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A Call For Stewardship

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					A Call For Stewardship
MN Chapter of the Association of Professionals in Infection Control and Epidemiology (APIC) September 28, 2009 Kimberly Boeser, ID PharmD. University of Minnesota Medical Center, Fairview

Objectives
• Define “stewardship” and Antimicrobial Stewardship • Review Infectious Disease Society of America (IDSA) and Society of Healthcare Epidemiology in America (SHEA) 2007 Guidelines for Antimicrobial Stewardship • Steps for development of a stewardship program-getting started • Overview of keys for implementation success • Goals, roles and procedures of an antimicrobial stewardship program • Measurements & outcomes • Obstacles, triumphs and the future

Healthcare-associated Infections & the Impact
• CDC focuses on healthcare-associated infections
– how they happen? – develop appropriate interventions

• A report from CDC updates previous estimates of healthcare-associated infections
– – – – 32% UTI 22% SSI 15% PNA 14% bacteremias

• Healthcare-associated infections:
– account for an estimated 1.7 million infections – 99,000 associated deaths each year – Total cost annually= $5 billion

Background-A Need for Stewardship
• Increasing prevalence of resistant bacteria
– Multi-Drug Resistant Organisms (MDRO)
• MRSA, VRE, VRSA/VISA, C.diff, GNB (ESBL’s, KPC’s)

– Over the past decades MDRO have steadily been rising

• • •

Increased morbidity and mortality Increased Antimicrobial expenditures Decrease in market research and development
– – – – Very few antimicrobials are currently in the pipeline takes ~10 years to bring a new agent to market An investment of $800 million to $1.7 billion 56% decrease in antimicrobial approval from the FDA (1983-87 to 1998-2002)

•

Focus of National Quality Organizations
– Institute for Healthcare Improvement (IHI) – JCAHO National Patient Safety Goal

Increasing prevalence of resistant bacteria & Increased morbidity and mortality

Methicillin Resistant S. aureus (MRSA)-Hospital Acquired
• First isolates of MRSA reported in 1968 • CDC reported 2% staphylococcal infections were MRSA in 1974
– 1990’s-Alarmingly increased to 20-25% – 1999-reported as >50% – 2003-NNIS reported at 59.5% in ICU’s

• High fatality for certain MRSA infections
– Bacteremia – Poststernotomy mediastinitis – Surgical site infections

• Mortality may increase with S. aureus isolates w/ reduced susceptibilities
– – – – MIC creep CoNS (S. epidermidis) MIC >2 VISA or VRSA Treatment failures

Vancomycin Resistant Enterococcus

(VRE)
• Enterococci leading cause of many infections
– Nosocomial bacteremia – Surgical wound infections – Urinary tract infections

• Third most acquired nosocomial infection
– Reported as 10-12% – Inhabit the bowel – Hardy organisms-tolerate many environments

• Most enterococcal infections are due to
– E. faecalis -isolated from ~80% of human infections – E. faecium

• Mortality Rates of 60-70% directly related to VRE

ESBL Gram Negative bacilli
• Similar adverse outcomes reported with antibiotic resistant GNR bacteria • Increasing resistance to beta lactams, fluoroquinolones, aminoglycosides and even carbapenems
– 1997 SENTRY Antimicrobial Surveillance Program K. pneumoniae resistance rates to Ceftaz and other 3rd generation cephalosporins
• • • • Bacteremia 6.6% Pneumonia 9.7% Wound infections 5.4% UTI 3.6%

– 2003 NNIS ICU isolates of K. pneumoniae resistance reported to same drugs
• 20.6%

Stewardship
-the conducting, supervising, or managing of something; especially : the careful and responsible management of something entrusted to one's care

Antimicrobial Stewardship
• What??? Is often the response

• Definition: the appropriate selection, dosing, route and duration of antimicrobial therapy

Antimicrobial StewardshipGoals
• Primary Goal: optimize clinical outcomes, while minimizing unintended consequences of antimicrobial use – Toxicity – Selection of pathogenic organisms (MRSA, VRE, ESBL gram negative bacteria)
• Emergence of RESISTANCE

• Secondary Goal: reduce health care costs w/out adversely impacting quality of care

Antimicrobial StewardshipSupport
• Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship: CID 2007 • Support – American Academy of Pediatrics – American Society of Health-System Pharmacists – Infectious Diseases Society for Obstetrics and Gynecology – Pediatric Infectious Diseases Society – Society for Hospital Medicine – Society of Infectious Diseases Pharmacists – Society for Healthcare Epidemiology of America – Infectious Diseases Society of America

How did we get started?

Background and a Call for a Stewardship Program
• Proposal developed and presented to senior leadership for approval
– UHC best practices, resistance trends, costs – Recommendations included: 1.0 FTE Pharmacist, 0.5 FTE Medical Staff
• 0.35 FTE medicine • 0.15 FTE pediatrics

– Covered the responsibilities of the service, measurements and implementation plan

Costs Analysis
• UMMC, Fairview has a $32 million operating drug budget • Anti-infectives accounted for 10% of the total budget • Compared to UHC Best Practices UMMC, Fairview ABx $/patient day were higher than average

Total Anti-infective costs University Campus
$6,000,000 $4,000,000 $2,000,000 $0 FY 03 FY 04 FY 05 FY 06 FY 07

Antimicrobial Management TeamUMMC, Fairview: Key Components
• Action Plan for Implementation
 January 2007

• Development of Guidelines for “restricted antibiotics” • Patient Monitoring Forms/Review Process • Education to medical and pharmacy staff • Rounds with Medicine ID, Surgical ID, and Pediatric ID • Establish Measurements • Obstacles-predict • Outcomes

Getting Started
• Identify the problems with our old system

• Creating a policy- “Antimicrobial Stewardship & Restricted Anti-infective Agents”
• Generate a list to flag the “restricted antibiotics”
 20 restricted agents  spectrum of activity, potential for emergence of resistance, adverse effect profiles and cost

• Establish interventions
 12 interventions

• Develop monitoring tool
• Create antibiotic guidelines for each agent

Interventions
• • • Change to more appropriate antibiotic based on lab data Change to alternative unrestricted anti-infective Discontinue one or more antibiotics (PO or IV)

•
• • • • • • • •

Change from IV to PO antibiotics
Better empiric antibiotic therapy Antibiotic dosage change Consult recommended (eg. Infectious Disease, Pulmonary/Critical Care, Renal, Urology, etc.) Additional/Further diagnostic testing recommended Simplify antibiotic regimen (eg. Inpatients on redundant or excessively broad spectrum antibiotics Recommend change in post-op antibiotic duration Other Agree with management

Antibiotic Guidelines
• Address the following:
      Reason for restriction of agent FDA Approved Indications UMMC/UMCH, Fairview Approved Indications Dosing recommendations Monitoring Cost information

• Antibiotic Guidelines printed into a booklet that was distributed to medical students, medical residents, medical staff, pharmacy staff and students

Education/Communication
• to Medical Staff and Residents and Pharmacy Staff • Presentation to Medical Grande Rounds • Presented and distributed the Guideline Booklets to medical residents and pharmacy • Met with unit/department medical directors • Education/presentation to pharmacy staff

Role of the AMT
• Daily rounds with medicine and surgery • Tuesday/Thursday rounds with Pediatrics • Review all patient data and antibiotics
 Do restricted agents meet our guidelines for use?

• Verbal and written recommendations
 Electronic notes  Talk to the primary teams

• Follow up in 24 hours that recommendation were accepted
 If not, address the issue with the teams  Pharmacist and Staff Physician discuss with Primary team Staff

Measurements/Outcomes
• Monthly antibiotic utilization –Number of doses dispensed • Antibiotic cost per patient day • Interventions and acceptance rates

• Average number of antibiotics –Per patient day –Per patient visit • Correlation with resistance patterns

Utilization of Anti-infectivesHurdles
• Increase of 3,200 patient days from 2006 to 2007 • Expansion of our Adult Bone Marrow Transplant unit • Antibiotics prescribing opened for upfront use with no restriction

• New class of medical residents not all aware of the guidelines for use of restricted agents

UMMC - UNIVERSITY CAMPUS TOTAL ANTIMICROBIAL AVERAGE COST PER PT DAY
$70.00
Implementation of Stewardship Program: January 2, 2007

$60.00

AVE COST PER PT DAY

$50.00

$40.00

$30.00

$20.00

$10.00

$Jul-06 Aug-06 Sep-06 Oct-06 Nov-06 Dec-06 Jan-07 Feb-07 Mar-07 Apr-07 May- Jun-07 Jul-07 Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 07 Actual Base Line Trend Line

UMMC - UNIVERSITY CAMPUS TOTAL ANTIMICROBIAL AVERAGE COST PER PT DAY
$70.00 Increased Utiliazation of a nonformulary agent

$60.00

AVE COST PER PT DAY

$50.00

$40.00

$30.00

$20.00

$10.00

$Jul-07 Aug-07 Sep-07 Oct-07 Nov-07 Actual Dec-07 Base Line Jan-08 Trend Line Feb-08 Mar-08 Apr-08 May-08

Antimicrobial Cost per Patient Day (2005-2008)

Antimicrobial Agents Activity Antimicrobial Agents Total Cost Total Patient Days Antimicrobial Agent Cost per Patient Day Change

2005

University Campus 2006 2007

2008 4,396,983 99,090 $44.37 $4.58

$5,712,589 $4,954,776 $4,841,578 96,791 $59.02 95,709 $51.77 $7.25 98,910 $48.95 $2.82

Intervention Data (2007)
Totals 1143 1991 1153 (57.9%) 370 (18.6%) 468 (23.5%)

# Patients # Interventions Accepts Agree with Management Declines

Obstacles
• Gaining trust of the primary teams • Recommendations taken and changes made within 24-48 hours • Overcoming the idea this is only a “cost savings” project • Conversion from paper notes to electronic record: =/• Information systems: Tracking resistance rates

Keys To Success
• ID staff support, medical unit director support, department director support

• Communication to primary teams
• Recommendations that are evidence based and follow national guidelines

• Collaboration & Multidisciplinary Approach
• DATA, DATA, DATA !!! • Show me the $$$ • Keeping in mind, “What is best for our patients as a whole” • Early wins

Future Plans
• Clinical Measurement Plan
– Expansion of other antibiotics

• Development of Clinical Pathways for disease states • Annual update of Antimicrobial Guideline Booklet • Incorporate our guidelines into electronic ordering • Expansion of Stewardship Program to other Fairview System Hospitals • Publishing our data: including cost and impact of antimicrobial utilization on resistance trends

Last Thought…
• “When you want to cook a frog, they say, don’t throw it into boiling water-it will only jump out. Instead place the frog in tepid water and, ever so slowly increase the heat.” Extending the Cure Campaign • Much like the frog, our awareness of resistance (danger) is there. The steady increase of resistance is known…but are we waiting for a crisis to respond?

Acknowledgements
• Department of Pharmacy
– Pam Phelps

• Infection Prevention Department
– Chris Hendrickson – Anita Guelcher – Sue Garayalde

• Dept. of Surgery, Pediatrics and Medicine physicians who have participated with AMT
– Greg Beilman, Matthew Byrnes, Jeff Chipman – Mark Schleiss, Mark Robein, Pat Ferierri – Phil Peterson, Susan Kline, Winston Cavert, Paul Bohjanen, Dave Boulware, Bryan Rock, Tim Schacker, Mark Cannon, David Strike

References
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Dellit TH, Owens RC, McGowan JE, et al. Infectious Diseases Society of American and the Society for Healthcare Epidemiology of America Guidelines for Developing an Institutinal Program to Enhance Antimicrobial Stewardship. CID. 2007; 44: 000. National Institute of Allergy and Infectious Diseases. The problem of antibiotic resistance. www.niaid.nih.gov/factsheets/antimicro.htm (accessed 2006 Nov). Centers for Disease Control and Prevention. National Nosocomial Infections Surveillance (NNIS) System report, data summary from January 1992 through June 2004, issued October 2004. www.cdc.gov/ncidod/dhap/pdf/nnis/2004NNISreport.pdf (accessed 2006 Nov). Infectious Diseases Society of America. Bad bugs, no drugs. As antibiotic discovery stagnates…a public health crisis brews. www.idsociety.org/pa/IDSA_Paper4_final_web.pdf (accessed 2006 Nov). Centers for Disease Control and Prevention. Management of Multidrug-Resistant Organisms In Healthcare Settings, 2006. www.cdc.gov/ncidod/dhqp/pdf/ar/mdroGuideline2006.pdf (accessed 2006 Nov). Turck C et al. Novel Agents for the Treatment of Methicillin-Resistant Staphylococcus aureus (MRSA) and Vancomycin Resistant Enterococci (VRE). University HealthSystem Consortium-Drug Monographs. 2006 Dec: 1-46. Wenzel RP. The Antibiotic Pipeline-Challenges, Costs and Values. N Engl J Med. 2004; 351(6):523-26. Nelson R.. Antibiotic development pipeline runs dry. The Lancet. 2003; 362: 1726-27. Kollef MH, Sherman G, Ward S, et al. Inadequate antimicrobial treatment of infections: a risk factor for hospital mortality among critically ill patients. Chest. 1999; 115:462-74. Scheetz MH, Hurt KM, Noskin GA, Oliphant CM. Applying antimicrobial pharmacodynamics to resistant gram-negative pathogens. Am J Health-Syst Pharm. 2006; 63: 1346-1360. Fridkin SK, hageman JC Morrison M, et al. for the Active Bacterial Core Surveillance Program of the Emerging Infections Program Network. Methicilin-resistant Staphylococcus aureus disease in three communities. N Engl J Med. 2005;352 (14): 1436-1444 Aslam S and Musher, DM. An Update on Diagnosis, Treatment, and Prevention of Clostridium difficileAssociated Disease. Gastroenterol Clin N AM. 2006 35:315-335. Blossom DB and McDonald LC. The Challenges Posed by Reemerging Clostridium difficile Infection. CID 2007;45:000-000


				
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