Lecture by Dr. Mediadora Saniel during the 22nd PHICS Annual Convention

1. The National Antibiotic Guidelines:
Shepherding Clinicians towards
Rational Use of Antibiotics
Mediadora C. Saniel, MD, MBA-H
PHICS 22nd Annual Convention
Crowne Plaza
May 26, 2016

3. Content Areas
• Why do we need antibiotic guidelines?
• National antibiotic guidelines overview
• How will guidelines help antimicrobial
stewardship?
• Implementation

4. Antibiotics are Societal Drugs!

7. AMR as a Global Public Health threat
7
• AMR kills
• AMR hampers the control of infectious diseases
• AMR increases the costs of health care
• AMR jeopardizes health care gains to society
• AMR has the potential to threaten health security,
and damage trade and economy
WHO fact sheet, 2011

8. The Antibiotic Resistance
Surveillance Program (ARSP)
• Very alarming rates of
resistance among various
pathogens
▫ Escherichia coli
▫ Klebsiella spp.
▫ Pseudomonas aeruginosa
▫ Acinetobacter spp.
▫ Streptococcus pneumoniae
▫ Staphylococcus aureus
▫ Neisseria gonorrheae

9. WHO Six-Point Policy Package
to Combat AMR
Policy Areas
(1) Committing to develop a master plan to
combat antimicrobial resistance
(2) Strengthening surveillance and
laboratory capacity
(3) Ensuring uninterrupted access to
essential medicines of assured quality
(4) Promoting rational use of medicines in
patient care and animal husbandry
(5) Enhancing infection prevention and
control
(6) Fostering innovations and research to
develop new tools and drugs
During the 62nd WHO regional Committee
Meeting in October 2011, the Philippines
committed to implementing the six-point
policy agenda to combat AMR

10. WHO GLOBAL ACTION PLAN ON
ANTIMICROBIAL RESISTANCE 2015
Goal
The overall goal is to ensure, for as long as
possible, continuity of the ability to treat and
prevent infectious diseases with effective and
safe medicines that are quality-assured, used
in a responsible way, and accessible to all
who need them.
10

11. WHO GLOBAL ACTION PLAN ON
ANTIMICROBIAL RESISTANCE 2015
Objectives
• Improve awareness and understanding of
antimicrobial resistance through effective
communication, education and training
• Strengthen the knowledge and evidence base
through surveillance and research
• Reduce the incidence of infection through effective
sanitation, hygiene and infection prevention
measures
11

12. WHO GLOBAL ACTION PLAN ON
ANTIMICROBIAL RESISTANCE 2015
Objectives
• Optimize the use of antimicrobial medicines in
human and animal health
• Develop the economic case for sustainable
investment that takes account of the needs of all
countries, and increase investment in new
medicines, diagnostic tools, vaccines and other
interventions
12

14. Administrative Order
no. 42 s. 2014
Creating an Inter-Agency Committee for the
Formulation and Implementation of the National
Plan to Combat Antimicrobial Resistance in the
Philippines

15. Administrative Order
no. 42 s. 2014
Creating an Inter-Agency Committee for the Formulation and
Implementation of the National Plan to Combat Antimicrobial
Resistance in the Philippines
• IC AMR
Co-Chairs: Department of Health
Department of Agriculture
Members: Department of Science and Technology
Department of Interior and Local Government
Department of Trade and Industry

16. Philippine Action Plan to Combat AMR:
One Health Approach
• 3-year comprehensive plan
• Emphasis on “One Health Strategy”
▫ The causation of AMR is inter-related and inter-
sectoral thereby requiring collaborative
multidisciplinary work at local, national, and global
levels to attain optimal health for humans, animals
and the environment

17. Philippine Action Plan to Combat AMR:
One Health Approach
• Vision
▫ A nation protected against the threats of
antimicrobial resistance
• Mission
▫ To implement an integrated, comprehensive and
sustainable national program to combat AMR geared
towards safeguarding human and animal health
while preventing interference in the agricultural,
food, trade, communication and environmental
sectors

18. Commit to a
comprehensive,
financed national
plan with
accountability and
civic society
engagement
Philippine Action Plan to Combat AMR:
One Health Approach
1
Strengthen
surveillance and
laboratory capacity
Regulate and
promote rational
use of medicines in
the human and
animal health
sectors and ensure
proper patient care
Ensure uninterrupted
access to essential
medicines of assured
quality
3
Enhance infection prevention
and control across all settings
5
Foster innovations and
research and development
6
Development of a Risk
Communication Plan to
combat AMR
7
2
4

19. Antimicrobial Prescribing Facts: The 30% Rule
• ~ 30% of all hospitalized inpatients 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 pharmacy costs can be saved by antimicrobial
stewardship programs
[Hoffman et al., 2007; Wise et al., 1999; John et al., 1997]

20. National AMS Program
aimed at ensuring rational
prescribing, dispensing
and use of antimicrobials in
the country
NATIONAL
ANTIBIOTIC
GUIDELINES
GOOD
PHARMACY
PRACTICE
AMS IN
HOSPITALS
PUBLIC /
CONSUMER
ADVOCACY
20

21. Antimicrobial Stewardship (AMS)
Coordinated approach to ensure the appropriate use of
antimicrobials by promoting the selection of the optimal
antimicrobial drug regimen:
21
RIGHT
Choice of antibiotic
Route of administration
Dose
Time
Duration
Minimize harm to
the patient and
future patients

22. Establishing AMS
22
Ohl CA, Dodds Ashley ES. Antimicrobial Stewardship Programs in Community Hospitals: The Evidence Base and Case Studies. Clinical Infectious Diseases. 2011;53(suppl 1):S23-S8.
To improve
patient
outcomes
To prevent or
slow the
emergence of
AMR
To reduce ADEs,
including
secondary
infections
To reduce health
care–related
costs

23. The fundamental challenge
Reducing unnecessary use of
antimicrobial therapy and
broad spectrum drugs (which
contribute to the development
of antimicrobial resistance)
Providing timely and
appropriate empirical broad
spectrum antimicrobial
therapy for individual patients
(consistently shown to
improve outcomes)
23

24. Establishing AMS programmes
PATIENT
Microbiology
Clinical
Pharmacist
Antibiogram
Nursing
Leadership
Education
Physicians
Timely and appropriate antibiotic
management
Infection
Control
Hospital
Leadership

25. CORE STRATEGIES of the
AMS Program in Hospitals
• Clinical Practice Guidelines/ Antibiotic
Guidelines
• Surveillance of antimicrobial resistance and
utilization
• Audit and Feedback
• Formulary Restriction and Pre-authorization
• Antimicrobial Order Tools
• Educational Programs
25

26. Creation of the National Antibiotic Guidelines
Committee (NAGCOM)
• Department Personnel Order No. 2014-4245
on September 25, 2014
• Rationale:
– Irrational use/misuse of antibiotics is a major
driver of AMR
– Development of National Antibiotic Guidelines is
an important tool to help promote rational
antibiotic use

27. Functions of NAGCOM
1. Develop the National Antibiotic Guidelines
for Primary Care and for Hospitals
2. Provide training/lectures to help
disseminate the guidelines

28. NAGCOM Composition
Chair: Dr. Mediadora C. Saniel
Members:
Dr. M. Delos Reyes - Philippine Society for Microbiology and Infectious Diseases
Dr. B. Galvez - Philippine Hospital Infection Control Society
Dr. C. Delos Reyes - Pediatric Infectious Disease Society of the Philippines
Dr. O. Limuaco - Philippine Pharmacists Association
Dr. C. Lazarte - Formulary Executive Council
Dr. C. Carlos - Research Institute for Tropical Medicine
Dr. R. Vianzon - National Center for Disease Prevention and Control
Dr. M. Lansang - UP College of Medicine
Dr. V. Roque - National Epidemiology Center
Dr. C. Fabregas - National Center for Health Facilities and Development
Supported by: Policy, Planning, Program Development and Research Division of the
National Center for Pharmaceutical Access and Management as its Secretariat

29. Representatives from other agencies, academia and
professional medical societies as resource persons
• Philippine Dental Association
• Philippine Dermatological Society
• Philippine Academy of Pediatric Pulmonologists
• Philippine College of Chest Physicians
• Philippine College of Physicians
• Philippine College of Surgeons
• Philippine Pediatric Society
• Philippine Obstetrical and Gynecological Society
• Philippine Society of Otolaryngology Head and Neck Surgery
• Philippine Academy of Ophthalmology
• Philippine Academy of Family Physicians
• Philippine Neurological Association
• Philippine Society of Nephrology

30. Process of Guidelines Formulation
Do Not Re-Invent the Wheel
• Inventory of Existing Guidelines
• Consolidation & Synthesis of Treatment Recommendations
• New Guidelines
– Systematic review by assigned subgroups
Grading of
Recommendations
Assessment,
Development and
Evaluation
• Quality of evidence, balance between benefits and harms,
applicability, cost considerations, patient preferences
• ARSP
• Phil National Formulary

31. Process of Guidelines Formulation
• Decision-Making
– By Consensus
– Majority Rule
• Consultation with Professional Societies and
other Stakeholders

32. Scope of Guidelines
• Treatment (and Prophylaxis)
• Specific Conditions by Organ System
– Priority Diseases
– Public Health Impact
• Adult and Pediatric
• Primary -> Tertiary Levels of Care

33. Treatment
• Urinary tract infections
• Upper respiratory tract infections
• Lower respiratory tract infections
• Soft tissue infections
• Central nervous system infections
• Gastrointestinal infections
• Genital tract infections
• Bloodstream infections
• Sepsis
• Cardiovascular infections
• Tuberculosis and other public health problems

36. LOW-RISK CAP:
• Stable vital signs (RR <30/min; PR <125/min; SBP >90 mmHg; DBP >60 mmHg; Temp >36o
C or <40o
C
• No altered mental state of acute onset
• No suspected aspiration
• No or stable co-morbid conditions
• Chest X ray: localized infiltrates; no evidence of pleural effusion
Etiology Preferred regimen Comments
Potential pathogens
• Streptococcus
pneumoniae
• Haemophilus
influenzae
• Chlamydophila
pneumoniae
• Moraxella catarrhalis
• Enteric Gram (-)
bacilli (among those
with co-morbid
illness)
Without co-morbid illness:
Amoxicillin 1 g tid
OR
Azithromycin dihydrate 500 mg od
OR
Clarithromycin 500 mg bid
With stable co-morbid illness:
Co-amoxiclav 1 g bid
OR
Cefuroxime axetil 500 mg bid
+/-
Azithromycin 500 mg od
OR
Clarithromycin 500 mg bid
Duration of Treatment:
• For S. pneumoniae: 5-7d or 3-5d if using
azithromycin
• For Mycoplasma and Chlamydophila: 10-14d
• Legionella: 14-21d; or 10d if azithromycin is used
Use of amoxicillin as first-line drug for
ipatients with no co-morbid illness is based
on the 2014 ARSP data.
Resistance of Streptococcus pneumoniae
to erythromycin is low (4.3%) as of 2014
(ARSP date). If allergic to beta lactam, use
extended spectrum macrolides
Fluoroquinolones are not recommended as
first line treatment . It is recommended that
they be reserved as potential second-line
agents for the treatment of pulmonary
tuberculosis, particularly for multi-drug
resistant tuberculosis.
Community-Acquired Pneumonia (CAP) in Adults

37. CAVEAT
• The guidelines are not intended to supersede a HC
provider’s sound clinical judgment.
• These should take into account:
– local microbiology, antimicrobial susceptibility
patterns, potential risk or unintended
consequences
– variations in clinical presentation, patient
preferences, and availability of resources

38. Antimicrobial Stewardship 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*
Antibiotic guidelines and clinical pathways*
Antimicrobial order forms
Education
Computerized decision support,
surveillance
Laboratory surveillance and feedback
Combination therapies
Antimicrobial cycling
Adapted from Dellit et al. Clinical Infectious Diseases 2007; 44:159-77
* Strategies with strongest evidence and support by IDSA.

39. Core strategies: Behaviour change
• Educate / Persuade
– changing knowledge and attitudes about
antimicrobial use
– providing access to locally appropriate antibiotic
guidelines
• Audit / Feedback
– active educational measures, e.g. audit and
feedback to support implementation of
guidelines
Duguid M and Cruickshank M (eds) (2010). Antimicrobial stewardship in Australian
hospitals, Australian Commission on Safety and Quality in Health Care, Sydney

40. Core strategies: Restrict/Direct
• Restrict / Direct
– Pre-prescription strategies
• restrict availability of selected antimicrobial agents
unless criteria are met and formal approval granted
– Post-prescription strategies
• review antimicrobial prescriptions and provide expert
advice with a focus on broad-spectrum empirical
therapy to promote streamlining or discontinuing
therapy, as indicated, on the basis of investigation
results and clinical response.
Duguid M and Cruickshank M (eds) (2010). Antimicrobial stewardship in Australian
hospitals, Australian Commission on Safety and Quality in Health Care, Sydney

41. AMS program measures for quality improvement
Structural indicators
•Availability of multi-disciplinary antimicrobial stewardship team
•Availability of antibiotic guidelines
•Provision of education in the last 2 years
Process measures
•Amount of antibiotic in DDD/100 bed days
– Promoted antibiotics
– Restricted antibiotics
•Compliance with acute empiric guidance (documented notes and policy compliance)
•% appropriate de-escalation; % appropriate switch from IV to oral
•Compliance with surgical prophylaxis (<60 min from incision, <24 hours and compliance with local policy
•Compliance with care “bundles” – all or nothing (3-day antibiotic review bundle, ventilator-associated
pneumonia, community-acquired pneumonia, sepsis)
Outcome measures
•C. difficile rates
•Surgical Site Infection (SSI) rates
•Surveillance of resistance
•Mortality: Standardized Mortality Rates (SMRs)
Adapted from Dumartin et al. J. Antimicrob. Chemother. 2011;66:1631-7; Morris et al. Inf. Control. Hosp. Epidemiol.
2012;33[3]:500-506

42. JAMA, October 20, 1999—Vol 282, No. 15

43. Barriers to Physician Adherence to Practice Guidelines
in Relation to Behavior Change
JAMA, October 20, 1999—Vol 282, No. 15

44. I PLEDGE TO USE
ANTIMICROBIALS RESPONSIBLY
As a health worker, I can make a difference by committing to
actively promote antimicrobial stewardship.
I, -------------, pledge to:
1. Judiciously use and prescribe appropriate antimicrobials
only when necessary based on the best current available
evidence.
2. Strive to educate my patients, family, friends and the
community to take antibiotics with strict adherence to the
prescribed regimen , avoiding self-medication and
prescription sharing.

45. 3. Practice infection control and other preventive
measures to limit the spread of infection in the
hospitals and the community.
4. Promote research that will help improve rational
antimicrobial use and combat antimicrobial
resistance.
I AM A RESPONSIBLE HEALTH WORKER AND I WILL WIN
THE WAR AGAINST ANTIMICROBIAL RESISTANCE!
Adapted from DOH’s WIN the WAR AGAINST AMR