Stewardship And Regulatory

Question 1

NARMS

Answer 1

National Antimicrobial Resistance MOnitoring System: Salmonella, Campylobacter, Shigella

Question 2

ABC

Answer 2

Active BActerial Core Surveillance: Strep pneumo, beta-hemolytic strep, MRSA

Question 3

HAIC

Answer 3

Healthcare associated infections Community interface: C. Difficile, Candida, CRE, MDR Acinetobacter

Question 4

NHSN

Answer 4

National Healthcare Safety Network: Staph aureus, Enterococcus, Enterobacteriaceae, Acinetobacter, Pseudomonas, Candida, C. Diff

Question 5

PCAST recommendations

Answer 5

AS recommendations from PCAST a. By the end of 2017, CMS should have federal regulations requiring development and implementa- tion of “robust antibiotic stewardship programs”

expand the Physician Quality Reporting System in the outpatient setting

Federal agencies should require implementation of antibiotic stewardship programs as a condition for receiving federal grants for health care delivery

Question 6

National Targets to Combat AR Bacteria for Urgent Threats by 2020

Answer 6

Reduce C. Diff incidence by 50% (vs 2011)
Reduce by 60% CRE
Keep CTX-R gonorrhea <2%

Question 7

Goals for National Action Plan

Answer 7

Antibiotic use data will be reported to NHSN by 95% of CMS-eligible hospitals and government facilities (U.S. Department of Defense, Veterans Affairs).

Reduce inappropriate use for monitored conditions/agents by 20% in inpatient settings and by 50% in outpatient settings.

Question 8

Limited Population Pathway for antibacterial and antifungal drugs

Answer 8

Sec 3042- Limited Population Pathway for antibacterial and antifungal drugs i. Allows that the FDA may approve an antibiotic or antifungal for use in a limited population if it is intended to treat a serious infection in a limited population ii. Requires that the label and prescribing information indicates that the drug has been approved for use only in a limited population.

Question 9

FDA susceptibility testing website

Answer 9

establishment (within 1 year after enactment of “Cures Act”) and maintenance of an FDA-hosted website that can efficiently be updated and contains a list of any appropriate new or updated susceptibility test interpretive criteria ii. Website launched in December 2017 - www.fda.gov/STIC

Question 10

Characteristics of QIDP

Answer 10

for QIDP: i. FDA priority review ii. Fast-track review (reduces 12 months to 8 months) iii. 5 years of additional market exclusivity (in addition to current 5 years)

Question 11

TJC Elements of Performance

Answer 11

Leaders establish AS as an organizational priority
Educate staff and practitioners
Educate patients and families
Multidisciplinary AS team
ASP includes CDC Core Elements
ASP uses organizational protocols
Organization collects analyzes and reports ASP data
Organization take actions on improvement opportunities

Question 12

California ASP regulations

Answer 12

SB 739 - Acute hospitals develop ASP processes
SB 1131 - Acute hospitals develop ASPs - required
SB361 - SNFs
SB 43 - antibiogram

Question 13

CDC Core Elemetns

Answer 13

Leadership commitment
Accountability
Drug expertise
Action (e.g. Audit and feedback)
Tracking
Reporting
Education

Question 14

IDSA Stewardship guidelines strong recommendations

Answer 14

Preauthorization and/or audit and feedback
Interventions to reduce use of antibiotics associated with CDI
Dedicated PK monitoring and adjustment - aminoglycosides
IV-PO conversion
Reduce duration to shortest effective

Question 15

Four components of CDC Core Elements for Outpatient antibiotic stewardship

Answer 15

Commitment
Action (implement at least one policy or practice and monitor)
Tracking and reporting with feedback
Education and expertise (for patients and providers)

Question 16

“5 D’s” process goals for ASPs

Answer 16

The process goal of an ASP is optimal antimicrobial use and ensuring that the five D’s of antimicrobial use are met. 1. Diagnosis 2. Drug 3. Dose 4. Duration 5. De-escalation

Question 17

SAAR categories and locations

Answer 17

SAARs are calculated for the following categories: i. Broad-spectrum antibacterial agents predominantly used for hospital-onset/multidrug- resistant infections ii. Broad-spectrum antibacterial agents predominantly used for community-acquired infections iii. Anti-MRSA antibacterial agents iv. Antibacterial agents predominantly used for surgical site infection prophylaxis v. All antibacterial agents

SAARs are also expressed by hospital wards. i. Adult medical, medical/surgical, and surgical ICUs ii. Adult medical, medical/surgical, and surgical wards iii. Pediatric medical, medical/surgical, and surgical ICUs iv. Pediatric medical, medical/surgical, and surgical wards