UPDATE ON ANTIMICROBIAL STEWARDSHIP REGULATIONS AND IMPLEMENTATION OF AN AMS PROGRAM Diane Rhee, Pharm.D. Associate Professor of Pharmacy Practice Roseman University of Health Sciences Chair, Valley Health System Antimicrobial Stewardship Committee
OBJECTIVES Review Joint Commission Standards for Antimicrobial Stewardship Evaluate CMS proposed rules for Antimicrobial Stewardship Assess CDC Antimicrobial Stewardship Criteria for implementation
ANTIMICROBIAL STEWARDSHIP Coordinated interventions designed to improve and measure the appropriate use of antimicrobials by promoting the selection of the optimal antimicrobial drug regimen, dose, duration of therapy, and route of administration. Antimicrobial stewards seek to achieve optimal clinical outcomes related to antimicrobial use, minimize toxicity and other adverse events, reduce the costs of health care for infections, and limit the selection for antimicrobial resistant strains. (IDSA) https://www.idsociety.org/stewardship_policy/
JOINT COMMISSION PREPUBLICATION STANDARDS: MEDICATION MANAGEMENT STANDARD (MM.09.01.01) Issued June 22, 2016 Hospitals and Critical Access Hospitals Separate for Skilled Nursing Facilities but same requirements Will go into effect January 1, 2017 Standard: The [critical access] hospital has an antimicrobial stewardship program based on current scientific literature. Elements 5-8: must show documentation https://www.jointcommission.org/assets/1/6/hap-cah_antimicrobial_prepub.pdf
1. Leaders establish antimicrobial stewardship as an organizational priority. 2. The [critical access] hospital educates staff and licensed independent practitioners involved in antimicrobial ordering, dispensing, administration, and monitoring about antimicrobial resistance and antimicrobial stewardship practices. Education occurs upon hire or granting of initial privileges and periodically thereafter, based on organizational need. 3. The [critical access] hospital educates patients, and their families as needed, regarding the appropriate use of antimicrobial medications, including antibiotics https://www.jointcommission.org/assets/1/6/hap-cah_antimicrobial_prepub.pdf
4. The [critical access] hospital has an antimicrobial stewardship multidisciplinary team that includes the following members, when available in the setting: l Infectious disease physician l Infection preventionist(s) l Pharmacist(s) l Practitioner Note 1: Part-time or consultant staff are acceptable as members of the antimicrobial stewardship multidisciplinary team. Note 2: Telehealth staff are acceptable as members of the antimicrobial stewardship multidisciplinary team https://www.jointcommission.org/assets/1/6/hap-cah_antimicrobial_prepub.pdf
5. The [critical access] hospital s antimicrobial stewardship program includes the following core elements: Leadership commitment: Dedicating necessary human, financial, and information technology resources. Accountability: Appointing a single leader responsible for program outcomes. Experience with successful programs shows that a physician leader is effective. Drug expertise: Appointing a single pharmacist leader responsible for working to improve antibiotic use. Action: Implementing recommended actions, such as systemic evaluation of ongoing treatment need, after a set period of initial treatment (for example, antibiotic time out after 48 hours). Tracking: Monitoring the antimicrobial stewardship program, which may include information on antibiotic prescribing and resistance patterns. Reporting: Regularly reporting information on the antimicrobial stewardship program, which may include information on antibiotic use and resistance, to doctors, nurses, and relevant staff. Education: Educating practitioners, staff, and patients on the antimicrobial program, which may include information about resistance and optimal prescribing. https://www.jointcommission.org/assets/1/6/hap-cah_antimicrobial_prepub.pdf
6. The [critical access] hospital s antimicrobial stewardship program uses organization-approved multidisciplinary protocols (for example, policies and procedures). Note: Examples of protocols are as follows: Antibiotic Formulary Restrictions Assessment of Appropriateness of Antibiotics for Community-Acquired Pneumonia Assessment of Appropriateness of Antibiotics for Skin and Soft Tissue Infections Assessment of Appropriateness of Antibiotics for Urinary Tract Infections Care of the Patient with Clostridium difficile (c.-diff) Guidelines for Antimicrobial Use in Adults Guidelines for Antimicrobial Use in Pediatrics Plan for Parenteral to Oral Antibiotic Conversion Preauthorization Requirements for Specific Antimicrobials Use of Prophylactic Antibiotics https://www.jointcommission.org/assets/1/6/hap-cah_antimicrobial_prepub.pdf
7. The [critical access] hospital collects, analyzes, and reports data on its antimicrobial stewardship program. Note: Examples of topics to collect and analyze data on may include evaluation of the antimicrobial stewardship program, antimicrobial prescribing patterns, and antimicrobial resistance patterns 8. The [critical access] hospital takes action on improvement opportunities identified in its antimicrobial stewardship program. https://www.jointcommission.org/assets/1/6/hap-cah_antimicrobial_prepub.pdf
CMS PROPOSED RULE CHANGES TO CONDITIONS OF PARTICIPATION Released June 13, 2016, 60 day comment period We believe that a closer, more streamlined connection between infection prevention and control and antibiotic stewardship programs with hospitals' QAPI programs will translate to better quality and healthier patients. Enhance the accountability of hospital leadership for the infection prevention and control and antibiotic stewardship programs as well as delineate the responsibilities for the leaders of the infection prevention and control program and the AS program respectively. Develop and manage an infection prevention and control program and antimicrobial stewardship program that reflects the scope and complexity of the hospital services provided. https://www.federalregister.gov/articles/2016/06/16/2016-13925/medicare-and-medicaid-programs-hospital-and-critical-access-hospital-cah-changes-to-promote#p-98
DESIGNATED LEADER OF ANTIMICROBIAL STEWARDSHIP PROGRAM RESPONSIBILITIES Development and implementation of facility-wide program based on nationallyrecognized guidelines Monitor and improve the use of antibiotics Responsible for all documentation, written or electronic, of stewardship activities Communicating and collaborating with medical and nursing staff, pharmacy leadership, infection control, and QAPI programs on antibiotic use issues Competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services at the hospital, on the practical applications of antibiotic stewardship guidelines, policies and procedures https://www.federalregister.gov/articles/2016/06/16/2016-13925/medicare-and-medicaid-programs-hospital-and-critical-access-hospital-cah-changes-to-promote#p-98
INFECTION PREVENTIONIST/INFECTION CONTROL PROFESSIONAL RESPONSIBILITIES Responsible for development and implementation of hospital-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines Responsible for all documentation, written or electronic, of prevention and control program, and its surveillance, prevention, and control activities Communicate with QAPI program on all infection prevention and control issues Direct role in competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services at the hospital, on the practical applications of infection prevention and control guidelines, policies, and procedures Responsible for preventing and controlling HAIs, including auditing of adherence to infection prevention and control policies and procedures by hospital personnel Communicate and collaborate with antibiotic stewardship program https://www.federalregister.gov/articles/2016/06/16/2016-13925/medicare-and-medicaid-programs-hospital-and-critical-access-hospital-cah-changes-to-promote#p-98
HOSPITALS HAVE TO: Demonstrate coordination among all components of the hospital responsible for antibiotic use and factors that lead to antimicrobial resistance, including, but not limited to, the infection prevention and control program, the QAPI program, the medical staff, nursing services, and pharmacy services Document the evidence-based use of antibiotics in all departments and services of the hospital Demonstrate improvements, including sustained improvements, in proper antibiotic use, such as through reductions in CDI and antibiotic resistance in all departments and services of the hospital. https://www.federalregister.gov/articles/2016/06/16/2016-13925/medicare-and-medicaid-programs-hospital-and-critical-access-hospital-cah-changes-to-promote#p-98
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Leadership Support Established at Facility Does your facility have a formal or written statement of support from leadership that supports efforts to improve antibiotic use (antibiotic stewardship) Does your facility receive any budgeted financial support for antibiotic stewardship activities (i.e. support for salary, training, or IT support) Accountability Is there a physician leader responsible for program outcomes of stewardship activities at your facility Drug Expertise Is there a pharmacist leader responsible for working to improve antibiotic use at your facility? https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Key Support for the Antibiotic Stewardship Program Does any of the below work with the stewardship leaders to improve antibiotic use? Established at Facility Clinicians Infection Prevention and Healthcare Epidemiology Quality Improvement Microbiology (Laboratory) Information Technology (IT) Nursing https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Actions to Support Optimal Antibiotic Use POLICIES Policy Established Does your facility have a policy that requires prescribers to document in the medical record or during order entry a dose, duration, and indication for all antibiotic prescriptions Does your facility have facility-specific treatment recommendations, based on national guidelines and local susceptibility, to assist with antibiotic selection for common conditions? https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Specific Interventions to Improve Antibiotic Use Are the following actions to improve antibiotic prescribing conducted in your facility? Broad Interventions Action Performed Is there a formal procedure for all clinicians to review appropriateness of all antibiotics at 48 hours after the initial order (i.e. antibiotic time out)? Do specific antibiotic agents need to be approved by a physician or pharmacist prior to dispensing (i.e. preauthorization) at your facility? Does a physician or pharmacist review course of therapy for specified antibiotic agents (i.e. prospective audit with feedback) at your facility? https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Pharmacist-Driven Interventions Are the following actions implemented at your facility? Automatic changes from intravenous to oral antibiotic therapy in appropriate situations? Action Performed Dose adjustments in cases of organ dysfunction Dose optimization (pharmacokinetics/pharmacodynamics) to optimize the treatment of organisms with reduced susceptibility Automatic alerts in situations where therapy might be unnecessarily duplicative Time-sensitive automatic stop orders for specified antibiotic prescriptions https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Diagnosis and Infections Specific Interventions Does your facility have specific interventions in place to ensure optimal use of antibiotics to treat the following common infections? Action Performed Community-acquired pneumonia Urinary tract infections Skin and soft tissue infections Surgical prophylaxis Empiric treatment of Methicillin-resistant Staphylococcus aureus (MRSA) Non-C. difficile infection (CDI) antibiotics in new cases of CDI Culture-proven invasive (i.e. bloodstream) infections https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
COMMUNITY-ACQUIRED PNEUMONIA May-16 % % Followed Algorithm 55 % PCN Allergy 16 Therapy if not CTX + Azith % Levofloxacin 17 % Moxifloxacin 17 % Doxycycline 2 % Minocycline 6 % Ceftaroline 2 % Other 0 % Prolonged QTc 12 % Alternate Therapy Appropriate 29 % Followed by ID 51 Jun-16 % % Followed Algorithm 51 % PCN Allergy 21 Therapy if not CTX + Azith % Levofloxacin 13 % Moxifloxacin 20 % Doxycycline 6 % Minocycline 8 % Ceftaroline 1 % Other 0 % Prolonged QTc 42 % Alternate Therapy Appropriate 40 % Followed by ID 49
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Tracking: Monitoring Antibiotic Prescribing, Use, and Resistance Process Measures Measure Performed Does your stewardship program monitor adherence to a documentation policy (dose, duration, and indication)? Does your stewardship program monitor adherence to facility-specific treatment recommendations? Does your stewardship program monitor compliance with one or more of the specific interventions in place? https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
Total # Interventions % Interventions Denied
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Tracking: Monitoring Antibiotic Prescribing, Use, and Resistance Antibiotic Use and Outcome Measures Measure Performed Does your facility track rates of C. difficile infection? Does your facility produce an antibiogram (cumulative antibiotic susceptibility report)? Does your facility monitor antibiotic use (consumption) at the unit and/or facility-wide level by one of the following metrics: By counts of antibiotics administered to patients per day (Days of therapy) By number of grams of antibiotic used (Define Daily Dose) By direct expenditure for antibiotics (purchasing costs) https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
CDC CORE ELEMENTS TO ANTIMICROBIAL STEWARDSHIP Reporting Information to Staff on Improving Antibiotic Use and Resistance Does your stewardship program share facility-specific reports on antibiotic use with prescribers Has a current antibiogram been distributed to prescribers at your facility Do prescribers ever receive direct, personalized communication about how they can improve their antibiotic prescribing? Education Does your stewardship program provide education to clinicians and other relevant staff on improving antibiotic prescribing? https://www.cdc.gov/getsmart/healthcare/pdfs/checklist.pdf
UPDATE ON ANTIMICROBIAL STEWARDSHIP REGULATIONS AND IMPLEMENTATION OF AN AMS PROGRAM Diane Rhee, Pharm.D. Associate Professor of Pharmacy Practice Roseman University of Health Sciences Chair, Valley Health System Antimicrobial Stewardship Committee