antibiotic stewardship - fha · • antibiotic stewardship is meant to optimize the use of...
TRANSCRIPT
ANTIBIOTIC STEWARDSHIP
Brian Mayhue, Pharm D, CGP Director of Pharmacy
Palm Beach Gardens Medical Center
Antibiotic Resistance “It is not difficult to make microbes resistant to penicillin in the laboratory by exposing them to concentrations not sufficient to kill them, and the same thing has occasionally happened in the body…there is the danger that the ignorant man may easily under-dose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant.” -Alexander Fleming, Nobel prize lecture, 1945
Antibiotic Resistance
Bad Bugs, No Drugs • IDSA expressed their concerns with the drying
pipeline of new antibiotics – Resistant bacteria cause infection in the young and old,
the healthy and frail – 2 million people acquire healthcare associated
infections (HAI); 90,000 die annually – Higher healthcare costs - ≈$5 billion annually – Big Pharma can’t turn a profit with antibiotics – 10 – 20 years and $800 million – $1.7 billion to bring a
drug to market – National and global security problem – Dwindling drug discovery and increasing antibiotic
resistance are increasing threats to the US public health
Antibiotic Development
0
2
4
6
8
10
12
14
16
'83-'87 '88-'92 '93-'97 '98-'02 '03-'07 '08-'12
Tot
al #
New
Ant
ibac
teri
al A
gent
s
Year Introduced Class of Drug 1935 Sulfonamides
1941 Penicillins
1944 Aminoglycosides
1945 Cephalosporins
1949 Chloramphenicol
1950 Tetracyclines
1952 Macrolides/lincosamides/streptogramins
1956 Glycopeptides
1957 Rifamycins
1959 Nitroimidazoles
1962 Quinolones
1968 Trimethoprin
2000 Oxazolidinones
2003 Lipopeptides
IDSA’s multi-pronged approach to antibiotic resistance
• fix the broken antibiotic drug pipeline • support the development and utilization of new rapid
diagnostic tests • enact the Strategies to Address Antimicrobial Resistance
(STAAR) Act (H.R. 2400) • implement effective infection prevention and control
programs • support the development of new vaccines and appropriate
immunization policies • stop non-judicious uses of antibiotics on U.S. farms
(animal and plant agriculture) • view antibiotic resistance as a global health issue • promote the judicious use of antibiotics in human
medicine (antimicrobial stewardship)
Magnitude of Antimicrobial Use • Antibiotics are the second most commonly used class of
drugs in the United States • More than 8.5 billion dollars are spent on anti -infectives
annually 200-300 million antimicrobials prescribed annually 53% for outpatient use
• 30-50% of all hospitalized patients receive antibiotics • Studies estimate up to 50% of antibiotic use is either
unnecessary or inappropriate across all type of health care settings
Unnecessary Use of Antimicrobials in Hospitalized Patients
• Prospective observational study in ICU • 576 (30%) of 1941 antimicrobial days of therapy deemed
unnecessary
Hecker MT et al. Arch Intern Med. 2003;163:972-978.
Most Common Reasons for Unnecessary Days of Therapy
192 187
94
0
50
100
150
200
250
Duration of TherapyLonger than Necessary
Noninfectious orNonbacterial Syndrome
Treatment ofColonization orContamination
Days
of T
hera
py
Antibiotic Misuse • Given when they are not needed • Continued when they are no longer necessary-
duration • Given at the wrong dose-renal and weight-based
dosing • Broad spectrum agents are used to treat very
susceptible bacteria • The wrong antibiotic is given to treat an infection
Summary • Multi-drug resistant pathogens are becoming more
common everywhere • New antibiotics with novel mechanisms of action are not
being produced by Big Pharma • Antibiotic stewardship is meant to optimize the use of
antibiotics, not to police them • California SB 739, CASPI can help kick-start national
legislation of ASP as a requirement for participation in CMS reimbursement
• We all need to do our part in the responsible prescribing of antibiotics; it effects all of us
Guidelines to develop an institutional Antimicrobial Stewardship Program (ASP)
• Antimicrobial Stewardship committee • Computer surveillance and decision support
software • Proactive microbiology lab • Monitoring of process and outcomes
measures • Elements of an ASP
– Active Strategies – Supportive Strategies
Goals of Antimicrobial Stewardship Programs
Optimize Patient Safety
Decrease or Control Costs
Reduce Resistance
Antimicrobial Stewardship Goals
• Improve patient outcomes • Optimize selection, dose and duration of Rx • Reduce adverse drug events including secondary infection
(e.g. C. difficile infection) • Reduce morbidity and mortality • Limit emergence of antimicrobial resistance • Reduce length of stay • Reduce health care expenditures
MacDougall CM and Polk RE. Clin Micro Rev 2005;18(4):638-56.
Ohl CA. J. Hosp Med. In press. Dellit TH, et. al. Clin Infect Dis. 2007;4
• Antibiotic exposure is the single most important risk factor for the development of Clostridium difficile infection (CDI). – Up to 85% of patients with CDI have antibiotic
exposure in the 28 days before infection1
• 20% of patients admitted to the ICU with CDI were receiving antibiotics without evidence of infection with an accompanying 28% in-hospital mortality2
1 Infect Control Hosp Epidemiol 2007; 28:926–931.
2 BMC Infect Dis 2007; 7:42
Antibiotic misuse adversely impacts patients- C. difficile
PBGMC C. Diff Rate
• Rate based on cases per 10000 admissions
0 0.5
1 1.5
2 2.5
3 3.5
4 4.5
5
Rate
2012 2013
Challenges • Literature often not clear in Infectious Diseases • Everyone thinks they know how to use antibiotics • Providers perceive autonomy is lost • Difficulty proving impact (no national measures) • Financial pressures dictating decisions
– Pharmaceutical manufacturers – Hospitals – Insurance companies – Patients
Getting Started Multidisciplinary team
– Physician champion – Clinical pharmacist (with ID training)
Decentralized (on the units) – Additional
– clinical microbiology – Information systems specialist – Infection prevention professional/ hospital
epidemiologist
Multidisciplinary Team Approach
* Hospital Epidemiologist
Infection Prevention
Medical Information Systems
Microbiology Laboratory
Infectious Diseases Director,
Quality
Chairman, P&T Committee
Partners in Optimizing Antimicrobial Use such as ED, hospitalists, intensivists and surgeons
Hospital and Nurse Administration
AMP Directors • Cl. Pharmacist • Physician Champion
Clinical Pharmacy Specialists
Decentralized Pharmacy Specialist
Modified: Dellit et al. ClD 2007;44:159-177. *based on local resources
Physician Champion • Basic knowledge of antibiotics*(does not have to
be an infectious disease MD but helps) • Must show interest in taking a leadership role in
the hospital • Respected by his or her peers • Good interpersonal skills • Good team player • Basic understanding of human factors and culture
transformation
Key Elements for Successful ASP
• Establish compelling need and goals for ASP • Senior leadership support • Effective physician champion • Adequate resources (pharmacy, infection prevention [IP],
microbiology, information technology [IT]) • Primary objectives: optimize clinical outcomes and reduce
adverse events, not necessarily reduce costs • Good teamwork and follow up
PBGMC Antibiotic Stewardship Program
• Prospective audit with intervention and feedback
• Streamlining or de-escalation of therapy • Dose optimization • Formulary restriction and pre-authorization • Parenteral to oral conversion
Prospective Audit and Feedback Back-end Approach
Physician writes order
Antibiotic Dispensed
At a later date, time antibiotics reviewed
Prescribing physician contacted and recommendations made
Prospective Audit and Feedback
• Advantages – Prescriber autonomy maintained – Educational opportunity provided – Patient information can be reviewed before
interaction – Inappropriate antibiotic use decreased – De-escalation
Prospective Audit and Feedback
• Disadvantages – Voluntary compliance – Identification of patients require computer
support (IT pharmacist helpful) – Prescribers reluctant to change if patient is
doing well – Some inappropriate antibiotic use permitted
Dose Optimization • New evidence for duration of therapy
– Uncomplicated urinary tract infection: 3-5 days1 – Community-acquired pneumonia: 3-7 days2 – Ventilator-associated pneumonia: 8 days3 – CR-BSI Coagulase-negative staphylococci: 5-7 days4 – Acute Hem Osteomyelitis in children-21 days5 – Meningococcal meningitis-7 days6 – Uncomplicated secondary peritonitis with source control: 4-7 days7
• Avoid 10-14 day course of antibiotic therapy
Dose Optimization
• Other steps taken at PBGMC – Implementation of extended infusion of
Pip/Tazo (started in Feb 2013) • Dosing based on renal function (either Pip/Tazo
3.375g IV q12hrs or q8hrs over 4 hr period)
– Renal Dosing Policy • Allows pharmacist to change dose/ frequency based
on renal function
Pip/Tazo purchases
0
20000
40000
60000
80000
100000
120000
Pip/Tazo
2012 2013
Formulary Restriction
• Restrict high cost antibiotics to infectious disease physicians – Examples: daptomycin, linezolid, tigecycline
IV to PO Conversion
• Develop a policy specifically targeting antibiotics which have same bioavailability to change to oral if certain criteria are met. – Azithromycin – Fluconazole – Fluoroquinolones (ciprofloxacin, levofloxacin) – Metronidazole – Linezolid – Clindamycin – Doxycycline
IV to PO Conversion
• Inclusion Criteria (must meet one) – Tolerating a regular or modified diet for at least
24 hours – Tolerating enteral nutrition for at least 24 hours – Receiving other scheduled medications by the
oral route – Signs and symptoms of infection have resolved
or are improving
IV to PO Conversion
• Exclusion criteria (must have none) – Unable to swallow, NPO, high risk for aspiration – Active N/V/D, GI obstruction, IBS, malabsorption, or ileus – Signs and symptoms of infection have not improved – Experienced severe trauma within last 72 hrs – Active GI bleed – Neutropenia (ANC<5000 – Documented CNS infection or endocarditis – Pneumonia with AIDS or severely immunocompromised – Pseudomonas infection and on antibiotics <24 hrs – Candidemia treated <7 days – Other infections where IV therapy is the preferred standard of care
(osteomyelitis)
Other Interventions
• Post antibiogram on line through our physician portal
• Work with Pharmacy Informatics to get computer generated reports to help clinical pharmacists identify opportunities
• Future opportunities (procalcitonin) to identify sepsis
PBGMC Antibiotic Spending
0
20000
40000
60000
80000
100000
120000
2012 2013
Lessons Learned
• Physician push back was a huge problem – Education does not always work- because they
“know” better – A peer (trusted colleague/ physician champion)
is the key to success – Showing physicians financial data vs their peers
does work
Lessons Learned
• One ID physician changing prescribing habits can make all the difference
• Getting simple policy and procedures thru P&T is not always simple
• Whatever is the driving force for starting an ASP it can be successful and can help substantially cut medication costs
Conclusion
• Effective empiric antimicrobial selection based on your particular hospital (antibiogram)
• Optimize dose and route of administration • Administer for the shortest duration
possible • De-escalate once susceptibility known • Stop if no infection identified