S43 - Antibiotic Stewardship Flashcards
The United States is the fifth most intensive user of antibiotics in the world, only surpassed by
France, Greece, Italy, and Belgium.
_____ of hospitalized patients receive antibiotics
25-40%
Antibiotics are the most common cause of emergency department visits for adverse drug events in
children under 18 years of age.
Section 505E(g) of the FD&C Act provides for the designation by FDA of certain antimicrobial products as
Qualified Infectious Diseases Product Designation (QIDP)
an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections
To establish and maintain a list of “qualifying pathogens,” and make public the methodology for developing the list. A qualifying pathogen is defined as a pathogen identified and listed by the Secretary . . . that has the potential to pose a serious threat to public health, such as ─
(A) resistant gram positive pathogens, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococcus;
(B) multi-drug resistant gram negative bacteria, including Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;
C) multi-drug resistant Tuberculosis; and
(D) Clostridium difficile
to encourage the development of new antibiotics, as each year at least two million people develop serious infections caused by antibiotic-resistant bacteria.
Generating Antibiotic Incentives Now (GAIN)Actwas passed as part of the Food and Drug Administration Safety and InnovationAct(FDASIA)
Newly Approved Antibiotics 2018 and 2019
Cefiderocol (2019) ***NEW*** Lefamulin (2019) Imipenem/cilastatin/relebactam (2019) Omadacycline (2018) Eravacycline (2018) Plazomicin (2018)
How are Antibiotics Misused?
Given when NOT indicated or for a non-infectious disease state
Wrong antibiotic selected
Wrong dose or route
Wrong duration of therapy
Inappropriate use of broad-spectrum antibiotics
Treatment of colonization/contamination
Redundancy in therapy/duplication
Consequences of Antibiotic Misuse
Adverse drug events
Increased prevalence of Multi-Drug Resistant Organisms (MDROs)
Increase in infection/ colonization with MDROs
Fewer susceptible antibiotics available
Most Common Adverse Drug Events (ADEs) Associated with Antibiotics
Allergic reactions/anaphylaxis
Hearing loss(ototoxicity)
Renal failure (nephrotoxicity)
Liver toxicity (hepatotoxicity)
Bone marrow suppression (myelosuppression)
QT prolongation and risk of sudden cardiac death
SPACE
(Serratia spp., Pseudomonas aeruginosa, Acinetobacter spp., Citrobacter spp., Enterobacter spp.)
SPICE
(Similar to SPACE, but “I” stands for Indole positive Proteae, such as Proteus vulgaris, Morganella morganii, and Providencia spp.)
ESKAPE
(Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter spp.)
ESCAPE
(Similar to ESKAPE, but “C” stands for Clostridiodes difficile and the second “E” stands for Enterobacteriaceae
CDC’s Antibiotic Resistance Threats Report 2019
Urgent
Carbapenem-resistant Acinetobacter NEW
Candida auris (C. auris) NEW
Clostridium difficile (now Clostridiodes difficile)
Carbapenem-resistant Enterobacteriaceae (CRE)
Drug-resistant Neisseria gonorrhoeae
CDC’s Antibiotic Resistance Threats 2019
Concerning Threats
Erythromycin-resistant Group A Streptococcus spp.
Clindamycin-resistant Group B Streptococcus spp.
**Vancomycin-resistant Staphylococcus aureus (VRSA)
removed from the list in 2019
CDC’s Antibiotic Resistance Threats 2019
Watch List NEW
Azole-resistant Aspergillus fumigatus (A. fumigatus)
Drug-resistant Mycoplasma genitalium (M. genitalium)
Drug-resistant Bordetella pertussis (B. pertussis)
Infection controlis the discipline concerned with preventing________or healthcare-associated infection, a practical (rather than academic) sub-discipline of____________.
nosocomial
epidemiology
Components of Infection Control include: Hand hygiene Sterilization Cleaning Disinfection Personal protective equipment Antimicrobial surfaces as well as :
Vaccination of health care workers Post-exposure prophylaxis Surveillance of infections Isolation and quarantine Outbreak investigation Training in infection control and health care epidemiology
What is Antimicrobial Stewardship?
A systematic and multidisciplinary approach to the appropriate use of antimicrobial agents to achieve optimal patient outcomes
Coordinated interventions
Improve the appropriate use of antibiotics
Measure the appropriate use of antibiotics
Promote the selection of the optimal antibiotic regimen
- Right antibiotic
- Right dose
- Right route of administration
- Right frequency of administration
- Right duration of therapy
- Right indication
ASP Core Team Players: A Multidisciplinary Approach:
Two primary players:
Infectious Diseases Physician Champion (Director)
Infectious Diseases trained/Antimicrobial Stewardship clinical pharmacist (Co-Director)
Responsibilities of the Antimicrobial Stewardship Program (ASP)
Monitoring of antimicrobial use
- Dangerous or toxic anti-infective broad-spectrum anti-infective where emerging resistance may be a problem for the facility
- High-cost items that may have more cost-effective alternatives
The ASP may use a variety of mechanisms to improve the use of antimicrobials within the hospital. These may include, but are not limited to the following:
Primary:
- Prospective audit with the intervention and feedback
- Formulary restriction and preauthorization requirement for specific agents
Secondary
- Education
- Guidelines and/or clinical pathways
- Antimicrobial cycling and scheduled antimicrobial switch
- Antimicrobial order forms
- Combination therapy: prevention of resistance versus redundant antimicrobial coverage
- Streamlining and/or de-escalation of therapy
- Dose optimization (e.g., renal dosing, pharmacokinetic dosing)
- Parenteral to oral conversion of antimicrobials
Barriers to Implementation of an ASP
Personnel shortages (ID physician, ID pharmacists)
Financial considerations (compensation for time)
Higher-priority clinical initiatives
Opposition from prescribers/other specialties (loss of autonomy in clinical decision making)
Resistance from administration
Restriction policies that may be difficult to adopt
Continued need to assess the success of a program in order to sustain efforts
National Action Plan for Combating Antibiotic-Resistant Bacteria issued by the White House in March 2015. This plan:
calls for establishment of ASPs in all acute care hospitals by 2020 and for the Centers for Medicare and Medicaid Services to issue a Condition of Participation that participating hospitals develop programs based on recommendations from the Centers for Disease Control and Prevention’s (CDC) Core Elements of Hospital Antibiotic Stewardship Programs.
2016 Antimicrobial Stewardship Guidelines
Updated Definition:
“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”
Removed Cost effectiveness and AE
**2016 Antimicrobial Stewardship Guidelines
We recommend preauthorization and/or prospective audit and feedback over
no such intervention (strong recommendation, moderate-quality evidence).
2016 Antimicrobial Stewardship Guidelines
General Interventions
We suggest against relying solely on didactic educational materials for stewardship (weak recommendation, low-quality evidence). New
We suggest ASPs develop facility-specific clinical practice guidelines coupled with a dissemination and implementation strategy (weak recommendation, low-quality evidence). New
We suggest ASPs implement interventions to improve antibiotic use and clinical outcomes that target patients with specific infectious disease syndromes (weak recommendation, low-quality evidence). New
**2016 Antimicrobial Stewardship Guidelines
We recommend antibiotic stewardship interventions designed to reduce the use of antibiotics associated with a high risk CDI compared
with no such intervention (strong recommendation, moderate-quality evidence). New
2016 Antimicrobial Stewardship Guidelines
We suggest the use of strategies (e.g., antibiotic time-outs, stop orders) to encourage prescribers to perform routine review of antibiotic regimens to improve antibiotic prescribing (weak recommendation, low-quality evidence). New
We suggest incorporation of computerized clinical decision support at the time of prescribing into ASPs (weak recommendation, moderate-quality evidence). New
We suggest against the use of antibiotic cycling as a stewardship strategy (weak recommendation, low-quality evidence). Continuation
**2016 Antimicrobial Stewardship Guidelines
We recommend that hospitals implement PK monitoring and adjustment programs for
aminoglycosides (strong recommendation, moderate-quality evidence). Expansion
**2016 Antimicrobial Stewardship Guidelines
We recommend that ASPs implement guidelines and strategies to reduce antibiotic therapy to the
shortest effective duration (strong recommendation, moderate-quality evidence). New
**2016 Antimicrobial Stewardship Guidelines
We suggest the use of rapid viral testing for respiratory pathogens to reduce
the use of inappropriate antibiotics (weak recommendation, low-quality evidence). New
**2016 Antimicrobial Stewardship Guidelines
In adults in the ICUs with suspected infection, we suggest
the use of serial PCT measurements as an ASP intervention to decrease antibiotic use (weak recommendation, moderate-quality evidence). New
CDC’s 12 Steps to Prevent Antimicrobial Resistance: Hospitalized Adults
Vaccinate Get the catheters out Target the pathogen Access the experts Practice antimicrobial control Use local data Treat infection, not contamination Treat infection, not colonization Know when to say “no” to vanco Stop treatment when infection is cured or unlikely Isolate the pathogen Break the chain of contagion
What can you do to be better Antibiotic Stewards?
Take a 48-hour to 72-hour time-out!
Think about situations where you can avoid antibiotics
Adjust your antibiotics appropriately
Laboratory monitoring
Educate patients about antibiotics
Pick the RIGHT antibiotic for the patient
