Antimicrobial Stewardship Program David R. Woodard, MSc, FSHEA, CIC CDC: Antibiotic Resistance Threats in the United States, 2013 http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ CDC Threat Levels 1
Antibiotic development Prolonged process Years Expensive Phase I Phase II Phase III Phase IV Licensing and patent COORDINATED JOINT EFFORT ID physician ID trained pharmacist Infection control practitioner Lab/microbiologist Hospital epidemiologist Information system specialist Hospital administration Joint Commission Medication Management Standard (MM.09.01.01) Issued June 22, 2016 Hospitals and Critical Access Hospitals Separate for Skilled Nursing Facilities but same requirements Standard: The <facility> has an antimicrobial stewardship program based on current scientific literature. Elements 5-8: must show documentation 2
TJC Elements of Performance 1. Leaders establish antimicrobial stewardship as an organizational priority. 2. Educates staff and licensed independent practitioners antimicrobial ordering, dispensing, administration, monitoring antimicrobial resistance antimicrobial stewardship practices. Occurs upon hire or granting of initial privileges and periodically thereafter, 3. Educate patients, (and families) EMERGENCY DEPARTMENT AND CLINICS CORRECT - use of antimicrobial medications https://www.jointcommission.org/assets/1/6/hap-cah_antimicrobial_prepub.pdf Elements of Performance 4. Antimicrobial stewardship multidisciplinary team as available in the setting: Infectious disease physician Infection preventionist(s) Pharmacist(s) Practitioner Note: Part-time or consultant staff are acceptable as members of the antimicrobial stewardship multidisciplinary team. Note: Telehealth staff are acceptable as members of the antimicrobial stewardship multidisciplinary team https://www.jointcommission.org/assets/1/6/hap-cah_antimicrobial_prepub.pdf Elements of Performance 5. The (essential) core elements: Leadership commitment: Accountability: Appointing a single leader responsible for program outcomes. 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 Monitoring the antimicrobial stewardship program, antibiotic prescribing and resistance patterns. Reporting: Physicians, nurses, and relevant staff. Education: staff, patients, and family regarding antibiotic stewardship 3
Elements of Performance 6. The organization uses organization-approved multidisciplinary protocols 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 Elements of Performance 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 Conditions of Participation 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. 4
Designated leader Development and implementation of facility-wide program Monitor and improve the use of antibiotics Ensures documentation, written or electronic, of stewardship activities Consolidate effort medical and nursing staff, pharmacy leadership, Laboratory (microbiology) infection control, QAPI programs on antibiotic use issues Competency-based training and education hospital personnel and staff, medical staff, personnel providing contracted services at the hospital, applications of antibiotic stewardship guidelines, policies and procedures Hospitals Have to Document the evidence-based use of antibiotics in all departments and services of the hospital Guidelines Recommendations Audit Interventions Demonstrate improvements Proper antibiotic use, Reductions in CDI Changes in the antibiogram Antibiotic costs (careful Will Smith) 5
Beta-lactam class ABX Class Drug Penicillins Ampicillin Drug of choice for Enterococcus sp. if susceptible Ampicillin/sulbactam (Unasyn) Piperacillin/tazobactam (Zosyn) Covers Gram +, -, and anaerobes (no Pseudomonas) Used to treat Pseudomonas aeruginosa Cephalosporins Cefazolin (Ancef) Drug of choice for surgical prophylaxis Ceftriaxone Cefepime Ceftaroline (Teflaro) Used for Community Acquired Pneumonia (CAP) Used to treat Pseudomonas aeruginosa Used to treat MRSA skin and CAP (not MRSA) Carbapenems Ertapenem Covers Gram +, -, and anaerobes (no Pseudomonas) Meropenem Used to treat Pseudomonas aeruginosa Monobactam Aztreonam Used to treat Pseudomonas aeruginosa in penicillinallergic patients Mixed ABX Class Drug Glycopeptide Vancomycin MRSA Oxyzolidinone Linezolid (Zyvox) MRSA (pneumonia), VRE Lipopeptide Daptomycin (Cubicin) MRSA/VRE blood, skin, UTI Fluoroquinolone Levofloxacin CAP from Pseudomonas aeruginosa, Oral for IV/PO or outpatient Ciprofloxacin Pseudomonas aeruginosaoral for IV/PO or outpatient Macrolides Azithromycin Community Acquired Pneumonia (CAP) Z-pac Lincosamide Clindamycin MRSA, anaerobe Sulfa Aminoglycosides Sulfamethoxazoletrimethoprim (Bactrim) Amikacin, gentamicin, tobramycin CA-MRSA, Gram negative (no Pseudomonas) Oral for IV/PO or outpatient Pseudomonas aeruginosa Polymyxin Colistin old drug Pseudomonas aeruginosa and Pan-resistant Gram - infections Common Antimicrobials Class Drug Nitroimidazole Metronidazole (Flagyl) Anaerobe infections, including C. difficile Macrocyclic Fidaxomicin (Dificid) $$ C. difficile Antifungal Azole Fluconazole Antifungal Echinocandin Micafungin Antifungal (does not treat UTI) Polyene Amphotericin B Antifungal Antivirals Acyclovir Treats HSV Oseltamivir, zanamivir Treats influenza AntiretroviralsARV Tenofovir, Lepidasvir HIV infection Ledipasvir/sofosbuvir Hepatitis C 6
Treatment Regimens Empiric: Unsure what pathogen Patient history Nursing home Outpatient exposure Hospital antibiogram Limited course 3 days or less! Prophylaxis Prophylaxis: used to prevent infection in certain patient populations Surgical prophylaxis: GUIDELINE DIRECTED! Cefazolin 2 gm q 4 hr dose within 60 minutes of incision, >120 Kg 3 gm 2 doses within 24 hours of surgery to prevent surgical site infection BUMP dose for long cases Beta-lactam allergic Vancomycin (may give over 2 hours) Clindamycin + gentamicin Note: Stanford Health Care Treatment Regimens Pathogen-directed: de-escalate therapy culture results, patient-specific therapy 7
Antibiograms Analyze and present data at least annually Include only species with at least 30 isolates Include diagnostic, not surveillance, isolates Include results only for drugs that are routinely tested Antibiogram Include first isolate/patient/period analyzed, irrespective of body site Calculate % susceptible (not including intermediates) For S. aureus, calculate and list % susceptible for all isolates, and subset for MRSA Antibiogram Demonstrate availability Laboratory dependent Contract laboratory community antibiogram 8
Organism NHSN (% resistance) Hospital (% resistance) MRSA 49.2 50.04 VRE (faecium) E. faecium (R-amp) 56.5 71 66.3 75.6 VRE (faecalis) 4.7 7 P. aeruginosa R-FQ R-Pip/tazo R-imi/mero R-ceftazadime R-cefepime K. pneumoniae R-ceftri/ceftaz R-imi/mero/erta 15.9 7.9 11.8 7.3 5.7 14.8 5.2 33.75 11.19 20.8 16.7 25.3 15.3 9 A.baumanii R-carbs 30.6 62.3 E coli R-FQ R-imi/mero/erta R-ceftria/ceftaz 22.7 2.5 5.3 30.5 0.8 8.3 Efficacy issues and concerns Prompt initiation of therapy Treat the infection (not viral) Correctly collected sample (avoid contamination) Virulence ability to cause the infection Susceptibility to the antibiotic Antimicrobial: dose, route, duration Renal/hepatic function, adverse effects, drug interactions, allergies, cost, penetration into site of infection Host: immunocompetent vs. immunocompromised Site of infection: abscess I&D, left-sided endocarditis surgery, etc. 9
Considerations Secondary issues Absorption (Renal/hepatic function) Allergy Other therapies Food Costs Site Abscess penetration (drainage) Brain blood/brain barrier Osteomyelitis (penetration of abx into site) Lungs - Daptomycin Resistance in Hospital Settings Inappropriate antimicrobials prescribed Colonization not being distinguished from infection Duration of therapy too long Inappropriate dose given Inappropriate administration timing Transmission of bacteria via environment or healthcare workers or cohorting Etest: MIC values Pure culture of microorganism from source plate Lawn of bacteria plated on special media Antibiotic strip placed on lawn Examined @ 24 hours Inhibition point is identified and response to report (not used for all abx (see KB method) 10
Kirby-Bauer (KB) Disk Diffusion: mm Pure culture of microorganism from source plate Lawn of bacteria plated on special media Selected antibiotics dropped (Gram + or -) Examined @ 24 hours Measure against standard MM of inhibition Questions David R. Woodard, MSc, FSHEA, CIC Program Coordinator Infection Prevention Certificate University of Nevada Las Vegas Infection Prevention Consultant Steven Hirsch and Associates David.woodard@unlv.edu Davidwoodard@shassociates.com Some of the slides in this presentation are derived from a presentation by Dr. Diane Rhee, PharmD thank you 11