PC2 mod 1.2 lec 2-3

_____ deaths annually as a result of resistant infections

>35,000

c. diff resistance cost _____ in 2017

$1 billion

resistance is developed by...

--> germs change or destroy ______ with ______

--> germs use _____

--> germs change the ______

- antibiotic --> enzymes

- pumps

- target

____% of antibiotics are used unnecessarily and this is commonly for ______ and _____ reasons

30%

- viral

- non-infectious

2 core strategies for antimicrobial stewardship

- front end

- back end

front end strategy of antimicrobial stewardships works by ________ before antibiotic is ordered then ______ is applied to evaluate appropriateness before the patient receives it

- restriction and pre-authorization

- institutional criteria and guidelines

back end strategy of antimicrobial stewardship has antibiotic ordered and received, then after 24-48h, appropriateness is reviewed through ______

prospective audit and feedback

advantages of front-end antimicrobial stewardship

--> reduced initiation of ______ antibiotics

--> optimized ______ and influences downstream use

--> decreases ______

- unnecessary/inappropriate

- empiric

- cost

advantages of back end antimicrobial stewardship

--> can increase visibility of _____

--> ______ maintained

--> can address ______ of antibiotics and duration of therapy

- stewardship program

- prescriber autonomy

- de-escalation

disadvantages of front-end antimicrobial stewardship

--> loss of _____

--> may ____ therapy

--> _____ resource intense system and may be presented in _____ way

- prescriber autonomy

- delay

- real-time

- bias

disadvantages of back-end antimicrobial stewardship

--> typically ______

--> prescriber may reluctant to change if patient is _______

- labor-intensive

- improving

4 D's of optimal antimicrobial therapy

drug, dose, de-escalation, duration

antimicrobials account for upwards of ___% of hospital pharmacy budget and this can increase due to _____ use, increased costs from _____ infections, and increased ______ from resistant infections

- 30%

- inappropriate/unnecessary therapy

- resistant

- morbidity/mortality

"Global Priority List of Antibiotic-Resistant Bacteria to Guide Research, Discovery, and Development of New Antibiotics" was created by ______ to prioritize ______ of new antibiotics

- WHO

- research and development

CDC 7 core elements of hospital antibiotic stewardship programs

- hospital leadership commitment

- accountability

- pharmacy expertise

- action

- tracking

- reporting

- education

CDC core element 4 of Action can be accomplished by

--> provider intervention through ABX ____ and assessing ____

--> pharmacy intervention through preventing ______, optimizing ______ and preventing ______

--> _______ intervention by culture proven infection and institutional guidelines

- time out and penicillin allergy

- duplicate therapy --> dosing --> drug interaction

- syndromic

_______ law required monitoring of antimicrobial use, resistance and stewardship program implementation in federal facilities, as well as providing UPDATED SUSCEPTIBILITY TEST interpretive criteria

21st Century Cures Act

_______ law added market exclusivity for antibiotics and was designed to stimulate development and innovation

Generating Antibiotic Incentives Now Act (GAINS)

Centers for Medicare and Medicaid Services Conditions of Participation requires all US hospitals and critical access hospitals to have _____ and _____ to receive payment

- infection prevention and control

- stewardship programs

The Joint Commission: Medication Management standard on Antimicrobial Stewardship requires hospitals and/or nursing care centers to have ______

antimicrobial stewardship program

8 elements of performance for Joint Commission antimicrobial stewardship

--> ______ establish antimicrobial stewardship

--> ______ staff members and practitioners

--> insure program includes _______

--> use ______ protocol in program

--> collect, analyze, and _____ data

--> ____ on opportunities for improvement

--> educate _____

--> has _____ team

- leaders

- educate

- CDC 7 core elements

- organization-approved multidisciplinary

- report

- act

- patients and family

- antimicrobial stewardship team

FDA GFI #213 is a process to transition medically important antimicrobials used in the feeding or drinking of animals to _______ oversight and to eliminate use of antibiotics in food-producing animals for _______

- veterinary

- growth purposes

you need ____ half lives to reach steady state

5

antimicrobial development in nonclinical stage is done to understand _______

concentration/response

antimicrobial development in phase 1 is done to describe _______ and select _____ for further evaluation

- concentration/response

- dose

antimicrobial development in phase 2a is done for preliminary ______

dose adjustment

antimicrobial development in phase 2b and 3 is done to confirm ______

dose adjustment

only _____ drug molecules can leave blood molecules and interact with bacteria

free

unbound antibiotic has to pass through ______ to enter _____ then pass through ______ to enter tissue cell and to reach antibiotic

- blood capillary wall

- interstitial fluid

- cell membrane

T>MIC can be prolonged by...

- SHORTER/LONGER dosing intervals

- SHORTER/LONGER infusion duration

- shorter

- longer

AUC/MIC can be prolonged by

- LOWER/HIGHER doses

higher

Cmax/MIC can be increased by...

--> LOWER/HIGHER dose

--> SHORTER/LONGER dosing intervals at the same daily dose

- higher

- longer

PK/PD parameters are generated during ______ studies and DO/DO NOT translate well to humans

- preclinical

- do

immune system plays a role in antibiotic therapy, such as ciprofloxacin needing ___x higher AUC/MIC in immunocompromised

4x

sometimes, _______ is not best target for treatment due to resistant bacteria population measured by _____

- MIC

- mutant prevention concentration (MPC)

_______ aims to promote optimum drug treatment by maintaining serum drug concentrations within "therapeutic range" (PK/PD target) and once a drug is chosen, a goal is set for desired serum conc.

therapeutic drug monitoring

in TDM, once drug is chosen, goal should be set for desired ______ and achieved with greatest precision allowing for _____ therapy

serum conc.

individualized

PK/PD in TDM

PK: time, AUC, Cmin, Cmax

PD: MIC

TDM best practice...

--> measure drug ________

--> use at least ____ samples

--> do not use ______

- drug conc.

- 2

- nomograms

2 samples for TDM should be drawn BEFORE/AFTER end of infusion

after

in some patients taking oral medication, conc. may be higher for 2nd sample due to...

delayed absorption

Bayesian theorem

--> _____: probability of event prior to new info

--> _____

--> _____: revised probability of event after getting new info

- bayesian prior

- new info

- posterior

Bayesian theorem applied to PK

--> prior:

--> new info:

--> posterior:

- population PK paramenter

- patient individual samples

- full PK profile and parameter

do you need 2 samples to calculate for Bayesian method?

yes

bayesian dose optimization software uses a well-developed _____ population PK model as the Bayesian prior together with ______ in the data file to calculate a _____ for the individual patient

- vancomycin

- individual patient drug conc

- bayesian posterior

Which of the following are advantages of preauthorization as a core strategy of antimicrobial stewardship? (sell all that apply)

(check all that apply)

a. Reduces initiation of unnecessary therapy for all antimicrobials

b. Reduces initiation of unnecessary therapy for restricted antimicrobials

c. Optimizes empiric choices

b. Reduces initiation of unnecessary therapy for restricted antimicrobials

c. Optimizes empiric choices

bioavailability (F) formula...

AUCextravascular/AUCiv * dose iv/dose extravascular

concentration formula...

dose/Vd

ke equation ...

lnC1-lnC2/change in time

t1/2 formula...

0.693/ke

CL formula

Vd*ke

AUC formula...

dose/CL

t>MIC can be prolonged by shorter ______ and longer ________

- doing intervals

- infusion duration

cmax/MIC can be increased by _______ and longer _______ at ______ dose

- higher dose

- dosing intervals

- same daily dose

TDM uses...

--> EARLY/LATE in therapy

--> ______ infection

--> ______ response

--> severe ____ abnormalities

--> ______

--> impaired _____

--> _____

- early

- severe/serious

- poor

- GI

- drug interactions

- clearance

- comorbidities