Chapter 39 - Antimicrobial Stewardship Program

3-39.1  INTRODUCTION

1. Purpose.  To establish multidisciplinary guidelines for the development of local policies and procedures for Indian Health Service (IHS) facilities to provide antimicrobial stewardship to protect patient safety and public health.
2. Background.  Antimicrobial stewardship is the effort to optimize effective prescribing of antimicrobials through the determination of the optimal antimicrobial agent, dose, route, and duration of treatment. Improving antimicrobial prescribing involves implementing effective strategies to modify prescribing practices to align them with evidence-based recommendations for diagnosis and management. The IHS recognizes the seriousness of antimicrobial resistance (AMR) to the nation’s population. Implementation of this policy will occur at the local level and may include both Area Offices and Service Units. Policies and procedures for antimicrobial stewardship may be tailored to meet specific needs at the local level, but must have core elements in place, as described in this policy document.

   Components of this policy were developed using evidence-based practice guidelines and are aligned with the Centers for Disease Control and Prevention (CDC) Core Elements of Antibiotic Stewardship for Hospitals, published by CDC, the CDC Core Elements of Antibiotic Stewardship for Outpatients, the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship.

3. Policy.  It is the policy of the IHS to maintain an Antimicrobial Stewardship Program (ASP) with the mission of promoting the appropriate use of antibiotics to treat infections and reduce possible adverse events associated with antibiotic use.
4. Definitions.
   1. Antibiogram. A collection of data usually in the form of a table summarizing the percent of individual bacterial pathogens susceptible to different antimicrobial agents.
   2. Antibiotic Time-Out (ATO). An antibiotic “time out” prompts a reassessment, after a defined period of time, of the continuing need and choice of antibiotics when the clinical picture is clearer and more diagnostic information is available.
   3. Antibiotic Stewardship. A component of antimicrobial stewardship focused on the appropriate use of antibiotics and other antimicrobials to stem AMR and the spread of infections caused by multi-drug resistant organisms.
   4. Antimicrobial Stewardship. A coordinated multidisciplinary effort to improve clinical outcomes through the appropriate management, diagnosis, and treatment of patients with infectious diseases.
   5. Automatic Stop Orders. A review of patient's antimicrobials after a determined timeframe has elapsed to assess the need to continue or alter the therapy.
   6. De-escalation. A strategy to replace empirical broad-spectrum antimicrobial treatment by using a narrower antimicrobial treatment.
   7. Diagnostic Stewardship. A component of antimicrobial stewardship focused on the appropriate use of microbiological diagnostics to guide therapeutic decisions.
   8. Dose Optimization. Dose adjustments based on therapeutic drug monitoring, optimizing therapy for highly drug-resistant bacteria, achieving central nervous system penetration and extended-infusion administration of beta-lactams.
   9. Duration of Therapy. Length of time that therapy lasts.
   10. Intravenous (IV) to Oral (Per Os, “By Mouth”) (IV to PO) Conversion. IV medication is changed to PO in appropriate situations for antibiotics with good absorption (e.g., fluoroquinolones, trimethoprim-sulfamethoxazole, and linezolid) which improves patient safety.
   11. Order Sets. Groups of related orders which a provider can place with a few keystrokes or mouse clicks. Order sets allows users to issue prepackaged groups of orders that apply to a specified diagnosis or a particular period of time. Order sets represent one clinical decision support tool within computerized provider order entry systems that promote safe, efficient, and evidence-based patient care.
   12. Pharmacokinetic Service. Efficacious dosage regimens developed through the application of pharmacokinetic/pharmacodynamic principles and the determination of drug serum concentrations.
   13. Multi-Drug Resistant Organisms (MDRO). Microorganisms, predominantly bacteria, that are resistant to one or more classes of antimicrobial agents.
   14. Renal Dosing Protocol. Protocol for medication dosing and use based on renal function of the patient.
   15. Route of Administration. The means by which a drug or agent enters the body, such as by mouth, topically, or by injection.
5. Responsibilities.
   1. Director, Office of Clinical and Preventive Services (OCPS). The IHS OCPS Director will oversee the ASP; provide technical assistance, guidance, and oversight to Area level management officials.
   2. The Chair of the National IHS Antibiotic Stewardship Program Workgroup (ASW) and National Diagnostic Stewardship Workgroup (DSW). The Chairs of the ASW and DSW will advise the Director, OCPS regarding aspects of the ASP under their purview.
   3. Area Chief Medical Officers (CMOs). Area CMOs will:
      1. Ensure distribution, awareness, and compliance with this policy by Area Staff, Service Unit Chief Executive Officers, and Clinical Directors.
      2. Act as liaison with Area Tribal Leadership and/or their designees to share ASP guidelines and solicit feedback.
   4. Service Unit Chief Executive Officers (CEOs) and Clinical Directors (CDs). CEOs and CDs will ensure compliance with this policy and supplement it with local policy.

3-39.2  REQUIREMENTS FOR LOCAL POLICIES AND PROCEDURES

1. Requirements.
   1. Required Training. Service Units will develop local training and requirements for facility personnel or refer to outside/third party training.
   2. Accountability. A local ASP Team will be established to be accountable for stewardship activities. The ASP Team will be approved by the CEO and CD and consist of, at a minimum, a primary care provider, pharmacist, nursing representative, infection preventionist, and laboratory representative.
   3. De-escalation Protocols. Service Unit policy will define if and when each of the following de-escalation protocols will be implemented:
      1. Optimizing the Use of Diagnostic Testing
      2. An Antibiotic Review Process, or ATO for antibiotics prescribed in the facility
      3. Local Resistance Patterns Antibiogram
      4. Dose Optimization
      5. Preferred Route of Administration
      6. Duration of Therapy
      7. Duplication of Therapy
      8. Drug Interactions
      9. Potential for Toxicity
      10. IV to PO Conversion
      11. Pharmacokinetic Service
      12. Renal Dosing Protocols
      13. Automatic Stop Orders
2. Surveillance. Service Unit policies and procedures will define how and when surveillance should occur, but at a minimum should include:
   1. Monitoring of antibiotic usage patterns on a regular basis.
   2. Obtaining and reviewing antibiograms, at least yearly, for regional and/or institutional trends of resistance.
   3. Monitoring antibiotic resistance patterns (Methicillin-Resistant Staphylococcus areus (MRSA), Vancomycin-Resistant Enterococci (VRE), Extended spectrum beta-lactamases (ESBL), Carbapenem-Resistant Enterobacteriaceae (CRE), etc.) and Clostridium difficile infections.
   4. Tracking of MDROs.
   5. Types of antibiotic ordered, route of administration, and duration of therapy.
   6. Monitoring the appropriateness of diagnostic testing (e.g., cultures and sensitivity) prior to initiating antimicrobial therapy.
   7. Antibiotic usage data including (but not limited to) numbers of antibiotics prescribed (e.g., days of therapy) and the number of patients treated each month.
   8. All required CDC National Healthcare Safety Network metrics to report (applicable only to Acute Care Hospitals/Facilities, Ambulatory Surgery Centers, Long-term Acute Care Facilities, Long-term Care Facilities, Outpatient Dialysis Facilities, Inpatient Rehabilitation Facilities, and Home Dialysis Facilities).
3. Reporting. The ASP Team will define how and when to review and report findings to the Pharmacy and Therapeutics Committee who will then provide feedback, as appropriate, to the medical staff and/or other applicable committees (e.g., Area Governing Board, Infection Control Committee, Quality Assurance/Performance Improvement program, etc.) regarding:
   1. Antibiotics prescribed (e.g., days of therapy) and patients treated with antibiotics each month.
   2. Patients on antibiotics that did not meet criteria for active infection.
   3. Antibiotics prescribed not meeting local antimicrobial guidelines.
   4. As applicable, individual ordering of cultures and sensitivity tests, antimicrobials prescribed, IV to PO conversions, and durations of therapy.
   5. The ASP Team, in collaboration with laboratory staff who provide microbiological diagnostic services, test utilization and integration of diagnostic stewardship into their routine work and MDRO trends.
4. Electronic Health Record (EHR) Order Sets. Service units will include, within their EHR, order sets to guide appropriate antibiotic use. Order sets will be:
   1. Based on best practices as defined by the local ASP team.
   2. Reviewed annually, at a minimum, for continued appropriateness.

3-39.3  RESOURCE REFERENCES

1. The CDC Core Elements of Hospital Antibiotic Stewardship Programs Exit Disclaimer: You Are Leaving www.ihs.gov .
2. The CDC Core Elements of Outpatient Antibiotic Stewardship Programs Exit Disclaimer: You Are Leaving www.ihs.gov .
3. The IDSA and SHEA Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship Exit Disclaimer: You Are Leaving www.ihs.gov .