Expense reduction is a primary concern for any facility. With the ever-changing state of reimbursement conditions, it is not clear from one year to the next what will be reimbursed, how much and for how long. It is up to us as cath lab managers and staff to stay ahead of this constantly changing curve in order to be cost effective and provide the standard of care that all of our patients deserve.
One of the many areas that our facility, Bay Medical Hospital, has addressed in light of this fact is the expense of the glycoprotein (GP) IIb/IIIa inhibitor eptifibatide (Integrilin®, Millenium Pharmaceuticals, Inc., Cambridge, MA). A Six Sigma team comprising of Stephen Melvin, PharmD, Robert Campbell, PharmD, Robbie Pippins, RN (cath lab procedure nurse) and myself was formed to review this issue in January 2006.
What is Six Sigma?
Six Sigma, at many organizations, simply means a measure of quality that strives for near perfection. Six Sigma is a disciplined, data-driven approach and methodology for eliminating defects (driving towards six standard deviations between the mean and the nearest specification limit) in any process from manufacturing to transactional and from product to service. The statistical representation of Six Sigma describes quantitatively how a process is performing. To achieve Six Sigma, a process must not produce more than 3.4 defects per million opportunities. A Six Sigma defect is defined as anything outside of customer specifications.1
The New Process
The team realized that eptifibatide in its current concentration and dosing incurred a 25-30% waste in the bolus. The estimated cost of this waste is approximately $23,000 per year (2005 figures, also dependent upon which drug used and each facility's drug cost). It was decided that the dosing regiment needed to be standardized. A prior bolus dose utilized 2mg/ml (10ml bottles), with the drip utilizing the 0.75mg/ml (100ml bottles). The new agreed-upon dosage standard utilizes the 0.75mg/ml (100 ml bottle) for each bolus and drip. The pharmacy stocks the 100ml bottles in the Acudose-rx® machines (McKesson Corp., San Francisco, CA) located in the cath lab. Eptifibatide is removed from the Acudose machine for each patient and kept in the procedure room, so that the drug is readily available for immediate use. If the drug is not used, it is returned to the Acudose machine and the patient is not charged. The initial bolus and drip is programmed and infused through a programmable IV infusion pump, the Alaris® (Cardinal Health, Dublin, Ohio). The initial bottle typically lasts 2 to 4 hours, depending on the size of the patient. At the conclusion of the procedure, the cath lab staff faxes an order sheet to pharmacy notifying them that a drip has begun. The pharmacy calculates the final volume and sends that amount to the patient's current location. The remainder of the infusion is compounded in pharmacy and is stable for 32 hours. The patient is only charged for the amount of drug that they receive. Patients are charged by the ml, not by bottle. The pharmacy will calculate the total amount of drip (in ml) that the patient will require for an 18- or 24-hour infusion (the objective is to have a standard 18-hour infusion rate) and prepare the bag for the patient. By doing this, waste is minimized. The reduction from 24 hours to 18 hours for the infusion rate could result in additional savings of about $24,000 annually. The pre-filled IV plastic Viaflex bag (Baxter, Deerfield, IL) is sent to each associated area with the total quantity of eptifibatide that will need to be infused. Company-sponsored research (Millennium Pharmaceuticals and Schering-Plough Corporation, Stability of Integrilin in Polyvinyl Chloride [PVC] Bags) shows that the drug is stable for 32 hours in a Viaflex bag.3 The bag is hung after the initial 100ml vial of eptifibatide has been started in the cath lab. Nurses no longer need to demand or hang any additional 100ml bottles of eptifibatide, and there is almost no wastage of the product.
This practice could reduce waste from 30% to virtually 0%, resulting in a potential cost savings anywhere from $30,000 to $50,000, dependent on individual facility costs. Results may vary depending on the class of IIb/IIIa used, cost, and combination of drugs, infusion times, and overall usage. Length of stay has not been tracked at our facility; therefore, we cannot say whether this element is affected. This project is ongoing at Bay Medical Center, and data is being collected to determine long-term cost savings results.
Pharmacological dosing and administration has undergone a myriad of trials or studies stemming back to the days of EPIC, CAPTURE, EPILOG, EPISTENT, IMPACT, ESPRIT, GOLD, RESTORE, ADMIRAL, TACTICS TIMI 18 and TARGET. Research evolved as a result of these trials, looking further at acute coronary syndromes with PRISM, PRISM PLUS, PURSUIT, PARAGON, and GUSTO IV, among others. The listed trials/studies are important to for understanding the importance of IIb/IIIa receptor inhibitors, since these drugs play a major role in the fight against coronary artery disease and research remains ongoing. Our knowledge of the effects of drugs in platelet aggregation, stent endothelization, thrombosis therapy, and dosing combinations with other clinically important drugs such as heparin, low-molecular-weight heparins, bivalirudin, clopidogrel bisulfate and aspirin, is paramount in the clinical treatments of cardiac patients, in particular, acute myocardial infarction (AMI) and ST-elevated myocardial infarction patients.
I would like to thank all of those who were actively involved or contributed in this project. In particular, I would like to thank Stephen Melvin, PharmD who directly contributed to this article and whose expert knowledge, experience and team spirit was significant in the project’s success.
Author Dennis Holloway can be contacted at email@example.com
1. i Six Sigma. Accessed August 14, 2006 at http://www.isixsigma.com
2. Dobesh PP, Kasiar JB. Administration of glycoprotein IIb-IIIA inhibitors in patients with ST-segment elevation myocardial infarction. Accessed August 14, 2006 at http://www.medscape.com/viewarticle/439806
3. Stability of Integrilin in polyvinyl chloride (PVC) bags. Company literature from Millennium Pharmaceuticals and Schering-Plough Corporation.