1. 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. DISCUSSION 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. CONCLUSIONS This 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®) 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. Nesiritide Costs Mean doses per patient3.75 + 4.17 Mean cost per patient$1587 + $1768 Total number of infusions prepared510 Total drug cost$215,944 Number wasted doses94 Lost product$39,801 Wesley Medical Center P&T Committee Goals: Threshold vs Actual REFERENCES Results  Prescribing services: Nephrology (46%) Cardiology (28%) CV Surgery (18%)  Initiated During CABG: 15% of patients  Documented indication in chart: CHF35% None25% 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.Panel of Cardiology Experts Provides Recommendations to Scios Regarding NATRECOR® http://www.sciosinc.com/scios/pr_1118721302. Accessed April 5 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. http://www.sciosinc.com/scios/pr_1136317444. Accessed April 5 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. CriteriaThresholdActual Justification for Use: 1. Acute Decompensated Heart Failure100%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 therapy100%72% 3. Use of pre-printed order100%77% B. Dosed within package insert parameters100%48% (bolus); 87% (drip) C. Absence of contraindications to therapy100% 79% D. Length of therapy < 48 hours78%51% E. BNP levels obtained while patient on nesiritide0%30% Complications 1. SBP < 90 mmHg on therapy11% 51% 2. Renal dysfunction (increase in SCr > 25% or > 0.5 mg/dL)15%31% 3. Death1.5%21% Outcome Measures 1. Length of stay5.4 days15.8 days 2. ICU length of stay2.5 days11.7 days 3. Readmission for any within 30 days20%21% 4. Readmission for heart failure within 30 days7%6%