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12/15/2015
Housewide Default to Extended Infusion Protocols
 Extended infusion Zosyn ® – Live since April 2015
− Old: 4.5g Q6H (30 min)
− New: 3.375g x1 (over 30 min), then 3.375g Q8H* (over 4 hours)
Extended Infusion Beta-lactam
Protocols
Go-Live: December 22, 2015
 Extended infusion cefepime, meropenem – Dec 22, 2015 Go-Live
− Same dosing regimens except:
 New: Initial “load/bolus” given over 30 minutes
 New: subsequent doses given over 3 or 4 hours
Emily Mui, PharmD, BCPS
Lina Meng, PharmD, BCPS
Examples:
Stanford Antimicrobial Safety and Sustainability (SASS) Program
Cefepime 1-2g x1 over 30 min, then 1-2g q8h* (over 4 hours)
Meropenem 1-2g x1 over 30 min, then 1-2g q8h* (over 3 hours)
Zosyn 3.375g x1 (over 30 min), then 3.375g Q8H* (over 4 hours)
*starts 4 hours after 1st dose
Confidential – For Discussion Purposes Only
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Rationale
Process
 Maximize the time-dependent bactericidal activity
 All orders will default to the extended-infusion regimen for Zosyn®, cefepime,
and meropenem except:
− Time which the free drug concentration exceeds the MIC of the organism (fT>MIC)
 Target pathogens with high MIC (e.g. pseudomonas)
 Please contact floor pharmacist to opt out
Goal target attainments by beta-lactam
class
Carbapenems
Cephalosporins
Penicillins
Grampositive
20-30% fT>MIC
40-50% fT>MIC
30-40%
fT>MIC
Gramnegative
40-50% fT>MIC
60-70% fT>MIC
50-50%
fT>MIC
− OR/PACU/pre-op
− Ambulatory care areas
 Improved mortality and lower length of stay
Pathogen
− One-time orders in the ER
− Medication scheduling and/or drug compatibility conflicts that cannot be resolved
without placing additional lines
− Patients who are on a prolonged course of antibiotics (e.g. osteomyelitis), are
clinically improving, AND the organism has an MIC ≤4
Lodise et al, CID 2007, Lodise et al, Pharmacotherapy 2006
Confidential – For Discussion Purposes Only
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Confidential – For Discussion Purposes Only
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Policy
 Upon provider request, SHC pharmacists will manage inpatient IV vancomycin
therapy in accordance with evidence-based guidelines and best practice
standards
 Pharmacist will:
Vancomycin per Pharmacy Protocol
Go-Live: January 5, 2016
− Based on MD/APP specified indication, select goal trough level per protocol/IDSA
guidelines
− Enter necessary drug and lab orders
 Vancomycin doses
 Vancomycin troughs ($342 each)
 SCr
 Exclusion Criteria:
− One-time dose
− Surgical/peri-operative prophylaxis
− Pediatric patients (<18 years of age)
Confidential – For Discussion Purposes Only
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12/15/2015
Provider Responsibility
EPIC Order
 Select “Vancomycin per Pharmacy Protocol” to indicate that pharmacist
should manage therapy
 Select “Vancomycin per Pharmacy Protocol”
− Modeled after “Warfarin per Protocol”
− This help order will remain on the MAR
 Other vancomycin doses will still be visible if you want to manage off-protocol
− Do NOT need to enter a vancomycin dose
 Specify:
− Initial Indication: Prophylaxis, empiric, definitive
− Suspected or definitive infection type: pneumonia, cellulitis, etc.
− Anticipated duration of therapy (days)
 May discontinue or re-initiate protocol at any time
− If discontinued, provider assumes responsibility for monitoring vancomycin therapy
Confidential – For Discussion Purposes Only
Not finalized. Image above is a sample screenshot, pending further modifications.
Confidential – For Discussion Purposes Only
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Initial Dosing*
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Goal Trough Levels
 Pharmacist to select based on indication:
CrCl (mL/min)
Optional Loading Dose**
Initial Regimen
Indication*
> 90
25-30 mg/kg x1
15-20 mg/kg Q8-12H
51-89
25-30 mg/kg x1
15-20 mg/kg Q12H
30-50
20-30 mg/kg x1
15-20 mg/kg Q12–24H
10-29
20-30 mg/kg x1
10-15 mg/kg Q24-48H
<10, AKI
15-25 mg/kg x1
10-15 mg/kg Q24-72H OR dose by level
IHD
15-20 mg/kg x1
CRRT
15-25 mg/kg x1
CAPD
1000 mg x1
5-15 mg/kg x1, then dose by level
Goal Trough
(mcg/ml)**
10 – 15
15 – 20
*Consult provider or ID pharmacist for infections not listed here.
**Trough levels >10 mcg/ml are recommended to avoid microbial resistance.
(See Section IV.D – Special Populations)
10-15 mg/kg Q24H
(See Section IV.D – Special Populations)
500-1000 mg Q48-72H
*Dose using TBW; Maximum single dose = 2.5 gm
**Loading Dose is recommended in critically ill patients with serious infections (sepsis, pneumonia,
endocarditis, meningitis), CRRT, obese patients
- Purpose: faster attainment of steady state (when targeting trough of 15-20 mcg/ml)
Confidential – For Discussion Purposes Only
Cellulitis, skin/soft tissue infections not penetrating bone
Pneumonia, bacteremia, endocarditis, osteomyelitis, deep seated
infections, mediastinitis, meningitis, sepsis, intra-abdominal infections,
necrotizing fasciitis, febrile neutropenia (empiric therapy; suspected
MRSA or severe infection)
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 What if you request a goal that does not match the protocol?
− If it is close to/within the protocol goal range, pharmacist will document the rationale
and proceed
− If it is significantly different than protocol goal range, pharmacist will request that it not
be managed per protocol
Confidential – For Discussion Purposes Only
Documentation
Questions?
 Pharmacist progress note will not be entered daily
 Protocol links
− Daily documentation will occur in pharmacist EPIC flowsheet
 Pharmacists will only enter notes in the following instances:
− Initiation of protocol (new start)
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− SHC Intranet  Policies  Pharmacy Policies Manual  Section 7: Medication
Monitoring
− http://portal.stanfordmed.org/policies/PharmacyPolicies/Documents/08-medicationmonitoring/Medication_Monitoring_Vancomycin_Per_Protocol.pdf
− http://portal.stanfordmed.org/policies/PharmacyPolicies/Documents/07-medicationadministration/medication_administration_EI_Zosyn_Protocol.pdf
− New trough level results
− Change in dose
− Change in patient’s status that impacts vancomycin dosing
 Contact:
− ID Pharmacists: [email protected]
− Janjri Desai, Pharmacy Manager of Clinical Effectiveness:
[email protected]
 Website:
− http://med.stanford.edu/bugsanddrugs.html
Confidential – For Discussion Purposes Only
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Confidential – For Discussion Purposes Only
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