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The National Antibiotic Guidelines: Shepherding Clinicians towards Rational use of Antibiotics


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

Published in: Health & Medicine
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The National Antibiotic Guidelines: Shepherding Clinicians towards Rational use of Antibiotics

  1. 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
  2. 2. Content Areas • Why do we need antibiotic guidelines? • National antibiotic guidelines overview • How will guidelines help antimicrobial stewardship? • Implementation
  3. 3. Antibiotics are Societal Drugs!
  4. 4. 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
  5. 5. 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
  6. 6. 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
  7. 7. 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
  8. 8. 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
  9. 9. 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
  10. 10. 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
  11. 11. 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
  12. 12. 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
  13. 13. 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
  14. 14. 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
  15. 15. 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]
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 19. 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
  20. 20. Establishing AMS programmes PATIENT Microbiology Clinical Pharmacist Antibiogram Nursing Leadership Education Physicians Timely and appropriate antibiotic management Infection Control Hospital Leadership
  21. 21. 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
  22. 22. 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
  23. 23. Functions of NAGCOM 1. Develop the National Antibiotic Guidelines for Primary Care and for Hospitals 2. Provide training/lectures to help disseminate the guidelines
  24. 24. 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
  25. 25. 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
  26. 26. 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
  27. 27. Process of Guidelines Formulation • Decision-Making – By Consensus – Majority Rule • Consultation with Professional Societies and other Stakeholders
  28. 28. Scope of Guidelines • Treatment (and Prophylaxis) • Specific Conditions by Organ System – Priority Diseases – Public Health Impact • Adult and Pediatric • Primary -> Tertiary Levels of Care
  29. 29. 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
  30. 30. 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
  31. 31. 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
  32. 32. 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.
  33. 33. 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
  34. 34. 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
  35. 35. 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
  36. 36. JAMA, October 20, 1999—Vol 282, No. 15
  37. 37. Barriers to Physician Adherence to Practice Guidelines in Relation to Behavior Change JAMA, October 20, 1999—Vol 282, No. 15
  38. 38. 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.
  39. 39. 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