ANTIBIOTIC STEWARDSHIP. Brian Mayhue, Pharm D, CGP Director of Pharmacy Palm Beach Gardens Medical Center

Transcription

1 ANTIBIOTIC STEWARDSHIP Brian Mayhue, Pharm D, CGP Director of Pharmacy Palm Beach Gardens Medical Center

2 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

3 Antibiotic Resistance

4 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 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

5 Antibiotic Development Total # New Antibacterial Agents '83-'87 '88-'92 '93-'97 '98-'02 '03-'07 '08-'12

6 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

7 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)

8 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 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

9 Unnecessary Use of Antimicrobials in Hospitalized Patients Prospective observational study in ICU 576 (30%) of 1941 antimicrobial days of therapy deemed unnecessary Most Common Reasons for Unnecessary Days of Therapy Days of Therapy Duration of Therapy Longer than Necessary Noninfectious or Nonbacterial Syndrome 94 Treatment of Colonization or Contamination Hecker MT et al. Arch Intern Med. 2003;163:

10 Antibiotic Misuse Given when they are not needed Continued when they are no longer necessaryduration 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

11 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

12 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

13 Goals of Antimicrobial Stewardship Programs Optimize Patient Safety Reduce Resistance Decrease or Control Costs

14 Antimicrobial Stewardship Improve patient outcomes Goals 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): Ohl CA. J. Hosp Med. In press. Dellit TH, et. al. Clin Infect Dis. 2007;4

15 Antibiotic misuse adversely impacts patients- C. difficile 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 infection 1 20% of patients admitted to the ICU with CDI were receiving antibiotics without evidence of infection with an accompanying 28% in-hospital mortality 2 1 Infect Control Hosp Epidemiol 2007; 28: BMC Infect Dis 2007; 7:42

16

17 PBGMC C. Diff Rate Rate based on cases per admissions Rate

18 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

19 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

20 Multidisciplinary Team Approach Infection Prevention Medical Information Systems Hospital Epidemiologist Microbiology Laboratory * Hospital and Nurse Administration AMP Directors Cl. Pharmacist Physician Champion Clinical Pharmacy Specialists Decentralized Pharmacy Specialist Infectious Diseases Director, Quality Chairman, P&T Committee Partners in Optimizing Antimicrobial Use such as ED, hospitalists, intensivists and surgeons *based on local resources Modified: Dellit et al. ClD 2007;44:

21 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

22 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

23 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

24 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

25 Prospective Audit and Feedback Advantages Prescriber autonomy maintained Educational opportunity provided Patient information can be reviewed before interaction Inappropriate antibiotic use decreased De-escalation

26 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

27 Dose Optimization New evidence for duration of therapy Uncomplicated urinary tract infection: 3-5 days 1 Community-acquired pneumonia: 3-7 days 2 Ventilator-associated pneumonia: 8 days 3 CR-BSI Coagulase-negative staphylococci: 5-7 days 4 Acute Hem Osteomyelitis in children-21 days 5 Meningococcal meningitis-7 days 6 Uncomplicated secondary peritonitis with source control: 4-7 days 7 Avoid day course of antibiotic therapy

28 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

29 Pip/Tazo purchases Pip/Tazo

30 Formulary Restriction Restrict high cost antibiotics to infectious disease physicians Examples: daptomycin, linezolid, tigecycline

31 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

32 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

33 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)

34 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

35 PBGMC Antibiotic Spending

36 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

37 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

38 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