time receive
antibiotics
• Over 30% of antibiotics are prescribed inappropriately in the
community
• Up to 30% of all surgical prophylaxis is inappropriate
• 30% of hospital pharmacy costs are due to antimicrobial use
• 10-30% of antimicrobial cost can be saved by antimicrobial
stewardship programs

8. Goals of antimicrobial stewardship program
• The primary goal of AMS is preventing emergence of AMR and to optimize clinical
outcomes while minimizing unintended consequences of antimicrobial use, including
toxicity. A secondary goal of AMS is to reduce healthcare costs without adversely
impacting quality of care.
Goal 1: Combat antimicrobial resistance:
Restricting antibiotic use results in reduction of antibiotic pressure, which in turn
prevents the development of antimicrobial resistance.
 Restricting antibiotic use can reduce colonization or infection with gram-positive or
gram-negative resistant bacteria.
Goal 2: Improve patient outcomes
 Improve infection cure rates
 Reduce surgical site infection rates
 Reduce mortality and morbidity.
cont.....................

9. Goal 3: Improve patient safety through minimizing unintended consequences of
antimicrobials.
Reduce antimicrobial consumption , without increasing mortality or infection related
readmissions, e.g. 22- 36% reduction in antimicrobial use (Dellit et al. 2007).
 Reduce C. difficile colonization or infection by controlling the use of "high -risk "
antibiotics (Valiquette et al. 2007).
Goal 4: Reduce healthcare costs toward antimicrobiale expenditure without adversely
impacting quality of care.

10. Antimicrobial stewardship team
• Medical directors- Prescriber of antibiotics should be fully engaged in prescribing
antiibiotics. They should provide supportive efforts to improve antibiotic use in
hospitalsthrough assessing, monitoring and communicating the changes by setting
standard antibiotic prescribing practices.
• Pharmacist - They have a responsibility to take prominent role in antimicrobial
stewardship program and participate in the infection prevention and control program of
health systems -American Society of Health Systems Pharmacists, 2010.
Responsibilities of pharmacist includes: avoid the dispersing of drugs over the counter
without prescription, emphasizing the correct drug, dose, duration and educating the
patient on the antimicrobial use and quality assurance activities.
• Microbiologist – can guide accurate and reliable diagnostic test for infectous disease.
They can suggest empirical therpy derived from cumulative antibiotic resistant report
available in hospitals. Clinical Microbiologist plays a crucial role in sending alerts of
multi drug resistant pathogens and educate about the rapid diagnostic tests available in
healthcare settings.
cont...........................

11. Infection prevention control committe
• They should monitor and prevent the spread of health care associated infections
through auditing, analyzing and reporting data. They track antibiotic use in hospitals,
adherence to evidence-based published criteria and review antibiotic resistance patterns
in the healthcare facility. They educate staff on the importance of appropirate antibiotic
use and implement antibiotic stewardhip strategies to optimize antibiotic use.

12. Implementation of antimicrobial Stewardship Programs
• A recent global survey outlined the range of stewardship activities across the continents. This survey provides
someunderstanding about current or planned activity and barriers.
1. Assess the motivations:
Analyse your situation and what problems you want to address.There are many international guidelines
available, but you will need to adapt them to your local situation.
 Define where you are and where you want to go, with quantitative figures. One of the ways of obtaining these
data is to measure the quantity and quality of antibiotic use.
 What can be implemented will depend on local needs/issues, geography, available skills / expertise and other
resources.
For example, easier or less costly approaches can include:
- Simple clinical algorithms
- Prescribing guidance for treatment, surgical prophylaxis
- Intravenous (IV) to oral conversion
- Provision of microbiological support
- Restricting availability of certain antibiotics (formulary restriction)
- Automatic therapeutic substitution
- IV antimicrobial batching
- Promoting education.

13. 2. Ensure accountability and leadership
To ensure a successful Antimicrobial Stewardship Program:
The program should be supported by the senior hospital management,
who are accountable for the outcomes.
 A team of people and resources should be allocated by the head of the
organization to implement and evaluate the program.
The ASP team members must possess power, expertise, credibility and
leadership. These individuals need to convince managers and healthcare
staff of the added value of the program.

14. 3. Set up structure and organization
• The key components of the structure and governance of the ASP are :
 Dedicated resources, including dedicated personnel time for stewardship activities, education, and
measuring/monitoring antimicrobial use.
A multidisciplinary AS team with core membership of:
• An infectious diseases physician (or lead doctor or physician champion)
• A clinical microbiologist
• A clinical pharmacist with expertise in infection.
• Other members could be specialist nurses, for example infection prevention or stewardship nurses, quality
improvement /risk management/patient safety managers and clinicians with an interest in infection.
Governance within the hospital’s quality improvement and patient safety governance structure
Clear lines of accountability between the chief executive, clinical governance, drug and therapeutics
committee, infection prevention and control committees, and the AST. Figure 7 illustratessuch an
organization structure.

15. 4. Define priorities and how to measure progress and success
• The objectives of the ASP and how they are going to be achieved and measured need to be agreed by all
the key stakeholders and communicated clearly.
One way of doing this is to produce a driver diagram. A Driver Diagram is a logic chart with three or more
levels, including:
A goal or vision,
The high-level factors needed to achieve this goal (called ‘primary drivers’)
 Specific projects and activities that would act upon these factors.
For more complex goals, each primary driver could have its own set of ‘secondary drivers’ (or lower level
drivers).
Driver diagrams can help an ASP team to:
Explore the factors that need to be addressed to achieve a specific overall goal,
 Show how the factors are connected,
Act as a communication tool for explaining a change strategy
Provide the basis for a measurement framework.

16. 5. Identify effective interventions for your setting
when establishing a new stewardship program, it is best to start with the core strategies
and focus on achieving and maintaining them before adding some of the supplemental
strategies.
core Strategies Supplemental Strategies
Formulary restrictions and preauthorization* Streamlining / timely de-escalation of therapy*
Prospective audit with intervention and feedback* Dose optimization*
Multidisciplinary stewardship team Parenteral to oral conversion*
Guidelines and clinical pathways*
Antimicrobial order forms
Education
Computerized decision support, surveillance
Laboratory surveillance and feedback Combination
therapies
Antimicrobial cycling
Antimicrobial Stewardship Toolkit: Quality of Evidence tosupport interventions.

17. Two core ASP strategies have emerged:
➤“Front–end strategies” where antimicrobials are made available through
an approval process (formulary restrictions and preauthorization).
➤ “Back-end“ strategies are where antimicrobials are reviewed after
antimicrobial therapy has been initiated (prospective audit with intervention
and feedback)

18. Role of microbiology laboratory
The clinical microbiology laboratory plays a critical role in the timely identification of
microbial pathogens and the performance of susceptibility testing.
Susceptibility testing can aid in the prudent use of antimicrobials and direct appropriate
therapy based on local guidelines.
Clinical microbiology laboratory should be actively involved in resistance surveillance.
Local antibiogram with pathogen-specific susceptibility data should be updated at least
annually, to optimize expert-based recommendations for empirical therapy.
Computerized surveillance can facilitate more-frequent monitoring of antimicrobial
resistance trends.
Clonal characterization of resistant strains through molecular typing can help focus
appropriate interventions, leading to a reduction in nosocomial infections with associated
cost savings.
cont.......................................

19. Appropriate culture should be obtained before starting antimicrobial therapy. Prior
therapy may interfere with bacterial growth.
Promote optimal usage of diagnostic services such as ensuring the specimens are
appropriate, clinically relevant and timely.
Undertake selective antimicrobial susceptibility testing especially those that are
listed in formulary.
Clinical interpretations to laboratory reports.
With hold the susceptibility reports when clinical information is inadequate.
Undertake rapid identification and susceptibility testing.
Collect and collate surveillance data and report trends and susceptibility profiles to
guide empirical therapy.

20. Barriers to antimicrobial stewardship:
• Clinician knowledge deficits regarding the optimal use of antibiotics;
• Opposition from clinicians to antimicrobial stewardship;
• Limited access to reliable clinical diagnostic or microbiologic testing;
• Limited or unreliable access to quality-assured antimicrobials;
• Fear that withholding antimicrobials, and especially antibiotics will lead to poor
outcomes;
• Limited or lack of communication between health care providers;
• Limited infrastructure and/or administrative support for antimicrobial
stewardship programmes or interventions;
• Limited access to data, including antimicrobial prescribing trends, at a facility,
and of data regarding the prevalence of AMR in the community;
• Limited public/patient acceptance of antimicrobial stewardship; and
• Public access to antimicrobials, such as antibiotics, without prescriptions inthe
community.

21. Conclusion
Healthcare is changing.
High quality care in cost constrained environment.
Antibiotic stewardship is about patient safety and delivering high-quality healthcare
Antibiotic stewardship is a set of commitments and actions designed to optimizethe treatment
of infectionswhile reducing the adverseevents associated withantibiotic use

23. Take Home Messages
 Antibiotic stewardship is important for patient safety.
 There are many opportunities to improve antibiotic use in
hospitals.
 Tracking and reporting of antibiotic use is critical to identify,
implement and assess stewardship interventions.

24. References
• Prof. Balram Bhargava. Antimicrobial Stewardship Program Guideline.
ICMR.National Health Policy’ (2017).
• World Health Organization.Antimicrobial stewardship programmes in
health-care facilities in low- and middle-income countries.A WHO
practical toolkit.2019
• Kerry L. LaPlante, PharmD, FCCP, Cheston B. Cunha, MD,Haley J.
Morrill, PharmD, Louis B. Rice, MD.Antimicrobial Stewardship:
Principles and Practice.2017.Typeset by SPi, Pondicherry, India Printed
and bound by CPI Group (UK) Ltd, Croydon, CR0 4YY.