1 All Rights Reserved, Duke Medicine 2007 Welcome to Spring Symposium 2013! • June 10, 2013 from 5:30 p.m. until 9:30p.m. • Duke University Hospital Room 2002 • Eight great topics by nine great speakers • Dinner and Fellowship with Colleagues All Rights Reserved, Duke Medicine 2007 And continuing education credit! Continuing Education Credit This symposium, ACPE # 0046-9999-13-117-L01-P will provide 3.0 contact hour of continuing pharmacy education credit. No partial credit will be given. To Receive CE credit, attendance must be acknowledged at the registration desk upon arrival at and departure of the program. Statements of credit can be viewed and printed from CPE Monitor. Participants will receive an email once credit processing has been completed and credit has been uploaded to the CPE Monitor site. This process can take up to 4 weeks to appear on the CPE Monitor site. The University of North Carolina Eshelman School of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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1
All Rights Reserved, Duke Medicine 2007
Welcome to Spring Symposium 2013!
• June 10, 2013 from 5:30 p.m. until 9:30p.m.
• Duke University Hospital Room 2002
• Eight great topics by nine great speakers
• Dinner and Fellowship with Colleagues
All Rights Reserved, Duke Medicine 2007
And continuing education credit!
Continuing Education Credit
This symposium, ACPE # 0046-9999-13-117-L01-P will provide 3.0 contact hour of continuing
pharmacy education credit. No partial credit will be given. To Receive CE credit, attendance
must be acknowledged at the registration desk upon arrival at and departure of the program.
Statements of credit can be viewed and printed from CPE Monitor. Participants will receive an
email once credit processing has been completed and credit has been uploaded to the CPE
Monitor site. This process can take up to 4 weeks to appear on the CPE Monitor site.
The University of North Carolina Eshelman School of Pharmacy is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
2
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Meredith T. Moorman, PharmD, BCOP
Hematology/Oncology Clinical Pharmacist
Duke University Hospital Spring Symposium
June 10, 2013
New Therapies for Chronic
Myelogenous Leukemia (CML)
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Disclosures
• The author of this presentation has nothing to
disclose concerning possible financial or personal
relationships with commercial entities that may have
a direct or indirect interest in the subject matter of this
presentation
All Rights Reserved, Duke Medicine 2007
Objectives
At the conclusion of this knowledge-based presentation,
the participant should be able to:
1. Name three new agents approved for the treatment
of CML
2. Identify how these agents differ from previously
approved therapies for CML
3. Compare and contrast side effect profiles of
bosutinib, ponatinib, and omacetaxine
3
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CML Incidence and Mortality
Sellers WR. Cell 2011;147(1):26-31.
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The Philadelphia Chromosome
http://www.mayoclinic.com/health/medical/IM03579
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Phases of CML Phase of
Disease
Criteria
Chronic
(CP)
•BCR-ABL positive
•Not classified as accelerated or blast phase
Accelerated
(AP)
•Presence of any of the following:
•Persistent or rising leukocytosis >10 x109/L and/or persistent or increasing
splenomegaly unresponsive to therapy
•Persistent thrombocytosis (>1000 x109/L) uncontrolled by therapy
•Persistent thrombocytopenia (<100 x109/L) unrelated to therapy
•Clonal cytogenetic evolution from diagnostic karyotype
•≥20% basophils in peripheral blood
•10-19% myeloblasts in the blood or bone marrow
Blast (BP) •≥20% blasts in peripheral blood or of bone marrow nucleated cells
•Extramedullary blast proliferation
(Blast lineage is myeloid in 70% of cases, lymphoid in 20%, and may be mixed
phenotype)
Swerdlow SH et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (4th edition). IARC Press: Lyon 2008.
Radium-223 Perez et al. Principles and Practice of Radiation Oncology. 5th ed.
Lippincott Williams & Wilkins;2007:103.
Cheetham PJ, et al. Oncology (Williston Park) 2012;26:330-337,341.
• Calcium mimetic natural bone-
targeting agent
• Preferential uptake in areas of
new bone formation
• Incorporated into bony matrix
• Excreted into small intestine
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Radium-223 (Xofigo)
ALSYMPCA: Phase 3 Randomized Trial
71
Parker C, et al. European Multidisciplinary Cancer Congress. 2011; Abstract no. 1LBA
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Month 0 3 6 9 12 15 18 21 24 27
Radium- 223 541 450 330 213 120 72 30 15 3 0
Placebo 268 218 147 89 49 28 15 7 3 0
ALSYMPCA: Overall Survival
0
10
20
30
40
50
60
70
80
90
100
%
Radium-223, n = 541
Median OS: 14.014.9 months
Placebo, n = 268
Median OS: 11.211.3 months
HR 0.695; 95% CI, 0.581-0.832
P = 0.00007
Adverse events: slightly worse with placebo Parker C, et al. ASCO 2012. Abstract LBA4512.
25
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ALSYMPCA: Updated Analysis
Adverse Events of Interest
Parker C, et al. ASCO 2012. Abstract LBA4512.
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Summary
• Compelling survival with abiraterone and enzalutamide in patients with heavily pretreated CRPC has reinforced the value of inhibiting the androgen receptor axis
• Need to further define the optimal application and timing of prostate cancer therapies
• Monotherapy vs. combination therapy and clinical efficacy?
• Financial implications of new agents
• New targeted therapies will need to be developed in conjunction with biomarkers that predict response (i.e., Her-2 trastuzumab in breast cancer)
74
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Self-Assessment Question
• Which of the following agent(s) is/are approved for
the treatment of metastatic castration resistant
prostate cancer (mCRPC) pre-chemotherapy?
A. Ketoconazole
B. Enzalutamide (Xtandi)
C. Abiraterone (Zytiga)
D. Radium-223 (Xofigo)
E. B and C
F. All of the above
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Implementation of Transitions of Care at
the Duke Outpatient Clinic June 10, 2013
Ben Smith PharmD, BCACP
Holly Causey PharmD, BCACP, CPP, CDE
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The authors of this presentation have the following to
disclose concerning financial or personal relationships
with commercial entities that may have a direct or
indirect interest in the subject matter of this
presentation:
Ben Smith: nothing to disclose
Holly Causey: nothing to disclose
Disclosures
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Objectives
Upon completion of this knowledge based program, the
• Target: Duke Outpatient Clinic patients with Medicaid
and Aging/Blind/Disabled
• Implementation: late October 2012
• Documentation: CMIS, Maestro Care
• Involvement:
– CCNC
– DOC clinical pharmacists
– PCP
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Phase 1 Process
Daily list of Medicaid ABD
patients hospitalized
and seen in ED
Contacted patient via phone for
comprehensive medication
review
Communicated with CCNC
care manager
PCP visit within 7-14 days
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Phase 2
• Target: all Duke Outpatient Clinic patients
• Incorporation of Medicare transitional billing codes
• Implementation: February 2013
• Documentation: CMIS if applicable, Maestro Care,
PCP sent reminder email
• Involvement: interdisciplinary
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Phase 2 Process
Hospital D/C list sent daily to front
desk staff
Phone call w/in 48 hours of discharge
PharmD call patient for medication review and follow up of other issues
Provider sees patient within
7-14 days post
discharge
Telephone note routed to Holly/Ben in Maestro Care
Telephone note routed to provider in Maestro Care
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Front Desk Follow-Up Call
• Follow-up visit scheduled or patient reminded of
appointment time/date
• Medication access addressed
• Transportation availability addressed
• Telephone note CC’d to Holly/Ben in Maestro Care
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Front Desk Follow-Up Call
• Contacted patient to remind and/or schedule patient for Duke
Outpatient Clinic hospital follow-up visit with physician. Patient
or caregiver asked to bring all medications, blood glucose
log/meter, and blood pressure log (as applicable).
• Patient or caregiver voiced understanding of appointment
date/time and informed that clinical pharmacist may contact
patient to discuss medications prior to visit.
Follow Up Appointment
1. The patient does have an appointment for follow up at Duke
Outpatient Clinic.
2. The patient believes that she can attend this appointment and
has transportation.
3. The patient verbalized that she was able to pick-up
medications prescribed at hospital discharge.
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PharmD Follow-Up Call Assessment
• New medications and knowledge of medications
• Knowledge of reason for hospitalization
• Knowledge of current self-care needs
• Documentation of educational needs
• Home health utilization
• Ability of patient to attend scheduled appointment
• Request medications and/or medication list brought to
follow-up visit
• At the conclusion of our call, the telephone note was CC’d
to patient’s PCP along with an email reminder
33
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Coordination of Care
• Avoid PharmD calls to patients targeted by other
services
– Community Care of NC
– Heart Failure follow-up team
– Stroke follow-up team
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Interdisciplinary Effort
• Patient Service Associates (PSA)
• Licensed Clinical Social Worker (LCSW)
• MD
• PharmD
• RN
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Hospital Follow-Up Visit
• RN assessment included in visit
• PCP Hospital Follow-Up Template Addresses:
– Medications
– Consultations/diagnostic tests
– Patient empowerment/education
– Home status/level of function
– Communication with providers/pharmacy
34
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Metrics – Discharge Phone Calls
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Metrics –Follow Up Scheduling
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Areas for Improvement
• Telephone documentation by PSA to include:
– Patient has an alternate PCP
– If appointment was scheduled
– If patient to reschedule later
• Scheduling patients in < 14 days of discharge if
appointment set > 14 days
– If patient refuses, this should be documented
in the initial telephone note
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Future of DOC Transitions
• Progress towards creating a transitions of care model
for all Duke ambulatory clinics
• Evaluate potential reduction of 30-day readmissions
• Evaluate increased primary care revenue capture
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Acknowledgements
• Community Care of North Carolina
• DOC Discharge Clinic Committee
• DOC staff
• Matthew Ransom PharmD, BCACP
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Self Assessment Question 1
• Question
– What are two tasks that health system
pharmacists can complete to facilitate care
transitions?
36
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Health Literacy SAY WHAT?!?
Evan Frasure, PharmD
Continuity of Care Coordinator
Department of Pharmacy
Duke University Hospital
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Disclosures
• The author of this presentation has nothing to
disclose concerning possible financial or personal
relationships with commercial entities that may have
a direct or indirect interest in the subject matter of this
presentation
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Objectives
• Define health literacy and its prevalence in the U.S.
population
• Describe the impact of health literacy on pharmacy
practice
• Identify strategies for counseling patients with low
health literacy, including the use of “universal
precautions’
37
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“The single biggest problem in
communication is the illusion
that it has taken place”
-George Bernard Shaw
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“It is not just, nor fair, to expect a
patient to make appropriate health
decisions and safely manage
his/her care without first
understanding the information
needed to do so.”
Reducing the Risk by Designing a Safer, Shame-Free
Health Care Environment. AMA, 2007
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What is Health Literacy Anyway?
“The ability to obtain, process,
and understand health
information to make informed
decisions about health care.”
AHRQ Health Literacy Universal
Precautions Toolkit
38
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How Common is it?
• 36% of the U.S. adult population has limited health
literacy
• Only 12% achieve the proficient level
• Varies by race, age, ethnicity, education, and
socioeconomics
• Low health literacy may be present regardless of the
above demographics
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National Center for Education
Statistics
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National Center for
Education Statistics
39
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National Center for
Education Statistics
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Low Health Literacy is associated with . . .
• Less knowledge about disease
• More healthcare utilization/cost
– Hospital admissions
– ED visits
• Decreased medication adherence
• Poorer health status in the elderly
• Increased mortality rate in the elderly
Berkman et al, Anal Intern Med.
2011;155:97-107
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PHARMACY SPECIFIC
IMPLICATIONS
40
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Take 1 pill by mouth once
daily.
Health literacy level
Adequate – 84%
Marginal – 78%
Low – 74%
Davis TC et al. JGIM 2008;24
(1):57-62.
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Take 1 pill by mouth every 12 hours
Health literacy level
Adequate – 61%
Marginal – 51%
Low – 30%
Davis TC et al. JGIM 2008;24
(1):57-62.
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Take two tablets by mouth twice daily
Health literacy level
Adequate – 71%
Marginal – 57%
Low – 33%
Davis TC et al. JGIM 2008;24
(1):57-62.
41
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Davis et al 2006. Adapted from
Table 3.
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WHAT CAN I DO ABOUT IT?
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Health Literacy Universal
Precautions Toolkit AHRQ
Pub. No. 10-0046-EF
42
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Universal precautions
• You cannot tell by looking
• Higher literacy skills does not equal understanding
• Health literacy is not a state but rather a trait
• Everyone benefits from clear communication
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Tool #3 - Raise awareness
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Tool #5 - Teach-Back method
• A way to confirm understanding
• NOT A TEST
• Helps create dialogue between the patient and
provider
• Once part of a routine, it does not take longer to
perform
43
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How do I get started?
• Start slowly
• Plan your approach
• Clarify
– As often as necessary
– Patient’s own words
• Practice, practice, practice
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EXAMPLES OF TEACH-BACK
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“Do you understand everything I told you today
about your diabetes?”
“We covered a lot today about your diabetes,
and I want to make sure that I explained things
clearly. So let’s review what I have discussed.
What are 3 things you can do that will help you
control your diabetes?”
44
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“To be sure you understand what I just said,
please tell me how you will take this new
medication.”
“I want to be sure I explained your new
medication correctly. Will you tell me how you
are going to use this medication?”
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Summary
• Health literacy is a major concern in today’s
healthcare environment
• Health literacy can greatly impact the proper use of
medications
• Using universal precautions including the teach-back
method can have significant impact
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Self-assessment question
What factor(s) determine a patient’s
health literacy?
a) Formal education
b) Ethnicity
c) Age
d) None of the above
e) All of the above
45
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BREAK TIME!
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Incidence of Vancomycin-Induced
Nephrotoxicity in Patients with and without
Concomitant Piperacillin-Tazobactam
Lindsey D. Burgess, PharmD
PGY1 Pharmacy Resident
Duke University Hospital
Durham, NC Co-investigator:
Richard H. Drew, PharmD, MS, BCPS, FCCP
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Disclosure Statement
These individuals have the following to disclose concerning possible financial or personal relationships with commercial entities (or their competitors) that may be referenced in this presentation:
– Resident: Lindsey D. Burgess, PharmD: Nothing to disclose
– Co-Investigator: Richard H. Drew, PharmD, MS, BCPS, FCCP: Nothing to disclose
46
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Objective
• Describe the relative incidence of nephrotoxicity
between vancomycin monotherapy and in
combination with piperacillin-tazobactam, and state
possible confounding factors
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Background
• Acute kidney injury (AKI) is a complication of many
illnesses and pharmaceutical agents
• Development of AKI in hospitalized patients increases
morbidity and mortality
• Drug-induced mechanisms
– Hypoperfusion
• Angiotensin converting enzyme inhibitors or nonsteroidal anti-
inflammatory drugs
– Renal tubular necrosis
• Aminoglycoside antibiotics
– Interstitial nephritis
• Penicillin antibiotics
Pannu, N et al. Crit Care Med. 2008;36:S216-23.
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Vancomycin
• Glycopeptide antibiotic used for the treatment of drug-
• Admitted to Duke University Hospital 7/1/09-7/1/12
• Minimum of 48 hours of vancomycin
• Minimum four days of measured serum creatinine concentrations
• For the cohort of patients on concomitant PT: >48 hours of PT concurrently with vancomycin and PT initiated within 48 hrs of initiation of vancomycin
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Population
• Serum creatinine >1.5 mg/dL or calculated creatinine
clearance <30 ml/min (based on Cockcroft-Gault
equation)
• Previous history of renal replacement therapy
• 1.5-fold increase in serum creatinine from that
measured at the time of hospital admission and
before the initiation of vancomycin
• Incomplete medical records
Exclusion Criteria
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Methods
• Subjects and data obtained from electronic records
from the Duke Enterprise Data Unified Content
Explorer (DEDUCE)
• Patients in each group were selected through random
number generation
• Data collection:
• Demographics
• Medication orders for vancomycin and PT
• Concomitant nephrotoxins
• Vancomycin trough concentrations
• ICD-9 codes for conditions to calculate Charlson score
• Serum creatinine concentrations
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Data Analysis
• Sample size
– 180 patients (90 in each group) for 80% power to detect the
minimal increase of 15%, assuming incidence of
nephrotoxicity in patients receiving vancomycin is 10%
• Statistical analysis
– Primary: chi-squared test with a one-sided p-value and
corresponding one-sided 95% confidence interval
– Secondary: univariate analysis to assess the effect of various
risk factors on the incidence of nephrotoxicity
– Multivariate logistic regression models were fitted to assess
the association of nephrotoxicity with the addition of PT
50
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Population
Vancomycin
198 patients screened
99 patients included*
Vancomycin + PT
176 patients screened
1 duplicate encounter excluded
92 patients included* •Selected by
•random assignment
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Results
Patient Demographics by Treatment Group
Description
Vancomycin
Monotherapy
n=99
Combination
Group
n=92 P=value
Male (%) / Female (%) 48 (47.1%) / 51
(57.3%)
54 (52.9%) / 38
(42.7%) 0.158
Age, yrs
Mean (SD)
Median (IQR)
56.3 (+15.9)
56.7 (46-68.8)
60.7 (+15.1)
62.0 (49-70.4)
0.054
Charlson Comorbidity Index
Median (IQR)
3 (2 – 5)
4 (2 – 5)
0.050
Concomitant nephrotoxins, n (%) 71 (77.8%) 74 (74.7%) 0.695
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Results
Characterization of Infection Site by Treatment Group
Infection Site(s)
Vancomycin
Monotherapy (%)
n=99
Combination
Group (%)
n=92 P=value
Bone and Joint
CNS
Respiratory
Urinary Tract
Blood
Intra-abdominal
Other
15 (17.1)
7 (8.0)
25 (28.4)
13 (14.8)
15 (17.1)
4 (4.6)
9 (10.2)
15 (14.0)
3 (2.8)
33 (30.8)
25 (23.4)
8 (7.5)
14 (13.1)
9 (8.4)
0.053
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Results
Diagnosis of Sepsis by Treatment Group
Sepsis Diagnosis
Vancomycin
Monotherapy
n=99
Combination
Group
n=92 P=value
None
Sepsis
Severe sepsis
Septic Shock
86.9
10.1
2.0
1.0
72.8
16.3
4.4
6.5
0.067
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Results: Primary Endpoint
Wald Χ2=3.04, one-sided p-value = 0.041
Nephrotoxicity by Treatment Group
Endpoint
Vancomycin
Monotherapy
(n=99)
Combination
Group
(n=92)
Nephrotoxic 8 (8.08%) 15 (16.3%)
Non-nephrotoxic 91 (91.92%) 77 (83.7%)
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Results: Secondary Endpoints
By univariate analysis
*All patients had vancomycin total daily dose ≤ 4gm/day
Risk of Nephrotoxicity in select subgroups
Description
Crude (Unadjusted)
Odds Ratio
95% CI
Age 0.98 0.95-1.01
Concomitant nephrotoxic agents 1.16 0.41-3.33
Vancomycin total dose ≥
4gm/day*
- -
Vancomycin trough ≥ 15 mcg/mL 3.67 1.07-3.02
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Multivariate Analysis
*Based on one-sided analysis of the hypothesis
Risk of Nephrotoxicity
Description
Adjusted
Odds Ratio
p-value*
Addition of PT 2.48 0.032
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Limitations
• Single center, retrospective cohort study
– Incomplete medical records
– Reliability of ICD-9 codes for Charlson score
• Lower incidence of nephrotoxicity than
postulated
– Vancomycin monotherapy: 8.08%
– Combination group: 16.30%
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Conclusions
• Significant increase in nephrotoxicity was observed in the
than Caucasians at days 60 and 90 following transplant
• Renal function improved in both groups throughout the
study period
• Overall incidences of rejection and concentration-related
side effects were low
60
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Acknowledgements
• DUH Pharmacy Research Committee
• Statistical Support
– Lan Lan, PhD
– John Pura, MPH
• Residency Program Director
– Beth McLendon-Arvik, PharmD
• Fellow Residents
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Self-Assessment Question
• What was the difference in dose needed to achieve
therapeutic tacrolimus concentrations in African-
American versus Caucasian patients in this cohort?
A) 0.03 mg/kg/day
B) 1 mg/kg/day
C) 0.1 mg/kg/day
D) There was no difference in total daily tacrolimus
doses between races
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Association between Oversedation from Continuous
Intravenous Sedation and Extubation Failures in
Mechanically-Ventilated Patients in the Pediatric
Intensive Care Unit
Jennifer M. Cole, PharmD
PGY1 Pharmacy Resident
Duke University Hospital
Durham, NC
Co-investigators: Travis Heath, PharmD, BCPS
David Turner, MD
61
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Disclosure Statement
These individuals have the following to disclose concerning possible financial or personal relationships with commercial entities (or their competitors) that may be referenced in this presentation:
• Jennifer Cole, PharmD: Nothing to Disclose
• Travis Heath, PharmD: Nothing to Disclose
• David Turner, MD: Nothing to Disclose
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Objective
• Describe the relationship between oversedation and
extubation failure in critically-ill pediatric patients, and
state associated risk factors
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Analgesia and Sedation in the Intensive Care Unit
Am J Health Syst Pharm. 2002 Jan 15;59(2):150-78.
New Horiz 1994;2(1):.64–74.
Am J Respir Crit Care Med 1999 Jun;159(6):1742-6.
• Provides anxiolysis and amnesia
• Improves tolerance to
mechanical ventilation
• Reduces stress response
• Prolongation of mechanical
ventilation
• ↑ rates of extubation failure
• ↑ risk for the development of
ventilator-associated pneumonia
• ↑ intensive care unit and hospital
length of stay
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State Behavioral Scale (SBS) Scores
• Most common, reliable tool used to assess level of
sedation in mechanically-ventilated pediatric patients
• Scoring system includes assessment of the following:
• Respiratory effort
• Coughing
• Response to external stimulus
• Attention to caregiver
• Ability to console
• Movement Pediatr Crit Care Med 2006 Mar;7(2):107-14.
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Score Description
-3 Unresponsive
-2 Responsive to noxious stimuli
-1 Responsive to gentle touch or voice
0 Awake and able to calm
+1 Restless and difficult to calm
+2 Agitated
State Behavioral Scale (SBS) Scores
Pediatr Crit Care Med 2006 March ; 7(2): 107–114.
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Extubation Failure
• Defined as the need for reintubation within 48-72
hours after extubation
• Pediatric Intensive Care Units (PICU) rates range from
2.7% to 22%
• Risk factors in adults include:
• Upper airway obstruction
• Pulmonary insufficiency
• Cardiac dysfunction
• Neurological impairment
• Poor muscle strength
• Excessive sedation Pediatr Crit Care Med 2005 May;6(3):312-8.
63
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Purpose
• Evaluate current sedation practices and their impact
on extubation failure in critically-ill pediatric patients
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Objectives
• Primary Objective
• Determine whether an association exists between
oversedation from continuous intravenous sedation
and extubation failures in mechanically-ventilated
patients in the PICU
• Secondary Objective
• Identify risk factors associated with oversedation and
with extubation failure
• Age, gender, weight, average daily doses, glasgow coma scale
(GCS) prior to intubation, duration of mechanical ventilation,
duration of continuous infusion, extubation readiness test
failures
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Study Design
• Retrospective, single-center, cohort study
• Large academic medical center
• IRB approved
• Subjects identified utilizing Duke Enterprise Data
Unified Content Explorer (DEDUCE)
• On-line research tool providing Duke investigators with
access to clinical information collected during patient care