Disclosures. Astellas. The Medicines Company. Theravance Biopharma

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2 Disclosures Astellas The Medicines Company Theravance Biopharma

3 Objectives Define antimicrobial stewardship using nationally accepted criteria Identify strategies to provide antimicrobial stewardship Review regulatory requirements from agencies such as The Joint Commission and the Centers for Medicare and Medicaid related to antimicrobial stewardship

4 Antimicrobial Stewardship Antimicrobial stewardship is defined as coordinated interventions designed to improve and measure the appropriate use of agents by promoting the optimal selection, dosage, duration, and route of administration of antimicrobials that results in: Improved patient outcomes Reduced adverse events Improved rates of antibiotic susceptibilities

5 Birth of Antimicrobial Stewardship Microbes are educated to resist penicillin and a host of penicillin-fast organisms is bred out in such cases, the thoughtless person playing with penicillin is morally responsible for the death of the man who finally succumbs to infection with the penicillin-resistant organism. I hope this evil can be averted. - Alexander Fleming

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7 Antimicrobial Stewardship Why do we need Antimicrobial Stewardship? Previously, when bacteria developed resistance to existing antimicrobials, new agents would come along that were active against them Very few new antimicrobials have come to market Few pharmaceutical companies want to invest in drugs that will be used for only a short period of time Drugs used for the management of chronic diseases (DM, HTN, CHF, etc) are much more profitable Estimated 50% of antibiotic orders in the hospital setting are unnecessary

8 Hospital Based Antimicrobial Stewardship Dedicated to improve antibiotic use Hospital Optimize treatment of infections Reduce adverse events associated with antimicrobial use Clinicians Improve quality of patient care Improve patient safety Increased infection cure rates Reduced treatment failures Correct prescribing for therapy and prophylaxis

9 Stewardship Strategies Front end approach: Restrict certain antimicrobials to Infectious Disease (ID) specialists or other designated specialties Use of these agents require prior authorization or ID consult Pre printed Order Sheets Limits duration of antimicrobial therapy Physician must state reason for antimicrobial or order is not processed Pre built order sets in Computer Physician Order Entry (CPOE) Physician scrolls through a menu of common infections Once an infection is selected, physician can choose the hospital s recommended empiric antimicrobial therapy

10 Stewardship Strategies Back End Approach: Daily post prescription prospective review ID pharmacist reviews charts of patients receiving antibiotics and determines their appropriateness Contacts physicians & asks them to: Switch to narrower spectrum agents Deescalate antimicrobials Change antimicrobial if the bacteria is resistant Change antimicrobial if it does not reach site of infection Discontinue antimicrobials due to no organism present or duration of therapy

11 Benefits of Antimicrobial Stewardship Programs Improved efficacy Increase the utilization of firstline treatment options Reduce the unnecessary use of broad spectrum agents Dose optimization Reduce bacterial resistance Improved safety Dose adjustments for organ dysfunction Dosing of agents with a narrow therapeutic index Dosing of agents with organ toxicities Cost savings Appropriate utilization of antimicrobials decreases usage De escalation of therapy typically changes therapy to a less expensive agent IV to PO conversions help facilitate discharge from the hospital decreasing antimicrobial cost as well has overall hospital expense Compliance Centers for Medicare and Medicaid Services (CMS) The Joint Commission (TJC)

12 The Joint Commission Requirements In June 2016 a new Medication Management (MM) standard was published - MM Effective date January 1, 2017 Applies to all hospitals and critical access hospitals Included 8 Elements of Performance (EP)

13 MM Elements of Performance

14 Element of Performance 1 Leaders establish antimicrobial stewardship as an organizational priority Examples Accountability documents Budget plans Infection Prevention plans Performance improvement plans Using the electronic health record to collect antimicrobial stewardship data

15 EP 1 Survey Tips Make sure your team leaders can discuss antimicrobial stewardship at your facility Examples of ways to meet this EP Formal written statement Strategic plan Dedicated support in the budget Job description of program leaders

16 Element of Performance 2 The hospital educates staff and licensed independent practitioners involved in antimicrobial: Ordering Dispensing Administration Monitoring Education occurs upon hire or granting of initial privileges and periodically thereafter, based on organizational need

17 EP 2 Survey Tips Understand the type of education that is the most effective for your program Try to incorporate education into an existing practice that is currently working at your facility Provide general information to all specialties first Have a realistic time-line in mind

18 Element of Performance 3 The hospital educates patients, and their families as needed, regarding the appropriate use of antimicrobial medications, including antibiotics Examples Centers for Disease Control and Prevention handouts Viruses or Bacteria What got you sick? An antibiotic is the wrong tool to treat a virus Do you need antibiotics

19 EP 3 Survey Tips Deleted - October 2017

20 Element of Performance 4 The hospital has an antimicrobial stewardship multidisciplinary team that includes the following members, when available in the setting: Infectious disease physician Infections preventionists Pharmacist Practitioner

21 EP 4 Survey Tips This list provided is not exhaustive or limiting Nurses Microbiologist Informaticist Provide documentation of who is on the team Organizational chart Membership list of the program sub-committee Meeting minutes

22 Element of Performance 5 The hospital s antimicrobial stewardship program includes the following core elements 1. Leadership commitment 2. Accountability 3. Drug expertise 4. Action 5. Tracking 6. Reporting 7. Education

23 CDC Core Elements Document Summarizes core elements of successful hospital Antimicrobial Stewardship Programs (ASP) Complement existing guidelines Infectious Diseases Society of America (IDSA) Society for Healthcare Epidemiology of America (SHEA) American Society of Health System Pharmacists (ASHP) The Joint Commission (TJC) Success is dependent on two key factors Defined Leadership Coordinated multidisciplinary approach

24 Summary of Core Elements Leadership Commitment Human, financial, and information technology resources Accountability Leader responsible for outcomes Tracking and Monitoring Monitoring prescribing and resistance patterns Reporting Antibiotic use and resistance to physicians, nurses, and relevant staff Drug Expertise Pharmacist leader responsible for improved antibiotic use Action Implementing recommended actions Education Clinicians regarding resistance and optimal prescribing Patients and families regarding antibiotic use and potential side effects

25 Leadership Commitment Critical component to the success of ASP Formal statement of support Facilitate training and education Adequate staffing Sustained financial support Ensuring ASP team leaders have time to perform the functions of the program Endorse participation from many groups that can support stewardship activities

26 Accountability Stewardship program leader or co-leaders Held accountable to the hospital leadership for meeting goals and targets Have expertise in antibiotic use and training in stewardship Infectious diseases Hospitalists Nurse practitioners Actively engage other groups in stewardship

27 Drug Expertise Pharmacy leader Identify a single pharmacy leader who will co-lead the program Formal training in infectious diseases is highly preferred Larger facilities have achieved success by hiring full time staff

28 Key Staff Clinicians Antibiotic prescribers Department Heads Staff resources Infection Preventionists Monitor and prevent infections Quality Management Quality and safety issues Laboratory / Microbiology Proper use of tests and flow of results Information Technology Integrate stewardship protocols Nurses Prompt discussions regarding stewardship

29 Actions to Support Optimal Antibiotic Use Utilize specific interventions that can be divided into three categories Broad Antibiotic Time outs Prior authorization Prospective audit and feedback Pharmacy driven IV to PO conversions Dose adjustment Duplicate therapy alerts Time-sensitive stop orders Drug-Drug interaction detection and prevention Infection and syndrome specific Community-acquired pneumonia Urinary tract infections Skin and soft tissue infections Empiric coverage of methicillin-resistant Staphylococcus aureus (MRSA) infections Clostridium difficile infections Treatment of culture proven invasive infections

30 Tracking and Monitoring Critical to identifying opportunities for improvement and assess the impact of improvement efforts Allows for assessment, monitoring, and improvement Measurement may involve Process Outcomes Antibiotic Use

31 Tracking and Monitoring Process measures Adherence to documentation policies Indications for antibiotic use Antibiotic time-outs Adherence to facilityspecific treatment guidelines Accurate antibiotic allergy and adverse reaction histories Outcome measures Tracking of antibiotic resistance patterns C. difficile infection rates 30-day readmission rates C. difficile Pneumonia

32 Tracking and Monitoring Antibiotic Use Measures Defined Daily Doses (DDD) A standardized metric for drug exposure endorsed by the World Health Organization (WHO) Assumed average maintenance dose per day for a drug used for its main indication in adults Days of Therapy (DOT) Adopted by National Healthcare Safety Network (NHSN) A single day of drug administration regardless of number of doses or strength Antibiotic Use (AU) Developed by the CDC Automatically collects and reports monthly DOT data, which can be analyzed in aggregate and by specific agents and patient care locations Standardized antibiotic administration ratio (SAAR) National Quality Forum (NQF) endorsed Benchmarking measure for antibiotic use Direct antibiotic expenditures Easiest to measure Could be easily misinterpreted

33 Reporting Regular reporting is a key element of a successful ASP Present facility-specific antibiotic use and outcomes Hospital leadership Pharmacy leadership Healthcare providers Infection control Quality management

34 Reporting Basic Standing ASP report to key stakeholders Report to medical staff committee and hospital board Intermediate Updates on progress toward ASP goals Newsletter articles that focus on antimicrobial use Advanced Provider-level information Antibiotic use Acceptance of ASP recommendations Audit and feedback Facility specific dashboard for ASP metrics for all staff to view

35 Education ASPs should provide regular updates regarding Antibiotic prescribing Antibiotic resistance Infectious disease management National issues Local issues Can motivate improved prescribing Education has been found to be the most effective when paired with Corresponding interventions Measurement of outcomes Ways to provide education Physicians and Staff Didactic presentations Posters Flyers Newsletters Electronic communications to the staff Patients and family members Verbal education Written education Educational videos Support groups Post-discharge phone calls

36 EP 5 Survey Tips This is the foundation of your stewardship program Surveyors may not be as familiar with this concept, be prepared to spend minutes discussing stewardship Be ready to detail you antimicrobial stewardship journey A binder can be helpful to have and reference during this portion of the survey

37 Element of Performance 6 The hospital s antimicrobial stewardship program uses organization-approved multidisciplinary protocols Examples Antibiotic formulary restrictions Assessment of appropriateness of antibiotics for specific diseases Plan for parenteral to oral antibiotic conversions Use of prophylactic antibiotics Guidelines for antimicrobial use

38 EP 6 Survey Tips Examples of protocols and processes need to be documented Clinical pathways Order sets Empiric antibiotic guidelines Dose adjustment protocols Specifically ask where clinicians go to find this information Looking for a basic structure to build from

39 Element of Performance 7 The hospital collects, analyzes, and reports data on its antimicrobial stewardship program Examples Evaluation of the antimicrobial stewardship program Antimicrobial prescribing patterns Antimicrobial resistance patterns

40 EP 7 Survey Tips This can seem like an overwhelming task Probably already doing something that can meet this EP Examples Clostridium difficile rates Antibiogram

41 Element of Performance 8 The hospital takes action on improvement opportunities identified in its antimicrobial stewardship program

42 EP 8 Survey Tips Should include quality improvement initiatives Should line up with data reported in the previous section Most important point Are you acting on the problems that you ve identified with data analysis

43 Centers for Medicare & Medicaid Services Condition of Participation (CoP)

44 2020 Benchmarks Stewardship initiatives implemented in all human healthcare delivery settings Establish regional efforts to reduce transmission of antibiotic resistant pathogens and improve antibiotic use Antibiotic Use (AU) 95% of hospitals will report to NHSN Inpatient: Inappropriate AU will be reduced by 20% Outpatient: Inappropriate AU for monitored conditions/agents will be reduced by 50% from 2010 levels

45 CMS Requirements ASP will be a Condition of Participation (CoP) Antimicrobial Stewardship Officer Institutional policies for appropriate use Identify areas for improvement Implement interventions Measure and report antimicrobial use Leadership support Work with regulatory agencies to establish best practices Will not be limited to acute care hospitals

46 CMS Expectations ASP must Demonstrate coordination between all components of the hospital responsible for antibiotic use and resistance Document the evidence-based use of antibiotics in all departments and services of the hospital Demonstrate improvements in proper antibiotic use ASP adheres to nationally recognized guidelines and best practices for improving antibiotic use ASP reflects the scope and complexity of the hospital services provided

47 CoP C.9 The hospital has written policies and procedures whose purpose is to improve antibiotic use 1.C.10 The hospital has designated a leader (e.g., physician, pharmacist, etc.) responsible for program outcomes of antibiotic stewardship activities at the hospital level 1.C.11 The hospital s antibiotic stewardship policy and procedures requires practitioners to document in the medical record or during order entry an indication for all antibiotics, in addition to other required elements such as does and duration

48 CoP C.12 The hospital has a formal procedure for all practitioners to review the appropriateness of any antibiotics prescribed after 48 hours from the initial orders (e.g., antibiotic time out) 1.C.13 The hospital monitors antibiotic use (consumption) at the unit and/or hospital level

49 CMS CoP Has not been implemented yet November 2017 was projected date of implementation Significant amount of money to implement ASP changes New administration Unsure of new CoP date

50 Summary Antibiotic overuse and misuse has driven antimicrobial resistance Changes to clinical practice to promote appropriate use are essential to the preservation of these life-saving medications Antimicrobial stewardship programs can optimize the treatment of infections and antibiotic use Stewardship can improve patient outcomes, slow the development of antimicrobial resistance, and reduce healthcare costs Government funding will be increasingly tied to implementing, measuring, improving, educating, and reporting of stewardship activities

51 References 1. Tamma PD, Cosgrove SE. Antimicrobial stewardship. Infect Dis Clin North Am 2011; 25(1): Drew RH. Antimicrobial stewardship programs: How to start and steer a successful program. J Manag Care Pharm 2009; 15 (2 Suppl): S Owens RC, Shorr AF, Deschambeault AL. Antimicrobial stewardship: sheparding precious resources. Am J Health Syst Pharm 2009; 66(12 Suppl 4): S Owens RC, Rice L. Hospital-based strategies for combating resistance. Clin Infect Dis 2006; 42(Suppl 4): S Dortch MJ, Fleming SB, Kauffmann RM, et al. Infection reduction strategies including antibiotic stewardship protocols in surgical and trauma intensive care units are associated with reduced resistant Gram-negative healthcare-associated infections. Surg Infect 2011; 12(1): Wong-Beringer A, Nguyen LH, Lee M, et al. An antimicrobial stewardship program with a focus on reducing fluoroquinolone overuse. Pharmacotherapy 2009; 29(6): Nuila F, Cadle RM, Logan N, et al. Antimicrobial stewardship and Clostridium difficile-associated disease. Infect Control Hosp Epidemiol 2008; 29(11): McNeil V, Cruickshank M, Duguid M. Safer use of antimicrobials in hospitals: the value of antimicrobial usage data. Med J Aust 2010; 193(8 Suppl): S114 7.

52 References 9. Talpaert MJ, Gopal Rao G, Cooper BS, et al. Impact of guidelines and enhanced antimicrobial stewardship on reducing broad-spectrum antibiotic usage and its effect on incidence of Clostridium difficile infection. J Antimicrob Chemother 2011; 66(9): Exec. Order. Combating antibiotic resistant bacteria CDC. Core Elements of Hospital Antibiotic Stewardship Programs. Atlanta, GA: US Department of Health and Human Services, CDC; Barlam TF, Cosgrove SE, Abbo LM, MacDougall C, Schuetz AN, et al. Implementing an antibiotic stewardship program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis;2016: e1-e Durkin, M. (2017, December). Is your antimicrobial stewardship program ready for a survey?. Retrieved from

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