METHODSMETHODSSetting: 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.

DISCUSSIONDISCUSSION• 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

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

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

patients. Inappropriate use of the drug may account for these elevations.

CONCLUSIONSCONCLUSIONSThis was a large, extensive DUE that will provide valuable information to

the hospital’s Pharmacy and Therapeutics Committee. It demonstrates that

nesiritide is not being used in full accordance with the outlined standards set

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

preprinted protocol-based orders, appropriate dosing, monitoring parameters,

and appropriate indication for use. This may include such mechanisms as

physician education, pharmacy intervention for patients falling outside the

appropriate use protocol, or restricting the medication to use by certain

physicians or physician groups. To reduce hospital costs, the pharmacy

department will need to discuss production processes that will reduce the

amount of wastage.

•ACC/AHA guidelines for the evaluation and management of chronic heart failure in the adult. Circulation.2001;104:2996-3007.•DiDomenico RJ, et al. Ann Pharmacotherapy. 2004;38:649-660.•Fonarow, GC. Rev Cardiovasc Med. 2001;2(Suppl 2):S32-S35.•Fonarow, GC. Rev Cardiovasc Med. 2002;3(Suppl 4):S18-S27. •McBride BF, et al. Pharmacotherapy. 2003;23:997-1020. •Natrecor® (nesiritide) [package insert]. Fremont, CA. Scios Inc; Oct 2003.•Natrecor® (nesiritide) [medical information]. Scios Inc; Nov 2004.•Peacock WF. Am J Health Syst Pharm. 2003;60(Suppl 4):S21-S26.•Publication Committee for the VMAC Investigators. JAMA. 2002;287:1531-1540.

Drug Usage Evaluation: Nesiritide (Natrecor®)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

ABSTRACTABSTRACTPurpose: 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.

PURPOSEPURPOSEBy 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.

Nesiritide Costs Nesiritide Costs Mean doses per patient 3.75 + 4.17

Mean cost per patient $1587 + $1768

Total number of infusions prepared 510

Total drug cost $215,944

Number wasted doses 94

Lost product $39,801

Wesley Medical Center P&T Committee Goals: Threshold vs ActualWesley Medical Center P&T Committee Goals: Threshold vs Actual

REFERENCESREFERENCES

ResultsResultsPrescribing services: Nephrology (46%)

Cardiology (28%)

CV Surgery (18%)

Initiated During CABG: 15% of patients

Documented indication in chart:

CHF 35%

None 25%

Renal Failure, Azotemia, etc. 22%

•Sackner-Bernstein JD, et al. Circulation. 2005;111:1487-1491.•Scios Inc. Panel of Cardiology Experts Provides Recommendations to Scios Regarding NATRECOR®. July 13, 2005. Available at: http://www.sciosinc.com/scios/pr_1118721302. Accessed April 5, 2006.•Scios Inc. SCIOS Submits Interim Report to FDA on Natrecor® (nesiritide) PROACTION Trial. January 3, 2006. Available at: http://www.sciosinc.com/scios/pr_1136317444. Accessed April 5, 2006.•Teerlink JR, et al. Circulation. 2005;111:1459-1461.•Topol EJ. N Engl J Med. 2005;353:1525-1527.•Wang DJ, et al. Circulation. 2004;110:1620-1625.

Criteria Threshold Actual

Justification for Use:    

1. Acute Decompensated Heart Failure 100% 35% 

Critical Indicators:    

A. Criteria for use met and documented    

1. Acute Decompensated Heart Failure (NYHA Class III-IV) 100%  35%

2. BNP level > 400 pg/mL prior to therapy 100% 72%

3. Use of pre-printed order 100% 77% 

B. Dosed within package insert parameters 100% 48% (bolus); 87% (drip)

C. Absence of contraindications to therapy 100%  79%

D. Length of therapy < 48 hours 78% 51%

E. BNP levels obtained while patient on nesiritide 0% 30%

Complications    

1. SBP < 90 mmHg on therapy 11%  51%

2. Renal dysfunction (increase in SCr > 25% or > 0.5 mg/dL) 15% 31%

3. Death 1.5% 21%

Outcome Measures    

1. Length of stay 5.4 days 15.8 days

2. ICU length of stay 2.5 days 11.7 days

3. Readmission for any within 30 days 20% 21%

4. Readmission for heart failure within 30 days 7% 6%