Moderator: Kayla R. Stover, Pharm. D. Assistant Professor of Pharmacy Practice, University of Mississippi Medical Center, Jackson, Mississippi

Transcription

1 Infectious Diseases PRN Focus Session Standards of Antimicrobial Stewardship Activity Number: L01-P, 1.50 hours of CPE credit; Activity Type: A Knowledge-Based Activity Tuesday, October 25, :15 p.m. to 4:45 p.m. Great Hall 4 Moderator: Kayla R. Stover, Pharm. D. Assistant Professor of Pharmacy Practice, University of Mississippi Medical Center, Jackson, Mississippi Agenda 3:15 p.m. Regulatory Standards Related to Acute Care Settings Emily L. Heil, Pharm. D., BCPS, AQ-ID Clinical Assistant Professor, University of Maryland School of Pharmacy, Baltimore, Maryland 3:45 p.m. Antimicrobial Stewardship Efforts Outside the Hospital Elias B. Chahine, Pharm. D., BCPS, AQ-ID Associate Professor of Pharmacy Practice, Lloyd L. Gregory School of Pharmacy, Palm Beach Atlantic University, West Palm Beach, Florida 4:15 p.m. Antimicrobial Stewardship Competencies and Outcomes Timothy Gauthier, Pharm. D., BCPS Antimicrobial Stewardship Pharmacist, Miami VA Healthcare System, Miami, Florida Conflict of Interest Disclosures Elias B. Chahine: Consultancies: (Allergan Plc, The Medicines Company), Speaker s Bureau: (Cubist, Merck, The Medicines Company), Grants: (Cubist) Timothy Gauthier: no conflicts to disclose Emily L. Heil: no conflicts to disclose Kayla R. Stover: Grants: (Astellas Pharma US, Inc.) Learning Objectives 1. Compare regulatory standards and policy changes related to antimicrobial stewardship in acute care settings. 2. Discuss the CDC Core Elements for Antimicrobial Stewardship. 3. Review the Joint Commission Standards for Accreditation. 4. Analyze the Centers for Medicare and Medicaid Services Conditions for Participation. 5. Describe antimicrobial stewardship efforts outside the hospital. 6. Explain the role of antimicrobial stewardship initiatives in outpatient clinics. 7. Describe approaches for implementing antimicrobial stewardship in nursing homes. 8. Develop strategies for implementing antimicrobial stewardship in community pharmacies. 9. Evaluate antimicrobial stewardship competencies and outcomes. 10. Discuss measures necessary to develop staff. 11. Formulate strategies to evaluate the success of these initiatives. American College of Clinical Pharmacy 1

2 12. Discuss approaches to improving quality. Self-Assessment Questions Self-assessment questions are available online at American College of Clinical Pharmacy 2

3 Regulatory Standards Related to Antimicrobial Stewardship in Acute Care Settings Emily Heil, PharmD, BCPS AQ ID University of Maryland School of Pharmacy Baltimore, Maryland October 25, 2016 Conflict of Interest I have no conflicts of interest to disclose related to the content of this presentation Learning Objectives 1. Compare regulatory standards and policy changes related to antimicrobial stewardship (ASP) in acute care settings. 2. Discuss the Centers for Disease Control and Prevention (CDC) Core Elements for Antimicrobial Stewardship. 3. Review The Joint Commission (TJC) Standards for Accreditation. 4. Analyze the Centers for Medicare and Medicaid Services (CMS) Conditions of Participation (CoP) Antimicrobial (an ti mī ˈkrō bē əl) destroying or inhibiting the growth of microorganisms and especially pathogenic microorganisms Stewardship (ˈstü ərd ˌship) the activity or job of protecting and being responsible for something Timeline PCAST Combating Resistance Report TJC Stewardship Standards Presented for Public Comment CMS Stewardship CoP Published in Federal Register Anticipated go live for TJC and CMS CDC Core Elements for Acute Care Stewardship National Action Plan for Combating Resistant Bacteria Leapfrog adds Stewardship (by CDC Core Elements) to survey TJC Standards Published American College of Clinical Pharmacy 3

4 CDC Core Elements of Hospital Stewardship Programs 1. Leadership Commitment 2. Accountability 3. Drug Expertise 4. Action 5. Tracking 6. Reporting 7. Education 1. Leadership Commitment Dedicating necessary human, financial and information technology resources Leaders establish ASP as an organizational priority Accountability documents, budget plans, performance improvement plans, strategic plans Reporting structure Budgeted financial support for antimicrobial stewardship activities 2. Accountability Identify a single leader responsible for program outcomes Ideally an infectious diseases trained physician 3. Drug Expertise Identify a single pharmacist leader responsible for working to improve antibiotic use. Ideally an infectious diseases trained pharmacist Provide support for institutions to complete antimicrobial stewardship certification in the absence of formal infectious diseases training Society of Infectious Diseases Pharmacists Antimicrobial Stewardship Certificate Program Making a Difference in Infectious Diseases Antimicrobial Stewardship Certificate Program 4. Action formulary restrictions time out Evidenced based antimicrobial usage Right drug for the right patient for the right period of time De escalation of therapy Duplicate coverage Dose optimization Maximize pharmacodynamic and pharmacokinetic aspects of antimicrobials IV to PO conversions Implement policy requiring dose, indication and duration for all antibiotic orders Implementation of antibiotic guidelines 5. Tracking Aggregate antibiotic use data needed for benchmarking, tracking use patterns/trends, and regulatory reporting requirements Adverse effects of antibiotics (e.g., C. difficile rates) Rates of multi drug resistant organisms American College of Clinical Pharmacy 4

5 6. Reporting Prescriber level and unit level data Reporting of prescriber practices back to end user, identify outliers Routine reporting to leadership Publicity to staff and the public 7. Education Routine education at the time of hiring/initial privileging and periodically thereafter Education for patients and families CDC Get Smart Week Tools Timeline PCAST Combating Resistance Report CDC Core Elements for Acute Care Stewardship National Action Plan for Combating Resistant Bacteria TJC Stewardship Standards Presented for Public Comment Leapfrog adds Stewardship (by CDC Core Elements) to survey CMS Stewardship CoP Published in Federal Register TJC Standards Published Anticipated go live for TJC and CMS Executive Order Combating Resistant Bacteria EXECUTIVE ORDER COMBATING ANTIBIOTIC RESISTANT BACTERIA By the authority vested in me as President by the Constitution and the laws of the United States of America, I hereby order as follows: Sec. 5. Improved Stewardship. (a) By the end of calendar year 2016, HHS shall review existing regulations and propose new regulations or other actions, as appropriate, that require hospitals and other inpatient healthcare delivery facilities to implement robust antibiotic stewardship programs that adhere to best practices, such as those identified by the CDC. HHS shall also take steps to encourage other healthcare facilities, such as ambulatory surgery centers and dialysis facilities, to adopt antibiotic stewardship programs. Timeline PCAST Combating Resistance Report CDC Core Elements for Acute Care Stewardship National Action Plan for Combating Resistant Bacteria TJC Stewardship Standards Presented for Public Comment Leapfrog adds Stewardship (by CDC Core Elements) to survey CMS Stewardship CoP Published in Federal Register TJC Standards Published Anticipated go live for TJC and CMS Medication Management Standard MM Effective January 1, 2017 Largely follows CDC Core Elements for Antimicrobial Stewardship The Standard: The hospital has an antimicrobial stewardship program based on current scientific literature American College of Clinical Pharmacy 5

6 MM Elements of Performance 1. Leaders establish ASP as an organization priority 2. Staff and prescribers receive education on appropriate antimicrobial prescribing and antimicrobial resistance at the time of initial privileging and periodically thereafter 3. Education provided to patients and their families on appropriate antimicrobial use MM Elements of Performance 4. The ASP teams includes the following Infectious diseases physician Infection preventionist(s) Pharmacist(s) Practitioner Consultant staff and telehealth staff are acceptable members of the ASP team. MM Elements of Performance 5. The ASP includes the CDC Core Elements 6. The ASP uses organization approved multidisciplinary protocols 7. The ASP collects, analyzes and reports data on program performance 8. QI/QA undertaken routinely to improve program Timeline PCAST Combating Resistance Report CDC Core Elements for Acute Care Stewardship National Action Plan for Combating Resistant Bacteria TJC Stewardship Standards Presented for Public Comment Leapfrog adds Stewardship (by CDC Core Elements) to survey CMS Stewardship CoP Published in Federal Register TJC Standards Published Anticipated go live for TJC and CMS Proposed CMS Rule b: Infection control and antibiotic stewardship programs Expands Infection Prevention and Control (IPC) COP originally issued in 1986 Places ASP (ownership, resources, reporting) with infection control Designate an individual, qualified through education, training, or experience in infectious diseases and/or antibiotic stewardship as the program leader Does not specify pharmacist vs MD American College of Clinical Pharmacy 6

7 CMS Rule b Not prescriptive in which guidelines should be used for reference (e.g., CDC, IDSA/SHEA guidelines) Promote evidence based use of antibiotics and reduce the incidence of adverse consequences of inappropriate antibiotic use including, but not limited to, C. difficile infections and growth of antibiotic resistance in the hospital overall CMS Rule b Estimates for ASP Staffing Hospital Beds PharmDCMS FTEs* MD CMS FTEs* IT CMS FTEs* 124 (average size) *CMS recommendations represent a minimum and do not account for patient complexity CMS Estimated Savings The CMS/Joint Commission Dream Team $1475 per bed in antibiotic costs saved Savings accrue primarily to hospital $2216 $5080 saved for each C. difficile case avoided (ASP + Infection Prevention assuming 50% effect reduction in CDI for combined IP/ASP) Savings accrue to insurers and hospitals IT Specialist ID PharmD Stewardship Team ID Physician Infection Control Microbiology Achieving Compliance Familiarize yourself with the CDC Core Elements for Antimicrobial Stewardship If you are starting from scratch, start small Utilize pre existing resources and toolkits National Quality Forum Antimicrobial Stewardship Playbook CDC assessment tools Institute for Healthcare Improvement Drivers and Change Package American College of Clinical Pharmacy 7

8 Antimicrobial Stewardship Efforts Outside the Hospital Elias B. Chahine, PharmD, FCCP, BCPS (AQ ID) Associate Professor of Pharmacy Practice Palm Beach Atlantic University West Palm Beach, FL October 25, 2016 Conflict of Interests Advisory board Allergan plc Grant support Cubist Pharmaceuticals, Inc. Speakers bureaus Cubist Pharmaceuticals, Inc. Merck & Co, Inc. The Medicines Company Learning Objectives At the conclusion of this presentation, the pharmacist should be able to: Describe antimicrobial stewardship efforts outside the hospital. Explain the role of antimicrobial stewardship initiatives in outpatient clinics. Develop strategies for implementing antimicrobial stewardship in community pharmacies. Describe approaches for implementing antimicrobial stewardship in nursing homes. Outline Antimicrobial overuse and abuse outside the hospital Antimicrobial stewardship efforts outside the hospital Antimicrobial stewardship in community pharmacies and ambulatory care clinics Antimicrobial stewardship in nursing homes Question Which statement is true regarding antibiotic prescriptions in the nursing homes? A) Less than 30% of prescriptions are necessary and appropriate B) Less than 30% of prescriptions are unnecessary or inappropriate C) Between 40 and 75% of prescriptions are necessary and appropriate D) Between 40 and 75% of prescriptions are unnecessary or inappropriate Antimicrobial Overuse and Abuse Outside the Hospital NAMCS/NHAMCS data 154 million prescriptions for antibiotics in clinics and EDs 30% are unnecessary 44% of outpatient prescriptions for acute respiratory conditions 50% are unnecessary unnecessaryprescriptions.html American College of Clinical Pharmacy 8

9 Antimicrobial Overuse and Abuse Outside the Hospital 60% of all antimicrobials are prescribed in the ambulatory care setting s were prescribed after: 21% of all pediatric office visits 10% of all adult office visits 25% of antibiotic use was unnecessary s are prescribed at 833 prescriptions per 1000 individuals Antimicrobial Overuse and Abuse Outside the Hospital In the nursing homes s are among the most frequently prescribed medications 70% of residents receive one or more course of antibiotics over a year 40 to 75% of prescribed antibiotics are unnecessary or inappropriate Harms from overuse are significant for many residents Klepser ME et al. ACSAP Book 3: Infection Primary Care. 2016; Question Efforts Outside the Hospital Which setting(s) does the National Action Plan for Combating Resistant Bacteria target? A) Ambulatory care clinics B) Community pharmacies C) Long term care facilities D) All of the above Executive Order Combating Resistant Bacteria issued by President Barack Obama in September 2014 Task Force agencies shall, as appropriate, define, promulgate, and implement stewardship programs in other healthcare settings, including office based practices, outpatient settings, emergency departments, and institutional and long term care facilities such as nursing homes, pharmacies, and correctional facilities. pressoffice/2014/09/18/executive order combating antibioticresistant bacteria Efforts Outside the Hospital National Action Plan for Combating Resistant Bacteria in March 2015 Select goals and objectives Strengthen stewardship in outpatient and long term care settings Strengthen educational programs about good antimicrobial stewardship Facilitate the development of new antibiotics and vaccines Develop and validate new rapid diagnostics Expand the availability and use of rapid diagnostics Implement annual reporting of antibiotic use in outpatient settings National target: 50% reduction in inappropriate use of antibiotics in outpatient settings _action_plan_for_combating_antibotic resistant_bacteria.pdf Efforts Outside the Hospital CDC s Get Smart: Know When Work CDC s Core Elements of Stewardship for Nursing Homes Society of Infectious Diseases Pharmacists Antimicrobial stewardship certificate Making a Difference in Infectious Diseases Pharmacotherapy Antimicrobial stewardship certificate National Association of chain Drug Stores Community pharmacy based point of care testing certificate American College of Clinical Pharmacy 9

10 Question Which antimicrobial stewardship strategy works best in community pharmacies? A) Formulary restriction and preauthorization B) Pharmacokinetic dosing for aminoglycosides and vancomycin C) Point of care testing and collaborative drug therapy agreement D) Prospective audit with intervention and feedback Community and Ambulatory Care Settings Audit and feedback Summarize clinical performance related to infectious diseases Aim at providing information to health professionals Allow them to assess and adjust their performance compared to standards Deliver feedback in real time or periodically in meetings Alter prescribing behaviors Klepser ME et al. ACSAP Book 3: Infection Primary Care. 2016; Community and Ambulatory Care Settings Prescriber education and behavioral intervention Written materials Live group presentations Alerts or prompts embedded within electronic medical records Individual face to face communication Prescriber self reflection Motivational interviewing Experience sharing between peers Case based learning Community and Ambulatory Care Settings Patient education Expectation to receive antibiotic prescriptions Patient satisfaction Adherence programs Delayed prescribing Computerized clinical decision support Develop clinical pathways or order sets Diagnostics Treatment Klepser ME et al. ACSAP Book 3: Infection Primary Care. 2016; Klepser ME et al. ACSAP Book 3: Infection Primary Care. 2016; Community and Ambulatory Care Settings Collaborative disease management programs CLIA waived point of care testing Influenza Streptococcal pharyngitis Hepatitis C HIV Community antibiograms Isolates from clinics, nursing homes, and emergency departments Isolates collected from hospitalized patients within 48 hours of admission Community and Ambulatory Care Settings Immunization programs Recommend vaccines according to Disease states Medications Travel Implement vaccination reconciliation programs May use standing orders Target common disease states RTIs, UTIs, and SSTIs Klepser ME et al. ACSAP Book 3: Infection Primary Care. 2016; Klepser ME et al. ACSAP Book 3: Infection Primary Care. 2016; American College of Clinical Pharmacy 10

11 Community and Ambulatory Care Settings Patient Care Segment Need to seek care Decision to use and select antibiotic Dispensing of an antibiotic Post encounter care Opportunity for Action Immunization programs Patient education Preventive medicine and wellness initiatives Use of point of care diagnostics Prescriber audit and feedback Prescriber education and behavioral intervention Development of community antibiograms Development of community or practice formularies Pharmacist education to encourage prescribers to include ICD 10 codes or diagnosis Telephone follow up 24 to 48 hours after the initial encounter Question Which of the following is part of the seven core elements of antimicrobial stewardship in nursing homes? A) Drug expertise and leadership commitment B) Pharmacokinetic dosing for aminoglycosides and vancomycin C) Streamlining according to culture and sensitivity D) Switching from IV to PO for antibiotics with high oral bioavailability Klepser ME et al. ACSAP Book 3: Infection Primary Care. 2016; Long Term Care Settings Leadership commitment Demonstrate support and commitment to safe and appropriate antibiotic use Accountability Identify physician, nursing, and pharmacy leads responsible for promoting and overseeing antibiotic stewardship activities Drug expertise Establish access to consultant pharmacists or other individuals with experience or training in antibiotic stewardship Long Term Care Settings Action Implement at least one policy or practice to improve antibiotic use Tracking Monitor at least one process measure of antibiotic use and at least one outcome from antibiotic use Reporting Provide regular feedback on antibiotic use and resistance to prescribing clinicians, nursing staff, and other relevant staff Long Term Care Settings Education Provide resources to clinicians, nursing staff, residents, and families about antibiotic resistance and opportunities for improving antibiotic use Long Term Care Settings Create a culture of antimicrobial stewardship Identify clinical and nursing leads Establish access to infectious diseases expertise Involve front line staff Use a standard assessment and communication tool for residents with suspected infections Use rapid diagnostics Morrill HJ et al. J Am Med Dir Assoc. 2016;17:183.e1 16 Rhee SM et al. Infect Dis Clin North Am. 2014;28: American College of Clinical Pharmacy 11

12 Long Term Care Settings Develop facility specific clinical guidelines for common infectious diseases syndromes Document antibiotic indication, dosing, and duration Review antibiotic prescriptions Focus on strategies to decrease unnecessary use Target CDI, RTIs, SSTI, and UTIs Evaluate the antibiotics listed on formulary Keys References and Readings Barlam TF, Cosgrove SE, Abbo LM, et al. Implementing an Stewardship Program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis. 2016;62:e CDC. The Core Elements of Stewardship for Nursing Homes. Available at stewardship.html. Accessed May 24, Heil EL, Kuti JL, Bearden DT, et al. The Essential Role of Pharmacists in Antimicrobial Stewardship. Infect Control Hosp Epidemiol. 2016;37: Society for Healthcare Epidemiology of America; Infectious Diseases Society of America; Pediatric Infectious Diseases Society. Policy statement on antimicrobial stewardship by the Society for Healthcare Epidemiology of America, the Infectious Diseases Society of America, and the Pediatric Infectious Diseases Society. Infect Control Hosp Epidemiol. 2012;33: Morrill HJ, Caffrey AR, Jump RL, et al. Antimicrobial stewardship in long term care facilities: a call to action. J Am Med Dir Assoc. 2016;17:183.e1 16. Morrill HJ et al. J Am Med Dir Assoc. 2016;17:183.e1 16 Rhee SM et al. Infect Dis Clin North Am. 2014;28: Key References and Readings Rhee SM, Stone ND. Antimicrobial stewardship in long term care facilities. Infect Dis Clin North Am. 2014;28: CDC. Get Smart: Know When s Work. Outpatient Stewardship. Available at prescribing/outpatient stewardship.html. Accessed May 28, Fleming Dutra KE, Hersh AL, Shapiro DJ, et al. Prevalence of inappropriate antibiotic prescriptions among US ambulatory care visits, JAMA. 2016;315: Klepser ME, Anderson KH. Community Based Antimicrobial Stewardship. In Dong BJ, Elliott DP. ACSAP Book 3: Infection Primary Care. 2016; Quality Enhancement Research Initiative. Antimicrobial Stewardship Programs in Outpatient Settings: A Systematic Review. Available at outpatient EXEC.pdf Drekonja DM, Filice GA, Greer N, et al. Antimicrobial stewardship in outpatient settings: a systematic review. Infect Control Hosp Epidemiol. 2015;36: American College of Clinical Pharmacy 12

13 Antimicrobial Stewardship Competencies & Outcomes Timothy P. Gauthier, Pharm.D., BCPS AQ ID Antimicrobial Stewardship & Infectious Diseases Pharmacist Miami Veterans Affairs Healthcare System Founder & Editor In Chief of Miami, FL October, 2016 Conflict of Interest Dr. Gauthier is an employee of the Department of Veterans Affairs. However, the views expressed in this presentation do not necessarily reflect the views of that Department or of the United States Government. Learning Objectives 1. Discuss measures necessary to develop staff 2. Formulate strategies to evaluate the success of these initiatives 3. Discuss approaches to improving quality Joint Commission Standard Critical Access Hospitals + Nursing Care Centers educates staff and licensed independent practitioners involved in antimicrobial ordering, dispensing, administration, and monitoring about antimicrobial stewardship practices occurs upon hire or granting of initial privileges & periodically thereafter may include information on antibiotic use and resistance, to doctors, nurses, and relevant staff... may include information about resistance and optimal prescribing Staff Development: What Awareness on antimicrobial stewardship in general Coordinated interventions designed to improve and measure the appropriate use of [antibiotic] agents by promoting the selection of the optimal [antibiotic] drug regimen including dosing, duration of therapy, and route of administration. Awareness on institution specific services & initiatives Antibiogram Contacting your antimicrobial stewardship program Locating institutional protocols and resources Staff Development: Who Pharmacy personnel Prescribers Nurses Others Barlam et al. Clin Infect Dis. 2016; 62(10): e51 e77 American College of Clinical Pharmacy 13

14 Staff Development: How Staff Development: When Develop a new required annual training module Integrate into existing mandatory training Infection control Quality January 1 st, 2017 External training sources MAD ID & SIDP training programs Going beyond the minimum Unit or service specific feedback & considerations Evaluating Staff Competencies Participation rates Standardized attendance sheets Administrator provided employee lists Learning & retention Actual Perceived Assessment of practice changes Crader MF. Hosp Pharm. 2014; 49(1): Striving For Quality Utilize existing resources Published literature Organizations & societies Institutional ASP websites Take a methodical approach Plan with the end in mind Align your objectives and outcomes Be realistic Become aware of available data Engage residents, fellows, students Include people outside of the pharmacy department American College of Clinical Pharmacy 14