Outpatient Parenteral Antibiotic Therapy...Outpatient Parenteral Antibiotic Therapy Katie Sheridan,...
Transcript of Outpatient Parenteral Antibiotic Therapy...Outpatient Parenteral Antibiotic Therapy Katie Sheridan,...
Outpatient Parenteral Antibiotic Therapy Katie Sheridan, DOMedical Director, OPAT Program UPMC Presbyterian CampusClinical Associate Professor of Medicine, Department of Medicine Division of Infectious Disease
Objectives› Define OPAT› Discuss OPAT in special populations› Discuss OPAT Program at PUH› OPAT Alternatives
What is OPAT? › Administration of parenteral antibiotics in a non-hospital
setting of at least 2 doses on different days› Established in United States since 1974
› Primary goal is to allow patients to complete safe & efficacious antibiotic courses in their home or an outpatient setting– Also prevents potential exposures to HAIs, reduce inconvenience to
patients, decrease cost of hospitalization
Efficacy of OPAT› First shown efficacious in treatment of chronic
bronchopulmonary infections in children with cystic fibrosis› Shown efficacious for the treatment of various types of
infections including but not limited to cellulitis, osteomyelitis, prosthetic joint infections, endocarditis, pyelonephritis and others
› Also demonstrated efficacious with various antibiotics› Can be administered in various settings including home,
infusion center, physician office, skilled nursing facility
Considerations for patient selection/disposition› Medical/Physical limitations › Insurance› Caregiver› Home environment
Antibiotic considerations› PK/PD › Bioavailability/Tissue penetration› Dosing schedule
Antimicrobial Pharmacodynamics
Antibiotics that can be administered as continuous infusion› Ampicillin*› Ampicillin/sulbactam*› Penicillin› Oxacillin/Nafcillin› Piperacillin-Tazobactam› Cefazolin
Antibiotics administered once daily› Ceftriaxone› Ertapenem› Moxifloxacin› Levofloxacin› Daptomycin› Gentamicin› Amikacin› Fluconazole› Caspofungin› Amphoptericin› Dalbavancin/Oritvancin*
Oral Bioavailability
Hydrophilic vs Lipophilic Agents
Monitoring while on OPAT› Evaluate for response to therapy› Therapeutic drug monitoring› Monitor for antibiotic associated adverse event› Monitor for new HAI› Monitor for vascular device associated complications› Ongoing review for drug-drug interactions› Ensure appropriate completion of antibiotic course
OPAT eHandbook IDSA
OPAT in Special PopulationsPWIDElderly patients
OPAT in PWID › Retrospective review of PWID
discharged from PUH 2013 to 2015
› OPAT Failure defined as ANY of the following:– Worsening or ongoing infection
requiring hospital readmission within 30 days
– Worsening or ongoing infection at office follow-up resulting in extension of therapy
– Premature discontinuation of OPAT
– Patient noncompliance– Death during treatment
› 91% of patients had a single organism with Staph Aureus being the most common
Diagnosis & Antibiotic Utilization
Risk Factors for OPAT Failure
› Of PWID enrolled in OPAT, 61% (41/67) failed OPAT
› Age, discharge location, diagnosis, pathogen isolated, drug choice, adverse event to antibiotic, and non-adherence to ID follow-up were not risks for OPAT failure
› Median time since last IVDU was shorter among patients who failed versus completed OPAT (3 weeks vs 8 weeks; P=0.02)
› By multivariate analysis, time since last IVDU was independently associated with OPAT failure (P=0.04)
Buehrle et al Open Forum Inf Dis 2017
OPAT in PWID at other sites› Review of Literature ~ 10 publications. 6 in US, 2 in Canada, 1 in Australia
and 1 in Singapore› Mainly Bone/joint infections 38%, Endocarditis 21%, SSTI 16%,
Bacteremia 7%› Mainly males with recent injection use within 4 weeks› OPAT completion rates ranged from 72-100% with duration of 18 to 42
days› OPAT non-adherence ranged from 1 to 36%› Mortality rates range from 0-10%› Venous access complications ranged from 2.7 to 9.4%› 1 study reported on drug relapse rate within 12 months: 40% among
“high risk”, 20 %in “medium risk” and no relapse in “low risk”
Suzuki et al Open Forum Inf Dis 2018
OPAT in the Elderly› Retrospective review from 2015 to 2018 of patients discharged from PUH, MUH, or Magee on
OPAT to compare 30 day readmission rates for patients aged >/= 80 or < 80 years of age
› Patients could be discharged to home, SNF/IPR or LTAC though patients > 80 were more likely to be discharged to a facility
› More comorbidities were observed in the >80 cohort
› Staph Aureus was the most common organism with vancomycin being the most commonly used antibiotic
Sheridan et al IDWeek 2019
OPAT in the Elderly at Other Sites
› Yale: patients > 65 did not have increased healthcare utilization compared to patients < 651
› Cleveland Clinic: Similar rates of ER visits, readmissions in > 90 years old & younger matched cohorts2
1 Datta et al IDWeek 2018 2 Blaskewicz et al IDWeek 2018
OPAT at UPMC
Background› OPAT Program at PUH/MUH & Magee began in December
2013› Baseline 30 day readmission rate for patients discharged on an
IV antibiotic was 32% compared to 25% for the general population
› Developed to reduce 30 day readmission rates, number of ER visits and prevent antibiotic associated adverse events
Background: CCID OPAT Program
= Addition of a Hospital. Northwest in 2014, Jameson, Horizon & Shadyside TID added in 2018
OPAT Goals
Evaluate Evaluate patients in the outpatient ID clinic within 7-14 days post discharge and prior to completion of IV course
Ensure Ensure better laboratory monitoring of patients to identify potential issues
Identify Proactively identify potential adverse events related to IV antibiotic use, i.e. a rise in serum creatinine in a patient receiving IV Vancomycin; blood dyscarias in a patient receiving beta lactam therapy
Decrease Decrease 30 day readmission rates for patients managed by ID service at PUH/MUH/MWH from 32% to 18%
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Current Participating HospitalsPATIENTS IDENTIFIED VIA CONSULTATION
› UPMC Montefiore (MUH)
› UPMC Presbyterian (PUH)– Transplant and non-transplant
patients
› Magee Women’s Hospital of UPMC (MWH)
› UPMC Shadyside/Hillman– Transplant patients w/blood cancers
PATIENTS IDENTIFIED VIA TELECONSULT
› UPMC Jameson
› UPMC Northwest
› UPMC Horizon– Shenango Valley– Greenville
Current Staffing› Medical Director› 9 MDs to staff 6 half day clinics per week › 2 APPs to staff 6 half day clinics per week› 1 Pharmacist› 1 Coordinator› 2 Nurses› Patients are evaluated inpatient by UPP Infectious Disease service
and referred to program› Visits can occur at Falk, Telemed Clinics (Northwest, Bedford,
Jameson) or through MyUPMC Telemedicine app
Continued Growth
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UPMC All UPMC Unique Patient All Unique Patients
2019 data through June 2019
Protocol for monitoring› IV Antibiotic discharge note› Outpatient evaluation within 7 days of discharge and prior to
end of therapy› Weekly lab monitoring based on IDSA recommendations› Epic flowsheet for lab monitoring› Collaborative practice agreement› Weekly huddle› Partner with Home health agency & Infusion pharmacy
What’s included in the Antibiotic Discharge Note› Patient name, MRN, discharge floor, Demographics, Height, Weight› Type of Infection› Monitoring MD › Office phone & fax number› Antibiotic name, dose, frequency, route. Antibiotic end date
– IDSA recommended lab auto-populates based on chosen antibiotic
› Follow up testing needed, ie CT scan, MRI, echo, blood cultures› When to follow up in clinic› Routine picc care orders: flushes, tubing etc› Antibiotic line lock orders› Additional fluid orders› Note incorporates into the Clinical Discharge summary
EPIC Documentation› Home IV Therapy episode
– Creates a flowsheet for lab tracking to identify lab trends more timely– Can be routed amongst team members for communication
› OPAT Patients are also tracked on a calendar that can be sorted by end date of antibiotic to aid with huddle review
General Characteristics
Readmission Rates– Overall Readmission rate 18.5% for those with ID Clinic follow-
up; 53.6% readmission rate for those with no follow-up
UPMC HealthPlan Video Visit Pilot› HealthPlan patients discharged from PUH/MUH can be offered
a video visit in place of in-office follow up› Have to have MyUPMC and ideally a smartphone
› Transplant patients excluded› Patients with a heart or lung infection also excluded› Uses vidyo platform through EPIC› Pilot started in mid-July 2019
› Data to come
Alternatives to OPAT
› Conducted at a French 830 bed acute care teaching hospital, average of 30,000 admissions per year
› Observational, retrospective› Patients were managed by ID based on European guidelines and
had to have definitive or possible IE by Duke’s criteria› Protocol for switch from IV to PO› Minimum duration of 7 days of IV prior› Evaluated daily: patient condition, fever resolution, CRP reduction,
negative blood cultures, normal WBC count, normal creat, normalization of imaging
› ALL criteria fulfilled to switch to PO
Patient Demographics
Outcomes› Patients in the PO group had
fewer comorbidities and criteria of severity
› Less likely to be Staph Aureus› Median time to switch was 21
days (0-70)– For Oral streptococci 14 days (7-
42)– Staph aureus 28 days (1-56)– Enterococci 28 days (14-42)– Other 21 days (0-70)
› Median range of follow-up was 5 months (0-147)
› 92 patients died (22%); 11 (3%) had relapse and 12 (3%) had reinfection
› Death occurred in 76 (36%) in IV arm vs 16 (8%) in PO arm
› then adjusted for age > 65, type I diabetes, immunosuppression, removal of PV, and S.aureus -> no increased risk of mortality in the PO group
› Relapse rate: 2 in PO vs 9 in IV› Reinfection rate 4 in PO vs 8 in IV
Oral regimens
› Investigator-initiated, multicenter, randomized, unblinded, noninferiority trial completed at cardiac centers in Denmark
› Adults, 18 or older in stable condition with left sided endocarditis– Native or prosthetic valve, left sided endocarditis
› Primary outcome: all-cause mortality, unplanned cardiac surgery, clinically evident embolic events or relapse of bacteremia with primary pathogen from randomization through six months after antibiotic completed
› July 2011 to August 2017
Patient Demographics
Outcomes
Oral group shifted from IV at a median of 17 daysOral group included 2 different antibiotics from 2 different classes that were both bactericidal
Rates of primary outcome in prespecified groups
Conclusion of the POET Trial & Limitations› In clinically stable patients with left sided endocarditis with
E.faecalis, Streptococcus, CONS or MSSA that have completed nearly half of the IV course for endocarditis may transition to PO regimen consisting of 2 levels
› Only 20% of screened population was randomized› No MRSA› Not clear if this will work in IVDA
› More trials needed
› Enrolled patients with bone or joint infections at 26 UK centers› IV therapy continued for 7 days from surgery date or 7 days total
before transition to PO› Patients randomly assigned to complete six weeks of IV vs PO but
could be followed by ongoing oral antibiotics› Primary end-point was treatment failure one year after
randomization› Median duration of antibiotics was 78 days in the IV course & 71 in
the PO course – IV arm was mainly glycopeptides & cephalosporins whereas PO was
quinolones or combination therapy– Rifampin could be added at any point but patients in the PO arm tended to
receive more rifampin then the IV arm (*though outcomes did not vary)
Baseline Characteristics
Outcomes› More catheter associated complications in the IV course› No difference in incidence of C. difficile› Hospital LOS was 14 days in the IV arm vs 11 in the PO arm
Conclusion› Oral therapy was non-inferior to IV therapy for orthopedic
infections › Half of the patients either did not have evidence of deep
infection or data was missing› Heterogeneous population› Majority had surgery in addition to antibiotic course
Oral therapy Conclusions› May be a viable option in select circumstances› More trials need to be conducted to address PWID population
Conclusions
› OPAT is a well established model of care since the 1970s in the US
but has increased in popularity in the last decade
› OPAT can be used to treat all types of infections
› OPAT is safe & efficacious with various antibiotic classes
› UPMC OPAT program has been in existence since December 2013
› Successful reduction in 30 day readmission rates, especially notable in patients that follow up in ID clinic
› Various options for ID follow
› Oral options may be considered in select scenarios but more trials
still needed