Transcript Document

Drug Usage Evaluation: Nesiritide (Natrecor®)
Karen Blackburn, Master of Physician Assistant Student; Joe Slechta, PharmD; LaDonna Hale, PharmD
Wichita State University, Dept of Physician Assistant & Wesley Medical Center, Wichita, KS
ABSTRACT
Purpose: Almost one million hospital admissions are attributed to congestive heart
failure (CHF), as well as nearly two million secondary diagnoses. Direct and indirect
heart failure treatment in the United States topped $24.3 billion in 2003. Nesiritide, a
human B-type natriuretic peptide, is the first new agent for treatment of acute heart
failure on the market in over 10 years; it was approved by the FDA in 2001. It carries
with it, though, strict monitoring parameters and a high cost. Based on the prevalence of
CHF and the high cost of treatment, it is critical that hospitals and health-care providers
are able to effectively treat their patients in the most cost-effective way. This drug usage
evaluation (DUE) will answer two questions: Does nesiritide administration match the
defined protocol at this facility? What are the outcomes of patients who are treated with
nesiritide?
Methods: The study is a retrospective, non-interventional design. It was conducted at
Wesley Medical Center in Wichita, Kansas, a 760-bed tertiary care facility and teaching
hospital. All patients who received nesiritide over a one-year time period were included
in the study. Necessary data was collected from the hospital’s integrated computer
documentation records and actual patient charts.
Summary of Results: Fifteen percent of nesiritide usage was during coronary artery
bypass graft surgery and not for the approved usage in acute heart failure. Nephrology
was the primary provider (46%). Systolic blood pressure dropped below 90 mmHg in
51% of patients, and 21% of patients had contraindications prior to admission. Average
length of total hospital stay was 15.8 days and 11.7 days in an intensive care unit.
Mortality rate was found to be 21%.
Conclusions: Nesiritide usage is not meeting the outlined criteria by the P&T
Committee at Wesley Medical Center.
PURPOSE
By review of patient charts and records, two questions will be answered:
▪ Does nesiritide administration match the defined protocol at this facility? The
defined protocol includes proper patient selection and required monitoring
parameters.
▪ What are the outcomes of patients who are treated with Nesiritide? Outcomes
will be described as length of hospital stay and mortality.
METHODS
Setting: Wesley Medical Center (Wichita, Kansas), a 760-bed tertiary care facility and
teaching hospital with a 45-bed ICU and a 20-bed CCU.
Study Population: All patients receiving nesiritide from March 2004 to February 2005
with 115 cases evaluated.
Study Design: Retrospective, non-interventional drug usage evaluation.
IRB Approval: Approved by WSU IRB and Wesley Medical Center IRB.
Wesley Medical Center P&T Committee Goals: Threshold vs Actual
Criteria
Justification for Use:
1. Acute Decompensated Heart Failure
Critical Indicators:
A. Criteria for use met and documented
1. Acute Decompensated Heart Failure (NYHA Class III-IV)
2. BNP level > 400 pg/mL prior to therapy
3. Use of pre-printed order
B. Dosed within package insert parameters
C. Absence of contraindications to therapy
D. Length of therapy < 48 hours
E. BNP levels obtained while patient on nesiritide
Complications
1. SBP < 90 mmHg on therapy
2. Renal dysfunction (increase in SCr > 25% or > 0.5 mg/dL)
3. Death
Outcome Measures
1. Length of stay
2. ICU length of stay
3. Readmission for any within 30 days
4. Readmission for heart failure within 30 days
Threshold
Actual
100%
35%
Initiated During CABG:
• The FDA approved use of nesiritide is to treat ADHF. Only 35% of patients
treated with nesiritide had CHF documented in the patient chart.
• Nephrology was the primary prescriber at this facility. There is ongoing
debate regarding nesiritide’s effects on renal function. Physicians use the
100%
100%
100%
100%
100%
78%
0%
35%
72%
77%
48% (bolus); 87% (drip)
79%
51%
30%
drug because of perceived renal benefit and improved diuresis, but there is
limited data to support this belief. Some studies have shown nesiritide to be
associated with a dose-dependent increase in serum creatinine.
• Further investigation is required to determine whether nesiritide actually
improves or stabilizes renal function in patients with ADHF and worsening
serum creatinine.
• Wesley Medical Center utilizes pre-printed nesiritide orders. Only 77% of
11%
15%
1.5%
51%
31%
21%
patients had these orders on the chart; only 56% of the pre-printed orders
were fully completed.
• Results show an increase in length of stay and mortality rate for these
5.4 days
2.5 days
20%
7%
15.8 days
11.7 days
21%
6%
patients. Inappropriate use of the drug may account for these elevations.
CONCLUSIONS
Results
Prescribing services:
DISCUSSION
Nephrology (46%)
This was a large, extensive DUE that will provide valuable information to
Cardiology (28%)
the hospital’s Pharmacy and Therapeutics Committee. It demonstrates that
CV Surgery (18%)
nesiritide is not being used in full accordance with the outlined standards set
15% of patients
by the committee, and a change in policy may be warranted. The committee
will now need to discuss mechanisms to increase compliance with use of the
Documented indication in chart:
CHF
35%
preprinted protocol-based orders, appropriate dosing, monitoring parameters,
None
25%
and appropriate indication for use. This may include such mechanisms as
Renal Failure, Azotemia, etc. 22%
physician education, pharmacy intervention for patients falling outside the
appropriate use protocol, or restricting the medication to use by certain
Nesiritide Costs
Mean doses per patient
3.75 + 4.17
physicians or physician groups. To reduce hospital costs, the pharmacy
department will need to discuss production processes that will reduce the
amount of wastage.
Mean cost per patient
$1587 + $1768
Total number of infusions prepared
510
Total drug cost
Number wasted doses
Lost product
$215,944
94
$39,801
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