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Antimicrobial Stewardship
1
Why we Need Antibiotics
Nearly One half of the
Hospitalized patients receive
antimicrobial agents.
• Antibiotics are valuable Discoveries of the
Modern Medicine.
• All current achievements in Medicine are
attributed to use of Antibiotics
• Life saving in Serious infections.
2
What went wrong with
Antibiotic Usage
• Treating trivial infections / viral Infections with
Antibiotics has become routine affair.
• Many use Antibiotics without knowing the Basic
principles of Antibiotic therapy.
• Many Medical practioners are under pressure for short
term solutions.
• Commercial interests of Pharmaceutical industry pushing
the Antibiotics, more so Broad spectrum and Newer
Generation antibiotics. as every Industry has become profit
oriented.
• Poverty encourages drug resistance due to
under utilization of appropriate Antibiotics.
3
Science magazine; July 18, 2008
• The last decade has seen the inexorable proliferation
of a host of antibiotic resistant bacteria, or bad bugs,
not just MRSA, but other insidious players as well.
...For these bacteria, the pipeline of new antibiotics is
verging on empty. 'What do you do when you're faced
with an infection, with a very sick patient, and you get
a lab report back and every single drug is listed as
resistant?' asked Dr. Fred Tenover of the Centers for
Disease Control and Prevention (CDC). 'This is
a major blooming public health
crisis.'"
4
Spread of Antibiotic Resistance
• Indiscrimate use of
Antibiotics in Animals and
Medical practice
• R plasmids spread among
co-inhabiting Bacterial
flora in Animals ( in gut )
• R plasmids may be mainly
evolved in Animals spread
to Human commensal, -
Escherichia coli followed
by spread to more
important human
pathogens Eg Shigella spp.
5
What is Misuse of Antibiotics?
Misuse of antibiotics can include any of the following
• When antibiotics are prescribed unnecessarily;
• When antibiotic administration is delayed in critically ill
patients;
• When broad-spectrum antibiotics are used too generously, or
when narrow-spectrum antibiotics are used incorrectly;
• When the dose of antibiotics is lower or higher than
appropriate for the specific patient;
• When the duration of antibiotic treatment is too short or too
long;
• When antibiotic treatment is not streamlined according to
microbiological culture data results.
6
Costs Associated with
Increased Bacterial
Resistance
• ↑Treatment failures
• ↑Morbidity and mortality
• ↑Risk of hospitalization
• ↑Length of hospital stays
• ↑Need for expensive and broad
spectrum antibiotics
7
Best way to keep the matters in Order
Every Hospital should have a policy which is
practicable to their circumstances.
Rigid guidelines without coordination will
lead to greater failures
The only way to keep Antimicrobial agents
useful is to use them appropriately and
Judiciously
(Burke A.Cunha, MD,MACP Antimicrobial Therapy. Medical
Clinics of North America NOV 2006)
8
“ what is Stewardship”????
• The office, duties, and
obligations of a steward
• The conducting,
supervising, or
managing of something
especially : the careful
and responsible
management of
something entrusted to
one's care
9
Therefore, Antibiotic
Stewardship…..
An activity that
includes
appropriate
selection, dosing,
route, and
duration of
antimicrobial
therapy.
10
What is Antibiotic Stewardship?
• A program that encourages judicious (vs
injudicious) use of antibiotics
– Antibiotics are relatively so effective, non-toxic and
inexpensive…so easy to use…that they are prone to
abuse
• When the diagnosis is uncertain, antibiotics are often
prescribed…
– Stewardship strives to fine tune antibiotic Rx in regards
to
• Efficacy
• Toxicity
• Resistance-induction
• C. difficile-induction
• Cost
• Discontinuation
11
Sobering Thoughts
The pipeline is drying up!
US FDA approval of new
antibacterials down 56% from
1983 to 2002
• Infectious diseases are still the
most common cause of death
worldwide.
• We are effectively living in
the post-antibiotic era
• Therefore, we must manage
carefully and responsibly
what we have
12
Should restrict and rationalize
antibiotic use
Antimicrobial stewardship
+
Infection control program
Can limit the emergence and transmission of
antimicrobial-resistant bacteria
13
Goals of Ab Stewardship
• Optimizing clinical outcomes while minimizing unintended
consequences of antimicrobial uses.
•Toxicity
•Selection of Pathogenic
organisms
•Emergence of Resistance
• A secondary goal is also the reduction of health care costs
without adversely impacting quality of care
14
GUIDELINES FOR DEVELOPING AN
INSTITUTIONAL PROGRAM TO ENHANCE
ANTIMICROBIAL STEWARDSHIP
An institutional program to
enhance antimicrobial
stewardship
Antimicrobial Stewardship
Team
Antimicrobial Stewardship
Program
15
Antibiotic Stewardship Team
• Infectious Disease Physician.
• Clinical Pharmacist with infectious disease training
• Clinical Microbiologist
• An information system specialist
• Infection control professional.
• Hospital epidemiologist (Optional)
Collaboration between the antimicrobial
stewardship team, the hospital infection
control, pharmacy and therapeutics
committees is essential
16
ELEMENTS OF AN ANTIMICROBIAL
STEWARDSHIP PROGRAM
Active Antimicrobial Stewardship Strategies
Supplemental
Antimicrobial
Stewardship
Strategies
Computer
Surveillance and
Decision Support
Microbiology
Laboratory
Comprehensive
Multidisciplinary
Antimicrobial
Management Programs
Monitoring of Process
and Outcome
Measurements
17
Active Antimicrobial Stewardship
Strategies
1. Prospective audit with intervention and
feedback.
• A medium-sized community hospital resulted
in a 22% decrease in the use of parenteral
broad-spectrum antimicrobials.
• They also demonstrated a decrease in rates of
C. difficile infection & nosocomial infection
compared with the preintervention period.
18
2. Formulary restriction & preauthorization
requirements for specific agents
 Most hospitals have a pharmacy and therapeutics
committee or an equivalent group
 They evaluates drugs for inclusion on the hospital
formulary on the basis of
 therapeutic efficacy
 toxicity
 cost
 They also limit redundant new agents with no
significant additional benefit.
19
Supplemental Antimicrobial Stewardship
Strategies
• Education.
• Guidelines and clinical pathways.
• Antimicrobial cycling
• Antimicrobial order forms.
• Combination therapy.
• Streamlining or de-escalation of therapy.
• Dose optimization.
• Conversion from parenteral to oral therapy.
20
Education
• Considered to be most essential part of
Stewardship Program:
– Antibiotics
– Resistance
– PK-PD
– Collateral damage ( unintended )
– Alignment of Ab to overcome anti-microbial resistance.
• Target Customers: Microbiologist and Clinicians.
21
Most frequently employed
intervention
• Educational efforts include passive activities
 conference/ presentations
 student and house staff teaching sessions
 provision of written guidelines
 e-mail alerts
However, education alone, without incorporation of
active intervention, is only marginally effective and
has not demonstrated a sustained impact
22
A good clinical practice saves
antibiotics
• Treatment should be limited
to bacterial infections, using
antibiotics directed against
the causative agent, given in
optimal dosage, interval and
length of treatment, with
steps taken to ensure
maximum patient
compliance with the
treatment regimen and only
when the benefit of
treatment outweighs the
individual and global risks
23
Antimicrobial cycling and scheduled
antimicrobial switch.
“Antimicrobial cycling”
refers to
24
the removal and substitution of a specific
antimicrobial or antimicrobial class to prevent or
reverse the development of antimicrobial resistance
within an institution or specific unit.
Choosing the drugs
• Substituting one
antimicrobial for another
may transiently decrease
selection pressure reduce
resistance
• But, reintroduction of the
original antimicrobial is
again however known to
develop resistance
• There are insufficient data to
recommend the routine use
over a prolonged period of
time
25
Antimicrobial order forms.
• The use of automatic stop orders and the
requirement of physician justification for
continuation
• Decrease antimicrobial consumption in
longitudinal studies
26
Use of peri-operative prophylactic order forms with
automatic discontinuation at 2 days resulted in a decrease
in the mean duration of antimicrobial prophylaxis (from 4.9
to 2.4 days)
Combination therapy
• Has a role in certain
clinical contexts
• Including use for
empirical therapy for
critically ill patients at
risk of infection with
multidrug resistant
pathogens
• To increase the breadth of
coverage and the
likelihood of adequate
initial therapy
27
Limitations of Combination of Antibiotics
• The role of combination
antimicrobial therapy for the
prevention of resistance is
limited to those situations in
which there is
 A high organism load
 A high frequency of
mutational resistance during
therapy.
• Classic examples are
tuberculosis or HIV
infection.
28
Streamlining or De-Escalation of
Therapy
–On the basis of culture and sensitivity
reports we can more effectively target the
causative pathogens, by elimination of
redundant combination therapy
–Resulting in decreased Ab exposure and
substantial cost savings
Dr.T.V.Rao MD 29
CDC vision for inpatient care
• Implementation of an antimicrobial
stewardship program in a healthcare facility
– regardless of inpatient setting – will help
ensure that hospitalized patients receive the
right antibiotic, at the right dose, at the right
time, and for the right duration. As a result,
there is reduced mortality, reduced risks of
Clostridium difficile-associated diarrhea,
shorter hospital stays, reduced overall
antimicrobial resistance within the facility,
and cost savings 30
Dose Optimization
Optimization of AB dosing based on
• Individual patient characteristics
• Causative organisms
• Site of infections
• PK-PD characteristics
• Systemic Plan from a broad spectrum to specific
narrow spectrum Ab, parenteral to oral Antibiotics.
Conversion from parenteral to oral
therapy
Enhanced oral bioavailability
among certain
antimicrobials—such as
fluoroquinolones,
oxazolidinones, metronidazole,
clindamycin, trimethoprim-
sulfamethoxazole, fluconazole,
and voriconazole
Therefore, allows for
conversion to oral therapy
once a patient meets
defined clinical criteria
32
Computer Surveillance and Decision Support
• Computer physician order
entry (CPOE) as 1 of the
most important “leaps”
that organizations can take
to substantially improve
patient safety.
• CPOE has the potential to
incorporate clinical
decision support and to
facilitate quality
monitoring
33
Our clinical Judgment carries many solutions…
These guidelines
are not a substitute
for clinical
judgment, and
clinical discretion is
required in the
application of
guidelines to
individual patients.
34
Multifaceted strategies can address and decrease
antibiotic resistance in hospitals
• Antibiotic prescribing practices and decreasing
antibiotic resistance can be addressed through
multifaceted strategies including:
 Use of ongoing education
 Use of evidence-based hospital antibiotic
guidelines and policies
 Restrictive measures and consultations
from infectious disease physicians,
microbiologists and pharmacists
35
Prudent prescribing to reduce
antimicrobial resistance
• Only use an antimicrobial
when clearly indicated.
• Select an appropriate
agent using local
antimicrobial prescribing
policy.
• Prescribe correct dose,
frequency and
duration.
• Limit use of broad
spectrum agents and de-
escalate or stop
treatment if appropriate
(Hospital).
36
Practice rationalism in antibiotic use-
promote antibiotic stewardship
• 1 Antibiotic overuse contributes to the growing
problems of Clostridium difficile infection and
antibiotic resistance in healthcare facilities.
2 Improving antibiotic use through stewardship
interventions and programs improves patient
outcomes, reduces antimicrobial resistance, and saves
money. Interventions to improve antibiotic use can be
implemented in any healthcare setting—from the
smallest to the largest. 3
Improving antibiotic use is a medication-safety and
patient-safety issue.
37
Continuous Medical Education
a Must ..
• Training and educating health
care professionals on the
appropriate use of antibiotics
must include appropriate
selection, dosing, route, and
duration of antibiotic therapy. To
ensure that training and education
is working, there should be
extensive collaboration between
the antibiotic stewardship and
hospital infection prevention and
control teams. Without
benchmarks, it is difficult to track
successes and weaknesses
38
Good hand washing practices still reduces
antibiotic resistance and spread
Dr.T.V.Rao MD 39
Implementation of WHONET CAN HELP TO
MONITOR RESISTANCE
• Legacy computer systems,
quality improvement
teams, and strategies for
optimizing antibiotic use
have the potential to
stabilize resistance and
reduce costs by
encouraging
heterogeneous prescribing
patterns and use of local
susceptibility patterns to
inform empiric treatment.
40
41

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Antibiotic Stewardship Programs Key to Combating Resistance

  • 2. Why we Need Antibiotics Nearly One half of the Hospitalized patients receive antimicrobial agents. • Antibiotics are valuable Discoveries of the Modern Medicine. • All current achievements in Medicine are attributed to use of Antibiotics • Life saving in Serious infections. 2
  • 3. What went wrong with Antibiotic Usage • Treating trivial infections / viral Infections with Antibiotics has become routine affair. • Many use Antibiotics without knowing the Basic principles of Antibiotic therapy. • Many Medical practioners are under pressure for short term solutions. • Commercial interests of Pharmaceutical industry pushing the Antibiotics, more so Broad spectrum and Newer Generation antibiotics. as every Industry has become profit oriented. • Poverty encourages drug resistance due to under utilization of appropriate Antibiotics. 3
  • 4. Science magazine; July 18, 2008 • The last decade has seen the inexorable proliferation of a host of antibiotic resistant bacteria, or bad bugs, not just MRSA, but other insidious players as well. ...For these bacteria, the pipeline of new antibiotics is verging on empty. 'What do you do when you're faced with an infection, with a very sick patient, and you get a lab report back and every single drug is listed as resistant?' asked Dr. Fred Tenover of the Centers for Disease Control and Prevention (CDC). 'This is a major blooming public health crisis.'" 4
  • 5. Spread of Antibiotic Resistance • Indiscrimate use of Antibiotics in Animals and Medical practice • R plasmids spread among co-inhabiting Bacterial flora in Animals ( in gut ) • R plasmids may be mainly evolved in Animals spread to Human commensal, - Escherichia coli followed by spread to more important human pathogens Eg Shigella spp. 5
  • 6. What is Misuse of Antibiotics? Misuse of antibiotics can include any of the following • When antibiotics are prescribed unnecessarily; • When antibiotic administration is delayed in critically ill patients; • When broad-spectrum antibiotics are used too generously, or when narrow-spectrum antibiotics are used incorrectly; • When the dose of antibiotics is lower or higher than appropriate for the specific patient; • When the duration of antibiotic treatment is too short or too long; • When antibiotic treatment is not streamlined according to microbiological culture data results. 6
  • 7. Costs Associated with Increased Bacterial Resistance • ↑Treatment failures • ↑Morbidity and mortality • ↑Risk of hospitalization • ↑Length of hospital stays • ↑Need for expensive and broad spectrum antibiotics 7
  • 8. Best way to keep the matters in Order Every Hospital should have a policy which is practicable to their circumstances. Rigid guidelines without coordination will lead to greater failures The only way to keep Antimicrobial agents useful is to use them appropriately and Judiciously (Burke A.Cunha, MD,MACP Antimicrobial Therapy. Medical Clinics of North America NOV 2006) 8
  • 9. “ what is Stewardship”???? • The office, duties, and obligations of a steward • The conducting, supervising, or managing of something especially : the careful and responsible management of something entrusted to one's care 9
  • 10. Therefore, Antibiotic Stewardship….. An activity that includes appropriate selection, dosing, route, and duration of antimicrobial therapy. 10
  • 11. What is Antibiotic Stewardship? • A program that encourages judicious (vs injudicious) use of antibiotics – Antibiotics are relatively so effective, non-toxic and inexpensive…so easy to use…that they are prone to abuse • When the diagnosis is uncertain, antibiotics are often prescribed… – Stewardship strives to fine tune antibiotic Rx in regards to • Efficacy • Toxicity • Resistance-induction • C. difficile-induction • Cost • Discontinuation 11
  • 12. Sobering Thoughts The pipeline is drying up! US FDA approval of new antibacterials down 56% from 1983 to 2002 • Infectious diseases are still the most common cause of death worldwide. • We are effectively living in the post-antibiotic era • Therefore, we must manage carefully and responsibly what we have 12
  • 13. Should restrict and rationalize antibiotic use Antimicrobial stewardship + Infection control program Can limit the emergence and transmission of antimicrobial-resistant bacteria 13
  • 14. Goals of Ab Stewardship • Optimizing clinical outcomes while minimizing unintended consequences of antimicrobial uses. •Toxicity •Selection of Pathogenic organisms •Emergence of Resistance • A secondary goal is also the reduction of health care costs without adversely impacting quality of care 14
  • 15. GUIDELINES FOR DEVELOPING AN INSTITUTIONAL PROGRAM TO ENHANCE ANTIMICROBIAL STEWARDSHIP An institutional program to enhance antimicrobial stewardship Antimicrobial Stewardship Team Antimicrobial Stewardship Program 15
  • 16. Antibiotic Stewardship Team • Infectious Disease Physician. • Clinical Pharmacist with infectious disease training • Clinical Microbiologist • An information system specialist • Infection control professional. • Hospital epidemiologist (Optional) Collaboration between the antimicrobial stewardship team, the hospital infection control, pharmacy and therapeutics committees is essential 16
  • 17. ELEMENTS OF AN ANTIMICROBIAL STEWARDSHIP PROGRAM Active Antimicrobial Stewardship Strategies Supplemental Antimicrobial Stewardship Strategies Computer Surveillance and Decision Support Microbiology Laboratory Comprehensive Multidisciplinary Antimicrobial Management Programs Monitoring of Process and Outcome Measurements 17
  • 18. Active Antimicrobial Stewardship Strategies 1. Prospective audit with intervention and feedback. • A medium-sized community hospital resulted in a 22% decrease in the use of parenteral broad-spectrum antimicrobials. • They also demonstrated a decrease in rates of C. difficile infection & nosocomial infection compared with the preintervention period. 18
  • 19. 2. Formulary restriction & preauthorization requirements for specific agents  Most hospitals have a pharmacy and therapeutics committee or an equivalent group  They evaluates drugs for inclusion on the hospital formulary on the basis of  therapeutic efficacy  toxicity  cost  They also limit redundant new agents with no significant additional benefit. 19
  • 20. Supplemental Antimicrobial Stewardship Strategies • Education. • Guidelines and clinical pathways. • Antimicrobial cycling • Antimicrobial order forms. • Combination therapy. • Streamlining or de-escalation of therapy. • Dose optimization. • Conversion from parenteral to oral therapy. 20
  • 21. Education • Considered to be most essential part of Stewardship Program: – Antibiotics – Resistance – PK-PD – Collateral damage ( unintended ) – Alignment of Ab to overcome anti-microbial resistance. • Target Customers: Microbiologist and Clinicians. 21
  • 22. Most frequently employed intervention • Educational efforts include passive activities  conference/ presentations  student and house staff teaching sessions  provision of written guidelines  e-mail alerts However, education alone, without incorporation of active intervention, is only marginally effective and has not demonstrated a sustained impact 22
  • 23. A good clinical practice saves antibiotics • Treatment should be limited to bacterial infections, using antibiotics directed against the causative agent, given in optimal dosage, interval and length of treatment, with steps taken to ensure maximum patient compliance with the treatment regimen and only when the benefit of treatment outweighs the individual and global risks 23
  • 24. Antimicrobial cycling and scheduled antimicrobial switch. “Antimicrobial cycling” refers to 24 the removal and substitution of a specific antimicrobial or antimicrobial class to prevent or reverse the development of antimicrobial resistance within an institution or specific unit.
  • 25. Choosing the drugs • Substituting one antimicrobial for another may transiently decrease selection pressure reduce resistance • But, reintroduction of the original antimicrobial is again however known to develop resistance • There are insufficient data to recommend the routine use over a prolonged period of time 25
  • 26. Antimicrobial order forms. • The use of automatic stop orders and the requirement of physician justification for continuation • Decrease antimicrobial consumption in longitudinal studies 26 Use of peri-operative prophylactic order forms with automatic discontinuation at 2 days resulted in a decrease in the mean duration of antimicrobial prophylaxis (from 4.9 to 2.4 days)
  • 27. Combination therapy • Has a role in certain clinical contexts • Including use for empirical therapy for critically ill patients at risk of infection with multidrug resistant pathogens • To increase the breadth of coverage and the likelihood of adequate initial therapy 27
  • 28. Limitations of Combination of Antibiotics • The role of combination antimicrobial therapy for the prevention of resistance is limited to those situations in which there is  A high organism load  A high frequency of mutational resistance during therapy. • Classic examples are tuberculosis or HIV infection. 28
  • 29. Streamlining or De-Escalation of Therapy –On the basis of culture and sensitivity reports we can more effectively target the causative pathogens, by elimination of redundant combination therapy –Resulting in decreased Ab exposure and substantial cost savings Dr.T.V.Rao MD 29
  • 30. CDC vision for inpatient care • Implementation of an antimicrobial stewardship program in a healthcare facility – regardless of inpatient setting – will help ensure that hospitalized patients receive the right antibiotic, at the right dose, at the right time, and for the right duration. As a result, there is reduced mortality, reduced risks of Clostridium difficile-associated diarrhea, shorter hospital stays, reduced overall antimicrobial resistance within the facility, and cost savings 30
  • 31. Dose Optimization Optimization of AB dosing based on • Individual patient characteristics • Causative organisms • Site of infections • PK-PD characteristics • Systemic Plan from a broad spectrum to specific narrow spectrum Ab, parenteral to oral Antibiotics.
  • 32. Conversion from parenteral to oral therapy Enhanced oral bioavailability among certain antimicrobials—such as fluoroquinolones, oxazolidinones, metronidazole, clindamycin, trimethoprim- sulfamethoxazole, fluconazole, and voriconazole Therefore, allows for conversion to oral therapy once a patient meets defined clinical criteria 32
  • 33. Computer Surveillance and Decision Support • Computer physician order entry (CPOE) as 1 of the most important “leaps” that organizations can take to substantially improve patient safety. • CPOE has the potential to incorporate clinical decision support and to facilitate quality monitoring 33
  • 34. Our clinical Judgment carries many solutions… These guidelines are not a substitute for clinical judgment, and clinical discretion is required in the application of guidelines to individual patients. 34
  • 35. Multifaceted strategies can address and decrease antibiotic resistance in hospitals • Antibiotic prescribing practices and decreasing antibiotic resistance can be addressed through multifaceted strategies including:  Use of ongoing education  Use of evidence-based hospital antibiotic guidelines and policies  Restrictive measures and consultations from infectious disease physicians, microbiologists and pharmacists 35
  • 36. Prudent prescribing to reduce antimicrobial resistance • Only use an antimicrobial when clearly indicated. • Select an appropriate agent using local antimicrobial prescribing policy. • Prescribe correct dose, frequency and duration. • Limit use of broad spectrum agents and de- escalate or stop treatment if appropriate (Hospital). 36
  • 37. Practice rationalism in antibiotic use- promote antibiotic stewardship • 1 Antibiotic overuse contributes to the growing problems of Clostridium difficile infection and antibiotic resistance in healthcare facilities. 2 Improving antibiotic use through stewardship interventions and programs improves patient outcomes, reduces antimicrobial resistance, and saves money. Interventions to improve antibiotic use can be implemented in any healthcare setting—from the smallest to the largest. 3 Improving antibiotic use is a medication-safety and patient-safety issue. 37
  • 38. Continuous Medical Education a Must .. • Training and educating health care professionals on the appropriate use of antibiotics must include appropriate selection, dosing, route, and duration of antibiotic therapy. To ensure that training and education is working, there should be extensive collaboration between the antibiotic stewardship and hospital infection prevention and control teams. Without benchmarks, it is difficult to track successes and weaknesses 38
  • 39. Good hand washing practices still reduces antibiotic resistance and spread Dr.T.V.Rao MD 39
  • 40. Implementation of WHONET CAN HELP TO MONITOR RESISTANCE • Legacy computer systems, quality improvement teams, and strategies for optimizing antibiotic use have the potential to stabilize resistance and reduce costs by encouraging heterogeneous prescribing patterns and use of local susceptibility patterns to inform empiric treatment. 40
  • 41. 41