Antimicrobial Stewardship Beyond the Hospital Setting Deanne Tabb

Antimicrobial Stewardship Beyond the Hospital Setting

Deanne Tabb Pharm. D, MT (ASCP) Infectious Disease Pharmacy specialist Clinical Microbiologist Midtown Medical Center, Columbus, Georgia

Disclosure I do not have (nor does any immediate family member have) actual or potential conflict of interest, within the last twelve months; a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity; or any affiliation with an organization whose philosophy could potentially bias my presentation.

Objectives • Evaluate the need for antibiotic stewardship beyond the acute care hospital setting • Outline core elements of antimicrobial stewardship in community and long term care facilities • Describe development and application of an antibiogram for various patient care settings • Provide specific examples of antimicrobial interventions following emergency room discharge

Significance and Relevance • Antibiotics are among the most commonly prescribed drugs used in human medicine • 50% are not needed or not optimally prescribed • Annual impact of antibiotic resistant infections • 2 million illnesses • 23, 000 deaths • 8 million additional hospital days • $20 -35 billion excess direct healthcare costs • Up to $35 billion societal costs PCAST Report to the President on Combating Antibiotic Resistance.

Annual Antibiotic Use http: //www. cnbc. com/2014/01/16/antibiotic-resistanceeconomist-proposes-superbug-solution. html

What is Antimicrobial Stewardship? • Using the right antibiotic at the right time at the right dose for the right duration • Primary goal Optimize clinical outcomes while minimizing unintended consequences of antimicrobial use, including toxicity, the selection of pathogenic organisms, and the emergence of resistance The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria. IDSA and the SHEA guidelines for developing an institutional program to enhance antimicrobial stewardship.

Timeline of Recent Events SEPTEMBER 2013 • CDC report: Antibiotic Resistance Threats in the United States SEPTEMBER 2014 • PCAST Report to the President on Combating Antibiotic Resistance • National Strategy to Combat Antibiotic-Resistant Bacteria (CARB) • Executive Order 13676: Combating Antibiotic-Resistant Bacteria MARCH 2015 JUNE 2015 NOVEMBER 2015 • National Action Plan for Combating Antibiotic-Resistant Bacteria • White House hosts the Forum on Antibiotic Stewardship • CARB First 180 Days Report • The Joint Commission (TJC) Proposed Standards for Antimicrobial Stewardship CDC Federal Engagement in Antimicrobial Resistance.

SEPTEMBER • CDC report: Antibiotic Resistance Threats in the United States 2013 Assessment of domestic antibiotic resistance threats • C. difficile • Carbapenem-resistant Enterobacteriaceae (CRE) • Drug-resistant Neisseria gonorrhoeae • • • MDR Acinetobacter DR Campylobacter ESBLs VRE MRSA • MDR Pseudomonas aeruginosa • Strep pneumonia • Fluconazole-resistant Candida • MDR & XDR TB • VRSA • Erythromycin-resistant Streptococcus Group A • Clindamycin-resistant Streptococcus Group B CDC Antibiotic Resistance Threats in the United States, 2013.

MARCH 2015 • National Action Plan for Combating Antibiotic-Resistant Bacteria (Goals) • Slow emergence of resistant bacteria and prevent spread • Strengthen National One-Health surveillance efforts to combat resistance • Advance development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria • Accelerate basic and applied research and development of new antibiotics, otherapeutics, and vaccines • Improve international collaboration and capacities for antibiotic-resistance prevention, surveillance, control, and antibiotic research and development The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

MARCH 2015 • National Action Plan for Combating Antibiotic-Resistant Bacteria • 5 year roadmap to guide the Nation in rising to the challenge • Outlines steps for implementing the National Strategy and addresses PCAST recommendations • Organized around 5 goals with objectives (Year 1, 3, 5) • Primary goal: guide activities by the federal government as well as actions by public health, healthcare, and veterinary partners to address this urgent drug-resistant threat The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

National Targets by 2020 Target CDC Recognized Urgent Threats � 50% Incidence of overall C. diff infection � 60% Hospital acquired CRE infections <2% Prevalence of ceftriaxone-resistant Neisseria gonorrhoeae Target CDC Recognized Serious Threats � 35% Hospital acquired MDR Pseudomonas species infections � ≥ 50% Overall MRSA BSI � 25% MDR non-typhoidal Salmonella infections � 15% Number of MDR TB infections � ≥ 25% Rate of antibiotic-resistant invasive pneumococcal disease <5 yo � ≥ 25% Rate of antibiotic-resistant invasive pneumococcal disease >65 yo The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

By 2020 significant outcomes of Goal 1 • Improve antibiotic stewardship across all healthcare settings • Reduce inappropriate antibiotic use by 50% in outpatient settings • Establish state antibiotic resistance prevention programs in all 50 states to monitor regionally important MDR organisms and provide feedback and technical assistance • Eliminate medically-important antibiotics for growth promotion in food producing animals • Requirement of veterinary oversight for use of medically-important antibiotics in the feed or water food-producing animals The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Goal 1: Objectives & Milestones q Strengthen antibiotic stewardship in outpatient and long-term care settings by developing, expanding, and monitoring progress Within 1 Year • Propose regulations to implement antibiotic stewardship programs in ambulatory surgery centers, dialysis clinics, and other inpatient facilities • National Healthcare Safety Network (NHSN) will begin tracking the number of facilities with stewardship policies and programs The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria. Antibiotic Stewardship HICPAC Update and Discussion July 2015.

Goal 1: Objectives & Milestones q Improve antibiotic stewardship across all healthcare settings Within 3 Years • Centers for Medicare & Medicaid Services (CMS) will issue new Conditions of Participation (COP) Interpretive Guidelines to advance compliance with recommendations in CDC’s Core Elements • All long-term acute care hospitals, post-acute care facilities, ambulatory surgery centers and dialysis centers governed by CMS COP will be required to implement antibiotic stewardship programs • Training webinars for CMS surveyors will be updated to include information on antibiotic utilization in nursing homes • CDC and others will issue guidance on AS and best practices for ambulatory surgery centers, dialysis centers, nursing homes, long term care facilities, doctor’s offices, and other outpatient settings, pharmacies, Emergency departments and correctional facilities. The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Goal 1: Objectives & Milestones q Improve antibiotic stewardship across all healthcare settings Within 5 Years • Department of defense will support stewardship programs and interventions critical for maintaining quality health care throughout the military healthcare system • CDC will work with select hospital systems to expand antibiotic use reporting and stewardship implementation, and will partner with nursing organizations to develop and implement stewardship programs and interventions in a set of nursing homes • All states will establish or enhance antibiotic stewardship activities in healthcare delivery settings The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Goal 1: Objectives & Milestones q Strengthen educational programs that inform physicians and public about good antibiotic stewardship. Within 1 Year • CDC & VA will apply lessons learned from pilot project to provide clinical decision support Within 3 Years • CDC & CMS will propose expanded quality measures for antibiotic prescribing • CMS will expand the Physician Quality Reporting System (PQRS) to include quality measures to discourage inappropriate antibiotic use to treat non-bacterial infections The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Goal 1. 1. 2 and 1. 1. 3 Objectives & Milestones q Expand collaborative efforts by groups of healthcare facilities that focus on preventing the spread of antibiotic-resistant bacteria Within 1 Year • DOD Multidrug-Resistant Organism Repository & Surveillance Network (MRSN) will expand its detection and reporting capabilities to include high-risk drug resistant pathogens q Implement annual reporting of antibiotic use in outpatient settings Within 1 Year • CDC will report outpatient prescribing rates and use this data to target and prioritize intervention efforts (number of prescriptions per population) • CDC will establish a benchmark for reduction in antibiotic use Within 3 Years • CDC will issue yearly reports on progress in meeting the national target of 50% reduction in inappropriate use in outpatient settings The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Goal 2: Objectives & Milestones q Enhance reporting infrastructure and provide incentives for reporting Within 1 Year • CDC will develop an implementation plan for regional laboratories that considers all aspects of operation, including specimen transport, testing, reporting and datasharing Within 3 years • CDC will charge at least 5 public labs with rapid detection of outbreaks caused by MDR pathogens q Provide incentives for timely reporting of antibiotic-resistance and antibiotic use in all healthcare settings Within 1 Year • It has been proposed for NHSN data reporting to add to an institution’s meaningful use The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Goals continued • Goal 3: Advance development and use of rapid and innovative diagnostic tests - To distinguish between bacterial and viral infections - Determine antibiotic-resistance profiles • Goal 4: Accelerate research to develop new antibiotics, otherapeutics, vaccines, and diagnostics • Goal 5: Improve international collaboration and capacities for prevention, surveillance and antibiotic research and development The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Core elements of Performance in Nursing Homes LEADERSHIP COMMITMENT ACCOUNTABILITY DRUG EXPERTISE ACTION TRACKING REPORTING EDUCATION CDC Core Elements of Antibiotic Stewardship for Nursing Homes. The Joint Commission. Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS.

Core Elements • Formal, written statement in support of improving antibiotic use • Include stewardship related duties in position descriptions for the medical director, clinical nurse leads, and consultant pharmacist • Communicate expectations about antibiotic use, monitor and inforce AS policies • Create a culture which promotes stewardship • Empower director to set standards for antibiotic prescribing • Empower the director of nursing to set the practice standards for assessing, monitoring and communicating changes in a resident’s condition by front-line nursing staff • Engage consultant pharmacist in supporting and reporting antibiotic use data CDC Core Elements of Antibiotic Stewardship for Nursing Homes The Joint Commission. Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS.

Core Elements • Infection preventionist review antibiotic resistance patterns, collect and analyze infection surveillance data which can be used for stewardship purposes • Laboratory support for MDR organism alerts, education on technology and creation of annual antibiogram • Incorporate consultant pharmacist trained in ID or antibiotic stewardship • Collaborate with antibiotic stewardship program leads at the hospitals within your referral network • Develop relationships with ID consultants interested in supporting your facilities stewardship efforts CDC Core Elements of Antibiotic Stewardship for Nursing Homes The Joint Commission. Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS.

Core Elements • Policies • • • Documentation of dose (route), duration (start/end date, planned days of therapy), indication (including rational/treatment site) for every antibiotic Develop treatment recommendations based on guidelines and local susceptibility Establish best practices for use of microbiology testing Review antibiotic agents available on site Broad interventions • Develop and implement algorithms for assessment of residents suspected of having an infection • • • Develop an antibiogram Antibiotic time out: clinicians to review antibiotics at 48 -72 hours Reduce prolonged antibiotic treatment courses for common infections CDC Core Elements of Antibiotic Stewardship for Nursing Homes The Joint Commission. Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS.

Example of Empiric Antibiotic Guideline

Internal AST Website

Core Elements Diagnosis and infection specific interventions • Reduce antibiotic use in asymptomatic bacteriuria • Reduce antibiotic prophylaxis for prevention of UTI • Optimize management of nursing home-associated pneumonia • Optimize use of superficial cultures for management of chronic wounds CDC Core Elements of Hospital Antibiotic Stewardship Programs. The Joint Commission. Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS.

Core Elements Process Measures • Completeness of clinical assessment documentation at the time of antibiotic prescription • Completeness of antibiotic prescribing documentation • Antibiotic selection is consistent with recommended agents for specific indications Measures of Antibiotic Use • Point prevalence of antibiotic use • Track new antibiotic starts • Antibiotic days of therapy (DOT/1000 resident-days) Antibiotic Outcome Measures • By counts of antibiotic(s) administered to patients per day = Days of therapy (DOT) /per 1000 patient days CDC Core Elements of Hospital Antibiotic Stewardship Programs. The Joint Commission. Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS.

Days of therapy (DOT) /per 1000 patient days CDC Core Elements of Hospital Antibiotic Stewardship Programs. The Joint Commission. Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS; Antimicrobial Stewardship Toolkit.

Post-Meditech implementation with CPOE Mandatory ID indication selection: (n=169) § 81% of all ID indications were included with CPOE orders § An additional 7% of indications were included in the progress note § Indication were unclear in the remaining 12% of antibiotic orders

% Defined antibiotic indication Pre/Post-Meditech implementation with CPOE Mandatory ID indication selection 100 90 80 70 60 50 40 30 20 10 0 % Defined indication in progress note % Defined indication in antibiotic order Pre-CPOE 2015 Post 2016 Post. Meditech implementation

Criteria for Use

Overall % Patients Met Criteria for Use (includes those not met that had Pharmacy intervention proposed & accepted) Goal > 98% Recommendation Monitoring/ analysis frequency Monthly Pharmacy Review Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Percentage Overall % Patients met criteria for use 100. 0% 98. 9% 100. 0% 99. 1% 100. 0% 99. 4% 99. 1% 99. 0% 97. 6% 100. 0% #N/A Numerator # Patients met criteria including those not met that had pharmacy intervention proposed & accepted 75 91 92 103 110 119 173 109 98 121 4 Denominator # Patients on use restricted antimicrobials 75 91 93 103 111 119 174 110 99 124 4 Benchmark Baseline (Mar-Apr 2010) 82% 82% 82% Goal Hospital Goal 98% 98% 98% 2015 Use Restricted Microbials - Overall % Patients Met Criteria for Use (includes those not met that had Pharmacy intervention proposed & accepted) 120% Percentage 100% 80% 60% 40% 20% 0% Jan-15 Feb-15 Mar-15 Apr-15 May-15 Baseline (Mar-Apr 2010) • Pre Intervention September: 96. 9% • Pre Intervention October: 89. 5% Jun-15 Jul-15 Hospital Goal Aug-15 Sep-15 Oct-15 Overall % Patients met criteria for use Nov-15 Dec-15

Empiric Use of Meropenem for Febrile Neutropenia 9 8 7 6 5 4 3 2 1 r be Oc to pt Se Au g l Ju n Ju ay M Ap r ar M b Fe n 0 Ja # of Patient on Meropenem 10

10 Month Linezolid Use January - October 2015 History of VRE with sepsis/confirmed VRE infection Vancomycin failure 1% 7% 9% 34% 11% History of VRE with sepsis/confirmed VRE infection 45 Vancomycin failure 33 Confirmed MRSA pneumonia 17 Vancomycin allergy 15 Vancomycin renal intolerance 12 Loss of IV access (short term use) 10 13% 25% Vancomycin renal intolerance Loss of IV access (short term use) Daptomycin failure 2

TJC EP 5 – Core Elements • Share facility-specific reports on antibiotic use with prescribers • Distribute current antibiogram to prescribers • Direct, personalized communication to prescribers about how they can improve their antibiotic prescribing • Provide education to clinicians and staff on improving antibiotic prescribing Informal + formal CDC Core Elements of Hospital Antibiotic Stewardship Programs. The Joint Commission. Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS.

Centers for Disease Control and Prevention (CDC): Perspective on Antimicrobial Stewardship Antibiotic resistance is a major public health problem. We now have organisms resistant to all readily available antibiotics. Some would argue that we are in the post-antibiotic era. Antibiotics are a shared resource. Benefits of Antibiotic Stewardship: • Helps streamline therapy and improve patient outcomes • Helps set duration of therapy • Improves handoff communication • Reduces the emergence of multi-drug resistant pathogens and C. difficile colitis • Reduces adverse drug reactions Principles of Antimicrobial Stewardship: • Obtain Quality Cultures • Before antibiotics initiated (if possible) • Utilize Respiratory Therapy to obtain sputum samples • Avoid surface cultures • Establish source control if applicable • Indications are written with all antibiotic orders • Stream line to narrow spectrum antibiotics following culture results • Set antibiotic durations of therapy at time of prescribing or immediately following clinical response Quality Measures Identified: • Multidisciplinary process to review antimicrobial utilization and local susceptibility patterns • Systems to prompt appropriate use of antimicrobial agents • Antibiotic orders include indication for use • Clinician review of need/selection of antibiotics at 72 hours • IV to PO program For more information refer to the stewardship website on OASIS (Medical access) or contact the Infectious Disease Pharmacist

Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data; Approved Guidelines 2014 (M 39 -A 4)

In vitro Susceptibility

Antibiogram • Introduction, scope and definitions • Information system design • Data analysis • Data presentation • Use of cumulative antimicrobial susceptibility reports • Limitation of data, data analysis and data presentation

Selection Criteria • Patient location • Specific ward, clinic, inpatient, outpatient, intensive care unit • Clinical service • Specimen type • Certain organism subgroups • Special populations

Pediatric 2016

Staphylococcus aureus Isolates Pediatric Patients 100 90 80 75 74 74 67 70 62 60 Percent MRSA 52 50 40 30 20 10 0 2009 2010 2011 Year 2013 2014 2015

Staphylococcus aureus Isolates Pediatric Patients 100 90 80 70 60 Percent Susceptibility TMP/SXT 50 ______ Clindamycin ______ 40 30 20 10 0 2009 2010 2011 2013 Year CD MRSA susceptibility = 98 % CD MSSA susceptibility = 89 % 2014 2015

Pediatric Empiric Guidelines

Interventions Following ETC Discharge

Interventions Post Discharge MDR community-acquired infections are on the rise, and inappropriate empiric therapies can lead to: • • Rehospitalizations Increased hospital costs Increased morbidity and mortality Decreased quality of life

Emergency Department Cultures • Mid level practitioners or ED physicians • Notification occurs via message, fax or call • Culture is then reviewed for antibiotic changes • Barriers/solution • • • ED patient turnover is high ED physicians do not have the time to review cultures Pharmacy programs could give ED physicians more time with current patients, reduce readmissions, and improve outcomes

Readmissions after 96 hours Methods: ED of Carolinas Medical Center NE Retroactive chart review one year before a pharmacist-managed process was introduced compared to new process Primary Outcome: Frequency and reason of readmission within 96 hours Subjects: ED patients with positive cultures Results ED Physician Led Pharmacist Managed Cultures Reported 2278 2361 Antimicrobial Modifications 12% 15% Readmitted within 96 hours of Discharge 15% 7%

Time to Culture Follow up, Patient or PCP notification, and Appropriateness of Therapy Methods: University of Rochester Medical Center • Pre-implementation data November – January 2008 • Post-implementation November – January 2009 Primary Outcome: Time to positive culture follow up, notification, and appropriateness of empiric or final antimicrobial therapy Subjects: Patients discharged from the ED with positive cultures Results Positive Cultures Reviewed Time to Culture Review Required Notification Time to patient/PCP notification There was no difference in appropriate therapies ED Physician Led Pharmacist Managed 104 73 3 days (1 – 15) 2 days (0 – 4) 74 (71. 2%) 36 (49. 3%) 3 days (1 – 9) 2 days (0 – 4)

Empiric Therapy Assessment following Culture Results Methods: 6 week retrospective ED Physician Assistant culture assessment versus 15 week pharmacist managed AS program Primary Outcome: Compliance with contacting patient and/or PCP if positive for STD or empiric therapy was inappropriate Subjects: ED discharged patients with positive results Results Contacted vs Not Contacted Current Practice ED Pharmacist Managed ASP 10/22 (45. 5%) 72/73 (98. 7%)

MMC Experience ID Indications (N = 505 patients) 10 6 5 20 16 15 Indications UTI - 351 SSTI - 82 Otitis Media - 20 82 Gastro - 16 Pyelonephritis - 15 Fever - 10 351 URI - 6 Pharyngitis - 5

SSTI Microorganisms 8 7 Staph. Aureus 38 E. coli Enterobacteriaceae 23 PSA Other 16

SSTI Antibiotics Clindamycin 35 Ampicillin 1 Bactrim 16 Levofloxacin 1 Cephalexin 10 Doxycycline 1 Ciprofloxacin 5 Vancomycin 1 Augmentin 3 Amoxicillin 2

SSTI Empiric Guidelines

SSTI Pathway

UTI Pathogens Bugs 3 16 15 E. coli 7 Enterobacteriaceae non-E. coli 19 PSA Staph. aureus 91 195 Enterococcus Coag Neg Other

ph Ce r he Ot s s lin rin cil ni sp o 37 Pe al o n nt oi s ne lo ra fu tro no ui oq 160 140 120 100 80 60 40 20 0 Ni ur Flo rim Ba ct UTI Antibiotics 151 103 44 7 7

Empiric Antibiotic Guidelines

Post-Lecture Test 1. True-False question Antimicrobial stewardship only affects acute care hospitals 2. Which of the following are proposed core elements of antimicrobial stewardship? a. b. c. d. e. Leadership commitment/Accountability Drug expertise Action/Tracking/Reporting Education All the above are included in core elements of performance 3. Which of the following represent examples of antibiogram reporting or application? a. b. c. d. Stratified in vitro sensitivity data of urinary isolates in the ED Empiric guidelines for skin soft tissue infection Development of a skin soft tissue pathway for use in the ED All of the above

Questions?

Deanne Tabb Pharm. D, MT (ASCP) deanne. tabb@crhs. net Visit GPh. Aconvention. com/grow to download materials from this and other presentations.