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

Content Areas

• Why do we need antibiotic guidelines?

• National antibiotic guidelines overview

• How will guidelines help antimicrobial stewardship?

• Implementation

Antibiotics are Societal Drugs!

AMR as a Global Public Health threat

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• 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

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

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

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.

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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

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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

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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

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

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

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

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

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]

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

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Antimicrobial Stewardship (AMS)

Coordinated approach to ensure the appropriate use of

antimicrobials by promoting the selection of the optimal

antimicrobial drug regimen:

21

RIG

HT

Choice of antibiotic

Route of administration

Dose

Time

Duration

Minimize harm to

the patient and

future patients

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

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)

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Establishing AMS programmes

PATIENT

Microbiology

Clinical Pharmacist

Antibiogram

Nursing Leadership

Education

Physicians Timely and appropriate antibiotic management

Infection Control

Hospital Leadership

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

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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

Functions of NAGCOM

1. Develop the National Antibiotic Guidelines

for Primary Care and for Hospitals

2. Provide training/lectures to help

disseminate the guidelines

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

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

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

Process of Guidelines Formulation

• Decision-Making

– By Consensus

– Majority Rule

• Consultation with Professional Societies and other Stakeholders

Scope of Guidelines

• Treatment (and Prophylaxis)

• Specific Conditions by Organ System

– Priority Diseases

– Public Health Impact

• Adult and Pediatric

• Primary -> Tertiary Levels of Care

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

LOW-RISK CAP:

• Stable vital signs (RR <30/min; PR <125/min; SBP >90 mmHg; DBP >60 mmHg; Temp >36oC or <40oC

• 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

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

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.

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

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

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

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

Barriers to Physician Adherence to Practice Guidelines in Relation to Behavior Change

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

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.

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