Think Smart About Antibiotics: Today s Presenter Katie Richards 2 Objectives Define antibiotic stewardship Understand upcoming CMS requirements Know the current data on sepsis and CDI Understand why sepsis prevention does not contradict the principles of antibiotic stewardship Receive background information on current stewardship initiatives in MD and VA 3 1
What is Antibiotic Stewardship? Coordinated interventions designed to improve and measure appropriate use of antibiotics by promoting the selection of optimal antibiotic drug regimen, dose, duration of therapy, and route of administration. Coordinated program that promotes the appropriate use of antibiotics, improves patient outcomes, reduces antibiotic resistance, and decreases the spread of infections caused by multidrug-resistant organisms. https://www.idsociety.org/stewardship_policy/ http://www.apic.org/professional-practice/practice-resources/antimicrobial- Stewardship 4 What is Antibiotic Stewardship? The 4 D s of optimal antimicrobial therapy 1. Drug 2. Dose 3. Duration of therapy 4. De-escalation Joseph J, RodvoldKA. The role of carbapenemsin the treatment of severe nosocomial respiratory tract infections. Expert Opin Pharmacother. 2008;9(4):561-575 5 Goals of Antibiotic Stewardship Optimize Patient Safety Decrease/Control Costs Reduce Resistance 6 2
Goals of Antibiotic Stewardship Optimize Patient Safety Decrease/Control Costs Reduce Resistance 7 How Does Antibiotic Resistance Happen? http://www.cdc.gov/drugresistance/about.html 8 Core Actions to Fight Resistance Four Core Actions to Fight Resistance http://www.cdc.gov/drugresistance/about.html 9 3
Goals of Antibiotic Stewardship Optimize Patient Safety Decrease/Control Costs Reduce Resistance 10 Antibiotic Stewardship Saves $$$ In acute care, antibiotic stewardship has been shown to reduce hospital pharmacy costs Inpatient antibiotic stewardship programs have consistently demonstrated $200K-$400K in annual savings Very few studies on antibiotic use in nursing homes have calculated financial costs De-escalation could reduce high-cost antibiotics http://www.cdc.gov/longtermcare/prevention/antibioticstewardship.html https://www.cdc.gov/getsmart/week/downloads/gsw-factsheet-cost.pdf 11 Goals of Antibiotic Stewardship Optimize Patient Safety Decrease/Control Costs Reduce Resistance 12 4
Antibiotic Stewardship Saves Lives! Patient harms from antibiotic overuse include Colonization and/or infection with antibiotic-resistant organisms Increased adverse drug events and drug interactions Risk of serious diarrheal infections from Clostridium difficile http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship.pdf 13 Antibiotic Stewardship: Where? Agriculture Acute Care Hospitals Nursing Homes Dentists Pharmacies Dialysis Centers Patients Outpatient Clinics Ambulatory Surgery Centers Urgent Care Centers Doctors Offices Home Health 14 Antibiotic Prescribing Up to 70% of long term care facility residents receive one or more antibiotics every year 40-75% of antibiotics prescribed in nursing homes may be unnecessary or inappropriate Antibiotic-related complications can be more severe among 65+ year old patients. http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardship.pdf 15 5
Antibiotic Stewardship: Who? Prescribers/Doctors Nurses Pharmacists Infection Preventionists Information Technology Microbiology Lab Administrators Patients, Families, Communities, etc. 16 Antibiotic Stewardship: How? CDC s Core Elements: Hospitals & NHs 1. Leadership Commitment 2. Accountability 3. Drug Expertise 4. Action 5. Tracking 6. Reporting 7. Education CDC s Core Elements: Outpatient 1. Commitment 2. Action 3. Tracking & Reporting 4. Education & Expertise http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html http://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html http://www.cdc.gov/getsmart/community/improving-prescribing/core-elements/core-outpatient-stewardship.html 17 CDC Core Elements for Antibiotic Stewardship in Nursing Homes 1. Leadership Commitment: Demonstrate support and commitment to safe and appropriate antibiotic use in your facility 2. Accountability: Identify physician, nursing and pharmacy leads responsible for promoting and overseeing antibiotic stewardship activities in your facility 3. Drug Expertise: Establish access to consultant pharmacists or other individuals with experience or training in antibiotic stewardship for your facility http://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html 18 6
CDC Core Elements for Antibiotic Stewardship in Nursing Homes 4. Action: Implement at least one policy or practice to improve antibiotic use 5. Tracking: Monitor at least one process measure of antibiotic use and at least oneoutcome from antibiotic use in your facility 6. Reporting: Provide regular feedback on antibiotic use and resistance to prescribing clinicians, nursing staff and other relevant staff 7. Education: Provide resources to clinicians, nursing staff, residents and families about antibiotic resistance and opportunities for improving antibiotic use http://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html 19 20 21 7
22 Existing Stewardship in MD LTC July 2012 pilot survey in Frederick and Washington Counties 16 LTCFs surveyed Only 2 facilities stated they had an antibiotic stewardship program Yet nearly all facilities already had elements of stewardship implemented Stop Orders, Stop Dates, Lab Verification, Antibiotic Indications, Antibiotic Restrictions, etc. *Data provided by Maryland Department of Health and Mental Hygiene Healthcare-Associated Infections Program Existing Stewardship in MD LTC HQI Infection Control Assessments collected in 2016 23 Existing Stewardship in MD LTC Of 10 responses (representing 10 different facilities): 90% reported leadership support 80% identified accountable leaders 90% have access to antibiotic prescribing expertise 50% have written policies on antibiotic prescribing 90% implemented practices to improve antibiotic use 70% have a report summarizing AU 80% have a report summarizing AR (antibiogram) 30% provide prescribers with feedback on prescribing 40% provided training on AU to nursing staff in past year 30% provided training on AU to providers in past year 24 8
Antibiotic Stewardship Resources CDC Core Elements of Antibiotic Stewardship for Nursing Homes: http://www.cdc.gov/longtermcare/prevention/antibioticstewardship.html AHRQ Nursing Home Antibiotic Stewardship Guide: http://www.ahrq.gov/nhguide/index.html Minnesota Antimicrobial Stewardship Program Toolkit for Long-term Care Facilities: http://www.health.state.mn.us/divs/idepc/dtopics/antibioticresistance/asp /ltc/ CDC s Get Smart: Know When Antibiotics Work Program: http://www.cdc.gov/getsmart 25 26 CMS Requirements CMS Regulation 81 FR 68688, AKA CMS Mega-Rule Effective 11/28/16 a. Antibiotic Stewardship in Phase 2, effective 11/28/17 Requires long term care facilities to develop an Infection Prevention and Control Program (IPCP) that includes an Antibiotic Stewardship Program a. includes antibiotic use protocols and a system to monitor antibiotic use https://www.federalregister.gov/documents/2016/10/04/2016-23503/medicare-and-medicaidprograms-reform-of-requirements-for-long-term-care-facilities 27 9
CDC Core Elements for Antibiotic CMS Mega-Rule Stewardship in Nursing Homes 1. Leadership Commitment: Develop Demonstrate Infection support Prevention and commitment and to safe and appropriate antibiotic use in your facility Control Program that includes 2. Accountability: Identify physician, nursing and pharmacy leads responsible for promoting and overseeing antibiotic Antibiotic stewardship Stewardship activities in your facility 3. Drug Expertise: Establish access to consultant pharmacists or other individuals with experience or training in antibiotic stewardship for your facility 4. Action: Implement at Antibiotic least one policy use protocols or practice to improve antibiotic use 5. Tracking: Monitor at least one process measure of antibiotic use and at least one outcome from antibiotic use in your facility System to monitor antibiotic use 6. Reporting: Provide regular feedback on antibiotic use and resistance to prescribing clinicians, nursing staff and other relevant staff 7. Education: Provide resources to clinicians, nursing staff, residents and families about antibiotic resistance and opportunities for improving antibiotic use 28 http://www.cdc.gov/longtermcare/prevention/antibiotic-stewardship.html Clostridium difficile 29 Clostridium difficile: An Overview Gram-positive bacillus Spore-forming Causes inflammation of the colon, known as colitis Shed in feces Often transmitted via environmental surfaces Most common microbial cause of HAIs in US hospitals http://www.cdc.gov/hai/organisms/cdiff/cdiff_faqs_hcp.html 30 10
Clostridium difficile Risk Factors Antibiotics Proton pump inhibitors GI surgery/manipulation Healthcare exposure Serious underlying illness Immunocompromised Age Sequelae Pseudomembranous colitis (PMC) Toxic megacolon Perforations of the colon Sepsis Death http://www.cdc.gov/hai/organisms/cdiff/cdiff_faqs_hcp.html 31 Clostridium difficile Infections (CDI) Symptoms Watery diarrhea Fever Loss of appetite Nausea Abdominal pain/tenderness Treatment Discontinue unnecessary antibiotics Appropriate Antibiotics Metronidazole Vancomycin Fidaxomicin Fecal transplant http://www.cdc.gov/hai/organisms/cdiff/cdiff-patient.html 32 http://www.cdc.gov/drugresistance/about.html 33 11
Clostridium difficile: The Stats 500,000 infections in a single year >100,000 infections among NH residents 1 in 5 patients with HA-CDI experience recurrence ~29,000 patients died within 30 days of initial diagnosis ~15,000 deaths directly attributable 80% of deaths occurred in 65+ population 1/3 of all CDI occur among 65+ 2/3 of HAI-CDI occur among 65+ 1 in 9 patients 65+ died within 30 days of diagnosis http://www.cdc.gov/media/releases/2015/p0225-clostridium-difficile.html 34 Burden of Clostridium difficile Infection Lessaet al, NEJM Feb 2015 293,300 Healthcare-Associated cases 107,600 Hospital Onset (36.7%) 104,400 NH Onset (35.6%) 81,300 Community Onset, Healthcare-associated (27.7%) 159,700 Community-Associated cases Lessaet al, Burden of Clostridium difficile infection in the United States. N EnglJ Med. 2015 Feb 26;372(9):825-34 35 Burden of Nursing Home-Onset CDI 60% of NHO-CDI cases had stool collected in-house >75% of NHO-CDI cases had documented receipt of antibiotics in 12 weeks prior 76% of NHO-CDI cases were discharged from a hospital in 12 weeks prior 48% within 2 weeks 75% within a month 112,800 cases of NHO-CDI cases estimated nationally 31,400 (28%) hospitalized within 7 days 20,900 (19%) had initial recurrence 14-60 days after last positive 8,700 (8%) died within 30 days Hunter et al, Burden of Nursing Home-Onset Clostridium difficileinfection in the United States: Estimates of Incidence and Patient Outcomes. Open Forum Infect Dis. 2016 Jan 18; 3(1):ofv196. 36 12
Clostridium difficile in Maryland 2011-2015= 7147 cases HCFO Total = 3262 Hospitalized = 1699 LTCF = 1535 (47%) CO Total = 3696 CA = 2291 HCFA = 1296 *Data provided by Maryland Department of Health and Mental Hygiene Emerging Infections Program 37 Clostridium difficile: Prevention Use antibiotics appropriately Rapidly identify and isolate patients with CDI Proper gown/glove use Hand Hygiene (soap & water!) Implement adequate environmental cleaning and disinfection Infection Control Program http://www.cdc.gov/hai/organisms/cdiff/cdiff_faqs_hcp.html 38 39 13
Sepsis: An Overview Complication caused by the body s overwhelming and life-threatening response to infection Can lead to tissue damage, organ failure, and/or death Medical Emergency! Severe Sepsis = Acute organ dysfunction secondary to documented or suspected infection Septic Shock = Severe sepsis plus hypotension not reversed with fluid resuscitation https://www.cdc.gov/sepsis/basic/qa.html http://www.sccm.org/documents/ssc-guidelines.pdf 40 Sepsis: Risk Factors Age (over 65 or under 1 years old) Weakened immune system Chronic medical conditions People who have suffered burns, trauma, or have wounds People with catheters HQI Resident and Family Guide to Understanding Sepsis http://www.cdc.gov/hai/organisms/cdiff/cdiff_faqs_hcp.html 41 Sepsis Symptoms * No single sign or symptom Minnesota Hospital Association and HQI Seeing Sepsis Toolkit 42 14
Sepsis: Treatment Antibiotics Oxygen IV fluids Minnesota Hospital Association and HQI Seeing Sepsis Toolkit https://www.cdc.gov/sepsis/basic/qa.html 43 Minnesota Hospital Association and HQI Seeing Sepsis Toolkit 44 Minnesota Hospital Association and HQI Seeing Sepsis Toolkit 45 15
Sepsis: The Stats >1.6 million people in the US are diagnosed with sepsis every year One every 20 seconds Sepsis begins outside the hospital for nearly 80% of patients 7 in 10 patients with sepsis had recent healthcare exposure 4 types of infections are most often associated with sepsis: lung, urinary tract, gut, skin http://www.sepsis.org/downloads/2016_sepsis_facts_media.pdf https://www.cdc.gov/vitalsigns/sepsis/index.html 46 Sepsis: The Deadly Stats Sepsis is the leading cause of death in US hospitals 258,000 people die from sepsis every year in the US One every 2 minutes Sepsis-related deaths increased 31% from 1999 to 2014 ~15% of all sepsis-related deaths occurred in nonacute care settings (home, LTCF, hospice, unknown) http://www.sepsis.org/downloads/2016_sepsis_facts_media.pdf Epstein et al. Varying Estimates of Sepsis Mortality Using Death Certificates and Administrative Codes United States, 1999 2014. MMWR MorbMortal WklyRep 2016;65:342 345 47 Sepsis: The Deadly Stats Among MD Medicare beneficiaries in 2015 1 in every 4.6 patients transferred from SNF to hospital w/sepsis POA died in-hospital 1 in every 2.8 patients transferred from SNF to hospital w/sepsis POA died in-hospital or within 30 days of d/c 1 in every 7 admissions w/sepsis (from anywhere) died inhospital 1 in every 4 admissions w/sepsis (from anywhere) died inhospital or within 30 days of d/c 48 16
Sepsis: The Deadly Stats Among VA Medicare beneficiaries in 2015 1 in every 4.4 patients transferred from SNF to hospital w/sepsis POA died in-hospital 1 in every 2.3 patients transferred from SNF to hospital w/sepsis POA died in-hospital or within 30 days of d/c 1 in every 7.4 admissions w/sepsis (from anywhere) died in-hospital 1 in every 3.9 admissions w/sepsis (from anywhere) died in-hospital or within 30 days of d/c 49 Sepsis Prevention: Patients 50 https://www.cdc.gov/sepsis/basic/qa.html Sepsis Prevention: Providers Healthcare Providers can: Prevent infections follow infection control requirements (hand hygiene) Educate patients and their families on the need to prevent infections, manage chronic conditions, and seek care if signs of sepsis are present Think sepsis know the signs and symptoms Act fast order proper testing and start antibiotics immediately Reassess patient management to change therapy as needed https://www.cdc.gov/vitalsigns/sepsis/index.html 51 17
BUT.. Stewardship = Don t use antibiotics! Sepsis = Start antibiotics promptly! 52 BUT.. Stewardship = Don t use antibiotics! = Use antibiotics appropriately! Sepsis = Start antibiotics promptly! 53 Stewardship and Sepsis: A Harmonious Relationship Stewardship policies with direct sepsis connections: 54 Require documentation of dose, duration, and indication Helps ensure antibiotics can be modified as needed based on additional laboratory and clinical information Develop facility-specific treatment recommendations Based on local susceptibilities Perform antibiotic time outs Can the spectrum of the antibiotic be narrowed (deescalation)? http://www.cdc.gov/longtermcare/pdfs/core-elements-antibiotic-stewardshipappendix-a.pdf 18
Stewardship and Sepsis A Lit Review. Searched for publications linking antibiotic stewardship and sepsis Majority studied sepsis-associated mortality Inappropriate empiric treatment increases mortality De-escalation lowers or does not affect mortality Antibiotic stewardship program lowers or does not affect mortality 55 Appropriate Empiric Treatment Adequate [antibiotic] treatment prior to ICU was a protective factor for mortality in patients with severe sepsis or septic shock. Our efforts should be directed to assure the correct administration [of] antibiotics before ICU admission in patients with sepsis. Garnacho-Montero et al. Adequate antibiotic therapy prior to ICU admission in patients with severe sepsis and septic shock reduces hospital mortality. CritCare. 2015 Aug 27;19:302 56 Antibiotic Time-Out Few true BSIs are detected after more than 48 hours of culture incubation. Clinicians may adjust empirical antibiotic coverage at this time with little risk for subsequent bacterial pathogen detection. Pardo et al. Time to positivity of blood cultures supports antibiotic deescalation at 48 hours. Ann Pharmacother. 2014 Jan;48(1):33-40. 57 19
De-Escalation Antibiotic de-escalation therapy has no detrimental impact on mortality in patients with severe sepsis and/or septic shock, as compared to the continuation of broadspectrum antibiotics. Since de-escalation affords an opportunity to limit overuse of broad-spectrum antibiotics, it should be considered as an option in clinical practice. Guoet al. De-escalation of empiric antibiotics in patients with severe sepsis or septic shock: A meta-analysis. Heart Lung. 2016 Sep-Oct;45(5):454-9 58 Integrate Antibiotic Stewardship Current deescalationpractices reflect physician reluctance when dealing with complicated, sicker patients or with drug-resistance or fungal sepsis. Integrating an antibiotic stewardship program may increase physician confidence and provide support towards increasing deescalation rates. Salahuddinet al. Determinants of DeescalationFailure in Critically Ill Patients with Sepsis: A Prospective Cohort Study. CritCare Res Pract. 2016;2016:6794861 59 Antibiotic Stewardship Helps Prevent Sepsis! Patients run an 80% higher chance of developing sepsis or septic shock after taking high-risk antibiotics in the hospital Sepsis risk is elevated regardless of which antibiotic are used Longer therapeutic courses are associated with higher sepsis incidence Regardless of the antibiotic used, patients on antibiotics >14 days had a 2-fold risk of developing sepsis Baggset al. Increased Risk of Sepsis during Hospital Readmission Following Exposure to Certain Antibiotics during Hospitalization. ID Week Oral Presentation. 10/27/2016. 60 20
What s Going on Locally? 61 Current Stewardship Initiatives Maryland CAAUSE: Campaign for Appropriate Antibiotic Use Formed: January 2016 Objective: To encourage proper antibiotic use and decrease the rates of drug resistance in MD by promoting antibiotic stewardship across the healthcare spectrum Virginia Virginia State wide Antibiotic Stewardship Campaign Planning work group of the Virginia HAI Advisory Council Statewide kickoff February 1, 2017 Reduce multidrug-resistant organisms across the healthcare spectrum through antibiotic stewardship 62 HQI s Stewardship Regional efforts Affinity Group Multidisciplinary committee of subject matter experts Outpatient Focus Implementing the Core Elements of Outpatient Antibiotic Stewardship in: Ambulatory Surgery Centers, Emergency Departments, Dialysis facilities, Outpatient clinics, Outpatient pharmacies, Pharmacy-based clinics, Physician offices, Public health clinics, and Urgent care centers In development! 63 21
QIN-QIO Aims Better Health Better Care Lower Costs Improving cardiac health & reducing cardiac disparities Reducing disparities in diabetes care Coordinating care through Immunization Reducing health-care acquired conditions (Nursing Homes) Coordinating care to reduce readmissions & adverse drug events Antibiotic Stewardship Quality Payment Program Local QIO Projects 64 Nursing Home Improvement Network 1. Decrease the use of unnecessary antipsychotics 2. Prevent and reduce healthcare associated infections 3. Improve Staff stability 4. Increase mobility of long-stay residents 5. Improve quality measures 6. Decrease potentially avoidable hospitalizations 65 National Nursing Home Quality Care C. difficile Collaborative Tracking and Preventing C. diff NHSN Enrollment Education and Sharing of Best Practices o Antibiotic Stewardship 52 MD Nursing Homes 55 VA Nursing Homes 66 22
Contact Information Katie Richards Improvement Consultant 804-289-5355 krichards@hqi.solutions 67 Q & A This material was prepared by Health Quality Innovators (HQI), the Medicare Quality Innovation Network-Quality Improvement Organization for Maryland and Virginia, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. HQI 11SOW 20161212-153814 68 23