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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 2 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 3 Confidential – For Discussion Purposes Only 4 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 6 1 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 7 Initial Dosing* 8 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) 9 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) 10 − 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 11 Confidential – For Discussion Purposes Only 12 2