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AMR
Antimicrobial Resistance
• Antimicrobials – medicines that inactivate or kill disease causing pathogens (bacteria, viruses,
fungi)
• Microbes develop resistance to antimicrobials over time – Antimicrobial Resistance (AMR)
• AMR occurs when previously susceptible microbes adapt and no longer respond to the
antimicrobial agent(s)
• Though a naturally occurring phenomena, catalyzed especially by:
• Poor infection control measures and poor sanitation
• Poor or complete lack of guidance of proper antimicrobial use (human & animal health)
• Broken down health systems (including supply chain)
• Increased global travel
*Of importance - antibiotic resistance (ABR) owing to health and economic burden resulting from
resistant gram negative bacteria in both healthcare and community settings
The Impact
Treatment Failure
• Increased mortality &
morbidity
• Increased treatment costs
• Limited therapeutic options
Global Economic Impact
• Reduced trade
• Reduced agricultural
productivity
• Lost manhours
New estimates have revealed that at least 1.27 million deaths per year are directly attributable to AMR,
requiring urgent action from policymakers and the health community to avoid further preventable deaths
These estimates are a warning
signal that AMR is already putting
extra pressure on frontline
healthcare workers by making
common infections harder to treat
and preventing them from saving
millions of lives
URGENT
New evidence shows that AMR is a
leading cause of death globally,
higher than HIV/AIDs or Malaria
We are not doing enough to
address AMR. Our current action
plans are not ambitious or fast
enough to control the threat
There are immediate actions
that can help countries around
the world protect their
health systems against the threat
of AMR
RELEVANT PREVENTABLE
REAL
Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis, The Lancet, Jan 2022
Conclusion
In the past 20 years, only two new antibiotic classes,
both active only against Gram-positive bacteria, have
received global regulatory approval by international
regulatory agencies. In the same time period, no new
antibiotics against Gram-negative bacteria have been
approved.
In addition, only two completely new drugs
for MDR-TB treatment (bedaquiline and delamanid)
have reached the market in over 70 years”.
Dr. Tedros Ghebreyesus, Director General WHO
Antimicrobial Stewardship – Definitions
• Antimicrobial Stewardship: coordinated efforts & activities that seek to measure and improve antimicrobials
use.
• Antimicrobial Stewardship Programs optimize the use of antimicrobials, improve patient outcomes, reduce
AMR and Health Care Associated Infections (HAIs) and save health care costs
• Rational Antimicrobials Use: the cost-effective use of antimicrobials which maximizes clinical therapeutic
effect while minimizing both drug-related toxicity & development of AMR (WHO Global Strategy)
• Ensures the providers selects the right antimicrobial, for the right indication/diagnosis, the right patient, at the
right time, with the right dose & route, causing the least harm (including financial harm) to the patient and
future patient
• Guiding tools – Essential Medicines List (EML); Standard Treatment Guidelines (STGs); Formulary;
Consumption indicators e.g Defined Daily Doses (DDD)/ Days of Therapy (DOT); Antibiograms; AMS
policies & guidelines
Importance of AMS
• AMS is one of three “pillars” of an integrated
approach to health systems strengthening in
addition to infection prevention and control (IPC)
and medicine & patient safety
• AMR Control – optimizes antimicrobial use when
applied in conjunction with antimicrobial use
surveillance, and the WHO essential medicines
list (EML) AWaRe classification (ACCESS,
WATCH,RESERVE)
• Promotes equitable and quality health care
towards the goal of achieving universal health
coverage (UHC).
Classification of Antibiotics: AWaRE
• Antibiotics were then categorized into three groups by
selection and use:
Access
Watch
Reserve
AWaRE
Classification of Antibiotics: AWaRE
• In 2017, WHO reviewed the use of antibiotics for specific
infections and identified empiric antibiotic choices for common
infections that could be used in a majority of countries.
• This review was based on:
• 21 priority infectious syndromes in adults and pediatrics;
• 5 specific bacterial infections in pediatrics;
• a review of antibiotics for specific sexually transmitted
infections.
Report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2017 (including the 20th WHO
Model List of Essential Medicines and the 6th WHO Model List of Essential Medicines for Children).
• WHO AWaRE Criteria
Selection Criteria
This group includes antibiotics
recommended as empiric, first or second
choice treatment options for common
infectious syndromes and are listed in the
EML/EMLc with the syndromes for which
they are recommended. They should be
widely available, at an affordable cost, in
appropriate formulations and of assured
quality. First choices are usually narrow
spectrum agents with positive benefit-to-risk
ratios, and low resistance potential, whereas
second choices are generally broader
spectrum antibiotics with higher resistance
potential, or less favorable benefit-to-risk
ratios
This group includes antibiotic classes that are
considered generally to have higher
resistance potential and that are still
recommended as first or second choice
treatments but for a limited number of
indications. These medicines should be
prioritized as key targets of local and
national stewardship programs and
monitoring. This group includes the highest
priority agents on the list of Critically
Important Antimicrobials (CIA) for Human
Medicine. Comprises 7 pharmacological
classes
This group includes antibiotics that should be
treated as ‘last-resort’ options, or tailored
to highly specific patients and settings, and
when other alternatives would be
inadequate or have already failed (e.g.,
serious life-threatening infections due to
multi-drug resistant bacteria). These
medicines could be protected and prioritized
as key targets of high-intensity national and
international stewardship programs
involving monitoring and utilization
reporting, to preserve their effectiveness. 8
antibiotics or antibiotic classes were
identified for this group.
The 2017 WHO EML AB chapter (6th June 2017). Presentation by Nicola Magrini, Secretary, WHO Expert Committee on the Selection
and Use of Essential Medicines, Essential Medicines Department, WHO, Geneva, October 2017.
Classification of Antibiotics: AWaRE
• The AWaRE categories define the levels of antimicrobial
stewardship and are linked to the WHO List of Priority
Pathogens.
• The goal of this method of classification is to improve access to
antibiotics, improve clinical outcomes, reduce potential for
development of resistance, and preserve last resort antibiotics.
• By 2023, 60% of antibiotics consumed should be from the Access
group.
Sharland M, Pulcini C , Harbarth S et al. Classifying antibiotics in the WHO Essential Medicines List for optimal use—be
AWaRe. Lancet Infect Dis. 2018; 18: 18-20. https://adoptaware.org/
https://aware.essentialmeds.org/groups
AWaRE Classification: Access
• Antibiotics in the Access group are those that have activity against
a wide range of commonly encountered susceptible pathogens
while also showing lower resistance potential than antibiotics in
the other groups.
• Included in this group are 1st and 2nd line choices for empiric
treatment of common or severe infectious syndromes.
• By designation as an Access antibiotic, these drugs are considered
antibiotic staples that should be universally available.
The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health
Organization; 2019. (WHO/EMP/IAU/2019.11).
Access Group Antibiotics Listed in WHO Essential Medicines
List 2019
The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health
Organization; 2019. (WHO/EMP/IAU/2019.11).
Antibiotic Class
Amikacin Aminoglycosides
Amoxicillin Penicillins
Amoxicillin/clavulanic Acid Beta lactam - beta lactamase inhibitor
Ampicillin Penicillins
Benzathine benzylpenicillin Penicillins
Benzylpenicillin Penicillins
Cefalexin First-generation cephalosporins
Cefazolin First-generation cephalosporins
Chloramphenicol Amphenicols
Clindamycin Lincosamides
Cloxacillin Penicillins
Doxycycline Tetracyclines
Gentamicin Aminoglycosides
Metronidazole (IV) Imidazoles
Metronidazole (oral) Imidazoles
Nitrofurantoin Nitrofurantoin
Phenoxymethylpenicillin Penicillins
Procaine benzylpenicillin Penicillins
Spectinomycin Aminocyclitols
Sulfamethoxazole/trimethoprim Trimethoprim - sulfonamide combinations
ACCESS
• This group includes antibiotics
recommended as empiric, first or
second choice treatment options for
common infectious syndromes and are
listed in the EML/EMLc with the
syndromes for which they are
recommended. They should be widely
available, at an affordable cost, in
appropriate formulations and of
assured quality. First choices are usually
narrow spectrum agents with positive
benefit-to-risk ratios, and low resistance
potential, whereas second choices are
generally broader spectrum antibiotics
with higher resistance potential, or less
favorable benefit-to-risk ratios
AWaRE Classification: Watch
• Antibiotics in the Watch category are indicated for limited
specific infections.
• There may be concerns for an increased potential for resistance
in this group.
• Many of the antibiotics in this group are also in the highest-
ranking group of the list of critically important antimicrobials for
human use and therefore should not be used prophylactically in
agriculture or food producing livestock.
(They are the only—or part of a limited number of—available
antimicrobials to treat serious bacterial infections in humans and are used
to treat infections caused by bacteria that may be transmitted to humans
from non-humans, or bacteria that may acquire resistance genes from
non-human sources.)
The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health Organization; 2019.
(WHO/EMP/IAU/2019.11).
WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR). Critically important antimicrobials for human medicine.
5th revision 2016. June 2017.
Watch Group Antibiotics Listed in WHO
Essential Medicines List 2019
The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health
Organization; 2019. (WHO/EMP/IAU/2019.11).
Antibiotic Class
Azithromycin Macrolides
Cefixime Third-generation cephalosporins
Cefotaxime Third-generation cephalosporins
Ceftazidime Third-generation cephalosporins
Ceftriaxone Third-generation cephalosporins
Cefuroxime Second-generation cephalosporins
Ciprofloxacin Fluoroquinolones
Clarithromycin Macrolides
Meropenem Carbapenems
Piperacillin/tazobactam Beta lactam - beta lactamase inhibitor (anti-pseudomonal)
Vancomycin (IV) Glycopeptides
Vancomycin (oral) Glycopeptides
WATCH
• This group includes antibiotic classes that
are considered generally to have higher
resistance potential and that are still
recommended as first or second choice
treatments but for a limited number of
indications. These medicines should be
prioritized as key targets of local and
national stewardship programs and
monitoring. This group includes the
highest priority agents on the list of
Critically Important Antimicrobials (CIA)
for Human Medicine. Comprises 7
pharmacological classes
AWaRE Classification: Reserve
• Reserve antibiotics are last resort options.
• Although these drugs should be accessible when needed,
their use should be limited to life-threatening infections such
as multi-drug resistant organisms, and when alternative
therapies have failed or are not an option.
• The antibiotics in this group should be the target of national
and international antimicrobial stewardship programs.
The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health Organization; 2019.
(WHO/EMP/IAU/2019.11).
Reserve Group Antibiotics Listed in WHO
Essential Medicines List 2019
The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health
Organization; 2019. (WHO/EMP/IAU/2019.11).
Antibiotic Class
Ceftazidime-avibactam Third-generation cephalosporins
Colistin Polymyxins
Fosfomycin (IV) Phosphonics
Linezolid Oxazolidinones
Meropenem-vaborbactam Carbapenems
Plazomicin Aminoglycosides
Polymyxin B Polymyxins
RESERVE
• This group includes antibiotics that
should be treated as ‘last-resort’
options, or tailored to highly specific
patients and settings, and when other
alternatives would be inadequate or
have already failed (e.g., serious life-
threatening infections due to multi-drug
resistant bacteria). These medicines
could be protected and prioritized as
key targets of high-intensity national
and international stewardship programs
involving monitoring and utilization
reporting, to preserve their
effectiveness. 8 antibiotics or antibiotic
classes were identified for this group.
Advantages of AWaRe Categorization
• Increased access, reduced costs—many antibiotics in the Access list
are the most affordable
• Better therapeutic results—the AWaRe categories specify which
antibiotics to use for specific syndromes, including when a laboratory
diagnosis is not available
• Public health gains—antibiotics, one of the biggest advancements in
modern medicine, will maintain their life- saving effectiveness by
increasing use of medicine in the Access list and reducing those of
Watch and Reserve
ACCESS WATCH RESERVE
Kenyan-EML 2019 listed AWaRE
• Medicines save lives and improve health
• Medicines are costly, they represent a largest expenditure after staff
salaries
• Funds are limited
• Large numbers of medicines are available in the market
• Impossible to keep up-to-date with all the medicines in the market
• It is important that pharmaceutical financing ensures access to essential
drugs for all segments of the population
Why Select?
Real situation on-ground
• Antimicrobials selection process in healthcare facilities influenced by:
• Funds allocated by administration towards medicines’ procurement
• Seasonal outbreaks (according to facility’s past experience)
• Antimicrobials prescribing & dispensing:
• Prescribers’ preference (severity/duration of illness; concerns of 2° infections)
• Patients’ preference (parents demands; self-prescribing)
• Medical representatives/marketing
Real situation on-ground contd.
• Antimicrobial Use:
• Mix of patients, prescribers & dispensers’- led factors aggravated in the face of
weak regulatory systems
• Patient-related factors include:
• Non-adherence to dosage regimens
• Misperceptions (injectables as silver bullets)
- Prescribers:
• Lack/poor access to updated information
• Lack of reliable diagnostics
• Fear of bad clinical outcomes
- Dispensers:
• Patient-driven demands
• Profit-driven/economic incentives
• Lack of knowledge/technical training
• Intra-abdominal Infections-Complicated, mild-to-moderate, community
acquired: 1-2 g/day IV in single daily dose or divided q12hr for 4-7 days, in
combination with metronidazole
• Acute Bacterial Otitis Media-50 mg/kg IM once,Persistent or treatment
failures: 50 mg/kg IV/IM for 3 days
• Pelvic Inflammatory Disease-250 mg IM as single dose with doxycycline,
with or without metronidazole for 14 days
• Prosthetic Joint Infection-2 g IV q24hr for 2-6 weeks; continue treatment
until clinical improvement observed and patient is afebrile for 48-72 hr
• Meningitis-2 g IV q12hr for 7-14 days
Ceftriaxone Indications
• Acute Uncomplicated Pyelonephritis
• Surgical Prophylaxis of surgical infection1 g IV 0.5-2 hours before
procedure
• uncomplicated urogenital, rectal, or pharyngeal gonorrhea, CDC recommends a single 500 mg IM dose of
ceftriaxone). For persons weighing ≥150 kg (300 lbs), a single 1 g IM dose of ceftriaxone should be
administered. If chlamydial infection has not been excluded, doxycycline 100 mg orally twice a day for 7 days
is recommended. When ceftriaxone cannot be used for treating urogenital or rectal gonorrhea because of
cephalosporin allergy, a single 240 mg IM dose of gentamicin plus a single 2 g oral dose of azithromycin is an
option.
• Septic/toxic Shock (Off-label)-2 g IV once daily; with clindamycin for toxic
shock
Acute Epididymitis
Sexually transmitted chlamydia and gonorrhea
•Ceftriaxone 250 mg IM X 1 dose PLUS
•Doxycycline 100 mg PO BID for 10 days
Sexually transmitted chlamydia, gonorrhea, and enteric organisms
•Men who practice insertive anal sex
•Ceftriaxone 250 mg IM X 1 dose PLUS
•Levofloxacin 500 mg PO qDay for 10 days OR
•Ofloxacin 300 mg PO BID for 10 days
Enteric organisms
•Levofloxacin 500 mg PO qDay for 10 days OR
•Ofloxacin 300 mg PO BID for 10 days
• Severe Acute Bacterial Rhinosinusitis (Off-label)-Infection requiring
hospitalization: 1-2 g IV q12-24hr for 5-7 days
• Other Gonococcal Infections (Off-label)
Gonococcal endocarditis: 1-2 g IV q12hr for 4 weeks
Gonococcal meningitis: 1-2 g IV q12hr for 10-14 days
Good Antimicrobial Prescribing Principles
1. Prescribe antibiotics only with clear clinical justification
2. Document decision-making in antimicrobial prescribing
3. Intervene surgically when required to control infection
4. Collect specimens for culture prior to starting therapy
5. Prescribe antimicrobials according to local/Standard
treatment guidelines guidelines
6. Prescribe antimicrobials at the correct dose
7. Choose narrow spectrum agents
8. Consider broad spectrum therapy in certain
circumstances
9. De-escalate broad spectrum therapy promptly
10.Prescribe WATCH and RESERVE antimicrobials only
with authorisation from microbiology
11.Limit surgical prophylaxis to 24 hours
12.Prescribe oral rather than IV antimicrobials
13.Consider IV therapy under justified circumstances
14.Switch IV to oral therapy promptly
15.Review antimicrobial therapy regularly and stop when
infection has resolved (or as per treatment guidelines)
16.In complicated or unresolving cases, seek expert
advise
Good Antimicrobial Principles Contd.
Microbiology therapy guides wherever possible
Indications should be evidence-based
Narrowest spectrum required
Dosage appropriate to the site & type of infection
Minimize duration of therapy
Ensure monotherapy in most cases
Source: Melbourne Therapeutic Guidelines 2010

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  • 2.
  • 3. • Antimicrobials – medicines that inactivate or kill disease causing pathogens (bacteria, viruses, fungi) • Microbes develop resistance to antimicrobials over time – Antimicrobial Resistance (AMR) • AMR occurs when previously susceptible microbes adapt and no longer respond to the antimicrobial agent(s) • Though a naturally occurring phenomena, catalyzed especially by: • Poor infection control measures and poor sanitation • Poor or complete lack of guidance of proper antimicrobial use (human & animal health) • Broken down health systems (including supply chain) • Increased global travel *Of importance - antibiotic resistance (ABR) owing to health and economic burden resulting from resistant gram negative bacteria in both healthcare and community settings
  • 4. The Impact Treatment Failure • Increased mortality & morbidity • Increased treatment costs • Limited therapeutic options Global Economic Impact • Reduced trade • Reduced agricultural productivity • Lost manhours
  • 5. New estimates have revealed that at least 1.27 million deaths per year are directly attributable to AMR, requiring urgent action from policymakers and the health community to avoid further preventable deaths These estimates are a warning signal that AMR is already putting extra pressure on frontline healthcare workers by making common infections harder to treat and preventing them from saving millions of lives URGENT New evidence shows that AMR is a leading cause of death globally, higher than HIV/AIDs or Malaria We are not doing enough to address AMR. Our current action plans are not ambitious or fast enough to control the threat There are immediate actions that can help countries around the world protect their health systems against the threat of AMR RELEVANT PREVENTABLE REAL Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis, The Lancet, Jan 2022 Conclusion
  • 6.
  • 7. In the past 20 years, only two new antibiotic classes, both active only against Gram-positive bacteria, have received global regulatory approval by international regulatory agencies. In the same time period, no new antibiotics against Gram-negative bacteria have been approved. In addition, only two completely new drugs for MDR-TB treatment (bedaquiline and delamanid) have reached the market in over 70 years”. Dr. Tedros Ghebreyesus, Director General WHO
  • 8. Antimicrobial Stewardship – Definitions • Antimicrobial Stewardship: coordinated efforts & activities that seek to measure and improve antimicrobials use. • Antimicrobial Stewardship Programs optimize the use of antimicrobials, improve patient outcomes, reduce AMR and Health Care Associated Infections (HAIs) and save health care costs • Rational Antimicrobials Use: the cost-effective use of antimicrobials which maximizes clinical therapeutic effect while minimizing both drug-related toxicity & development of AMR (WHO Global Strategy) • Ensures the providers selects the right antimicrobial, for the right indication/diagnosis, the right patient, at the right time, with the right dose & route, causing the least harm (including financial harm) to the patient and future patient • Guiding tools – Essential Medicines List (EML); Standard Treatment Guidelines (STGs); Formulary; Consumption indicators e.g Defined Daily Doses (DDD)/ Days of Therapy (DOT); Antibiograms; AMS policies & guidelines
  • 9. Importance of AMS • AMS is one of three “pillars” of an integrated approach to health systems strengthening in addition to infection prevention and control (IPC) and medicine & patient safety • AMR Control – optimizes antimicrobial use when applied in conjunction with antimicrobial use surveillance, and the WHO essential medicines list (EML) AWaRe classification (ACCESS, WATCH,RESERVE) • Promotes equitable and quality health care towards the goal of achieving universal health coverage (UHC).
  • 10. Classification of Antibiotics: AWaRE • Antibiotics were then categorized into three groups by selection and use: Access Watch Reserve AWaRE
  • 11. Classification of Antibiotics: AWaRE • In 2017, WHO reviewed the use of antibiotics for specific infections and identified empiric antibiotic choices for common infections that could be used in a majority of countries. • This review was based on: • 21 priority infectious syndromes in adults and pediatrics; • 5 specific bacterial infections in pediatrics; • a review of antibiotics for specific sexually transmitted infections. Report of the WHO Expert Committee on Selection and Use of Essential Medicines, 2017 (including the 20th WHO Model List of Essential Medicines and the 6th WHO Model List of Essential Medicines for Children).
  • 12. • WHO AWaRE Criteria Selection Criteria This group includes antibiotics recommended as empiric, first or second choice treatment options for common infectious syndromes and are listed in the EML/EMLc with the syndromes for which they are recommended. They should be widely available, at an affordable cost, in appropriate formulations and of assured quality. First choices are usually narrow spectrum agents with positive benefit-to-risk ratios, and low resistance potential, whereas second choices are generally broader spectrum antibiotics with higher resistance potential, or less favorable benefit-to-risk ratios This group includes antibiotic classes that are considered generally to have higher resistance potential and that are still recommended as first or second choice treatments but for a limited number of indications. These medicines should be prioritized as key targets of local and national stewardship programs and monitoring. This group includes the highest priority agents on the list of Critically Important Antimicrobials (CIA) for Human Medicine. Comprises 7 pharmacological classes This group includes antibiotics that should be treated as ‘last-resort’ options, or tailored to highly specific patients and settings, and when other alternatives would be inadequate or have already failed (e.g., serious life-threatening infections due to multi-drug resistant bacteria). These medicines could be protected and prioritized as key targets of high-intensity national and international stewardship programs involving monitoring and utilization reporting, to preserve their effectiveness. 8 antibiotics or antibiotic classes were identified for this group.
  • 13. The 2017 WHO EML AB chapter (6th June 2017). Presentation by Nicola Magrini, Secretary, WHO Expert Committee on the Selection and Use of Essential Medicines, Essential Medicines Department, WHO, Geneva, October 2017.
  • 14. Classification of Antibiotics: AWaRE • The AWaRE categories define the levels of antimicrobial stewardship and are linked to the WHO List of Priority Pathogens. • The goal of this method of classification is to improve access to antibiotics, improve clinical outcomes, reduce potential for development of resistance, and preserve last resort antibiotics. • By 2023, 60% of antibiotics consumed should be from the Access group. Sharland M, Pulcini C , Harbarth S et al. Classifying antibiotics in the WHO Essential Medicines List for optimal use—be AWaRe. Lancet Infect Dis. 2018; 18: 18-20. https://adoptaware.org/
  • 16. AWaRE Classification: Access • Antibiotics in the Access group are those that have activity against a wide range of commonly encountered susceptible pathogens while also showing lower resistance potential than antibiotics in the other groups. • Included in this group are 1st and 2nd line choices for empiric treatment of common or severe infectious syndromes. • By designation as an Access antibiotic, these drugs are considered antibiotic staples that should be universally available. The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health Organization; 2019. (WHO/EMP/IAU/2019.11).
  • 17. Access Group Antibiotics Listed in WHO Essential Medicines List 2019 The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health Organization; 2019. (WHO/EMP/IAU/2019.11). Antibiotic Class Amikacin Aminoglycosides Amoxicillin Penicillins Amoxicillin/clavulanic Acid Beta lactam - beta lactamase inhibitor Ampicillin Penicillins Benzathine benzylpenicillin Penicillins Benzylpenicillin Penicillins Cefalexin First-generation cephalosporins Cefazolin First-generation cephalosporins Chloramphenicol Amphenicols Clindamycin Lincosamides Cloxacillin Penicillins Doxycycline Tetracyclines Gentamicin Aminoglycosides Metronidazole (IV) Imidazoles Metronidazole (oral) Imidazoles Nitrofurantoin Nitrofurantoin Phenoxymethylpenicillin Penicillins Procaine benzylpenicillin Penicillins Spectinomycin Aminocyclitols Sulfamethoxazole/trimethoprim Trimethoprim - sulfonamide combinations
  • 18. ACCESS • This group includes antibiotics recommended as empiric, first or second choice treatment options for common infectious syndromes and are listed in the EML/EMLc with the syndromes for which they are recommended. They should be widely available, at an affordable cost, in appropriate formulations and of assured quality. First choices are usually narrow spectrum agents with positive benefit-to-risk ratios, and low resistance potential, whereas second choices are generally broader spectrum antibiotics with higher resistance potential, or less favorable benefit-to-risk ratios
  • 19. AWaRE Classification: Watch • Antibiotics in the Watch category are indicated for limited specific infections. • There may be concerns for an increased potential for resistance in this group. • Many of the antibiotics in this group are also in the highest- ranking group of the list of critically important antimicrobials for human use and therefore should not be used prophylactically in agriculture or food producing livestock. (They are the only—or part of a limited number of—available antimicrobials to treat serious bacterial infections in humans and are used to treat infections caused by bacteria that may be transmitted to humans from non-humans, or bacteria that may acquire resistance genes from non-human sources.) The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health Organization; 2019. (WHO/EMP/IAU/2019.11). WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR). Critically important antimicrobials for human medicine. 5th revision 2016. June 2017.
  • 20. Watch Group Antibiotics Listed in WHO Essential Medicines List 2019 The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health Organization; 2019. (WHO/EMP/IAU/2019.11). Antibiotic Class Azithromycin Macrolides Cefixime Third-generation cephalosporins Cefotaxime Third-generation cephalosporins Ceftazidime Third-generation cephalosporins Ceftriaxone Third-generation cephalosporins Cefuroxime Second-generation cephalosporins Ciprofloxacin Fluoroquinolones Clarithromycin Macrolides Meropenem Carbapenems Piperacillin/tazobactam Beta lactam - beta lactamase inhibitor (anti-pseudomonal) Vancomycin (IV) Glycopeptides Vancomycin (oral) Glycopeptides
  • 21. WATCH • This group includes antibiotic classes that are considered generally to have higher resistance potential and that are still recommended as first or second choice treatments but for a limited number of indications. These medicines should be prioritized as key targets of local and national stewardship programs and monitoring. This group includes the highest priority agents on the list of Critically Important Antimicrobials (CIA) for Human Medicine. Comprises 7 pharmacological classes
  • 22. AWaRE Classification: Reserve • Reserve antibiotics are last resort options. • Although these drugs should be accessible when needed, their use should be limited to life-threatening infections such as multi-drug resistant organisms, and when alternative therapies have failed or are not an option. • The antibiotics in this group should be the target of national and international antimicrobial stewardship programs. The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health Organization; 2019. (WHO/EMP/IAU/2019.11).
  • 23. Reserve Group Antibiotics Listed in WHO Essential Medicines List 2019 The 2019 WHO AWaRe classification of antibiotics for evaluation and monitoring of use. Geneva: World Health Organization; 2019. (WHO/EMP/IAU/2019.11). Antibiotic Class Ceftazidime-avibactam Third-generation cephalosporins Colistin Polymyxins Fosfomycin (IV) Phosphonics Linezolid Oxazolidinones Meropenem-vaborbactam Carbapenems Plazomicin Aminoglycosides Polymyxin B Polymyxins
  • 24. RESERVE • This group includes antibiotics that should be treated as ‘last-resort’ options, or tailored to highly specific patients and settings, and when other alternatives would be inadequate or have already failed (e.g., serious life- threatening infections due to multi-drug resistant bacteria). These medicines could be protected and prioritized as key targets of high-intensity national and international stewardship programs involving monitoring and utilization reporting, to preserve their effectiveness. 8 antibiotics or antibiotic classes were identified for this group.
  • 25. Advantages of AWaRe Categorization • Increased access, reduced costs—many antibiotics in the Access list are the most affordable • Better therapeutic results—the AWaRe categories specify which antibiotics to use for specific syndromes, including when a laboratory diagnosis is not available • Public health gains—antibiotics, one of the biggest advancements in modern medicine, will maintain their life- saving effectiveness by increasing use of medicine in the Access list and reducing those of Watch and Reserve
  • 26.
  • 27. ACCESS WATCH RESERVE Kenyan-EML 2019 listed AWaRE
  • 28. • Medicines save lives and improve health • Medicines are costly, they represent a largest expenditure after staff salaries • Funds are limited • Large numbers of medicines are available in the market • Impossible to keep up-to-date with all the medicines in the market • It is important that pharmaceutical financing ensures access to essential drugs for all segments of the population Why Select?
  • 29. Real situation on-ground • Antimicrobials selection process in healthcare facilities influenced by: • Funds allocated by administration towards medicines’ procurement • Seasonal outbreaks (according to facility’s past experience) • Antimicrobials prescribing & dispensing: • Prescribers’ preference (severity/duration of illness; concerns of 2° infections) • Patients’ preference (parents demands; self-prescribing) • Medical representatives/marketing
  • 30. Real situation on-ground contd. • Antimicrobial Use: • Mix of patients, prescribers & dispensers’- led factors aggravated in the face of weak regulatory systems • Patient-related factors include: • Non-adherence to dosage regimens • Misperceptions (injectables as silver bullets) - Prescribers: • Lack/poor access to updated information • Lack of reliable diagnostics • Fear of bad clinical outcomes - Dispensers: • Patient-driven demands • Profit-driven/economic incentives • Lack of knowledge/technical training
  • 31. • Intra-abdominal Infections-Complicated, mild-to-moderate, community acquired: 1-2 g/day IV in single daily dose or divided q12hr for 4-7 days, in combination with metronidazole • Acute Bacterial Otitis Media-50 mg/kg IM once,Persistent or treatment failures: 50 mg/kg IV/IM for 3 days • Pelvic Inflammatory Disease-250 mg IM as single dose with doxycycline, with or without metronidazole for 14 days • Prosthetic Joint Infection-2 g IV q24hr for 2-6 weeks; continue treatment until clinical improvement observed and patient is afebrile for 48-72 hr • Meningitis-2 g IV q12hr for 7-14 days Ceftriaxone Indications
  • 32. • Acute Uncomplicated Pyelonephritis • Surgical Prophylaxis of surgical infection1 g IV 0.5-2 hours before procedure • uncomplicated urogenital, rectal, or pharyngeal gonorrhea, CDC recommends a single 500 mg IM dose of ceftriaxone). For persons weighing ≥150 kg (300 lbs), a single 1 g IM dose of ceftriaxone should be administered. If chlamydial infection has not been excluded, doxycycline 100 mg orally twice a day for 7 days is recommended. When ceftriaxone cannot be used for treating urogenital or rectal gonorrhea because of cephalosporin allergy, a single 240 mg IM dose of gentamicin plus a single 2 g oral dose of azithromycin is an option. • Septic/toxic Shock (Off-label)-2 g IV once daily; with clindamycin for toxic shock
  • 33. Acute Epididymitis Sexually transmitted chlamydia and gonorrhea •Ceftriaxone 250 mg IM X 1 dose PLUS •Doxycycline 100 mg PO BID for 10 days Sexually transmitted chlamydia, gonorrhea, and enteric organisms •Men who practice insertive anal sex •Ceftriaxone 250 mg IM X 1 dose PLUS •Levofloxacin 500 mg PO qDay for 10 days OR •Ofloxacin 300 mg PO BID for 10 days Enteric organisms •Levofloxacin 500 mg PO qDay for 10 days OR •Ofloxacin 300 mg PO BID for 10 days
  • 34. • Severe Acute Bacterial Rhinosinusitis (Off-label)-Infection requiring hospitalization: 1-2 g IV q12-24hr for 5-7 days • Other Gonococcal Infections (Off-label) Gonococcal endocarditis: 1-2 g IV q12hr for 4 weeks Gonococcal meningitis: 1-2 g IV q12hr for 10-14 days
  • 35. Good Antimicrobial Prescribing Principles 1. Prescribe antibiotics only with clear clinical justification 2. Document decision-making in antimicrobial prescribing 3. Intervene surgically when required to control infection 4. Collect specimens for culture prior to starting therapy 5. Prescribe antimicrobials according to local/Standard treatment guidelines guidelines 6. Prescribe antimicrobials at the correct dose 7. Choose narrow spectrum agents 8. Consider broad spectrum therapy in certain circumstances 9. De-escalate broad spectrum therapy promptly 10.Prescribe WATCH and RESERVE antimicrobials only with authorisation from microbiology 11.Limit surgical prophylaxis to 24 hours 12.Prescribe oral rather than IV antimicrobials 13.Consider IV therapy under justified circumstances 14.Switch IV to oral therapy promptly 15.Review antimicrobial therapy regularly and stop when infection has resolved (or as per treatment guidelines) 16.In complicated or unresolving cases, seek expert advise
  • 36. Good Antimicrobial Principles Contd. Microbiology therapy guides wherever possible Indications should be evidence-based Narrowest spectrum required Dosage appropriate to the site & type of infection Minimize duration of therapy Ensure monotherapy in most cases Source: Melbourne Therapeutic Guidelines 2010