Antimicrobial Stewardship Beyond the Hospital Setting

Antimicrobial Stewardship Beyond the Hospital Setting

Deanne Tabb PharmD, 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 These are conservative estimates that are believed to under-estimate the total burden of bacterial resistant disease PCAST Report to the President on Combating Antibiotic Resistance.

Annual Antibiotic Use

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

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

National Action Plan for Combating Antibiotic-Resistant Bacteria (Goals)
March 2015 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, other therapeutics, and vaccines Improve international collaboration and capacities for antibiotic-resistance prevention, surveillance, control, and antibiotic research and development March 27, 2015 the president (White House) released the resulting National action plan for Combating Antibiotic Resistant Bacteria The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

National Action Plan for Combating Antibiotic-Resistant Bacteria
March 2015 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 March 27, 2015 the president (White House) released the resulting National action plan for Combating Antibiotic Resistant Bacteria The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

CDC Recognized Urgent Threats CDC Recognized Serious Threats
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 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 for food-producing animals CMS does not currently have regulations in place to require ASP in hospitals, but they expanded a section in the infection control survey to include questions about stewardship The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Goal 1: Objectives & Milestones
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 Align with CDC’s Core Elements CDC added 12 questions to the 2015 annual facility survey of the NHSN, based on the 7 CDC core elements. Results will/should be published on CDC Get Smart Website, however the preliminary results are show on the slide. The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria. Antibiotic Stewardship HICPAC Update and Discussion July 2015.

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. CMS does not currently have regulations in place to require ASP in hospitals, but they expanded a section in the infection control survey to include questions about stewardship The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

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 CMS does not currently have regulations in place to require ASP in hospitals, but they expanded a section in the infection control survey to include questions about stewardship The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

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 CDC resources for education + additional resources The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

Goal 1.1.2 and 1.1.3 Objectives & Milestones
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 Implement annual reporting of antibiotic use in outpatient settings 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 National healthcare safety network has antibiotic use (AU) and antimicrobial resistance AR modules that receives hospital data on amts of specific antibiotics used, cases of drug resist SAARS = metric, it has been approved & CDC has responded to all public comments, vote will be in fall 2015…. The White House. National Action Plan for Combating Antibiotic-Resistant Bacteria.

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 data-sharing Within 3 years CDC will charge at least 5 public labs with rapid detection of outbreaks caused by MDR pathogens Provide incentives for timely reporting of antibiotic-resistance and antibiotic use in all healthcare settings It has been proposed for NHSN data reporting to add to an institution’s meaningful use Require reporting of abx resistance data to NHSN as part of CMS hospital IQRP CDC expects to launch ABX resistance patient safety atlas early 2016 118 facilities have submitted at least 1 month of AU data, none are reporting AR data Proposed option to qualify for EHR incentive payments by electronically reporting antibiotic use and resistance data 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, other therapeutics, 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.

Leadership commitment
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 Formal statement was signed by CEO to be on the Georgia ASP Honor Roll Informatics system, Theradoc has been chosen once finances are in order. Scott Hill did approach a year ago asking what did we want. Dr. Fletcher=Champion /chair 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 Formal statement was signed by CEO to be on the Georgia ASP Honor Roll Informatics system, Theradoc has been chosen once finances are in order. Scott Hill did approach a year ago asking what did we want. Dr. Fletcher=Champion /chair 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 Broad interventions Develop an antibiogram
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 hours Reduce prolonged antibiotic treatment courses for common infections Implementing policies that support optimal Abx use and interventions to improve abx use. CDC divides interventions in 3 categories broad, pharmacy driven, and diagnosis and infection specific 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 These interventions are intended to ensure optimal use of abx to treat the following common infxn C diffe-> review antibiotics and stop any unnecessary At 72h after a pathogenic BC if no repeat BC are orders, pharmacy has the authorization to order new set just to notify (leave note on chart that we ordered) sepsis, bacteremia bundle is put on the chart Laminated SCIP 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 Measures of Antibiotic Use
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 Documentation: Dose, duration, indication Antibiogram = cumulative antibiotic susceptibility report Other metrics include by # of grams of abx used = defined daily dose (DDD) Direct expenditure for abx = purchasing costs 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
Figure 5-2 from the TJC free toolkit represents a sample of usage data for 3 antimicrobials commonly used to empirically cover Gram (-) pathogens 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

Pre/Post-Meditech implementation with CPOE Mandatory ID indication selection
% Defined antibiotic indication

Criteria for Use

Pre Intervention September: 96.9% Pre Intervention October: 89.5%
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% 99.1% 99.4% 99.0% 97.6% #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 93 111 174 99 124 Benchmark Baseline (Mar-Apr 2010) 82% Hospital Goal 98% Pre Intervention September: 96.9% Pre Intervention October: 89.5%

10 Month Linezolid Use 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 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 (M39-A4)

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
Percent MRSA Year

Staphylococcus aureus Isolates Pediatric Patients
TMP/SXT ______ Clindamycin ______ Percent Susceptibility Year CD MRSA susceptibility = 98 % CD MSSA susceptibility = 89 %

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 Common reasons for readmission were treatment failure, patient noncompliance, allergy to medication, and adverse drug reactions ED Physician Led Pharmacist Managed Cultures Reported 2278 2361 Antimicrobial Modifications 12% 15% Readmitted within 96 hours of Discharge 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 There was no difference in appropriate therapies ED Physician Led Pharmacist Managed Positive Cultures Reviewed 104 73 Time to Culture Review 3 days (1 – 15) 2 days (0 – 4) Required Notification 74 (71.2%) 36 (49.3%) Time to patient/PCP notification 3 days (1 – 9)

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 Current Practice ED Pharmacist Managed ASP Contacted vs Not Contacted 10/22 (45.5%) 72/73 (98.7%)

ID Indications (N = 505 patients)
MMC Experience ID Indications (N = 505 patients)

SSTI Microorganisms

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

SSTI Empiric Guidelines

SSTI Pathway

UTI Pathogens

UTI Antibiotics

Empiric Antibiotic Guidelines

Post-Lecture Test True-False question
Antimicrobial stewardship only affects acute care hospitals 2. Which of the following are proposed core elements of antimicrobial stewardship? 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? 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 PharmD, MT (ASCP) deanne.tabb@crhs.net
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Antimicrobial Stewardship Beyond the Hospital Setting

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